College of American Pathologists Accreditation for Public Health Laboratories

Transcription

1 College of American Pathologists Accreditation for Public Health Laboratories Romesh Gautom, PhD Director, Washington State Public Health Laboratory Garry McKee, PhD, MPH Director, Oklahoma State Public Health Laboratory Michael Skeels, PhD, MPH Director, Oregon State Public Health Laboratory

2 CAP Accredited State Public Health Laboratories Lead Lab 2 Branch labs Source: APHL

3 CAP accreditation does not replace CLIA certification CAP is one pathway to CLIA certification CAP must assure compliance with CLIA standards in accredited labs CAP & APHL Laboratory System Improvement Program (L-SIP) are complementary

4 History 1949 First CAP chemistry survey conducted 1962 CAP Inspection & Accreditation Program established 1967 CLIA enacted 1988 CLIA-88 enacted

5 CAP Accreditation Process Application Lab receives customized checklists, prepares for inspection Inspection team assigned Inspection conducted (1st announced, subsequently unannounced) Lab corrects deficiencies & demonstrates compliance

6 CAP Accreditation Process Lab accredited for two years Self-inspection in alternate years Proficiency testing monitored continually

7 CAP Accreditation Process Team leader and team members trained by CAP Peer review process with rigorous criteria and objectivity Inter-laboratory reciprocity; accredited labs inspect other similar labs Integrated quality management approach 1,700 of 3,200 CAP checklist questions are not matched to CLIA requirements (exceed CLIA)

8 Anatomic Pathology Chemistry & Toxicology Cytogenetics Cytopathology Flow Cytometry Forensic Drug Testing Hematology & Coagulation Histocompatibility Immunology Laboratory General Limited Service Laboratory Microbiology Molecular Pathology Point-of-Care Testing Reproductive Laboratory Team Leader Assessment of Director & Quality Transfusion Medicine Urinalysis CHECKLISTS

9 Checklist Question Examples GEN Phase II N/A YES NO Does the laboratory have a documented quality management (QM) program? NOTE: There must be a document that describes the overall QM program. The document need not be detailed, but should spell out the objectives and essential elements of the QM program. The QM plan may be based upon some reference resource such as CLSI HS01-A2, GP-22, or GP-26; the ISO 9000 series or ISO 15189:2003; AABB's quality program; CAP's quality management publications; or it may be of the laboratory's own design

10 Checklist Question Examples GEN Phase II N/A YES NO Does the laboratory have written procedures for proficiency testing sufficient for the extent and complexity of testing done in the laboratory? NOTE: The laboratory must have written procedures for the proper handling, analysis, review and reporting of proficiency testing materials. There must be written procedure(s) for investigation and correction of problems that are identified by unacceptable proficiency testing results. The laboratory should also have procedure(s) for investigation of results that, although acceptable, show bias or trends suggesting a problem. CAP-accredited laboratories must participate in proficiency testing (PT) (when available through CAP or a CAP-approved alternate provider) for all patient tests designated by CAP. The current list of analytes for which CAP requires PT is available on the CAP website [ or by phoning (or ), option 1. The CAP office audits PT participation to assure that accredited laboratories participate in PT as appropriate.

11 Checklist Question Examples MIC Phase II N/A YES NO Are there documented instructions for microbiology specimen collection and handling that include all of the following? 1.Method for proper collection of culture specimens from different sources 2.Need for prompt delivery of specimens to ensure minimum delay and prompt processing (CSF, wound cultures, anaerobes) 3.Use of transport media when necessary 4.Method for preservation of specimens if processing is delayed (e.g., refrigeration of urines) 5.Procedures for safe handling of specimens (tightly sealed containers, no external spillage) 6.Proper labeling of culture specimens NOTE: The Inspector must provide specific details of any deficiencies in Part B (Deficiency Summary) of the Inspector's Summation Report.

12 The CAP website is a valuable resource

13 My Own Observations Inspecting other labs is a great teambuilding and educational opportunity Private sector labs respect and appreciate our CAP accreditation CAP information system requirements helped us obtain IT resources Inspections are thorough and very helpful in lab improvement