Provider Performed Microscopy Testing The Wet the Wild

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

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

Classification of Tests CDC 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.

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.

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)

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

Criteria to Qualify for a PPM License • 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

Common PPM Tests* (Moderately Complex Tests) • 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

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

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

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

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

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

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

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

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

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. )

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.

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.

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.

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