1. PinnacleHealth System
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 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.

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. 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

8. 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

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-