Chapter 21 - Diagnostic Imaging

Title	Section
Introduction	3-21.1
Purpose	3-21.1A
Scope	3-21.1B
Authority	3-21.1C
Policy	3-21.1D
Definitions	3-21.1E
Responsibilities	3-21.2
Director, Office of Clinical and Preventive Services (OCPS)	3-21.2A
Director, Office of Environmental Health and Engineering (OEHE)	3-21.2B
Area Director	3-21.2C
Area Chief Medical Officer (CMO)	3-21.2D
Area OEHE Director	3-21.2E
Chief Executive Officer (CEO)	3-21.2F
Radiation Safety Officer (RSO)	3-21.2G
Managers/Supervisors	3-21.2H
Diagnostic Imaging Service Qualifications and Training	3-21.3
Personnel Staffing Qualifications	3-21.3A
Personal Services Contractors	3-21.3B
Training	3-21.3C
Professional Affiliations	3-21.3D
Facilities Planning and Construction	3-21.4
IHS Facility Requirements	3-21.4A
Contracting for Mobile Diagnostic Imaging Service	3-21.4B
Diagnostic X-Ray Radiation Protection	3-21.5
Objectives	3-21.5A
Appropriateness Criteria	3-21.5B
Reducing Exposure to Patients and Occupationally Exposed Personnel	3-21.5C
X-ray Device Performance Monitoring	3-21.5D
Maintenance of X-ray Equipment	3-21.5E
Program Operation	3-21.6
Radiographic Procedures	3-21.6A
Fluoroscopic Procedures	3-21.6B
Ultrasound Procedures	3-21.6C
Mammography	3-21.6D
Patient, Client, or Customer Considerations	3-21.7
Quality Assurance	3-21.8
General Requirements	3-21.8A
Equipment Technique Guide for X-ray Exposures	3-21.8B
Imaging Reject Analysis	3-21.8C
Film Based Imaging Systems	3-21.8D
Digital (Electronic) Radiographic (DR) Imaging Systems	3-21.8E
Performance Improvement	3-21.8F
Diagnostic Imaging Records	3-21.8G
Safety Other Than Radiation	3-21.8H
Required Reports	3-21.9
Management Control	3-21.10
Diagnostic Imaging Services Review	3-21.10A
Program Reviews of Diagnostic Imaging Departments	3-21.10B
Area Diagnostic Imaging Services Review	3-21.10C

3-21.1  INTRODUCTION.

1. Purpose.  This chapter establishes policy and procedures pertaining to the delivery of diagnostic imaging services administered by the Indian Health Service (IHS).  This chapter ensures:
   1. that IHS beneficiaries receive high quality diagnostic imaging services;
   2. that patient ionizing radiation dose is minimized, while being consistent with clinical requirements.  This includes the use of non-ionizing radiation imaging technologies when appropriate, the elimination of unnecessary X-ray exams, and the elimination of unnecessary radiation dose during exams; and
   3. that radiation exposure to medical, dental and ancillary personnel is as low as reasonably achievable and lower than the occupational absorbed dose limits established by the National Council on Radiation Protection and Measurements (NCRP) and the Occupational Safety and Health Administration (OSHA) in Ionizing Radiation, 29 Code of Federal Regulations (CFR), §1910.1096.
2. Scope.  The policy addresses diagnostic modalities commonly used in the IHS including: medical and dental X-ray, ultrasound, mammography, and computed tomography (CT).  Imaging services and radiation services not covered by this policy include nuclear medicine, magnetic resonance imaging (MRI), and therapeutic radiation.  Some IHS facilities offer diagnostic imaging through a contracted service.  Contracted vendors shall be required to provide equivalent levels of patient and employee radiation safety as those described in this policy.  Tribally-operated facilities are strongly encouraged to adopt and implement similar standards for the quality and safety of diagnostic imaging services.

   The policy and chapter content relate to the quality and safety of diagnostic imaging services.  Compliance with CMS requirements related to billing/payment not directly related to the cited standards should be addressed elsewhere in Area, Service Unit, or facility policies and procedures as appropriate to the CMS provider type and imaging modality(ies).

3. Authority.  The primary authority regarding diagnostic imaging services is the Centers for Medicare and Medicaid Services (CMS).  The Food and Drug Administration (FDA), the American College of Radiology (ACR), NCRP, the Accreditation Association for Ambulatory Health Care, Inc., (AAAHC), Det Norske Veritas (DNV), and The Joint Commission (TJC) are also lead authorities for medical practice and diagnostic imaging in the United States.  The regulations and standards of these organizations are referenced throughout this chapter.
   1. CMS, Condition of Participation (Hospitals):  Radiological Services, 42 CFR, §482.26(b).
   2. CMS, Condition of Coverage (Ambulatory Surgical Centers) - Laboratory and Radiological Services, 42 CFR, §416.49(b).
   3. CMS, Condition of Participation (Critical Access Hospitals): Radiology Services, 42 CFR §485.635(b)(3).
   4. CMS, State Operations Manual, Appendix AExit Disclaimer: You Are Leaving www.ihs.gov  - Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, 2015.
   5. FDA, Mammography Quality Standards Act Regulations (MQSA), 21 CFR §900Exit Disclaimer: You Are Leaving www.ihs.gov .
   6. OSHA, Ionizing Radiation, 29 CFR, §1910.1096.
4. Policy.  The IHS shall offer high quality diagnostic imaging services and protect patients and staff from unnecessary radiation exposure by complying with applicable CMS and FDA regulations, to include the following nationally-recognized standards of practice guidelines regarding appropriate use, quality assurance programs, dose minimization, and equipment performance monitoring as follows:
   1. (1) Medical radiology services (using CT, fluoroscopy, general above table radiography, portable general radiography X-ray systems, dual-energy X-ray absorptiometry, and podiatry devices) will follow applicable accreditation organization standards, and professional practice parameters and technical standards prescribed by the ACR.  These may include, but are not limited to:  ACR Appropriateness Criteria, Diagnostic Radiology, Diagnostic Fluoroscopy, Adult and Pediatric Radiology, Computed Tomography, and Medical Physics Practice.
   2. Mammography services shall comply with the FDAs, MQSA regulations.Exit Disclaimer: You Are Leaving www.ihs.gov 
   3. Oral health services (using intraoral and panoramic X-ray devices) will follow standards of practice guidelines prescribed by the NCRP and the America Dental Association (ADA), including but not limited to:
      1. NCRP, Report Number 145 - Radiation Protection in Dentistry, October 2004.  NRCP reports can be purchased hereExit Disclaimer: You Are Leaving www.ihs.gov .
      2. ADA/FDA, The Selection of Patients for Dental Radiographic Examinations, November 28, 2012Exit Disclaimer: You Are Leaving www.ihs.gov .
   4. Computed and Digital Radiographic Systems will follow standards of practice guidelines regarding information technology data transfer protocols and digital storage including the ACRadiology, ACR-AAPM-SIIM Technical Standard for Electronic Practice of Medical Imaging, 2012.  These guidelines can be found at the ACR websiteExit Disclaimer: You Are Leaving www.ihs.gov .  (Consistent with IHS policy, Interconnection Security Agreements or Data Exchange Agreements are required for the exchange of patient health information with vendors.
   5. The IHS facility design and operations will follow general radiation protection guidelines of the NCRP including, but not limited to, the following NCRP Reports:
      1. NCRP, No. 049 - Structural Shielding Design and Evaluation for Medical Use of X Rays and Gamma Rays of Energies up to 10 MeV, 1976.
      2. NCRP, No. 054 - Medical Radiation Exposure of Pregnant and Potentially Pregnant Women, 1977.
      3. NCRP, No. 099 - Quality Assurance for Diagnostic Imaging, 1988.
      4. NCRP, No. 102 - Medical X-Ray, Electron Beam and Gamma-Ray Protection for Energies Up to 50 MeV (Equipment Design, Performance and Use, 1989.
      5. NCRP, No. 105 - Radiation Protection for Medical and Allied Health Personnel, 1989.
      6. NCRP, No. 133 - Radiation Protection for Procedures Performed Outside the Radiology Department, 2000.
      7. NCRP, No. 145 - Radiation Protection in Dentistry, 2003.
      8. NCRP, No. 147 - Structural Shielding Design for Medical X-Ray Imaging Facilities, 2004.
      9. NCRP, No. 172 - Reference Levels and Achievable Doses in Medical and Dental Imaging: Recommendations for the United States, 2012.
   6. Diagnostic Ultrasound services will follow practice parameters and technical standards prescribed by the ACR.  This includes, but is not limited to: ACR-SPR-SRU Practice Parameter for Performing and Interpreting Diagnostic Ultrasound Examinations.  This practice parameter as well as more specific applications of ultrasound service practices parameters and technical standards can be found at the ACR websiteExit Disclaimer: You Are Leaving www.ihs.gov .
   7. The most recent versions of the national standards of practice will be used.
   8. In addition to these national standards of practice, all diagnostic imaging services shall meet or exceed CMS, TJC, DNV, AAAHC, and/or applicable State standards and regulations.
5. Definitions.
   1. Certified Equipment and Components.  Electronic products certified by the manufacturer to be in compliance with applicable standards described in 21 CFR, part 1020, "Performance Standards for Ionizing Radiation Emitting Products."
   2. Diagnostic Imaging.  The creation of human anatomy images.  Diagnostic imaging is used to aid in the diagnosis and treatment of disease, trauma, or other abnormality.  Diagnostic Images may be produced through the use of X-ray radiation (Diagnostic X-ray Imaging), sound waves (Ultrasound/Sonography), or magnetic resonance.
   3. Diagnostic Imaging Services (DIS).  For the purpose of this chapter, DIS includes both radiology department and dental department imaging services, as well as all treatment spaces where imaging services are provided.
   4. Exposure Creep.  A phenomenon in computed and digital radiography in which patient exposures gradually increase over time to avoid the appearance of noise in underexposed images.
   5. Licensed/Certified.  Licensing and certification is a process whereby a state government or non-governmental agency or association grants recognition to whoever meets certain predetermined qualifications.
   6. Mammography Technologist.  A registered radiologic technologist who meets the requirements of the "FDA Mammography Quality Standards Act."
   7. Patient Dose and Exposure.  Usually an estimate of patient exposure using a patient-simulated phantom.  There are several estimates of dose that will be determined by a qualified medical physicist.  The primary estimates include:
      1. Achievable Dose.  Approximately the median (50th percentile) of the study dose distribution i.e., half of the facilities are producing images at lower doses and half are using higher doses.  Further information on ADs is available in NCRP Report 172.
      2. Diagnostic Reference Level (DRL).  An investigational level used to identify unusually high radiation doses for common diagnostic medical X-ray imaging procedures.  DRLs are suggested action levels above which a facility should review its methods and determine if acceptable image quality can be achieved at lower doses.
      3. Entrance Skin Exposure.  The amount of radiation delivered at the skin surface (also called tissue dose). Common entrance skin exposure tests include adult chest Posterior to Anterior (PA), abdomen Anterior to Posterior (AP), and lateral spine AP for above table and portable general use X-ray devices, as well as dental intraoral bitewing radiographs.
      4. Organ Dose.  The distribution of absorbed dose in a patient depends on the amount of incident radiation, the location and direction of the incident beam, and the attenuation of the beam in the body.  Calculating patient organ doses is difficult based on these factors.  This difficulty in calculating organ doses is one reason the FDA has chosen to use "free-in-air," patient entrance skin exposure measurement in its Nationwide Evaluation of X-ray Trends studies.
   8. Other radiation exposure measurements include:
      1. For mammography, the FDA requires that the average glandular dose delivered during a single cranio-caudal view of an FDA-accepted phantom simulating a standard breast shall not exceed 3.0 milligram (0.3 rad) per exposure.
      2. In fluoroscopy, exposure is measured as air kinetic energy released in material (kerma) rates in the context of a maximum exposure rate as regulated by the FDA.
      3. Computed Tomography Dose Index volume for the adult body and head scan.
   9. Phantom.  A device that absorbs and scatters X-rays in approximately the same way as tissues of the body.  A body phantom is used to make measurements that include scattered radiation.
   10. Quality Assurance Program.  Facility based activities to improve the Diagnostic Imaging Services.  The quality assurance program is a system of plans, tests, reviews, reports, records, and actions, whose purpose is to protect patients and radiation workers from unnecessary exposure to radiation and to reduce the occurrence of misdiagnosis caused by faulty equipment and operator error.
   11. Qualified Medical Physicist.  Certified qualified medical physicists meeting the American Association of Physicists in Medicine (AAPM) definition.  AAPM defines a qualified medical physicist as, an individual with the following credentials:
       1. Has earned a master's or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university;
       2. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education.  The AAPM, Definition of a Medical Physicist is available at the AAPM websiteExit Disclaimer: You Are Leaving www.ihs.gov ; and
       3. Medical physicists conducting mammography surveys must have additional qualifications and training as required under the Mammography Quality Standards Act regulations.
   12. Radiographer or Radiologic Technologist.  An individual who has successfully completed at least a course of study in the arts and science of radiologic technology in a program accredited by the Joint Review Committee on Education in Radiologic Technology and who is board certified by the American Registry of Radiologic Technologists (ARRT).  A radiographer is licensed to perform, or may be called upon to perform a comprehensive scope of diagnostic imaging procedures employing equipment which emits ionizing radiation, and is delegated or exercises responsibility for the operation of radiation-generating equipment, the shielding of patient and staff from unnecessary radiation, the appropriate exposure of radiographs, or other procedures which contribute to any significant extent to the site or dosage of ionizing radiation to which a patient is exposed.
   13. Radiologist.  Licensed physician who has successfully completed a certified residency program in radiology.
   14. Radiology Technician.  An individual who has successfully completed less than a two year course in radiologic technology and gained his/her experience through more than six months of on-the-job training.
   15. Significant Deficiencies.  All findings that may contribute to unnecessary radiation exposure to patients or staff, or created unsafe working conditions.
   16. Sonographer.  An individual who has specialized training and skills in producing ultrasound images and is eligible for national certification as an American Registered Diagnostic Medical Sonographer (ARDMS).
   17. Trained X-ray Machine Operator.  An individual who is a minimally trained operator of radiographic equipment and meets the training requirements of Public Law (P.L.) 97-35, Consumer-Patient Radiation Health and Safety Act of 1981, 42 U.S.C. 10001-10008, 1981.  Trained X-ray machine operators are clinical professionals occasionally called upon to assist in diagnostic radiology examinations limited to a few specific body sites and/or standard procedures. This includes dental staff trained to take radiographs.
   18. Ultrasound Technician.  An individual who has specialized training in producing ultrasound images that is not certified by ARDMS.
   19. X-rays.  A form of electromagnetic ionizing radiation with the physical characteristics of photons generated from the electron shells of atoms.  X-rays are useful in diagnostic radiological imaging because their energy and quantity are controlled.

3-21.2  RESPONSIBILITIES.

The IHS is organized into three major administrative levels:  Headquarters, Area Office, and Service Units.  A line of authority exists from the Director, IHS, to Area Directors, to Chief Executive Officers (CEO).  The Area and Headquarters health program staff shall be responsible for providing consultation to and evaluation of the diagnostic imaging services at the Service Units.  A technical and consultative relationship exists among the diagnostic imaging staff at each level.

1. Director, Office of Clinical and Preventive Services (OCPS).  The Director, OCPS, is responsible to the Director, IHS, for advising on activities relating to the provision of diagnostic imaging services.  The Director, OCPS, or their designated representative, will:
   1. develop and implement IHS-wide diagnostic imaging policies, procedures, and standards;
   2. coordinate the review of this chapter in accordance with IHS Indian Health Manual guidelines;
   3. advocate for resources for the delivery of imaging services; and
   4. recommend staffing guidelines and equipment requirements for new departments based on projected workloads.
2. Director, Office of Environmental Health and Engineering (OEHE).  The Director, OEHE, or their designated representative(s), shall provide technical consultation on employee radiation safety and facility design.  The Associate Director, OEHE, or their designated representative(s), will:
   1. conduct or arrange for radiation protection review of plans for new or remodeled radiology departments by a qualified medical physicist, and verify shielding installation following remodeling or rearranging X-ray units;
   2. consult with the DIS to verify that facilities are designed, built, and maintained to prevent unnecessary radiation exposure to patients, staff, and other building occupants both inside and outside of medical imaging rooms and dental operatories where X-rays are used.  Plans shall include shielding design approved by a qualified medical physicist;
   3. support the Clinical Engineering Program to coordinate medical equipment planning as specified in IHM Part 5, Chapter 14; and support the acceptance testing of newly installed equipment by a qualified contractor or medical physicist.
   4. verify that X-ray imaging processing and reading systems are properly installed, and where applicable, securely communicate to IHS networks.
3. Area Director.  The Area Director is ultimately responsible for the safe provision of medical and dental diagnostic imaging services to patients.  The Area Director will ensure full adherence to this policy.  The Area Director, or their designated representative(s), shall provide technical consultation on implementation of this policy and employee radiation safety.
4. Area Chief Medical Officer (CMO).  The Area CMO shall be responsible to advise the Area Director and to consult with Service Units regarding the delivery of diagnostic imaging services.  The Area CMO will:
   1. advocate for resources for the delivery of imaging services;
   2. provide consultation to Tribal programs on delivery of diagnostic imaging services; and
   3. ensure Area DIS reviews are conducted to determine compliance with elements of this chapter of the Indian Health Manual.
5. Area OEHE Director.  The Area OEHE Director, or their designated representatives, shall be responsible to advise the Area Director and Area CMO regarding engineering and environmental health related aspects supporting the DIS.  The Area OEHE Director, or their designated representatives from Facilities Planning and Construction, Biomedical Engineering, or Institutional Environmental Health (IEH), will:
   1. conduct or arrange for radiation protection review of plans for new or remodeled radiology departments.  Verify shielding installation following remodeling or rearranging X-ray units;
   2. consult with the DIS to verify that facilities are designed, built, and maintained to prevent unnecessary radiation exposure to patients, staff, and other building occupants both inside and outside of medical imaging rooms and dental operatories where X-rays are used.  Plans shall include shielding design approved by a qualified medical physicist;
   3. support the Clinical Engineering Program to coordinate medical equipment planning as specified in IHM Part 5, Chapter 14; and support the acceptance testing of newly installed equipment by a qualified contractor or medical physicist.
   4. verify that X-ray imaging processing and reading systems are properly installed, and where applicable, securely communicate to IHS networks;
   5. provide technical assistance with the anticipation, recognition, evaluation and control of physical hazards, including radiation;
   6. conduct audits to assess medical imaging and dental program radiation safety compliance; and
   7. in cooperation with the local Service Unit or facility Radiation Safety Officer (RSO), investigate instances of excessive/abnormal occupation exposure (quarterly dose exceeding 600 mRem) to determine the cause and recommend measures to prevent recurrence.  Excessive exposure shall be reported to the Area CMO and Director, OCPS.
6. Chief Executive Officer (CEO).  The CEO shall be responsible for the safe operation of medical and dental imaging programs and compliance with the national standards of practice described in section 3-21-1.D.  The CEO will:
   1. ensure that high quality diagnostic imaging services are provided to IHS beneficiaries;
   2. provide adequate resources to comply with this policy, regulations and national standards of practice;
   3. ensure patient and employee safety procedures are in place as prescribed by this policy and that the organization is adhering to radiation protection national practice guidelines;
   4. appoint the medical or dental department supervisor, or a qualified medical imaging employee as a radiation safety officer for every installation utilizing X-ray equipment;
   5. ensure that personnel using diagnostic imaging equipment are knowledgeable of this policy and departmental policies and procedures, including radiation protection practices.

      Only trained and competent personnel are permitted to prescribe and interpret diagnostic images, operate X-ray equipment, conduct quality assurance, provide preventive maintenance, and conduct medical physicist performance monitoring.  A process for annual education, review, and competency testing will be established and instituted for physicians and technologists.

   6. establish a medical provider peer review process to ensure that appropriateness criteria are properly followed so that each patient receives the correct diagnostic exam, at the optimal exposure as described in section 3-21-5.B and C;
   7. ensure that all personnel occupationally exposed to radiation are periodically monitored consistent with OSHA and CMS requirements;
   8. ensure all personnel utilizing imaging equipment are instructed in radiation protection practices and that all safety devices are utilized; and
   9. ensure that X-ray devices are performing safely through preventive maintenance, performance monitoring and qualified medical physicist quality assurance, and that quality assurance programs are in place.
7. Radiation Safety Officer (RSO).  The RSO, usually a member of the medical imaging team or the department supervisor when an RSO is not appointed by the CEO, shall be qualified by training and experience to conduct the activities listed here.  The RSO will:
   1. review diagnostic imaging service policies and procedures to ensure adherence to the national standards of practice described in 3-21.1D;
   2. help to develop these radiation safety policies and procedures in cooperation with the directors of the medical imaging and dental programs;
   3. train mobile radiographic unit operators;
   4. evaluate lead aprons and shields used to protect patients and staff annually;
   5. provide radiation protection training for operators of diagnostic radiographic equipment, when requested;
   6. manage the personnel monitoring (dosimetry) program;
   7. ensure that all personnel occupationally exposed to ionizing radiation are periodically monitored in accordance with OSHA and CMS requirements; and will
      1. review personnel monitoring exposure reports.  Investigate reported over-exposures with the employee and supervisor to determine causation and remediate hazards;
      2. ensure that quarterly and annual monitoring results are provided to occupationally exposed staff and their supervisor consistent with IHS privacy/confidentiality practices;
      3. maintain the records from the monitoring devices.  The employees' annual radiation exposure report shall be maintained by the facility throughout the employment of the person plus thirty years; and
      4. remain current in the knowledge, skills, and methods of diagnostic imaging.
8. Managers/Supervisors.  Service Unit medical imaging and dental managers/supervisors are the principal advisors to the Service Unit Clinical Director and the CEO concerning DIS issues.  The Service Unit medical and dental imaging managers and supervisors:
   1. provide diagnostic imaging services to patients of the Service Unit within the framework of Headquarters and Area policies;
   2. maintain liaison with national diagnostic imaging organizations;
   3. remain current in the knowledge, skills, and methods of diagnostic imaging to assist with the improvement of the health status of the IHS beneficiaries;
   4. ensure that Service Unit diagnostic imaging services meet and maintain the national standards of practice described in 3-21.1.D;
   5. establish and institute a process for diagnostic imaging annual education, review, and competency testing for physicians and technologists;
   6. ensure quality assurance is properly conducted and documented; and
   7. participate actively in Service Unit risk management activities, which include:
      1. identifying general areas of potential risk in the clinical aspects of patient care and safety;
      2. developing criteria for identifying specific cases with potential risk in the clinical aspects of patient care and safety;
      3. correcting problems in the clinical aspects of patient care and safety identified by risk management activities; and
      4. designing programs to reduce risk in the clinical aspects of patient care and safety.

3-21.3  DIAGNOSTIC IMAGING SERVICE QUALIFICATIONS AND TRAINING

1. Personnel Staffing Qualifications.
   1. Diagnostic radiological imaging services provided by the IHS shall be provided by qualified, licensed and/or certified medical providers, diagnostic medical imaging technologists, or dental personnel complying with the standards in 42 CFR Part 75 or NCRP Reports No. 127, 134, and 145.
   2. Only personnel meeting the requirements of the national standards of practice described in sections 3-21.1.D and E shall be permitted to operate diagnostic imaging equipment when performing patient care.
2. Personal Services Contractors.  Personal services contractors (where allowed) shall be required to follow IHS hiring policy qualifications by having an active state or national license/credential/certification in good standing prior to being assigned to an IHS facility.
3. Training.  The IHS encourages the support at all program levels of training and continuing education. Imaging technologists, including sonographers, licensed by ARRT are required to maintain national certification and licensure. Continuing education is required for acquiring new skills or techniques and updating knowledge related to current trends in clinical diagnostic imaging practice.  Training programs, including in-service workshops as well as Area or regional refresher courses, may be established by the Areas or through the Director, OCPS.

   All diagnostic imaging personnel are encouraged to participate in training activities to keep abreast of developments in the field of diagnostic imaging.

   All personnel utilizing X-ray equipment are instructed in radiation protection practices at least annually by the RSO.

4. Professional Affiliations.  Diagnostic imaging personnel have the responsibility to participate in the advancement of their respective professions.  They should participate in national and local professional organizations.  They should develop professional collegial relationships both within and outside the IHS, and assist in training American Indian and Alaska Native students, where applicable.

3-21.4  FACILITIES PLANNING AND CONSTRUCTION

1. IHS Facility Requirements.  The IHS Health Systems Planning (HSP) program is used for space allocation criteria for new health care facilities, including medical imaging and dental departments. Standards of diagnostic imaging practice in the IHS dictate some construction criteria, (i.e., adequate number of imaging rooms, space for automated electronic image or film processing and necessary equipment, and a separate medical imaging inpatient waiting area).  For more specific information regarding diagnostic imaging and dental department construction and space allocation criteria, see the IHS HSP document and the IHS Architect/Engineer Design Criteria and Standards.

   For additional information on medical equipment planning related to equipment selection, see the IHM Part 5, Chapter 14 "Clinical Engineering Program".  All X-ray facilities shall have shielding which conforms to the recommendations of NCRP.  The Area Office Division of Facility Management Engineering, the facility manager and/or the RSO are responsible for ensuring that shielding plans designed by a qualified medical physicist are included in the renovation or new facility construction documents.

   Mobile X-ray equipment used routinely in one location, i.e., the unit is located and operated in the same room, shall be considered a fixed installation and as such shall comply with all shielding and other requirements of fixed installations.  A mobile medical X-ray unit shall not be used as the sole radiographic system at an IHS facility except under extenuating circumstances.  The RSO shall provide this justification to the Area Chief Medical Officer and the Director, OCPS, for review and approval prior to the start of such an arrangement.

2. Contracting for Mobile Diagnostic Imaging Service.  Mobile contract diagnostic imaging services should be considered when it would result in cost savings for the Government when compared with developing in-house service.  Elements of cost evaluation can include:  the expense to purchase, maintain, and monitor equipment performance; if technologists must be hired or trained to operate the equipment; and if radiologist services are needed for advanced imaging system diagnostic reading requirements, such as CT and mammography.  The contracting service must meet the qualifications set forth in this chapter.

3-21.5  DIAGNOSTIC X-RAY RADIATION PROTECTION

1. Objectives.
   1. To reduce radiation exposure to patients to the minimum level consistent with clinical requirements.  This includes using non-ionizing radiation imaging technologies when appropriate, reducing excessive radiation by reducing retake rates, and reducing unnecessary examinations (e.g., routine employment physicals and pre-operative chest X-ray exams without clinical indications).
   2. To assure that the American Indian and Alaska Native people receive quality radiographic service that produces the maximum diagnostic information while minimizing patient radiation exposure.
   3. To reduce radiation exposure to medical, dental, and ancillary personnel to a level as low as reasonably achievable (ALARA) and lower than the occupational, absorbed and effective dose limits established by the NCRP and OSHA.
2. Appropriateness Criteria.  A critical aspect of controlling patient dose and employee exposure is ensuring that each patient receives the correct radiographic exam, at the optimal exposure.
   1. Patients shall be X-rayed only when clinically indicated.

      To this end, Medical Imaging programs will utilize the American College of Radiology "Appropriateness Criteria."  The Oral Health Program will utilize the American Dental Association/Food and Drug Administration's "The Selection of Patients for Dental Radiographic Examinations."

   2. Sufficient clinical information shall be provided on all X-ray exam requests to ensure the correct clinical area of interest is radiographed and to focus the interpretive efforts of the radiologist or dentist.
   3. Evaluation of use of appropriateness criteria should be part of the quality assurance process and/or the medical physicist evaluation.
3. Reducing Exposure To Patients and Occupationally Exposed Personnel.
   1. Patient Dose Optimization.  Patient exposure shall be kept at the minimum consistent with clinical objectives. Qualified medical physicists will be consulted to assist in dose optimization.
      1. For imaging systems capable of calculating and displaying dose estimates, estimated exam patient doses shall be recorded as part of the digital image header, and/or in the patient chart or electronic health record to track and monitor patient exposures.  If the dose estimate exceeds the substantial radiation dose level, which is typically set at 5 gray, provisions should be made for patient follow-up to allow for detection and management of possible radiation effects.
      2. If estimated dose data are not available for fluoroscopic procedures, the exposure time and the number of acquired images (radiography, cine, or digital subtraction angiography) should be recorded in the patient's medical record.
      3. On the occasion of the need to estimate the dose delivered to an individual patient because of a specific situation (e.g., pregnancy, prolonged fluoroscopy, multiple examinations), the physician should consider requesting a formal written medical physics consultation with the Qualified Medical Physicist.  The specific X-ray parameters of the diagnostic examination should be provided to the Qualified Medical Physicist to allow the rendering of an estimate of the specific dose to a given location in the patient, such as the location of the embryo or fetus, the patient's midline, or the patient's skin.  The consultation request should be signed by the requesting physician.  The Qualified Medical Physicist's report should be signed by the Qualified Medical Physicist and should be incorporated into the patient's medical record.  Diagnostic Reference Levels or Achievable Doses should not be used for patient dose estimates.
   2. Only persons required for the radiographic procedure shall be permitted in the room during an exposure.
   3. Patient Restraint.  No staff or family members/caregivers shall hold or restrain patients during exposures, or hold dental film holders in position, except in extraordinary circumstances.  During situations when holding the patient or film holder is required to complete needed imaging, the holding individual(s) shall use lead or lead-equivalent protective clothing.

      Each medical facility shall establish a policy on the use of patient restraints during radiographic procedures.  The policy shall state that restraints and positioning devices shall be used in preference to requiring the use of personnel to hold the patient.

   4. Modality Specific Safety Concerns.
      1. Dental.
         1. To ensure the lower patient dose and employee exposure, the highest speed imaging processing system will be used.  Direct digital imaging systems are recommended because they require the least amount of radiation to achieve a quality radiograph.  If film must be used, only F-speed or faster speed film shall be used.
         2. In only extraordinary cases shall the image receptor (solid-state detectors, photo-stimulable phosphor imaging plate holder, or film) be held during exposure by dental staff wearing all appropriate personal protective equipment.
         3. Unless protective shielding is provided for the operator, the installation should be so arranged that the operator, when making exposures, can stand at least 6 feet from the patient and well away from the useful beam.  When protective shielding is provided, the operator shall always be entirely behind the shield during the exposure.
      2. Fluoroscopy.
         1. Fluoroscopy procedures shall be performed only with image intensifying systems or equivalent digital technology.
         2. Any systems being replaced that did not include automatic brightness controls shall be replaced with an upgraded system that does include this function.
         3. Fluoroscopy shall only be performed by practitioners qualified for fluoroscopic procedures.  Only those personnel required to perform the procedure shall be allowed in the radiation area.
         4. All personnel present in the radiation area shall use appropriate protective devices (i.e. lead lined aprons or wheeled partitions) when radiation exposures are generated.
         5. The hands of the fluoroscopist shall not be placed in the useful beam unless the beam is attenuated by the patient, and a protective glove of at least one-quarter millimeter lead or equivalent is worn.
      3. Mobile and Fixed Above Table Radiographic, and CT Units.
         1. The exposure to the patients shall be kept to the practical minimum consistent with clinical objectives.  All diagnostic radiologic equipment shall be DR equipment and flat plate fluoroscopy, where possible, to reduce patient exposure.  All CT scanners should use low-dose protocols to reduce patient exposure.  Only screen films and detector plates appropriate to the examination shall be used.
         2. The exposure switch on mobile units shall be so arranged that the operator may stand at least 2 meters (6 feet) from the patient, the X-ray tube, and the useful beam.  The operator shall be positioned at least 2 meters (6 feet) from the radiographic equipment and shall wear a protective apron or stand behind a suitable shield.
         3. Mobile equipment shall be used only for examinations where it is impractical or hazardous to the patient's physical condition to transfer the patient to the permanent radiographic installation.
         4. The Service Unit RSO shall ensure that the operators of mobile equipment understand the proper use and limitations of the equipment to avoid needless exposure of the patient or other persons in the vicinity.
         5. A chart of techniques for common exams shall be maintained with each mobile unit for reference by users.  The RSO or a qualified medical physicist shall review and update the chart at least annually.
         6. The exposure switch on fixed radiographic units, except for those used in conjunction with "spot-film" devices in fluoroscopy, shall be arranged so that the operator cannot conveniently operate the switch outside a shielded area.
         7. Doors leading into radiographic procedure rooms shall be closed during procedures and an outside-the-room indicator light/sign shall be visible when the room is in use.
   5. Fetal Protection.
      1. Each facility shall establish a fetal protection policy that conforms with the current issuance of the NCRP publication #116, "Limitation of Exposure to Ionizing Radiation."  This policy shall ensure that occupational exposure levels for female employees of child-bearing age are within the NCRP guidelines.  A qualified medical physicist should be consulted when fetal dose estimation is needed.
      2. Medical imaging and dental departments shall establish and implement a program to identify women between the ages of 12 and 50 years who may be pregnant.  The following information should be obtained by the referring physician or practitioner and recorded on the X-ray requisition form:
         1. Obtain the date of last menstrual period.  If this date is more than 10 days before the date of the examination, question at 3-21.5C(5)b.(ii) shall be asked.
         2. Is there a possibility of pregnancy?  If YES, it is recommended that the examination be rescheduled to within 10 days after the patient's next menstrual period or there should be further investigation into the possibility of pregnancy.  If NO, question at 3-21.5C(5)b.(iii) shall be asked.
         3. How is the client sure of not being pregnant?  Answer given should be included on the X-ray requisition.  Standard medical imaging examinations should be postponed, if possible, when pregnancy is confirmed or suspected.  When the clinical evaluation by the referring physician or practitioner indicates the diagnostic imaging procedure is medically necessary (i.e. positive finding as a result of the procedure could be more beneficial for the patient than the exposure to radiation) the referring physician or practitioner shall acknowledge the medical necessity of the procedure as a life threatening situation.  The referring physician or practitioner shall explain the risks and benefits of the procedure to the patient or the patient's representative, guardian, or power of attorney.  The referring physician or practitioner will document in the Electronic Health Record that the explanation of the procedure was provided and whether consent or refusal of the imaging procedure was given.  After obtaining proper consent, imaging will proceed with a modified or limited X-ray examination.
   6. Collimation and Use of Protective Garments.  All persons (patients, employees, and visitors) shall be properly shielded and protected.
      1. Appropriate and effective shielding for critical organs (e.g., breast, gonads, and thyroid) shall be used on patients during selected medical X-ray examinations.  Shadow shields, lead aprons, waist aprons, and breast shields shall be used on all patients where such shielding will not interfere with the visualization of the diagnostic area (such as scoliosis examinations). Factors to consider for the need of the patient shall include:
         1. The clinical objectives of the radiographic examination shall not be compromised.
         2. Specifically for female clients with reproductive potential, the gonads shall not be within the primary X-ray beam area, or within close proximity (i.e., 5 cm) to the beam edge of an adjacent primary beam exposure area, despite proper beam limitation. Excluded examinations would include, but not be limited to, abdomen, pelvis, hips, and barium enema studies.
         3. Radiation protection equipment (e.g., lead shields or patient restraining devices) are used during diagnostic imaging procedures and are maintained in good repair.
         4. Annual inspection/testing of leaded aprons/gloves shall be performed and documented.
      2. The useful beam should be collimated to the smallest area necessary to obtain the diagnostic information needed.  Only the patient's body part shall be in the useful beam.
   7. Patient Preparation.
      1. Thorough patient preparation, including patient measurements, shall precede any radiographic exposure to optimize radiographic technique and reduce the need for retakes.
      2. Patients shall be properly prepared and instructed in the proper methods of breathing and holding still for images, CT examinations, and other radiographic examinations to avoid motion during radiographic procedures.
4. X-ray Device Performance Monitoring.
   1. Only certified equipment and components shall be used for diagnostic radiological imaging examinations.  Such equipment shall be selected based on its appropriateness to the diagnostic radiological imaging needs of the population served by the facility and in consultation with the Biomedical Engineering program.

      All new X-ray systems and major components must comply with the Food and Drug Administration diagnostic X-ray equipment standards found in 21 CFR, part 1020 "Performance Standards for Ionizing Radiation Emitting Products," specifically section 1020.30 "Diagnostic X-ray systems and their major components," section 1020.31 "Radiographic equipment," section 1020.32 "Fluoroscopic equipment," and section 1020.33 "CT equipment."

   2. X-ray devices shall be in safe operating condition.  A qualified medical physicist will conduct device performance monitoring and quality assurance reviews in accordance with the methods and frequencies described below.  The qualified medical physicist may approve properly trained staff (e.g. Radiology, IEH, or Biomed staff) to assist in obtaining test data for performance monitoring under the direction of a qualified medical physicist (QMP) in accordance with the 2015 CMS Interpretive Guidelines, the 2016 ACR Technical Standards for Diagnostic Medical Physics Performance Monitoring of Radiographic and Fluoroscopic Equipment and NCRP Report No. 145 "Radiation Protection in Dentistry."
      1. Computed Tomography, ACR Technical Standard For Diagnostic Medical Physics Performance Monitoring Of Computed Tomography Equipment, 2012.
         1. Acceptance testing upon installation and before clinic use.
         2. Annual device performance monitoring.
         3. Annual assessment of patient dose.Performance check after replacement or repair of major components.
         4. Consult with radiology program to develop policies, procedures, and protocols to minimize patient dose.
         5. Assist in establishing a facility quality assurance program.
      2. Radiology - Portable X-Ray, Above Table X-Ray - ACR-AAPM Technical Standard For Diagnostic Medical Physics Performance Monitoring Of Radiographic Equipment, 2016.
         1. Acceptance testing upon installation and before clinic use.
         2. Annual device performance monitoring.
         3. Annual assessment of patient dose.
         4. Performance check after replacement or repair of major components.
         5. Consult with radiology program to develop policies, procedures, and protocols to minimize patient dose.
         6. Assist in establishing a facility quality assurance program.
      3. Fluoroscopy - C-Arm Fluoroscopy, Fluoroscopy - ACR-AAPM Technical Standard For Diagnostic Medical Physics Performance Monitoring Of Fluoroscopic Equipment, 2016.
         1. Acceptance testing upon installation and before clinic use.
         2. Annual device performance monitoring.
         3. Annual assessment of patient dose.
         4. Performance check after replacement or repair of major components.
         5. Consult with radiology program to develop policies, procedures, and protocols to minimize patient dose.
         6. Assist in establishing a facility quality assurance program.
      4. Mammography - Food and Drug Administration Mammography Quality Standards Act Regulations - 21 CFR Part 900 - Mammography, 2009.
         1. Annual survey.
         2. Additional evaluations shall be conducted whenever:
            1. a new unit or processor is installed;
            2. a unit or processor is disassembled and reassembled at the same or a new location; and
            3. major components of a unit or processor equipment are changed or repaired.
      5. Dental (includes portable, hand-held, and panoramic devices) - NCRP, Report Number 145: Radiation Protection in Dentistry, 2003.
         1. New devices must be surveyed prior to use.
         2. Resurveys shall be performed no less than every four years.
         3. A resurvey shall be made after any change in the installation, workload, or operating conditions that might significantly increase occupational or public exposure (including X-ray machine service or repair that could affect the X-ray machine output or performance).
      6. Performance monitoring shall include Entrance Skin Exposures (ESEs) measured at the time of conducted surveys and after acceptance testing of newly installed/renovated imaging systems.
         1. The ESE evaluation shall address commonly used imaging systems, such as automatic exposure control, and/or manual techniques using FDA Center for Devices and Radiological Health (CDRH) or equivalent radiological phantoms.  Standard radiographic examinations for AP abdomen (23 cm), AP lumbar spine (23 cm), PA chest (23 cm), and dental intraoral (bitewing) will be evaluated for general radiography, portable radiology, and dental devices.  Patient dose surveys will also be conducted for mammographic and CT devices.  Maximum exposure rates will be evaluated for fluoroscopy devices.
         2. For imaging systems, any radiographic examinations with ESE measurements that exceed the 75% quartile values of the current CRCPD patient exposure and dose guide shall be evaluated to determine the cause.  In addition to the ESE phantom tests, digital or computed radiography system manufacturer exposure indices will be evaluated.  Exposures should fall within manufacturer recommended exposure index ranges.  If exposure index values fall outside of the manufacturer recommended exposure index range, the device servicing company should be consulted to determine and remediate the cause.
         3. National exposure reference levels will be used to evaluate IHS diagnostic radiological imaging programs exposure results. The primary reference levels for general and dental radiography are found in the FDA/Conference of Radiation Control Program Directors' (CRCPD) National X-ray Exposure Trends documents.  The maximum dose level for mammography is mandated by the Mammography Quality Standards Act.  The maximum exposure rate capacity for fluoroscopy devices is regulated by the FDA.

            Recommended diagnostic reference levels for computed tomography can be found in the ACR, ACR Practice Guideline for Diagnostic Reference Levels in Medical X-Ray Imaging, (2009).  The qualified medical physicist may elect to measure dose using other methods relevant to current research, technology, and professional judgment.

         4. The functioning parameters of X-ray generating equipment, image processing and technique factors should be considered during this evaluation.
         5. As needed, the Qualified Medical Physicists will provide recommendations to reduce the exposure or dose in consultation with the facility radiologist and lead radiology technologist.  Records of exposure and dose measurements shall be included in the performance monitoring reports.
5. Maintenance of X-ray Equipment.
6. Radiographic equipment shall receive preventive maintenance and calibration in accordance with the manufacturer recommendations. Facility, Service Unit, and Area diagnostic radiological imaging and biomedical engineering staff will maintain records related to equipment recalls, software updates, etc.
7. Each facility with an imaging processor shall have a preventative maintenance program that consists of written policies and procedures for the operation and maintenance of the processor.
8. An equipment maintenance log and the date indicating when corrections were completed shall be maintained in the biomedical or medical/dental imaging department.  All work conducted by IHS biomedical staff must be logged in the electronic equipment inventory and management system.
9. Maintenance, cleaning schedules, and other related mammography activities shall be conducted at the frequency required by the MQSA.

3-21.6  PROGRAM OPERATION

1. Radiographic Procedures.  Radiographic procedures shall be performed by radiographers and radiologic technologists with appropriate credentials to perform these activities, except as limited by the requirements of this chapter.
   1. Only providers privileged by the facility to order diagnostic imaging procedures will be allowed to do so.
   2. Only radiologists qualified to interpret CT images are permitted to interpret CT studies.
   3. Dental X-ray examinations shall be ordered by Doctors of Dental Surgery or Dental Medicine.
   4. IHS dental assistants or hygienists must receive formal IHS radiation safety training and certification prior to taking X-rays.
2. Fluoroscopic Procedures.  Fluoroscopic procedures shall be performed only by properly trained physicians with appropriate privileges granted by the Service Unit governing body.  Each registered radiology technologist who uses fluoroscopy shall have written authorization from the Chief Radiologist and/or Clinical Director.  The authorization shall describe the situations when fluoroscopy may be used.  The authorization statement shall be on file in the facility administration office and radiology/medical imaging department.
3. Ultrasound Procedures.  Ultrasound procedures shall be performed by sonographers, radiologists, radiologic technologists and/or physicians trained to meet the minimum qualifications set forth in section 3-21.1.E. Definitions.
4. Mammography.
   1. Medical imaging departments performing mammography shall meet all requirements of the MQSA.
   2. Only radiologic technologists who meet the requirements of the MQSA are permitted to perform mammography studies.
   3. Only radiologists who meet the requirements of MQSA are permitted to interpret mammography studies.

3-21.7  PATIENT, CLIENT, OR CUSTOMER CONSIDERATIONS

1. The patient has the right to considerate and respectful care, including consideration of the psycho-social, spiritual, and cultural variables that influence perceptions of illness.  The patient has the right to accept or deny the diagnostic imaging examination and the decision shall be honored.  A notation in the patient's medical chart shall so state that the patient refuses to have the procedure performed.
2. The patient has the right to make health care decisions, including the right to accept or refuse diagnostic imaging procedures or treatment to the extent permitted by law.  The patient shall be informed of the medical consequences of such refusal.  The right of the patient to deny the diagnostic imaging examination may be overridden by their designated representative or surrogate power of attorney, i.e. decision maker participating in the consideration of issues that arise in the care of the patient.  The diagnostic imaging staff members could decide to proceed with the examination without direct permission from the patient based on ethical considerations.  A notation in the patient's medical chart shall so state that the patient's designated representative granted permission for the patient to have the procedure performed against the wishes of the patient.
3. It is the right of the patient's guardian, next of kin, or legally authorized responsible person to exercise, to the extent of the law, the rights delineated on behalf of the patient if the patient is incapable of understanding the proposed treatment or procedure, is unable to communicate their wishes regarding treatment, or is a minor.
4. Following explanation of a procedure, the patient has the right to request a technologist or chaperon of the same sex to be present during the examination. Every effort shall be made to honor the client's request.  Examples:  genital urinary exams, mammography, barium enemas, ultrasounds, etc.
   1. Video Tape Examinations or Procedures.  The use of photographic imaging equipment shall not be permitted during an examination or procedure without the patient's written informed consent.
   2. Static Picture of the Unborn Fetus.  A static picture of the unborn fetus produced from the ultrasound imaging equipment may be taken and given to the expecting mother.
   3. Tele-Radiography.  Images sent electronically via tele-radiography shall comply with Health Insurance Portability and Accountability Act (HIPAA) guidelines and ACR recommendations for image quality and interpretation.

3-21.8  QUALITY ASSURANCE

1. General Requirements.  All IHS facilities containing imaging equipment will conduct quality assurance programs appropriate to all imaging modalities present in accordance with the national standards of practice described in section 3-21-1.D.  In addition, facilities with computed tomography will conduct quality assurance in accordance with the ACR's, 2012 Computed Tomography Quality Assurance Manual, 2012.
   1. Imaging processors shall be operated, cleaned, and serviced according to the manufacturer's recommendations.
   2. Each Service Unit diagnostic imaging service shall maintain complete quality control manual(s) (QCM) for all diagnostic imaging equipment in use. The QCM shall contain all information required by Sections 3-21.8.E through H.  The QCM will contain:
      1. documentation for each type of equipment;
      2. reports/dates of QC tests;
      3. software patches or security updates.  (See:  Standard Operating Procedure for IHS Enterprise Patch Management);
      4. information for machines generating diagnostic medical images, i.e. X ray machines, fluoroscopes, mammography, ultrasound, and CT including the image processing systems; and
      5. when available, quality assurance/quality control phantoms and software shall be purchased from the device manufacturer to ensure that manufacturer recommended quality assurance tests are conducted.
2. Equipment Technique Guide for X-ray Exposures.  Each medical and dental program shall maintain a technique guide for X-ray exposures for each X-ray machine.  The guide shall be reviewed annually.  The guide shall be based on patients' body habitus and imaging projection.  The guide shall be updated when equipment is repaired, re-calibrated, or reformatted.  The date of equipment update shall be placed on the upper right or upper left hand corner of the guide, or on the physicist evaluation.
3. Imaging Reject Analysis.  Medical and dental departmental image reject analysis shall be performed to evaluate continuous quality improvement of patient care, operating cost, departmental efficiency, and reason for rejects (i.e., over exposure, under exposure, positioning, motion, technical errors, quality control testing, artifacts, processor clean-up, and waste).  Screens, cassettes, and detector plates should have an identification number to provide a means of correlating with unsatisfactory radiographs so that defective items can be removed from service.
4. Film Based Imaging Systems.  Routine automatic film processor testing shall be performed for medical and dental processors.  The following items apply to X-ray film processor testing:
   1. Film consistency testing.  This testing shall be done daily to assure the processing and X-ray unit are operating consistently.
      1. Medical X-ray film processors should be tested daily for temperature, base plus fog, contrast, and speed.
      2. A reference film shall be used for daily comparisons.  A box of film shall be designated and used for quality control testing.  A crossover procedure shall be conducted when a new box of film (with a different emulsion batch number) is used.  For dental film processors, a dental radiographic normalizing and monitoring device may be used.
      3. Compare clinical radiographs to the selected reference film for density, contrast, sharpness, and overall quality.
   2. Darkroom and Screen Cleanliness.  The film loading bench and counter top shall be clear and free of dust or moisture.  Cassettes and screens shall be cleaned in accordance with the manufacturer's instructions at least every six months, or more often when indicated to remove blood, bodily fluids, etc.
   3. Radiographic film should be stored according to the manufacturer's specifications.  Outdated or film exposed to heat or radiation should not be used.  Defective film should not be stored with new film stock.  Film should not be stored for more than 6 months without refrigeration.  Unexposed X-ray film shall not be stored in or near a controlled area without proper shielding.
   4. Storing and safeguarding of exposed films following radiologist interpretation:  diagnostic films shall be placed in secure storage at the Service Unit.  Proper atmospheric conditions shall be maintained to prevent film deterioration.
   5. Darkroom Integrity.  Darkroom or processor fog testing should be done at least annually or when a problem is suspected.
   6. Screens should be checked visually for defects and film/screen contact testing every six months.
   7. New or replacement grids should be examined for damage prior to use.
5. Digital (Electronic) Radiographic (DR) Imaging Systems.
   1. Image processing quality control will be conducted as recommended by the manufacturer and other industry accepted standards.
   2. Manufacturer provided phantom image (QC test tool) testing shall be conducted as recommended by the imaging system manufacturer.
   3. Removable cassettes and imaging plates shall be inspected and cleaned as recommended by the manufacturer.  DR plates should be protected from fluid exposure and properly charged.  Technologists/Assistants shall be responsible for proper handling of cassettes, Computed Radiography (CR) plates, and DR detector plates.  Damaged CR or DR plates or improperly charged detector plates should not be used.
   4. Monitors and work stations shall be checked for quality control purposes as recommended by the manufacturer and other industry accepted standards.  This also includes that workstations are properly protected from software vulnerabilities, and that networked devices are properly segregated from the broader IHS network.  Additional information can be found hereExit Disclaimer: You Are Leaving www.ihs.gov .
   5. Recording Exposure Indices.  Each facility shall measure and evaluate patient exposure and exposure index numbers from representative radiographic exams in order to avoid exposure creep.
   6. Grids shall be used on all body parts that exceed 10 cm thickness.
   7. Imaging plates shall be cleaned in accordance with imaging system manufacturer's recommendation.
6. Performance Improvement.  Radiology/medical imaging departments shall have a written performance improvement (PI) plan designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems.  The Service Unit shall implement this plan as part of the PI program.  The PI written plan shall describe the program's objectives, organization, scope, and mechanisms for overseeing the effectiveness of monitoring, evaluation and problem-solving activities. Indicators of dysfunction shall be documented and appropriate action taken to correct.  If dysfunction is found, the issue shall be highlighted in subsequent searches.  At a minimum, there should be a PI indicator for the radiographer (such as repeat rates), medical staff (such as essential agreement of initial impression with the radiologist interpretation) and the radiologist (such as peer review).
7. Diagnostic Imaging Records.  Diagnostic imaging records shall be identified, numbered, filed, safeguarded, maintained and disposed according to the following criteria:
   1. Patient Identification.  Standard input of data throughout IHS facilities shall follow a specific pattern, such as: last name, first name, NO space between names; and Use of CAPITAL letters for the full name.  Also, L shall be used for left and R for right.
   2. Diagnostic Films.  Diagnostic films shall be identified by:
      1. The patient's name;
      2. His/her facility registration number;
      3. The medical facility name; and
      4. The date of examination and the case number.
   3. Film Folder Identification.  The patient's last name, first name, middle initial, and facility identification number shall be recorded on the film jacket.
   4. Diagnostic Imaging Locator Cards.  Examination records should be easily available for each patient either in the form of hard copy or electronically.  The information contained should consist of the name of the patient, the facility registration number, the date, and the type of examination.
   5. Resource and Patient Management System Radiology Package.  The Resource and Patient Management System (RPMS) radiology package is recommended for implementation at Service Units.  The use of the radiology RPMS software will improve record keeping, billing, and tracking of information.  Daily QC activities may be performed for examination status review for accuracy and accountability.
   6. Release of Films and Medical Images.  The release of imaging films, including electronic images, shall be in compliance with the Privacy Act and HIPAA and any other applicable law.
   7. Record Retention and Disposal.  Records retention and disposal shall be in accordance with the Indian Health Manual, Part 5, Chapter 15, "Records Management Program."  The IHS Records Disposition Schedule (IHSRDS) lists records and how long to keep them.  Most radiology records can be found in the IHSRDS, Schedule 3, Section 6.  Personal dosimetry records (annual summary reports) must be maintained by the facility throughout employee careers plus thirty years, consistent with regulatory requirements."
   8. Electronic Records.  Electronic records should be stored both on-site and remotely at a separate location so that a back-up copy is available, in compliance with HIPAA requirements.  The record copy of "paperless" or "filmless" electronic diagnostic imaging records cannot be destroyed until the Archivist of the United States has approved a disposition for IHS electronic diagnostic imaging records.  Storage requirements for on-site electronic imaging records should be assessed by the facility medical staff to ensure adequate on-site availability of prior imaging studies.
   9. Equipment Records.
      1. Maintain equipment inventory record until equipment replacement occurs.
      2. Maintain records of X-ray Performance Monitoring reports, software updates, equipment maintenance and repairs until equipment is replaced.
8. Safety Other Than Radiation.  Refer to specific Area or Service Unit guidelines as they pertain to safety in accordance with OSHA and the National Fire Protection Association.

3-21.9  REQUIRED REPORTS

Workload Reports.  Where required by the Service Unit, workload reports should indicate units of total diagnostic examinations completed by specific sections (i.e., X-ray, mammography, CT, and ultrasound).  The report should include the number of patient visits and percentage of repeated diagnostic exposures.  The Director, Radiology/Medical Imaging Department or the lead technologist shall submit the report to the CEO of the facility.

3-21.10  MANAGEMENT CONTROL

1. Diagnostic Imaging Services Review.  A DIS review shall be conducted at the discretion of the Director, OCPS, and/or upon request of the Area Director or his/her designee.  The Director, OCPS, or a review team shall review the policies and procedures to:
   1. Define and help resolve special concerns or needs of the program staff;
   2. Identify successful projects and practices deserving dissemination;
   3. Share the latest information on program development, planning, policies, staff opportunities, etc.; and
   4. Determine compliance with elements of this IHM Chapter.
2. Program Reviews of Diagnostic Imaging Departments.  The Area Director or their designee may request the Director, OCPS, to conduct a program review of specific Service Units within their scope of responsibility.  A report of the program review shall be submitted to the Area Director, Area Associate Director, OEHE and the CEO within a timely manner following the review process.  The Director, OCPS, or a review team shall review that:
   1. the CEO/program director ensures all corrective measures are implemented expeditiously;
   2. a record of corrections is maintained in the facility;
   3. the survey report is submitted to the CEO for follow-up and corrective action; and
   4. a process is implemented to address continual significant deficiencies (such as forwarding reports to the governing body for follow-up action).
3. Area Diagnostic Imaging Services Review.  A program review may be requested for each Area Diagnostic Imaging Service and its performance as directed by Section 3-21.2A and further described in the IHM, Part 5, Chapter 16, "Management Control Systems."