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Approaches to Providing Quality Testing for Rare Diseases:

Discussion Outline. Institutional Charge: to ensure quality of all patient care testing at JHMIPrinciples appliedSpecific strategies employedSummary of results:All laboratoriesRare heritable disease laboratoriesKey programmatic considerationsCurrent work in progress. Charge to Ensure Quali

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Approaches to Providing Quality Testing for Rare Diseases:

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    1. Approaches to Providing Quality Testing for Rare Diseases: Johns Hopkins University Experience Patricia Charache, M.D. May 21, 2004

    2. Discussion Outline Institutional Charge: to ensure quality of all patient care testing at JHMI Principles applied Specific strategies employed Summary of results: All laboratories Rare heritable disease laboratories Key programmatic considerations Current work in progress

    3. Charge to Ensure Quality of Patient Care Testing 1992: Laboratory Survey for CLIA: (Performed by JCAHO): 26 citations, all in non-Pathology laboratories Johns Hopkins Medical Institutions (Hospital and University) charged Pathology with establishing a program to ensure quality.

    4. Summary of Non-Pathology Laboratories Total: 37 Laboratories, 33 Lab Directors 8 Rare heritable diseases labs Locations: Pediatrics, (9), Medicine (7), Anesthesiology, (3), Oncology (3), Neurology (3), Radiology (3), Dermatology (3), Gyn/Ob (2), Ophthalmology (2), Psychiatry (1), Urology (1)

    5. Rare Heritable Diseases Laboratories Molecular Testing (PCR) 4 Cytogenetic 2 Other 2

    6. Principles Applied Strategy needed to ensure accuracy, e.g. Pathology and non-Pathology laboratories would be held to the same standards of good laboratory practices All tests had to be documented; with both analytical and clinical validation Reports must be timely, and include test limitations and interpretations.

    7. Principles Applied (Continued) All laboratories must meet CLIA and JCAHO standards. (We found that research labs lacked good laboratory practices, such as reliable patient identification, specimen rejection criteria, run to run sensitivity validation, etc. We therefore elected not to have a CLIA Laboratory confirm a research lab’s positive results, given the risks of false negatives as well due to sample degradation, etc..)

    8. Specific Strategies Approach # 1: Laboratory Review Program Approach # 2: Credentialing Program for Laboratory Directors and Practitioners

    9. Specific Strategies: Laboratory Review Program Laboratories are surveyed (initially by a non-Hopkins independent consultant) Written survey summaries are provided to the Lab Director (and Department Chair), flagging specific CLIA/JCAHO deficiencies Lab Directors replies with corrective action programs Laboratory re-reviewed to document corrections Process is repeated q 2 years, and as necessary

    10. Specific Strategies: Credentialing Program By-Laws of Johns Hopkins Hospital were changed to require that all Directors and practitioners of Pathology or Laboratory Medicine had to have Privileges granted by the Department of Pathology. The Pathology Credentials Committee was enlarged by 3 non-Pathology members Criteria for privileges were defined and applied to both Pathology and non-Pathology faculty.

    11. Credentialing Program: Criteria for Laboratory Directors Results of Laboratory Reviews Proficiency test results and ability to problem solve errors Reports of occurrence/complaints Ability to establish and validate new tests

    12. Outcomes Laboratories Closed: 5 (3/5 continued research, 2 were closed) Work transferred to Pathology: 11 (9/11 were friendly arrangements) Pathologist appointed as Director: 7 (Former director became Medical Dir.) Independent Laboratories: 14 Divided Responsibility: 3

    13. Outcomes: Rare Heritable Diseases Laboratories Laboratories Closed: 2 (3/5 continued research, 2 were closed) Work transferred to Pathology: 0 (9/11 were friendly arrangements) Pathologist appointed as Director: (1) (Former director became Medical Dir.) Independent Laboratories: 6 Divided Responsibility: 0

    14. Outcomes CLIA/JCAHO Survey Results: (71 laboratories plus Point of Care sites, Pathology and non-Pathology) Rare citations: Non-Pathology laboratories = Pathology labs

    15. Key Programmatic Considerations Educational approach Pathology Medical and Administrative Leadership Laboratory Technical Staff Institutional Leadership Legal Department Department Chairmen Credentials Committee Clinical Laboratory Directors

    16. Key Programmatic Considerations (Cont) Avoid any appearance of bias Evidence based data Work through academic structure; (Foster institutional support, unpopular decisions made by Department Chairs) Provide information and support to all laboratories evenly

    17. Work in Progress Need to address special needs of transitional laboratories (especially personnel requirements) IRB education: recognition of certain protocols that using laboratory tests that should have oversight Funding for a rapidly expanding research-based need

    18. Discussion Summary Institutional Charge: to ensure quality of all patient care testing at JHMI Principles applied Specific strategies employed Summary of results: All laboratories Rare heritable disease laboratories Key programmatic considerations Current work in progress

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