Provider Performed Microscopy Testing: The Wet, the Wild and the Wiggly

1. Provider Performed Microscopy Testing: The Wet, the Wild and the Wiggly Robert L. Sautter, Ph D. PinnacleHealth System

2. History of PPM testing • CLIA Classifications • Waived • Moderate Complexity • PPMP • High Complexity

3. Classification of TestsCDC described the System • 7 categories were used to classify 1,200 original laboratory tests. • A point system was used in each category, 1-3. • 3 categories were associated with the analyst. • 3 were associated with the test • and one was calibration, QC and proficiency testing.

4. Categories used for Classification • Knowledge • Training and Experience • Reagents or Material Preparation • Characteristics of the testing steps • QC, Calibration, Proficiency Testing • Trouble Shooting and Maintenance • Interpretation and Judgement of the Analyst.

5. POCT at Pinnacle Health System • 1996 Merger of 3 hospitals, additional 1 hospital added in 1999. • Exception to Section 5.22(f)(to direct more than two laboratories) • Inpatient POCT • Outpatient POCT • Training/Competency Testing of Resident and Staff Physicians over the last 5 years at ~ 30 out-patient sites and in-patient employed physicians. (200 Practitioners)

6. Regulating Agencies • College of American Pathologist • Joint Commission on Hospital Accreditation • State Department of Health.

7. The examination must be performed by a Physician, Mid Level Practitioner, or a Dentist The procedure must be classified as Moderately Complex The microscope must be of the bright field or phase contrast type. The specimen is labile or delay will compromise the accuracy of the test. Control materials are not available for the entire testing process. Limited specimen handling or processing Criteria to Qualify for a PPM License

8. Wet Mounts- vaginal, cervical and skin All Potassium (KOH) preparations Pinworm Exams Fern Test Post-coital direct, qualitative exam of vaginal or cervical mucous Nasal smears for eosinophils Microscopic urinalysis Fecal leukocyte examination Semen analysis, or sperm motility *This is different from the PPT tests for CAP Common PPM Tests* (Moderately Complex Tests)

9. Regulated Physician Testing • CAP - PPT (Physician Performed Testing- includes a different menu compared to PPMP) • Both Waived and PPMP tests are included. • Amniotic fluid pH • Gastric biopsy for urease • Occult blood, fecal and gastric • Synovial fluid for crystals • Urine dipstick

10. Personnel Requirements • Confined to Physicians, Midlevel practitioners, and Dentists. • Other requirements for this test differ by agency

11. Physician Training CAP STATE JCAHO Document No distinction During Doc’s training between Docs training and other Mid-Level analysts Practitioner, evidence of training

12. Physician Competency CAP STATE JCAHO Evidence of Competency No training assessment required, no requirement or distinction for Docs credentialing between Midlevel- yes analysts

13. Procedures CAP STATE JCAHO Tech Complete Written Procedure manual , procedures that includes patient ID, including specimen prep, collection, specimen handling labeling, handling preservation, transport and processing

14. Quality Improvement Program CAP STATE JCAHO QC of reagents Same, as Scopes used including stains both agencies should be in Instrument good working maintenance order and review and corrective cleaned and action taken serviced regularly

15. Verifying Accuracy of Results CAP STATE JCAHO Same as others How are The lab uses a tests with no PT system for evaluated at least verifying every 6 months accuracy and for “unregulated” reliability tests? PT, of test results biannual review for tests not program, split samples requiring PT testing with ref lab, or by law split samples in laboratory

16. Reporting of Results CAP STATE JCAHO Is the system for Do test records All results for reporting PPT include the: PPM should be adequate? patient name filed promptly Patient identifier, or unique identifier, in the patient’s test ordered, date and time of clinical record Performed,docs specimen collection, along with the date name or identifier, receipt, reason for and name of analyst. date/time rejection, date of test, of sample collection, identity of analyst result,reference interval, interpretive notes and any additional comments sample quality

17. Pinnacle Health System Procedure • PPM procedures in place 12/1997 • Training of Docs began 1/1998 • Paper competencies began 1998. • On-line competencies began 2000. • Tests included, Wet mount all types, KOH, pin worm preparation, gram stains (one clinic only), urine microscopic, PPT testing (one clinic only- Docs at other clinics have other analysts performing tests.)

18. Twice a year PPM • Performed for first time users, live sample presentation with Dawn, Jenny and myself. • Primarily for residents. • Every 6 months to assess competency of analyst and for procedure verification.

19. Resident Training • First Year residents in Family Practice and Internal Medicine (key- make it practical and interesting!) • Scheduled time with all of them at once. • Power Point, slides, “wet samples”. • Formalized to include “other parameters” • including-CLIA regulations, office practice, technical presentation on PPM, costs of tests, collection of samples, in-depth tour of entire laboratory, predictive value of lab tests.

20. Physician Competencies • Over 200 performed twice a year • Pictures you are seeing are those used. • Always have an educational sample • Key-teach them • Don’t just satisfy the regs.

21. Calcofluor White Stain • Report what you see! • Questions- e-mail Bsautter@PinnacleHealth.org