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Department of Veterans Affairs Veterans Health Administration Washington, DC 20420

VHA HANDBOOK 1106.01

Transmittal Sheet January 29, 2016

D.26 PATHOLOGY AND LABORATORY MEDICINE SERVICE PROCEDURES

1. REASON FOR ISSUE: This Veterans Health Administration (VHA) Handbook is issued to provide procedures for the administration, accreditation, staffing, and functioning of clinical and anatomic pathology laboratories in Department of Veterans Affairs (VA) facilities or facilities managed by VA.

2. SUMMARY OF MAJOR CHANGES: This VHA Handbook contains implementation instructions for VHA Directive 1106. The following procedures for the administration, accreditation, staffing, and functioning of clinical and anatomic pathology laboratories in VA facilities or managed by VA facilities have been updated:

a. Paragraph 3: New definitions paragraph.

b. Paragraphs 5.a., b., and c.: Responsibilities for National Director Pathology and Laboratory Medicine Service, National Enforcement Officer, and Regional Commissioner have been defined.

c. Paragraphs 5.d., e., and f.: Responsibilities for the Facility Director, Chief of Staff, and Veterans Integrated Service Network (VISN) Director have been extracted from the document and placed in the new responsibilities paragraphs.

d. Paragraph 5.g.(23): Clarified the role and responsibilities of contracted pathologists and the oversight responsibilities of the VA in compliance with government regulations.

e. Paragraphs 6, 7 and 8: Clinical Laboratory Improvement Amendments (CLIA) requirements, proficiency testing requirements, and accreditation requirements have been extracted from throughout the handbook and placed in separate paragraphs.

Defined laboratory director requirements. Clarified CLIA application requirements.

f. Paragraph 13. f.: Revised patient self-testing requirements consistent with new VHA patient self-testing policies.

g. Paragraph 15 (1) (c)-(d): Revised qualification requirements for individuals performing anatomic pathology reports.

h. Paragraph 17 and Appendices: Removed references to Special Reference Laboratory for Pathology at Armed Forces Institute (AFIP) and the Systematic External Review of Surgical (SERS) cases program. Replaced the paragraph and appendices with information on the new VHA agreement with the Joint Pathology Center (JPC).

i. Paragraph 19: Incorporated regulatory changes to the select agent security requirements.

j. Appendix D: Added new appendix on personnel standards according to the requirements outlined in this Handbook and the federal regulations.

VHA HANDBOOK 1106.01 January 29, 2016

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k. Revised autopsy requirements consistent with VHA Directive 2011-019, The Autopsy As A Critical Component Of Quality Management

4. RELATED ISSUES: VHA Directive 1106.

5. RESPONSIBLE OFFICE: The National Director, Pathology and Laboratory Medicine Service (P&LMS), Diagnostic Services (10P4D) is responsible for the contents of this Handbook. Questions may be addressed to (202) 632-8418.

6. RESCISSIONS: VHA Handbook 1106.1, dated October 8, 2008, is rescinded.

7. RECERTIFICATION: This VHA Handbook is scheduled for recertification on or before the last working day of January 2021.

David J. Shulkin, M.D.

Under Secretary for Health

DISTRIBUTION: Emailed to the VHA Publications Distribution List on 2/3/2016.

January 29, 2016 VHA HANDBOOK 1106.01 i

CONTENTS

PATHOLOGY AND LABORATORY MEDICINE SERVICE (P&LMS) PROCEDURES

1. PURPOSE:

2. BACKGROUND:

3. DEFINITIONS:

4. SCOPE:

5. RESPONSIBILITIES:

6. VA NATIONAL ENFORCEMENT PROGRAM CLIA APPLICATION PROCESS: . 18

7. ACCREDITATION:

8. PROFICIENCY TESTING:

9. P&LMS NATIONAL ENFORCEMENT PROGRAM PROTOCOL:

10. CATEGORIZATION OF SPECIFIC LABORATORY TEST SYSTEMS, ASSAYS,

AND EXAMINATIONS BY COMPLEXITY:

11. TESTING PERSONNEL:

12. QUALITY MANAGEMENT PROGRAM (QM):

13. ANCILLARY TESTING:

14. IMMUNOHEMATOLOGY, BLOOD TRANSFUSIONS, AND TRANSFUSION

MEDICINE TESTING:

15. SURGICAL PATHOLOGY, CYTOPATHOLOGY AND ELECTRON

MICROSCOPY TESTING:

16. POST-MORTEM EXAMINATION:

17. JOINT PATHOLOGY CENTER (JPC) REFERENCE LABORATORY SERVICES:

18. INFECTIOUS DISEASES, INFECTION CONTROL, AND EPIDEMIOLOGY:

19. BIOSECURITY AND BIOSAFETY PROCEDURES:

20. ENVIRONMENTAL AND SAFETY ISSUES IN THE LABORATORY:

APPENDIX A

POST-MORTEM QUALITY ASSURANCE SURVEY (Autopsy Review)

APPENDIX B

FORMER PRISONERS OF WAR (POWs), AGENT ORANGE/VIETNAM SERVICE

VETERANS, KUWAIT/PERSIAN GULF WAR VETERANS, OPERATION IRAQI

ii

FREEDOM/IRAQ SERVICE VETERANS, AND OPERATION ENDURING

FREEDOM/AFGHANISTAN VETERANS

APPENDIX C

GUIDANCE FOR REQUESTING AN AUTOPSY

APPENDIX D

VA PERSONNEL REQUIREMENTS BY TEST COMPLEXITY

PATHOLOGY AND LABORATORY MEDICINE SERVICE PROCEDURES

1. PURPOSE

This Veterans Health Administration (VHA) Handbook provides procedures for the administrative structure and management of services and service lines providing laboratory testing in Department of Veterans Affairs (VA) facilities and their outreach functions. The Handbook further defines requirements unique to VA. AUTHORITY:

Public Law 100-578 (1988), Public Law 102-139 (1991), and 42 CFR Part 493.

2. BACKGROUND

a. In 1988, Congress passed the Clinical Laboratory Improvement Amendments (CLIA) as part of the Public Health Service Act (Title 42 United States Code (U.S.C.)

263a). These amendments codified into law requirements for the staffing, management, procedures, and oversight of United States (U.S.) laboratories that perform testing used in the diagnosis, treatment, and prevention of disease in patients.

The Department of Health and Human Services (HHS) then published implementing regulations for CLIA under Title 42, Code of Federal Regulations (CFR) Part 493.

b. In 1991, Congress passed Public Law (Pub. L.) 102-139, Sec. 101(a), which exempted VHA from CLIA and stated that the Secretary of Veterans Affairs would, in consultation with the Secretary of HHS, publish regulations that would “establish standards equal to that applicable to other medical facility laboratories in accordance with the requirements of Section 353(f) of the Public Health Service Act.”

NOTE: This requires VA laboratories to meet the requirements of CLIA, but left the enforcement and oversight of the regulations to VA.

c. This Handbook supplements 42 CFR Part 493 for those areas where VA regulations do not provide explicit guidance.

3. DEFINITIONS

a. Administrative Laboratory Chief.

(1) In situations when a qualified pathologist cannot be successfully recruited to serve as the Chief or Director, Pathology and Laboratory Medicine Service (P&LMS) in the P&LMS Service-line, a non-pathologist Administrative Laboratory Chief must be appointed to perform the laboratory director functions and to provide direction and oversight whenever a technical consultant is retained (e.g., consulting pathologist). The Administrative Laboratory Chief will serve as the laboratory director (signer of the CLIA application) and therefore must meet the laboratory director personnel qualifications for the appropriate laboratory complexity according to laboratory accreditation requirements, this Handbook (paragraph 6.c. and Appendix D), and as outlined in the laboratory director personnel standards in 42 CFR Part 493, Subpart M.

(2) The Administrative Laboratory Chief must be aligned under the oversight of a VA pathologist who serves in the P&LMS service-line (e.g., aligned under a Chief or

Director, P&LMS at a VA medical facility or under a pathologist service-line Chief or Director at the Veterans Integrated Service Network (VISN) level). Testing decisions must be made by a pathologist in the P&LMS service-line.

b. Ancillary Testing. Ancillary testing is laboratory testing performed within and under the administration of the VA medical facility, health care system, or its outreach functions (clinics, etc.), but outside the physical facilities of the main clinical laboratory.

This includes all laboratory testing sites, such as point of care testing, satellite or specialty laboratories, community-based outpatient clinic (CBOC) testing sites, and home-based health care (HBHC) when such testing is performed by a VA employee.

Ancillary testing includes all laboratory testing sites that fall under the auspices of the main parent facility even when they may be under a separate laboratory director, CLIA registration number, or separate accreditation.

c. Autopsy Review. An autopsy review is the comparison of pre-mortem diagnoses and diagnostic assessment procedures with post-mortem diagnoses and other autopsy findings to assess diagnostic accuracy. This process is covered by 38 U.S.C. 5705 and its implementing regulations.

d. Blood Management Principle. Blood Management Principle is the appropriate use of blood and blood components, with the goal of minimizing their use.

e. Blood Utilization Review/Transfusion Utilization Chair. The Blood Utilization Review/Transfusion Utilization Chair is the individual appointed by the VA medical facility Director responsible for the oversight of blood product usage review.

f. Blood Utilization Review. The Blood Utilization Review is a review of all aspects of blood services to determine whether blood and blood products are appropriately ordered and stored, delivered, and provided in a safe, timely, and therapeutic manner. Evaluation of transfusion errors and reactions is included. This process is covered by 38 U.S.C. 5705 and its implementing regulations.

g. Chief or Director, P&LMS. The Chief or Director, P&LMS directs and coordinates the patient care, administration, education, and research functions of the P&LMS service-line and provides oversight for all laboratory testing performed under the medical center/health care system and CBOC laboratory CLIA number(s) including ancillary testing sites, specialty labs, HBHC testing sites, or research labs performing testing used for patient care.

h. High Complexity Testing. High complexity testing refers to the most complicated laboratory tests requiring the most rigid testing requirements outlined in the CLIA regulations. Test complexity is determined by the Food and Drug Administration (FDA) according to the criteria outlined in the 42 CFR 493.17. Testing sites performing high complexity testing must obtain a high complexity CLIA certificate.

i. Infection Control Review. Infection Control Reviews are surveillance activities to identify and monitor the rate of nosocomial infections. This process is covered by 38 U.S.C. 5705 and its implementing regulations.

j. Laboratory Director. The laboratory director is the individual designated on the CLIA certificate as the laboratory director and is the individual responsible for all aspects of laboratory testing performed under that CLIA certificate.

k. Laboratory Test. A laboratory test is an examination, diagnostic, or monitoring procedure on a human specimen removed from the body to determine specific information for diagnosis, treatment, or prevention of disease, and to detect the impairment of health status, or to assess the health of human beings.

l. Moderate Complexity Testing. Moderate complexity testing is the rating given by the FDA to commercially marketed in vitro diagnostic tests based on their risk to public health level. The complexity is determined based on the scoring criteria outlined in 42 CFR 493.17. Testing sites performing moderate complexity testing must obtain a moderate complexity CLIA certificate.

m. Mohs Surgery. Mohs Surgery is the procedure for microscopically-controlled removal of skin tumor developed by Frederic E. Mohs.

n. Non-waived Testing. Non-waived testing refers to tests categorized as either moderate complexity (including provider-performed microscopy) or high complexity by the FDA, according to a scoring system used by the FDA.

o. Peer Review for Quality Management. A Peer Review for Quality Management is a critical review of care performed by a peer or group of peers. Peer review processes are protected under 38 U.S.C. 5705 and its implementing regulations. A quality management review may be used to prompt a performance review. However, since a peer review for quality management is protected, it cannot be substituted for a performance review.

p. Performance Reviews. A performance review is any review that is conducted for purposes other than quality improvement related to decisions affecting individual providers. Performance reviews are not protected under 38 U.S.C. 5705. Examples that fall under this classification are: Administrative Investigation Boards and Ongoing Professional Practice Evaluations.

q. Point of Care Testing. Point of care testing refers to tests designed to be used at or near the site where the patient is located, and that are performed outside the physical facilities of the clinical laboratory.

r. Privileged Provider. A privileged provider is an individual who meets the personnel qualifications for provider performed microscopy (PPM) as defined in the CLIA regulations, 42 CFR 493.1363 and is privileged by the medical center to perform laboratory testing as part of their clinical scope of practice. The CLIA PPM testing personnel qualifications are outlined in Appendix D, paragraph 2.c. of this Handbook.

s. Proficiency Testing. Proficiency Testing (PT) is a program in which samples with unknown values are periodically sent to a laboratory for analysis in which each laboratory’s results are compared with peer laboratories and reported to the participating laboratory and the VA National Enforcement Program.

t. Provider Performed Microscopy Testing. Provider performed microscopy (PPM) testing refers to a subset of specific moderate complexity light microscopy procedures outlined in the CLIA regulations, which a physician, midlevel practitioner, or dentist performs on a specimen obtained from the provider’s own patient.

u. Select Agents. Select agents are biological agents and toxins that could pose a severe threat to public or plant health, or to animal or plant products.

v. Specialty Laboratory. A specialty laboratory is a laboratory dedicated to a single specialty of testing or esoteric testing.

w. Testing Site. A testing site is any location where laboratory testing is performed (waived or non-waived) when such testing is used in the diagnosis, treatment, or assessment of patients within the VA health care organization and outreach functions.

This includes any testing that may occur outside the physical facilities of the main laboratory.

x. Transfusion Medical Director. A Transfusion Medical Director is the individual responsible for the medical and technical oversight of the transfusion service.

y. VA Laboratory. A VA laboratory is any site within a VA medical facility or its ancillary testing sites that performs laboratory testing used in the diagnosis, treatment, or assessment of patients.

z. Waived Testing. Waived testing refers to a category of tests defined as simple laboratory examinations. Testing sites performing waived tests must obtain a VA CLIA certificate for minimal complexity testing.

4. SCOPE

a. This Handbook applies to the VA Central Office (VACO), VISNs, P&LMS Program Office, National Enforcement Program Office, Regional Commissioner’s Offices, VA medical facilities, and supported medical facilities. This is both a reference document and management tool for leadership, medical staff, laboratory professionals, and stakeholders at all levels in VHA to develop and maintain a system to support quality health care delivery to Veterans.

b. P&LMS provides the principal medical diagnostic laboratory testing and transfusion functions in all VA medical facilities and sets the standards for quality, test methods, and procedures for laboratory testing for patient care in the VA medical facility and supported clinics.

c. All laboratory testing within VA used for the diagnosis, treatment, and prevention of disease in patients must be provided in compliance with the requirements outlined in this Handbook and 42 CFR Part 493, CLIA.

(1) These standards must be met for any laboratory service offered within a VA medical facility and outreach clinics, regardless of the physical relationship to the main P&LMS or the administrative service assigned to direct the personnel, research, or technical aspects of the testing site.

(2) The same standard must be met for contracted laboratory services performed on site at VA laboratories, outreach clinics, or testing sites.

d. Laboratory testing, where applicable, must also meet the requirements of the following organizations:

(1) The Joint Commission;

(2) College of American Pathologists (CAP);

(3) AABB (formerly the American Association of Blood Banks);

(4) FDA;

(5) Occupational Safety and Health Administration (OSHA); and

(6) Nuclear Regulatory Commission (NRC).

e. All VA laboratories, including CBOC sites performing waived and PPM testing, are required to register with the P&LMS National Enforcement Program in VACO, Washington, DC, and must be assigned a CLIA number as outlined in the interagency agreement between the Center for Medicare and Medicaid Services (CMS) and VA.

f. All laboratory testing, regardless of location, must undergo an on-site inspection by a VA-designated accrediting agency as outlined in paragraph 7 of this Handbook.

g. When the requirements of the accrediting agency and VA requirements differ, the more stringent requirements apply.

h. All laboratory testing, regardless of complexity level or where it is performed, must be under the oversight of the Chief or Director, P&LMS.

(1) Chief or Director, P&LMS is required to provide oversight for all laboratory testing performed under the medical center and CBOC laboratory CLIA number(s) including ancillary testing sites, specialty labs, or research labs performing testing used for patient care.

(2) The Chief or Director, P&LMS is responsible for all aspects of laboratory testing performed under the laboratory’s accreditation umbrella and testing under the CLIA certificates for which the Chief or Director, P&LMS serves as the laboratory director.

(3) The Chief or Director, P&LMS may choose to remove waived or PPM testing performed by privileged providers from underneath the accreditation umbrella of the laboratory. These testing sites must obtain their own separate VA CLIA numbers issued through the P&LMS National Enforcement Program. While the Chief or Director, P&LMS is not responsible for the results released by the provider, the Chief or Director, P&LMS must provide guidance for performing these laboratory procedures and ensure that they are carried out in compliance with 42 CFR Part 493 and current VHA policies.

NOTE: Minimal testing guidance for all laboratory procedures within VHA is provided in paragraph 13.h. of this Handbook.

i. The main clinical laboratory in each VHA health care network and each VA medical facility must be directed by a Chief or Director, P&LMS who is a licensed pathologist and board certified in anatomic pathology and/or clinical pathology by the American Board of Pathology. The clinical laboratory and anatomic pathology services are under the direction of the Chief or Director, P&LMS. This individual must have the appropriate training and background to meet the requirements of 42 CFR 493.1443 and must be able to discharge the responsibilities cited in 42 CFR 493.1445 and this Handbook.

NOTE: The administrative separation of organizational sections providing anatomic pathology, blood transfusion, and clinical pathology services is not permitted in a VA medical facility or its outreach functions.

j. Specialty laboratories that fall outside the accreditation umbrella of the main laboratory may have a non-pathologist physician or an individual with a doctoral degree in biological science appointed to serve as the laboratory director.

(1) This individual must be qualified by virtue of documented training, expertise, and experience in the area of analytical testing, and biological, chemical, or clinical science specifically related to the laboratory testing site’s special testing functions.

(2) This individual must meet the laboratory director qualifications required by 42 CFR Part 493, Subpart M and must be able to discharge the responsibilities cited in 42 CFR Part 493, Subpart M, and this Handbook.

(3) The appointment must be approved by the local Chief or Director, P&LMS and the National Enforcement Officer.

(4) The Chief or Director, P&LMS must serve as a consultant for these specialty laboratories and ensure that testing is carried out in compliance with 42 CFR Part 493 and current VHA policies. Testing should be overseen under the ancillary testing program.

k. The scope of testing and services provided in anatomic and clinical pathology is to be appropriate for the nature of the patient care services at the facility. P&LMS either performs those tests and services required to provide quality care to patients or arranges for these services to be performed by an accredited laboratory.

l. Research laboratories within VHA are not allowed to report laboratory results that are used for diagnosis, treatment, and prevention of disease in patients, unless they are properly accredited and meet all requirements of 42 CFR Part 493.

5. RESPONSIBILITIES

a. National Director, Pathology and Laboratory Medicine Service.

(1) Reports to the Chief Consultant, Diagnostic Services under the direction of the Office of Patient Care Services (PCS).

(2) Provides guidance and recommendations to senior leadership for the establishment of VHA national policies applicable to all VA sites performing patient laboratory testing.

(3) Provides P&LMS guidance to VHA senior leadership and the VA laboratory community to ensure that timely, cost effective, and high quality anatomic and clinical pathology services are provided for VA patients.

(4) Provides oversight and enforcement of the policies defined in Directive 1106 and this Handbook in conjunction with the National Enforcement Officer and the Pathology Regional Commissioners.

(5) Oversees the quality of services provided by VA laboratories as well as laboratory compliance with regulatory, accreditation, and policy guidelines.

(6) Utilizes organizational resources and collaborates with the CMS, the Department of Defense (DoD), the FDA, the various accrediting organizations, and other Federal and civilian external agencies.

(7) Ensures that laboratories and testing sites are appropriately accredited by a VA-designated accrediting agency under the VA national contract as outlined in paragraph 7 of this Handbook and that the required accreditation programs are fully implemented.

Arranges and monitors PT programs in anatomic pathology.

(8) Ensures that anatomic pathology testing sites participate in external quality review and PT programs for assessment in surgical pathology and cytopathology.

(9) Maintains a national database on the performance of postmortem examinations in the Veterans Health Care System. This database includes at least the monthly and annual autopsy rates for each VHA inpatient facility (acute and long-term care).

(10) Advises the VISN Directors of problems and concerns relating to the quality of the pathology and laboratory services provided and all laboratory testing performed in medical facilities under their purview.

(11) Works with the National Enforcement Officer, Pathology Regional Commissioners, and the Chief or Director, P&LMS at each VA facility to ensure that corrective action is implemented where problems which have the a potential for adverse patient outcome are identified.

b. National Enforcement Officer.

(1) Reports to the National Director, P&LMS.

(2) Provides oversight to assess regulatory compliance and enforcement for VA laboratory testing sites for requirements as defined in 42 CFR Part 493, this Handbook, and related VA Directives with the assistance of the VA Regional Commissioners and Regional Technologists. Provides direction to the VA Regional Commissioners and Regional Technologists on all VA laboratory enforcement matters.

(3) Directs the VA CLIA Program and ensures that all VA testing sites are registered with the P&LMS National Enforcement Program and are issued a VA CLIA number.

(4) Coordinates a nationwide contract for accreditation by a VA designated laboratory accreditation agency and for PT procurement in collaboration with the National Director P&LMS.

(5) Ensures that all laboratory testing sites within the VA are accredited by a VA designated accrediting organization. Evaluates accrediting and regulatory agency summary reports and ensures appropriate corrective action if necessary.

(6) Advises the VISN Director of problems and concerns relating to the quality of the pathology and laboratory services provided and all testing performed in medical facilities under their purview.

(7) Ensures that all VA testing sites successfully participate in an approved PT program for each analyte and instrument or method.

(8) Initiates focused reviews of laboratory testing sites if indicated and requires that corrective action is implemented to ensure that a high standard of service and patient care is provided.

(9) Develops the strategic plan for the National Enforcement Program by incorporating goals, objectives, strategies, and performance measures to track and measure the extent of achieving strategic objectives of the VHA and Patient Care Services.

(10) Develops coordinated action plans to address data management and aligns key organizational activities to VA strategic objectives.

c. VA Regional Commissioner.

(1) Reports to the National Director, P&LMS and the National Enforcement Officer,

(2) Provides oversight and enforcement of the policies defined in this Handbook and related directives under the direction of the P&LMS National Enforcement Officer and the National Director, P&LMS.

(3) Ensures that all VA testing sites and laboratories are registered under the National Enforcement VA CLIA Program.

(4) Works with the National Enforcement Officer to ensure that all VA testing sites are in compliance with the inspection and accreditation requirements.

(5) Advises the P&LMS National Enforcement Officer of problems and concerns relating to the quality of the work in P&LMS and laboratory-related services.

(6) Delegates responsibilities and functions to the Regional Technologist.

d. VISN Director.

(1) Ensures that all laboratories or individuals performing testing used for the diagnosis and treatment of patients, transfusion medicine, and anatomic pathology are in compliance with the policies in 42 CFR Part 493, related VHA Directives, and this Handbook.

(2) Ensures that all laboratory testing sites within the VISN meet the requirements for external P&LMS accreditation.

(3) Ensures that small facilities that cannot recruit a pathologist to serve as the Chief P&LMS, align the Administrative Laboratory Chief under the oversight of a VA pathologist who serves in the P&LMS service-line (e.g., aligned under a Chief or Director, P&LMS at another VA medical facility or under a pathologist service-line Chief or Director at the VISN level).

(4) Communicates pathology and laboratory medicine management priorities and maintains a mode for communication with the VACO P&LMS Program Office to ensure alignment and coordination with national priorities.

(5) Ensures that facility action plans addressing P&LMS non-compliance with accreditation and regulatory requirements and VA regulations are implemented and completed.

(6) Ensures that VA medical facilities establishing a diagnostic Electron Microscopy (EM) Program in P&LMS prepare an application in accordance with the current requirements as outlined by the National EM Program Coordinator. The application must be transmitted through the VISN Director's Office with a statement from the medical facility Director expressing approval and certifying that the proposed EM resource will not create a redundancy.

(7) Ensures that each inpatient facility (acute and long-term care) within the VISN completes the autopsy monthly report and sends it to the National Director of P&LMS in VACO, no later than 30 days after the end of each month being reported.

(8) Ensures that autopsy reports are completed within 30 working days of the autopsy unless exception for special studies is established by the local medical staff.

(9) Ensures each medical facility has the capability to perform autopsies, whether on site or an alternative to performing autopsies at the medical facility is provided. This service may be contracted to another VA or accredited non-VA facility.

(10) Ensures that an alternative to performing autopsies at the medical facility is provided. This service may be contracted to another VA or accredited non-VA facility.

NOTE: Establishment of Regional Autopsy Centers at VISN or multi-VISN level may provide access to a quality and cost-effective alternative.

e. VA Medical Facility Director.

(1) Ensures that the applicable requirements of 42 CFR Part 493, this Handbook, and appropriate accrediting agencies are met when any laboratory patient care services are offered by VA laboratories, regardless of the physical location of the laboratory or the service or administrative structure assigned to direct the personnel or technical aspects of the test site.

(2) Ensures that the clinical laboratory is under the direction of a qualified, licensed pathologist, board certified in anatomic pathology and/or clinical pathology by an American Board of Pathology. Ensures that the Chief or Director, P&LMS possesses a broad knowledge of clinical medicine, basic medical sciences, clinical laboratory sciences, and management operations.

(3) Ensures that the Chief or Director, P&LMS is appointed as a voting member to the Clinical Executive Board or analogous medical staff committee, and all other appropriate committees.

(4) Ensures the following in a small or remote VA medical facility, when a full-time or part-time pathologist cannot be recruited to serve as the Chief or Director, P&LMS:

(a) Retains the services of a qualified, licensed consulting pathologist to fulfill the CLIA defined laboratory technical functions as cited in 42 CFR Part 493, Subpart M.

(b) Appoints a qualified individual to serve as the Administrative Laboratory Chief to provide oversight and direction for laboratory functions and to provide direction for the technical functions provided by a consulting pathologist. When a consulting pathologist is retained, the Administrative Laboratory Chief serves as the laboratory director and therefore must meet the laboratory director personnel qualifications for the appropriate laboratory complexity according to laboratory accreditation requirements, this Handbook, and as outlined in the laboratory director personnel standards in 42 CFR Part 493, Subpart M.

(c) Ensures the consulting pathologist fulfills the technical functions as cited in 42 CFR Part 493.

(d) Ensures the consulting pathologist is provided the appropriate resources to fulfill the requirements outlined in 42 CFR Part 493 and this Handbook.

(e) Assigns the consulting pathologist as a member of the Clinical Executive Board or analogous medical staff committee, and all other appropriate committees.

(f) Ensures that the consultant has an active role in the educational and staff competency programs of the institution and laboratory.

(g) Ensures that the services of the consulting pathologist are provided on a regular basis and that a written report of the consulting pathologist's evaluation and recommendations is provided with each visit.

(5) Ensures that all testing sites that perform laboratory tests categorized as moderate or high complexity are inspected and accredited by a VA-designated accrediting organization as outlined in paragraph 7 of this Handbook.

(6) Ensures that sites performing only waived testing and/or PPM procedures are inspected and accredited as part of the main laboratory accreditation or in conjunction with the main facility accreditation process.

(7) Ensures that all laboratory testing, regardless of complexity level or the physical location, is performed under the oversight of the Chief or Director, P&LMS including testing sites that may be under a separate laboratory director, CLIA registration number, or accreditation.

(8) Ensures that all ancillary testing sites are under the quality oversight or technical direction of the Chief or Director, P&LMS.

(9) Ensures that individuals performing testing meet the personnel requirements defined in 42 CFR Part 493 for the identified test complexity.

(10) Ensures that all laboratory testing performed within the facility, ancillary testing sites, and outreach clinics is performed under a current CLIA certificate of the appropriate complexity level for the testing performed.

(11) Ensures that P&LMS and all ancillary testing sites successfully participate in a CMS-approved PT program. The laboratory PT program must meet the requirements of CLIA, the accrediting agency, and VA, for all analytes for which PT is available, including waived, PPM, and unregulated analytes. For analytes for which no PT is available, an alternate method must be in place. Laboratories must perform PT at all sites and on every instrument used for patient testing, including backup instruments.

(12) Ensures that the facility has a working Blood Utilization Review Committee/Transfusion Utilization Committee and program designated that adheres to the mandates of this Handbook, associated Directives, and 38 U.S.C. 5705 and its implementing regulations and that there is a formalized comprehensive process to monitor transfusion-related activities. Appoints a Blood Utilization Review Committee/Transfusion Utilization Committee Chair who must be a physician with knowledge and experience in transfusion medicine. The Blood Utilization Review/Transfusion Utilization Chair is responsible for the oversight of blood usage review.

(13) Ensures that P&LMS providing anatomic pathology services participates in the non-gynecologic (GYN) cytopathology program designated by the National Director, P&LMS, a CMS approved GYN Cytopathology Proficiency Program, and any other such PT programs designated as mandatory by the National Director, P&LMS.

(14) Ensures that the facility laboratory participates in the VHA and CAP customized Laboratory Management Index Program (LMIP) and any other information queries or surveys initiated by the National Director, P&LMS for the purpose of needs assessment or evaluation of the effectiveness of P&LMS.

(15) Ensures that the facility Information Technology Office provides resources to laboratory information management for appropriate operator support, training, hardware, and backup procedures for computer downtime.

(16) Ensures that permission to perform an autopsy (i.e., post mortem examination) is requested in every instance when a patient dies while an inpatient at a VA facility or under the immediate care of a VA facility (such as during an outpatient or emergency care visit, or during an ambulatory care procedure). NOTE: It is recommended that the physician provider responsible for the patient at the time of death be delegated with the task to request an autopsy from the surviving spouse or next-of-kin. Guidance for requesting an autopsy may be found in Appendix C.

(17) Ensures that documentation of the request for autopsy is included in the patient’s medical record. This documentation must include notation of the participants in the discussion and whether the permission was granted or denied. When permission is denied, the reasons for the denial are to be recorded in the medical record. NOTE:

Under certain circumstances, detailed in 38 CFR 17.170, the medical facility Director may cause an autopsy to be performed in the absence of consent from the decedent’s surviving spouse or next of kin.

(18) Ensures that autopsies on coroner and medical examiner cases are performed at VHA facilities only with the concurrent permission of both the coroner or medical examiner and the surviving spouse or next-of-kin. NOTE: If the United States does not have exclusive jurisdiction over the area where the decedent’s body is found, the local coroner or medical examiner will be informed. Coroner or medical examiner cases are defined by local statute, and need to be enumerated in the local facility autopsy policy.

(19) Ensures restricted autopsy examinations (those limited to a specific area, i.e., brain and spinal cord, chest cavity, or abdominal cavity) meet the requirements for autopsy.

(20) Ensures that the results of autopsies are included in facility medical staff education and quality management programs.

(21) Ensures autopsies in cases of infection with high-risk pathogens are performed using appropriate personal protective equipment, environmental controls, and proper decontamination procedures commensurate with the biosafety precautions indicated for the known or suspected pathogen. If the Chief or Director, P&LMS cannot ensure or comply with appropriate biosafety precautions, there must be a local policy, approved by the medical staff, to guide if and how autopsies on cases of infection with high risk pathogens are conducted. This local policy must comply with all of the biosafety precautions indicated for the known or suspected pathogen, as well as with all of the other requirements of this Handbook.

f. Chief Of Staff or Director of Clinical Services.

(1) Ensures that the Chief or Director, P&LMS is provided with an inventory of the location and type of all ancillary testing equipment and sites where ancillary testing is performed, including bedside testing sites, methodology to be used, and the estimated number of tests to be performed annually.

(2) Ensures that VA medical facilities with no permanent pathologist have a 10 percent random retrospective second review performed for all surgical pathology, Moh’s pathology, and cytology diagnoses for the purpose of quality assurance.

(a) Ensures that quality reviews are provided by a qualified pathologist (board certified, licensed, and experienced in anatomic pathology work). An individual who meets the VA requirements for a specific specialty as outlined in paragraphs 15.a.(1), (c), and (d) of this Handbook may perform a quality review within that specialty.

(b) Quality reviews must occur on at least a quarterly basis.

(c) The 10 percent review system is also mandated for contract or sharing agreement pathologists who provide surgical pathology or cytopathology diagnostic services for VA medical facilities.

(3) If Mohs surgery is performed on site and the Mohs lab is not included as part of the main laboratory accrediting process, the Chief of Staff must ensure that a 10 percent random retrospective second review is performed for all Mohs surgeries and 100 percent review is performed for any Mohs case for which a previous tissue diagnosis has not been performed by the local VA P&LMS.

(4) Ensures that all laboratory testing performed outside of the main laboratory is managed under the ancillary testing program under the oversight of the Chief or Director, P&LMS including all laboratory testing performed by providers (e.g., physicians, dentists, nurse practitioners, midwives, clinical pharmacists, and physician assistants).

(5) Ensures that when the medical center privileging process is utilized to fulfill any element of the PPM or waived testing competency assessment requirements, the provider must be privileged to perform the specific procedures (e.g., fecal occult blood, vaginal wet preps, etc.) they perform and that the tests performed are appropriate and performed within the provider’s specialty. A provider cannot be privileged to perform a blanket category of procedures such as waived procedures.

(6) Ensures that there is a mechanism in place to mandate that providers or testing sites identified by the Chief or Director, P&LMS as failing to follow laboratory testing requirements are not allowed to continue performing laboratory tests on patients.

(7) In conjunction with the Chief or Director, P&LMS ensures that there is an ongoing mechanism for monitoring and evaluating the usefulness and appropriateness of referral testing, and ensures that referral testing is appropriate for patient care.

(8) When patients are to receive treatment at a VA facility based on tissue samples obtained elsewhere (either at another VA facility or non-VA facility), ensures that the patient’s clinical provider obtains and submits the outside tissue slides to the VA pathologists at the facility where the patient will receive treatment so that the diagnosis can be confirmed. Any treatment or procedure on the patient should not be performed until confirmation of the diagnosis has been obtained.

(9) Provides overall management of post-mortem examination services that include:

(a) Arrangements for securing post-mortem examination authorizations. NOTE: It is VHA policy that permission to perform a post mortem examination must be requested in every instance when a patient dies while an inpatient at a VA facility or under the immediate care of a VA facility;

(b) Provision of sufficient competent staff for the examinations and for timely completion of post-mortem examination reports;

(c) Maintenance of suitable facilities and appropriate coordination with funeral directors and local authorities;

(d) Ensuring that post-mortem examination findings become a continuing component of the internal monitoring of medical practice of the VA medical facility.

g. Chief or Director, P&LMS. The Chief or Director, P&LMS serves as an active member of the medical staff, directing and coordinating the patient care, administration, education, and research functions of P&LMS. The Chief or Director, P&LMS, need not perform all responsibilities personally. Selected functions may be delegated to qualified pathologists, medical laboratory scientists, laboratory managers, and supervisors.

Medical care responsibilities may only be delegated to physicians. Technical responsibilities may be delegated to qualified laboratory personnel, as appropriate. The Chief or Director, P&LMS, however, remains responsible for the overall operation and administration of the laboratory, ensuring that quality patient services are provided and that personnel operations and laboratory management are run efficiently and effectively.

(1) Provides consultation and guidance to health care providers regarding matters pertaining to pathology and laboratory medicine and the medical significance of laboratory findings. The Chief or Director, P&LMS, designates, in writing, which is authorized to perform pathology consultations and to document medical diagnoses and information in a patient's record.

(2) Serves as a voting member of the Clinical Executive Board, or analogous medical staff committee, and all other appropriate committees.

(3) The Chief or Director, P&LMS, or designee, participates in applicable cross-organizational performance-improvement activities, develops and communicates objectives, and coordinates efforts to integrate patient care and support services.

(4) Provides educational direction for the medical and laboratory staff and participates in educational programs of the institution as appropriate. NOTE: This education may also involve many levels, including medical students, allied health students, graduate students, and residents from academic affiliates.

(5) Directs and coordinates the functions of the service within the medical facility and all outreach clinics based upon the mission, special needs, and size of the facility. The functions of this position are diverse and encompass patient care, administration, education, and research.

(6) Provides overall operation and administration of the laboratory, ensuring that quality patient services are provided and that personnel operations and laboratory management are efficient and effective.

(7) Identifies all laboratory testing performed within the facility and its outreach clinics regardless of the complexity or where the testing is performed within the organization, and provides assistance and oversight to ensure that all patient laboratory testing performed is in compliance with 42 CFR Part 493 and VHA policies. This includes oversight responsibility for ancillary testing sites, and participation in the evaluation of test appropriateness for the institution regardless of the testing site.

(8) Ensures current accreditation of all testing sites that perform non-waived laboratory tests for patient care by a VA designated CMS “deemed” accrediting organization(s).

(9) Submits corrective actions for findings of accrediting and regulatory agency inspections or accreditation processes to the VA Regional Commissioners.

(10) Ensures that all laboratory testing sites performing patient care testing meet requirements for hospital accreditation.

(11) Ensures that the facility submits to annual registration and FDA inspection if the facility draws or prepares components or provides transfusion services.

(12) Ensures that, if the P&LMS has a blood bank or transfusion service that meets any of the criteria as described in paragraph 7.b.(3) of this Handbook, that the blood bank/transfusion service undergoes and maintains current AABB inspection and accreditation.

(13) Provides oversight for ancillary testing sites. Ancillary testing encompasses or includes all laboratory testing sites that are outside of the physical limits or physical address of the main VA medical facility’s P&LMS. Additionally, ancillary testing includes all laboratory testing sites that fall under the auspices of the main parent facility even when they may be under a separate laboratory director, CLIA registration number, or separate accreditation. Point of care testing and HBHC, when such testing is performed by a VA employee or a contracted service employee in a patient’s home, is also included.

(a) Ensures that testing is in compliance with VA policies, and that good testing practices are utilized in all ancillary testing sites, including sites that fall outside of the accreditation umbrella of the main laboratory and are under the directorship of an individual other than the Chief or Director, P&LMS. A separate CLIA certificate is required for each separately-accredited test site. In such sites the Chief or Director, P&LMS is not directly responsible for results reported, but retains the responsibility of providing oversight and assistance to ensure that any testing performed is in compliance with 42 CFR Part 493 and existing VHA policies.

(b) Ensures that all laboratory testing performed, including testing performed by providers (e.g., physicians, dentists, nurse practitioners, midwives, clinical pharmacists, and physician assistants), is conducted under the oversight of the Chief or Director, P&LMS. The Chief or Director, P&LMS has a responsibility to ensure that the tests are being performed in accordance with 42 CFR Part 493 and existing VHA policy. In concert with the Chief of Staff, the Chief or Director, P&LMS must ensure that providers who fail to follow these testing requirements are not allowed to continue performing testing.

(c) Ensures that all laboratory testing performed by individuals without formal laboratory training is limited to those procedures classified as waived or moderate complexity level testing and is conducted under the oversight of the Chief or Director, P&LMS under the ancillary testing program.

(14) Acts as a consultant for the medical facility whenever a non-VA provider is contracted to perform laboratory testing for Veteran patients. The Chief or Director, P&LMS must ensure that documentation is obtained to verify that the contracted laboratory is appropriately CLIA certified.

(15) Selects and monitors all reference laboratories for quality of service.

(16) Assumes responsibility for the implementation of the quality management (QM) program and monitors the ongoing effectiveness of a comprehensive continuous QM plan. Ensures the QM program is conducted consistent with 38 U.S.C. 5705 and its implementing regulations.

(17) Ensures the QM program is assessed for continuous improvement and effective corrective and preventative actions on a regular basis.

(18) Ensures that test results are entered into the laboratory module of the Veterans Health Information Systems and Technology Architecture (VistA) or other VA designated management systems.

(19) Provides, for all ancillary testing sites, signatory support for legal medical interpretive reporting when the laboratory director of the ancillary testing site is a doctoral scientist. The VA medical facility's ancillary testing coordinator or other staff appointed by the Laboratory Director must provide QM oversight in each ancillary testing site.

(20) Encourages research; this may include externally-funded projects from national agencies such as VA, National Institutes of Health, American Cancer Society, etc.

(21) Manages data and trend analysis. All laboratories performing moderate or high complexity testing must participate in the VA Laboratory Management Information Program (LMIP), informational queries or surveys initiated by the National Director, P&LMS, or any other management information program designated as a VA national laboratory program.

(22) Provides the direction of professional aspects of post-mortem examinations.

(23) Exception: The use of an Administrative Laboratory Chief with a Consulting Pathologist. In a very small or remotely located VA medical facility, or in any VA medical facility where a pathologist cannot be successfully recruited, or there is not enough histology, cytopathology, or clinical pathology workload to justify a full-time or part-time pathologist in the laboratory, a board-certified, qualified, licensed consulting pathologist must be retained to fulfill the CLIA defined laboratory technical functions and an Administrative Laboratory Chief must be appointed. Before hiring a contracted consultant pathologist the following must be considered:

(a) Shared VA Chief or Director, P&LMS and Laboratory Director. Smaller VA laboratories within a VISN may choose to have a VA employed pathologist serve as the Chief or Director, P&LMS of more than one laboratory…