Lake County Health Department
And Community Health CenterPRIMARY CARE
Title
POINT OF CARE TESTING (POCT) / SOP Number
I H 6
/ Issue Date08/17/04
Page 1 of 6
POLICY
Point of Care Testing processes must be monitored and evaluated for quality, while assuring accurate, reliable and prompt reporting of results, to identify and correct problems, and assure the competency of the staff performing any point of care test, while continuously improving patient service.
Clinical decisions may be made based on POC test results. In some instances inpatients may perform their own POC testing for training purposes or as an adjunct to laboratory testing, but clinical decisions should not be based on patient performed tests.
SCOPE
l Physician / Medical Providers m Medical Records
l Nursing m Billing
m Administration m Clerical
l WIC l Lab
m Dental l Counselors/Case Management
1. DEFINITIONS
Point of Care Testing (POCT) refers to any clinic employee performing any type of laboratory test outside of the central laboratory. The following are waived Point of Care Tests performed at LCHD/CHC Clinics:
Fecal Occult Blood / Wet Mounts / Fern Test
PH by Nitrazine Paper / Whole Blood Glucose
A. TEST COMPLEXITY
The Food and Drug Administration is responsible for categorizing tests as waived, moderate complexity, high complexity or Provider Performed Microscopy. LCHD/CHC POC testing includes waived and provider performed microscopy. Each test is classified according to a complexity formula.
Waived testing is the category of tests using methodologies so simple and accurate that the likelihood of erroneous results is considered negligible. Provider-performed microscopy is limited to a few unstained microscopic exams performed by a provider. Waived tests at LCHD/CHC Clinics can be used in the capacity of screening, monitoring, and adjustment of therapy. All POCT done at LCHD/CHC Clinics is classified as waived testing.
B. CERTIFICATION
Laboratory tests must be performed under the appropriate CLIA certification. This includes waived and provider performed microscopy. The Laboratory has oversight of all certificates held by any LCHD/CHC Clinic site. The Clinical Laboratory has developed a list of all tests performed at every LCHD/CHC Clinic. It is essential that test changes, deletions, or additions are communicated to the Clinical Laboratory Coordinator.
TitlePOINT OF CARE TESTING (POCT) / SOP Number
I H 6
/ Issue Date08/17/04
Page 2 of 6
C. PERSONNEL REQUIREMENTS
The Personnel requirements are consistent with the Federal requirements outlined in CLIA-88.
1.Waived Testing
Testing Personnel: A minimum of a high school education is preferred. Documentation of successful completion of the training program for every test that the employee will perform is required.
POCT. Technical Consultant: A POCT representative who has a minimum of a 2 years science degree and 2 years testing experience with waived tests.
2. Provider Performed Microscopy
Testing Personnel: Physicians, mid-level practitioners (such as a nurse practitioner, nurse midwife, or physician assistant),. Documentation of successful completion of the training program for every test that the employee will perform is required.
Technical Consultant: A POC representative who has a minimum of a 4 year science degree and 2 years testing experience with moderate complex tests.
2. QUALITY ASSURANCE MONITORS
A quality assurance monitor is an activity that is systematically observed as an indicator that the process is functioning within defined limits.
The quality assurance monitors that LCHD/CHC Clinics POCT program uses on an organization wide basis are described below. They are adapted from the 10 basic QA areas '493.1703 - '493.1721 of the Federal Register for the CLIA-88 regulations. Some of the QA monitors will reflect the unique needs of a particular unit or clinic.
A. '493.1703: Patient Test Management: Required of all tests under JCAHO guidelines. A system must be in place that assures integrity and identification of patient specimens during the testing process and accurate reporting of test results.
<div align="left">Responsible</div> / <div align="center">Test</div> / <div align="center">Frequency</div><div align="left">Clinic</div> / <div align="left">Refer to individual test procedures to insure proper specimen collection, test performance, results reporting and recording, and quality control performance.</div> / <div align="left">Ongoing</div>
<div align="left">Clinical Lab</div> / <div align="left">Written Procedures containing proper specimen collection, test procedure, results reporting and recording, and quality control performance information. </div> / Ongoing<div align="left"</div>
B '493.1705: Routine Quality Control : required of all tests under JCAHO guidelines. To ensure accurate and reliable patient results through written quality control procedures that monitor and evaluate the analytic testing process of each method.
TitlePOINT OF CARE TESTING (POCT) / SOP Number
I H 6
/ Issue Date
08/17/04
Page 3 of 6
<div align="left">Responsible</div> / <div align="center">Test</div> / <div align="center">Frequency</div>
<div align="left">Clinic</div> / <div align="left">
1. Perform QC as defined by test procedure.
2. Document QC or instrument failures and Action Taken to resolve the problem.
3. Record daily temperatures when indicated in the test procedure.
4. Use reagents appropriately, date reagents when opened, etc.
5. Keep all QC documents for 2 years.
6. Keep all instrument maintenance documents for the life of the instrument.
</div> / <div align="left">Ongoing</div>
C. '493.1713; Personnel Assessment: required of all tests under HCFA regulations and JCAHO guidelines. An ongoing assessment mechanism to assure employee competence in performance of patient testing.
<div align="left">Responsible</div> / <div align="center">Item</div> / <div align="center">Frequency</div>Clinical Lab or Designee / Document that every employee performing a POC Test has received appropriate training. / Initial Training
Clinical Lab or Designee / Document competency assessment of every employee with every POC Test that she/he performs. / Annually
Annual Competency can be demonstrated through review of test procedure and one of the following:
1. Successful performance of a proficiency test
2. Routine performance of quality control tests
3. Observed performance of a patient test by a qualified operator
4. Successful completion of a written test.
5. All providers are deemed competent to perform POC Testing. Competency is considered commensurate with their basic medical education.
D. '493.1707; Proficiency Testing Assessment: required of all moderate complex tests under HCFA regulations and JCAHO guidelines. Areas performing certain critical waived tests will also be required to participate in proficiency testing assessments. Proficiency test requirements will be determined annually by the Point-of-Care-Testing Coordinator and communicated to the Clinical Areas/Clinics. Proficiency Testing (PT) provides a method to externally evaluate the quality of a laboratory's performance. A PT program consists of unknown samples for each test procedure, three times per year.
POINT OF CARE TESTING (POCT) / SOP Number
I H 6
/ Issue Date08/17/04
Page 4of 6
<div align="left">Responsible</div> / <div align="center">Item</div> / <div align="center">Frequency</div>
Clinical Lab / Will manage and distribute the proficiency tests when they are received to the appropriate Clinical Area/Clinic. / 3 times a year
Clinic / All personnel performing proficiency testing will perform them in a manner as consistent with patient testing as possible. / 3 times a year
Clinical Lab / Will review all graded results and contact the Clinical Area/Clinic if results are unacceptable. / 3 times a year
Clinical Lab &Clinic / Remedial action will be initiated, documented and results of the remedial action will be noted with the proficiency report. / As needed
E. '493.1721 QA Records: required of all tests under JCAHO guidelines. A system exists for documentation of all activities, including problems and corrective actions, and is available for review. All records must be kept for a minimum of two years.
<div align="left">Responsible</div> / <div align="center">Item</div> / <div align="center">Frequency</div>Clinical Lab / Update the Clinical Area/Clinics on compliance issues with POC Testing, clinic policies, or new test procedures. / Ongoing
Clinics / Will implement and maintain compliance with POC Testing, clinic policy, or new test procedures. / Ongoing
Clinical Lab / When a problem or non-compliance issue is identified, the Clinic Manager will be contacted with problem and corrective action plan. / As Identified
Clinic Manager / The Clinic Manager will contact the Clinical Lab and initiate the corrective action plan. / Within 2 weeks
Clinical Lab / If no response has been received, the Medical Director will be contacted. / Three weeks after first e-mail.
F. '493.1717 Complaints: required of all tests under JCAHO guidelines. To assure that there is a system to document all reported complaints and problems; that investigations are made and, when appropriate, corrective action is taken.
TitlePOINT OF CARE TESTING (POCT) / SOP Number
I H 6
/ Issue Date08/07/04
Page 5 of 6
Responsible / <div align="center">Item</div> / <div align="center">Frequency</div>
Clinics / Inform Clinical Lab of any problems or concerns with any instrument or test / Ongoing
Clinical Lab / Clinical Lab Coordinator will maintain a POC Test Action Logbook of POC Test problems, investigation, and correction action. / Ongoing
G. '493.1709; Test Comparison: required of all tests under HCFA regulations and JCAHO guidelines; where multiple testing sites and/or instrumentation is used. To assure that different test sites and instrument methodologies give consistent patient results within the institution. The comparisons will be accomplished by split sample analysis. The Clinical Lab will coordinate comparison testing activity and Clinic staff will perform the tests. All comparison testing records will be maintained by the clinical lab.
<div align="center">Whole Blood Glucose</div> / <div align="center">±15%</div> / <div align="center">10</div> / <div align="center">2 times/hr</div>
<div align="center">Hemoglobin</div> / <div align="center">±7%</div> / <div align="center">10</div> / <div align="center">2 times/yr</div>
*Performance limits based on CLIA-88 guidelines.
3. CONSULTING SERVICES
Services offered through the Clinical Lab in order to streamline paperwork, aide in compliance, and assure ongoing commitment to improvement and communication.
Clinical Lab / Written Test Procedures and Updates / As Needed
Clinical Lab or Designee / Provide Training Documents and Conduct Training Sessions / As Requested
Clinical Lab / Provide Competency Assessment Tools / As Requested
Clinical Lab / Instrument Investigation and Cost Analysis / As Requested
Clinical Lab / Assist with Certification Change / As Requested
Clinical Lab / Work with Clinical Areas/Clinics to improve processes and assure continuing improvement of patient care. / Ongoing
Title
POINT OF CARE TESTING (POCT) / SOP Number
I H 6
/ Issue Date08/17/04
Page 6 of 6
WAIVED TESTING REQUIREMENTS
TEST / CLINICAL USE / COMPETENCY / QUALITY CONTROLWHOLE BLOOD GLUCOSE BY GLUCOMETER ELITE / DIAGNOSTIC / ANNUALLY / LOW AND HIGH LEVEL CONTROL RUN ON EACH DAY PATIENT TESTING IS PERFORMED
URINE PREGNANCY TEST / DIAGNOSTIC / ANNUALLY / INTERNAL WITH EACH PATIENT NEGATIVE AND POSITIVE CONTROLS WITH EACH NEW LOT NUMBER
STOOL FOR OCCULT BLOOD BY HEMOCCULT / SCREENING / ANNUALLY / INTERNAL WITH EACH PATIENT
HEMOGLOBIN BY HEMOCUE / SCREENING / ANNUALLY / LOW AND HIGH LEVEL CONTROL RUN ON EACH DAY PATIENT TESTING IS PERFORMED
URINE DIPSTICK BY MULTISTIX 10SG, URISTIX, URISTIX 4, KETO-DIASTIX / DIAGNOSTIC / ANNUALLY / NORMAL AND ABNORMAL CONTROLS RUN ON EACH BOTTLE WHEN FIRST OPENED
pH BY NITRAZINE PAPER / DIAGNOSTIC / ANNUALLY / 2 LEVELS OF VERIFIER FOR EACH BATCH.
WET MOUNT FOR TRICHOMONAS AND CANDIDA / DIAGNOSTIC / ANNUALLY / N/A
FERN TEST / DIAGNOSTIC / ANNUALLY / N/A
REFERENCES
Comprehensive Accreditation Manual for Pathology and Clinical Laboratory Services, JCAHO, 2003
Oregon Health and Science University Point of Care Policy, 2002
Signature ______Date ______
Zita Yorro, M.D.
Clinical Laboratory Director
Signature______Date ______
Aureo P. Roxas, MT, (ASCP)
Clinical Laboratory Coordinator
Signature ______Date ______
Harry Ginsberg, M.D.
Medical Director
Signature ______Date ______
Irene Pierce, RN, MSN
Director, Primary Care Services
Original 1/02
Reviewed/Revised: 2/04, 2/04, 08/04