SAMARITAN NORTH HEALTH CENTER 9000 N. Main Street Dayton, OH  45415   Sponsored By ABBOTT LABORATORIES AND LIFESCAN

Member List

The meeting started by thanking Joanne Born, Executive Director of Laboratory Program, JCAHO for speaking to the group on Point of Care Testing and JCAHO Laboratory Accreditation (click here).  In addition, many thanks went out to Charlene Stephenson, New Visions Laboratory, Lima, OH for organizing the meeting and to Kim Douglas, LifeScan and Mark York, Abbott for sponsoring the meeting.

Pat Kraft, Good Samaritan Hospital/Samaritan North Health Center, addressed the members regarding organization of our group.  A consensus was reached by the members to keep the group and meetings informal at this time, with no hierarchy or bylaws established.  This may change if it becomes too difficult for volunteers to organize the meetings.  The group agreed to keep the location of the meetings at Samaritan North Health Center. Members also agreed to meet three times per year. The group was asked to keep in mind that we might not always get lunch at each meeting; we may have a speaker only. 

Our meeting minutes will be posted on Point of Care.net, subweb Ohio site.  Please access this address to contact group members and get meeting minutes and information.  Everyone who attended the meeting agreed to have his or her name made public on this website for networking access.

Pat Kraft asked the group to share information and experiences regarding inspections.  At Pat’s institution, the inspection was expanded from 1 to 4 days due to numerous ACT sites and outside ambulatory care center/clinics.  Some of the big issues addressed by inspectors included the rotation of proficiency testing among the nursing staff, identification of person performing testing, safety, and justification of why nursing performs point of care testing. 

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Cathy Hargrove, Fairfield Medical Center, shared her experiences with inspections from both JCAHO and CAP this year.  POCT was kept very general, and inspectors spent most of their time on the floor.

Pam Kotinski of the Cincinnati area questioned why a Point of Care program would choose CAP over JCAHO, or vise versa.  CAP currently inspects Pam’s program, but procedures and checklists don’t necessarily apply to POCT.  The group discussed that JCAHO is thorough, but is more interested in the “big picture”, where as CAP is much more specific, looking at the “nuts and bolts”.  Pat Kraft shared that she uses JCAHO terms with her nursing staff, as it makes her more understandable than if she refers to CAP.  She agreed that the CAP checklist does not necessarily apply to waived testing, but applies more so to moderate complexity testing.  We discussed that most inspectors look for compliance with intent of standard.

Deb Russell, St. Vincent-Toledo, shared with the group that her program would have a harder time passing a CAP inspection, so they chose to be inspected by JCAHO.  During their inspection, the Joint Commission surveyor asked nurses to explain definitive versus screening testing, in addition to questions about the procedure manual. 

Deb Russell also asked the group if anyone was using their POCT expertise as a consultant for doctor’s offices to make extra money for their hospital.  The group agreed that there is probably a large market for this service, since POLs that fail COLA inspections must hire a consultant to fix the deficiencies.  One group member stated that she did indeed render her services as a consultant, but on her own time outside of her institution. 

Pat Kraft shared her experiences with CAP and their new training program for would-be inspectors.  CAP will train you to do inspections for free either by attending training sessions or by training on-line.  CAP is currently trying to train all inspectors so that there is more consistency in the inspection process.  CAP is emphasizing the importance of the inspectors leaving the lab, getting out to the nursing units, and visiting all sites, including those off site. 

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Next Meeting Scheduled

The next meeting of the Ohio Valley POC Network will be Wednesday, November 20, with times to be announced.  Our sponsor will be MAS, and the topic will be CONNECTIVITY Using a Multi-Vendor Platform (click here for more information).  Deb Russell of St. Vincent-Toledo will be organizing this meeting.  Deb would like specific questions regarding connectivity e-mailed to her prior to the meeting so that she can pass these along to our speaker.  Hope to see you all there!

Minutes complied by: Jennie Klosterman, Miami Valley Hospital, Dayton, Ohio

Point of Care Testing and JCAHO Laboratory Accreditation
Joanne M. Born MT (ASCP) Executive Director of Laboratory Program

1.  Mission Statement of Joint Commission

• To continuously improve the safety and quality of care provided to the public through the provision of health care accreditation and related services that support performance improvement in health care organizations.

2.  How Mission is Accomplished

• Develop contemporary approaches to evaluating health care quality in

• collaboration with health professionals and others

• Survey and accredit organizations

• Stimulate organizations to meet or exceed standards through recommendations for improvement, education, and consultation.

3.  JCAHO Laboratory Accreditation…

• Recognized as a symbol of quality

• Doing the "right things well to reduce risk and errors in the delivery of care.

• Streamline lab processes and costs, standardize methods, enhance purchasing power, integrate Point of Care Testing throughout continuum.

• Gain improvement.

4.  Facts about the Laboratory Accreditation Process

• The Joint Commission evaluates the laboratory services that contribute to

• patient care and affect patient outcomes.

• This evaluation reviews technical functions such as quality control, and

• organization functions such as leadership and management of human resources.

5.      Facts about the Laboratory Accreditation Process

• JCAHO accredits approximately 4500 CLIA certificates.

• Meets CLIA (deemed status)

• Labs in hospitals, clinics, physician office labs, IVF, long term care and home health facilities, donor centers, private reference labs.

• Main Lab or Point of Care

• Conducted by laboratory specialists

6.      Accreditation Cycle

• The laboratory accreditation cycle is for two years, as determined by federal mandate (CLIA)

• Accreditation is not automatically renewed.  To become accredited again, and organization must reapply, participate in a survey and demonstrate compliance with the standards.

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7.      Point of Care Testing

• May be waived testing only

• May be moderately complexity

• May be a combination of the two

• May involve 2 accreditors if more that 1 CLIA certificate is used.

8.      Point of Care Survey, JCAHO

• If Point of Care includes moderate complexity testing, the laboratory accreditor will survey it according to the accreditor's standard or checklist/criteria.

• If waived testing is only performed, the lab accreditor and the hospital accreditor may survey it.

9.      JCAHO Standards

• Focus on actual performance

• Organized by key functions to encourage integration of activities across the organization

• Flexible, encourage innovation

• Emphasize outcomes

• Address CLIA requirement

• Waived testing has 7 standards requirements, only.

10.  Function

• Organizational functions

• Technical functions

11.  Organizational Functions (Moderate Complexity Testing)

• Improving Organization Performance

• Leadership

• Management of the Laboratory Environment

• Management of HR

• Management of Information

• Surveillance, Prevention and control of Infection

12.  Improving Organization Performance

• Designing, planning on-going process to evaluate services and outcomes

• Data collection

• Aggregation and analysis

• Achieving performance

• Sections of CLIA refer to "Quality Improvement and Quality Assurance" with a focus on quality assessments for pre-analytical, analytical, and post-analytical processes.

13.  Leadership

• Planning and designing services

• Directing Services

• Integrating Services

• Improving Performance

• CLIA specifies the qualifications and responsibilities for directorship.

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14.  Management of the Laboratory Environment

• Planning

• Implementation

• Other Environmental Considerations

• Measuring outcomes of Implementation

• CLIA focuses on equipment checks, maintenance, and calibrations.

15.  Management of Human Resources

• Human Resource Planning

• Orientation, Training and Education of Staff

• Competence Assessment

• Handling Staff Requests

• CLIA focus is on staff qualifications based on test complexity and competency assessment.

16.  Management of Information

• Information Management Planning

• Laboratory-Specific Data and Information

• Aggregate Data and Information

• Knowledge-Based Information

• Comparative Data and Information

• CLIA focus is on patient test management-specimens, ID, requisitions reports.  Also, reference ranges, procedure manuals.

17.  Surveillance, Prevention, and Control of Infection

• Surveillance, Prevention, and Control of Infection

• Relates more to OSHA and Blood Borne Pathogen Guidelines than to CLIA.

18.  Technical Functions

• Quality Control (Moderate or High Complexity)

• Waived Testing (Only for methods approved as waived).

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19.  QC- Moderate/High Complexity

• Proficiency Testing

• Systems

• Specialty and Subspecialty

• Dominates the CLIA requirements, very prescriptive, tied to Medicare reimbursements.

20.  Waived Testing

• 7 Standards addressing basic needs in accurately performing, monitoring, and interpreting waived testing results.

• CLIA focus has primarily been on the certificate.  Heightened scrutiny in 2002.

21.  JCAHO Compliance Issues

• Most frequently cited standards receiving Type One recommendations

• Data included (June 2002 through May 2002)

22.  Frequently Cited (continued)

• QC issues

• Human Resources

•  Leadership

• Waived Testing

23.  QC-Proficiency Testing (All CLIA mandates)

• QC 1.1-Enrollment in PT for all regulated analytes

• QC 1.1.1-PT record keeping, review, remedial action

• QC1.1.3-PT performance is maintained at acceptable level

24.  QC, Cont.

• QC5.11.2-system to investigate adverse reactions to transplanted tissue

• QC7.1-Hematology and Coagulation QC performance frequency (CLIA)

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25.  Human Resources (CLIA Mandate)

• HR 7-Competency Assessment, annual frequency, pre-analytic, analytic, post-analytic processes.

26.  Leadership (CLIA Mandate)

• LD 2-Appropriate directorship and CLIA certificate based on testing complexity

• A Med Tech or RN may NOT direct a PPMP certificate or test under it.

• Read package inserts carefully.

27.  Waived Testing (GROAN)

• WT 1.4-QC performed, documented as defined in policies, procedures and package inserts.

• WT 1.5-Appropriate records maintained, result found in medical record and linked to QC performed and testing conducted by trained personnel.

• Increased scrutiny by CMS

28.  Point of Care Testing -Key Areas of Focus

• Informatics, connect the dots

• Staff training and competency (annual competency assessment documentation)

• Correlation of results between instruments, sites performing same test for same population

• QC, calibration, remedial action, proficiency testing

• Leadership, directorship issues.

29.  Fact vs. Fiction

• If only WT is performed, only WT standards apply

• If POC is moderate complexity testing, all appropriate standards in lab standards manual apply

• CMS DOES consider quality issues with WT and PPMP-2% or more reviewed, higher for individual states.

30.  Compare

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31.  Compliance Confusion

• JCAHO does NOT require calibration verification of moderate complexity instruments such as iSTAT (CAP does)

• JCAHO does NOT have a requirement for linearity or correlation on waived test methods (CAP does).

• JCAHO must be invited to conduct your laboratory survey-if the hospital is JCAHO accredited, it does not mean the lab is JCAHO accredited.

32.  Laboratory Standards Success

• 36% of Joint Commission accredited laboratories achieve accreditation with Full Standards Compliance.

• 62% achieve accreditation with requirements for improvement.

• 1% achieve conditional accreditation

• 1% achieve provisional accreditation.

33.  In the Pipeline at JCAHO…..

• Electronic Application for survey (request for survey) option in July 2002.

• Staffing effectiveness criteria available on website.

• Standards seminars for POCT in 2003.

• New format for standards in 2004.

34.  Staffing Effectiveness

• Human Resources criteria (vacancy or turnover rates)

• Service/Clinical criteria (Delayed tests, misidentified specimens)

• Assessed in confirmation, may give assistance in determining staffing numbers, mix, training issues.

• Proposed for 2004 or 2005

• No quotas or ratios

• Every category of Sentinel Event-root cause analysis identifies staffing as a contributing factor.

35.  2003 JCAHO National Patient Safety Goals

• Improve the accuracy of patient identification (2 identifiers, not room number)

• Improve the effectiveness of communication among caregivers (verification or read-back process for verbal orders, standardize abbreviations)

• 6 Goals total-consult FAQ's on website.

36.  Resources….

• www.JCAHO.org

• Standards Interpretation, lab specialist (Megan) 630-792-5917.

• How to Meet the Most Frequently Cited Standards

• From Practice to Paper: Survey Documentation for Laboratories

• Customer Service Center:  630-792-5800 (8-5 CT)

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