Chapter 6 - Laboratory Services

Title	Section
Introduction/General	3-6.1
Purpose	3-6.2
Goal and Objective	3-6.3
Functional Responsibilities	3-6.4
Headquarters Functions	3-6.4A
Area Office Functions	3-6.4B
Service Unit Laboratory Supervisor Functions	3-6.4C
Anatomic Pathology Services	3-6.5
Contracted Services	3-6.6
Contracting for Referral Laboratory Services	3-6.6A
Cervical Cytology Contracts	3-6.6B
Reference Laboratory Selection Guide	3-6.6C
Reference Laboratory Evaluation Checklist	3-6.6D
Pathology Consultants	3-6.7
Autopsies	3-6.8
Staffing	3-6.9
Quality Assurance	3-6.10
Training	3-6.11
Records	3-6.12
Workload	3-6.13
Health Promotion/Disease Prevention	3-6.14
Safety	3-6.15
General Requirements for Personnel and Laboratory Safety	3-6.15A
Warning Signs and Labels	3-6.15B
Fire Prevention and Control	3-6.15C
Electrical Safety	3-6.15D
Compressed Gases	3-6.15E
Chemical Hazards	3-6.15F
Carcinogens	3-6.15G
Bacteriologic Hazards	3-6.15H
AIDS Protocol Precautions/Laboratory Guidelines	3-6.15I
Nuclear Medicine	3-6.15J
Reports of Incidents and Accidents	3-6.15K

3-6.1  INTRODUCTION

This chapter establishes general policy and procedures pertaining to the management of laboratory services.

There are two major Federal regulatory programs for clinical laboratories, both of which are currently administered by the Health Care Financing Administration (HCFA) of the Department of Health and Human Services (DHHS).  The two programs are:  (1) Medicare and Medicaid certification of facilities receiving reimbursement under these programs, and (2) licensure of laboratories testing interstate commerce under the Clinical Laboratories Improvement Act of 1967 (CLIA-1967).  It is Indian Health Service (IHS) policy that every effort must be made to assure that IHS laboratories meet and/or exceed the standards published by the Joint Commission on Accreditation of Hospitals (JCAH), the College of American Pathologists (CAP) for Clinical Laboratories or the HCFA Regulatory Requirements.

3-6.2  PURPOSE

This revised chapter describes the policies, procedures, responsibilities and guidelines of the Laboratory Service.  It brings up to date the chapter's goal and objectives, standards, scope of program services, and the staffing criteria and responsibilities to be followed in attaining and maintaining accreditation by HCFA, JCAH, and CAP.  This accreditation is to provide a continued effort for improvement of the health care of American Indians and Alaska Natives (AI/AN).

3-6.3  GOAL AND OBJECTIVE

1. Goal

   The goal of the laboratory services is to provide the best possible support in anatomical pathology and clinical laboratory services to the clinical staff in the provision of comprehensive health care to American Indians and Alaska Natives, thereby assisting them in meeting the overall goal of the IHS.

2. Objective
   • Attain and maintain accreditation by HCFA, JCAH, or CAP.
   • Assure laboratory services meet the need of the service area and are performed in the most accurate and expeditious manner within available resources.
   • Pursue an active role in assisting patients and patient care providers in Health Promotion and Disease Prevention (HP/DP) activities.
   • Provide consultation, supervision, monitoring, and quality assurance of the acquisition and performance of off site testing.

3-6.4  FUNCTIONAL RESPONSIBILITIES

1. HEADQUARTERS FUNCTIONS

   The Chief, Laboratory Services Program, IHS, is responsible to the Director, Indian Health Service, through the Director, Division of Clinical and Preventive Services, IHS, Headquarters (HQ), as coordinator, consultant and advisor for all matters and activities relating to the laboratory services program.

   The incumbent is responsible for coordination, formulation and development of IHS-wide laboratory policies, procedures and standards.

   1. In addition, the Chief, Laboratory Services Program, IHS, in collaboration with Headquarters and Area administrative support services, will:
      1. Notify Director, Indian Health Service and Area Directors of nonparticipation in the required CAP proficiency testing and quality assurance programs and inspection and accreditation programs.
      2. Plan and assist in development of systems to assess IHS laboratory performance by periodic on-site evaluation of laboratory facilities.
      3. Develop budget requirements.
      4. Review and provide guidance for contract negotiations and make recommendations on discontinuance of any contract whenever there is a violation of Federal regulations.
      5. Provide laboratory resource allocation criteria. Recommend space criteria, staffing guidelines, equipment requirements, and the application of approved criteria to all lab facilities based on immediate and projected workloads.
      6. In conjunction with Area Consultants, professional laboratory personnel of Government and private agencies, develops, implements and/or refines laboratory quality assurance programs and procedures.
      7. Provide operations analysis for redistribution and reallocation of resources and services.
   2. The Chief, Laboratory Services Program, IHS, and the Area Laboratory Program offices will collaborate to assure:
      1. The quality assurance of the program;
      2. Review and evaluation of laboratory performance;
      3. Inspection and accreditation of laboratories;
      4. Participation in the CAP workload recording system; and
      5. Participation in the CAP proficiency testing program.
   3. Tribal Programs (P.L. 93-638) the Chief, Laboratory Services Program, IHS, will:
      1. Provide consultation to P.L. 93-638 contracted programs;
      2. In collaboration with Area Laboratory Program Officer review, monitor, and evaluate P.L. 93-638 contract programs; and
      3. In collaboration with Ares Laboratory Program Officer, provide tribal programs with IHS laboratory program operations procedures, criteria and standards.
2. AREA OFFICE FUNCTIONS

   Responsibilities of Area Laboratory Program Officers

   Area Laboratory Program Officers are the principal consultants and technical advisors responsible to the Area Director and his/her staff regarding the scope of the Area-wide program, its operations, quality of service, priorities and identification of unmet needs.  Their specific responsibilities include but are not limited to the following:

   1. Program Planning.
      1. Analyzes and interprets Area-wide laboratory reporting system, CAP workload data and other IHS data sources.
      2. Participates in Area planning activities and develops Area-wide laboratory program plans.
      3. Identifies Area-wide staffing requirements.
   2. Standard Setting
      1. Reviews and interprets national and regulatory standards for laboratory services and professional practice, assists in the development of policies and determines applicability for Area-wide use.
      2. In collaboration with Service Unit/Tribal staff, develops laboratory program requirements.
      3. Assists laboratory staff at Service Units to develop facility and tribal specific standards/protocols and operational guidelines for laboratory services.
      4. In collaboration with Service Unit Director, clinical director and laboratory personnel, reviews and updates facility program priorities.
   3. Program Operations
      1. Provides technical assistance and consultative support services to Area Director, Area Administrators, and Area Program Staff.
      2. Provides consultation and technical assistance to laboratory staff on program planning, operations, standards of practice, quality assurance, evaluation and management of available resources.
      3. Collaborates with Chief, Laboratory Services, Indian Health Service (IHS) to assure:
         • quality assurance program;
         • review and evaluation of laboratory performance;
         • inspection and accreditation of laboratories;
         • participation in CAP workload recording system;
         • participation in CAP proficiency testing survey program;
         • provision of Laboratory Data Base, i.e., quarterly reports or as requested.
      4. Provides consultation and assistance to Service Unit Director, clinical directors, and other appropriate IHS staff.
      5. Provides information to laboratory staff on accreditation, national trends and IHS policies/standards which would impact on Area and Service Unit operations.
      6. Maintains liaison relationship with local, State and other Federal programs and agencies, schools and professional organizations, attendance at appropriate professional meetings/seminars to build service networks, develops new programs, becomes involved in pertinent research, locating and placement of qualified staff and introduces new information into IHS.
      7. Develops the statement of work, provides technical assistance and monitoring of CHS/Tribal contracts for the Contract Health Care Branch to purchase services from private laboratories, hospitals and pathologists, to supplement laboratory services which are neither technically nor economically feasible at the Service Unit, for laboratory services.
      8. Notifies Chief, Laboratory Services, IHS, of nonparticipation in CAP proficiency testing survey program, inspection, and accreditation programs.
   4. Quality Assurance and Monitoring Activities
      1. Monitors the Service Unit Laboratories to insure compliance with IHS requirements, HCFA, JCAH, CAP and other professional standards.
      2. Documents and makes recommendations to correct deficiencies for compliance.
      3. Monitors or acts as project officer for the laboratory portion of contracts with Contract Health Services, Tribal, referral laboratories, and Consulting Pathologist Contracts.
      4. Monitors the quality assurance of the acquisition and performance of off-site testing.
   5. Program Evaluation
      1. Ensures that Quality Assurance (QA) programs are developed, implemented and ongoing at each Service Unit and complies with HCFA, JCAH, CAP and Area/Headquarters requirements, assuring the participation of all laboratories in the Area.
      2. Conducts on-going evaluations of the Areas' laboratory operations through the review of accreditation deficiencies, on-site visits, CAP workload data, manual review, proficiency testing reports, and other laboratory reports and documents.
      3. Participates in Area management reviews and other interdisciplinary evaluations of the IHS health care system.
      4. Provides Chief, Laboratory Services, IHS results of annual evaluations of the Area laboratory service programs and notifies Chief, Laboratory Services, IHS, of nonparticipation in proficiency testing. program, inspection and accreditation programs.
   6. Resource Management
      1. Assists Service Units and Tribal administrations in locating and placing qualified personnel and advising on their assignments within the Area.
      2. In collaboration with the Service Unit laboratory personnel, assists in identifying continuing education needs and appropriateness of the laboratory programs in service units.
      3. Assists in orientation of staff, regarding the Area and IHS laboratory program.
      4. Actively participates in planning for construction and/or remodeling of Area directors and laboratory staff regarding CAP workload statistics in arriving at staffing levels and requirements.
      5. Actively participates and collaborates with Service Unit Directors, clinical directors and laboratory staff regarding CAP workload statistics in arriving at staffing levels and requirements".
      6. Collaborates with Service Unit and Health Center Directors, Clinical Directors, and Chief Medical Officers in determining level of laboratory services to be performed at hospitals, health centers and health stations.
      7. Actively participates in determining priorities in repair and preventive maintenance contracts of the Areas laboratory instrumentation.
      8. Directly involved in on-going evaluations of laboratory instrumentation and procurement of laboratory instruments.
   7. Tribal Programs (P.L. 93-638)
      1. The Area Laboratory Program Officer's relationship to Tribal programs is consultative and will provide technical advice and in collaboration with tribal administrative supervisor will carry out the normal duties of the Area Laboratory Program Officer position.
      2. Program evaluations will be done on-site, utilizing identical criteria as is used in IHS operated facilities to include HCFA, JCAH, and/or CAP requirements.
      3. Laboratory Program officers will assist project officers by conducting on-site reviews, reviewing the technical portions of the contractors' reports, and providing recommendations concerning findings to the project officers and the tribes.
      4. During proposal stages, Laboratory Program Officers will provide Program descriptions, IHS Program requirements, level of performance standards, and regular reporting requirements to comply with Area P.L. 93-638 contracting procedures.  Laboratory Program Officers will review proposals submitted under P.L. 93-638 and submit a written report regarding the laboratory program portion to the project officers.
      5. Service Unit staff and Service Unit Directors will keep the Laboratory Program Officer apprised of tribal situations which may affect their laboratory programs.
3. SERVICE UNIT LABORATORY SUPERVISOR FUNCTIONS

   The Service Unit Laboratory Supervisor is responsible to the Service Unit Director for the total Service Unit laboratory program, its quality assurance program and quality of services.  The specific responsibilities include but are not limited to the following:

   1. Planning, organizing and administrating the laboratory service to assure prompt and accurate performance of laboratory procedures as required by the Service Unit.
   2. Implementing policies, operational procedures and program guidelines to maintain high performance standards in accordance with HCFA, JCAH, CAP, IHS and Area policies/regulations.
   3. Participating in and maintaining a quality assurance program as defined by Headquarters, Area, and accreditation bodies.
   4. Effectively utilizing available staff to provide adequate staff coverage for the services offered by the Service Unit.
   5. Providing prompt response to requests by Area Office.
   6. In collaboration with Area Laboratory Program Officer, identifies training needs of Service Unit laboratory personnel and makes recommendations for training to the Service Unit Director.
   7. Provides technical assistance and support to the Service Unit Director, administrative and medical staff.
   8. Provides consultation, supervision, quality assurance, and monitoring of the acquisition of performance of off site testing.

3-6.5  ANATOMIC PATHOLOGY SERVICES

Anatomic pathology services consist of processing tissues to study the changes in structure of diseased organs and tissues.

Surgical Pathology

All specimens removed during a surgical procedure should be properly labeled and sent to the pathologists, who shall determine the extent of examinations necessary for diagnoses.  Exceptions are those agreed to by the medical staff (e.g., placentas from term normal delivery).  The specimen must be accompanied by pertinent clinical information, including its source and the pre-operative and post-operative surgical diagnoses.  Although a microscopic examination of all specimens is desirable, certain exceptions can be established with the approval of the medical staff.  Special stains with specific positive controls may be needed to help with diagnosis. The final product is a surgical pathology report containing the gross, microscopic findings and the diagnosis.  The histopathologic diagnosis helps the attending physician with clinical diagnosis, therapeutic decisions, follow-up.

Rapid intraoperative surgical pathology consultation (frozen section) is done to help with an immediate surgical decision.  The pathologist must be experienced, conservative in attitude and reliable in judgment.  A great degree of accuracy is a must.  If a diagnosis cannot be made with certainty, it should be deferred for permanent sections.  A verbal report of the diagnosis is made directly to the surgeon in the operating room, 15-20 minutes from the time the specimen is received.  The frozen section diagnosis is written on the requisition and becomes part of the final report.

Formalin fixed tissues are kept at least 30 days or until the cases are signed out.  Paraffin blocks must be clearly identified and stored in a cool place for as long as possible.  Microscopic glass slides must be clearly identified with permanent etchings, stored at room temperature, protected against damage and readily available for use in consultation.  In most facilities the reports and glass slides are kept indefinitely.

Cytology

Cytodiagnostic services to meet the needs of the hospital should be available.  Cells from various sites are suitable for cytologic examination: exfoliated cells from epithelial/endothelial surfaces, brushings, washings, body fluids, fine needle aspirated material.  Cytopreparatory techniques include: smearing onto slides, cytocentrifugation, membrane filtration, cell block preparation, high speed blending.  The Papanicolaou stained cytology slides are screened by a cytotechnologist.  The quality of this service shall be insured by direct supervision of a pathologist or a physician with training in cytopathology, who shall review all suspicious and positive cases and 10% of the negative cases.  All reports and all abnormal slides should be kept indefinitely.  Negative slides may be discarded after 2 years.

3-6.6  CONTRACTED SERVICES

1. CONTRACTING FOR REFERRAL LABORATORY SERVICES

   Before entering into a contract or laboratory services, the following guides will be followed.

   1. Establish that the laboratory is licensed under the Clinical Laboratories Improvement Act (CLIA) of 1967.  All laboratories engaging in Interstate Commerce must be licensed under this Act.
   2. If the laboratory is not licensed under CLIA 1967, establish that it is licensed by the State in which it operates.

      Individuals having responsibility for the issuance of contracts for laboratory services will familiarize themselves with the regulations as outlined in CLIA and by the state involved.

2. CERVICAL CYTOLOGY CONTRACTS

   Cervical cytology contracts require the use of standardized reporting terminology for the results of cervical cytologic examinations.  This will facilitate the clinical interpretation of cytology reports and provide uniform data throughout the IHS.

   1. Terminology should be descriptive, and not include such terms as Class I, III, etc., or CIN gradations.
   2. The IHS should require the use of terms recommended by the American Society of Cytology and International Academy of Cytology.

      DIAGNOSTIC TERMINOLOGY IN CERVICAL CYTOLOGY

      Unsatisfactory (cite reason and recommendation)

      No abnormal cells

      Mild squamous atypia atypia
            Metaplasia
            Inflammation (with organism if identified)
            Regeneration and repair
            Radiation effect
            Viral effect
            Others (specify)

      Cytologic findings consistent with dysplasia squalmous-cell carcinoma
            Mild
            Moderate
            Severe (carcinoma in situ)

      Cytologic findings consistent with invasive
            squamous-cell carcinoma

      Abnormal cells not specifically categorized.

   3. All contractors should provide monthly reports.  These reports should identify individual patients, and include cytology results by degree of dysplasia.
   4. Turn around time should not be more than three days.
   5. The quality of the cytology service shall be assured through direct supervision by a pathologist certified in Anatomical Pathology.  Each cytotechnologist shall meet the requirements specified in the Clinical Laboratory Improvement Act of 1967.
   6. The contractor shall telephone all atypical cytology reports to the facility from which it was sent, immediately upon the pathologist's interpretation.
   7. The cytology report shall include, in addition to patient information, cytological description of the specimen, diagnosis (degree of intraepithelial neoplasia and/or degree of invasiveness) and recommendation for further investigation and/or treatment.
   8. The contractor will provide, within the day of specimen receipt, urgently needed cytology reports on specimens collected in cases with a life-threatening clinical presentation.  Special or urgent handling will be noted on the request form.
   9. Results of cytology studies shall be returned to the appropriate facility within 3 days from date of receipt at contractor?s facility.  The report shall be typed in triplicate, the original shall be chart ready.
   10. The contractor shall provide, upon verbal or written request, a copy of the original report(s) and the original slide(s) to the party designated by the attending physician.
   11. The contractor shall maintain a permanent cytology register which will include patient name, IHS patient identification number, date of birth, facility location, and results.  A data retrieval system must be available so that the cytology report on a particular patient seen at a given facility on a specified date can be available within 1 day using the 6 identification criteria listed above.
   12. The contractor shall, provide a quarterly list of all patients who have had cytology services performed to Chief, Maternal and Child Health Program, IHS, with date of specimen, results, and location of patient.
   13. The contractor shall provide monthly a list of all patients who have had cytology services performed, with date of specimen and results, to each facilities designated individual.
3. REFERENCE LABORATORY SELECTION GUIDE FOR IHS LABORATORY PROGRAM

   In deciding to purchase the services of a reference laboratory by means of competitive bid techniques, various critical factors must be analyzed.  These can be divided into five major areas: 1) operations; 2) accreditations; 3) staffing; 4) quality control and preventive maintenance; and 5) account (user) satisfaction.

   Operations

   1. Financial review:  The advantage of learning about the financial operation and ownership of the organization can assist a potential consumer in evaluating whether or not this company is going to be in operation for a long period of time or if the parent company appears to have plans to liquidate the reference laboratory in an attempt to consolidate its assets.

      If possible, review the reference laboratory?s financial statement to determine the liquidity of the assets, of the corporation as well as the net profit contribution.  In addition, the organization should have been in operation for a period of three years (thus suggesting some organizational stability), and if possible, demonstrate the growth over the same period of time.  Laboratories that have been in operation for a period of less than one year should be evaluated very carefully.  The financial statement will also indicate whether or not the laboratory is privately owned or part of a parent organization.

   2. Maintenance:  The evaluation of reference laboratory services should determine whether or not the laboratory is an individual, free-standing facility or uses the concept of satellite facilities.  If satellite facilities exist, procedures performed there need to be identified and determination made as to whether or not the satellite laboratories use the same procedures as the main laboratory.  If satellite facilities use protocols different from those of the main laboratories, the potential for out-of-control situations is increased.  Finally, the hours of operation for the main laboratory as well as the satellite laboratories need to be specified to ensure that activities in these areas coincide with workload and staffing patterns of your institution.  With this information at hand, an on-site inspection visit is recommended to ensure that the physical plant is adequate to perform the work that is referred.  The visit should include an evaluation of instrumentation records for adequate and preventive maintenance programs as well as the performance capacity for tests referred.  Ideally, it is desirable that the reference laboratory do all tests on-site rather than refer them to another facility.  This helps to assure greater specimen control.
   3. Pricing:  Evaluate the reference laboratory?s fee schedule to determine if it is competitive with other reference laboratories; however, price should not be the sole determining factor.  Service and quality are major factors to consider.
   4. Specimen pickup, delivery, and reporting:  The method used to facilitate specimen transportation between a laboratory and a reference laboratory is a key decision element.  Ideally, the reference laboratory, should have a private courier service or at least have control over an individual who serves as a courier.  In addition, specimen shipping containers, labels, dry ice, etc., should be provided as well as complete instructions on how specimens are to be processed prior to shipment.  Information material should also include the method used for notifying the sender that unsatisfactory specimens were received.  The sender should be notified within the 24-hour period immediately following specimen pickup.  Report turnaround time should be approximately 24 hours for most tests; however, most complex tests will require longer times.
   5. Pricing arrangements:  The development of a contract between a hospital laboratory and a reference laboratory requires that certain conditions be met.  A discount schedule must be agreed upon between the account and the reference laboratory.  The discount that can be obtained depends upon the reference laboratory?s net profit contribution and how much is required in fixed pricing guarantee.  This is one way a hospital laboratory can successfully combat inflation.  A volume incentive clause is another factor which ensures vendor awareness of responsibility to the customer.  The method used to bill the reference laboratory should be specified in the contract.  Ideally, the billing should be on a monthly basis.

   Accreditations

   Include in the on-site visit an inspection of the laboratory?s accreditation.  The accrediting agencies should be identified, and the accreditation date should be current.  In addition, reports of previous visits should be available upon request.  Such reports should indicate that the laboratory has consistently demonstrated good to excellent performance in proficiency testing surveys, i.e., a minimum of 90%.

   Account Satisfaction

   Request an unedited user list from the reference laboratory.  Use this list to conduct a random sample of the users to ascertain whether or not they are satisfied with the services and the quality of the results.  It is appropriate to ask them what kind of financial arrangements had been negotiated between them and the reference laboratory; however, such information will probably not be provided.

   Staffing - Contracted Services

   Personnel records should be available for your review upon your visit to a reference laboratory.  Your review of the personnel records should identify whether or not personnel are qualified to perform the tests routinely conducted by the reference laboratory.  In addition, the personnel records should indicate whether or not individuals are employed on a full-time or part-time basis and the shift(s) that, the individual(s) work.  In addition, personnel records should indicate whether or not the individual(s) are classified as supervisory personnel.  It is important to identify the distribution of staff and supervisory individuals per shift.  For example, many reference laboratories perform the bulk of their work on night shift.

   Since this is the peak workload for that particular reference laboratory, the greatest amount of staff should be employed on this shift.  Another critical factor that needs to be assessed, is the availability of in-service and continuing education activities to reference laboratory personnel.  A review of the employee personnel files can indicate the frequency with which the individuals are able to attend such presentations.  Clearly, individuals should go to at least one continuing education activity per year.  Finally, the rate of employee turnover should be examined for the previous 24 months.  Consistent turnover in staff and supervisory positions is a good indicator that the laboratory has some substantial management problems.  In such situations, a consumer of services from such a laboratory must be cautious before signing any contractual agreement.

   A critical review of the quality control data and preventive maintenance records is most important.  Such a review clearly gives the potential consumer of laboratory services strong indicators as to the quality of overall operations.  All laboratory manuals should show documented evidence of annual review and have up-to-date reference citations.  The proficiency testing data should not show a total number of deficiencies greater than 10% throughout any proficiency testing year.  Daily quality control documentation should also be examined.  Deficiencies should be detected and recorded in an approximate frequency of 1 out of every 20.  Reference laboratories that show no deficiencies during any 20 day period are probably not recording or performing their quality control.  All deficiencies in quality control should be clearly documented and include that normality has been restored during a period of time not exceeding five days.  All quality control deficiencies and data should be reviewed and signed by the laboratory director or his designee.  If, on initial examination, quality control and preventive maintenance data appear acceptable, you as the potential account should request that the potential reference laboratory accept split samples from you as a test of proficiency.

   In addition, such a practice should be incorporated into a contractual agreement signed with any reference laboratory, for which no fee till be levied by the reference laboratory.  The advantage of such an up front agreement is that the account is going to periodically inspect its proficiency.

   SUMMARY

   Individuals charged with the responsibility of managing competitive bid situations should consider the following:

   1. Carefully evaluate what procurement techniques may seem to offer the best advantages to the user before deciding on a final approach.  It is also advisable to weigh the disadvantages of each technique.
   2. Be sure to include quality in the specifications.  For example, if you are purchasing reference laboratory services, items such as personnel qualifications, staffing patterns, accreditation of the laboratory, adequate supervision and direction of the laboratory, quality control (both internal and external), and a review of the physical plan of the laboratory, as well as the amount of time the laboratory has been in business will be of interest.  The turnover of laboratory personnel might also provide an indication of how well the laboratory is managed.  Results of the proficiency testing by particular external surveys should be made available to the individual purchasing the services through the competitive bidding process.
   3. Write the contract specifications with great care, being certain to cover even what may appear to be the smallest possible details concerning the contract.
   4. Develop comparative shopping lists.
   5. If possible, a committee should be established to assist in evaluating and reviewing the comparative bid data.
4. REFERENCE LABORATORY EVALUATION CHECKLIST

   I.  Operations

   1. Is the financial statement favorable?
   2. What is the margin of this lab?
   3. What are the salary and supply expenses as a percentage of revenue?
   4. Has this laboratory operated for less than three years?
   5. Is this laboratory a subsidiary of a parent company?  Specify.
   6. Designate the ownership, if different from #5.
   7. Does this laboratory operate satellite facilities (SFs)?  Specify location(s).

      7a.  Are the SFs complete, free-standing labs?
      7b.  What procedures do the SFs perform? Specify.
      7c.  Do all SFs use procedures identical to those used in the main labs?  Specify if different.

   8. What are the normal hours of operation?  Specify by shift.

      8a.  Do SFs have same hours of operations?  Specify if different by each SF.

   9. In what scientific areas does this laboratory conduct testing?

      9a.  Does this laboratory usually perform the tests on all specimens submitted for analysis?
      9b.  What is the total number of tests performed per year per section?

   10. Does the laboratory refer specimens to other reference labs for analysis?

       10a.  Which test(s) are referred?
       10b.  What are laboratories are used as reference?
       10c.  What percentage of these tests per year are referred to another lab for analysis?

   11. Are prices competitive for list pricing?
   12. What discount will this laboratory offer?

       12a.  Why is this laboratory willing to offer such a discount?  Explain (see 1-5 above).
       12b.  Term of price protection (1 year, 2 years, greater).

   13. Does this laboratory have its own courier service?

       13a.  If not, how is specimen pickup/delivery handled?  How are stats handled?

   14. What is average test turnaround time?
   15. Will this laboratory install a telex printer or CRT unit at the account to facilitate communications?
   16. Are specimen containers/labels provided?
   17. Are billing statements issued monthly?  If not, specify.
   18. Was a tour of the laboratory available on request?

       18a.  Did you tour the laboratory?

   19. What instrumentation is located in this laboratory?  (List instrument type and approximate acquisition date.)

   II.  Accreditation

   20. Is this laboratory accredited?  Specify the accrediting agency(ies).

   III.  Account Satisfaction

   21. Was a (limited) (unlimited) user list provided upon request?
   22. Were present laboratory users satisfied with the service and quality of results?   Comments.

   IV.  Staffing

   23. Are personnel records available for review?
   24. Are personnel qualified to perform tests?  (check satellite labs).

       24a.  Specify the number of FTEs and PTEs by shift.
       24b.  Specify the number of MT, MLT, and CLA, OJT by shift.
       24c.  Specify the number of supervisors.

   25. Are qualified personnel assigned to all shifts?
   26. Are supervisors qualified?
   27. What is the distribution of supervisors per shift?
   28. What is the staff/supervisor ratio?
   29. Is evidence of periodic review present in the employee file?
   30. Is workload volume broken down by shift to assist in evaluating staffing?
   31. Does this laboratory use CAP workload recording or some comparable method?
   32. Is staffing adequate for the volume of tests performed?
   33. Is adequate staffing maintained during vacations, sick leave, holidays, educational leave, etc.?  Explain.
   34. Is adequate in-service and continuing education available to personnel?  Explain.
   35. What is the rate of employee turnover expressed as a percent for the past 24 months?

       35a.  Turnover staff positions/shift.
       35b.  Is turnover primarily in one or two specific sections or shift(s)?  Specify.

   V.  Quality Control (QC) & Preventive Maintenance

   36. Are the laboratory manuals current?
   37. What is the total number and percentage of quality control tests and standards to the total number of tests performed per year?
   38. Were any QC deficiencies detected and documented during the past 12 months?
   39. What percentage of the total number of QC tests is represented by these deficiencies?
   40. Are all QC deficiencies documented to include restoration normality?
   41. Are all QC data reviewed and signed by the director to appropriate program?
   42. Is the work of technicians countersigned by qualified supervisors?
   43. Does the laboratory subscribe to an external proficiency testing (PT) program?

       43a.  Total number of PT specimens per year?
       43b.  Total number of deficiencies per year?
       43c.  Number of successive deficiencies per year?
       43d. Names of PT program providers.

   44. Are the results from PT programs available to accounts on request?  Explanation.
   45. Is this laboratory willing to accept blind unknowns from accounts as a test of proficiency for which no fee will be levied?  Specify terms.

3-6.7  PATHOLOGY CONSULTANTS

The JCAH standards state:

?Good personnel and supervision are very important factors.  It would be ideal if every hospital had its own pathologist.  The amount of work in smaller hospitals does not justify the full-time services of a pathologist.

The JCAH believes strongly that if a hospital does not have the full-time services of a pathologist, it should at least have the services of a pathologist on a regular part-time or consultative basis.  A hospital is not criticized for sending tissues out to a pathologist but if that hospital has not been regularly visited by or had its laboratory supervised by a pathologist, it must of necessity be scrutinized very carefully as to quality of services given.?

In those facilities maintaining laboratory services which do not have a pathologist on the staff, the Indian Health Service Area Director will require that consultative services be furnished by a pathologist on the staff to the Area Office or an Area Medical Center or by contractual arrangement with a private practitioner or group qualified in the respective specialties.  In either event, on-site consultation, inspection and evaluation shall be held with a written report to be filed at the facility and in the Area, Office, demonstrating that the standards have been met.  The Indian Health Service Area Director shall arrange for adequate consultation from a pathologist, either IHS staff or under contract.

3-6.8  AUTOPSIES

1. Purpose

   The autopsy is generally done to determine the cause of death, extent of disease, effect of treatment, etc.  The information obtained may then be used for clinico-pathologic correlation, QA program, expanding knowledge on disease process and management.  Each autopsy procedure and autopsy report shall be sufficiently thorough to meet the needs of the medical staff.  A provisional anatomic diagnosis should be available for patient?s medical records within 24-48 work hours.  The autopsy report including the final anatomic diagnosis should be completed in one month for uncomplicated cases, and in 2-3 months in complicated cases.

2. Regulations

   Title 42, Part 35, Sub-part A., Section 35.16 (Rev.) of the Code of Federal Regulations provides:

   ?Autopsies, or other post-mortem operations, including removal of tissue for transplanting, may be performed on the body of a deceased patient only by direction of the officer in charge and only if consented to in writing by a person authorized under the law of the State in which the station or hospital is located to permit an autopsy or such other post-mortem operation under the particular death involved.?

   ?Restrictions or limitations imposed by the person consenting thereto on the extent of the autopsy or other post-mortem operation shall be observed.  Documents embodying consent shall be made a part of the clinical record." (Emphasis supplied).

3. Procedure
   1. Where death occurs to a patient in an Indian Health Service facility under normal circumstances and is not considered to be the result of criminal activity, consent for autopsy must be obtained in accordance with the above requirements of Sec. 35.16, Federal Regulations.
   2. Where death occurs to a patient in an Indian Health Service facility under unusual circumstances or when wrongful death is suspected:
      1. if state criminal jurisdiction is involved, an autopsy may be performed upon request of coroner, medical examiner or the State equivalent, or
      2. if Federal criminal jurisdiction is involved, autopsy may be performed upon request of the Department of Justice.  In either case, consent of the surviving spouse or next of kin is not needed and should, in general, not be requested.
   3. Service Officers who perform autopsies without proper consent may be personally liable to the surviving spouse or next of kin.
   4. In order to assure protection of the interest of the Service and cooperation with Federal and local authorities, close working relationships should be established with the Bureau of Indian Affairs Area Office, the Office of Agency Superintendent and the Office of the U.S. Attorney so that their advice may be obtained as to the appropriate procedures for securing proper authority for autopsies in case of unusual or wrongful death.
   5. Only individuals specifically trained (pathologists or forensic medicine specialists) should be allowed to perform autopsies.

3-6.9  STAFFING

Laboratory staffing must be given a high priority to ensure high standards and accurate laboratory results and that accreditation requirements by HCFA, JCAH , and CAP are met, Depending upon the size of the laboratory, a combination of technologists and technicians may be used.  The ratio of technologists and technicians must be adequate to ensure the technician is working under direct supervision of a technologist.

1. Technologist

   The GS 644 standards for medical technologists specify the minimum qualifications for medical technologists.  Technologist positions must be filled with personnel who meet these standards.

2. Technician

   The GS 645 standards for medical technicians specify the minimum qualifications for medical technicians.  Personnel must meet these standards to qualify at the technician level.

3. Joint Commission on Accreditation of Hospitals (JCAH)

   There shall be sufficient qualified personnel with documented training and experience to supervise and conduct the work of the laboratory.  JCAH requires that personnel working alone, or on call back must meet the technologists standards and/or be supervised by a Medical Technologist.

4. The College of American Pathologists (CAP)

   For accreditation, CAP requires the medical technologist to meet the supervisor qualifications to be supervisor of the laboratory.  All work performed in the laboratory must be reviewed and signed by the supervisor before the reports go out from the laboratory.  Work done by a laboratorian on call must be reviewed and signed the next workday by the supervisor.

5. Job Descriptions

   Job descriptions for the GS-644 and 645 categories should be written in the OPM, Factor Evaluation System (FES) format.  These descriptions must be inclusive of all functions expected to be performed by the person as well as physical capabilities and environmental demands.

6. P.L. 93-638 Contracts - Personnel

   Laboratories operating under P.L. 93-638 contracts must use personnel meeting the above A-D in order to obtain and continue accreditation programs.

3-6.10  QUALITY ASSURANCE

Each clinical laboratory shall have a quality assurance policy which complies with the standards established by HCFA, JCAH, and CAP.  The policy should include but not be limited to the following:

1. Participation in an internal daily QC Program.
2. Participation in CAP Proficiency Testing Survey Program.
3. Preventive Maintenance program.
4. Active participation in the Service Unit QA Program.

The quality assurance systems within the pathology laboratory shall be designed to insure the quality and appropriateness of laboratory data.

1. Internal QC Program

   Each procedure performed in the laboratory must be checked at least daily for its intended reactivity by the use of reference material.  Acceptable limits for standards and controls shall be established covering the range of clinically significant values.  Standard deviation, coefficient of variation and other statistical data will be used to monitor the daily operation of the laboratory.  The laboratory supervisor in collaboration with the clinical director will assist in evaluating the quality control reports on a routine basis.

2. External CAP Proficiency Testing

   Participation in the CAP proficiency testing program is required.  Unknown specimens are received at least quarterly from the CAP to be analyzed in the same manner as patient samples.  Appropriate records must be maintained for each. proficiency survey.  Any analyte shown to be outside the acceptable limits must have documented response of action taken to resolve the out of limits analyte.

3. Preventive Maintenance

   Instruments and equipment must be evaluated at established intervals to ensure their proper function at all times.  Appropriate records must be maintained for each instrument or piece of equipment, showing the date of inspection, or performance evaluation, along with significant corrective action taken in response to revealed defects.

4. Service Unit Quality Assurance Program

   There shall be active participation in the ongoing Service Unit quality assurance program.  The QA program is designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities in improved patient care and resolve identified problems.  Laboratory quality assurance activities should be integrated and coordinated with all other Service Unit quality assurance activities.  There must be a program for the validation of new testing methods which includes valid calibration techniques along with an established procedure for continual surveillance of the results obtained, using suitable reference samples.  Each clinical discipline is responsible for identifying and resolving problems related to patient care.

   The laboratory role of patient care monitoring activities must include:

   1. Chart Reviews
   2. Peer Reviews
   3. Appropriate test ordering
   4. Monitor testing procedures that are performed at location other than in the laboratory settings, e.g., Glucose monitoring, Women/Infants/Children (WIC) Programs, etc.

The following Quality Assurance components will be the essential steps used in the assessment of important aspects of patient care and the correction of identified problems:

1. Identification of important or potential problems.
2. Objective assessment of the cause and scope of problems or concerns, including the determination of priorities for both investigating and resolving problems.
3. Implementation of decisions or actions that are designed to eliminate identified problems.
4. Monitoring activities designed to assure that the desired result has been achieved and sustained.
5. Documentation that reasonably substantiates the effectiveness of the overall program to enhance patient care and to assure sound clinical performance.

3-6.11  TRAINING

The ever-increasing complexity of procedures and techniques in laboratories requires that technologists and technicians be provided training opportunities to keep abreast of developments.  Training programs, including in-service workshops, Area or Regional refresher courses, Centers for Disease Control courses, etc., shall be established by the Areas.  All technologists and technicians and aides are encouraged to participate in training activities, preferably biannually, to the extent that the Area can support this.  It is vital to the program that all personnel be kept abreast of developments in the field of laboratory science.

3-6.12  RECORDS

Records and reports are required to be maintained by the laboratory.  The manner in which the records are maintained can vary as long as the information is retrievable.

Information required:

1. Patient specimens - A positive identification system of patient specimens, must be maintained.  The system must provide a means whereby each step in processing the specimen can be followed from the time it enters the laboratory until the final result is obtained.  These records must be kept for 2 years (except American Association Blood Banks [AABB] requires 5 years for blood bank records) unless a State regulation specifies a longer time in that state.
2. Quality Control - All quality control activity must be recorded each day.  Instrument printouts of quality control activity must be retained for 2 years.  Lot numbers of control material and reagents must be recorded.
3. Maintenance - All maintenance work must be recorded when performed (as specified in the manual).  The records for equipment should be retained for the life of the equipment.  These records produce a history of the equipment and can be used for information in the acquisition of new equipment.
4. Personnel - Records on personnel must adhere to Office of Personnel Management (OPM) regulations.  The type of personnel records a government laboratory should keep are:  training, medical, performance standards with evaluation, awards, etc.
5. Reports - The final laboratory report must contain the completed laboratory results and patient identification, the identification of the physician ordering the test, the specimen date and the report date, reference values for test, values outside of the reference range either marked or annotated, and the name and address of the laboratory performing the laboratory procedures.  A copy of this final report must be retained in the laboratory in a readily retrievable manner for 2 years.
6. When in doubt regarding how long to keep a record, keep the record in a retrievable manner for 2 years.

3-6.13  WORKLOAD

All laboratories will participate in the College of American Pathologist's (CAP) workload recording program.  The ability to measure technical workloads in medical laboratories in a uniform manner is essential for management in order to review past experiences and for projection of future trends in equipment and staffing.  To obtain this uniform measure of technical workloads each laboratory must participate EACH month in the CAP workload recording (WLR).  The WLR is a management tool designed to effectively measure the productive time expended by technical, clerical, and aide staff.  The CAP WLR is an established and validated system for providing essential management information.  The CAP method is based on a standardized unit value per procedure that represents the mean number of laboratory workload units (expressed in minutes) of time required to perform all the steps necessary to complete the defined procedure once.  These expressed units are specified time spent on a defined procedure.  Nonspecified hours should be monitored.  The nonspecified hours are also used when developing staffing requirements.  Nonspecified hours consist of the time spent in the laboratory doing tasks such as: administrative activities, computer oriented activities and those not set up in the specified WLR.

The WLR must be sent to CAP. by the 10th of each month to be entered in the CAP computer system.  If the information does not reach CAP by the 10th, there will be no information received for that month.

Management application received from CAP each month with the WLR are:  paid productivity, worked productivity and specified productivity.  This data is a management aid designed to measure the productivity of the laboratory and determine appropriate staffing requirements, space requirements, current and projected service capabilities.

3-6.14  HEALTH PROMOTION/DISEASE PREVENTION

The Health Objectives of the Nation as presented by the Surgeon General are grouped into 3 categories:  Preventive Health Services, Health Protection, and Health Promotion.  Emphasis has traditionally been on primary prevention but it can be expected that parallel efforts in the secondary and tertiary realms will follow.  Even the best primary prevention efforts will not prevent the development of diseases of intrinsic origin.  Early case finding and the monitoring of therapy to minimize the progress of disease represents an important and traditional role for IHS Laboritorians.

Activities in which IHS Laboratorians should participate are:

1. Health Promotion:

   Health Fairs

   Health Awareness activities in the community schools
   Employee Fitness
   Daily contact with outpatients presents countless opportunities to seize the "teachable moment"
   Consultation with the patient on the significance of laboratory testing.

2. Health Protection:

   Infection control for the clinic and hospital
   Safety programs for the clinic, hospital, schools and community
   Safety procedures for specimen handling by non-laboratory individuals, patient and health-care providers.

3. Preventive Health Services:

   Support the teaching of primary care providers concerning the need for appropriate prenatal and postnatal care, making a contribution to healthier pregnancies and improved infant health.

4. Provide Information and Education Concerning the Benefits of:

   Reduced sodium intake
   Weight loss
   Physical activity
   Stress reduction

5. Consultation with the Patient on the Significance of Laboratory Testing
6. Quality Assurance for Non-Laboratory Testing Devices:

   Over 100 different medical tests can be performed outside of the laboratory.  Correlation studies and monitoring performance of users are laboratory responsibilities.  Examples of medical tests that can be performed at home or at the bedside are:

   Detection of occult blood
   Glucose
   Pregnancy tests

7. Collaboration with Allied Health Professionals in QA for Non-Laboratory Testing:

   Public health nurses
   Community health representatives; and
   Community health aids.

3-6.15  SAFETY

Each laboratory must prepare a Laboratory Safety Manual, which should be readily available to all employees.

The safety responsibilities of the laboratory include the following:

1. Establish safety policy.
2. Provide a safe workplace.
3. Comply with established safety and health standards.
4. Review and act on reports of the following:
   1. Safety Committee
   2. Safety Officer
   3. Accidents
   4. Inspections
5. Recommend facilities adequate for the task required in the laboratory.
6. Instructions for all staff in safety procedures.

3-6.15A  GENERAL REQUIREMENTS FOR PERSONAL AND LABORATORY SAFETY

Sections

(1)  Smoking
(2)  Eating and Drinking
(3)  Food
(4)  Cosmetics
(5)  Contact Lenses
(6)  Face Protection
(7)  Clothing
(8)  Shoes
(9)  Hair
(10)  Beards
(11)  Hand Washing
(12)  Mouth Pipetting
(13)  Aisles and Exits
(14)  Precautions - Isolation Procedures
(15)  Good Housekeeping
(16)  Glassware
(17)  Centrifuges
(18)  Autoclaves

1. Smoking is prohibited in the technical work area.  Smoking is hazardous to health.  Burning cigarettes are an ignition source to flammable solvents and affect some clinical values.  The handling of cigarettes from bench to mouth is a route of exposure for bacteria, viruses, and certain toxic materials, such as mercury.
2. Eating and drinking are also prohibited in the technical work areas.  It is poor laboratory practice, a source of contamination, and specimens (blood, urine, feces, sputum) containing a variety of pathogens are handled daily in the technical work area and stored in the lab refrigerators.
3. Food is not permitted in the technical refrigerators.
4. Application of cosmetics in the technical work area is prohibited.
5. Contact lenses, especially the soft ones, will absorb certain solvents and also constitute a hazard in splashes or spills, offer no protection from a splash and may concentrate caustic material against the cornea or prevent tears from washing a caustic away.  You are strongly advised not to wear contacts in the laboratory.
6. Face shields or eye protectors, must be worn when handling caustic materials.
7. Clothing:  Uniforms ,or laboratory coats shall be worn when working.  Do not wear clothing with a high percentage of acetate, or other highly flammable material.  Laboratory coats should be worn either in the lab and removed when out of the lab, or worn over the uniform when out of the laboratory and removed when, working.  (Policies may vary.  The intent of the rule is to reduce the transfer of micro-organisms from the lab to patients and vice versa).
8. Shoes:  Should be comfortable, rubber soled, and cover the entire foot (lace or loafer type).
9. Hair shall be secured back and off the shoulders in such a manner as prevent it from coming into contact with contaminated materials or surfaces and also to prevent shedding of organisms into the work area.  This is especially true in bacteriology.  It is also important to keep hair out of moving machinery such as a centrifuge.
10. Men with beards must observe the same precautions.  Long beards are a danger in regard to moving equipment and all beards are a source of bacterial contamination.
11. Hand washing:  Hands should be washed frequently during the day, before leaving the laboratory, before and after contact with patients, and before eating or smoking.
12. Mouth pipetting of specimens is prohibited.  There are pipetting aids available for every task.
13. Exits and Aisle:
    1. Must not be obstructed in any way.  No equipment, chairs, supplies or trash are permitted in exit routes or areas.
       
    2. Wheel chair or stretcher patients should be placed so as not to obstruct aisles or routes of exit.
       
    3. Doors to the laboratory should be kept closed, but exit doors must not be blocked, bolted, or obstructed in any way to block exit.
14. Isolation procedures:  The standard isolation and precaution policies of the hospital should be observed when indicated.
15. Good Housekeeping:
    1. Rags and/or flammable solvents will be disposed of in self-closing metal containers.
       
    2. Do not hang clothing on or near radiators, steam pipes, heating instruments, or open flames.
       
    3. Do not allow trash to accumulate in any area.  Trash should be disposed of daily.
       
    4. Trash containers into which ash trays have been emptied should be inspected for fire at the end of each day.
       
    5. Festive decorations will be limited to designs on glass outside of laboratory work areas.  Hanging decorations and wax candles are prohibited.  Decorations on lights and instruments are prohibited.
16. Glassware:
    1. Do not use broken or chipped glassware.  Discard it and order new.
       
    2. Do not leave pipets sticking out of bottles, flasks or beakers.
       
    3. Do not attempt to remove stoppers on glass tubing by force.  If they are stuck, cut them off.
       
    4. Glass blowing and other artistic endeavors are prohibited.
       
    5. Decontaminate glass exposed to possible hepatitis-containing samples.
       
    6. Dispose of broken or discarded pieces in a specially marked separate container.  (Disposal of broken glass along with paper and trash is a hazard to the custodial staff.)
       
    7. Hot glass - heated to the containers should be with a heat resistant glove.
17. Centrifuges:
    1. Do not operate centrifuges unless the covers are closed (including serofuges).  Keep hair, beard, neckties, hair ribbons or other frilly or dangling items OUT OF THE WAY.
       
    2. Do not centrifuge uncovered tubes of specimens (blood, urine, sputum) or flammable liquids.  Centrifugation creates a vacuum and volatilizes liquids.  (Contaminated items become aerosols, flammable liquids become bombs, etc.)  USE CAPS OR PARAFILM.
18. Autoclaves:
    1. Personnel should not operate autoclaves until they have been checked out in the proper operation.
    2. Do not open until both temperature and pressure are back to normal.
    3. Be sure intake steam valve is off before opening.
    4. Use heat resistant gloves, then putting items into or removing items from the autoclave.  The sides and door may be hot in addition to the material being autoclaved.

       NOTE:  Beware of steam which will permeate heat resistant gloves.

    5. Loosen caps of any containers to allow equalization of pressures inside containers.  This prevents explosions, boil-overs, and implosions.
       
    6. Cellulose nitrate tubes may explode.

3-6.15B  WARNING SIGNS AND LABELS

(1)  Purpose
(2)  Policies
(3)  Labeling
(4)  Signs

1. Purpose

   To provide a uniform policy and procedure for indicating the presence of certain hazards that may not be apparent to the casual observer.

2. Policies:
   1. Area designations:  In most routine clinical laboratories there are not "high-risk" areas except in the chemical and bacteriologic hoods and in the storage area.  The technical work areas will be considered to be "moderate risk" and restricted to laboratory personnel.  Administrative, clerical and patient areas are considered to be "low risk" areas and are not restricted.
      
   2. Posting:  In some laboratories there may be high risk periods of time that require posting while the hazard exists.  In others the designations are permanent and restrictions and signs should be permanent.
      
   3. Labels with appropriate warnings will be affixed to all hazardous reagents in addition to required labels indicating content.
3. Labeling:  All reagent kits and materials must be labeled in regard to:

   Content
   Concentration (if applicable)
   Date Received (or prepared)
   Date placed in service
   Storage requirements
   Expiration Date

1. All hazardous reagents must also be labeled in regard to:

   Caution required
   Type of hazard (poison, irritant, inhalant, carcinogen)
   Precautions (do not pipet, avoid skin contact, do not inhale, use only in enclosed area, use only in ventilated area, etc.)
   Instruction in case of accident (wash immediately).

2. The Hazard Identification System of the National Fire Protective Association (NFPA) will be used.  Ref:  Hazardous Clinical Data (NFPA No. 49)) Manual of Hazardous Clinical Reactions (NFPA No. 49, M), Fire Hazard Properties of Flammable Liquids, Gases & Volatile Solids (NFPA No. 325 M) and Recommended System for the Identification of the Fire Hazard of Materials (NFPA No. 704 M).
4. Signs:  Should be posted as needed.  For example:  Type of hazard: Biologic, Radiation Area, etc., type of caution required:  Restricted to lab personnel.

3-6.15C  FIRE PREVENTION AND CONTROL

(1)  Prevention
(2)  Priorities in case of fire:  alarm, evacuation, control
(3)  Responsibilities
(4)  Control of fires

a.  Evaluation
b.  Solid combustibles
c.  Flammable liquds
d.  Electrical
e.  Gas

(5)  Fire safety equipment in the laboratory.

1. Prevention
   1. Be aware of ignition sources - open flames, cigarettes, heating elements and spark gaps (motors, light switches, friction and static).  SMOKING is not permitted in the technical work are of the laboratory.
   2. Do not use flammable liquids in the presence of ignition sources - and conversely - keep ignition sources away from area where flammable liquids are used and/or stored.
   3. Flammable liquids give off vapors which may also burn or explode.  Be sure flammable liquids are properly stored.
      1. Quantities of one gallon or over in SAFETY CANS.
         
      2. BULK STORAGE should be in a safety cabinet.
         
      3. Small quantities, 1 pint or less, "in use" should be stored in well ventilated areas.
   4. DO NOT STORE ETHER IN REFRIGERATORS OR COLD ROOMS.
   5. Do not store any flammable liquids in areas exposed to direct sunlight.
   6. Festive decorations are restricted. Hanging decorations are prohibited.
2. Priorities in case of fire:
   1. Sound alarm first to get help and to initiate evacuation of the area or building.  This is essential because small fires can rapidly become conflagrations.  Time wasted fighting a fire may only delay effective control and may cost lives.
   2. Procedures for Reporting:
      1. Activate alarm system - OR -
      2. Call the hospital operator and say "This is (name) I want to report a fire in the laboratory.
3. Precautions:
   1. DO NOT HANG UP
   2. Check to be sure the message has been received and passed on to the fire department.
   3. Evacuation:
      1. Evacuate the immediate area of the fire.
         
      2. There will be no general evacuation unless a General Alarm is sounded, i.e., to evacuate the entire building.
         
      3. WALK - DO NOT RUN, to the nearest exit.  Assemble all laboratory personnel together outside the building.
4. Responsibilities.
   1. Supervisor in charge:  check to be sure all personnel have been evacuated.
   2. Fire marshals:  (Designated by the Laboratory Supervisor):
      1. Close doors and windows.
      2. Shut down electrical and gas equipment.
      3. Conduct orderly evacuation.
   3. Control of Fire:
      1. Evaluation:
         1. Evaluate the type and extent of the fire.  If it's going to be a large fire, get out!  Control measures should only be undertaken for small isolated fires.
         2. Evaluate the type of material burning (wood, flammable liquids, electrical or gases).
      2. Solid combustibles:
         1. Small objects may be handled with heat resistant gloves and extinguished with water, CO₂ or Halon.
         2. Water or dry chemical extinguishers may be needed for large fires.
      3. Flammable liquids:
         1. Dry chemical extinguishers are usually needed for safe and effective control of burning liquids.  CO₂ will be effective only on a small fire.  DO NOT USE WATER (it enhances spread).
         2. If flammable liquids have spilled but not ignited, sand (or other nonflammable absorbent) may be used to prevent spread and reduce the fire hazard.  A dry chemical extinguisher should be available in case of fire.
      4. Electrical:
         1. Do not use water unless the circuit has been shut down.
         2. Shut down circuit if possible.
         3. Halon, CO₂ or dry chemicals are safe and effective.
      5. Gas:
         1. Shut off source if possible.
         2. "Blow out" flame with CO₂ (possible only when gas has been shut off).
         3. Keep other flames away from gas cylinders.
5. Fire safety equipment in the laboratory:
   1. Sand or absorbent material:  is to be used to contain spread of spilled liquids.
   2. Fire extinguishers:  are of the Halon or CO₂ and dry chemical type.  They may be used on any type of fire.  Unauthorized use (for play or cooling beverages) is strictly prohibited and grounds for disciplinary action.
   3. Fire blankets:  May be used to smother a clothing fire by wrapping the victim or rolling them on the ground.  Fire blankets may also be wrapped around a person who has to pass through a burning area.
   4. Heat resistance gloves:  May be used to move or handle a small burning object, or to handle hot vessels, or to turn off hot valves or handles.

   CAUTION:  Heat resistant gloves are permeable, steam or hot liquids can soak through and cause injury.

3-6.15D  ELECTRICAL SAFETY

(1)  Grounding
(2)  Report shocks
(3)  Corrective actions
(4)  Repairs on instruments
(5)  Repairs on building
(6)  Extension cords

1. Grounding:  All instruments must be grounded including household type appliances, coffee pots, etc.  The only exceptions to the rule are items entirely encased in plastic (such as microscopes).
2. Report shocks:  All shocks must be reported immediately, including small tingles.  Small shocks often proceed major shocks and a light tingle may indicate potential trouble.
3. Corrective actions:  Shut off the current and/or unplug the instrument.  Do not attempt to use an instrument that is causing shocks.  Not only is it potentially dangerous, but any results from the instrument would be suspect.
4. Repairs:  DO NOT work on or attempt to repair any instrument while it is plugged in.  An exception is the calibration of instruments which require adjustment while plugged in.  In this case, be sure hands are dry, remove all jewelry (watches and rings) and proceed with caution.
5. Repairs: on the electrical system of the building are prohibited.  Any work performed on switches, outlets or circuit boxes (fuses, circuit breaker) must be referred to the building maintenance personnel.
6. Extension cords should be avoided.  If used, they must be 3-way type and properly grounded. Gang plugs are prohibited.

3-6.15E  COMPRESSED GASES

(1)  Introduction
(2)  General standards
(3)  Flammable gases (hydrogen, acetylene)
(4)  Pressure regulators and needle valves
(5)  Leak testing
(6)  Empty cylinders

1. Introduction:  Compressed gases constitute several hazards.  Any gas cylinder with a broken valve head becomes a missle capable of penetrating walls.  Specific gases may be toxic or flammable.  Finally, heating of cylinders may result in explosion.
2. General standards:
   1. Cylinders must be secured at all times so they cannot fail.
   2. Valve safety covers should be left on until pressure regulators are attached.
   3. Containers must be marked clearly with the name of the contents.  Tanks with wired on tags or color code only should not be accepted.
   4. Hand trucks or dollies must be used in moving cylinders.  Do not roll or drag cylinders.
   5. The use of oil, grease or lubricants on valves, regulators, or fittings is prohibited.
   6. Fire extinguishers are not to be used for cooling beverages or other non-emergency use.
   7. Do not attempt to repair damaged cylinders or force frozen cylinder valves.
3. Flammable gases:  Special care must be used when gases are used in confined spaces.
   1. No more than two cylinders should be manifolded together; however, several instruments or outlets are permitted for a single cylinder.
   2. No more than one cylinder of highly flammable gas shall be in one room without specific review by the director (or safety officer).
   3. Standby cylinders (full or empty) must not be stored in the lab.
   4. Cylinder size is limited to 200 cubic feet.
   5. Valves on all flammable gas cylinders shall be shut off when the laboratory is unattended.
4. Pressure regulators and needle valves:  Needle valves and regulators are designed specifically for different families of gases.  Use only the properly designated fittings.
   1. Threads and surfaces must be clean and tightly fitted.  Do not lubricate.
   2. Tighten regulators and valves firmly with the proper sized wrench.  (Do not use adjustable wrenches or pliers.  They damage the nuts.)  Do not force tight fittings.
   3. Open valves slowly.  Do not stand directly in front of gauges (the gauge face may blow out).  Do not force valves that ?stick.?
   4. Check for leaks at connections.  Leaks are usually due to damaged faces at connections or improper fittings.  Do not attempt to force an improper fit.  (It may only damage a previously undamaged connection and compound the problem.)
   5. Valve handles must be left attached to the cylinders.
   6. The maximum rate of flow should be set by the high pressure valve on the cylinder.  Fine tuning of flow should be regulated by the needle valve.
   7. Shut off cylinders when not in use.
5. Leak testing:  Cylinders and connections should be tested by ?snoop? or a soap solution.  First test the cylinders before regulators are attached and test again after the regulators or gauges are attached.
6. Empty Cylinders:
   1. Must be marked empty.
   2. Empty or unused cylinders must be returned promptly.  Demurrage charges continue until the tank is returned to the supplier.
   3. Replace valve safety caps.

3-6.15F  CHEMICAL HAZARDS

(1)  Introduction
(2)  Classification
(3)  Labeling
(4)  Storage of corrosives
(5)  Storage of flammables
(6)  Handling caustic materials
(7)  Breaks and spills
(8)  Mercury
(9)  Disposal of chemical wastes

1. Introduction:  A number of routine procedures in a clinical laboratory involve the use of highly caustic, poisonous, or flammable reagents.  These should be appropriately labeled to indicate the hazards.  Read labels and observe precautions.  Failure to follow safe practices is cause for disciplinary action.
2. Classification:  Dangerous chemicals may be grouped into the following:
   1. Caustic or corrosive:  Acids and alkalies may cause burns of skin or mouth, or eyes and may also cause damage to equipment and storage areas.
   2. Poisons:  Almost any substance in quantity can be poisonous.  For these purposes, a poison will be classified as a substance which may cause death or serious effects if relatively small amounts are inhaled, ingested, or contact the skin (such as concentrated phenols).  Poisons may be gas, liquid, or solid.
   3. Carcinogens:  Substances designated by OSHA as carcinogenic require special handling.
   4. Flammables:  Such materials that easily ignite, burn, and serve as fuel for a fire.
   5. Explosives:  Materials which may explode under special circumstances.
3. Labeling:  All dangerous chemicals must be labeled to indicate:

   Need for caution...........................CAUTION
   Type of hazard..............................IRRITANT
   Precautions to be observed ..... AVOID SKIN CONTACT.....DO NOT PIPET
   Instructions in case of accident..... WASH EXPOSED AREA IMMEDIATELY

4. Storage of corrosives:
   1. Store caustic and corrosive materials near the floor to minimize danger of bottles falling from shelves.
   2. Separate containers to facilitate handling.  Organic acids (acetic acid and acetic anhydride) should be stored separately from strong oxidizing agents (sulfuric, nitric, or perchlorate) to prevent interaction of fumes and corrosion of storage cabinets.
   3. Acid bottle carriers must be used for containers over 1 qt. in size.
5. Storage of flammables:
   1. Quantities of one gallon or over must be stored in a safety can.  If a reagent must be stored in glass for purity, the glass container may be placed in a bottle carrier 40 lessen the danger of breakage.
   2. Small quantities (working amounts) may be stored on open shelves, but bulk storage (more than 5 gallons) must be in a safety storage area.
   3. Do not store ether in a closed area such as a refrigerator.
   4. Do not store flammables in areas exposed to direct sunlight.
6. Handling caustic materials:
   1. If quantities of acids or alkalies are being used, use a shield or barrier of some kind or work in a sink so that the breaks or spills can be controlled.
   2. Wear aprons, gloves, and eye protection devices when handling highly corrosive materials.
   3. Do not pipet by mouth.
   4. Do not sniff reagents.
   5. Dilution:  Use great care and add reagents SLOWLY.  Always add ACID to WATER, never water to acid.  Allow acid to run down the side of the container and mix slowly by gentle rotation.  Avoid over heating.
7. Breaks and spills:
   1. Skin/eye/mouth contact:  wash area immediately.
   2. Clothing spills:  take item of clothing off immediately to avoid soaking through to skin.  This includes belts and shoes (if affected).
   3. Contain spills with sand or absorbent materials.  Wash area thoroughly after clean up.
   4. Disposal:  liquids should be flushed down the sink with copious amounts of water.  Sand or absorbent material should be placed in a sealed can and marked ?CHEMICAL WASTE--HAZARDOUS."
8. Mercury
   1. Avoid or minimize spills of elemental mercury as far as possible.
   2. CLEAN UP GROSS spills with a pipet or "sweeper".  Ventilate area well to remove mercury vapors.
   3. The NO EATING OR SMOKING rule is especially important on benches where mercury is handled.  Mercury can be picked up on tips of cigarettes and is easily absorbed by injection and inhalation.
   4. Chronic exposure and absorption of mercury may lead to a metallic taste in the mouth, a "lead line" (grey line) around gums, and neurologic problems (irritable, hyperreflexic, comatose).
   5. Do not place elemental waste in drains.
9. Disposal of chemical wastes:  the volume of wastes disposed of by small hospital laboratories is usually not sufficient to constitute a hazard.
   1. Liquids should be flushed into the sewer system with copious amounts of water.
   2. Solid wastes should be placed in a sealed container labeled ?Chemical wastes--hazardous? before disposal.

      NOTE:  If large quantities of a hazardous material are being disposed of, special precautions may be required.  Local and regional regulations for environmental protection should be checked for compliance.  Consideration should also be given to recovery and reclaiming materials.

3-6.15G  CARCINOGENS

(1)  Introduction
(2)  Carcinogens
(3)  Requirements
(4)  Limitations

1. Introduction:   Specific regulations have been established by OSHA regarding the handling of certain compounds designated as carcinogenic.  There are only a few of these, used to dilute solutions, in routine use in most clinical laboratories.  An inventory of all such materials must be maintained and specific protective measures must be observed.
2. Carcinogens:   Substances considered by OSHA to be carcinogenic and requiring special precautions are:

   4 Nitro biphenyl	Alpha-naphthylanine
   4, 4'-Methylene bio (2 chloroaniline)	3, 3'-dichloro-benzidine(and its salts)
   Methyl chloromethyl ether	Bis-chloromethylether
   Beta-Naphtylamine	Benzidine and its salts
   4 Aminodiphenyl	Ethylenimine
   Beta-propiolactone	2-Acetylaminofuorene
   4-Dimethlaminoazobenzene	N-Nitrosodimethylamine

3. Requirements for the possession and use of items listed include:
   1. Designation of specific work areas with restricted access.
   2. Listing of personnel authorized to work in the area.
   3. Inventory of types and quantities of reagents on hand.

      NOTE:  Inventories may have to be reported to the Director of Safety, DHHS annually, but the extent of the requirement is not certain.  Inventory reporting may not be required for non-Federal laboratories.

   4. Personnel must be specifically trained in safe handling procedures.
   5. Records of exposure of personnel must be maintained.
   6. Procedures for monitoring, storage, decontamination, disposal and emergency procedures must be established.
   7. Medical surveillance of personnel includes:
      1. Preassignment examination
      2. Periodic examination
      3. Records
   8. Protective clothing must be provided and cleaned daily.  Gloves must be provided if indicated.
   9. Eating, drinking, and smoking are prohibited and mouth pipetting is prohibited also.  Hand washing is required immediately after handling carcinogenic materials.
   10. Work areas must be limited to access and properly identified.  Work surfaces must be impervious (for decontamination) and procedures must be performed in a hood or closed area to control aerosols.
   11. Facilities for changing clothes and showers must be available to personnel.
4. Limitations:  Hospital laboratories may not be able to meet all of the requirements for compliance with Federal regulations.  As a bare minimum it is recommended that:
   1. An inventory of reagents and materials be taken.
   2. Any substances listed should be set aside in a special area for proper labeling and for controlled access.
   3. The use of these reagents should be reviewed and limited to special procedures as outlined by the director of the laboratory.
   4. Policies for use should be established.  The technologists designated to use carcinogenic agents may require special physical exam and medical monitoring.

   NOTE:  A simple method of compliance is to use an isolation or glove box or safety cabinet to provide safe storage and controlled access.

3-6.15H  BACTERIOLOGIC HAZARDS

(1)  Introduction
(2)  Routes of infection
(3)  Policies for handling specimens
(4)  Policies for processing cultures
(5)  Policies for disposal of contaminated materials
(6)  Procedures to be followed following exposure or accident
(7)  Reports

1. Introduction:  The laboratory director and supervisor are responsible for bacteriologic hazards from the time a specimen is collected until it is permanently disposed of (i.e., dead and buried).  Policies for handling specimens before they reach the laboratory should be defined in the specimen collection manual.  This section will cover handling within the laboratory and up to final disposal.
2. Route of infection:   Infections may be spread by several routes.  The actual occurrence of an infection depends on both the virulence of the infecting agent and the susceptibility of the host.
   1. Air borne:  droplets and aerosols may be formed by simply removing caps or cotton plugs or swabs from tubes.  Heating liquids on needles too rapidly may also create an aerosol.  Breakages in centrifuges are serious accidents.
   2. Ingestion:  may occur through mouth pipetting, failure to wash hands after handling specimens or cultures, and by handling of cigarettes.
   3. Direct inoculation:  scratches, needles, broken glass or animal bites may permit direct inoculation.
   4. Skin contact:  some very virulent organisms, and others not so virulent, can enter through small cuts or scratches, or through conjunctiva of the eye.
   5. Vectors:  mosquitoes, ticks, fleas, and other ectoparasites may be potential sources of infection in the laboratory, especially if animal work is performed.
3. Handling specimens:
   1. Specimens with GROSS EXTERNAL contamination should not be accepted.  If left, place in a plastic bag to protect subsequent handlers, discard and request new specimen.  Use gloves or wash hands after handling.
   2. WEAR GLOVES when processing specimens and putting up cultures.  Wash hands afterwards.
   3. CENTRIFUGE:  If specimens must be centrifuged, they MUST BE COVERED by a sealed cap to prevent aerosol formation.
   4. SAFETY HOOD:  Specimens for fungus culture, plague, tuberculosis, should be placed in and handled in the biologic safety cabinet.
   5. Specific policies for handling specimens outside of the laboratory (prior to receipt) should be defined in the specimen collection manual.
4. Processing Specimens:
   1. ALL CULTURES ARE POTENTIAL PATHOGENS - USE CAREFUL TECHNIQUES AT ALL TIMES.
   2. Large numbers of plates should be handled in baskets.  Test tube racks or trays are required for tubed cultures.  (DO NOT place tubes in glasses or paper cups.)
   3. Tuberculosis, plague and fungus specimens and cultures should be handled and processed in the biologic safety cabinet.
   4. Needles, and loops should be allowed to cool briefly after being sterilized so as not to cause spattering of material when used.
   5. Disinfect benches in the morning before work is begun and in the afternoon after work is finished.
5. Disposal of contaminated materials:
   1. Specimens, culture plates, and tubes should be double bagged and incinerated or autoclaved prior to discarding.
   2. Discard specimens and cultures into containers with a double plastic lining.  Bags should be changed when about half full.
   3. Both inner and outer bags should be sealed securely to prevent leakage.
   4. Label the outer bag to clearly indicate the nature of the biologic hazard, how to handle it, and who to notify in case of accident or spillage.
   5. Materials or containers, which are to be reused should be autoclaved prior to cleaning.  Place them in a sealed and clearly labeled container to minimize hazard to others prior to sterilization.
   6. Any breakage of bags or leakage of contaminated materials should be reported to the laboratory director or supervisor at once for instructions on procedures for safe cleanup.
6. Accidents and spills:
   1. Immediate actions:

      (i)  Clear the area at once.
      (ii)  Shut down air conditioning and/or ventilation to area if possible.
      (iii)  Notify the supervisor and laboratory director.
      (iv)  Assess the type of spill and degree of hazard involved.
      (v)  Determine most effective and least hazardous approach to clean up and decontamination.

      NOTE:  Laboratories handling highly virulent infectious agents must have specific plans for handling accidents.  Procedures for such circumstances are beyond the scope of this manual.  The reader is referred to other sources such as DHEW publication CDC 75-8118, ?Laboratory Safety at the Centers for Disease Control,? Centers for Disease Control, Atlanta, Georgia.

   2. ?Dry? spills (overturned or broken culture plate) with no significant aerosol formation.

      (i)  Evacuation of room probably not indicated.
      (ii)  Flood area with disinfectant solution.
      (iii)  Soak up the disinfectant and contaminated material with an absorbent material (sand, kitty litter, paper towels) and dispose of in a plastic bag or sealed container.  Gloves should be worn for cleanup.
      (iv)  The spill area should be thoroughly washed after cleanup.
      (v)  Autoclave the contaminated material.

   3. Liquid spills on bench or floor:

      (i)  If significant aerosols were formed, the area should be evacuated and not reentered for at least one hour.
      (ii)  Cover the spill with an absorbent (sand, kitty litter, paper towels).  Gloves should be worn during cleanup.
      (iii)  Dispose of the absorbent and contaminated material in plastic bags or a sealed container and autoclave.
      (iv)  The spill area should be thoroughly washed after cleanup.

   4. Centrifuge spills:

      (i)  Shut off instrument, evacuate area at once, and shut down ventilation to area.
      (ii)  Do not reenter area for at least one hour until aerosols have settled.
      (iii)  The person entering the area to cleanup should wear protective clothing, gloves, and mask.
      (iv)  If liquids are present, soak up in an absorbent material and handle as above.  If not, clean the instrument and clean the room thoroughly before resuming work.

   5. Spills in incubators, autoclaves, or other closed area:

      (i)  Soak up liquids with an absorbent and dispose of as outlined previously.
      (ii)  If routine cleanup is not possible, the unit may have to be decontaminated by means of a sterilizing gas such as formaldehyde or gluteraldehyde left overnight.
      (iii)  The unit should be thoroughly washed (if possible) after decontamination.

7. Reports:  Major accidents, must be documented and reported in detail.  The report should indicate:

   a.  Cause of accident.
   b.  Type of contaminations or hazard.
   c.  List of personnel possibly exposed.
   d.  Decontamination procedures.
   e.  Actions taken to prevent recurrence.

3-6.15I  ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS) PROTOCOL PRECAUTIONS/LABORATORY GUIDELINES

1. Purpose:

   To prevent any possible nosocomial transmission of AIDS or other opportunistic infections to laboratory personnel.

2. General Comments:

   Laboratory personnel handling blood and other samples from AIDS patients should be aware of the known potential infectiousness of such samples.  Groups at highest risk of acquiring AIDS continue to be homosexual males, intravenous drug users, Haitians and patients who are frequent recipients of blood and blood products (e.g. hemophiliacs.)  The failure to identify cases among friends, relatives and co-workers of AIDS patients provides evidence that casual contact offers minimal risk of acquiring the syndrome.  No evidence currently exists that casual contact in the community or during the performance of one?s job places a worker in any increased risk for acquiring AIDS.

   A large percentage, perhaps all, of AIDS patients are infected with Cytomegalovirus (CMV).  CMV infection of a fetus can be acquired in vitro, causing cytomegalic inclusion disease, a very serious and often fatal neonatal infection.  AIDS patients also are frequently infected with Epstein-Barr virus (EBV), the virus responsible for infectious mononucleosis.  Because of the prevalence of CMV and EBV in AIDS patients, it is recommended that female staff in the childbearing years be made aware of the risks of CMV infection in pregnancy.

   Epidemiologic evidence suggests that the transmission of AIDS is similar to that of Hepatitis B and because as many as 20% of the AIDS patients are chronic carriers of the Hepatitis B virus, Laboratory personnel should use the same precautions when handling specimens from patients with AIDS as those used for HBV.

   Specifically laboratory personnel should avoid direct contact with blood, blood products, excretions, secretions and tissues of patients on AIDS precautions.

   Isolation patients in IHS hospitals are clearly identified.  This ensures the safety of all other patients and employees.  Body fluids of AIDS patients should be treated with the same precautions taken from those patients with HBV.  Notification of isolation precaution should appear on orders directed to various departments (e.g., Laboratory, Diagnostic Radiology, Dietary, Phlebotomy).

   Needlesticks and specimen spills should be reported immediately to the Laboratory Supervisor as well as the Hospital Epidemiology Service and Employee Health Office.

   All laboratory personnel should be aware of and follow precautions instituted for AIDS patients.  Laboratory personnel should be made aware of both the known transmissibility of agents commonly infecting these patients (e.g., CMV, HBV, and EBV).  The importance of following proper Laboratory procedures cannot be overemphasized.

3. Specific Comments
   1. Disposable syringes and needles are preferred.  Only needle-locking syringes or one-piece needle-syringe units should be used to aspirate fluids from patients, so that collected fluid can be discharged through the needle, if desired.  If reusable syringes are employed, they should be decontaminated before reprocessing.
   2. All procedures and manipulations of potentially infectious material should be performed carefully to minimize the creation of droplets and aerosols.
   3. Biological safety cabinets (Class I or II) and other primary containment devices (e.g., centrifuge safety cups) are advised whenever procedures are conducted that have a high potential for creating aerosols or infectious droplets.  These include centrifuging, blending, sonicating, and vigorous mixing.  Fluorescent activated cell sorters generate droplets that could potentially result in infectious aerosols.  Translucent plastic shielding between the droplet-collecting and the equipment operator should be used to reduce the presently uncertain magnitude of this risk.  Primary containment devices are also used in handling materials that might contain concentrated infectious agents or organisms in greater quantities than expected in clinical specimens.
   4. It is recommended that laboratory work surfaces be decontaminated with a disinfectant, such as sodium hypochlorite solution, following any spill of potentially infectious material and at the completion of work activities.  Also it is recommended that 1:10 (rather than 1:100) dilution of 5.25% sodium hypochlorite (household bleach) with water be used.
   5. All potentially contaminated materials used in Laboratory tests should be decontaminated, preferably by autoclaving, before disposal or reprocessing.
   6. All personnel should wash, their hands following completion of Laboratory activities, removal of protective clothing, and before leaving the Laboratory.  Particular attention should be given to thorough handwashing both before and after handling specimens of AIDS patients.  Handwashing is the single most effective means of preventing the spread of infection within the laboratory.
   7. Laboratory coats, gowns, or uniforms should be worn while working with potentially infectious materials and should be discarded appropriately before leaving the laboratory.
   8. Gloves should be worn to avoid skin contact with blood, specimens containing blood, blood-soiled items, body fluids, excretions, and secretions, as well as surfaces, materials, and objects exposed to them.
   9. Specimens (blood, urine, feces, sputum, other fluids) should be put in labeled containers with the lid securely closed.
   10. Containers should clearly indicate ?AIDS Protocol Precautions? before being sent to the laboratory.
   11. If the outside of the specimen container is visibly contaminated with blood, it should be discarded, if feasible.  Contaminated samples should be handled according to hospital procedures.  If such a sample must be sent to the laboratory, it should be first thoroughly cleaned with a disinfectant (such as 1:10 dilution of 5.25% sodium hypochlorite [household bleach] with water).
   12. It is recommended that all blood specimens be placed in a second container, such as an impervious bag, for transport.

3-6.15J  NUCLEAR MEDICINE

1. Introduction:  In many clinical laboratories, the exposure levels of radiation are well below the limits established by State or Federal regulations for which specific safety precautions are required.  The following procedures are suggested as a guide for good practices and to meet State or Federal regulations if applicable.
2. Warning signs and labels
   1. Warning signs indicating the presence of radioactive materials shall be placed in the radionuclide storage area;
   2. Appropriate labels shall be placed on all containers of radionuclides including radiopharmaceutical preparations made up in the laboratory.
3. Receipt and notification:  Most routine shipments of radionuclides are exempt from regulations.  However, the following procedures are recommended if applicable:
   1. Radionuclides should be delivered directly to the laboratory or the laboratory notified on arrival to enable immediate pickup.
   2. The technologist on duty will:

      (i)  Receive the package and sign courier?s receipt.
      (ii)  Inspect package for damage.
      (iii)  Monitor if necessary.
      (iv)  Log shipment in inventory log.
      (v)  Place shipment in the lead lined refrigerator.

   3. Inspection of shipment:

      (i)  Note condition of package:

      (a)  If undamaged, note condition in log and place in storage.
      (b)  If the package is crushed, torn, punctured, or wet (suggesting leakage), it must be checked for radiation.

      (ii)  Monitoring for leakage is required for:

      (a)  All shipments with evidence of damage or leakage.
      (b)  All shipments of I-131 therapy.

      (iii)  Not required for routine shipments if packages are not damaged.
      (ii)  Tolerance limits:

      (a)  Surface activity should not exceed 200 millirads/hr.
      (b)  Activity at 3 feet should not exceed 10 millirads/hr.

   4. Notification procedures:  If tolerance limits are exceeded:

      (i)  Notify the supervisor or laboratory director.
      (ii)  Notify the courier and supplier.
      (iii)  Notify the Atomic Energy Commission (AEC) regional office.
      (iv)  Complete and file an incident report documenting the date, time of receipt, condition of package, surface activity, procedures followed and persons notified.
      (v)  Give incident report to laboratory supervisor or laboratory director.  Copies should go to:

      (a)  Administration
      (b)  Safety Committee
      (c)  Laboratory Director
      (d)  Laboratory File

   5. Procedures for handling damaged packages:

      (i)  Place packages in a plastic bag to prevent further leakage.
      (ii)  Place bagged package in the lead or shielded storage area.
      (iii)  Survey all areas where the package has been to identify areas of contamination.  Mark areas (wax pencil, chalk, or signs) to restrict traffic in area until cleaned up.
      (iv)  Notify housekeeping immediately to wash down areas of contamination.
      (v)  Monitor area after cleaning to determine effectiveness of decontamination.

4. Inventory log, storage, and security:
   1. Record all shipments into the inventory log.
   2. Note the following:

      (i)  Date and time received.
      (ii)  Supplier/courier.
      (iii)  Radionuclide.
      (iv)  Condition of package.
      (v)  Monitor results (if indicated).
      (vi)  Notifications (if applicable).
      (vii)Actions taken (if applicable).

   3. Storage:  Place all shipments in the lead lined refrigerator or behind the lead brick storage area.
   4. Security

      (i)  Shipments of radionuclides must not be left unattended in a public place.
      (ii)  Shipments must be received directly by an authorized person (laboratory personnel) and placed in the isotope storage area.
      (iii)  The storage area should be locked whenever laboratory personnel are not in attendance.

5. Disposal procedures:
   1. Patient wastes:  Secretions, urine, blood samples, and/or fecal specimens may be disposed of into the sanitary sewer system and flushed with copious amounts of water.
      

      NOTE:  Amounts disposed on this manner are negligible.

   2. Test procedures:  Effluents from in vitro tests are aspirated and flushed into sink with copious amounts of water.  The amounts should not exceed 20 microcuries per day.  If large quantities are being disposed of, they should be trapped and allowed to decay before disposal.
   3. Unused isotopes:

      (i)  Are allowed to decay in storage.
      (ii)  May be returned to the supplier for recycling of containers.

   d.  No radioactive materials are incinerated or buried.
   4. Handling of radionuclides:
      1. Liquids:

         (i)  Do not pipet or handle directly.  Remove liquid from vials with a syringe and needle or automatic pipetting device.
         (ii)  Leave vials inside the lead containers.
         (iii)  Wash hands after each procedure.

      2. In vitro test kits:

         (i)  The level of activity is generally very low.
         (ii)  Use care in adding labeled materials to test tubes.
         (iii)  Cover tubes with the caps provided.
         (iv)  Washing:  Flush with aspirators and wash into the drain with adequate amounts of water.  Avoid splashing rinse water.

      3. Capsules:  Handle indirectly with forceps or with plastic or paper cups.  Do not handle directly.
      4. Clothing:

         (i)  Wear a lab coat or apron when handling liquids.
         (ii)  Change immediately if coat or apron becomes contaminated.  Have coat washed or set aside until contamination decays.
         (iii)  Check coat or apron with survey meter periodically to detect contamination.

   5. Spills.
      1. Capsules may be picked up with forceps.
      2. Liquids:

         (i)  Notify supervisor or pathologist immediately.
         (ii)  Keep other personnel out of the area.
         (iii)  Put on rubber gloves and soak up the spill with absorbent paper.  Place the wet toweling in a plastic bag and add the gloves to the bag when finished.  Place the bag behind adequate shielding to decay before disposal.
         (iv)  Scrub the area with soap and water rinse adequately.
         (v)  Survey the area with the portable rate meter to detect residual contamination.  Repeat washing if necessary.
         (vi)  Wash hands thoroughly.

   6. Environmental and Personnel Monitoring:
      1. Surveys:

         (i)  Monitor the work area, storage area, specimen receipt area, and scanning room daily.  Record results.
         (ii)  Tolerance limits:

         (a)  Surface areas should not exceed 200 mrem/hr.
         (b)  Excessive or unusual contamination should be reported to the pathologist.

      2. Personnel monitoring:

         (i)  Film badges should be made available for all personnel but are NOT REQUIRED for low level exposures encountered with in vitro testing.
         (ii)  Film badges are required for personnel working with Mo99/Tc99 generators and therapy doses.
         (iii)  Reports of environmental surveys and personnel exposure levels must be available to employees on request.

   7. Personnel:  General requirements for notification of employee rights and of potential hazard.
      1. All personnel handling or exposed to radionuclides must be notified and instructed regarding the presence and potential hazard of radionuclides and instructed in safe handling procedures.
      2. Personnel performing in vitro tests should be required to wear film badges (primarily for legal purposes).
      3. Personnel are entitled to:
         1. Reports of exposure records (film badges) upon request.
         2. A report of any, accidental exposure (i.e., notice of any reports sent to AEC).
         3. File complaints.
         4. Accompany an AEC inspector during an inspection of a facility.

            Complaints:  Must be filed in writing and directed to:
            Director of Regulatory Operations
            US Atomic Energy Commission
            Washington, DC 20545

   8. Personnel:  Notification and Restrictions:
      1. Posting of notices:  Federal regulations require posting of the following:
         1. Regulations pertaining to notices, instructions, and reports.  Title 10, Chap. I, Part 19.

             (a)  Posted on bulletin board.
             (b)  Copy in Procedure Manual.

         2. License and conditions on file in:

             (a)  Isotope Committee book.
             (b)  Administrator's office.
             (c)  Laboratory.

         3. Notices:  On bulletin board.
      2. Instructions:  Personnel safety procedures:
         1. Only those who have been instructed in proper techniques and safety precautions will handle radioisotopes.
         2. Persons with open cuts or sores will not handle isotopes.
         3. THERE WILL BE NO SMOKING IN THE LABORATORY, PARTICULARLY IN OR AROUND THE AREA WHERE RADIOISOTOPES ARE HANDLED.
         4. Pregnant women are advised of potential hazard but are not excluded from working.

   NOTE:  It is reemphasized that not all of the policies listed above are required by law.  The policies should be modified to comply with prevailing State or Federal regulations and meet the needs of the individual laboratory in regard to the type and extent of exposure encountered.

   3-6.15K  REPORTS OF INCIDENTS AND ACCIDENTS

   1. Introduction:  Reporting of incidents and accidents is required by law.  Relatively minor incidents without personal injury or only minor injury should be reported to the facility on the laboratory report form.  Serious accidents (fatalities and multiple hospitalization injuries) must be reported directly to OSHA.
   2. Reportable incidents include:
      1. Every accident (injurious or non-injurious)
      2. Accidents resulting in damage to instruments or the building.
      3. Situations or conditions which have the potential for injury, hazard to health, or damage to the property.
   3. Serious accidents include:
      1. Fatalities.
      2. Injuries requiring hospitalization.
      3. Injuries involving three or more people.
      4. Property damage exceeding $25,000.
      5. Biologic exposure resulting in lost time or which may involve the public.
      6. Accidents resulting in spillage or radioactive materials.
   4. Investigation:
      1. Minor incidents reported to the supervisor will be investigated and a report given to the laboratory director, and safety officer with an evaluation and any recommendations.
      2. Major accidents or serious incidents will be investigated by the supervisor and director in conjunction with the hospital safety committee.