Provider Performed Microscopy Testing: The Wet,

the Wild and the Wiggly

Robert L. Sautter, Ph D.

PinnacleHealth System

History of PPM testing

• CLIA Classifications– Waived– Moderate Complexity– PPMP– High Complexity

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.

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 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

Personnel Requirements

• Confined to Physicians, Midlevel practitioners, and Dentists.

• Other requirements for this test differ by agency

Physician Training

CAP STATE JCAHODocument No distinction During Doc’s

training between Docs training

and other Mid-Level

analysts Practitioner,

evidence of training

Physician Competency

CAP STATE JCAHO

Evidence of Competency No training

assessment required, norequirement

or distinction for Docs

credentialingbetween Midlevel- yesanalysts

Procedures

CAP STATE JCAHOTech Complete Written

Procedure manual , procedures

that includes patient ID, including

specimen prep, collection, specimen

handling labeling, handling

preservation,

transport and processing

Quality Improvement Program

CAP STATE JCAHOQC 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

Verifying Accuracy of Results

CAP STATE JCAHOSame 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 ResultsCAP STATE JCAHOIs 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

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@PinnacleHealth.org