Most Common POCT Deficiencies

Transcription

1 LAP Audioconference Most Common POCT Deficiencies November 18, 2009 Cynthia Foss Bowman, MD, FCAP Chair, Point of Care Testing Resource Committee 2009 College of American Pathologists. Materials are used with the permission of the faculty

2 Learning Objectives List the most common deficiencies related to the CAP POCT checklist Identify best practices to avoid POCT problems Identify strategies to demonstrate continuous compliance with POCT accreditation requirements 2

3 LIJMC Team Cathy Dreschel Annabelle Joson May Tso 3

4 What is POCT? National Academy of Clinical Biochemistry definition: Laboratory testing conducted close to the site of patient care, typically by clinical personnel whose primary training is not in the clinical laboratory sciences or by patients (self testing). POCT refers to any testing performed outside of the traditional core or central laboratory. 4

5 Different Perspectives on Defining POCT Geographic Functional Technologic Operator 5

6 POCT vs Traditional Lab Testing Technology Operators, turnover, training Different perspectives and priorities Focus on quick results vs process Documentation of process and results Confidence vs. skepticism in test results Scope: sites, uses, changes 6

7 LIJMC POC Test Volumes 800+ bed hospital with adult acute care, pediatric hospital, and inpatient psychiatry Central lab 2-3 million tests/year, 165 FTEs On site POCT Glucometers: 2767 operators, 167 meters, 325,000 tests/year ABGs: 55,000 panels/year from OR, PICU, NICU Cath lab, ECMO, cardiac units for oximetry, ACTs Off site POCT 16 sites, on campus and in NYC boroughs, schools, clinics, etc. BGM, UAs, FOBT, throat swabs, Hemoglobin A1c, HCG, hgb 2 supervisors 7

8 Stats on Growth Waived testing: 9 to >70 analytes and >1600 test systems Growth: %/year (cardiac POC markers 16-30%) Worldwide IVD: $39.5B Worldwide POCT: $6.7B; US POCT $2.3B Drivers: multiple 8

9 POC Tests Common: Glucose, UA, FOBT, urine HCG, group A strep, hemoglobin, lipids, PT Emerging tests: New uses for old tests, cardiac markers, coagulation, rapid molecular 9

10 CLIA and CAP/Waived Testing CLIA regulations: Follow manufacturers instructions CAP requirements: At least as stringent (deemed status) Set higher standards Waived only requirements: QC, reagents, calibration Common requirements: PT, QM, specimen handling, instrumentation, results reporting, personnel, competency, safety 10

11 Inspections: Central Lab and POCT Common and different issues Compare deficiencies Central lab 2008 POCT 2007, 2008 CAP POCT sites: primarily in hospitals and system-based Other: POLs, independent sites, etc, etc, etc. 11

12 Pathologist s Role: Why Get Involved? Passive reasons regulations, obligation Active reasons Professional resource Patient service Exposure, great opportunity Team Member Coordinator: support! 12

13 Checklist Deficiencies Phase I Requirements do not seriously affect the quality of patient care or endanger the lab worker. Written response required. Phase II Requirements may seriously affect quality of patient care or health and safety of hospital/lab personnel. Deficiencies must be corrected with a plan of action and supporting documentation that plan is implemented. 13

14 Ways to Comply General Site specific: LIJMC Practical 14

15 Top Phase I Deficiency POC Does the lab s current CAP Activity Menu accurately reflect the testing performed? 5.6% POCT 4.4% MIC % HEM % CHM

16 Explanation Menu required to assess compliance with PT Ask, check requisitions, computer order screens, SOPs, patient reports May not include esoteric tests, panels instead of individual tests may be listed Not calculations 16

17 POC.01650: Ways to Comply Have a plan/system with cross links Mechanism to be informed about testing Many sites and operators Use your partners to monitor Vendors, rules for onsite visits, be partners 17

18 Phase II Requirements POC Are calibrators, reagents and solutions properly labeled, as applicable, with following elements Content and quantity, concentration or titre Storage requirements Date prepared or reconstituted by user Expiration date 18

19 Labeling Deficiencies 7.5% POCT 5.7% HEM % CHM % URN % MIC

20 POC.04800: Ways to Comply Education and understanding; Process vs. results issue Multifaceted reasons and corrections Moving target: constant and varied oversight Electronic controls, labels Manual requirement remains; must label the container Room temp, refrigerated, change in expiration 20

21 Requirement POC Is there a documented program to ensure that each person performing POCT maintains satisfactory levels of competence? 7.1% POCT 8.3% GEN

22 Competency Requirements During first year, competency must be checked within first 6 months, then again at one year Competency must be reassessed at least annually. All of the elements that are applicable to an individual s duties must be evaluated for that individual Director can choose which 6 elements to include and all are NOT required each year (as of 9/2007). Physician competency can be established and reassessed through institution credentialing 22

23 Competency Some elements of competency assessment include, but are not limited to: Direct observations of test performance, patient prep, specimen handling, processing and testing Monitoring recording/reporting of results Review of intermediate test results, worksheets, QC records, proficiency results and maintenance records Direct observation of maintenance/function checks Assessment of performance through testing previously analyzed specimens blind samples, proficiency testing samples Evaluation of problem-solving skills 23

24 POC.06900: Ways to comply Education/understanding: satisfaction and confidence Skills fair for different audiences; involve residents, lab staff Partners; nurses are masters of competency assessment Electronic assists Documentation Web resources 24

25 Web Resources A number of companies are now offering web-based training and competency programs College of American Pathologists Allows tracking/documentation employee training/competency Develop customized exams and track employee scores RALS-e-Quiz POCT data management vendor electronic competency exams and operator scores with web-based access HealthStream e-course library to help sites meet regulatory compliance, not lab specific but good resource for general safety, HIPAA, and nursing specific education programs/interactive assessments NetLearning Modules for authoring your own web training, competency, managing staff, and performance reviews Washington State Medical Training Solutions Program e-competency exams for a variety of POCT devices with operator administration and web-based access Abbott/Patient Education Programs LLC Institution can customize training and competency over web 25

26 Requirement POC Is there documentation of at least annual review of all policies and procedures for POCT by the current director or designee? 5.9% POCT 8.5% CHM % MIC

27 Annual Review Annual review is part of ensuring that the Lab Director is taking an active role in the lab Review must ensure all package inserts in use are current Paper/electronic signature review must be at level or each procedure, or as multiple signatures on a listing of named procedure (like a table of contents) A single signature on a title page or index or all procedures is not sufficient to ensure each procedure has been reviewed Signature or initials on each page of a procedure is not required 27

28 POC.04100: Ways to Comply Document control and calendar Medical director involvement, evidence Master log: duplicate SOPs Electronic copies vs. accessibility Watch for: customized versions, involved users to avoid Package inserts, integrate into SOP, current? 28

29 Requirement POC When applicable, are all patient results reported with accompanying reference (normal) intervals or interpretive ranges? 4.8% POCT 1.3% CHM

30 Explanation Age, gender specific reference ranges must be reported as applicable Not necessary to include if results are part of a treatment protocol, e.g., glucose and insulin level Lists or tables distributed separately are fraught with difficulties unless tightly controlled 30

31 POC.04500: Ways to Comply Include in SOP Manual issues: incorporate into chart, labels, logs, etc. Electronic issues: connectivity or EMR ideal Standardize devices and reference ranges Correlation between devices and central lab 31

32 Requirement POC Is a complete procedure manual available in the work areas? 4.6% POCT 3.1% CHM % MIC

33 POC.03900: Explanation Package inserts cannot replace SOP Can be used as part of procedure if describe the POC procedure, are current and reviewed Vendors SOPs for instrument and reagents are acceptable as part of overall SOPs Card files can be used as quick reference If reflect actual SOP and formal manual is acceptable Need document control 33

34 POC.03900: Explanation Electronic manuals must Be readily available to staff and inspectors Have backup system for computer downtime Comply with document control and evidence of review requirements 34

35 POC.03900: Ways to Comply See POC Electronic vs. hard copy accessibility Available to inspectors Cannot be modified without approval 35

36 Requirement POC If the laboratory/poct program uses more than one instrument to test for a given analyte, are the instruments checked against each other at least twice a year for correlation of patient results? 4.4% POCT 4.9% CHM

37 Explanation Applies to quantitative tests for same or different instruments, makes/models Prefer fresh human samples to avoid matrix effects unless stability is an issue Issues with non-waived single or unit device use May correlate with lots of cartridges, then compare QC across the same devices Applies only to devices under same CAP number 37

38 POC.07568: Ways to Comply Why? Patients mobile, care in different sites, need comparability Glucometer examples Specimen stability issues: PTH, ABGs, NY traffic Economic and time concerns by users 38

39 Quality Control POC Are control results documented for quantitative and qualitative tests, as applicable? 4.3% POCT 0.6% CHM POC Are controls run daily for quantitative and qualitative tests? 4.1% POCT 0.8% CHM

40 Explanation QC must be performed according to manufacturer s instructions Testing personnel or supervisor must review QC on days when controls are run to detect problems and trends Lab director or designee must review the data monthly Many variables, so CAP makes no additional review recommendation 40

41 Explanation For internal controls, acceptability must be documented each day of testing For multiple devices, lab director decides if each site must document daily acceptable controls 41

42 On Days of Testing Quantitative: 2 controls at 2 different concentrations run daily Qualitative: positive and negative controls run daily Electronic or built-in controls acceptable for non highly complex testing under specific conditions See checklists 42

43 QC: Ways to Comply Many variables to control Mindset, understanding potential for error, patient safety issues Electronic, lockout controls Logs: make them intuitive for user input Ownership, assign, partners Oversight multifaceted Corrective actions: timely, PI, link to competency, performance assessment 43

44 Strategies for a Successful Inspection Inspection readiness mindset Pathologist as active partner Know all your sites Understand the checklists 44

45 Strategies for a Successful Inspection All stakeholders build the process Education: build understanding, buy-in Make practical, reliable systems 45

46 Strategies for a Successful Inspection Continuous Monitoring Be creative Electronic, automatic systems QM program Publicize 46

47 Strategies for a Successful Inspection CAP Resources Inspector training courses Mock and real inspections Correct deficiencies, monitor Education, listserv, peers 47

48 Technical Assistance: , ext

49 Questions? 49