3Classification 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 testand one was calibration, QC and proficiency testing.
4Categories used for Classification KnowledgeTraining and ExperienceReagents or Material PreparationCharacteristics of the testing stepsQC, Calibration, Proficiency TestingTrouble Shooting and MaintenanceInterpretation and Judgement of the Analyst.
5POCT 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 POCTOutpatient POCTTraining/Competency Testing of Resident and Staff Physicians over the last 5 years at ~ 30 out-patient sites and in-patient employed physicians. (200 Practitioners)
6Regulating Agencies College of American Pathologist Joint Commission on Hospital AccreditationState Department of Health.
7Criteria to Qualify for a PPM License The examination must be performed by a Physician, Mid Level Practitioner, or a DentistThe procedure must be classified as Moderately ComplexThe 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
8Common PPM Tests* (Moderately Complex Tests) Wet Mounts- vaginal, cervical and skinAll Potassium (KOH) preparationsPinworm ExamsFern TestPost-coital direct, qualitative exam of vaginal or cervical mucousNasal smears for eosinophilsMicroscopic urinalysisFecal leukocyte examinationSemen analysis, or sperm motility*This is different from the PPT tests for CAP
9Regulated Physician Testing CAP - PPT (Physician Performed Testing- includes a different menu compared to PPMP)Both Waived and PPMP tests are included.Amniotic fluid pHGastric biopsy for ureaseOccult blood, fecal and gastricSynovial fluid for crystalsUrine dipstick
10Personnel Requirements Confined to Physicians, Midlevel practitioners, and Dentists.Other requirements for this test differ by agency
11Physician Training CAP STATE JCAHO Document No distinction During Doc’straining between Docs trainingand other Mid-Levelanalysts Practitioner,evidence of training
12Physician Competency CAP STATE JCAHO Evidence of Competency No trainingassessment required, no requirementor distinction for Docscredentialing between Midlevel- yes analysts
13Procedures CAP STATE JCAHO Tech Complete Written Procedure manual , proceduresthat includes patient ID, includingspecimen prep, collection, specimenhandling labeling, handlingpreservation,transport and processing
14Quality Improvement Program CAP STATE JCAHOQC of reagents Same, as Scopes usedincluding stains both agencies should be inInstrument good workingmaintenance order andreview and corrective cleaned and action taken servicedregularly
15Verifying Accuracy of Results CAP STATE JCAHOSame as others How are The lab uses atests with no PT system forevaluated at least verifyingevery 6 months accuracy andfor “unregulated” reliabilitytests? PT, of test resultsbiannual review for tests notprogram, split samples requiring PT testingwith ref lab, or by lawsplit samples in laboratory
16Reporting of Results CAP STATE JCAHO Is the system for Do test records All results forreporting PPT include the: PPM should beadequate? patient name filed promptlyPatient identifier, or unique identifier, in the patient’stest ordered, date and time of clinical recordPerformed,docs specimen collection, along with the datename or identifier, receipt, reason for and name of analyst.date/time rejection, date of test,of sample collection, identity of analystresult,reference interval,interpretive notes and any additional commentssample quality
17Pinnacle Health System Procedure PPM procedures in place 12/1997Training of Docs began 1/1998Paper 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.)
18Twice a year PPMPerformed 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.
19Resident TrainingFirst 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.
20Physician Competencies Over 200 performed twice a yearPictures you are seeing are those used.Always have an educational sampleKey-teach themDon’t just satisfy the regs.
21Calcofluor White Stain Report what you see!Questions-