Laboratory of Pathology - Staff

Accreditation and Regulatory Compliance 

Accreditation and Certification

The Laboratory of Pathology's clinical sections maintain Certification of Accreditation by the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for all disciplines involved with reporting patient reports for moderate- and high-complexity testing.

LP is certified pursuant to the Clinical Laboratory Improvement Amendments (CLIA) by the Center for Medicare and Medicaid Services (CMS), and adheres to all Federal, state or local laws that have jurisdiction on LP’s functions.

LP adheres to statutes that govern the Department of Health and Human Services, the National Institutes of Health, and the NIH Clinical Center.

Compliance with laws and regulations may include, but are not limited to: tissue handling, radiation safety, shipping infectious or diagnostic material, reporting infectious disease results, personnel qualifications, retention of specimens or records, hazardous waste handling, fire safety, medical examiner or coroner jurisdiction, medicolegal testing, accepting specimens only from authorized personnel, handling controlled substances, patient consent for testing, confidentiality of test results, and use of material transfer agreements.

Documentation or evidence of compliance is available upon request. 

Certificates are publicly available: 

• College of American Pathologists (CAP) Certificate
• Clinical Laboratory Improvement Amendments (CLIA) Certificate
• Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

Educational Programs

The Accreditation Council for Graduate Medical Education accredits LP for its residency program in Surgical Pathology and fellowship programs in Cytopathology and Hematopathology. LP has a strong commitment to education and has several other research fellowships throughout the department, and all staff have the ability and are encouraged to participate in the NIH Clinical Center’s continuing medical education (CME) program. All medical, technical, and professional staff have access to the CME Grand Rounds Lecture Series offered by the NIH Clinical Center.

Policy on Compliance with CAP Terms of Accreditation

As part of its compliance with the terms of CAP accreditation, the Laboratory of Pathology will cooperate with any investigating agency, including but not limited to, the CAP, Joint Commission, FDA, OSHA, CMS, and Federal, State or local oversight agency. The LP Medical Director will inform the CAP within a reasonable timeframe, typically within 2 working days, if any of the following events occur:

1. Investigation of the Laboratory of Pathology by a Government entity or other Oversight Agency.*
2. The Laboratory of Pathology becomes a subject of a validation inspection.
3. Adverse media attention related to the clinical performance of the Laboratory of Pathology.
4. Any changes in laboratory activity menu prior to beginning that testing or implementing scope of service changes, or the laboratory permanently or temporarily discontinues some or all testing.
5. Change in location of the Laboratory of Pathology’s offices and labs.
6. Change in directorship of the Laboratory of Pathology with CAP notification 30 days prior to change, or within 2 working days after if unexpected.
7. Discovery of laboratory personnel actions that appear to violate national, federal, state (or provincial), or local laws that regulate laboratories.
8. When a new test is to be brought into practice it will be the responsibility of the individual lab directors (section chiefs) to notify the Laboratory Director for the Laboratory of Pathology who will notify CAP prior to beginning patient testing. New testing should not begin before CAP is notified. The Laboratory Director will notify CAP in the event that any of the other conditions are met.

* Notification of any investigation will be made to the CAP within two (2) working days after the Laboratory learns of an investigation or adverse media attention. This notification must include any complaint investigations conducted or warning letters issued by any oversight agency.

In addition, to ensure compliance with CAP terms of accreditation, the LP will ensure:

1. Provision of a trained inspection team comparable in size and scope to that required for its own inspection during the two-year accreditation period, if requested by the regional and/or state commissioner. This is typically coordinated with the NIH CC Department of Laboratory Medicine.
2. Availability, on a reasonable basis, the laboratory's annual PT results upon request of any person.
3. Provisions to allow the CMS or its agent to perform a validation or complaint inspection at any time during the laboratory's hours of operations and permit the CMS to monitor the correction of any deficiencies found during such an inspection
4. Adherence to the Certificate Mark Terms of Use/Agreement for the CAP Certification Mark and Design if the laboratory is/or will use the CAP Certification Mark for accreditation. The agreement can be downloaded and printed from cap.org.

Accreditation Readiness – Biennial Self-Inspection

In accordance with CAP terms of accreditation, the Laboratory of Pathology conducts an interim self-inspection each year that there is not an onsite CAP inspection.

1. The interim self-inspection is an important aspect of continuing education and laboratory improvement.
2. The use of a variety of mechanisms for self-inspection (residents, technologists or other inspectors) is strongly endorsed.
   1. LP's self-inspections will be performed by the clinical technical, medical staff and Residents. It is preferred that technical staff, not supervisors, be inspected.
   2. It is recommended that one clinical section inspects another (e.g. Histology Supervisor plus one Histology Technician and a Clinical Resident inspects Cytology).
3. The inspection will be conducted as similarly as a formal onsite CAP inspection.
4. Prior to each section inspection, the Activity Menu must be reviewed and verified by the Section Head to ensure all tests are on the test menu.
5. Deficiency reports of the self inspection will be provided to the sections' technical director and general technologist supervisor, and corrective actions must be completed within one month of the inspection.
6. Corrective actions will be reviewed and approved by the Medical Director, and the final inspection report may be discussed in the monthly QM Committee Meeting if the corrective action has a potential impact to other clinical services.
7. The final self-inspection deficiency reports and corrective actions will be turned in to the Clinical Manager, and originals kept in the sections to provide to CAP inspectors.

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