The Joint Commission Laboratory Program- What’s New Jennifer Rhamy Executive Director

What’s New at The Joint Commission Me- and excited to be working with all of you Lab STAT News monthly emails Recent customer survey to hear voice of the customer Dedicated account executives for laboratory Increased alliance of the hospital and lab programs

Ongoing Lab Focus quarterly newsletter Lab Advantage program Discounted program for bundled proficiency testing, ASCP educational programs, and The Joint Commission accreditation. See www.labadvantage.org for more information

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

EXAMPLE: Crosswalk Display for Home Health CMS Requirements—may include multiple CMS areas Joint Commission EP

EXAMPLE: Crosswalk: Ambulatory Care

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

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

Tips For A Successful Survey use these colors Tips For A Successful Survey Kathie Steffens Field Director

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.

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

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.

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

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

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.

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

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.

Tips for Survey Point-of-Care Sites Off-site locations 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.

2010 Standards - Tips & Topics Megan E. Sawchuk, MT(ASCP) Associate Director, Standards Interpretation Group

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

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

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)

Organizational standards applicable to laboratory services Waived testing: APRs, NPSGs, LD.04.01.01, 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 482.27 Hospital Laboratory Services

Tip: Hospital standards related to blood administration EC.02.05.03 Emergency power for blood storage systems HR.01.02.01 Special training provided for transfusion administration MS.05.01.01 Medical staff involved in PI activities for blood & blood use PC.02.01.01 Transfusions administered per law & medical staff policy PC.05.01.09 HIV/HCV Notification (Look back) policies PC.03.01.01 Transfusion administration equipment is available for operative and other high-risk procedures PI.01.01.01 Organization collects data on blood and blood use, and all reported and confirmed transfusion reactions RI.01.03.01 Informed consent process NPSG.01.01.01 Two identifiers used to ID patient for transfusion NPSG.01.03.01 Two persons verify patient ID and product for transfusion UP.01.01.01  Standardized pre-op verification list, including blood product availability (and other laboratory reports)

Tip: Hospital standards related to laboratory services HR.01.02.01 Testing personnel meet the qualifications defined in the CLIA regulations IC.01.02.01 Laboratory resources are provided to support infection prevention and control program IC.02.02.01 Cleaning and disinfection of bedside point-of-care instruments, e.g. glucose meters LD.04.01.01 All laboratory services have CLIA certificates and licenses required by regulation LD.04.03.01 Pathology and clinical laboratory services are provided (essential service) to meet patient needs LD.04.03.09 Performance management of contracted laboratory services; maintaining evidence of CLIA compliance for reference and contract laboratory services MM.01.01.01 Necessary laboratory results are available to those managing a patient’s medications

Tip: Hospital standards related to laboratory services MS.05.01.01 Medical staff involved in PI activities for autopsies MS.06.01.01 – MS.06.01.13 Credentialing and privileging of licensed independent practitioners (LIPs) providing interpretive reports, e.g. pathologists performing histopathology MS.08.01.01 – MS.08.01.03 Ongoing & Focused Practitioner Performance Evaluation (OPPE & FPPE), applies to the above LIPs NPSG.02.03.01 Reporting of critical results (clinical reporting intervals, such as nurse to physician, not those of the main laboratory) NPSG.03.05.01 Baseline and ongoing testing for anticoagulation therapy provided per written protocol/policy approved by medical staff PC.03.01.08 Surgical tissue specimen policies, e.g. gross only, exceptions to submission to pathology, specimen handling TS.03.01.01 – TS.03.03.01 Tissue storage and issuance (if lab oversees) WT.01.01.01 – WT.05.01.01  Waived Testing

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

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.01.01.01 – QSA.01.05.01) Systems standards – all apply (QSA.02.01.01 – QSA.02.14.01) Specialty & subspecialty – specific groups apply, listed alphabetically (QSA.03.01.01 – QSA.21.01.01) Example: Chemistry QSA.06.01.01 – QSA.06.02.01 Waived testing: APRs, NPSGs, LD.04.01.01, WT chapters apply Survey includes tissue, clinical transfusion practices and perioperative transfusion services

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

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

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)

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

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 Only by The Joint Commission

The E-dition and Organization Customized Standards (OCS)

E-dition Standards Available Online

Customize your own service profile

View only applicable standards

View only applicable Elements of Performance

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

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)

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

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)

Comparison of waived and non-waived testing requirements

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

Equivalent QC (EQC) Requirements Joint Commission Requirement Non-waived QSA.02.04.01 Waived* WT.04.01.01 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 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.06.02.01) All others: 2 levels *Use of Option 1 or 2 requirements exceeds the standards.

Competency Requirements Joint Commission Requirement Non-waived HR.01.04.01 & HR.01.06.01 Waived WT.03.01.01 Content Use all six methods Blind testing Direct observation of routine testing Monitoring QC performance (by each user) Written testing Direct observation of instrument checks Monitoring result reporting Use 2 of 4 methods Initial training and annual assessment Yes Semiannual in 1st year 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 46

Comparison of Requirements Joint Commission Requirement Non-waived Waived CLIA certificate Yes Certificate of Accreditation (COA) Certificate of Waiver (COW) Establish P&P Initial training and annual competency Semiannual in 1st year 2 levels of QC each day 3 for ABGs Reference intervals on patient chart Quantitative results Critical result reporting

Comparison of Requirements Joint Commission Requirement Non-waived Waived Method validation Yes No Equivalent QC (EQC) validation Semiannual correlation studies Semiannual calibration verification Proficiency testing (Or other verification procedure for nonregulated analytes) Regulated: 3x per year Nonregulated: Semiannual

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.

Personnel Qualifications Qualification routes specify required education and experience High complexity testing requires Associate’s degree or higher [42CFR 493.1489(b)(1-7)] Moderate complexity testing requires high school diploma or higher [42CFR 493.1423(b)(1-4)] Credentials requiring advanced degrees are not sufficient to demonstrate education, e.g. MT(ASCP), CLS (NCA) or R.N. license

Resources on the Web Centers for Medicare and Medicaid Services (CMS) CLIA: www.cms.hhs.gov/clia CoPs: www.cms.hhs.gov/CFCsAndCoPs/ Centers for Disease Control and Prevention (CDC) www.phppo.cdc.gov/clia Food and Drug Administration CLIA Database Search www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm The Joint Commission’s Frequently Asked Questions (FAQs) http://www.jointcommission.org/Standards/FAQs

To Subscribe: Lab Focus: http://www.jointcommission.org/Library/Newsletters/list_serve.htm Lab Stat News qualitylabs@jointcommission.org

Contact Us General information: Information on becoming accredited Your account executive (see your organization’s secure Extranet site for specifics) Information on becoming accredited Contact Jennifer Rhamy Phone: 630-792-5754 Email: jrhamy@jointcommission.org Standards questions Contact Megan Sawchuk or Cherie Ulaskas Phone: 630-792-5900, Option 6 Online: http://www.jointcommission.org/Standards/OnlineQuestionForm/

QUESTIONS????

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