Quality Assurance for POCT

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Quality Assurance for POCT

• Christine Collier, PhD, FCACB
• Clinical Biochemist, Kingston General Hospital
• Associate Professor, Pathology, Queens
  University
• Presented at Ontario Society of Clinical Chemists
  2001

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Acknowledgements

• Kingston General Hospital
• Dr. Robyn Houlden, Endocrinologist
• Susan Rhymer, POCT Coordinator
• Belleville General Hospital
• Mark Hudgins,
• Graphic Design
• Michael Collier,
• RM Design

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The most important quality of a laboratory
result, regardless of where it is performed is
its

• accuracy and precision because ultimately they
  have the greatest impact on patient outcome!

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Response to Article in CAP Today on Nurses and
POCT, August 2000

• We laboratorians have had little to do with
  the development of CLIA 88 or the other agency
  regulations governing POCT, and we resent meeting
  resistance from nonlaboratory personnel at every
  turn in having to implement the regulations and
  police those working under them.
• An 82 rate for QC, which nursing might view
  as pretty good, is unacceptable. What if the
  laboratory results were incorrect 18 of the
  time??

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Another response Us versus them

• What did surprise me was how openly several
  nurses in leadership positions demonstrated their
  fundamental lack of understanding and respect for
  the laboratory and their resistance to learning
  more.

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To eradicate Us versus them

• Collaborative multidisciplinary POC testing
  committee with authority.This allows all
  involved parties to learn about each other, share
  concerns, and arrive at mutually agreed upon
  policies and procedures.

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To eradicate Us versus them

• Leadership at every level must embrace the
  program and be unequivocal about the expectation
  that compliance with policy and procedure is a
  condition of employment.
• "People in positions of leadership must discard
  their resentment and commit to working
  collaboratively with their counterpartsmodeling
  a professional attitude of respect and
  cooperationin the best interest of the patient.

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Learning outcomes

• upon reflecting on the issues raised in this
  session, you will be able to enhance the real
  value of your quality assurance program by
  focusing on the P of POCT.

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QA of POCT The Issues

• The reality of POCT and QA
• Who? Why? What? When?
• What is the relationship between POCT and
  QA?
• What the guidelines really tell us about QA for
  POCT
• Doing the right thing, right!

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POCT Who?Nurses!
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POCT

• Why? Fast and convenient monitoring
• To improve patient care
• What? Testing performed on a collected specimen
  (process, documentation, interpretation)
• When? Policies that identify the population,
  indications, interpretations and actions,
  therapeutic decisions, and frequency of testing

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QA Who?

• Laboratorians.because of our training and
  expertise?
• Nurseswith more education, training, and
  continuing education?
• Why are our cultures so different?

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Why would a laboratorian do QA ?

• Accepted standard of practice in laboratory
  medicine
• lots and lots of guidelines!
• To measure and monitor accuracy and
  imprecision as an indication of the quality of
  patient results.
• Risk management to identify and minimize errors.
  

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What do we commonly do for QA?

• QA Samples
• QC
• In-house QA programs split samples, first
  patient sample
• EXQC (external QC)
• CAP (College of American Pathologists)
• Proficiency Testing (PT) QMPLS

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PATIENT CARE
OK
QC
Call Sue
Repeat OK
3 meters removed in 5 years
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Guidelines from Expert Panels

• Canadian Association of Pathologists, 1988
• Canadian Society of Clinical Chemists, 1988
• Q-Probes, College of Amer. Pathologists, 1994
• NCCLS Ancillary Blood Glucose Testing, 1994
• NCCLS Point of Care In Vitro Testing, 1995
• Ontario Ministry of Health POCT, 1995
• American Diabetes Association, 1996
• CLIA88, JCAHO, CAP, from Ehrmeyer, 1995
• Canadian Council of Health Facilities
  Accreditation Standards, 1992

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Expert Recommendations

• Responsibility
• Development of POCT program
• Training Program
• Personnel Issues
• Quality Control
• Quality Assurance
• Participation in external proficiency testing
• Patients performing their own testing

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1. Responsibility

• Designation of responsibility to an individual or
  committee(8)
• Approval of testing by Medical Advisory
  Committee(4)
• Ultimate responsibility held by institutions
  board(1)
• Accountability of individual performing testing
  for following polices/procedures and ensuring
  self-proficiency(2)
• Multi-disciplinary approach(3)
• Laboratory Involvement(8)
• Authority to withdraw program if serious
  proficiency problem(3)

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2. Development of Program

• Indications for monitoring delineated(4)
• Criteria for approval of location of testing
  sites(4)
• Single model of meter(4)
• Selection of meter done collaboratively with the
  lab(6)
• Procedure for instrument evaluation(5)
• Written policies and procedures(10)

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2. Development of Program, continued

• Documentation
• Results are identified as meter results(3)
• Results are signed by the operator(5)
• Each meter has a log book for documentation(4)
• Regularly scheduled meter maintenance(7)
• Criteria for
• Repeat testing(4)
• Critical values(5)
• Confirmation of result by laboratory(6)
• Hematocrit limits(2)

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3. Training Program

• Involves laboratory(5), uses a variety of
  media(2), has a written examination(2)
• Training addresses
• Specimen collection to ensure integrity(3),
  equipment use/maintenance/troubleshooting(4),
  policies/procedures(4), result evaluation/confirma
  tion/troubleshooting(4), documentation(1),
  limitations of method (potential sources of
  error)(3), skill demonstration (proficiency)(3),
  universal safety precautions(4), QC/QA (theory,
  policies, procedures, documentation,
  troubleshooting)(4)

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4. Personnel Issues

• Formal training program(11)
• Ongoing demonstration of Proficiency(8)
• Authorization/certification procedure and
  documentation(7)
• Reauthorization of personnel at regular
  frequencies (ie annually)(7)

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5. Quality Control

• QC each shift or daily(7)
• QC only if patient on shift requires testing(3)
• QC with 2 or more glucose concentrations(6)
• QC required by each operator (eg weekly)(2)
• Regular review of QC data(7)

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6. Quality Assurance

• Periodic analysis of QA samples by each operator
  (split samples, blind samples, EXQC
  participation)(5)
• Regular comparison with lab (split samples)(9)
• Acceptable Difference
• lt10 at glucose levels 1.7 22 mmol/L(2)
• lt15 (goal lt10) (1)
• lt20 at glucose levels gt5.5 mmol/L or lt0.83
  mmol/L at glucose levels lt5.6 mmol/L (1)

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6. Quality Assurance continued

• Periodic review of QA program sharing of data
  with operators (4)
• Indicators monitored, data shared, problems
  corrected(4)
• Eg. QC not performed,
• no troubleshooting when QC unacceptable,
  difference from lab unacceptable,
• patient tests per year per operator
• 7. Participation in external proficiency program
  (6)

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8. Patients performing their own testing

• Institution has a policy on
• patient self-testing(3)
• Patient uses own materials and equipment(1)
• Written permission is required by physician(2)
• Policy on Insulin administration(1)

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1999 MOH-LTC POCT Policy Appendix A

• QC/QA
• QC and troubleshooting, error messages, critical
  values, repeat testing, supply inventory and
  equipment maintenance
• monitor the program regularly for performance
  quality and ensure all the necessary
  communication takes place.

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1999 MOH-LTC POCT Policy Appendix A

• Risk management through a quality management
  system
• Evaluation and selection of instruments
• Personnel training and proficiency
• Protocols for procedure, QC, QA
• Withdrawing instruments
• Safety and infection control
• Patient self-testing policy
• Assessment of clinical need and review of
  utilization

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QMPLS POCT accreditation requirements

• Responsibilities
• Personnel Policies
• Document Control
• Purchasing and Inventory
• Process Improvement
• Equipment
• Pre-Analytical Process
• Analytical Process
• Quality Assurance
• Post-Analytical Process (Reporting)

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QMPLS POCT accreditation Process Improvement

• Periodic evaluation of the POCT in terms of
  cost-benefit, clinical need, utilization,
  clinical effectiveness, and cost efficiency
• Periodic audits of POCT shall be reviewed by
  management group
• Identify opportunities for improvement
• Make appropriate changes to program
• Procedure for resolution of complaints or other
  feedback

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QMPLS POCT accreditation Quality Assurance

• Quality Manager for POCT
• QC (Process, review, split samples,
  troubleshooting)
• EXQC participation and review
• Withdrawal of instruments
• Monitor performance quality and ensure
  correlation with central laboratory
• Patient self-testing
• QC document retention for 2 years

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Monitor performance quality and ensure
correlation with central laboratory

• monitor the performance of
  operators and compliance with policies
  and procedures
• Retraining shall be offered to operators that are
  not performing to acceptable standards
• Records of performance of each POCT testing
  location and/or meter

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15 years later still Us vs Them!

• We have structure and process guidelines
• We have a lot of experience
• We have a lot of QC data
• but what have we got to show?
• But do we know the average quality of the results
  or the common error rate?

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Relationship of POCT to QA
Door to lab
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Hospital administration, nurses and laboratorians
need an effective QA program

• To measure and monitor accuracy and
  imprecision as an indication of the quality of
  patient results.
• To identify and minimize errors.
  

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Efficacy of feedback from quarterly laboratory
comparison in maintaining quality

• 61 nurses continued with the practice of regular
  quarterly split-sample comparisons with feedback.
• 63 nurses did no comparisons over the 12 month
  study
• Primary outcome of accuracy was determined
  through 5-7 additional samples at 0, 6, 12 months

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Significant difference at 12 months

• Nurses with feedback had a mean difference from
  lab results of 11-12 at 0, 6, and 12 months
  nurses without feedback were 3.5 worse (eg. 15
  difference)
• Nurses with feedback had on average 81 of their
  results deemed acceptable (eg less than 20
  difference) nurses without feedback had on
  average only 69 acceptable comparisons

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The Issue

• Nurses are responsible for
• their own competence
• And
• The hospital administration, via laboratorians,
  is responsible for assuring the quality and
  minimizing the risks of POCT

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Maintenance of Competence Training
EXQC or PT QC Procedures Policies
QA
Professional Judgement
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For effective QA. personnel need

• Advanced instruments
• robust, easy, smart and automated, error
  detection and connectivity
• Comprehensive training
• sessions, manuals, expectations, at nursing
  schools
• Front-load your QA efforts!

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For effective QA. personnel need

• On-going support
• technical resource person
• easy, pleasant verbal and written
  communication system
• articles, sessions (in-house, conferences)

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For effective QA. personnel need

• Efficient, effective QA system
• Timely feedback on QC, EXQC, PT results.
• Input and ownership of error logs, summary
  reports, audits and indicators

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Potential Outcome Indicators

• and type of problems reported
• QA statistics
• Stat tests / routine tests
• Repeat frequency
• Duplicate testing
• Cost
• Satisfaction
• Management issues
• Personnel issues

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Potential Outcome Indicators

• and type of problems reported
• Sample collection instrument reliability QC
  reporting clinical response requests for
  re-training compliance issues
• QA statistics
• Annual patient tests number and accuracy of
  QC QA, PT, split sample frequency and accuracy
  documentation clinical action for critical
  results documentation of troubleshooting

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Potential Outcome Indicators

• Repeat Frequency
• tests repeated by meter or by laboratory as
  confirmation ( difference, explanation)
  simultaneous testing by meter and laboratory.
• Management issues
• Impact on patient management (time frame and type
  of change), frequency of testing, impact on
  length of stay, impact on acute complications,
  adverse outcomes due to non-timely or inaccurate
  results

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What we really need is

• Plenty of caring technologists
• People often communicating together
• Proper operator comprehensive training
• Promoting our cultures together
• Patient outcomes continuously improving
• and
• Plenty of mutual respect

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In Summary,POCT is not just about Testing
its about People, both Patients nurse
Practitioners

• POCT.
• Plenty Of Caring Technologists
• People Often Communicating Together
• Proper Operator Comprehensive Training
• Promoting Our Cultures Together
• Patient Outcomes Continuously Improving

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POCT

• Thank you!
• See On-Line presentations atwww.path.queensu.ca

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References

• CMLTO, Point of Care Testing. Position Paper,
  April 1995
• Jones, Cleave, Zinman, Szalai, Nichol, Hoffman.
  Efficacy of Feedback from Quaterly Laboratory
  Comparison in Maintaining Quality of a Hospital
  Capillary Blood Glucose Monitoring Program.
  Diabetes Care 19(20) 168-170, 1996
• Colllier, Houlden. A Survey of Quality Assurance
  Programs for Bedside Blood Glucose testing in
  Ontario Healthcare Facilities. Can J. Diabetes
  Care 20(4)21-28, 1996
• Clinical Laboratory Strategies. Managing the
  Many-Headed Monster Keeping POCT Programs Under
  Control. 2(10), 1997
• Collier, Houlden, Gleeson, Patryzkat, Rhymer. A
  survey to identify potential outcome indicators
  for a hospital blood glucose monitoring program.
  Clin Biochem 31(4) 263 - 268, 1998
• Collier, Houlden, Rhymer. How to Develop an
  Effective Decentralized Laboratory Testing
  Program. CLM Reviews 12(6) 418 - 423, 1998

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• References Continued.
• Nichols. Management of Point of Care Testing.
  Blood Gas News 8(2)4-13, 1999
• Nichols, Kickler, Dyer, Humbertson, Cooper,
  Maughan, Oechsle. Clinical Outcomes of Point of
  Care Testing in the Interventional Radiology and
  Invasive Cardiology Setting. Clin Chem
  46(4)543-550, 2000
• Waldenstrom. Proposal for another step on the
  path to Total Quality Management.
• eJIFCC 13(1) http//www.ifcc.org/ejifcc/vol13no1
  /1301200105.htm
• Fraser. Optimal Analytical Performance for POCT.
  
• eJIFCC 13(1) http//www.ifcc.org/ejifcc/vol13no
  1/1301200106.htm
• Kost. Preventing Medical Errors in Point of Care
  Testing Security, Validation, Performance,
  Safeguards, Connectivity. Arch Pathol Lab