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© Copyright, The Joint Commission The Joint Commission Laboratory Program- What’s New Jennifer Rhamy Executive Director.

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1 © Copyright, The Joint Commission The Joint Commission Laboratory Program- What’s New Jennifer Rhamy Executive Director

2 March 2010 Audio Conference 2 © Copyright, The Joint Commission What’s New at The Joint Commission  Me- and excited to be working with all of you  Lab STAT News monthly s  Recent customer survey to hear voice of the customer  Dedicated account executives for laboratory  Increased alliance of the hospital and lab programs

3 March 2010 Audio Conference 3 © Copyright, The Joint Commission Ongoing  Lab Focus quarterly newsletter  Lab Advantage program –Discounted program for bundled proficiency testing, ASCP educational programs, and The Joint Commission accreditation. –See for more informationwww.labadvantage.org

4 March 2010 Audio Conference 4 © Copyright, The Joint Commission Coming Soon  Crosswalk of The Joint Commission and CLIA standards available as part of e-dition  Development of the next revision of Laboratory Accreditation Standards and working collaboratively with ASCP to identify volunteers  2010 Laboratory Accreditation Overview  Leading Practices Database  eApplication for lab in 2011  Deeming process in late 2010

5 March 2010 Audio Conference 5 © Copyright, The Joint Commission EXAMPLE: Crosswalk Display for Home Health Joint Commission EP CMS Requirements—may include multiple CMS areas

6 March 2010 Audio Conference 6 © Copyright, The Joint Commission EXAMPLE: Crosswalk: Ambulatory Care

7 March 2010 Audio Conference 7 © Copyright, The Joint Commission Come meet with us!  Will have a booth at AACC, CLMA, and ASCP this year  Speaking at SEABB  Another free audio conference next fall  Other audio conferences and publications listed on the web site

8 March 2010 Audio Conference 8 © Copyright, The Joint Commission Summary  We want to hear from you  Initiatives are being driven by communications out to the accredited facilities or getting feedback  Concentrating on standards and accreditation process improvements in 2010

9 March 2010 Audio Conference 9 © Copyright, The Joint Commission Tips For A Successful Survey Kathie Steffens Field Director use these colors

10 March 2010 Audio Conference 10 © Copyright, The Joint Commission Documents and Information  Test Menu and Instruments Used –Tests that you perform in your laboratory  Total Test Volume for each CLIA –ABG =1 procedure –pH, pCO2, pO2 = 3 tests  CLIA Certificate(s) –For all laboratory services provided on-site.

11 March 2010 Audio Conference 11 © Copyright, The Joint Commission Documents and Information  Environmental and Safety Inspections –Safety Committee Reports –Hazardous Waste Disposal Manifests –Infection Control Policy and Processes  Performance Improvement –Data gathered –Data analysis and conclusions –Improvements Implemented –On-going monitoring

12 March 2010 Audio Conference 12 © Copyright, The Joint Commission Documents and Information  Proficiency Testing for last 6 events –Copies (hard copy or electronic) of original test performance – Procedure for handling and assessing PT –Attestation signed by testing personnel –Review of PT results from vendor –Investigation and corrective action of all unacceptable results.

13 March 2010 Audio Conference 13 © Copyright, The Joint Commission Documents and Information  Policy and Procedures –Do not need to move to a central location  Quality Control Data –Last 24 months accessible  Calibration and Calibration Verification –Performance over last 24 months accessible

14 March 2010 Audio Conference 14 © Copyright, The Joint Commission Documents and Information  Maintenance Records –Last 24 months accessible  Personnel Files –Have someone available who knows HR file system. –Validation of educational requirements –State licenses as applicable  Competency Assessment Records –Current and last annual assessment

15 March 2010 Audio Conference 15 © Copyright, The Joint Commission Tracer Activity  Patient tracers cover all specialties and subspecialties across the period from the last full survey –May be less than 24 months. –Labs converting from another accreditor are reviewed for prior four months activity, except for PT which is for 24 months.

16 March 2010 Audio Conference 16 © Copyright, The Joint Commission Tips for Survey  Know how to access information. –If on paper, how to retrieve if information is in storage –If electronic, what program(s) will you need to access for historic data –If using EMR, who will be needed to access patient information

17 March 2010 Audio Conference 17 © Copyright, The Joint Commission Tips for Survey  Encourage staff to openly participate. –If staff doesn’t understand what the surveyor wants, ask the surveyor to explain in more detail. –If staff doesn’t know the answer to a question, it’s okay to say they don’t. –Tell the surveyor how your lab complies with standard within your lab. –Every lab doesn’t comply the same way. –Have open discussion about standards.

18 March 2010 Audio Conference 18 © Copyright, The Joint Commission Tips for Survey  Point-of-Care Sites –Inform all staff that they will be asked to participate in survey.  Off-site locations –Inform all staff of same information that will be required for their survey activity.  Staff availability –Let the surveyor know who might be available only on certain days.

19 © Copyright, The Joint Commission 2010 Standards - Tips & Topics Megan E. Sawchuk, MT(ASCP) Associate Director, Standards Interpretation Group

20 March 2010 Audio Conference 20 © Copyright, The Joint Commission Standards Applicability  Standards are applicable based on: –Definition of a lab test as regulated by CLIA –Exceptions –Multiple test complexity levels –Multiple laboratory accreditors –Multiple health care accreditation programs, e.g. hospital, ambulatory, lab

21 March 2010 Audio Conference 21 © Copyright, The Joint Commission Which organization standards apply to laboratory services?  Accreditation programs include: –Hospital –Critical Access Hospital –Ambulatory –Office Based Surgery –Long Term Care –Home Care –Behavioral Health  Manuals include complementary “core” standards  Similar across all The Joint Commission accreditation programs  Standards often met with organizational policies

22 March 2010 Audio Conference 22 © Copyright, The Joint Commission Core standards chapters  Accreditation Participation Requirements (APR)  Environment of Care (EC)  Emergency Management (EM)  Human Resources (HR)  Infection Control (IC)  Information Management (IM)  Leadership (LD)  National Patient Safety Goals (NPSG)  Performance Improvement (PI)  Transplant Safety (TS)  Waived Testing (WT)

23 March 2010 Audio Conference 23 © Copyright, The Joint Commission Organizational standards applicable to laboratory services  Waived testing: APRs, NPSGs, LD , WT chapters  Non-waived testing: Other standards could be reviewed incidental to hospital tracer, e.g. safety, infection control, general policies (specimen collection & transport) –No technical testing requirements would be surveyed  Other related clinical and hospital requirements, e.g. transfusion medicine –Many related to Medicare’s Conditions of Participation (CoPs), e.g. 42 CFR Hospital Laboratory Services

24 March 2010 Audio Conference 24 © Copyright, The Joint Commission Tip: Hospital standards related to blood administration  EC Emergency power for blood storage systems  HR Special training provided for transfusion administration  MS Medical staff involved in PI activities for blood & blood use  PC Transfusions administered per law & medical staff policy  PC HIV/HCV Notification (Look back) policies  PC Transfusion administration equipment is available for operative and other high-risk procedures  PI Organization collects data on blood and blood use, and all reported and confirmed transfusion reactions  RI Informed consent process  NPSG Two identifiers used to ID patient for transfusion  NPSG Two persons verify patient ID and product for transfusion  UP Standardized pre-op verification list, including blood product availability (and other laboratory reports)

25 March 2010 Audio Conference 25 © Copyright, The Joint Commission Tip: Hospital standards related to laboratory services  HR Testing personnel meet the qualifications defined in the CLIA regulations  IC Laboratory resources are provided to support infection prevention and control program  IC Cleaning and disinfection of bedside point-of-care instruments, e.g. glucose meters  LD All laboratory services have CLIA certificates and licenses required by regulation  LD Pathology and clinical laboratory services are provided (essential service) to meet patient needs  LD Performance management of contracted laboratory services; maintaining evidence of CLIA compliance for reference and contract laboratory services  MM Necessary laboratory results are available to those managing a patient’s medications

26 March 2010 Audio Conference 26 © Copyright, The Joint Commission Tip: Hospital standards related to laboratory services  MS Medical staff involved in PI activities for autopsies  MS – MS Credentialing and privileging of licensed independent practitioners (LIPs) providing interpretive reports, e.g. pathologists performing histopathology  MS – MS Ongoing & Focused Practitioner Performance Evaluation (OPPE & FPPE), applies to the above LIPs  NPSG Reporting of critical results (clinical reporting intervals, such as nurse to physician, not those of the main laboratory)  NPSG Baseline and ongoing testing for anticoagulation therapy provided per written protocol/policy approved by medical staff  PC Surgical tissue specimen policies, e.g. gross only, exceptions to submission to pathology, specimen handling  TS – TS Tissue storage and issuance (if lab oversees)  WT – WT Waived Testing

27 March 2010 Audio Conference 27 © Copyright, The Joint Commission The Joint Commission Laboratory Accreditation Program  Laboratory application submitted to The Joint Commission  Survey every two years led by an MT/CLS surveyor (Masters prepared or managerial background) –Only non-waived services can be accredited –Could be main lab, POCT only, or both –Organization could have more than one laboratory accreditor, e.g. main lab CAP, POCT The Joint Commission  Having Joint Commission hospital accreditation does not mean the laboratory services are also Joint Commission accredited –Survey every three years for hospitals –Team of RN, MD, LSC, Administrator –No technical elements of testing are reviewed

28 March 2010 Audio Conference 28 © Copyright, The Joint Commission Which standards apply if there are Joint Commission accredited non-waived laboratory services?  Laboratory standards manual –Non-waived testing: All chapters apply, except WT –Core chapters (identified on prior slide) –Document Control (DC) –Quality Systems Assessment – 3 sections –Proficiency testing – all apply (QSA – QSA ) –Systems standards – all apply (QSA – QSA ) –Specialty & subspecialty – specific groups apply, listed alphabetically (QSA – QSA ) Example: Chemistry QSA – QSA –Waived testing: APRs, NPSGs, LD , WT chapters apply  Survey includes tissue, clinical transfusion practices and perioperative transfusion services

29 March 2010 Audio Conference 29 © Copyright, The Joint Commission If organization & NONE of the non-waived laboratory services are Joint Commission Accredited:  Laboratory should follow: –Their non-waived laboratory accreditor’s requirements, e.g. CAP or COLA (surveyed every two years) –The Joint Commission organizational standards (surveyed every three years) –Waived testing requirements –Follow the most stringent requirements when standards vary between accreditors –Other clinical and hospital requirements related to lab service

30 March 2010 Audio Conference 30 © Copyright, The Joint Commission If organization & SOME of the non-waived laboratory services are Joint Commission Accredited:  Most common scenario  Laboratory should follow: –The Joint Commission laboratory standards for services in which the organization applied, waived testing, tissue, clinical side of transfusion services, and perioperative transfusion services (surveyed every two years) –The other laboratory accreditor’s requirements (CAP or COLA) for the services in which they applied for accreditation (surveyed every two years) –The Joint Commission organizational standards (surveyed every three years) –Waived testing requirements –Follow the most stringent requirements when standards vary between accreditors –Other clinical and hospital requirements related to lab service

31 March 2010 Audio Conference 31 © Copyright, The Joint Commission If organization & ALL of the non-waived laboratory services are Joint Commission Accredited:  Simplest scenario –The Joint Commission Laboratory standards (surveyed every two years) –The Joint Commission organizational standards (surveyed every three years)  Sites currently evaluating the opportunity for concurrent organization and laboratory survey every six years (every other organizational survey)

32 March 2010 Audio Conference 32 © Copyright, The Joint Commission When should we participate in the Periodic Performance Review?  PPR Software –Web enabled tool via secure extranet –Self-assessment—non-punitive process –Submitted annually –Plans of Action / Measures of Success  Conference Call (Optional) –Standards Interpretation Staff (SIG) –Approval of POA and MOS

33 March 2010 Audio Conference 33 © Copyright, The Joint Commission Completing the PPR  Always participate in the hospital’s PPR and the WT standards!  And if the laboratory services are surveyed… –Only by a Cooperative Partner –Support the hospital’s PPR with completing related standards –Participate in the partner’s self assessment process –By a combination of laboratory accreditors –Complete PPR review against the applicable standards in lab manual and support the related hospital standards –Participate in the partner’s self assessment process –Only by The Joint Commission –Complete PPR review against the applicable standards in lab manual and support the related hospital standards

34 March 2010 Audio Conference 34 © Copyright, The Joint Commission The E-dition and Organization Customized Standards (OCS)

35 March 2010 Audio Conference 35 © Copyright, The Joint Commission E-dition Standards Available Online

36 March 2010 Audio Conference 36 © Copyright, The Joint Commission Customize your own service profile

37 March 2010 Audio Conference 37 © Copyright, The Joint Commission View only applicable standards

38 March 2010 Audio Conference 38 © Copyright, The Joint Commission View only applicable Elements of Performance

39 March 2010 Audio Conference 39 © Copyright, The Joint Commission Organization Customized Standards (OCS)  Linked to specialties and services selected in application  Selections in application populate Survey Technology –Surveyors apply only those standards  Future – link application to E-dition?  Standards Applicability Grid in manual for reference  Advantages: Single set of standards, customizable based on specialty and service

40 March 2010 Audio Conference 40 © Copyright, The Joint Commission 2010 Standards “Changes”  No changes to the actual requirements  Standards Improvement Initiative –Improved clarity –Eliminated duplication –Reformatted/renumbered  NPSGs simplified  New chapter headings –Document Control (DC) –Emergency Management (EM) –Transplant Safety (TS)

41 March 2010 Audio Conference 41 © Copyright, The Joint Commission National Patient Safety Goals  Retained –Two Patient Identifiers –Hand Hygiene  Revised (based on field input) –Critical Reporting –2010 goal is refocused on critical results –Critical tests no longer surveyed as part of the goal

42 March 2010 Audio Conference 42 © Copyright, The Joint Commission National Patient Safety Goals  Moved to standards –Verbal results read-back –Do Not Use abbreviations –Hand-off communications  Removed –Modified Universal Protocol for bedside procedures (duplicates organization standard) –Treat Healthcare Acquired Infection (HAI) as sentinel event (duplicates Sentinel Event policy) –Patient involvement in care (duplicates organization standard)

43 © Copyright, The Joint Commission Comparison of waived and non- waived testing requirements

44 March 2010 Audio Conference 44 © Copyright, The Joint Commission Equivalent QC / Alternative QC  Traditional QC uses external liquid controls  Equivalent QC (EQC) may use electronic or internal monitors, e.g. simulators, on-board or automated QC  Also known as Alternative QC (AQC), to differentiate from Electronic QC  If the system simulates two levels of controls, it can be used to meet Joint Commission daily QC requirements for both waived and non-waived testing  Electronic “checks” are not sufficient

45 March 2010 Audio Conference 45 © Copyright, The Joint Commission Equivalent QC (EQC) Requirements Joint Commission Requirement Non-waived QSA Waived* WT Internal EQC minimums ABGs: 2 levels daily with one q8 hours All others: 2 levels once daily At least once daily Initial evaluation of internal monitoring system to determine Option Option 1 Monitors entire analytical process Option 2 Monitors portion of analytical process Not required Initial parallel validation of EQC vs. external QC 10 consecutive testing days 30 consecutive testing days Not required Ongoing external QC - Frequency Once per calendar month & per lot and shipment Once per calendar week & per lot and shipment Per manufacturer instruction or lab policy Ongoing external QC - Levels ABGs: 3 levels (per QSA ) All others: 2 levels Per manufacturer instruction or lab policy *Use of Option 1 or 2 requirements exceeds the standards.

46 March 2010 Audio Conference 46 © Copyright, The Joint Commission Competency Requirements Joint Commission Requirement Non-waived HR & HR Waived WT Content Use all six methods 1. Blind testing 2. Direct observation of routine testing 3. Monitoring QC performance (by each user) 4. Written testing 5. Direct observation of instrument checks 6. Monitoring result reporting Use 2 of 4 methods 1. Blind testing 2. Direct observation of routine testing 3. Monitoring QC performance (by each user) 4. Written testing Initial training and annual assessment Yes Semiannual in 1 st year Yes Signatures Director/supervisor must sign that the individual has received training and is competent prior to performing testing independently Both the director/supervisor and the employee must sign that the individual has received training and is competent prior to performing testing independently

47 March 2010 Audio Conference 47 © Copyright, The Joint Commission Comparison of Requirements Joint Commission Requirement Non-waivedWaived CLIA certificate Yes Certificate of Accreditation (COA) Yes Certificate of Waiver (COW) Establish P&PYes Initial training and annual competency Yes Semiannual in 1 st year Yes 2 levels of QC each day Yes 3 for ABGs Yes Reference intervals on patient chart Yes Quantitative results Critical result reportingYes

48 March 2010 Audio Conference 48 © Copyright, The Joint Commission Comparison of Requirements Joint Commission Requirement Non-waivedWaived Method validationYesNo Equivalent QC (EQC) validation YesNo Semiannual correlation studies YesNo Semiannual calibration verification YesNo Proficiency testing (Or other verification procedure for nonregulated analytes) Yes Regulated: 3x per year Nonregulated: Semiannual No

49 March 2010 Audio Conference 49 © Copyright, The Joint Commission Personnel Qualifications  Continues to be an area of focus  Recent years - emphasis on leadership roles –Laboratory Director (LD) –Clinical Consultants (CC) –Technical Supervisor (TS) and Technical Consultants (TC) –General Supervisor (GS)  Future - Anticipate added rigor for all roles  TIP: Laboratories must have records to demonstrate testing personnel meet the qualifications specified in CLIA at Subpart M.

50 March 2010 Audio Conference 50 © Copyright, The Joint Commission Personnel Qualifications  Qualification routes specify required education and experience  High complexity testing requires Associate’s degree or higher [42CFR (b)(1-7)]  Moderate complexity testing requires high school diploma or higher [42CFR (b)(1-4)]  Credentials requiring advanced degrees are not sufficient to demonstrate education, e.g. MT(ASCP), CLS (NCA) or R.N. license

51 March 2010 Audio Conference 51 © Copyright, The Joint Commission Resources on the Web Centers for Medicare and Medicaid Services (CMS) CLIA: CoPs: Centers for Disease Control and Prevention (CDC) Food and Drug Administration CLIA Database Search The Joint Commission’s Frequently Asked Questions (FAQs)

52 March 2010 Audio Conference 52 © Copyright, The Joint Commission To Subscribe:  Lab Focus: Newsletters/list_serve.htm Newsletters/list_serve.htm  Lab Stat News

53 March 2010 Audio Conference 53 © Copyright, The Joint Commission Contact Us  General information: –Your account executive (see your organization’s secure Extranet site for specifics)  Information on becoming accredited –Contact Jennifer Rhamy –Phone: –  Standards questions –Contact Megan Sawchuk or Cherie Ulaskas –Phone: , Option 6 –Online:

54 March 2010 Audio Conference 54 © Copyright, The Joint Commission QUESTIONS????

55 March 2010 Audio Conference 55 © Copyright, The Joint Commission Thank you for participating!


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