D.7 VHA HANDBOOK 1106.1 - ATTACHED.pdf

Department of Veterans Affairs VHA HANDBOOK 1106.01 Veterans Health Administration Transmittal Sheet Washington, DC 20420 October 6, 2008

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 CONTENTS. This Handbook contains implementation instructions for VHA Directive 1106 and procedures for the administration, accreditation, staffing, and functioning of clinical and anatomic pathology laboratories in VA facilities or managed by VA facilities.

3. RELATED ISSUES. VHA Directive 1106.

4. RESPONSIBLE OFFICE. The Office of Patient Care Services, Diagnostic Services Strategic Health Care Group (115), is responsible for the contents of this Handbook. Questions may be addressed to (202) 461-7357.

5. RESCISSIONS. VHA Handbook 1106.1, dated June 4, 2003, and VHA Handbook 1106.2 dated May 4, 2004, are rescinded.

6. RECERTIFICATION: This VHA Handbook is scheduled for recertification on or before the last working day of October 2013.

Michael J. Kussman, MD, MS, MACP Under Secretary for Health

DISTRIBUTION: CO: E-mailed 10/13/08 FLD: VISN, MA, DO, OC, OCRO, and 200 – E-mailed 10/13/08

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D.7 VHA HANDBOOK 1106.1 - 36C26225R0004

D. 7 VHA HANDBOOK 1106.1

October 6, 2008 VHA HANDBOOK 1106.01

CONTENTS

PATHOLOGY AND LABORATORY MEDICINE SERVICE POLICIES

PARAGRAPH PAGE

1. Purpose

2. Background

3. Scope of Laboratory Testing

4. Qualifications, Role, and Responsibilities of the Chief or Director, Pathology and Laboratory Medicine Service

a. Qualifications

b. Role

c. Responsibilities

d. Delegation of Responsibilities

e. Exception (the use of Consulting Pathologists)

5. Categorization of Specific Laboratory Test Systems, Assays and Examinations by Complexity

6. Testing Personnel

7. Quality Improvement

a. Scope

b. Inspection and Accreditation

c. Required Elements for Quality Improvement in Laboratory Services and Ancillary Testing Sites

d. Blood Bank Transfusion Service Requirements

e. Anatomic Pathology Program Requirements

f. External Proficiency Testing (PT) Program

g. Test Methods and Equipment Standards

h. Patient Test Management

i. Specimen Identification for Drug Abuse Testing

j. Retention of Samples, Slides, and Records

k. Discontinuation or Merger of Anatomical Pathology Services

8. Ancillary Testing

a. Scope

b. Responsibilities i

VHA HANDBOOK 1106.01 October 6, 2008

CONTENTS Continued

PARAGRAPH PAGE

c. Ancillary Testing Coordinator

d. Test Results

e. Ancillary Testing Devices

f. Patient Self-testing

g. HBHC Testing

9. Immunohematology, Blood Transfusions and Transfusion Medicine Testing

a. Scope

b. Inspection, Accreditation, and Standards

c. Responsibilities

d. Operation of a Homologous (Allogeneic) and Autologous Blood Donor Program

e. Special Procedures

f. Transfusion Complications

g. Computer Requirements for Blood or Blood Component Transfusion

h. Blood Bank and Transfusion Service Quality Plan

10. Surgical Pathology, Cytopathology, and Electron Microscopy Testing

a. Scope

b. Responsibilities of Chief or Director, Pathology and Laboratory Medicine Service

c. Evaluation of Anatomic Pathology Specimens

d. Continuous Quality Improvement (CQI)

e. Competency Assessment in Anatomic Pathology

f. Accessing and Examination of Specimens

g. Internal Quality Control-Mandated Second Review of Cases

h. Anatomic Pathology Reporting and Specimen Slide Storage

i. Data Processing for Anatomic Pathology

j. Diagnostic Electron Microscopy (EM) in Laboratory Services

k. Operations of Diagnostic EM Units

l. Immunohistochemistry

m. Discontinuation or Merger of Anatomical Pathology Services

11. Post-mortem Examinations Testing

a. Scope

b. Post-mortem Examination Rates as a Percentage of Hospital Deaths

c. Performance of Post-mortem Examinations

d. Post-mortem Reports

e. Recovery of Pacemakers or Implantable Defibrillators and Procedures for Returning or Disposing of These Devices

f. Quality Improvement in the Post-mortem Examination Service ii

PARAGRAPH PAGE

g. Use of Post-mortem Examination Tissues for Diagnostic, Scientific, or Therapeutic Purposes

h. Confidential Treatment of Post-mortem Examination Records

12. Armed Forces Institute of Pathology Reference Laboratory Service

a. Scope

b. Armed Forces Institute of Pathology

13. Infectious Diseases, Infection Control, and Epidemiology

a. Scope

b. Facility Infection Control Activities

c. Food-borne Illnesses

14. Biosecurity and Biosafety Procedures

a. Scope

b. Clinical Laboratory Standards

c. Site Requirements for Handling Select Agents

d. Shipping Biological and Infectious Substances

15. Environmental and Safety Issues in the Laboratory

a. Scope

b. Laboratory Safety Program

c. Training

16. Enforcement Requirements

a. Scope

b. Pathology and Laboratory Medicine Service National Enforcement Office

c. VA Pathology Regional Commissioners

d. Enforcement Procedures

APPENDICES

A Sample Format for a Facility Quality Plan .......................................................................... A-1

B Protocol for Second Review of Surgical Pathology Cases ................................................... B-1 iii

PARAGRAPH PAGE

C Sample of a Format for a Post-mortem Quality Assurance Survey ...................................... C-1

D Guidelines for Performing Post-mortem Examinations on Former Prisoners of War (POWs) .................................................................................... D-1

E Schedule for Examination of Systematic External Review of Surgical (SERS) Cases at The Armed Forces Institute of Pathology ...................................................................................................................... E-1 iv

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.

2. BACKGROUND

a. In 1988, Congress passed the Clinical Laboratory Improvement Amendments (CLIA’88) as part of the Public Health Services Act (Title 42 United States Code (U.S.C.) 263a). This amendment 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’88, under Title 42, Code of Federal Regulations (CFR) Part 493.

b. In 1992, Congress passed Public Law (Pub. L.) 102-139, Sec. 101(a), which exempted VHA from CLIA’88 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 Services Act.”

NOTE: This requires VA laboratories to meet the requirements of CLIA’88, but left the enforcement and oversight of the regulations to VA.

c. The CLIA regulations (42 CFR 493) have been and continue to be modified over time.

Rather than revising and publishing VA regulations so that they are equal to 42 CFR 493, this Handbook substitutes 42 CFR 493 for those areas where VA regulations do not provide explicit guidance.

3. SCOPE OF LABORATORY TESTING

a. Pathology and Laboratory Medicine Service provides the principal medical diagnostic laboratory testing and transfusion functions in all VA medical centers and sets the standards for quality, test methods, and procedures for laboratory testing for patient care in the medical center and supported clinics.

b. All laboratory testing within VA used for the diagnosis, treatment, and prevention of disease in patients must be provided in compliance with the procedures outlined in this Handbook and meet the requirements of 42 CFR 493, CLIA’88. Laboratory testing, where applicable, must also meet the requirements of the following organizations:

(a) The Joint Commission;

(b) College of American Pathologists (CAP);

(c) American Association of Blood Banks (AABB);

(d) Food and Drug Administration (FDA);

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

(f) Nuclear Regulatory Commission (NRC).

c. All laboratory testing, regardless of location, must undergo an on-site inspection by an approved accrediting agency.

(1) All testing sites that perform tests categorized as moderate complexity or higher (non-waived) must be accredited and inspected by the Laboratory Accreditation Program (LAP) of an accrediting agency with deemed status from the Center for Medicare and Medicaid Services (CMS). Reaccreditation inspections for these sites are required every 2 years.

(2) Sites that perform only tests categorized as waived or provider-performed microscopy (PPM) procedures may be inspected as a part of the main laboratory LAP or may optionally be accredited and inspected as a part of the main facility accrediting process. Reaccreditation inspections for these sites must be conducted as required by the respective accrediting agency.

The decision as to whether these testing sites need to be included under the LAP, or as part of the facility accreditation process, must be made in consultation with the Chief or Director of Pathology and Laboratory Medicine Service, the medical staff, and senior leadership within the individual facility.

NOTE: The PPM category of testing is exclusively for physicians, dentists, nurse practitioners and midwives, and physician assistants performing the test as part of a patient examination. If PPM procedures are performed by anyone other than this select group of providers, then the procedure is classified as moderately complex and those requirements apply.

(3) All testing, regardless of complexity level or where it is performed, is under the direct or indirect oversight of the Chief or Director, Pathology and Laboratory Medicine Service.

(a) Direct oversight by the Chief or Director of Pathology and Laboratory Medicine is required for all testing performed under the Medical Center and Community-based Outpatient Clinic (CBOC) laboratory CLIA number(s). Testing under direct oversight of the Chief or Director of Pathology and Laboratory Medicine typically includes all testing performed under the laboratory’s accreditation umbrella. Direct oversight is required for all ancillary testing performed by non-providers.

(b) Indirect oversight by the Chief or Director of Pathology and Laboratory Medicine is provided when the organization chooses to remove waived or PPM testing performed by providers from underneath the accreditation umbrella of the laboratory. These testing sites must obtain their own separate VA CLIA numbers issued through the Pathology and Laboratory

Medicine Service National Enforcement Office located in Washington, DC. While the Chief or Director, Pathology and Laboratory Medicine Service is not directly responsible for the results released by the provider, such as might be found at some PPM sites, the Chief or Director, Pathology and Laboratory Medicine must provide guidance for performing these laboratory procedures and ensure that they are carried out in compliance with 42 CFR 493 and current VHA policies. NOTE: Minimal testing guidance for all laboratory procedures within VHA is provided in Paragraph 7. However, these are minimum requirements and when the requirements of the accrediting agency are more stringent, the more stringent requirements apply.

(4) All independently accredited VHA laboratories, including CBOC sites performing waived and PPM testing, must be assigned CLIA numbers as outlined in the Interagency Agreement between CMS and VA.

d. The main clinical laboratory in each VHA health care network and each medical center must be directed by a Chief or Director, Pathology and Laboratory Medicine Service, who is a licensed pathologist and board certified in pathology by the American Board of Pathology. The clinical laboratory and anatomic pathology services are under the direction of the Chief or Director, Pathology and Laboratory Medicine Service. NOTE: No Chief or Director may direct more than five laboratories that perform PPM, moderate or higher complexity testing as defined by CMS.

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

e. For the previously described laboratory sites that fall outside the accreditation umbrella of the main laboratory, a non-pathologist physician or doctoral scientist may be appointed to serve as the chief or medical director (laboratory director). This individual must be qualified by virtue of documented training, expertise, and experience in the areas of analytical testing, and biological, chemical, or clinical science specifically related to the laboratory testing site’s special testing functions. This individual must meet the laboratory director qualifications required by 42

CFR 493.

f. The applicable requirements of 42 CFR 493 and appropriate accreditation standards must be met for any laboratory services offered within a VA medical facility and outreach clinics, regardless of the physical relationship to the main Pathology and Laboratory Medicine Service, or the administrative service assigned to direct the personnel, research, or technical aspects of the test site.

g. 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. Pathology and Laboratory Medicine Service 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.

h. 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 493.

4. QUALIFICATIONS, ROLE, AND RESPONSIBILITIES OF THE CHIEF OR

DIRECTOR, PATHOLOGY AND LABORATORY MEDICINE SERVICE

a. Qualifications. The Chief or Director, Pathology and Laboratory Medicine Service, must possess a broad knowledge of clinical medicine, basic medical sciences, clinical laboratory sciences, and management operations. 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.

b. Role. NOTE: The Facility Director is responsible for ensuring that the Chief or Director, Pathology and Laboratory Medicine Service, is appointed as a voting member to the Clinical Executive Board, or analogous medical staff committee.

(1) The Chief or Director and staff pathologists of Pathology and Laboratory Medicine Service provide consultation and guidance to health care providers regarding matters pertaining to pathology and laboratory medicine and the medical significance of laboratory findings. The scientist(s) in clinical areas and medical technologists provide consultation on laboratory technical findings to patient care personnel according to local policies established by each VA medical center. The Chief or Director, Pathology and Laboratory Medicine Service, designates, in writing, who is qualified to perform consultation and to place medical diagnoses and information in a patient's records.

(2) The Chief or Director, Pathology and Laboratory Medicine Service, or designee, participates in applicable cross-organizational performance-improvement activities, develops and communicates objectives, and coordinates efforts to integrate patient care and support services.

(3) The Chief or Director, Pathology and Laboratory Medicine Service, 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.

c. Responsibilities. The Chief or Director, Pathology and Laboratory Medicine Service, is responsible for:

(1) Directing and coordinating the functions of the service within the medical center 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.

(2) Establishing a laboratory management data collection system, using Veterans Health Information Systems and Technology Architecture (VistA) or other approved management systems.

(3) Identifying all testing performed within the facility and its outreach clinics, and to provide assistance and oversight to ensure that any testing performed is in compliance with 42 CFR 493 and VHA policies to include oversight responsibility for Ancillary Testing Sites, and participating in the evaluation of test appropriateness for the institution regardless of the testing site.

(4) 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 Pathology and Laboratory Medicine Service and also includes all 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 (POCT) and Home-based Health Care (HBHC) when such testing is performed by a VA employee or a contracted service employee in a patient’s home is also included.

(a) In Ancillary Testing Sites that fall outside of the accreditation umbrella of the main laboratory, a non-pathologist physician or doctoral scientist may serve as the chief or medical director. This individual must meet the laboratory director requirements for the appropriate complexity of testing as stated in 42 CFR 1406 and 42 CFR 1443 and be qualified by virtue of documented training, expertise, and experience in the areas of analytical testing, and biological, chemical or clinical science specially related to the Ancillary Testing Site's special testing functions. NOTE: A separate CLIA certificate is also required for each separately-accredited test site. In such sites, the Chief of Pathology and Laboratory Medicine serves as a consultant to ensure testing is in compliance with VA policies, that good testing practices are utilized; and the Chief of Pathology and Laboratory Medicine is not directly responsible for results reported.

(b) All testing performed by providers (physicians, dentists, nurse practitioners, midwives, and physician assistants) must be limited to those procedures classified as waived or PPM procedures and must be carried out under the indirect oversight of the Chief or Director, Pathology and Laboratory Medicine Service. The Chief or Director, Pathology and Laboratory Medicine Service, is not directly responsible for the results of laboratory tests performed by the providers, but does have a responsibility to ensure that the tests are being performed in accordance with 42 CFR 493 and existing VHA policy (see subpar. 7e). Every VHA facility must have a mechanism in place, such as a protocol approved by the medical staff, that ensures providers identified by the Chief or Director, Pathology and Laboratory Medicine Service, as failing to follow these testing requirements are not allowed to continue performing laboratory tests on patients.

(c) A provider must also be privileged to perform the specific PPM and waived procedures (e.g., fecal occult blood, urine dipstick testing, etc.) that 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. NOTE: Hereafter, the term “privileged provider” is used to designate this group of specifically-privileged providers.

(d) All testing performed by non-providers must be carried out under the direct oversight of the Chief or Director, Pathology and Laboratory Medicine Service.

(5) Acting as a consultant for the medical center whenever a non-VA provider is contracted to perform laboratory testing for veterans at a satellite clinic. Documentation must be provided to ensure that the contracted laboratory is appropriately CLIA’88 certified, and all test results are entered into the laboratory module of VistA. NOTE: This would not apply to testing that is ordered by a non-VA provider and used by a VA provider to treat or monitor a VA patient, as might be the case for shared or co-managed patients. In that case, the results and all appropriate information (e.g., reference range, name of testing laboratory, etc.) need to be included in a Progress Note, included in the paper medical record. or scanned into the patient’s electronic medical record as a Note. Only laboratory results that are ordered by a VA provider and tested by a VA laboratory, VA-contracted laboratory, or agent of the VA laboratory are to be entered into the laboratory module of VistA or approved-laboratory software.)

(6) Providing, for all Ancillary Testing Sites, signatory support for legal medical interpretive reporting when the Chief or Director of the Ancillary Testing Site is a doctoral scientist. The VA medical center's Ancillary Testing Coordinator or other staff appointed by the Laboratory Director must provide quality improvement oversight in each and every Ancillary Testing Site.

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

(8) Managing data and trend analysis. All laboratories performing moderate or high complexity testing must participate in the VA Laboratory Management Information Program (LMIP) or any other management information program designated as the VA national laboratory program.

d. Delegation of Responsibilities. The Chief or Director, Pathology and Laboratory Medicine Service, need not perform all responsibilities personally. Selected administrative functions may be delegated to qualified clinical 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, Pathology and Laboratory Medicine Service, 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 smoothly and efficiently.

e. Exception (the use of Consulting Pathologists). If the Chief or Director, Pathology and Laboratory Medicine Service, is not a board-certified pathologist the services of a consulting pathologist must be retained.

(1) In a very small or remotely located VA medical center, or in any VA medical center where a pathologist cannot be successfully recruited, or there is not enough surgical pathology or cytopathology workload to justify a full-time or part-time surgical pathologist in the laboratory, the services of a board-certified, qualified, licensed consulting pathologist must be retained to serve as the laboratory director. This consulting pathologist must ensure the laboratory director responsibilities are discharged as cited in 42 CFR 493.1445.

(a) The consulting pathologist must be a member of the Clinical Executive Board or analogous medical staff committee, and all other appropriate committees.

(b) The consultant must play an active role in the educational and staff competency programs of the laboratory and of the institution.

(2) When the services of the pathologist are limited to those of consultant status, these services must be provided on a regular basis.

(a) A written report of the consulting pathologist's evaluation and recommendations must be provided with each visit.

(b) At each visit, the consultant must sign in and out in the Office of the Chief of Staff or Director of Clinical Services on official VA log sheets.

5. CATEGORIZATION OF SPECIFIC LABORATORY TEST SYSTEMS, ASSAYS

AND EXAMINATIONS BY COMPLEXITY

A laboratory test is defined as an examination, diagnostic, or monitoring procedure on a human specimen 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.

a. CLIA’88 and its implementing regulations categorize specific laboratory test systems, assays, and examinations by complexity. VHA generally recognizes the complexity level for these laboratory procedures as listed in 42 CFR 493, but requires certain minimal standards be met for performing and documenting these procedures.

b. Minimal testing guidance for all laboratory procedures within VHA is provided in Paragraph 7. In addition, all testing within VHA is subject to inspection and accreditation, and such testing must be performed in compliance with any standards defined by the relevant accrediting organization.

c. According to 42 CFR 493, tests not categorized by the Centers for Disease Control and Prevention (CDC) are considered to be highly complex. Any deviation from the manufacturer’s guidance or VHA policy for performing the procedure must also result in the procedure being classified as highly complex.

6. TESTING PERSONNEL

a. Individuals performing laboratory testing must meet the personnel requirements as defined in 42 CFR 493. Furthermore, any non-providers who perform laboratory procedures may only do so under the Ancillary Testing Site program and direct oversight of the Chief or Director, Pathology and Laboratory Medicine Service.

b. Privileged providers performing testing under the main laboratory’s accreditation umbrella, may do so only under the ancillary testing program.

c. When waived or PPM testing is performed by privileged providers that is not included under the laboratory accreditation umbrella, the testing site must comply with all requirements as listed in paragraph 7.

7. QUALITY IMPROVEMENT

a. Scope

(1) This paragraph defines the structure of quality improvement programs for laboratory testing in all VA medical facilities, their outreach functions, and Ancillary Testing Sites; and it applies to all sites that perform testing for the diagnosis, treatment, or prevention of disease in patients.

(2) The VA medical center must provide an ongoing, comprehensive continuous Quality Improvement Program under the direction of the Chief or Director, Pathology and Laboratory Medicine Service, which:

(a) Evaluates the effectiveness of the laboratory and the medical center policies and procedures in providing the highest quality laboratory medicine test results and anatomic pathology reports.

(b) Ensures the availability of accurate, reliable, and timely laboratory medicine test results, and anatomic pathology reports to the patient's health care provider.

(c) Documents all quality improvement activities.

(3) There must be an on-going, planned, systematic, and objective process for the monitoring and evaluation of the quality improvement plan, and the appropriateness of patient care provided by Pathology and Laboratory Medicine Service.

b. Inspection and Accreditation

(1) The Chief or Director, Pathology and Laboratory Medicine Service, must ensure current accreditation of all testing sites that perform laboratory tests for patient care by the appropriate, nationally recognized CMS “deemed” accrediting bodies. NOTE: Primary accreditation and biennial inspection must be coordinated under the nationwide contract initiated by the National Director, Pathology and Laboratory Medicine Service, or the Chief Officer, Policy, Planning and Performance.

(2) All VA laboratories are required to register with the Pathology and Laboratory Medicine Service National Enforcement Office and be issued a CLIA’88 number.

(a) Each VA facility-based and independently accredited outpatient clinic laboratory must be issued a separate CLIA’88 number.

(b) All Ancillary Testing Sites under the accreditation umbrella of the main laboratory must be included under the main laboratory CLIA’88 registration.

(c) The organization can choose to remove waived testing or PPM testing performed by privileged providers from under the jurisdiction of the laboratory accreditation umbrella. If that option is elected however, these sites must register with the Pathology and Laboratory Medicine Service National Enforcement Office for a waived or PPM CLIA’88 certificate.

(d) VHA facilities are required to revalidate their CLIA’88 certificate with the Pathology and Laboratory Medicine Service National Enforcement Office every 2 years.

(3) Testing sites outside the physical limits of the main VA medical laboratory facilities, including those performing Mohs’ surgery, are to be included as part of the main laboratory accrediting process, or must maintain current accreditation by an appropriate, nationally recognized, CMS “deemed” accrediting body in compliance with CLIA’88, Title 42 CFR 493.

NOTE: VA medical centers are strongly encouraged to also apply for institutional membership in AABB, a nationally recognized professional organization, actively engaged in improving blood banking through educational and accreditation programs.

(4) The Chief or Director, Pathology and Laboratory Medicine Service, that has a blood bank or transfusion service, must ensure current inspection and accreditation of the facility with AABB if any of the following criteria are met:

(a) Has six or more full-time equivalent (FTE) employees dedicated to the blood bank section.

(b) Provides specialized training for medical technology trainees in blood banking. This training is over and above the rotational training normally provided to all medical technology trainees.

(c) Draws autologous, directed or allogeneic blood donors.

(d) Performs apheresis, therapeutic or non-therapeutic.

(e) Performs blood banking and/or transfusion medicine services for other VA medical centers (does not apply to consolidations or mergers), or community institutions.

NOTE: The costs of membership, or alternatively of accreditation and biennial inspection, must be borne by the facility.

(5) The Chief or Director, Pathology and Laboratory Medicine Service, is mandated to participate in the annual registration and FDA inspection if the facility draws or prepares components or provides transfusion services.

(6) The Chief or Director, Pathology and Laboratory Medicine Service, is responsible for ensuring that all laboratories performing patient care testing meet requirements for hospital accreditation.

(7) On a periodic basis, accrediting and regulatory agencies summarize and submit the findings of their inspection and accreditation processes to the Pathology and Laboratory Medicine Service National Enforcement Office, the VA Pathology Regional Commissioners, and to the individual facilities.

(8) The National Director, Pathology and Laboratory Medicine Service, VHA Central Office, provides oversight responsibility to ensure:

(a) Current accreditation with each of the aforementioned groups and agencies. In those instances where problems having a potential for adverse patient outcome are identified and require corrective action, the Pathology and Laboratory Medicine Service National Enforcement Office works with the Pathology Regional Commissioner, and the Chief or Director, Pathology and Laboratory Medicine Service, at the facility to ensure that corrective action is implemented in a timely manner.

(b) That the required accreditation programs are fully implemented.

(9) Should the organization choose to remove waived testing or PPM testing performed by privileged providers from under the jurisdiction of the laboratory accreditation umbrella, the Chief or Director, Pathology and Laboratory Medicine Service, retains the responsibility to identify testing performed within the facility and to provide assistance and oversight to ensure that any testing performed is in compliance with 42 CFR 493 and existing VHA policies. In addition, a separate laboratory director for the waived or PPM testing must be identified on a separate CLIA certificate, which must be renewed every 2 years.

c. Required Elements for Quality Improvement in Laboratory Services and Ancillary Testing Sites

(1) Quality Improvement Requirements. With the exception of tests classified as waived or PPM and performed by appropriately privileged providers, the Chief or Director, Pathology and Laboratory Medicine Service, is directly responsible for ensuring that all laboratory testing performed within a VA facility, its outreach functions, and stand-alone outpatient clinics meet the quality improvement requirements listed as follows:

(a) Appropriate written policies and procedures are in place for a comprehensive Quality Improvement Program designed to monitor and evaluate the overall quality of the laboratory testing process in all testing sites in the medical center and its outreach functions, including ancillary testing, and satellite outpatient laboratories. These policies must meet the requirements of the accrediting agencies.

(b) A system is in place to ensure that all complaints and problems reported to the laboratory are documented. Investigation of complaints and patient incident reports must be made and corrective action instituted, when indicated.

(c) There is an ongoing mechanism for monitoring and evaluating the usefulness and appropriateness of referral testing, i.e., that testing is sent to a CLIA’88-accredited laboratory, that the results obtained are of high quality, and that the test is appropriate for patient care.

(d) If tests are performed using different methodologies, instruments, or at other testing sites within the VA medical center, the Pathology and Laboratory Medicine Service must ensure that correlation studies between the main laboratory and these other test sites are performed at least twice yearly.

(e) A system is in place to provide training and ongoing assessment of the competency of the individuals performing patient testing.

(f) All fatalities or other events considered “sentinel events” by The Joint Commission must be reported to the appropriate VA Pathology Regional Commissioner.

(2) Privileged Provider Minimal Testing Standards. The following minimal standards must be met for all testing, including waived and PPM procedures, regardless as to whether or not such testing is under the direct oversight of the Chief or Director, Pathology and Laboratory Medicine Service. While the Chief or Director, Pathology and Laboratory Medicine Service, in some instances may not be directly responsible for the laboratory results released by these providers, the Chief or Director, Pathology and Laboratory Medicine Service, must be involved in selecting test methods that are appropriate for use by the providers and must ensure that there is a mechanism in place that validates compliance with required testing standards, and VHA policy. The recommended mechanism to achieve this outcome is to include all such testing in the ancillary testing program.

(a) Personnel performing these procedures are expected to follow good laboratory practices in terms of quality control, quality assurance, and proficiency testing.

(b) The procedure must be performed strictly in accordance with the manufacturer’s instructions.

(c) Written policies and procedures must be in place for performing the test.

(d) Patient test results must be documented in the patient’s medical record. For qualitative results of patient tests performed by privileged providers (such as occult blood tests), the patient test results and the date the test was performed, may be documented in a progress note in the patient’s record. All other results (qualitative or quantitative) require entry into the VHA computer system.

(e) Quality control lot numbers and results must be documented for review and trending purposes using manual logs or computer-based programs. For non-instrument based waived or PPM patient tests performed by privileged providers (such as occult blood tests), the quality control results may be documented in the patient chart or in separate logs. The quality control lot number used for the patient testing must also be documented.

(f) All test sites must enroll in a formal proficiency testing program according to the VA requirements, when one is available. When a formal proficiency testing program is not available the organization must have a system in place that verifies, at least twice a year, the accuracy of test results.

(g) A system must be in place to provide ongoing assessment of the competency of the individuals performing patient testing.

(h) All testing must be carried out in accordance with applicable accreditation standards.

(i) When testing is performed at more that one site within the organization, correlation testing must be performed between the testing sites at least twice per year. Correlation testing must be performed between the main laboratory and ancillary testing sites.

(j) When a new test methodology is implemented, the organization must perform and document method validation for all testing complexities, including waived testing, consistent with the requirements listed in 42 CFR 493.1253.

d. Blood Bank Transfusion Service Requirements

(1) The Blood Bank Transfusion Service must have an ongoing mechanism for monitoring and evaluating those aspects of care that are most important to the health and safety of the patient, including the incidence of various types of transfusion reactions.

(2) All hemolytic and other life-threatening transfusion reactions must be immediately reported to the patient's physician.

(3) All hemolytic and other life-threatening transfusion reactions must be reported through the medical center's Patient Incident Reporting Program. All fatalities or other events considered “sentinel events” by The Joint Commission must be reported to the appropriate VA Pathology Regional Commissioner and the FDA. VA Pathology Regional Commissioners are then responsible for expediently reporting the incident to the Pathology and Laboratory Medicine Service National Enforcement Office.

(4) Biological product deviations must be reported directly to FDA and a copy forwarded to the appropriate Pathology Regional Commissioner.

e. Anatomic Pathology Program Requirements. Pathology and Laboratory Medicine Service must have an ongoing mechanism for monitoring and evaluating those aspects of care that are most important to the health and safety of the patient, including:

(1) The communication of surgical pathology and cytopathology diagnoses (including significant report modifications) to attending physicians and medical personnel authorized to receive or transmit diagnoses.

(2) Any potential and actual detrimental patient outcomes resulting from delays in surgical pathology or cytopathology diagnoses.

(3) Any potential and actual detrimental patient outcomes resulting from incorrect surgical pathology or cytopathology diagnoses.

f. External Proficiency Testing (PT) Program. As an enhancement to the internal Quality Control Program, to ensure reliability of patient testing in the laboratory, and to maintain accreditation requirements, each Pathology and Laboratory Medicine Service and all Ancillary Testing Sites must subscribe to external PT programs that meet CLIA’88 requirements for all analytes for which PT is available, including waived testing, PPM, and unregulated analytes.

(1) The laboratory must participate in PT events that contain a minimum of five challenges per analyte per event, whenever five challenge events are available from the VA-contracted PT vendor.

(2) For analytes that do not have PT available, an alternative method must be in place to assess the method accuracy at least twice a year (e.g., split samples analyzed in conjunction with another laboratory, or testing materials with assigned values as unknowns). The laboratory must perform PT on every instrument (including backups) utilized for patient testing and for every site where patient testing is performed.

g. Test Methods and Equipment Standards

(1) Each Chief or Director, Pathology and Laboratory Medicine Service, must establish standards and policies for the selection of tests, validation and implementation of analytical systems, and test methods.

(2) For all FDA-approved analytical systems and test methods, including waived tests, a system must be in place to ensure all test methods are validated prior to the implementation of all test methods. The validation protocol is at the discretion of the Laboratory Director, but at minimum must meet the manufacturers' recommendations, accreditation requirements, and be consistent with the requirements outlined in 42 CFR 493.1253, as applicable.

(a) Initial correlation studies must be performed between the new test or method and current instruments or methods providing results for the same analyte.

(b) If applicable, equivalent quality control is validated in accordance with current accepted scientific guidelines or accrediting agency requirements.

(3) For non-FDA-approved, laboratory modified FDA-approved methods, or tests developed in-house, the laboratory must perform an extensive study to establish and document the method’s performance specifications. Protocols using Clinical Laboratory Standards Institute (CLSI) guidelines are recommended. For in-house developed methods or systems, the frequency of calibration depends on the scientific data to ensure reliable testing is provided by the laboratory.

(4) All test methods and instruments must have clearly written manuals available in each testing area to substantially comply with current laboratory accreditation requirements.

(5) The laboratory must, as a minimum, follow the manufacturer’s recommendations for performing the testing including, but not limited to: quality control, reagent storage, maintenance, function checks, etc.

(6) New lots of reagents must be validated for all tests including waived testing.

(7) Analytes measured from commercial test-kit procedures must be FDA-approved and meet the same general guidelines and standards of the analytical system.

(8) If tests are performed using different methodologies, instruments, or at other testing sites within the VA medical center, the Pathology and Laboratory Medicine Service must ensure that correlation studies between the main laboratory and these other test sites are performed at least twice yearly.

(a) For waived tests, patient correlations need only be performed on a subset of instruments twice yearly.

(b) The Laboratory Director determines the size of the subsets.

(9) Whenever possible, the major routine analytical systems must be interfaceable to the VA medical center’s VistA computer system.

h. Patient Test Management. The Chief or Director, Pathology and Laboratory Medicine Service, must ensure that for all testing sites within and affiliated with each VA medical facility that perform laboratory tests on patients for diagnosis, monitoring therapy, or the progress of disease that:

(1) The standards, procedures, and policies are developed for reporting of timely, accurate, reliable and clear test results.

(a) Policies for detection of potential errors or differences in test results for the same analyte between the clinical laboratory and all ancillary testing sites in the VA medical center are established.

(b) All laboratory test results are carefully reviewed for accuracy of reporting by the testing personnel performing the test before the data is released to the health care providers and wards.

(c) All laboratory tests, regardless of where they are performed, will have the results entered into the patient’s electronic medical record. This includes all tests performed on VA patients by non-VA laboratories where specimens or test results are processed through Pathology and Laboratory Medicine Service and where testing has been ordered by a VA provider or contract provider for use in providing patient care. This would not apply to testing that is ordered by a non-VA provider and used by a VA provider to treat or monitor a VA patient, as might be the case for shared or co-managed patients. In that case, the results and all appropriate information (e.g., reference range, name of testing laboratory, etc.) should be included in a progress note or included in the paper medical record or scanned into the patient’s electronic medical record.

This would also not apply to patient self-generated results. Patient self-generated or self-test results may be entered elsewhere in the patient’s electronic medical record, but will not be included in the laboratory test file. NOTE: Only laboratory results that are ordered by a VA provider and tested by a VA laboratory, VA contracted laboratory, or agent of the VA laboratory should be entered into the laboratory module of VistA or approved laboratory software.

(2) If an error is found on a released-patient result, the appropriate designee must communicate immediately with the health care provider in charge of the patient. The Chief or Director, Pathology and Laboratory Medicine Service, or designee, must ensure that the report is corrected in the VistA computer system. Both original and corrected results automatically become part of the data released to the health care providers, to the wards, and to become part of the patient’s permanent record.

(3) Clearly written policies and procedures are developed to:

(a) Review processes for electronic data transmission. For example, programs must be developed so that the VistA computer system checks the entered data against predefined limits established by the Chief or Director, Pathology and Laboratory Medicine Service, for such tests that are identified and flagged with high, low and critical values. Entries or results outside of the predefined limits will not be accepted.

1. Previous patient test results display a delta check.

2. All significant abnormalities must be identified by an audible "beep" and a visual "flag" observed next to the test values.

(b) Ensure correction of detected errors and documentation of correction.

(c) Ensure correct patient identification.

1. The testing site must have written policies which ensure the positive identification of the patient, and all patient specimens, from the time the specimen is collected until testing has been completed and the results reported.

2. In addition to ensuring the positive identification of specimens, the testing site must ensure optimum integrity of the specimens from the time of collection until testing has been completed, and the results reported.

(4) The Necessary Reports Generated by VistA

1. In the case of the interim reports generated by VistA and intended to serve as the health care provider's work copy, the name of the requesting provider must be included along with the name and address of the testing facility.

2. The original report, or a duplicate of each report (including preliminary and final, except for microbiology preliminary report), must be retained in a manner that permits prompt retrieval of information by the testing site personnel and clinical personnel; it must be maintained as part of the patient's record.

i. Specimen Identification for Drug Abuse Testing. If specimens are collected for drug abuse testing, the Chief or Director, Pathology and Laboratory Medicine Service, must ensure a written specimen collection and identification policy, to be used in testing employees for drug abuse, is in place. The laboratory must follow Federal regulations for collection and specimen management. This policy must include:

(1) Standards on specimen requirements;

(2) Validity of specimen and person;

(3) Chain of custody;

(4) Security of specimen, and

(5) Preservation of confidentiality of the individual and the individual test results.

j. Retention of Samples, Slides, and Records

(1) Samples, slides, and records must be retained in accordance with the requirements of VHA Records Control Schedule 10-1, Section VIII- Laboratory Service (113), CLIA '88, AABB, CAP, The Joint Commission, or other deemed status accrediting organization, whichever is the most stringent.

(2) The test requisition or the test report must be maintained as part of the patient’s chart or medical record complying with CLIA’88 requirement, if:

(a) The requisition is available to the laboratory at the time of testing and available to inspection groups upon request, and

(b) The test report is readily available to the laboratory and available to inspection groups upon request.

(3) PT records include those for:

(a) Test handling, preparation, processing, and examination;

(b) The results of reporting;

(c) The signed attestation statement; and

(d) The evaluation reports.

k. Discontinuation or Merger of Anatomical Pathology Services. When anatomical pathology services at a VA facility are discontinued or merged with another VA facility, all documentation and specimens required to be maintained must be transferred to the VA facility where the scope of services for the patients of that facility have been transferred.

8. ANCILLARY TESTING

a. Scope

(1) This paragraph provides direction and guidance to VA medical facilities regarding ancillary testing. Ancillary testing is defined as laboratory testing or services performed within a VA medical center or its outreach functions (clinic, et al.), but outside the physical facilities of the main clinical laboratory.