Chapter 3 - Health Information Management

Part 3 - Professional Services

3-3.1  INTRODUCTION

1. Purpose.  The purpose of the Health Information Management (HIM) chapter is to establish policy, objectives, staff responsibilities, operating relationships, and standards relating to health record services in the Indian Health Service (IHS).
2. Background.  This chapter integrates current HIM practices with the regulatory requirements of the Health Insurance Portability and Accountability Act (HIPAA), implements an IHS electronic health record (EHR) system, and complies with the Centers for Medicare and Medicaid Services (CMS) regulations and other laws.  The chapter also formally adopts the name change from Medical Records to HIM.
3. Policy.  It is IHS policy that all health information professionals, health care providers, managers, and staff who are responsible for the creation, maintenance and disposition of health records will maintain and preserve the confidentiality of the patient's health record.
4. Authorities.
   1. Privacy Act of 1974, as amended, 5 United States Code (U.S.C.) § 552a
   2. General Administrative Requirements, 45 Code of Federal Regulations (CFR) Part 160.
   3. Health Insurance Portability and Accountability Act, Privacy and Security Rule, 45 CFR Part 164
   4. Confidentiality of Alcohol and Drug Abuse Patient Records Regulations, 42 CFR Part 2
   5. Freedom of Information Act (FOIA), 45 CFR Part 5
   6. Indian Health Service Records Disposition Schedule
   7. Federal Information Security Management Act
   8. Office of Management and Budget (OMB) Circulars A-123 and A-130
   9. Indian Health Service Rules of Behavior for appropriate use of information systems and technology resources
   10. Entry for negotiation of release or settlement, 42 CFR 35.13
   11. Accrediting or certifying organizations such as the Joint Commission and CMS.
5. Goal.  To support the IHS mission to raise the health status of American Indians and Alaska Natives (AI/AN) by maintaining a progressive HIM system that encompasses all aspects of a comprehensive health program.
6. Objectives.  The IHS will:
   1. Maintain a readily available, complete, and accurate health record on all individuals evaluated and/or treated in an IHS facility or by IHS staff in a community health setting.
   2. Ensure to the maximum extent possible that patients rights to privacy are protected by all who use the health record or are aware of its contents in the course of supporting patient care activities or providing patient care.
   3. Facilitate the exchange of health information among health care providers within IHS facilities, contract facilities, or other facilities providing health care to IHS patients.
   4. Maintain secondary records and indexes (either manual or electronic) in order to provide vital statistics, statistical information, and research information.

3-3.2  HEALTH RECORD

1. Communication.  The health record is a means of communication among the physicians, nurses, and allied health professionals who plan and conduct the care and treatment of the individual patient.
2. Definition.  The health record is a chronological documentation of health care and medical treatment given to a patient by professional members of the health care team and includes all handwritten and electronic components of the documentation.  It is an accurate, prompt recording of their observations including relevant information about the patient, the patient's progress, and the results of the treatment.  The health record:
   1. may be paper or electronic or both (hybrid).
   2. creation, content, maintenance, management, processing, and expected quality measures must be standardized.
3. Division.  The health record may be composed of two divisions:
   1. Documentation of all types of health care services provided to an individual, in any aspect of health care delivery.  It includes individually identifiable health information, in any medium collected and directly used in and/or for documenting health care.  The term includes records of care in any health-related setting used by health care professionals while providing patient care service, and to review patient data or to document their own observations, actions, and instructions.
   2. The administrative record is an official record pertaining to the administrative aspects involved in the care of a patient, including demographics, eligibility, billing, correspondence, and other business-related aspects.
4. Electronic Health Records.  Electronic capture and storage of patient health information will be implemented to enhance access to patient data by health care practitioners and other authorized users.  Electronically stored and/or printed health information is subject to the same medical and legal requirements as handwritten information in the health record.
5. Encumbered.  An employee who currently occupies an official position.
6. Finances.  The health record is the original source document for any financial activity involving patient care.  Primary examples are the use of health records in audits of third-party collections by outside payers; in internal audits to verify allocation processes; and to develop and maintain cost management programs and cost management systems.
7. Legal Document.  The health record is a legal document that benefits the patient, the physician, other health care providers, and the health care program.
8. Legal Health Record.  The EHR and the paper record combined is the legal health record.
9. Station.  An IHS health station is an ambulatory care facility (fixed or mobile) which is geographically separate from an inpatient hospital or health center, that provides one or more clinical services, and is operated less than 40 hours per week.
10. Statistics.  The health record is the source document for statistical research, planning, and budgeting.
11. Training.  The health record is a tool for training members of the medical and paramedical professions and for conducting medical research. It is the primary means for evaluating the quality and appropriateness of medical care rendered.

3-3.3  HEALTH INFORMATION PROFESSIONALS

Health information professionals serve as a resource to the facility and are active in the facility's decision-making activities related to health information systems, health record content, authentication of record entries, correction of documentation errors, documentation approaches, and information system backup and disaster recovery.  Health information professionals play an active role along with the administration and the clinical staff in the development of future strategies for initiatives based on the organization's health information.  Health information professionals are involved in all decisions, both technical and administrative, that impact, define, and/or control access to patient health records.  Health information professionals convey a positive, professional image, and share expertise with the administration and other departments, organization staff, medical staff, and health care professionals in the community.

The term management is synonymous with effectiveness.  In addition to internal department activities, the health information professional and staff participate in the ongoing measurement, evaluation, and improvement of organization-wide performance by taking part in establishing priorities, identifying best practices, working on committees, preparing reports, empowering staff, and collecting and analyzing data.

1. Facility Level HIM.  The health information professional(s) at the facility level:
   1. may serve as the Privacy Official;
   2. assists in planning, managing, advising, and directing the health information program in accordance with applicable Federal laws, facility bylaws, IHS policy, and accreditation or certification standards; and
   3. assists in creating and monitoring systems to ensure accurate, timely, and complete health records, in accordance with IHS policy and accreditation or certification standards; and
   4. prepares credentialed health information professionals to:
      1. direct health information programs;
      2. develop systems that document, manage, validate, and use health information; and
      3. advise medical staff and management on medico-legal, compliance, research, quality assurance, and other related issues.
2. Credentials.  The American Health Information Management Association (AHIMA) credentials both the Registered Health Information Administrator (RHIA) and the Registered Health Information Technician (RHIT) health information professionals.
3. Guidelines.
   1. The AHIMA Code of Ethics may be found at:

      AHIMA Code of EthicsExit Disclaimer: You Are Leaving www.ihs.gov 

   2. The IHS Ethics policy may be found at:

      IHS Ethics Policy

3-3.4  RESPONSIBILITIES

1. Chief, Health Information Management.  The Chief, HIM, is responsible for:
   1. representing the HIM profession in planning and developing a comprehensive health program for the IHS;
   2. serving in a key role for all activities involving data systems, including planning, developing, implementing, and evaluating systems;
   3. advising the IHS Director and members of the Director's staff on policy formulation and activities involving HIM services, data quality, and third party reimbursement in all types of facilities;
   4. providing professional and technical guidance to Area HIM consultants in developing and administering HIM programs to enable IHS facilities to meet IHS goals and objectives;
   5. planning the recruitment, professional development, and effective use of professional and technical level HIM personnel throughout the IHS; and
   6. planning orientation and training activities for HIM personnel.
2. Area HIM Consultant. The Area HIM Consultant is responsible for:
   1. assisting in planning and developing a comprehensive health program for the Area that is consistent with IHS goals and objectives;
   2. advising the Area Director, Area staff, Chief Executive Officers (CEO), and their staffs on the implementation of policies and activities involving health records, data quality, third-party reimbursement, utilization review, and quality improvement;
   3. assisting Service Unit HIM Supervisors or Directors in meeting equal employment opportunity objectives;
   4. participating in planning, developing, implementing, and evaluating data systems;
   5. assisting Service Unit personnel in planning facilities construction/remodeling and procuring equipment;
   6. advising and assisting Service Unit HIM staff in performing quality review programs to meet requirements of the Joint Commission, CMS, the Accreditation Association for Ambulatory Health Care, and other regulatory and/or accrediting agencies;
   7. assisting in recruitment, use, and evaluation of professional and technical level Service Unit HIM staff;
   8. assisting in planning for career advancement and professional development of Area HIM staff using workshops, institutes, online courses, audio seminars, and college-based HIM courses;
   9. providing orientation to Area professional and administrative personnel on HIM policies and standards training;
   10. assisting the CEO and staff with orientation and indoctrination in HIM;
   11. providing guidance to Area and Service Unit staff in medico-legal matters, including compliance with the Privacy Act of 1974, HIPAA, FOIA, and Confidentiality of Alcohol and Drug Abuse Patient Records regulations;
   12. writing and submitting narrative reports for submission to the Chief Headquarters HIM Consultant and report at the biannual Area HIM Consultants meeting.  The report should briefly discuss (as appropriate) the following:
       1. staffing levels in each facility for the following categories:  Permanent, temporary, credential levels, and positions encumbered by credentialed professionals (Credentialed is defined as an active registration or accreditation by the AHIMA);
       2. changes in HIM positions, personnel components, and vacancies;
       3. accomplishments;
       4. proposed action for future quarter;
       5. recruiting activities;
       6. problems and, if possible, recommended solutions; and
       7. ongoing educational programs, regularly scheduled workshops, and outside training.
3. Service Unit HIM Directors.  Service Unit HIM Directors are administratively responsible for all HIM activities within the Service Unit, hospitals, and clinics; they are responsible to:
   1. assist Service Unit staff in planning and developing a comprehensive health program to meet IHS goals and objectives;
   2. direct HIM department activities, implement IHS policies, and develop procedures to administer the facility HIM program;
   3. advise the CEO and staff in matters involving HIM policies, data quality, and third-party reimbursement;
   4. plan for recruiting, developing, and use of facility HIM personnel;
   5. assist in evaluating and analyzing statistical data for epidemiological or other studies, program planning, and budgeting;
   6. collaborate with the clinical application coordinator (CAC) on setting up, maintaining, accessing, and using the Resource and Patient Management System (RPMS) EHR;
   7. provide on-the-job training to HIM personnel;
   8. conduct HIM orientation for department heads and professional employees in HIM policies and procedures; and
   9. perform quality review studies with professional personnel from other disciplines in order to meet IHS requirements and those of certifying or accrediting organizations.
4. Health Facility, Center, or Station HIM Supervisor.  A health facility, health center, or station HIM supervisor is administratively responsible for HIM activities within a health facility, health center, or station.  In consultation with the Area HIM Consultant or Service Unit HIM Director, the health facility, health center, or station HIM supervisor is responsible for:
   1. implementing IHS and Area policies, and developing procedures to carry out the functions of the HIM program;
   2. coordinating HIM activities with other members of the health team, such as the GAC;
   3. assisting in evaluating statistical and other medical data, to the level of his or her professional competence; and
   4. advising the health center staff.
5. Non-supervisory HIM Technicians.  Non-Supervisory HIM Technicians are directly supervised by the Service Unit or facility HIM supervisor and may be assigned any duty within the functions of the HIM department.  The HIM professionals and the CAC work collaboratively to set-up, maintain, access, and use the RPMS EHR system.  The HIM professional participates in, or contributes to, the orientation of all new staff expected to have contact with, or access to, health records. Orientation and training must include, but is not limited to, the following:
   1. confidentiality of health records and the proper procedures for releasing health information; accreditation/certification standards of clinical staff health record entries,
   2. accreditation/certification standards of clinical staff health record entries, including authentication, and other documentation requirements outlined in this chapter;
   3. format of proper documentation for health records;
   4. time standards for documentation;
   5. error correction or addenda to records;
   6. diagnostic information required when ordering;
   7. meets applicable medical necessity requirements;
   8. chart deficiency protocols;
   9. dictation and transcription protocols; and
   10. Health Information Management operational services, including hours and staff availability.

3-3.5  HEALTH INFORMATION MANAGEMENT DEPARTMENT

1. Administrative Responsibilities.  The HIM department will maintain the facilities and services necessary to provide health records that are documented accurately and in a timely manner; that are readily accessible and contain all current information; and that permit prompt retrieval of information, including statistical data.
2. Committee Responsibilities.  The HIM Director or Supervisor assists the Medical Record Review Committee with reviewing health records to ensure compliance with accreditation or certification standards; preparing meeting agendas; minutes, and reports; data collection and display; and appraisal of such department resources as equipment, physical environment, and staffing needs.
   1. Health Record Completion.  The HIM staff must review a representative sample of charts from each inpatient and outpatient service or program to ensure documentation is adequate, timely, complete, and properly authenticated according to all accreditation/certification standards and all IHS directives.  Staff must report inadequate records to the appropriate committees as outlined in the facility's Medical Staff Bylaws, Rules and Regulations.
   2. Minutes.  Where committees are combined, separate headings for each committee function will be maintained in the minutes.  Minutes will not contain direct patient identifiers such as name or unit health record number.  Patient references will be used only when necessary and only in coded form.  The key to patient identification codes will be maintained by a designated coordinator and destroyed when direct patient reference is no longer needed.
   3. Confidentiality of Committee Minutes.  Committee actions will be maintained in strict confidence.  The distribution and storage of minutes will be controlled. All persons receiving minutes will be held accountable for the document's security and its destruction when the minutes are no longer needed.
3. Health Information Management Director.  The HIM Director is administratively responsible for ensuring that:
   1. Each individual treated within the facility or in the community by a member of the health care team will be registered. A health record is maintained for each individual who receives service as an outpatient, inpatient, newborn, emergency patient, community health patient, school student, and contract health service (CHS) beneficiary.
   2. The health record is maintained in strict confidence.  Information from health records will be disclosed only in conformance with applicable Federal laws and regulations, policies of the IHS, and the laws of the State or Tribe in which the facility is located.
   3. Only authorized personnel will have access to health records.  Service Unit policy and procedures shall specify those employee positions within the Service Unit who are authorized to access health records on a "need-to-know" basis. A listing of specific individuals with health record access is maintained by the CEO or the Service Unit HIPAA Privacy Official and updated as necessary (Refer to Part 2, Chapter 7, IHM).
   4. The HIM department will be secured at all times.
   5. Health records will be removed from the facility only by court order from a court of competent jurisdiction in consultation with the Office of General Counsel (OGC), or for retirement to the Federal Records Center (FRC).  A court order is necessary for removal of a record (other than for retirement) containing information about alcohol or drug abuse. See Section 3-3.12R, "Court Order and Subpoena Duces Tecum." (Refer to 45 CFR § 2.5 and 45 CFR § b9(b)(11) for discussion of a valid subpoena or court order.)
   6. The HIM department assists in medical care evaluation by providing information needed to assess the quality and appropriateness of care provided by the facility.  The specific role of the HIM department will be defined in the policies of each facility and will vary depending on organization and staffing.
   7. The HIM department maintains a health records identification and filing system.
   8. Statistical information is maintained to provide data as required by State, Federal, and accrediting/certifying organizations.
   9. Policies and procedures regarding the responsibilities and functions of the HIM department are developed, implemented, and updated.
   10. The HIM department maintains a permanent signature index for each provider who documents patient events in the health record. Providers include a medical doctor (MD), doctor of osteopathy (DO), registered nurse (RN), licensed practical nurse (LPN), registered pharmacist RPh), master social worker (M.S.W.), physician assistant (PA), and physician assistant certified (PA-C).  The signature file shall be secured and maintained permanently in the office of the HIM Director or supervisor and shall contain the following:
       1. provider's name;
       2. provider's signature;
       3. provider's initials;
       4. provider's professional description;
       5. provider's entry on duty date; and
       6. provider's exit date.
4. Program Responsibilities.
   1. Reception and Registration of Patients.  The reception and registration of all patients may be an HIM function depending on the facility's responsibilities.  Questions regarding patient eligibility for care or treatment will be referred to the CEO or designee (Refer to Part 2, Chapters 1-5, IHM).
   2. Health Record Number.  A unique health record number is assigned to each patient's record when they first register, whether outpatient, inpatient, newborn, emergency patient, community health patient, school student, or CHS beneficiary.  The health record number is used to identify patients' records and the documents filed in them.  The reissue of an assigned number is strictly prohibited.
   3. Number Control Log.  A permanent log (paper or electronic) of unit numbers issued at a facility will be maintained and contain the patient's name, registration date, and date of birth. Health record numbers will be issued according to Service Unit policy.  The Number Control Log form (IHS-209), may be used.
   4. Master Patient Index.  A permanent current Master Patient Index (MPI) will be maintained by each facility.  The Patient Index Card form (IHS-198), may be used and filed alphabetically by the patient?s last name.  This alphabetical index of patients is key to the identity and location of the health records and may be paper or electronic.  Update a patient's name change in the RPMS Patient Registration package and ensure that the MPI index card is cross-referenced with the patient's former name.  The MPI will be monitored according to local policy and/or Part 2, Chapter 4, Item 4.3, Revenue Operations Manual, on the IHS Web site.
   5. Comprehensive Health Record System.  A unit record system will be maintained for all reports of health care provided to an inpatient, outpatient, or emergency patient.  The unit record system includes reports of care provided to a community health patient receiving professional level care (RN, LPN, MD, DO, or physician extender as approved by the medical staff), discharge summaries, and consultation reports from contract hospitals and physicians.  See Section 3-3.8L, "Hospital Facilities Health Record Format," for the inpatient and outpatient format.
   6. Centralized Files.  Active health records will be filed in the centralized file room of the health records department.
      1. All records must be filed by terminal-digit method.
      2. Guides are required as necessary to facilitate filing activities.
      3. Files will be audited to ensure correct filing and to prevent loss.
   7. Terminal-Digit Numeric Filing System.  Terminal-digit numeric filing is a simple and accurate filing method that increases productivity for file clerks.  Usually a six-digit number is used and divided with a hyphen into three parts, each part normally contains two digits.  The primary digits, used as the key filing unit, are the last two digits on the right-hand side of the number.  The secondary digits are the middle two numbers, and the tertiary digits are the first two on the left side of the number.  In a terminal-digit numeric file, there are 100primary sections, ranging from 00-99.
      • Number - 15-71-10
      • Primary - 10
      • Secondary - 71
      • Tertiary - 15
   8. Record Activity.  The health record activity status will be maintained using an activity stamp, year sticker, pre-printed folders, or a report from the RPMS.
   9. Record Retention.  The length of time a health record is retained in active or inactive status depends on the facilities available filing space and research activity.   A facility may inactivate a health record three to seven years after the patient's last episode of care.  Inactive records will be purged annually and transferred to the appropriate Federal Records Center (FRC).  The IHS Records Disposition, Schedule 3-1, "Medical Records File" may be found here.
   10. Retention Justification.  Retention of health records is justified for continuity of health care, research or other studies; medico-legal needs, and is applicable to State or Federal statutes of limitation.
   11. Health records may be saved on microfilm/microfiche if filing space is inadequate.
   12. Filming and subsequent retirement of health records shall be performed in accordance with established regulations.
   13. Photographic Reproductions.  By statute, photographic reproductions of hospital records may be admitted in court as evidence.  It may be necessary to legally establish the following:
       1. standards for accuracy of the photographic process;
       2. the original health record and its validity as primary evidence;
       3. the reason(s) the original health record is not available; and
       4. the statute or case law allowing the use of filmed records as original records for legal evidence.
   14. Forms.  Only standard forms (SF) and IHS clinical record forms are used in the health record.  Proposed new or revised forms must be submitted through the Area Office to IHS Headquarters for approval in order to become an authorized part of the health record.  Refer to Part 5, Chapter 24, IHM, TN No. 04-02, 07/16/04.
   15. Electronic Health Records and Patient Care Component + Templates.  A local process for initiating, developing, and approving new electronic templates must be established under the auspices of the health record review function.  As part of the health record review function, proposed templates must be reviewed for legal, policy, regulatory compliance, and ease of use.  Requests must be approved prior to implementation of electronic health record templates.  All components must reflect the health record number, date of documentation, date of service, and facility name.  Paper forms are preferred for specific components of the record as a guideline for developing electronic templates.
   16. Charge-Out System.  A charge-out system is maintained to ensure that all health records are available upon request.  The charge-out sheet must contain the patient's health record number and name, requestor's name or location, and date the record is charged-out.
   17. Statistical Data.  For information and instructions for gathering statistics, refer to Part 4, Chapter 3, Section 1, Ambulatory Patient Care Services (Outpatient), Section 2, Clinical Record Brief - IHS Inpatient Services, and Section 6, Monthly Report of Inpatient Services - IHS Hospitals, IHM.
   18. Medical Coding.  The HIM Department is responsible to review and analyze health records in order to apply diagnostic and procedural codes to individual patient encounters for retrieving and analyzing data, and processing claims.

       IHS HIM coding requirements and guidelines are in the IHS Revenue Operations Manual and Internal Control Policy.

   19. Physician Query.  All codes must be based on physician documentation in the patient's health record.  Physician query forms may be filed in the body of the health record or maintained in a separate file according to facility policy.  Physician queries must be written clearly and concisely and not "lead" the physician to provide a particular response.

       Facilities need to establish policies and procedures for obtaining physician clarification, such as allowing the coder to directly contact the physician to ask about a diagnosis or procedure.  Communication tools such as summary forms, attestation sheets, and query forms must never be used as a substitute for appropriate physician documentation in the health record.  A physician's response to a coding query to be used to support a code assignment must be documented by the physician in the health record.

   20. Transcription of Clinical Reports.  The HIM department shall provide services for transcribing clinical reports on a timely basis either through direct hire or on a contracted basis.  Contractual arrangements do not relieve the HIM department of responsibility for transcription services. Effective management of the clinical transcription unit directly affects the quality and timeliness of health information in either the paper or electronic environment.  Management activities may include:
       1. developing and monitoring quality standards for transcribed documents that are uploaded into the EHR, including document turnaround time from completion of dictation to electronic signature; and
       2. specifying and monitoring turnaround time, quality, and confidentiality compliance.

          When transcription service is contracted, the transcribed medical information may be sent to a dedicated fax machine or printer in the facility.  The transcribed medical information may be encrypted and sent electronically or by overnight or certified mail to the facility, Ensure that the HIPAA IHS Business Associate Agreement Clause H-1 is attached to the requisition.  For more information follow HIPAA IHS Business Associate Agreement.

3-3.6  PATIENT CARE - DEFINITIONS AND STATISTICAL TERMINOLOGY

1. Age Grouping.  Patient age groupings are as follows:
   1. Child (pediatric):  A person (excluding newborn admission) from birth through age 14;
   2. Infant:  A child under 1 year of age;
   3. Preschool:  A child 1 year of age or older but less than 5 years of age;
   4. Other pediatric:  A child 5 years of age or older but less than 15 years of age;
   5. Adult:  A person who is 15 years of age or older.
2. Ambulatory Patient Care Encounter.  Ambulatory patient care (APC) encounters with a health care provider (including covered contractors) in an organized clinic within an IHS facility where the patient or a personal representative (designated only to pick up prescriptions) is physically present and services are not part of an inpatient stay, require an APC record (Patient Care Component (PCC) Encounter Record).  A licensed, credentialed health care provider, or other provider qualified by the medical staff or facility administrator, must write a note in the health record.
3. APGAR Score.  The APGAR score is a systematic measure for evaluating the physical condition of an infant at specific intervals following birth.  A score of zero indicates a severely jeopardized infant; the higher the score, up to a maximum of 10 the better the condition of the infant.
4. Autopsy.  An autopsy is the a post-mortem examination of a human body to determine the cause of death and to evaluate any disease or injury present.
5. Average Daily Census - Average Daily Patient Load.  The mean number of hospital inpatients present in the hospital each day for a given period of time.
6. Average Daily Patient Load Formula.  The formula to find the Average Daily Patient Load:

   [(Patients at the census hour prior to beginning of period averaged) multiplied by (Number of admissions for the period) minus (discharges for the period) divided by (Number of days in the period)].

7. Average Length of Stay.  The Average Length of Stay (ALOS) is the mean length of stay for hospital inpatients discharged during a given period of time. ALOS = (Day of discharge) - (Day of admission)
8. Beds.  The different types of beds are as follows:
   1. Adult Hospital Bed.  A hospital bed immediately available for regular use by an inpatient who is 15 years of age or older.
   2. Pediatric Bed.  A bed immediately available for regular use by an inpatient, other than newborn, under the age of 15years.  A crib and bassinet maintained for use by other than a newborn infant is considered a pediatric bed.
   3. Newborn Bassinet.  A bed immediately available for regular use by an infant newly born in the hospital.  Newborn infant bassinets placed in maternity patients rooms should be included in the total count of newborn infant bassinets.  The count of newborn infant bassinets does not include incubators used for the treatment of newborn infants, but days of care shall be included in the count of newborn or pediatric days (as appropriate) during periods of treatment in incubators.
   4. Swing Bed.  A hospital bed that may be used flexibly to serve as a long-term care bed.
   5. Observation Bed.  A bed used for up to 24 hours to observe and evaluate an outpatient's condition or to determine if the patient should be admitted.
9. Categories of Death.
   1. Anesthetic Death.  Death occurring on the operating table and caused by anesthetic agents, not surgical complications.
   2. Fetal Death.  Death prior to the complete expulsion or extraction of a product of human conception from its mother, irrespective of the duration of the pregnancy, and which is not an induced termination of pregnancy.  The death is indicated by the fact that after such expulsion or extraction, the fetus does not breathe or show other evidence of life, such as heart beat, umbilical cord pulsation, or definite movement of voluntary muscles.

      Heart beats are to be distinguished from transient cardiac contractions; respirations are to be distinguished from fleeting respiratory efforts or gasps.

   3. Infant Death.  The death of a live-born infant at any time from the moment of birth to the end of the first year of life (364 days, 23 hours, 59 minutes from the moment of birth).
   4. Institutional or Hospital Death.  Death occurring in the hospital after admission.
   5. Neonatal Death.  The death of a live-born infant within the first 27 days, 23 hours, and 59 minutes following the moment of birth.
   6. Maternal Death.  The death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management, but not from accidental or incidental causes.
   7. Postoperative Death.  A death occurring within the first ten days postoperatively.
10. Daily Patient Load - Daily Census.  The number of inpatients present at the census-taking time each day, plus any inpatients who were both admitted and discharged after the census-taking time the previous day.
11. Diagnosis.
    1. Diagnosis.
       1. The art or act of identifying a disease from its signs and symptoms;
       2. a medical determination of disease or syndrome;
       3. identification of a disease or condition from which an individual patient suffers or a condition for which the patient needs, seeks, or receives medical care.
    2. Admitting Diagnosis.  A provisional description of the reason a patient requires care in an inpatient hospital setting.
    3. Preoperative Diagnosis.  The reason for surgery or the expected findings of surgery.
    4. Postoperative Diagnosis.  The clinical findings of the surgery.
    5. Pathological Diagnosis.  A description of the morphology or cellular characteristics of tissue removed during surgery.
    6. Principal Diagnosis.  The condition established after study to be chiefly responsible for patient admission to the hospital for care.
    7. Secondary Diagnosis.  A statement of conditions co-existing during a hospital episode affecting treatment received or the length of the hospital stay.
    8. Comorbidity.  A medical condition that coexists with the primary cause for hospitalization and affects the patient's treatment and length of stay.
    9. Complication.  A medical condition arising during an inpatient hospitalization (for example, a postoperative wound infection) that modifies the course of the patient's illness or the medical care required.
12. Discharge Transfer.  The transfer of an inpatient to another health care institution at the time of discharge.
13. Emergency.  Any medical condition for which immediate medical attention is necessary to prevent the death or serious health impairment of an individual.
14. Fetal Death.  Death prior to the complete expulsion or extraction of a product of human conception from its mother, irrespective of the duration of the pregnancy, and which is not an induced termination of pregnancy.  The death is indicated by the fact that after such expulsion or extraction, the fetus does not breathe or show other evidence of life, such as heart beat, umbilical cord pulsation, or definite movement of voluntary muscles.  Heart beats are to be distinguished from transient cardiac contractions; respirations are to be distinguished from fleeting respiratory efforts or gasps.
    1. The National Center for Health Statistics (NCHS) recommends reporting fetal deaths occurring in fetuses weighing 350 grams or more, or those at 20 weeks of gestation or greater.  This recommendation is, however, only a guideline and reporting practices vary among States.  For more information, visit the NCHS web site.Exit Disclaimer: You Are Leaving www.ihs.gov .
    2. Fetal deaths are not counted as admissions and discharges, and are not to be credited with hospital days.
    3. Fetal death records-certificate, autopsy authorizations and protocols shall be filed in the obstetrical patient's record (mother's record).
    4. Fetal death groups with respect to weeks of age at death are categorized as follows:
       1. Group I:  Less than 20 completed weeks of gestation (early fetal death).
       2. Group II.  20 completed weeks of gestation but less than 28 (intermediate fetal death).
       3. Group III:  28 or more completed weeks of gestation (late fetal death).
       4. Group IV:  gestation period not classified in Groups I, II, and III.
15. Hospital Infection.  Invasion of the body by pathogenic microorganisms, and the reaction of tissue to their presence and to the toxins generated by them; occurring after the patient is admitted to the hospital and under circumstances which should have been prevented by the hospital.
16. Hospital Inpatient.  A patient who is provided with room, board, and continuous general nursing services in an area of an acute care facility where patients generally stay at least overnight.
17. Immature Infant.  A live-born infant whose birth weight is 5 1/2 pounds (2,500 grams) or less, or who is specified as immature.  If weight is not specified, a live-born infant with a gestation period of less than 37 weeks, or who is specified as premature by the delivering physician or attending pediatrician, shall be classified as an immature infant.
18. Immunization.  The process by which a patient is rendered immune to a disease.
19. Inpatient Admission.  A patient admitted for inpatient services based on the standing, verbal, or written order by a physician or a licensed independent practitioner.  Admission involves the occupancy of an adult or pediatric hospital bed or newborn infant bassinet and the maintenance of a hospital chart during observation, care, diagnosis, or treatment.  If, after discharge, an inpatient returns to the hospital for admission, it is a separate admission.

    Adults without complaint or sickness who are at the hospital for the benefit of a hospitalized patient or for the convenience of the hospital are not inpatients.

20. Inpatient Day.  A unit of measure denoting the services received by one inpatient in one 24-hour period.  Certain conventions are followed when using this measuring unit:
    1. The 24-hour period is the period between the census-taking hours on two successive days.  When the census-taking hour is midnight, this 24-hour period will be the same as the calendar day (i.e., from 12:01 a.m. through 12:00p.m.).
    2. The day of admission, but not the day of discharge, is counted as an inpatient day.
    3. A patient admitted and discharged on the same day is counted as one inpatient day.
    4. The unit of one inpatient day is never divided or reported as a fraction of a day.
21. Inpatient Discharge.  The formal release and termination of stay of an inpatient by the hospital.  A death is recorded as a termination of stay and as a specific type of inpatient discharge.
    1. A decedent brought to the hospital is not counted on the census as an inpatient admission or discharge.
    2. If a patient died in the Emergency Room (ER), billing is for the ER service, but not for inpatient service.
22. Inpatient Hospitalization.  The period in which an individual is a patient in one hospital without interruption, except by an intervening patient leave of absence.
23. Intrahospital Transfer.  A change in the medical care unit, the medical staff unit, or the responsible physician or other licensed independent practitioner providing medical care to an inpatient.
24. Live Birth.  The complete expulsion or extraction of a product of human conception from its mother, irrespective of the duration of pregnancy, which after such separation breathes or demonstrates other evidence of life such as heart beat, umbilical cord pulsation, or definite movement of voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached.  A child who breathes or demonstrates other evidence of life after complete birth, even momentarily, should be registered as a live birth.
25. Medical Consultation.  Two or more medical staff reviewing the patient's history and examination results, and giving recommendations and/or opinions in a consultation report.
26. Newborn Infant.
    1. An inpatient newborn infant who occupies a newborn infant bassinet and a hospital chart is maintained during its period of care.  Newborns infants are inpatient admissions and are recorded as newborn inpatients on the monthly census.
    2. Infants born outside the hospital and admitted to the pediatric nursery are recorded as regular pediatric inpatient admissions and not as newborn infants or hospital births.

1. AObstetrical or Puerperal Morbidity.  A temperature of 100.4ºF. (38ºC) occurring on any two of the first 10 days postpartum, excluding the first 24 hours, may constitute febrile morbidity. A diagnosis of febrile morbidity is accompanied by a statement of causative factors when possible.
2. BOperation.  An operation is surgery performed in the operating room. A given operation may consist of several procedures.
3. CPatient in Transit.  A patient who must stop over and board at an IHS hospital while en route to another designated location or a patient waiting for transportation arrangements either to another hospital or home.  All such individuals who are admitted as patients and for whom a clinical record is established are included in the count of patients on the monthly report.  It is important that the diagnosis be recorded on the patient's chart.
4. DPercentage of Occupancy.  The total number of inpatient service days for a given time period divided by the total number of inpatient bed count days for the same period. Percentage Occupancy = [(patient days of care divided by bed count days) multiplied by 100 percent].
5. EPostoperative Infection.  Infection occurring in a clean surgical case.
6. FReadmission.  An inpatient's readmission to the same IHS Hospital.
7. GSterilization.  Any procedure rendering an individual incapable of reproducing, such as castration, vasectomy, salpingectomy, oophorectomy, and hysterectomy.
8. HTypes of Visits.
   1. First Visit.  The first ambulatory care visit for an episode of care.
   2. Revisit.  The second or subsequent ambulatory care visit for the episode of disease or condition treated.
   3. Prenatal Visit.  A prenatal patient is considered once as a "prenatal first visit" during each pregnancy.  All other prenatal visits are considered "revisits." Examinations performed within six weeks following delivery are considered postpartum examinations.

3-3.7  STAFFING CRITERIA

1. Service Units.  Each Service Unit management team is responsible for providing the staffing necessary to establish and maintain a health record service that meets institutional needs, accrediting or certifying organization standards, third-party payer requirements, and IHS standards.
2. Service Unit HIM Professional.  The Service Unit HIM professional is responsible for informing management of the HIM workload and subsequent staffing changes.
3. Hospitals and Health Centers.
   1. Director of the HIM Department.  It is recommended that a RHIA supervise the hospital HIM department.  In smaller hospitals, a RHIT may supervise the HIM Department.
   2. Health Centers.  All field and health centers HIM Departments shall be adequately staffed with qualified personnel.  It is recommended that an RHIT supervise and conduct departmental activities.  Optimal staffing requirements are included in the Resource Requirements Methodology (RRM) Module: Medical Records, which can be found here.

3-3.8  HEALTH RECORD DOCUMENTATION

1. Description.  The health record documents the care of the patient and is an important element contributing to high quality care.  The documentation in a health record contains a compilation of scientific and subjective data from which conclusions or judgments are derived.
2. Purpose.  Health record documentation is required to record pertinent facts, findings, and observations about a patient's health history including past and present illnesses, examinations, tests, treatments, and outcomes.
3. Facilitation.  The health record facilitates the following:
   1. the physician and other health care professional's ability to evaluate and plan the patient's immediate treatment, and to monitor the patient's health care over time;
   2. the communication and continuity of care among physicians and other health care professionals involved in the patient's care;
   3. the accurate and timely claims review and payment;
   4. the appropriate utilization review and quality of care evaluations;
   5. the collection of data that may be useful for research and education;
   6. the accurate coding of diagnosis and procedures performed; and
   7. the source of aggregate data to be used as the basis for planning future health programs or initiatives.
4. Documentation Principles.  Conducting reviews to evaluate clinical competency and support privileging activities.
5. Documentation Standards.  Documentation standards include, but are not limited to, the following:
   1. A complete health record shall be maintained for each patient who receives direct or indirect health services at an IHS facility or field location, whether as an outpatient, inpatient, contract health patient, community health patient, school student, or emergency patient.
   2. The accreditation or certification standards regarding documentation pertinent to care and treatment records apply to both paper and electronic records.
   3. The RPMS (including the EHR) or the paper record are mediums for documentation of all patient care activities within the IHS.
   4. Attending providers are ultimately responsible for the accuracy of the health record for each patient under their care. The Clinical Director, or designee (equivalent), has oversight responsibility for health record timeliness, accuracy, and completion.
   5. Medical staff members and other individuals who have been granted such clinical privilege within their scope of practice must document or authenticate opinions requiring medical judgment.
   6. Health care practitioners must document according to regulatory standards and generally accepted documentation practices for completeness and timeliness.
   7. Health care practitioners involved in the patient's care must document each event of the patient's care in the health record.
   8. The practitioner who treats the patient is responsible for documenting and authenticating the care provided.
6. Prompt Documentation.  Each clinical event, including history and physical examination (PE), shall be documented as soon as possible after the occurrence and within requirements set by the accreditation and/or certification standards for the type of facility or program.  Health records of discharged or released patients shall be completed as specified in the facility's Medical Staff Bylaws, Rules and Regulations.
   1. Scope of Documentation.  The health record must reflect candid statements but avoid derogatory or critical comments.  Individual employee names are not included in health record documentation unless the purpose is to identify practitioners for continuing care.  Emphasis is placed on relevant day-to-day entries.  Timely entries must be made on appropriate documents following examination and treatment as specified in IHS and facility policies.  Each patient event must include or refer to the following: the chief complaint and/or reason for visit and, as appropriate, relevant history, examination findings and prior diagnostic test results; assessment, clinical impression, or diagnosis; plan for care and date and legible identity of the health care professional; and identification of appropriate risk factors.  The scope of documentation must be organized, complete, and comprehensive enough to:
      1. provide continuity of care;
      2. reflect all treatment;
      3. support health care provider's reported workload; and
      4. support services that are reimbursed by third-party payers.
7. Signatures or Authentication.  All entries in the health record shall be dated and authenticated with full signatures.  Also, MD, RN, RPh, or other professional designation shall be included with the signature to indicate essential or basic competencies of the person making an entry.  Entries made by an extern or student shall be countersigned by the physician or other licensed independent practitioner in charge of the care.  Signature stamps with original signature are authorized by the facility and must be kept in the signatory's complete control.  Initials with professional designation may be used by providers for authentication purposes where those initials are readily recognized by other staff and where approved in the record of Medical Staff Executive Committee actions.  A signature file listing must be maintained on all individuals who document in the health record, either electronic or on paper.  See 3-3.5C(10).
8. Electronic Signatures.
   1. Electronic signatures may be used for Schedule II drug prescriptions for inpatient prescriptions.
   2. Electronic signatures cannot be used for Schedule II out-patient drug prescriptions according to the CFR pursuant to Drug Enforcement Agency (DEA) regulations.  When the DEA permits such electronic authentication, it is permitted in the IHS health records.
9. Time Frames.  Each entry in the record is completed (including authentication) within the time frames delineated by the facility's Medical Staff Bylaws, Rules and Regulations.  A policy must include guidance on disciplinary action taken when time frames are not met.  When a pertinent entry is missing or not written in a timely manner, a late entry is used to record the information in the health record with a notation giving the reason for the late entry.  The entry of missing documentation or authentication is identified as "late entry" and must note the actual date the event occurred, not the date of documentation.  In the EHR, the date of entry identifies the date the documentation actually occurred.  Physicians and other health care providers must monitor computerized prompts for signature and take appropriate action.
10. Record Content.  Health record content within the IHS will comply with:  Requirements of the accreditation or certification standards for the type of facility or program, requirements for participation in third-party payment programs, and with licensure requirements of the providers or other special programs.
11. General Requirements.  All written entries shall be made in permanent dark ink that does not soak through and obliterate information to ensure microfilmed or other copy media are legible.  The health record shall contain sufficient information to:
    1. identify the patient;
    2. support the diagnoses/treatment
    3. justify the care, treatment, and services provided;
    4. document the course and results of selfcare, treatment, and services provided;
    5. describe the patient's condition upon release or discharge
    6. document instructions to patient regarding follow-up care, self care, home care, activity levels; necessary medications; and
    7. document environmental, family, and socioeconomic factors affecting the patient's health.
12. Hospital Facilities Health Record Format  The patient's identification information and the facility's name must be on each page of the health record.  This standardized IHS format facilitates authorized use of the health record for review or to make entries, and to retrieve patient information for administrative, statistical, and quality assurance purposes.
    1. Outpatient Medical Record Format.  (Left side of medical record folder):
       1. PCC Health Summary
       2. Medication profile
       3. Chronic Medication Report or RPMS Chronic Medication List
       4. Ambulatory Care Record Brief
       5. PCC Encounter Record form (IHS-803) and other PCC forms (most recent visit date on top)
    2. Outpatient Dividers.  (IHS-677 series)
       1. Laboratory
       2. X-Ray and EKG
       3. Graphs and Flow Charts
       4. Consultations/Summaries
       5. Contact Care/Miscellaneous
       6. Immunizations
       7. Diabetes (IHS-677-1)
       8. Dental (IHS-677-2)
       9. Public Health Nursing (IHS-677-3)
       10. Eye (IHS-677-4)
       11. Emergency Room (IHS-677-5)
       12. Ambulatory Surgery (IHS-677-6)
       13. Unassigned (IHS-677-7)
       14. Patient/Family Education (IHS-677-8)
       15. Observation (IHS-677-9)
    3. Inpatient Medical Record Format.  (Right side of medical record folder).  Dividers (IHS-830) shall be used to separate each admission (1st through 10th).
       1. Advance Directive
       2. Inpatient Clinical Record Brief form (IHS-44-1)
       3. PCC Inpatient Supplement and Discharge Follow-up Record (IHS-485) (Optional)
       4. Referral Care Information System printout
       5. Discharge Summary
       6. History and Physical
       7. Prenatal Record (after delivery, file under Graphs and Flow Charts divider tab on Outpatient)
       8. Obstetrical, Labor, and Delivery
       9. Consultations
       10. Doctor's Orders
       11. Progress Notes
       12. Laboratory
       13. X-Ray
       14. Consent Forms
       15. Anesthesia (pre and post anesthesia)
       16. Operation Report
       17. Pathology or Tissue Report
       18. Vital Signs (temperature, pulse, and respiration)
       19. Medication Administration Record
       20. Flow Sheets

       Fetal monitoring strips are maintained separate from the health record. The mother's name, health record number, and date fetal monitoring was performed must be documented on the strips. (Refer to IHS Records Disposition Schedule, Schedule 3, Professional Service, Item 3-18.)

13. Health Centers Health Record Format.  The following is the recommended standardized format for use throughout IHS health centers.
    1. Right side of the Health Record Folder.
       1. PCC Health Summary
       2. Advanced Directive
       3. PCC Medication Profile
       4. Chronic Medication Report or RPMS Chronic Medication List
       5. PCC Ambulatory Encounter Record form (IHS-803) and other PCC forms (most recent visit on top)
    2. Left side of the Health Record Folder.
       1. Ambulatory Care Record Brief
       2. Outpatient Dividers (IHS-677)
       3. Laboratory (IHS-677)
       4. X-ray and EKG (IHS-677)
       5. Graphs and Flow Charts (IHS-677)
       6. Consultations/Summaries (IHS-677)
       7. Contract Care/Miscellaneous (IHS-677)
       8. Immunizations (IHS-677)
       9. Diabetes (IHS-677-1)
       10. Dental (IHS-677-2)
       11. Public Health Nursing (IHS-677-3)
       12. Eye (IHS-677-4)
       13. Unassigned (IHS-677-7)
       14. Patient/Family Education (IHS-677-8)
    3. Problem Oriented Records.  Problem oriented records conform to the same general requirements as do other record formats.
14. Problems.  The presentation of clinical information is organized around the number and titled problem indexed on the problem list.  Problems shall be documented by physicians and other members of the health care team as required by current documentation standards and the facility's Medical Staff Bylaws.  Active problems shall be listed on the electronic or paper master problem list:
    1. The problem may be the diagnosis, symptom, history of major illness or surgery, social, or economic.
    2. Problems should be stated at teir highest level of resolution.  A symptom should not be listed for a confirmed diagnosis.  Possible diagnoses and "rule outs" should not be recorded on the problem list.  Information must be sufficiently detailed regarding the patient's history, physical exam, diagnostic test results, diagnoses and treatment to facilitate continuation of medical care for the patient.
    3. Problems shall be documented on the PCC Encounter Record form or in the EHR then displayed on the PCC Health Summary.  A provider may add new problems, inactivate problems, and change the problem narrative.  Problems are titled and numbered and serve as a table of contents to the record.
15. Abbreviations.  The approved abbreviation list and the "Do Not Use" abbreviation list must be available to all those authorized to make entries in the health record and to those who interpret them.
16. Specific Requirements for Inpatient Documentation.  Health records must be complete and available for the provision of inpatient care according to the facility's Medical Staff Bylaws, Rules and Regulations.
    1. Required demographic/sociological data shall be obtained for each admission.
    2. Only practitioners authorized by the facility's Medical Staff Bylaws and standing orders shall admit patients.
    3. Chief complaint or reason for admission shall be clearly stated on the "facesheet" of the Inpatient Clinical Record Brief form (IHS-44-1).  If the patient is admitted for surgery, the condition necessitating the surgery (not the title of the operative procedure to be performed) shall be stated.
17. Complete and Incomplete Records.  Patient records must be timely, relevant, necessary, complete, and authenticated.  Complete patient records include all required and authenticated data; all final diagnoses are recorded without use of abbreviations; and complete transcription of dictated information is inserted and/or uploaded into the record.  A delinquent record is an incomplete record that has not been finished within the time frame specified in the facility's Medical Staff Bylaws, Rules and Regulations.  Health record completion and delinquency policies must be developed and must be consistent with accreditation or certification standards, regulatory requirements, and medical staff guidelines.  These health record completion and delinquency policies must:
    1. specify time standards for completing health record content and authentication accreditation/certification standards and/or facility policy;
    2. describe procedures for continuous health record monitoring and reporting delinquent records, responsible clinicians, and re-occuring delinquency patterns to the appropriate staff and committees as outlined in the facility's Medical Staff Bylaws, Rules and Regulations;
    3. define when health record deficiency patterns will become part of the health provider's (including residents) evaluation and be placed in their credentials file; and
    4. define when an inpatient record becomes delinquent; however, in no case may the time period detailed in the facility's Medical Staff Bylaws, Rules and Regulations exceed 30 calendar days.
18. Responsibility.  The facility medical staff has ultimate oversight responsibility for health record timeliness, accuracy, and completion.  The author of the entry is responsible for completing, authenticating, and correcting any health record deficiencies within the time frame defined by the facility's policy or Medical Staff Bylaws.
19. Authenticating Documents.  No medical staff member is required to authenticate the entries of another in a patient record with whom the staff member is not familiar so that the record may be filed (as incomplete).  However, if the original staff member responsible for the patient's care is no longer available, a staff member may summarize a course of treatment based on existing patient record documentation, or review a summary for consistency with existing patient record documentation.  In such cases, a notation must be made in the record that the summarization (review) is prepared from existing documentation in the absence of the medical staff member responsible for the patient's care and without personally treating the patient.  The completed summarization must be authenticated and dated by the medical staff member preparing the summary, and/or the supervising physician, or other licensed independent practitioner.
20. Unauthenticated Documents.  Unauthenticated documentation is considered "Incomplete" and in RPMS, is subject to revision and potential deletion by the author.  Incomplete documents will not be purged from RPMS.  All facilities must establish policy and procedures to track and complete unauthenticated documentation.
21. Declaring a Record "Complete for Filing".  An inpatient record is declared "Complete for filing" when all required documentation is present and authenticated.  If unusual circumstances prevent proper completion, the record must be referred to the appropriate medical staff committee or designee for review and/or completion.
    1. The appropriate medical staff committee may declare an incomplete health record to be filed as complete.  The health record must note the committee's decision and the portion(s) known to be incomplete with the reason(s) normal completion could not be accomplished.  This information must be documented in an administrative progress note signed by the HIM professional or designee as part of the health record
    2. The health care provider shall sign those portions of the record the provider wrote, or is responsible for.  This may include countersignature of other provider notes to avoid redundant entries.
    3. A sample statement such as "Approved for filing incomplete on (date) by Medical Staff Committee due to (reason)" may be used to note the health record is incomplete.  This statement does not legally imply that the signer is validating the contents of the document, but is only administratively completing the health record.  This statement must not be used on a routine basis to close records because an available physician or licensed independent practitioner failed to sign the documents.
22. Initial Assessment.  The patient's health care team members must document initial assessments that must meet the applicable accreditation/certification standards of the Joint Commission, CMS, and other regulatory and/or accrediting agencies.
    1. An initial screening and/or assessment (e.g., nutrition, nursing, social work, functional, cultural, occupational and physical therapies, psychosocial, spiritual, legal, etc.) must be completed within 24 hours of admission, except for extended care when initial screening and/or assessment is to be completed within 14 days of admission.
    2. A patient's educational needs, preferences, abilities, and readiness to learn are assessed on admission.  The education process is interdisciplinary, as appropriate, to the care plan. Documentation of the patient's education related to nutrition, nursing, and rehabilitation is required in the health record.
23. History and Physical Examination.  History and physical examination (H&P) documentation are to be written, dictated, or supervised and countersigned by members of the active medical staff. History of present illness, past medical history, personal/family/social history, and review of body systems must be fully documented.  Where possible, the history is obtained from the patient.  Requirements shall be in accordance with the facility's Medical Staff Bylaws and in compliance with accreditation/certification standards.
24. Obstetrical Records.  Obstetrical (OB) documentation includes prenatal history and information.  A formal H&P examination by a physician or other licensed independent practitioner must be documented or dictated prior to the performance of an operative or non-operative delivery.  Provisional diagnoses, based on findings of the PE, and the plan of care must be recorded.
25. Physical Examinations.  The PE documentation includes all positive and significant negative findings.
26. Prior to Admission.  A durable legible copy of the patient's PE performed within 30 days prior to admission may be used in the patient's record if there have been no changes in the patient or if the changes are documented at the time of admission.  When the patient is readmitted within 30 days for the same or a related problem, an "interval" physical exam reflecting any changes may be used, provided the original exam is readily available.  In either case, an interval note for the health record must be completed indicating the following:
    1. the H&P is still accurate;
    2. that an appropriate assessment was completed prior to surgery confirming that the necessity for the procedure or care is still present; and
    3. that the patient's condition either has not changed since the H&P was originally completed, or that any changes are documented.

1. APrior to Surgery.  An H&P must be available prior to surgery.  When the H&P is done within 30 calendar days prior to surgery, the prior H&P may be used but an interval note must be completed indicating the following:
2. BDiagnostic and Therapeutic Orders.  All orders must contain the date and time the order was written, and the name of the practitioner who placed the order.  Orders must be signed and correspond to the practitioner's scope of practice as defined by the facility's Medical Staff Bylaws.
3. CAdmission Orders.  The initial order for level of care should be clearly documented in the patient's health care record; for example, "admit as inpatient," "admit as outpatient," "admit to outpatient surgery," or "admit to observation." Applicable diagnostic information to justify the ordered service must be documented.  The patient may be discharged only by order of a physician or other licensed independent practitioner.
4. DDischarge Orders.  A discharge order must be written and signed by a physician or other licensed independent practitioner unless the patient leaves against medical advice (AMA) or is absent without leave (AWOL).  For patients leaving AMA, it is so noted by the attending physician on the discharge progress note and the patient should be asked to sign a Release from Responsibility for Discharge form (IHS-338).
5. EVerbal or Telephone Orders.  Verbal or telephone order(s) by authorized individuals are accepted and transcribed by qualified personnel or category, as stated in the facility's Medical Staff Bylaws, Rules and Regulations.  The physician who signs the verbal or telephone order(s) can be the ordering physician or other physician assuming care.  All order(s) must be authenticated by the ordering physician or other physician assuming care who is in agreement with the continuation of the order.
6. FMedications.  Medications must be identified by name, strength, route of administration, and frequency.  Medication orders must be reviewed and rewritten when a patient is transferred between services and/or specialties, or is transferred to a critical care unit.
7. GSeclusion and Restraint.  Use of seclusion and restraint requires a time-limited order written by a licensed independent practitioner and must follow the facility's Medical Staff Bylaws, Rules and Regulations, and national patient safety guidelines.  The order must specify start and end times, indicate which extremities are to be restrained, and the type of restraint to be used.  Orders must never be given for the use of restraint and seclusion on an as-needed or as-necessary basis (e,g,, PRN (Pro Re Nata)).
8. HStanding Orders.  Routine or standing orders are a set of orders designed for routine care of patients with a certain diagnosis or procedure, (e.., OB and tonsillectomy).  These orders are typically documented on the Doctor's Orders for (IHS-611) or in the EHR, and must be signed by the physician.  All standing orders must be approved annually by the medical staff.  The use of standing orders is discouraged because the specified services may not be medically necessary for some patients.
9. IDiagnostic and Therapeutic Procedure Reports.  The Diagnostic and Therapeutic Procedure Report is filed within 24 hours of completion.  It is a detailed report of diagnostic and therapeutic procedure(s) performed outside the operating room.  Diagnostic and therapeutic procedure(s) must be documented in the progress notes by the practitioner performing the procedure and must contain the following:
   1. name of the procedure;
   2. name of the practitioner who performed the procedure;
   3. details of the procedure performed;
   4. major findings and conclusions;
   5. whether or not tissue was removed;
   6. any complications; and
   7. the practitioner's signature, title, and the date.
10. JIn-House Consultations.  In-house consultations may be included in progress notes, or on the paper or electronic Consultation Sheet form (SF-513).  A written or verbal request for a consult may be generated by a licensed independent practitioner, or as otherwise defined by the facility Medical Staff Bylaws.  A consultation is a service performed for further evaluation and/or management of the patient (e.g., opinion and/or advice).  The opinion or advice must be expressed in a report that follows health record documentation requirements (e.g., the name of the consultation requester, tests ordered, the diagnosis, and recommended treatment).  The service is a consultation if the consultant initiates a diagnostic or therapeutic service in order to provide the opinion or advice requested.

    The staff practitioner must meet with each patient who received consultation by a resident and perform a personal evaluation.  The staff practitioner must write a personal progress note to include written concurrence with the resident consult or countersign with an addendum to the resident's note detailing the staff practitioner's involvement.

    1. The consultant's report of advice, opinion, and any services that were ordered or performed must be documented on the Consultation Sheet form (SF-513) or in the EHR, the consult authenticated, and closed.  The authenticated consultation report must contain:
       1. an opinion of the consultant's findings for making a diagnosis or providing treatment advice for a specific patient;
       2. confirmation that the patient was examined;
       3. confirmation that the patient's record was reviewed;
       4. the date of the consult: and
       5. the consultant's signature.
    2. When the consultant assumes responsibility for the patient's continuing care, subsequent services provided by the consultant are no longer a consultation.
11. KReferrals.  The Referral form (IHS-199-1) must state the reason for a patient's admission, the diagnosis, current medical information, and the rehabilitative potential.  A copy of the Referral form and other pertinent clinical information is given to the receiving provider.
12. LSurgeries and Procedures.  All aspects of a surgical patient's care, including ambulatory surgery, preoperative, operative and postoperative care, must be documented.  Surgical interventions, diagnostic procedures, or other invasive procedures must be documented in detail to support associated coding data and to provide continuity of patient care.
13. MOperative Report.  An Operative Report (SF-516) must be dictated and completed by the operating surgeon immediately following surgery.  The body of the report must contain the date, and the start, and end time of the surgery.  It also contains the following:
    1. preoperative diagnosis;
    2. indication for the procedure;
    3. operative findings;
    4. technical procedure used;
    5. specimens/tissues removed;
    6. estimated blood loss;
    7. postoperative diagnosis;
    8. name of the attending surgeon, the primary surgeon, and assistants; and
    9. indicate the presence and/or involvement of the attending surgeon.  If there is a delay in dictating the operative report, the surgeon must write a progress note immediately following surgery.  The operative report is signed by the operating surgeon.
14. NRecovery Room Note.  Post-operative documentation (e.g., Recovery Room Note) must include the following information:
    1. patient's vital signs and level of consciousness;
    2. medications, blood and blood components; and
    3. unusual events or postoperative complications, including blood transfusion reactions, and how these events were managed
15. OTissues/Pathology Report.  A pathologist will examine specimens removed during surgery in accordance with tissue examination criteria established by the facility medical staff.  The dated and signed original report must be filed in the patient's medical record within 24 hours following the completed specific examination.
16. PAnesthesiology Records and Reports.  A physician's or other licensed independent practitioner's pre-anesthesia documentation shall include information to support the choice of anesthesia and specify the anticipated surgery or procedure.  The documentation must specify on the record when general, spinal, or regional anesthesia is used.  Except in emergency events, this documentation process must be done before the patient is transferred to the operation site and before preoperative medication is administered.
    1. Pre-anesthesia Note.  The anesthesiologist or anesthetist must document the pre-anesthesia note prior to induction of anesthesia.  This note must include a description of the dialogue between the anesthesiologist or anesthetist and the patient (or the patient's representative); and based on an assessment of the patient's medication and/or drug history, pertinent lab and imaging data, the patient's past anesthetic experiences, potential for anesthetic problems, and the type of anesthetic that is to be used during the planned surgical (or non-operating room) procedure.  The preanesthesia notes must specify the date and time; the preparer's name; and be documented in the progress notes.
    2. The Authorization for Administration of Anesthesia and For Performance of Operations or Other Procedures consent form (IHS-515) must be completed and signed by the patient or the patient's representative for administration of anesthesia, surgery, or procedure and verified prior to administering anesthesia, except in a medical emergency.  Form (IHS-515) must be completed during anesthesia administration and signed by the physician or other licensed independent practitioner who administers the anesthesia.
    3. Post-anesthesia notes must be timed and shall indicate the presence or absence of anesthesia-related complications after the patient recovers from anesthesia. The anesthesiologist or anesthetist must document the post-anesthesia note which must include the patient's level of consciousness when entering and leaving the recovery room, their vital signs, the status of infusions when used, surgical dressings, tubes, catheters, and drains.

       After the patient leaves the recovery room, there must be at least one timed post-anesthesia visit which includes a description of the presence or absence of anesthesia-related complications.  The health record must document the name of the licensed independent practitioner responsible for the patient's release from the recovery room, or clearly document the discharge criteria used to determine release.

17. QProgress Notes.  The IHS adopted the Problem Oriented Record System; therefore, notes should be written in the subjective, objective, assessment, and plan (SOAP) format.  The progress notes must document the patient's course and response to treatment.  The frequency of the physician's or other licensed independent practitioner's progress notes is determined by the change in the patient's condition, but must be adequate to document the severity of illness and the intensity of service during the patient's hospitalization.
18. RDischarge Progress Notes and/or Discharge Instructions.  The physician or licensed independent practitioner must complete a discharge progress note and/or instruction sheet for each period of a patient's hospitalization.  It must contain the following:
    1. date and type of discharge, diagnoses, discharge medications, recommendations relative to diet and exercise, limit of disability, condition on discharge (to include character of the surgical wound, if appropriate), place of disposition, recommendations for follow-up, and patient education.
    2. The record must indicate instructions that are given to the patient or the patient's personal representative.  A formal narrative summary (discharge summary) does not substitute for a discharge and/or instruction progress note.
    3. In cases involving death, the time and date the patient expired and the events leading to the death must be recorded by the physician.
19. SNurses Notes.  Entries by specified professional personnel shall contain pertinent, meaningful observations and information documented to reflect the level of training and expertise of the author.  Nursing staff must also write admission and discharge progress notes.  It is preferred that nurses notes be written with a multidisciplinary approach.
20. TFinal Diagnoses.  All relevant diagnoses and operative procedures must be recorded upon the patient's discharge.  The final diagnoses must be consistent and sequenced the same on the Inpatient Clinical Record Brief form (IHS-441), PCC Inpatient Supplement and Discharge Follow-Up Record form (IHS-485) if used, and the Discharge Summary.  No abbreviations or symbols are to be used in final diagnoses and operative procedures.
21. UDischarge Summary..  The following elements are recommended for Discharge Summaries:  date of admission/date of discharge; admitting diagnosis and history; significant findings; hospital course (including procedures performed and treatment rendered); complications; discharge instructions (including activity, diet, and medications); condition on discharge; disposition (if transferred, e.g., state the level of care the receiving facility will provide rehab, acute care, etc.); principal diagnosis (that condition established after study to be chiefly responsible for the patient's admission to the hospital); additional diagnoses (those conditions identified, evaluated, treated, or that required additional resources or extended the length of stay); co-morbid conditions (chronic obstructive pulmonary disease; congestive heart failure, diabetes, etc.); complications; and a follow-up care plan.
    1. A Discharge Summary is required for all discharges including death cases, complicated delivery, and complicated newborn cases.  If approved by the medical staff, a final progress note is sufficient for normal delivery, normal newborn, and patients hospitalized 48 hours or less for a minor complaint.
    2. The Discharge Summary must be prepared for all patient discharges from IHS care, including deaths.  Transfers to other levels of care, such as to another IHS facility, must be documented by a Discharge Summary.
    3. Responsibility for the preparation of the Discharge Summary and for its content rests exclusively with the member of the medical staff having primary care responsibility for the patient.  The treating specialty having primary care responsibility for the patient is exclusively responsible for completing the discharge summary.
    4. The summary must be documented prior to discharge, or within 24 hours of death and irregular discharge.  When the Discharge Summary is completed more than 24 hours prior to discharge, local policy determines the time frame when an addendum is required.
    5. If not the author, the attending physician must review the Discharge Summary, make appropriate edits, and sign it to indicate approval.
    6. All Discharge Summaries must be prepared as follows:
       1. List the principal diagnosis (i.e., that condition established after study to be chiefly responsible for admitting the patient to the hospital for care).  Then, list all other diagnoses for which treatment was given in order of clinical importance. Diagnoses must include postoperative complications or infections and drug or serum reactions.  All diagnoses must include a site and etiology when applicable, must be stated in full without symbols or abbreviations, and in accordance with the latest edition of the International Classification of Disease, and Psychiatric Diagnoses and the latest edition of the Diagnostic and Statistical Manual of Mental Disorders.  The diagnosis must be recorded in AXIS format and, if applicable, must include the Global Assessment of Functioning score.
       2. Operations and surgical procedures must be stated in full, without symbols and/or abbreviations.  The site involved and the procedures performed must be stated.  The listing must include all operations, diagnostic, and therapeutic procedures as well as the date performed. Document all procedures in the text of the discharge summary.
       3. The body must include: The name of the physician or other licensed independent practitioner responsible for the patient's care; reason for admission, (principal diagnosis, e.g., the condition established after study to be chiefly responsible for the patient's admission to the hospital); other diagnoses and/or conditions treated; all operations and procedures performed; the treatment rendered during current admission and the dates of each; pertinent past history; pertinent points in review of systems (including allergies or drug sensitivities); pertinent findings of laboratory and radiological data;
       4. pertinent findings of physical examination, particularly abnormalities;
       5. brief course in hospital stay to include treatment received and condition on discharge.  Condition on discharge must be more specific than "improved" and should permit measurable comparison with the patient's condition on admission;
       6. condition of wound, if applicable;
       7. type of disposition, (e.g., home, nursing home, etc.);
       8. discharge instructions to patient or responsible representative include: information regarding condition or proper home care, continued care, medications, diet instructions, activity and/or limitations; and
       9. if the Discharge Summary concerns a death case there must be a statement that an autopsy was or was not performed.
22. VAgainst Medical Advice and Absent Without Official Leave.  The attending physician or other licensed independent practitioner shall note patients who leave against medical advice (AMA) or are absent without official leave (AWOL) on the discharge progress note, and the patient shall be asked to, sign the Release from Responsibility For Discharge form (IHS-338).
    1. A patient leaving AMA must have a final progress note written by a physician or other licensed independent practitioner indicating any known reason for leaving and any special disposition arrangements.
    2. A Discharge Summary is required for all patients who leave the hospital AMA or AWOL.
23. WSpecific Requirements for Outpatient Documentation.
    1. Required demographic/sociological data must be obtained on the initial registration of the patient and updated according to facility policy.
    2. The health care practitioner must document a pertinent progress note at the time of each ambulatory and/or outpatient care visit.  Cancelled appointments, no-shows, telephone calls, and chart reviews are captured according to facility policy.
    3. The health care practitioner must initiate and maintain a summary and/or problem list by the patient's third visit.  The list must include known significant diagnosis (diagnoses), conditions, pertinent past procedures, drug allergies, medications, and significant procedures performed at other health care facilities.
    4. The physician or health care practitioner must document only those diagnoses treated during a patient encounter or those that require further treatment.  An assessment must be documented following the purpose of the visit or diagnosis to determine if continued care is required.
    5. Elements for health factors and performance measures must be documented when appropriate.
    6. The outpatient clinic note should include, but is not limited to:
       1. identification of clinic (General, Pediatrics, etc.);
       2. date and time of the visit;
       3. subjective findings: refers to historical data gathered from the patient;
       4. objective findings: physical examination and pertinent laboratory data and other test results;
       5. assessment of patient's condition, if needed, to clarify the problem;
       6. plans: further information needed to more clearly define the problem and those manifestations that should be followed over time;
       7. reason (i.e., the medical necessity) for ordering tests, consults, or changes in medication;
       8. specific treatments and goals of the treatment;
       9. outpatient surgery;
       10. patient education: what the patient needs to understand in order to participate in the management or treatment of the problem;
       11. health factors;
       12. follow-up treatment and patient instructions; and
       13. signature and professional designation of the health care professional providing care.
24. XEmergency Visit.  Any appraisal, advice, or initial treatment to the extent provided must be documented on the PCC Emergency Visit Record form (IHS-114) or in the EHR.
25. YEmergency Condition.An emergency condition is defined as a critical condition that requires immediate medical attention to sustain life, prevent further damage or injury, or alleviate pain.  Documented information should include the following:
    1. patient identification;
    2. time and method of patient's arrival and by whom transported;
    3. care received prior to arrival;
    4. present problem(s) (e.g., the reason for visit, history, and objective data relevant to the presenting problem).  When it is not possible for the patient to give a history, document the reason;
    5. assessment of the problem;
    6. treatment plan for the problem;
    7. primary and secondary diagnoses, (e.g., only those dealt with during this encounter);
    8. basis for ordering test, consult, or changes in medication;
    9. elements for health factors and performance measures must be documented when appropriate;
    10. consent for emergency treatment is not required unless local policy requires consent (otherwise consent is implied for treatment);
    11. condition at discharge;
    12. final disposition;
    13. discharge instructions;
    14. signature of provider attending the patient;
    15. documentation on emergency transfers;
    16. reason for transfer;
    17. stability of patient;
    18. acceptance by the receiving organization;
    19. responsibility during transfer; and
    20. medication list.

    The ER Log shall be forwarded by the nursing personnel to the HIM department when the log book is full (Refer to the IHS Records Disposition Schedule, Schedule 3, Professional Services, Item 3-20.)

26. ZProcessing Dead on Arrival Cases.  A person who is dead on arrival (DOA) is not to be recorded on hospital records as a gain or a loss.  All administrative and medical documents prepared for the person who is DOA must be filed in the person's health record, including the Disposition of Body form (SF-523A).

1. AAA.Emergency Medical Treatment and Active Labor Act.  This statute requires that any patient who comes to the emergency department requesting examination or treatment for a medical condition must be provided with an appropriate medical screening examination to determine if the patient is suffering from an emergency medical condition.  If confirmed, the hospital is obligated to either stabilize the patient or transfer the patient to another hospital in conformance with the statute's directives.
2. BBB.Preparing Records for Litigation.  Records for litigation requested by the court or the OGC with unsigned or incomplete entries must be completed before submission to the OGC or to the court.
3. CCC.Inpatient Census Report.  The RPMS Admission/Discharge/Transfer (ADT) of the Patient Information Management System (P.I.M.S.) is preferred for compiling the daily Admission and Discharge Sheet.  If the nursing staff does not use the ADT package for census reporting, the following is the manual process:
   1. An original and one copy of the Inpatient Census Report for Nursing form (IHS-165-2) is initiated by the nurse or ward clerk daily during the evening or midnight shifts as of 11:59 P.M.  All admissions, discharges, transfers, and deaths, of adults and pediatric patients; and all births, discharges, deaths, and transfers to other hospitals are to be recorded by name and service in the appropriate section of the Inpatient Census Report for Nursing form (IHS-165-2).
   2. The original Inpatient Census Report for Nursing form (IHS-165-2) is forwarded to the HIM Department by 7:00 a.m., each morning and a copy retained at the nursing station.  The HIM Department verifies the accuracy of the census report and notifies the Inpatient Nursing Service of errors to be corrected. The corrections must be made on both copies immediately.
4. DDDPreparation of Admission and Discharge Sheet.
   1. ADT File.  Following verification of the Inpatient Census Report for Nursing form (IHS-165-2), the HIM Department staff shall update the ADT file listing the movement of patients within the hospital.  The hospital to which the patient is admitted can be listed but no medical information may be included on this sheet.  Sufficient copies (or read access if electronic) of the ADT sheet can be prepared for the following suggested distribution:
      1. dietitian or food service supervisor;
      2. social service/mental health;
      3. Public Health Nurses in the Service Unit; and
      4. others who need the information to perform their official job duties.
   2. Inpatient Reports.  The ADT package can generate the following reports:
      1. Current Inpatient Census;
      2. Current Inpatient Listing;
      3. Admission forms;
      4. ADT Statistical Reports;
      5. Inpatient Appointments;
      6. Bed Availability;
      7. Provider's Incomplete Charts;
      8. Patient Movement reports;
      9. M202 Monthly Report; and
      10. Y202 Yearly Report.

3-3.9  ELECTRONIC HEALTH RECORD PRINCIPLES

1. General.  The RPMS EHR is intended to help providers electronically manage all aspects of patient care by providing a full range of functions for data retrieval and capture to support patient review, encounter, and follow-up. By moving data retrieval and documentation activities to the electronic environment, patient care activities and access to the record can occur simultaneously at multiple locations eliminating the need to depend on the availability of a paper chart.

   The RPMS EHR combines the powerful database capabilities of the RPMS with a familiar and comfortable presentation layer, the graphical user interface (GUI).  Integration of various RPMS components into the GUI allows providers to obtain a more comprehensive view of the clinical process.  Also integrated into the RPMS EHR is VistA Imaging which allows the collection, storage, and display of radiologic images, electrocardiograph tracings, imaging from other sources, and document scanning.

   As technology allows, all patient care documentation must be stored in the health information infrastructure via (a) direct data entry using RPMS and/or EHR, (b) Text Integration Utility (TIU), (c) VistA Imaging (or other VistA interfaces that facilitate dictation, transcription, uploading documents, voice recognition, document scanning), and (d) other technologies deemed appropriate by IHS.

2. Health Record Creation.  A separate, unique health record is created and maintained for every individual assessed and treated by the IHS, as well as those receiving community ancillary care by the IHS, such as visits by Public Health Nurses, e.g., home visits, health fairs, etc. Printing and filing paper documents from electronic media for active records is not required.
3. Electronic Notes Standards.  Electronically stored patient information is subject to the same medical and legal requirements as the hand-written information in the paper health record.  Entries must be accurate, relevant, timely, and complete.

   Viewing unsigned notes is not allowed because current technology does not provide an audit trail of the note status.  Viewing unsigned notes poses a risk of clinical decision-making based on data that may be revised or deleted.  However, limited access to unsigned notes may be determined by local policy.

   Approved templates may be provided to complete the note text.  Standardized note titles facilitate retrieval of specific patient information.  Issues regarding note title standardization are part of the health record review function.  Appropriate note titles must match note content and the credentials of the author to enhance the ability to find a note quickly and easily.  Notes must be reviewed and signed promptly, as defined by facility policy.

4. Copy and Paste Functions.  The electronic copy and paste function is a powerful tool; however, this functionality must be used with caution and according to strict enforceable policy.  Each facility must develop a policy that ensures the elimination and/or judicious use of this electronic function.
5. Clinical Postings.  Postings consist of crisis notes, clinical warnings, patient allergies, and advance directives.  Postings are entered with an appropriately titled progress note and, if unsigned, may be rescinded by changing the note title.
6. Clinical Reminder.  Clinical reminders are a clinical decision support tool to assist health care staff, but are not part of the clinical record.  The reminders are recommendations based on clinical and administrative policy, and are always to be interpreted within the context of the practitioner's knowledge of the patient.  If an inappropriate clinical reminder is triggered due to an improper code selection, corrections must be made based on facility policy.
7. Patient Flags.  Patient Flags can be setup in the RPMS and added to a patient's record to notify the health care provider of a specific medical condition or situation.  The flags are removed when the patient's condition or situation is resolved.
8. Electronic Signatures.  Facility policy must provide adequate security measures to identify users (authors) who document in the health record by verifying the authenticity of electronic signatures.  Authors are responsible for the sole use of their electronic signature.
   1. Authentication includes the identity and professional discipline of the author, and the date and time a document is signed.  Notes made and authenticated by health care team members must be individually identified either by the use of the individual's title or by appropriate professional credential designation.  Once affixed, authentication of electronic documents cannot be rescinded or repudiated.
   2. No editing or alteration of any documentation with a manual or electronic signature is permitted without approval of the Chief, Medical Information Services, or HIM Director.
   3. An electronic document in the health record may have more than one signature because each has a distinct and separate purpose depending on the role of the signer.  For example, the signers may include the author, transcriptionist/recorder, supervising practitioner, or witness.
9. Document Scanning.  Scanning, or imaging, is a process of converting a paper document to an electronic file.  Scanned documents may be linked to TIU documents and displayed with the TIU document.  Scanned documents do not require an electronic signature but are marked administratively complete.  Only those documents that cannot be created in or interfaced with the EHR will be scanned.  Development of document scanning policies is a shared responsibility among facility HIMs and other appropriate services.
10. Health Record Alterations and Modification.  Electronic progress notes, operative reports, and discharge summaries are occasionally entered by practitioners in the TIU and the EHR software for the wrong patients, or the information within the document(s) may be erroneous.  A local procedure, following the EHR for HIM Guide found at here, must be established for correcting erroneous patient information entered electronically.  It is the responsibility of the HIM to ensure there is a process in place to correct erroneous health record information.  (Refer to Manual Exhibit 3-3-A Comparison of Update, Administrative Correction, Addenda, and Amendment Requests.)

3-3.10  INTERDEPARTMENTAL RESPONSIBILITIES

This section defines for the responsibilities of the medical staff, nursing service, CEO, Privacy Act Liaison (PAL)/Privacy Official (PO), dental, pharmacy, behavioral health, nutrition/dietetics, optometry/ophthalmology, and committees.

1. Medical Staff.  The facility medical staff is composed of independent licensed practitioners with delegated responsibility and authority to maintain and improve proper standards of medical care.  The medical staff ensures adequate documentation of medical events in the patient?s record.
2. Medical Staff Bylaws.  The Medical Staff Bylaws shall specify:
   1. categories of professional personnel who may make entries in the health record;
   2. requirement of health care providers to authenticate those portions of the patient health record for which they are responsible;
   3. categories of personnel who by designation are authorized to accept and transcribe verbal diagnostic orders; and categories of diagnostic and therapeutic verbal orders associated with potential hazard to the patient;
   4. requirement that each patient's medical history and physical examination be completed no more than 30 days before or 24 hours after admission by a physician or other licensed independent practitioner qualified by the medical staff (e.g., a doctor of medicine or osteopathy, a doctor of dental surgery or dental medicine, or a doctor of podiatric medicine);
   5. requirement that verbal or telephone orders be countersigned within 24 hours of issue by a physician or other licensed independent practitioner responsible for the patient's care;
   6. health care providers, other than physicians and dentists, authorized to admit patients or prescribe medication and treatment under standing orders, and those providers whose orders must be countersigned by the attending physician or other licensed independent practitioner; and
   7. action to be taken by the HIM director/supervisor regarding extended health record deficiencies.
3. Nursing Service.  The nursing service shall establish and enforce a health record documentation policy for nursing personnel.
4. Nursing Policy.  Nursing policy is established by the local nursing unit.  The nursing policy must include a section regarding physician's orders including responsibilities for authentication of verbal and telephone orders (Refer to Part 3, Chapter 4, Nursing, IHM).
5. Local Nursing Unit.  The local nursing unit also determines the type, manner, and frequency of documentation that nursing personnel must enter into the health record.
   1. Nursing Supervisor.  The nursing supervisor is responsible for monitoring nursing documentation.  It is considered appropriate for the nursing service to address documentation through its own administrative systems.
   2. Ward Clerks.  Ward Clerks are responsible to assemble the individual health record according to IHS inpatient format.  See 3-3.11H(2)a.(ii) Inpatient Format.  The health record must be reviewed to ensure completion before it is sent to the HIM department.  The HIM staff will provide orientation or training in health records to each ward clerk.
   3. Health Record Maintenance.  The health record is maintained on the nursing unit during a patient's hospitalization.  Current and previous health records are forwarded to the HIM department no more than 1 day after the patient is discharged.
6. Chief Executive Officer.  The CEO ensures the following:
   1. that individual staff or classes of staff who need to use Protected Health Information (PHI) in order to perform their official duties have access, and specify conditions appropriate for such access;
   2. that research projects involving the use of health records have the appropriate IHS Headquarters and IHS Area approvals, and that confidentiality of health records is not breached.  (Refer to Part 1, Chapter 7, Research Activities, IHM, and Part 2, Chapter 7, Health Insurance Portability and Accountability Act Privacy Rule and the Privacy Act, IHM.)
7. Privacy Act Liaison/HIPAA Privacy Official.  The Privacy Act Liaison/HIPAA Privacy Official (PAL/PO) is responsible to the CEO or designee for appropriate release of information from health records; for granting patient's access to their health records; for informing the patient of provisions of the Privacy Act and HIPAA Privacy; and for orienting and training employees in matters regarding the Privacy Act and HIPAA.  The PAL/PO is responsible for monitoring this requirement.
8. Freedom of Information Act Officer.  Unless specifically exempt under the FOIA, a FOIA request may be released only by the IHS Headquarters FOIA Officer.
9. Patient Registration Clerk.  The patient registration clerk ensures that each patient, parent, or personal representative acknowledges the receipt of the Notice of Privacy Practices by using the Acknowledgment of Receipt of the Notice of Privacy Practices form.
10. Dental.  Dental is responsible for compliance with their own standards regarding dental outpatient documentation.  Dental film (X-ray) in the record must be removed prior to the retirement of the record to the FRC.  (Refer to the IHS Records Disposition Schedule, Professional Services, Section 2, Dental Services.)
11. Pharmacy.  All pharmacist entries in the health record must be signed and include professional designation and date of entry.  Drug profiles and flow sheets may be maintained in the record or within an automated portion of the record.
12. Behavioral Health.
    1. Behavioral health (social service/mental health/substance abuse) visits are documented within the health record.  The documentation must contain diagnosis, therapy, and follow-up care plans.  Other relevant information is recorded on progress notes or referral notice.
    2. Psychotherapy notes are process notes (not progress notes) recorded in any medium by a health care provider who is a mental health professional documenting or analyzing the contents of conversation during a private counseling session or a group, joint or family counseling session for the provider's use only, and are kept separate from the patient's medical record.  (Refer to Part 2, Chapter 7, Health Insurance Portability and Accountability Act Privacy Rule and the Privacy Act, IHM.)
13. Nutrition or Dietetics.  A nutritionist or dietician will record all observations and information pertinent to nutrition and dietetic assessment or treatment in the health record, and make recommendations for other providers involved in the care of a patient.
14. Optometry or Ophthalmology.  The optometrist or ophthalmologist is responsible for compliance with Part 5, Chapter 15, Records Management, IHM, regarding patient health records and their own standards regarding documentation.
15. Medical Record Review Committee.  The facility's Medical Record Review Committee is an interdisciplinary team composed of the medical staff, nursing staff, other relevant clinical professionals, and the HIM Director or the HIM Supervisor or their designee.  This committee enhances the ability of the IHS to improve health record quality across the continuum.  Coordination and collaboration with other services such as compliance, nursing, and external peer review programs, must be employed to avoid duplicity.  The Medical Records Review Committee will review patient health records:
    1. for timely completion, clinical pertinence, and overall quality assessment activities; and, when necessary, as medico-legal documents;
    2. for the results of all tests and therapies ordered to ensure they reflect the condition and progress of the patients; and
    3. for the format of the complete health record, the forms used in the record, and for use of electronic data processing and storage systems for health record purposes.
16. Quality Management/Performance Improvement Committee.  This committee is composed of representatives from the facility's provider disciplines (e.g., mental health, pharmacy, nursing, dental, health records) and specialties of medicine as well as administration.  The committee may be organized into subcommittees by specialty or department.  The committee will assist efforts to:
    1. improve patient care within a facility;
    2. examine health care provider's performance against measurable criteria;
    3. perform quality review studies on a retrospective, concurrent, and prospective basis;
    4. objectively measure, analyze, and identify problems;
    5. analyze variations from established facility criteria;
    6. determine patterns and causes of variations;
    7. specify corrective action; and
    8. provide follow-up.

3-3.11  QUANTITATIVE ANALYSIS OF THE HEALTH RECORD

1. Quantitative Analysis.  Quantitative analysis is a review of prescribed areas of the health record for identifying specific deficiencies in recording to ensure that it is complete, accurate, and timely.  Items that do not meet the criteria should be on the deficiency form or in the EHR and completed by the responsible health care provider.
2. Purpose.  The purpose of quantitative analysis is primarily to identify obvious and routine omissions that are easily corrected in the normal course of patient care.  This ensures the health record is more complete for reference in continuing patient care; for protecting the legal interests of the patient, physician, and hospital; and for meeting provider licensing or regulatory and/or accrediting/certifying and IHS requirements.
3. Quantitative Analysis of Outpatient Records.  The availability of a complete, accurate, and current outpatient record is as important as the inpatient record.  It is a part of the total picture of the health status of the patient.  The HIM personnel shall perform an initial review of the record following an outpatient visit.  Procedures shall be developed at the IHS Service Unit to ensure that information is received from contract facilities and physicians.  The following items of documentation shall be assessed as specified in IHS policy or in the facility's Medical Staff Bylaws, Rules and Regulations:
   1. Clinic record.
      1. completion of sociological data;
      2. diagnoses and clinical notes;
      3. use of standard terminology;
      4. approved abbreviations;
      5. do not use abbreviations;
      6. recording of pertinent dental and medical care;
      7. history and physical findings;
      8. date of visit;
      9. chief complaint or reason for visit;
      10. care and treatment;
      11. diagnosis;
      12. instructions to patient; and
      13. signatures/discipline.
   2. Diagnostic tests, x-rays.  Reports for all tests and x-rays ordered are filed in the chart.
   3. Types of treatment.  Documentation of various types of treatment.
      1. Operative Permit
      2. Report of Operation
      3. Pathology Report, if appropriate
      4. Copies of routine physical examinations maintained in record
      5. Obstetrical history, if appropriate
      6. Reports of CHS medical care
      7. Hospitalization summaries by referral hospital or physician
4. Quantitative Analysis of Inpatient Records.
   1. Availability of Records.  The first step in discharge analysis is verification that a record has been received in the HIM Department for each patient discharged.  Verification is made through admission and discharge listings (paper or electronic).  It is important that the health record be made available immediately following discharge (within 1 workday).
   2. Timeliness of Documentation and Review.  It is necessary that the component parts of the health record be recorded as soon as possible after diagnostic procedure, care, or treatment of the patient has occurred, and that the information is summarized immediately following discharge in order to ensure accuracy and credibility.  The legal value of documentation is inversely proportional to the length of time between an event and the documentation of that event.

      It is extremely important that the initial review of a health record be made no later than the first workday following discharge of the patient in order to facilitate meeting accreditation/certification standards, third-party billing requirements, and avoid situations where corrections are required by personnel who are no longer employed at the facility.

   3. Arrangement of Inpatient Health Record.  While the patient is hospitalized, the health record forms of the current admission are arranged in a manner prescribed by the medical and nursing staff.  Upon discharge from the hospital, the health record is rearranged for permanent filing in accordance with the standardized format approved by the IHS.  It is necessary for the filing sequence for health records to be consistent in order to facilitate consultation and review activities.
   4. Record Deficiency Forms.  It is preferred that the Incomplete Chart (IC) option of the ADT module of the RPMS P.I.M.S. be used.
   5. Analysis of Inpatient Record.  Review the inpatient record for the following:
      1. Proper patient is identified on each form.
      2. Signature with the date on the following:
         1. History and physical exam
         2. Orders
         3. Nursing assessment
         4. Care plan
         5. Progress notes
         6. Lab, radiology, as appropriate
         7. Consultations
         8. Consent Forms (e.g., blood transfusion)
         9. Discharge summaries
         10. Operative reports
         11. Patient education
         12. Medical student and resident co-signature
      3. The need for a time frame for documentation is required according to facility policy and/or other regulatory and/or accrediting/certification Agency guidelines.
      4. Coders may further examine the record for completeness to ensure medical necessity or other documentation requirements.  See 3-3.8R, Specific Requirements for Inpatient Documentation.
   6. Review of Component Parts of the Record.  Review inpatient record for the following:
      1. Sociological Data.  The completion of sociological data on each hospital admission, including sex, age, and other significant information.
      2. Health Record Number.  Verify that the correct health record number is indicated; that the most recent admission and other parts of the record are present; and that data is consistent between component parts.
      3. Medical Data.  Completion of all medical data pertinent to the record, with particular note that infections, complications, cause of death, and/or trauma information are properly recorded.
      4. Correlation of Medical Data.  Diagnosis covers the conditions within the record; diagnosis for each operative procedure; final diagnosis to coincide with the pathological diagnosis; and final diagnosis stated in appropriate medical terminology.
      5. History.  Signature of physician or provider taking and writing patient history, with countersignature of responsible physician, if appropriate.
      6. Physical Examination.  Statements of observations and findings, but do not use the terms "negative" or "normal".
      7. Signature.  Signature of the physician or provider performing and writing the physical examination, and, if appropriate, countersignature of the physician.

         One signature or countersignature may be sufficient for both history and physical examination if the same physician is responsible for both documents and if this practice is allowed in the facility Medical Staff Bylaws, Rules and Regulations.

      8. Progress Notes.  Special treatments performed in patient room or elsewhere, necessitating the use of forms other than progress note form; (e.g., biopsy and endoscopic examinations).
         1. in the event of death, note by physician pronouncing patient dead;
         2. signature of author and the date of each progress note; and
         3. time progress note is prepared on the following: anesthesia notes, notes relative to critical events (codes, etc.), and notes pronouncing the patient dead.
      9. Doctor's Orders.  Orders signed or countersigned, if appropriate.
         1. compare orders for tests and x-rays with chart to ensure that reports of tests ordered are filed;
         2. orders for a condition that indicate a complication (e.g., an order for a wound culture in a clean surgical case);
         3. check progress notes for verification of a final diagnosis;
         4. check for completed discharge order written and signed by physician or other licensed independent practitioner, or completed Release from Responsibility for Discharge form (IHS-338).
      10. Laboratory Tests.
          1. laboratory tests adequately recorded;
          2. in the EHR, lab tests are ordered and signed for in the "Orders" window;
          3. any test suggesting complications (e.g., positive wound culture in clean surgical case);
          4. other diagnostic tests indicated (e.g., x-ray report in fracture cases);
          5. pathological report of any tissue removed. Correlate pathology report with final diagnosis and a statement of tissue removal from the operative report; and
          6. reports related to procedures performed in operating room
      11. Consultation.  Completion of all component parts. In the EHR, consults are ordered and completed in the "Consults" window.
      12. Blood Transfusion.  A form for each blood product unit given.
          1. completion of all component parts;
          2. appropriate signatures; and
          3. signed consent of patient.
      13. Surgical Unit Documentation.  Operative permit properly signed for each operation (e.g., bronchoscopy or cystoscopy, surgery, or procedure performed in operating room, or administration of a general anesthesia).
          1. in hospitals, a Pre-anesthetic Summary is recorded for all major surgery;
          2. anesthetic record adequately completed for each operation;
          3. recordings of post-anesthetic visits indicating presence or absence of anesthesia-related complications;
          4. operative report containing all component parts for each operation;
          5. pathology report for surgery where tissue is removed unless procedure is excluded by medical staff (e.g., tissue removed in tubal ligation is usually excluded from the requirement for tissue examination);
          6. consultation report, if the surgeon is other than attending physician;
          7. operative report is accurate. (transcribed title of all procedures present, with accurate and complete anatomical specifications); and
          8. presence of signed and completed patient consent form.
      14. Radiology. In the EHR, radiology is ordered and signed for in the Orders Tab.  If the radiology procedures are outsourced, then the facility will receive the signed report.
      15. Special Reports.
          1. Electrocardiogram.  The electrocardiogram requires appropriate segments of tracing and a report with signature of physician making interpreting it.
          2. Autopsy.  Autopsy requires authorization and report, if autopsy was performed.
5. Qualitative Analysis of Health Records.  Qualitative analysis is a review of health record entries for inconsistencies and omissions that signify the health record is inaccurate or incomplete.  Such an analysis requires a knowledge of medical terminology, anatomy and physiology, fundamentals of disease processes, health record content, standards of provider licensing and other regulatory and/or accrediting/certifying agencies.  It is usually performed by a qualified HIM professional.
   1. Purpose.  As is true of quantitative analysis, the purposes of qualitative analysis include making the health record complete for reference in patient care, protecting legal interests, and meeting regulatory requirements.  However, because it is more in-depth than quantitative analysis, it serves these purposes more fully.  It also contributes background or supporting information for quality improvement and risk management activities.  Qualitative analysis also assists in diagnosis and procedure coding specificity and sequencing that is important for ongoing health research, administrative studies, and reimbursement.
   2. Components.  The components of qualitative analysis include a review of the health record content (assuming the completion of quantitative analysis) for the following:
      1. complete and consistent recording of diagnostic statements;
      2. consistency in entries by all health care providers;
      3. description and justification for the course of the patient's hospitalization;
      4. recording of all necessary instances of informed consents;
      5. application of good documentation practices; and
      6. occurrence of a potentially compensable event.
   3. Examples of Qualitative Analysis.  Review of records for indication of post-op wound infection; review of records for indication of postpartum infection; and review of physical exam for essential data items such as:
      1. pelvic and rectal exam prior to abdominal surgery and quality of documentation of findings;
      2. review of blood and component use against criteria established by the Tissue and Transfusion Committee;
      3. review of documentation items involved in quality review activities which are identified by the medical staff or medical staff body;
      4. review of potentially compensable events; and
      5. review and compare Pathology Reports with Operative Reports and Diagnoses to ensure compatibility and consistency.
   4. Requirements.  Qualitative analysis is not something that may be undertaken lightly.  It requires an in-depth understanding of health record science and management.  The qualitative analysis must be performed or directly supervised by a credentialed HIM professional who is experienced in record analysis and quality review activities.
   5. Frequency.  Qualitative analysis may be done routinely or on a sampling basis depending on facility needs and staffing patterns.  However, the review of results should be a major part of the facility's Medical Record Review Committee activity.

3-3.12  MEDICO-LEGAL ASPECTS OF HEALTH RECORDS

1. Definition of Court of Competent Jurisdiction.  The OGC, Department of Health and Human Services (HHS), has determined that only Federal courts are inherently courts of competent jurisdiction for Privacy Act purposes, whereas because of the doctrine of sovereign immunity, Tribal (and State) courts may be courts of competent jurisdiction only if the United States submits to the jurisdiction of such courts.  The OGC advice and guidance is as follows: "The IHS, upon receipt of a Tribal court subpoena for Federal medical records, has the option of either complying with the subpoena (e.g., voluntarily submitting to the jurisdiction of the court) or processing it pursuant to 45 CFR § 2.5 under rules established in 45 CFR Part 5 (FOIA).  The decision, however, should be made by IHS in consultation with the OGC."
2. Statement of Legal Liaison between Government Agencies.
   1. The Department of Justice (DOJ), through the OGC, is the legal representative of the HHS.
   2. All issues involving litigation shall be directed by the CEO to the Area Director, who shall refer the matter to the appropriate OGC attorney.
3. Characteristics of the Health Record as a Legal Document.  The legal health record is the documentation of health care services provided to an individual during any aspect of health care delivery in any type of IHS facility for administrative, business, or payment purposes.  The legal health record contains individually identifiable health information, stored on any medium, which is collected for documenting health care or health status.  When the legal health record consists of information created as paper documents and information created in electronic media, it is considered to be in a hybrid environment.
   1. The significance of the health record as evidence in a court of law dictates that considerations be given to the following health record characteristics:
      1. All handwriting shall be in dark permanent ink (no red) that is legible when photocopied or microfilmed.  The ink shall not be of the type that soaks through and obliterates information.  Pencil entries in any part of the record are unacceptable.  (Due to extended record retention periods, black permanent ink is preferred.  No highlighters or white-out will be used in the record).
      2. All entries shall be dated and authenticated, including signature and title of the author.  (Signature stamps with original signatures are authorized).  Electronic signatures will be allowed pursuant to the facility's specific guidelines.  Handwriting is deemed to be illegible if two people cannot read the handwriting.
      3. The electronic signature is a computer data compilation of any symbol or series of symbols executed, adopted, and/or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.  The electronic signature is never shared.
      4. Each page within the health record shall contain the patient's identification information and the facility name.
      5. The health care provider shall sign those portions of the health record containing documentation of care for which that person is responsible, including countersignatures where appropriate.
      6. Transcription of dictated information shall be accurate, complete, and authenticated by appropriate signature.
      7. Correction of health record data shall be as follows:
         1. no erasure or other obliteration shall be made;
         2. incorrect data shall be lined out with a single line; and
         3. the date of correction, the signature of the person making the correction, the correct information, and the reason for the correction shall be added.
      8. Any request by the patient for correction/amendment of previously recorded PHI shall be handled by the Privacy Act/HIPAA Privacy Rule.  Refer to Part 2, Chapter 7, IHM.
   2. The health record shall not be removed from the facility at any time except by court order or retirement to a FRC.  Restrictions concerning records removal are:
      1. Court orders must be signed by a judge and specify that the health record be presented for admission as evidence during a legal proceeding, such as, a court case, formal deposition, or grand jury investigation. All court orders received by the HIM Consultant must be forwarded to the OGC for review and the decision to comply is made by the IHS in consultation with the OGC.
      2. Discovery subpoenas (subpoenas issued to gain access to records for the purpose of examination) shall not be honored without the consent of the subject individual.
   3. Health records shall be retained at the facility for the legally specified period of time and shall be transferred to the FRC in accordance with the National Archives and Record Administration regulation (usually after 3-7 years of inactivity).  The IHS Records Disposition Schedule 3-1, Medical Records File is found here.
4. Property and Custody of the Health Record.  The health record is the physical property of the facility and the IHS.  However, information within a health record is the property of the patient.  Original records shall be sent only by certified or registered mail (e.g., to return a record to the FRC).
5. Protect and Secure the Health Record.  To protect the health record from scrutiny or tampering by unauthorized individuals, Service Unit policy shall provide that:
   1. No patient shall transport a health record. Indian Health Service employees must transport patient records within the facility.
   2. Chart runners may transport the health record.
   3. The HIM department shall be secured at all times and accessible to authorized staff only.
   4. During hours when the HIM department is closed, accessibility is limited to authorized staff for the purpose of patient care.
   5. The HIM staff is encouraged to challenge visitors and others not authorized to enter the HIM department.
   6. All mail addressed to the HIM department shall not be opened in the mail room, but delivered directly to the addressee.
6. Privacy and Confidentiality of the Health Record and Information Security.
   1. Confidentiality.  Patient records are confidential regardless of medium.  The privacy of patient information must be preserved, therefore, the information will not be made accessible to or discussed with unauthorized persons.  All staff with access to patient information in the performance of their duties is informed of their responsibility to maintain the confidentiality of patient information.  Every employee with access to patient records in any medium is responsible for proper handling of the patient records.  Each employee is accountable for safeguarding patient confidentiality and privacy, and failure to do so may result in disciplinary or other adverse action up to, and including, termination.
   2. Access.  Access to health care information is controlled to ensure its integrity, to minimize the risk of compromising confidentiality, and to increase reliability.  Access to health records and health record file areas is limited to authorized personnel.  (Refer to Part 2, Chapter 7, IHM.)  Only authorized personnel are allowed to print extractions from the electronic health record or to make copies from the paper chart.
7. Security.  Security measures for authorizing access to the patient's health record must be delineated in local policy.  Only the Director, HIM, or his or her designee, may approve the physical removal of original health records from the treating facility.  Health records in file areas and other areas where health records are temporarily stored (clinic or treatment areas, record review areas, quality assurance areas, release of information, etc.) must be secured when responsible personnel are not present to ensure the security of the area and to ensure records are not accessible to unauthorized individuals.  Precautions must be taken by staff to ensure that patient records on computer screens cannot be seen by unauthorized individuals.  The use of computer privacy screens is encouraged.  All patient-identifiable waste paper and discarded materials from all departments must be shredded or disposed of in accordance with approved disposal policies and procedures of the facility.  Locked containers or shredders must be provided in employee work areas for disposal of all sensitive patient identifiable information.
8. Disaster Recovery Plan.  A disaster recovery plan for protecting and recovering health records damaged or destroyed by fire, flood, or by other means must be in place at all facilities.  Staff must be knowledgeable of the overall plan, as well as their particular responsibility, in the event of natural or man-made disaster impacting normal operations.  The disaster recovery plan must emphasize that the goal is to prevent damage, but to focus on recovery of lost, damaged, or destroyed records.  The plan should include: preparation, response, and recovery with issues for consideration including, but not limited to:
   1. identification of possible disasters causing interruption of services, for example, loss of electricity, flood, fire, or earthquake;
   2. identification of key services (work processes) required to support patient care until normal operations are resumed, and the development of a contingency plan to provide these services;
   3. dentification of contingency methods to provide access to records (e.g., back up MPI) stored on paper or electronically;i
   4. identification of required immediate HIM staff action depending on the type of disaster, i.e., moving records, turning off electricity to areas, closing doors;
   5. coordinate with ancillary departments such as Admitting, ER, Risk Management, and Nursing;
   6. identification contract disaster recovery services vendors; and
   7. identification of equipment on hand or to be purchased, for example, back up generators for lighting, waterproof boxes, carts for transporting records to alternate location.
9. Area Disaster Recovery Services.  Contact the Area disaster recovery vendor/contract staff and document the scope of their available services; advance arrangements must be made, with the disaster recovery vendor to provide priority service to the facility, if possible, for the facility to receive priority service.
   1. Staff must know the location of the disaster recovery manual materials.
   2. Routine disaster drills must be conducted.
   3. Following a disaster, document any portion(s) of patient records deemed lost, damaged, or destroyed, by noting date, data, and reason for loss in the patient record, or in a newly "created" patient record.
10. Continuity of Operations Plan.  A continuity of operations plan for protecting and recovering health records damaged or destroyed by fire, flood, or by other means must be in place.  Staff must be knowledgeable of the overall plan, as well as their particular responsibility, in the event of natural or man-made disaster impacting normal operations.  The continuity of operations plan must emphasize that the goal is to prevent damage first, and then focus on recovery if records are damaged or destroyed.  The plan should include: mitigation, preparedness, response, and recovery with issues for consideration including but not limited to:
    1. Identification of possible disasters causing interruption of services, such as loss of electricity, flood, fire, or earthquake;
    2. identification of key services (work processes) required to support patient care until normal operations can be resumed, and the development of contingency plans to provide these services;
    3. contingency methods to provide access to records, as in back up MPI, in electronically stored or paper form;
    4. identification of required immediate HIM staff action according to the disaster such as moving records, turning off electricity to areas, closing doors, etc.;
    5. coordination with ancillary departments such as Admitting, ER, Risk Management, and Nursing;
    6. identification of contract vendors offering disaster recovery services; and
    7. identification of equipment on hand or in need of purchase such as waterproof boxes, carts for transporting records to alternate location, etc.
11. Area Incident Management Staff.  Area staff with designated responsibility for supporting incidents must be contacted and the scope of their offerings must be documented; advance arrangements must be made, where possible, for the facility to receive priority service.
    1. Staff must be oriented to the location of continuity of operations plans and emergency management plans.
    2. Health Information Management services should be part of routine disaster drills.
    3. Following a disaster, document any portion(s) of patient records deemed irretrievable or lost, by noting date, data, and reason for loss in the patient record, or in the newly "created" patient record, if disaster is of that proportion.
    4. The HIM portion of the continuity of operations plan should be reviewed at least annually along with the overall plan.
12. Rules of Behavior.  The IHS Rules of Behavior (RoB) are published by the IHS information security awareness program.  The IHS RoB can be found at:  Rules of Behavior.

    Procedures are the minimum RoBs for all users and shall be followed by everyone requesting any type of access to the IHS systems. Users realize that the RoBs apply even if the RoBs are not read. Users who do not comply with the prescribed RoBs are subject to penalties that may be imposed under existing policy, regulations, and laws. The IHS may enforce the use of penalties against any user who violates any IHS or Federal systems security and related policy, regulation, or law as appropriate.  Refer the IHS General User Security Handbook at:  IHS User Security Handbook.

13. E-Mail Communication.  Electronic communications (Microsoft Outlook) shall not be used to transmit confidential or sensitive information unless the communications are encrypted and secured.  Users may send patient information on Microsoft Outlook but the subject line must never include a patient's full name, Social Security number (SSN), date of birth, health record number, or address.  The body of the message cannot contain complete patient identifying information.
14. Employee Health Records.  The employee health records are under the management of the Employee Health Nurse and are maintained in a separate location from health records (paper or electronic).  Facilities using the RPMS EHR can set up a note title, Employee Health Record, to be viewed by the Employee Health Nurse or by appropriate staff.
15. Facsimile.  Information received via facsimile (fax) is acceptable and may be included in the patient's health record.  The fax machine transmittals must be limited to immediate need to render patient care.  All established fax protocols must be strictly observed.  (Refer to IHM, Manual Exhibit 2-7-1, Policy and Procedure for Sending and Receiving Protected Health Information by Facsimile.)
16. Confidentiality Statement.  A confidentiality statement must be attached to the cover page when transmitting individually identifiable health information.  The following is an example of a recommended statement:

    THIS FAX IS INTENDED ONLY FOR THE USE OF THE PERSON OR OFFICE TO WHOM IT IS ADDRESSED, AND CONTAINS PRIVILEGED OR CONFIDENTIAL INFORMATION PROTECTED BY LAW. ALL RECIPIENTS ARE HEREBY NOTIFIED THAT INADVERTENT OR UNAUTHORIZED RECEIPT DOES NOT WAIVE SUCH PRIVILEGE, AND THAT UNAUTHORIZED DISSEMINATION, DISTRIBUTION, OR COPYING OF THIS COMMUNICATION IS PROHIBITED BY FEDERAL LAW. IF YOU HAVE RECEIVED THIS FAX IN ERROR, PLEASE DESTROY THE ATTACHED DOCUMENT(S) AND NOTIFY THE SENDER OF THE ERROR BY CALLING (enter applicable Service Unit or Area Office phone number and extension).

17. Compliance.  There must be periodic review, or audit, of access to patient records to ensure compliance with health record privacy and confidentiality standards.  The RPMS Sensitive Patient Tracking system of the P.I.M.S. is used to track accessed records.
18. Responsibility for Use and Disclosure of Protected Health Information.  Providing requested records and the information therein shall be the responsibility of the CEO, or designee who typically is the HIM professional.  The authenticity of each request for information must be determined before disclosure is made.  Disclosure must be made only in accordance with applicable regulations, IHS policy, Privacy Act of 1974 (Privacy Act), HIPAA Privacy Rule, FOIA, Confidentiality of Alcohol and Drug Abuse Patient Records, 42 CFR Part 2.
19. Privacy Act of 1974 and HIPAA Privacy Rule.  The HIM professional safeguards and discloses health information.  The HIM professional is responsible for:
    1. developing policies that comply with the Privacy Act and the HIPAA Privacy Rule;
    2. developing processes and procedures designed to protect the privacy of patient health information and the confidentiality of health records;
    3. monitoring and safeguarding protected health information; and
    4. ensuring that HIM personnel are trained in the proper use or disclosure of PHI under the routine uses of the Privacy Act and the HIPAA Privacy Rule.
20. Routine Uses of the Privacy Act System of Records.  The routine uses in the IHS Medical, Health, and Billing Records, System No. 09-0170001 are listed in the Federal Register, Vol. 73, Number 226, Pages 70655-70662, dated November 21, 2008.  The following are routine uses:
    1. Records may be disclosed to Federal and non-Federal (public or private) health care providers who provide health care services to IHS patients for purposes of planning for or providing such services, or for reporting results of medical examination and treatment.
    2. Records may be disclosed to Federal, State, local, or other authorized organizations that provide third-party reimbursement or fiscal intermediary functions for the purposes of billing or collecting third-party reimbursements.  Relevant records may be disclosed to debt collection agencies under a business associate agreement arrangement directly or through a third-party.
    3. Records may be disclosed to State agencies or other entities acting pursuant to a contract with CMS, for fraud and abuse control efforts, to the extent required by law or under an agreement between IHS and respective State Medicaid agency or other entities.
    4. Records may be disclosed to school health care programs that serve AI/AN for the purpose of student health maintenance.
    5. Records may be disclosed to the Bureau of Indian Affairs (BIA) or its contractors under an agreement between IHS and the BIA relating to disabled AI/AN children for the purpose of carrying out its functions under the Individuals with Disabilities Education Act (IDEA), 20 U.S.C. 1400 et seq.
    6. Records may be disclosed to organizations deemed qualified by the Secretary, HHS, and under a business associate agreement to carry out quality assessment/improvement medical audits, utilization review or to provide accreditation or certification of health care facilities or programs.
    7. Records may be disclosed under a business associate agreement to individuals or authorized organizations sponsored by IHS, such as the National Indian Women's Health Resource Center, to conduct analytical and evaluation studies.
    8. Disclosure may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of that individual.  An authorization, Form IHS-810, "Authorization for Use or Disclosure of Health Information," is required for the disclosure of sensitive PHI (e.g., alcohol/drug abuse patient information, human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), sexually transmitted diseases (STD), or mental health) that is maintained in the medical record.
    9. Records may be disclosed for the following research purposes to the extent permitted by determining that:
       1. the use(s) or disclosure(s) are met under 45 CFR 164.52 1(I); or
       2. the use(s) or disclosure(s) are met under 45 CFR 164.514(a) through 45 CFR 164.514(c) for de-identified PHI, and 5 U.S.C. 552a(b)(5): or
       3. the requirement of 45 CFR 164.5 14(e) for limited data sets, and 5 U.S.C. 552a(b)(5) are met.
    10. Information from records includes, but is not limited to, the following: information concerning the commission of crimes; suspected cases of abuse (including child, elder, and sexual abuse); the reporting of neglect; sexual assault; or domestic violence; births; deaths; alcohol or drug abuse; immunization; cancer; or communicable diseases, may be disclosed to public health authorities, epidemiology centers established and funded under 25 U.S.C. 1621m, and other appropriate government authorities which are authorized by applicable Federal, State, Tribal, or local law, or regulations to receive such information.

        In Federally conducted or assisted alcohol or drug abuse programs, under 42 CFR Part 2, disclosure of patient information for purposes of criminal investigations must be authorized by court order issued under 42 CFR Part 2.65, except in cases of suspected child abuse that may be reported to the appropriate State or local authorities under State law.

    11. Information may be disclosed from Federally conducted or assisted alcohol or drug abuse programs records regarding suspected cases of child abuse to:
        1. Federal, State, or Tribal agencies that need to know the information in the performance of their duties; and
        2. Members of community child protection teams for the purposes of investigating reports of suspected child abuse, establishing a diagnosis, formulating or monitoring a treatment plan, and making recommendations to the appropriate court.  Community child protection teams are comprised of representatives of Tribes, the BIA, child protection service agencies, the judicial system, law enforcement agencies, and IHS.
    12. The IHS may disclose information from these records in litigations and/or proceedings related to an administrative claim when:
        1. The IHS has determined that the use of such records is relevant and necessary to the litigation and/or proceedings related to an administrative claim and would help in the effective representation of the affected party listed in subsections (i) through (iv) below, and that such disclosure is consistent with the purpose for which the records were collected. Such disclosure may be made to the HHS OGC and/or DOJ, pursuant to an agreement between IHS and OGC, when any of the following is a party to litigation and/or proceedings related to an administrative claim or has an interest in the litigation and/or proceeds related to an administrative claim:
           1. HHS or any component thereof; or
           2. any HHS employee in the employee's official capacity; or
           3. any HHS employee in his or her individual capacity where the DOJ (or HHS where it is authorized to do so) has agreed to represent the employee; or
           4. the United States or any agency thereof (other than HHS) where HHS/OGC has determined that the litigation and/or proceedings related to an administrative claim is likely to affect HHS or any of its components.
        2. In the litigation and/or proceedings related to an administrative claim described in subsection (a) above, information from these records may be disclosed to a court or other tribunal, or another party before such tribunal in response to an order of a court or administrative tribunal, provided that the covered entity discloses only the information expressly authorized by such order.
    13. Records may be disclosed under a business associate agreement to an IHS contractor for the purpose of computerized data entry, medical transcription, duplication services, or maintenance of records contained in this system.
    14. Records may be disclosed under a personal services contract or other agreement to student volunteers, individuals working for IHS, and other individuals performing functions for IHS who do not technically have the status of Agency employees, if they need the records in the performance of their Agency functions.
    15. Records regarding specific medical services provided to an unemancipated minor individual may be disclosed to the unemancipated minor's parent or legal guardian who previously consented to those specific medical services, to the extent permitted under 45 CFR 164.502(g).
    16. Records may be disclosed to an individual having authority to act on behalf of an incompetent individual concerning health care decisions, to the extent permitted under 45 CFR 164.502(g).
    17. Information may be used or disclosed from the IHS hospital directory in response to an inquiry regarding a named individual from a member of the general public to establish the individual's presence (and location when needed for visitation purposes) or to report the individual's condition while hospitalized (e.g., satisfactory or stable), unless the individual objects to disclosure of this information.  The IHS may provide the religious affiliation only to members of the clergy.
    18. Information may be disclosed to a relative, a close personal friend, or any other person identified by the individual that is directly relevant to that person's involvement with the individual's involvement with the individual's care or payment for health care.  Information may also be used or disclosed in order to notify a family member, personal representative, or other person responsible for the individual's care, of the individual's location, general condition, or death.  If the individual is present for, or otherwise available prior to, a use or disclosure, and is competent to make health care decisions.
        1. may use or disclose after the facility obtains the individual's consent;
        2. provides the individual with the opportunity to object and the individual does not object; or
        3. based on professional judgment it could reasonably infer that the individual does not object.

           If the individual is not present, or the opportunity to agree or object cannot practicably be provided due to incapacity or emergent circumstances, an IHS health care provider may determine, based on professional judgment, whether disclosure is in the individual's best interest, and if so, may disclose only what is directly relevant to the individual's health care.

    19. Information concerning exposure to HIV may be disclosed to the extent authorized by Federal, State, or Tribal law to the sexual and/or needle-sharing partner(s) of a subject individual who is infected with HIV under the following circumstances:
        1. the information has been obtained in the course of clinical activities at IHS facilities;
        2. the IHS has made reasonable efforts to counsel and encourage the subject individual to provide information to the individual's sexual or needle-sharing partner(s)
        3. the IHS determines that subject individual is unlikely to provide the information to the sexual or needle-sharing partner(s) or that the provision of such information cannot reasonably be verified;
        4. the notification of the partner(s) is made, whenever possible, by the subject individual's physician or by a professional counselor and shall follow standard counseling practices; and
        5. the IHS has advised the partner(s) to whom information is disclosed that they shall not re-disclose or use such information for a purpose other than for which the disclosure was made.
    20. Records may be disclosed to Federal or non-Federal protection and advocacy organizations that serve AI/AN for the purpose of investigating incidents of abuse and neglect of individuals with developmental disabilities (including mental disabilities), as defined in 42 U.S.C. 10801-10805(a)(4) and 42 CFR 51.41-46, to the extent that such disclosure is authorized by law and the conditions of 45 CFR 1386.22(a)(2) are met.
    21. Records of an individual may be disclosed to a correctional institution or a law enforcement official, during the period of time the individual is either an inmate or is otherwise in lawful custody, for the provision of health care to the individual or for health and safety purposes. Disclosure may be made upon the representation of either the institution or a law enforcement official that disclosure is necessary for the provision of health care to the individual, for the health and safety of the individual and others (e.g.,other inmates, employees of the correctional facility, transport officers), and for facility administration and operations.  This routine use applies only for as long as the individual remains in lawful custody, and does not apply once the individual is released on parole or placed on either probation or on supervised release, or is otherwise no longer in lawful custody.
    22. Records including patient name, date of birth, SSN, gender, and other identifying information may be disclosed to the United States Social Security Administration (SSA) as is reasonably necessary for the purpose of conducting an electronic validation of the SSN(s) maintained in the record to the extent required under an agreement between the IHS and SSA.
    23. Disclosure of relevant health care information may be made to funeral directors or representatives of funeral homes in order to allow them to make necessary arrangements prior to and in anticipation of an individual's impending death.
    24. Records may be disclosed to a public or private covered entity that is authorized by law or charter to assist in disaster relief efforts (e.g., the Red Cross and the Federal Emergency Management Administration), for purposes of coordinating information with other similar entities concerning an individual's health care, payment for health care, notification of the individual's whereabouts and the patient's health status or death
    25. Records may be disclosed to appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in this system of records, and the information disclosed is relevant and necessary for that assistance.
21. Policies and Procedures.  The HIM professional is responsible for ensuring that the following are adhered to:
    1. Policies and Procedures (P&P) for Patients Rights to Access, Inspect, and Obtain a Copy of Their Protected Health Information
    2. P&P for Matters Related to Accounting of Disclosures of Protected Health Information
    3. P&P for the Transmittal of Confidential Communication by Alternate Means or to an Alternate Location
    4. P&P for Use or Disclosure of Health Information Pursuant to Authorization or Valid Written Request
    5. P&P for Requests for Correction/Amendment of Protected Health Information
    6. P&P for De-Identification of Protected Health Information and Subsequent Re-Identification
    7. P&P for Use and Disclosure for Directory Purposes
    8. P&P for the Use and Disclosure of Protected Health Information during a Disaster and for Disaster Relief Purposes
    9. P&P for Sending and Receiving Protected Health Information by Facsimile
    10. P&P for Creating a Limited Data Set
    11. P&P for Limiting the Use or Disclosure of and Requests for Protected Health Information to the Minimum Necessary
    12. P&P for Providing Indian Health Service Notice of Privacy Practices
    13. P&P for Use and Disclosure of Protected Health Information for Involvement in the Patient's Care and for Notification Purposes
    14. P&P for Maintenance, Use, and Disclosure of Psychotherapy Notes
    15. P&P for Use and Disclosure of Protected Health Information for Research Purposes
    16. P&P for Request for Restriction(s) on the Use and Disclosure of Protected Health Information
    17. P&P for Disclosure of Protected Health Information of Unemancipated Minors
    18. P&P for Verification of Identity Prior to Disclosure of Protected Health Information
    19. P&P for the Use and Disclosure of Protected Health Information for Emancipated Minors and Adults with Personal Representatives or Legal Guardians
    20. P&P for the Disclosure of Protected Health Information to Law Enforcement Officials.  The HIPAA Privacy Rule Policies and Procedures, Part 2, Chapter 7, IHM, can be found at:  HIPAA.
22. Court Order and Subpoena Duces Tecum.
    1. Disclosure.  The Privacy Act provides that records may be disclosed without an individual's consent if disclosure would be made "pursuant to the order of a court of competent jurisdiction." Hence, a court order must be directed to the Custodian of Record.  The request to produce an individual's health record will be honored if signed by a judge having authority to issue and enforce a judgment in the case before that court.  Additional requirements apply to records of patients treated for drug or alcohol abuse; court orders for such records will be handled in accordance with 42 CFR Part 2, Subpart E.  A subpoena is not a court order unless it is signed by the judge, in which case it would be treated as an order of court.  Usually a subpoena duces tecum is signed by the attorney who wants the record produced (45 CFR § 2.5) (45 CFR § b.9(b)(11).  Under HHS regulations, subpoenas duces tecum for records of the HHS will be deemed a request for records under the FOIA.  This means that IHS cannot disclose health records that are subpoenaed unless the service has written consent of the individual to whom the records pertain.  The Regional Attorney may be advised promptly of the receipt of a subpoena or court order.  Where the U.S. Government is a party to the litigation, the HHS Claims Office will also be notified.
    2. Preparation of a health record for subpoena and other legal purposes.  The HIM Director or Supervisor shall:
       1. verify that the individual has been evaluated and treated at the facility;
       2. ensure that all reports of therapeutic and diagnostic tests performed on the individual are filed in the record, and that the record is complete; and
       3. collect all material requested in the subpoena, such as x-ray film.
    3. Availability of Subpoenaed Record.  Once the subpoena duces tecum has been issued, the health record shall be available for continuity of health care.
23. Confidentiality of Alcohol and Drug Abuse Patient Records.
    1. Confidentiality Requirements.  Public Law (PL) 93-282 imposes strict confidentiality requirements on hospitals and other providers who receive Federal funds, either directly or indirectly, for the performance of any program or activity relating to alcoholism or drug abuse education, training, treatment, rehabilitation, or research (42 CFR Part 2).  Regulations also apply to medical or psychiatric diagnoses that are a known result of alcohol and drug abuse.  Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with any drug or alcohol prevention function are also confidential and shall not be disclosed except as expressly authorized; namely:
       1. To medical personnel to the extent necessary to meet a bona fide medical emergency;
       2. To qualified personnel engaged in research, management and financial audits, or program evaluations providing that the patient's identity remains anonymous; and
       3. On order of a judge from a court of competent jurisdiction granted after application showing good cause.  In determining the extent of disclosure, the court shall impose appropriate safeguards against unauthorized disclosure.  The past, present, or scheduled participation of a patient in such a program or facility is also confidential and shall not be disclosed except as above.
    2. Criminal Investigation.  Unless authorized by court order, no record of an alcohol or drug abuse patient may be used to initiate or substantiate, criminal charges against the patient, or to conduct any investigation of the patient.
    3. Disclosure with Patient's Consent.  Must meet requirements set forth in the HIPAA P&P for "Use or Disclosure of Health Information pursuant to Authorization or Valid Written Request."
24. Privacy of the Patient - Patient Information.
    1. Responsibility for Privacy of the Patient.  The patient's right to privacy is the responsibility of all employees of each IHS facility, regardless of whether direct or contract care programs.  The facility policies shall prescribe procedures that comply with the Privacy Act of 1974 and HIPAA Privacy Regulations.  The procedure should specify the following:
       1. Persons officially authorized to provide information that may be released to news agencies on police cases.
       2. A listing of the type and amount of information that may be released to the press in other than law enforcement.
       3. All such policies shall be directed to promoting the well-being of the patient, protecting the patient's privacy, and assisting the press in covering the news.  When in doubt, the patient's right to privacy takes precedence over the public's right to know.
    2. Newspaper Publicity of Patients.  Indian Health Service personnel shall not release detailed information to the press and shall not permit photographs of the patient without the signed authorization of the patient or his or her authorized representative.  Such authorizations shall become a part of the patient's health record.  Photographs shall be placed in an envelope and properly identified with patient name, health record number, and date photograph was taken.
       1. Information may be used or disclosed from the IHS hospital directory in response to an inquiry about a named individual from a member of the general public to establish the individual's presence (and location when needed for visitation purposes) or to report the individual's condition while hospitalized (e.g., satisfactory or stable), unless the individual objects to disclosure of this information.  (Refer to IHS HIPAA P&P For Use and Disclosure for Directory Purposes.)
       2. The presence of a patient being treated for alcohol or drug abuse shall not be disclosed without the patient's consent. This prohibition includes evaluation, counseling, or treatment of abuse or addiction, and medical or surgical treatment of conditions that are a known direct result of alcohol or drug abuse.
    3. Photographs of Patients.  The signed authorization of the patient shall be obtained when the hospital or any person desires to take a photograph of a patient or any part of the body of a patient for any purpose whatsoever.  The Authorization for Administration of Anesthesia and for Performance of Operations or Other Procedures form (IHS-515) is required for any pictures, films, etc., that are included in the health record.  All media that capture and/or store patient health information are considered part of the health record and are, therefore, subject to confidentiality regulations.  The original or copy of the signed consent becomes a part of the patient's health record.
       1. Clinical Photography.  Permission is not required for photographing surgical or postmortem specimens, if the identity of the patient is not to be revealed.
       2. Television, Video, Motion Pictures.  The Authorization to Produce and Use Audiovisual Materials form (IHS-859) is required for photographs, movies, video and audio tapes taken of the patient.  Unless there is an express agreement to deliver the photograph or the negative to the patient, the patient has no basis for claiming possession of either, but has the right to a copy if Privacy Act and HIPAA Privacy policies are followed.
    4. Visitors to the Patient in Hospital.  Patients have a right to be protected against intrusion upon their privacy in the hospital by laymen who have no connection with their treatment, such as insurance company investigators, salesmen, clergymen, and other persons whom they have not authorized to visit them.  Law enforcement officials should be encouraged to get permission of a patient's attending physician before seeing the patient.  Members of the clergy visiting patients who request patient information will be provided only the following:
       1. the name of hospitalized patients who are of the same faith;
       2. the location of such patients;
       3. whether or not any restrictions or precautions on visitation have been ordered or requested; and
       4. the patient may waive the right to privacy by signing a written authorization for visitation.
    5. Legal Business within an IHS Facility.  Solicitation of legal business is prohibited (42 CFR 35.12).  The solicitation, directly or indirectly, of legal business or a retainer or agreement authorizing an attorney to render legal services, is prohibited in all IHS facilities.
       1. Entry for Negotiation of Release or Settlement Assistance.  No person shall be permitted to enter an IHS facility for the purpose of negotiating a settlement or obtaining a general or special release or statement from a patient with reference to illness or personal injury for which the patient is receiving care or treatment, or for the purpose of conferring with the patient as an attorney or representative of an attorney with reference to such illness or injury, unless the patient has signified willingness to have such person enter for such purpose and, in the judgment of the patient's attending physician the physical or mental condition of the patient will not thereby be impaired (42 CFR 35.13).

          Any person entering an IHS facility for the purpose stated in the above paragraph shall register in the manner prescribed by the attending physician, and shall furnish for the records of the Service Unit or hospital, the name of each patient by whom he or she has been received for such a purpose.

       2. Authorization.  The signed authorization for visitation by such persons shall become a part of the patient's medical record.
       3. Solicitation of Legal Business; Negotiation of Release or Settlement Assistance is Prohibited.  All employees of the Service Unit and all persons attached in any capacity to a Service Unit or hospital, including patients, are forbidden to communicate, directly or indirectly, with any person for the purpose of aiding in the solicitation of legal business or in the negotiation of a settlement or the obtaining of a general or specific release or statement from any patient with reference to any illness or personal injury for which the patient is receiving care or treatment therein (42 CFR 35.14).  No patient is prohibited by this section from communicating on his own behalf with an attorney of his choice or with other persons.

3-3.13  CONSENTS TO MEDICAL AND SURGICAL PROCEDURES

1. Characteristics of an Informed Consent.  All health records must include evidence that informed consent was obtained from the patient or personal representative prior to undertaking any treatment or procedure.  Separate, specific, and informed consent is required for any aspect of treatment or procedure that involves research.  In addition, documentation in the health record must comply with accreditation/certification standards.
   1. Knowledge Before Signing.  The procedure to be performed must be explained in laymen's terms to the patient by the health care provider, so that the patient knows which procedure is being consented to; knows specifically what is to be done; knows the expected results; understands the risks involved; knows the type of anesthesia involved; and is aware of alternative procedures.  At the time of explanation and signing, the patient must not be under the influence of anesthetic or sedation.  If the patient does not understand English, the consent should be explained by an interpreter who must sign as a witness.
   2. Content.  An informed consent document must include the following information:
      1. Name of the facility in which the operation or procedure is to be performed, and the time and date the consent is signed;
      2. Name of provider to perform the procedure;
      3. Name of the patient on whom operation or procedure is to bed performed;
      4. Statement of the nature of the operation or procedure to be performed;
      5. Statement by patient, parent, or guardian, of procedure, risks, and alternatives as the patient understands it.  If written by the provider, it must be in laymen's terms;
      6. Authorization to perform such additional operations or procedures considered necessary or desirable in the judgment of the surgeon or provider;
      7. Consent to dispose of tissues or amputated parts removed at operation;
      8. Authorization for taking photographs in the course of treatment for the purpose of advancing medical knowledge;
      9. Signature of patient or personal representative authorized to give consent on patient's behalf; and
      10. Signature of the witness.
   3. Length of Validity of Consent.  Consents are considered to be valid for a reasonable time after signing.  There is no specific limitation in hours or days after which a new consent must be obtained.  As a matter of policy, no consent is deemed valid after the patient has been discharged.
   4. Emergency Procedure Without Consent.  A procedure may be performed when immediate surgery is necessary and the patient's state is such that he or she cannot rationally consent, or where delay in obtaining the consent of the parent or guardian poses a serious risk to the patient.  Verbal or telephone consent, if obtained, shall be documented in the health record by the responsible practitioner.  When a surgeon operates under such circumstances, the surgeon shall document in the patient's record:
      1. that an immediate operation was necessary;
      2. that consent could not be obtained from the patient or from any person authorized to act for the patient;
      3. that the operation performed was necessary to save the patient's life; or
      4. that delay might involve serious risk to the patient.
2. Consent Form.  The Authorization for Administration of Anesthesia and For Performance of Operations or Other Procedures consent form (IHS-515) shall be used in all IHS facilities.  The age of majority for consent to medical and surgical procedures is in accordance with State laws. Minors may consent to care and treatment in specific categories such as sexually transmitted disease, family planning (Refer to 3-13, Maternal Child Health, IHM), or alcohol/substance abuse counseling and treatment.  Exception: Elective sterilization may not be consented to, or performed on, any patient prior to age 21 according to regulations regarding Federal funding of elective sterilizations.  Patient consent shall be obtained for the following procedures:
   1. Major and Minor Surgery.  Anesthesia; non-surgical procedures that involve more than a slight risk of harm to the patient or that involve risk of a change in the patient's body structure; x-ray therapy; intravenous pyelograms; and all other procedures determined by the medical staff to require a specific explanation to the patient.
   2. Outpatient and Inpatient Care.  Competent adult patients who present themselves for treatment as either outpatients or inpatients consent to the ordinary diagnostic and therapeutic measures used by physicians and other medical personnel; it may be assumed that they know in general that their diagnosis and treatment may entail several procedures and that their request for treatment would include the willingness to submit to these ordinary procedures.  It is recommended that each facility's medical staff create lists of invasive and non-invasive procedures performed at the respective facility requiring informed consent.
   3. Immunizations.  Where State or Federal law requires a written consent for administration of certain vaccines, the consent shall be obtained prior to vaccination of a patient.
   4. Consent for Operative Procedures.  The consent or refusal for consent shall be made a part of the health record.
      1. Consent for Surgery.  Except in emergencies when the patient is physically or mentally incapable of consenting or when the delay required to obtain the consent of natural parents or legal guardians would seriously endanger the patient's health, no operative procedure shall be undertaken unless the patient (or in the case of a minor or incompetent, that person's natural or legal guardian) gives informed consent; nor shall any major operative procedure or the administration of preoperative medication or a general anesthetic be undertaken unless informed consent has been obtained in writing.
      2. Consent for Administration of Anesthesia.  The patient's written informed consent is required for the administration of general or spinal anesthesia.  The patient must be informed in laymen's terms of the procedure to be performed and the risks involved.  The surgeon performing the procedure is responsible for obtaining the consent.  The witness to the consent form shall not be a member of the operating team.
      3. Cesarean Section.  Only the consent of the patient is necessary. The signed authorization becomes a part of the health record.  In emergency cases where the life of the mother and/or child is threatened and the mother is unable to provide written consent, the provider should obtain oral consent from the mother and document the consent in the health record.  If, in addition, the mother is unconscious or otherwise unable to provide informed consent, and a spouse or other appropriate family member is unavailable to provide consent, then no consent is required, however, the basis for proceeding with the cesarean section without consent should be documented in the health record.
      4. Sterilization.  An individual desiring sterilization that is not medically indicated because of specific pathology involving reproductive organs must be 21 years or older and mentally competent.  A full explanation, both orally and in writing, shall be furnished of the procedure to be followed, risks and subsequent discomforts, benefits to be expected, and alternative methods of family planning.  The individual shall be informed that a decision against sterilization will not prejudice future care or treatment. A sterilization procedure will not be performed for 30 days following execution of an informed consent nor more than 180 days after consent is executed (42 CFR 50.201,202,203).  An individual may consent to be sterilized at the time of a premature delivery or emergency abdominal surgery, if at least 72 hours have passed since he or she gave informed consent for the sterilization.  In the case of premature delivery, the informed consent must have been given at least 30 days before the expected date of delivery.  A separate Consent for Anesthesia and Surgery must be signed immediately prior to the surgery.  This is an additional consent to meet requirements for the surgical procedure itself. (Refer to Part 3, Chapter 13, Section 12F(5), Maternal and Child Health IHM.)
      5. Special Therapy.  Consideration should be given to the need for consent in the event that the patient is given therapy that may be hazardous. The patient shall be informed and it should be documented in the health record.
      6. Special Situations.  In certain special situations, additional procedures and documentation are required. These include consent for unusual or extremely hazardous treatments or procedures, forced administration of psychotropic drugs, testing and treatment for HIV, and research. These are also specific notice and documentation requirements for medical emergencies and for the release of evidentiary information from the health record when the practitioner suspects the patient might have been subject to abuse or neglect.
3. Consent to Examination in Sexual Assault Cases.
   1. Sexual Assault Kit.  The contents of the sexual assault kit shall be maintained in a separate envelope and filed according to local facility policy.
   2. Adult.  In the case of an adult who voluntarily presents for treatment at an IHS facility, such action constitutes sufficient evidence of consent to examination and to such therapeutic measures as deemed necessary.
   3. Minor.  When a minor is presented by parents or legal guardian, a request for examination or treatment is sufficient evidence of consent.  In the absence of a parent or legal guardian, the minor may consent to the examination and treatment.
   4. Examination Requested by Police or other Law Enforcement Official.  If a police or other law enforcement official requests that an alleged rape victim be examined in order to obtain evidence in a possible criminal prosecution, and the alleged rape victim refuses to undergo the examination, the requested examination shall not be undertaken.  The IHS facilities are not adjuncts to law enforcement agencies and have no authority to require a beneficiary to submit to examination solely for police purposes.  To do so would subject the physician to possible liability for assault and battery.

      The examining physician shall obtain written consent and record in the patient's record the following:

      1. date, time, and place of examination;
      2. age of patient;
      3. the manner in which the examination was requested;
      4. the names of accompanying persons and their relationship to patient;
      5. the history and physical findings; and
      6. the treatment rendered.
4. Other Consents and Release from Responsibility.
   1. Release from Responsibility for Discharge.  When a patient refuses to remain in the hospital for essential continued care or when parents of a minor refuse to allow the patient to continue to receive necessary hospital care, the patient or personal representative should be requested to sign the Release from Responsibility for Discharge form (IHS-338).  If the signing of a release from responsibility is refused, this fact shall be recorded on the form by the attending physician or other licensed independent practitioner together with the signature of a witness to the request.  The Release from Responsibility for Discharge form (IHS-338) shall be made a part of the health record.
   2. Transfer of Patients and Records to another Facility.  Patients transferred from an IHS facility to another IHS, public, or privately owned facility for continuity of health care must sign an informed consent to the transfer.  Inpatients being transferred must sign the Patient Transfer form (IHS-814).  Patients transferred from the ER should sign the Out-of-Hospital Transfer Record form (IHS-517).  A person who signs the consent form on behalf of the patient must have the legal authority to do so.  The release of medical information to the receiving facility is authorized as a "Routine Use" for records that do not contain information regarding alcohol or drug abuse treatment.  When the patient is unable to consent in an emergency situation, the attending physician or other licensed independent practitioner documents the patient's condition and the need for transfer on the discharge progress note.
   3. Do Not Resuscitate.  A Do Not Resuscitate Order (DNR) is an order that is signed by the attending physician into the patient's medical record stating the patient will receive all medically appropriate therapeutic and/or palliative care, but in the event the patient suffers cardiac or respiratory arrest, cardiopulmonary resuscitation (CPR) will not be attempted.  The DNR order may be written to provide for limited or modified CPR efforts in accordance with the patient's or the patient's representative wishes.  (Refer to Part 3, Chapter 25, Patient Self-Determination and Advance Directives, IHM, as well as local facility policy.)
   4. Advance Directive.  An advanced directive is a written instruction, such as a living will or durable power of attorney for health care, recognized under State law, either by statute or case law, and designed to direct the health care of the patient to whom it applies.  An advance directive takes effect when the patient to whom it applies becomes incompetent to make medical decisions.  (Refer to Part 3, Chapter 25, Patient Self-Determination and Advance Directives, IHM, as well as local facility policy.)

3-3.14  MINORS

1. Legal Definition of a Minor Patient.  A minor patient is a person who is under the age of legal competence.  This age is established by State law in which the IHS facility resides.  Where no State statute exists, eighteen (18) is considered the age of majority.  (Exception: Elective sterilization may not be consented to, or performed on, any patient prior to age 21 according to regulations regarding Federal funding of elective sterilizations.)  State laws and Federal court case law establish certain conditions that may be treated without parental consent of a minor patient.  However, in most instances it is best to obtain consent of both the patient and parent.  Although age is often the sole criterion given consideration for ability to give legal consent for treatment, the effects of marriage, maturity, and emancipation must also be considered.
2. Care or Treatment of Minors.  A parent or legal guardian of a minor patient is authorized to act on the patient's behalf.  An individual authorized to act on behalf of a minor patient will be viewed as if he or she were the subject individual with the exception of total access to the patient's health record.  A parent or legal guardian will furnish verification of identity as required in 45 CFR 5b.5.
3. Consent for Operation and Treatment of Minors.  The laws of States are generally consistent with Federal regulations and case law in allowing treatment of minors for certain conditions such as sexually transmitted disease, drug addiction, alcoholism, birth control, and obstetric care without parental consent.  However, if State and Federal laws conflict refer the issue to OGC.
   1. Parent(s) or Guardian.  Operations on minor children shall be lawfully authorized by the parent or a court-appointed legal guardian.
   2. Age of Reason.  Patient consent should be obtained from a minor patient who is determined by the health care provider to be mature and understands the nature and potential consequences of the procedure.
   3. Divorce.  Consent for procedure in the case of a minor is a matter of State law when the minor patient's legal parents are divorced.  In the absence of State law prohibition, or court granted restraining order on one of the natural parents, both natural parents are equally the next of kin of the minor child and as such have a right to consent to medical procedures.  However, in the case of divorce, the consent of the custodial parent should be obtained when possible or practical.
   4. Court-Appointed Legal Guardian.  The minor has a guardian appointed by the court to manage his affairs if he has no parents, or the parents have been deprived of the child's custody or control by the court.
   5. Adult Siblings.  Permission of adult siblings of a minor cannot substitute for the permission of the parent.  In emergencies, policies regarding emergency cases would prevail and the written permission of the adult sibling should be obtained in the absence of the next of kin or court appointed guardian.
4. Definition of Emancipated Minors.  Emancipated minors, as used in reference to the parent-child relationship, are those who live independently of their parents; and involves an entire parental surrender of the right to the care, custody, and earnings of the minor as well as a renunciation of parental duties.  The criteria for emancipation may vary by State; however, most include court orders, marriage, and financial independence.  Emancipation may be expressed, implied, or granted by court petition.  Married minors are not required to obtain the consent of a spouse or parent for medical treatment; minor parents may consent to the treatment of their children.
5. Court Orders.  If parents or legal guardians do not authorize medically necessary treatment, a court of competent jurisdiction may order a procedure not only in an instance when the life of a child or incompetent adult is to be saved, but also in cases in which the health, limbs, or future of the patient is at risk.  Where such State laws exist, the court may find that the child is "neglected" or "dependent" and appoint a legal guardian in place of the parent.
6. Medical Procedures without Consent.
   1. Emergency State.  A medical emergency in which a procedure may be performed when immediate surgery is imperative and delay in obtaining the consent of a minor's parent or legal guardian involves serious risk to the patient. Attempts to reach the parents or legal guardian should be well documented in the health records.  Policies stated in the section 3-3.13 "Consents to Medical and Surgical Procedures" for adult patients also apply in this instance.
   2. Unmarried Pregnant Minor Females.  The patient may consent to prenatal care, delivery, and postnatal care.
   3. Discharge of Infant to Person Other than Parents.  If the infant is to be taken from the hospital by a person other than the parents or legal guardian, a signed release Authorization for Release of Minor and/or Minor's Records to Person other than Parent or Guardian form (IHS-214) shall be made part of the record.
   4. Consent of Parent or Legal Guardian or Other Person Who Has Primary Responsibility for the Care of the Child.
      1. Parental consent shall be obtained for surgical procedures except in emergency cases.
      2. State laws requiring consent for immunizations shall be complied with.
   5. Boarding School.  While most Indian children attend regular public schools, about 10 percent attend the 171 BIA schools that are funded by Bureau of Indian Education (BIE) and operated either by the BIA or by various Tribes through grants or contracts.  While the child is enrolled and living at the BIE boarding school, the Consent of Parent or Legal Guardian or Other Person Who Has Primary Responsibility for the Care of the Child form (IHS-47) that documents parental authorization for routine procedures and emergency care must be obtained by the boarding school and kept on file.  Parents must sign a new authorization form each year.

3-3.15  DEATHS AND AUTOPSIES

1. Responsibility to Pronounce Patient Dead.  Only a physician is qualified to pronounce a patient dead.  Official pronunciation of death shall be recorded in the health record by the physician indicating time, date, examination of vital signs; and the physician must sign it.
2. Consent to Autopsy and Other Postmortem Operations.  The Authorization for Autopsy form (SF-523) shall be used to obtain the consent for an autopsy.  Consent to Autopsy and Other Postmortem Operations 42 CFR Chapter 1, § 35.16 states that autopsies or other postmortem operations, including removal of tissue for transplanting, may be performed on the body of a deceased patient only by direction of the physician in charge and only if consented to in writing by a person authorized under the law of the State in which the Service Unit or hospital is located to permit an autopsy or such other postmortem operation under the circumstances of the particular death involved.  Restriction or limitations imposed by the person consenting thereto on the extent of autopsy or other postmortem operation shall be observed.  Documents embodying consent shall be made a part of the clinical record.
3. Persons Eligible to Provide Consent.  In general, consent for an autopsy is given by the person entitled to possession of the body for disposition.  Ordinarily this right rests with the next of kin.  The order of progression of entitlement is generally as follows:  spouse of an adult decedent; or all competent adult children in the absence of a spouse; or the parent(s) of a minor; or an adult in the absence of spouse or adult children; or the decedent's siblings in absence of spouse, parent, or adult children.  All siblings are recognized as being an equal next of kin by law because the law does not make the oldest son or daughter or sibling the representative of others.
4. Conflict.  Conflict can occur regarding issues such as the rights of minor children versus adult siblings.  When such conflict exists, the IHS will take no action until so ordered by a court of competent jurisdiction.
5. Medical Examiner's and Coroner's Cases.  (Refer to Part 3, Chapter 6, Section 8, Laboratory Services, IHM.)  Generally, the following types of cases are reported: deaths occurring without previous medical attention, as defined by State law; homicides; suicides; deaths caused by communicable disease; deaths resulting from accidents on the job; and sudden death arousing suspicion of crime or foul play; manslaughter cases, regardless of the cause; criminal abortions; accidents causing death directly or indirectly as a result of gunshot wounds; poisonings; and bums or scalds resulting from fires, explosions, and conflagrations; deaths occurring under the influence of an anesthetic, whether in an operating room or a patient's room; drowning; deaths resulting from acute alcoholism or drug addiction; and deaths occurring in the hospital as a result of an injury sustained there.
   1. Autopsy/Disposal of Stillborn.  Parental consent is required to autopsy live born infants who expired, as well as on stillborns regardless of gestation period at expiration.

      Exception:  When required to perform an autopsy by court order or State law.  If the parents or other persons have the right to bury but do not exercise that right or to dispose of the stillborn child, written consent for disposal by the hospital must be obtained. However, if only oral consent for disposal can be obtained it should be documented and attested to by a witness, in the mother's health record.  When the parent(s) or other party authorized to give legal consent to dispose cannot be located, and the State, county, or municipal government will not accept responsibility for disposal, it shall be documented in the mother's health record before the hospital effects disposal.

      If the parents choose to dispose/bury the stillborn but fail to claim the stillborn within 3 days after the mother is discharged, the parents will be notified by certified mail that the stillborn is still held by the hospital.  If there is no response from the parents in 12 days, the facility will dispose of the stillborn and document it in the mother's health record.

   2. Disposition of Body.  If a morgue exists in the facility, the hospital employee who brings the decedent to the morgue shall complete the first part of the Receipt of Body at the Morgue form (SF-523A).  The Certificate of Removal portion shall be completed and signed by the hospital employee who releases the body to the mortuary representative or other authorized individual.
   3. Physician Statement.  The physician's statement regarding the condition of the decedent at release indicate whether or not an autopsy was performed.  A description of cuts, incisions, traumatic or surgical fractures, discolorations, and abrasions are noted.  The completed form shall be filed with the copy of the death certificate in the patient's record.

3-3.16  VITAL STATISTICS

1. Birth Certificates.  Information entered on birth certificates shall be obtained from the mother and/or the father of the child.  The mother and/or the father will review and sign the birth certificate to certify that the information is correct and the birth shall be registered, either manually or electronically, with the State's Vital Statistics Office in accordance with applicable State statutes.  Correction of birth certificates is the responsibility of the child's parents through the State Bureau of Vital Statistics.  The IHS records shall be changed only when authorized with an official copy of the corrected birth certificate or upon order of a court of competent jurisdiction.

   Indian Health Service facilities are not authorized to provide copies of birth certificates for any purpose.  If a prematurely aborted fetus shows signs of life such as a heartbeat, umbilical cord pulsation, or movement of voluntary muscles, a certificate of live birth shall be completed; and upon death, a death certificate shall be completed.  A health record is also created.

2. Fetal Death or Death Certificates.  The death certificate has two areas of information:
   1. Demographic Information.  The health records department is responsible for completing the demographic portion.
   2. Medical Information.  The physician or other licensed independent practitioner is responsible for completing the medical portion

      Refer to the Medical Examiners' and Coroners' Handbook on Death Registration and Fetal Death Reporting for specific guidelines on completing the death certificate.