1. Call-In Information Web meeting address: https://www.webmeeting.att.com –Meeting number 8773361828 –Access Code: 1666469 Join the audio portion at: –877-336-1828 –Access code 1666469 (yes, they are the same) (the audio will not be able to be streamed through the computer)

2. Michigan Regional Laboratory System Laboratory In-service: Laboratory Director and Site Coordinator Training Jeffrey P. Massey, Dr.P.H., HCLD(ABB) Michigan Department of Community Health Quality Manager 517-335-8074 masseyj@michigan.gov

3. Agenda Laboratory Quality Commandments Guidelines for review of QC documentation Good Laboratory Practice & Laboratory Documentation Responsibilities –Lab Director –Clinical Consultant –Site Coordinator

5. Laboratory Quality Commandments Yes, they are carved in stone!

6. I. I.Thou shall not perform any clinical test for which thou are not trained and checked for competency.

7. . II.Thou shall not use any expired reagents or supplies to perform any clinical test, including quality control evaluations

8. III. III. Thou shall not perform any patient test for which any of the Quality Control checks have failed.

9. IV.Thou shall not perform any test in any manner except as specified in the written standard operating procedure or manufacturers product insert.

10. Laboratory Quality Commandments There are no exceptions!

11. Quality Assessment answers these questions Does the procedure work the way it is supposed to work? Does the data produced reflect a real condition in the client?

12. Quality Control: Quality Assessment Component Intended to detect, reduce, and correct errors prior to the release of patient results. QC measures of precision or how well the measurement system reproduces the same result over time and accuracy or if that measurement is what is really present in the patient.

13. Quality Control In practice, we have three parameters to evaluate: 1.The Instrument: Does the instrument perform as expected*? 2.The Reagents: Do the reagents perform as expected? 3.The Analyst: Is the person performing the test correctly? * within the parameters in the manufacturer’s insert as approved by the FDA

14. Quality Control: Equipment What equipment preventative maintenance is indicated by the manufacturer? Has the indicated maintenance been performed: – on schedule? – and documented?

15. Quality Control: Equipment Instrument Checks –Display shows what it is supposed to when power is turned on. Self check is ok? –Instrument check device Optics Cuvette Calibration Cassette Calibration strip, tag, stick –Calibration checks are within expected range

16. Quality Control: Reagents Guidelines apply to Test reagents and QC materials! Determine closed vial (or other container) expiration date specified by manufacturer. –Specific date (March 13, 2011 = March 13, 2011) –End of the month (June 2011 = June 30, 2011) Determine open vial expiration date –30, 60 or 90 days after opening –Open vial expiration date CANNOT exceed the closed vial expiration date

17. Quality Control: Reagents Store according to manufacturer’s instructions –Protect from moisture and light –Bring to room temperature before opening packet unless manufacturer says otherwise Open only what you need –Monitor/document room temperature if reagents stored at room temp or test performed at room temp

18. Quality Control: Reagents If any of your reagents are expired, then you can not perform the test for clinical purposes. Options: –Find some reagents that are not expired –Use your backup plan, or –Cancel your clinic!

19. Quality Control A Reagent Cardinal Rule NEVER, EVERNEVER, EVER use expired reagents to test clinical specimens. Expired reagents should be: –Discarded –Marked: Warning: EXPIRED. Use for training only. Not for clinical use.

20. Quality Control: Reagents QC material has an established value (or range of values) for the analyte being measured by the test. QC frequency minimally must follow those established by the lab director for non-waived tests or is stated in the manufacture’s insert for waived tests. Record the results of QC materials at the time of testing. Do not proceed with patient testing if QC values are not acceptable

21. Quality Control ”The job is not done until the paperwork is complete” Quality Control Log Sheets –The frequency or interval for QC testing depends upon the test: check your procedure manual for appropriate intervals –Document instrument control checks Make sure the machine works before you proceed to test the reagents. –Document results at the time you obtain the result – don’t rely on your memory by filling in the result later

22. Quality Control Quality Control Log Sheets Document lot numbers and expiration dates (both open vial and closed vial expiration dates) Test both high and low level controls. (Positive and negative if pregnancy or urine dipstick).

23. Reporting Results: Positive Be consistent in how positive results are documented Positive –P –Pos –Positive –Do not use the Symbol “+”

24. Reporting Results: Negative Be consistent in how negative results are documented: Negative –N –Neg –Negative –Do not use the symbol “-”

25. Reporting Results: Quantitative Use 1+, 2+, 3+, 4+ Do not use +, ++, +++, ++++

26. Quality Control Quality Control Log Sheets If the results for high and/or low controls were out of range, consult the Trouble Shooting Guide Record any corrective action(s) taken on the QC Log –Your surveyor will say, “If you didn’t record it then I must assume that you didn’t do it”.

27. Quality Control Have a back up plan! You may not use that procedure for clinical testingIf your instrument or reagents fail the quality control checks; You may not use that procedure for clinical testing until; –Corrective action has been taken and –The instrument and reagent checks pass all quality control checks. There are no exceptions to this ruleThere are no exceptions to this rule.

28. The Penalty for Reporting Results if there is a QC Failure ……

29. Quality Control QC Logs need to be reviewed: –By the Site Coordinator on a regular basis (monthly or quarterly) –By the Laboratory Director on a regular basis May review a representative sample rather than all records –Your assigned Technical Consultant will review if requested (Enhanced Services Option) Corrective action is required if problems are identified QC Records need to be filed for 2 years in a manner that allows ready retrieval.

30. Quality Control: Testing Personnel Qualifications –Moderately complex –PPM –Waived Training –Cover all phases of testing –Checklists helpful Documented Competency –Direct observation –Trouble shooting scenarios

31. Quarterly Chart Audit An Important Quality Assessment activity Required for non-waived testing, recommended for waived testing Quarterly Chart Audit. –Verify that the QC Logs are completed for each test performed Lot # & expiration date, QC within acceptable limits, corrective action initiated as required –Randomly select 3-5 clients for each test. Verify that laboratory data is accurately transcribed to their chart; QC was performed and acceptable on the day of testing, testing personnel was trained and competent on the day of testing.

32. Quality Control “Quality in never an accident. It is always the result of an intelligent effort. It is the will to produce a superior thing.” John Ruskin

33. Good Laboratory Practice Quality Records & Documentation: Characteristics of a Good Record –Overall appearance –Permanence (pen not pencil) –Initials vs. Signature on record –Timing –Completeness –Appropriate error correction

34. Overall Appearance Include document control elements Keep forms simple Allow enough room for data entry Entries must be legible

35. Characteristics of a Good Record: Overall appearance/permanence Legibility is essential Write in permanent ink –No pencil –No White Out Is this Jan or Jun?Is this 2000 or 2006? Is this 1 or 7?

36. Quality Record Permanence Always use: –Black or blue indelible ink DO NOT USE: –Markers, felt tip pens, gel pens, glitter pens, pencil, liquid paper, White Out

37. Characteristics of a Good Record: Timing RoomCompleted (Place a √) InitialsDate 105√JPM4/16/104/15/10 106√JPM4/16/104/15/10 Date completed: April 15, 2010 WRONG CORRECT By waiting to record tasks, you may forget to fill out the documentation. A later date causes speculation. If it is not documented – the task was not done.

38. Quality Records and Documentation: Completeness of Record Decimals Not applicable (N/A) Not in Use / Test Not Performed Expression of dates Arrows/ditto marks Initials vs. Signature

39. Completeness of Record Not Applicable (N/A) When completing a form, indicate the spaces or blanks that do not require a response. Record “NA” in spaces or blanks that do not apply to the situation. Do not leave spaces blank

40. Completeness of Record Not Applicable (N/A) RoomCompleted (Place a √) DateInitials 105√4/16/10JPM 106 Blanks look as though operator forgot to complete the entry

41. Completeness of Record Not Applicable (N/A) RoomCompleted (Place a √) DateInitials 105√4/16/10JPM 106N/A4/16/10JPM Fill in any entry spaces that are not to be completed with “N/A”

42. Completeness of Record Not in Use or Test Not Performed When an instrument is not used that day, enter “Not in Use” in the appropriate space. Include your initials and the date where needed. When a Test was not performed, enter “TNP” in the appropriate space, and include your initials and the date where needed.

43. Completeness of Records Expression of Dates All dates should be entered as month, day, year –Examples April 16, 2010 Apr 16, 2010 4/16/10 04/16/2010 The year must be recorded on all forms

44. Correction of Erroneous Entries DO Not: –Use “White Out” (e.g., Liquid Paper) –Use erasors –Obliterate –Write over –Tape over

45. Appropriate Error Correction: Obliteration Do Not Obliterate an Entry –What would a reviewer think? –Site Coordinator –Laboratory Director –Surveyor

46. Appropriate Error Correction Write Over Do Not write over incorrect entries Again – what would a reviewer think??

47. Procedure for correcting erroneous entries 1. Incorrect Result 2. Draw a single line through incorrect entry 3. Write correct result next to incorrect entry 4. Initial and date the correction

48. Laboratory Director: Primary Responsibilities (both Waived & Non-Waived Labs) Has ultimate responsibility for ALL testing Must ensure quality laboratory services Assign in writing the duties/responsibilities for each person involved in all phases of the testing process

49. Responsibilities of Lab Director: Waived Laboratory Ensure testing is performed EXACTLY as stated by the manufacturer (including QC) Ensure that laboratory staff follow good laboratory practice Permit announced or unannounced inspections Maintain current CLIA certification

50. Laboratory Director Responsibilities (for moderate complexity testing) Ensure safe working environment Ensure tests chosen provide quality of results required for client care Ensure enrollment in PT program Ensure Quality Control & Quality Assessment programs are established & maintained Ensure corrective action is taken & documented

51. Laboratory Director Responsibilities (cont.) Ensure test results only reported when test is functioning properly Ensure reports of test results include information for interpretation Ensure consultation of test results Ensure the lab employs sufficient number of testing staff

52. Laboratory Director Responsibilities (cont.) Ensure testing staff are trained and competent Ensure procedure manual is available (review and sign on annual basis) Specify in writing the responsibilities of each consultant and testing staff

53. Responsibilities That CAN Be Delegated Selection of test menu Enrollment in PT program Maintenance of QC/QA program Corrective action program Training and Competency of staff Make procedure manual available to staff

54. Responsibilities that CAN be Delegated to Clinical Consultant Interpretation of test results Consultation available to clients concerning quality of test results

55. Responsibilities that CANNOT be delegated by Lab Director Ensure safe working environment Ensure proper size of testing staff Ensure overall quality of test results Ensure annual review and signature of test procedures

56. Questions?

57. Questions???