Description: | Competency: | New Employees | Reviews: | Surveys: | Quality Control: | CLIA Certificates: | POCT Supplies: | POCT Procedure | Record Retention: | POCT Sites | References:
United Clinical Laboratories (UCL) will evaluate and prepare procedures for POCT (Point of Care Testing) as directed by the UCL Technical Director. The patient care, treatment and services context, in which these tests are used, is defined in the individual procedure and are reviewed by the Director of Record. That review is documented by their signature at the end of this policy for the procedures relevant to their facility. UCL will also prepare an in-service test to be used in staff training on new testing. UCL will in-service a core group of trainers at POCT sites. These trainers are responsible for training the rest of the POCT site staff, documentation of training and retention of training records.
Tests currently performed under the direction/consulting of UCL are: Urinalysis Chemical Screen, Precision PXP and Xtra Glucose, Gastroccult, pH Testing, Bilichek (Bilirubin), Gem Premier 3000 (Blood Gases, Na, K, Hct, iCa, Glucose), Hepcon HMS Plus (ACT/HDR/HPT), PCL ACT, Genzyme Strep A, QuickVue Urine hCG, HemoCue Hb, Coagucheck (INR), Alere INRatio 2 (INR), Cholestech (Chol/Trig/HDL/Glu), Metrika HbA1c, DCA HbA1c, Clinitek Status UA, Fern Testing, Hemoccult, QuickVue Influenza A/B.
1. Staff are authorized to perform testing according to the Certification Section listed in each POCT procedure. Staff identify themselves for tests that they have run by initialing the test log, or results entry in the patient chart.
2. Annual competency tests are prepared in October in conjunction with the UCL Annual Competency Program. These tests are distributed to the POCT sites. The POCT sites are responsible for making sure all staff performing POCT complete the competency testing. They are also responsible for the review and retention of documentation for competency testing.
MHC: Annual competency is recorded in Healthstream.
Finley: Annual competency is recorded in Net Learning.
3. Physician-performed waived testing that does not require an instrument doesn’t require documentation of competency when the test is a logical part of the physician’s practice and the hospital (clinic) has specifically privileged him or her for that test.
1. POCT sites are responsible for training new employees on POCT procedures to be performed. Documentation, review and record retention are the responsibility of the POCT site.
MHC: Training is recorded in Healthstream.
Finley: Training is recorded in Net Learning.
2. Precision PXP meter: New employees will run 5 - 10 normal control samples. A Precision PXP form is completed and sent to UCL Technical Director for review. The results are reviewed to determine if acceptable performance was achieved. If acceptable, the operator number is entered into the Precision PXP QC Manager program. At that time the operator will be able to use their password to operate the PXP meters. The form will be returned to the appropriate site indicating if performance was acceptable or not.
3. All other POCT tests: Nurse educators that have been previously trained on POCT tests will train new employees on tests to be performed. New employees will read the written procedure and complete the appropriate self-instructional competency test. New employees will perform test and the Nurse educator will sign as witness.
1. Monthly Review:
MMC Nursing Service:
Emergency Dept: Strep A, QuickVue Urine hCG
Ambulatory: QuickVue Urine hCG
2. Quarterly Review:
Logs, procedure manuals and supplies are checked:
A. MMC Dyersville
B. MMC Perfusion Services
C. Cascade Immediate Care
D. Finley Occupational Health
E. MMC Family Pharmacy – Elm St.
F. MMC Family Pharmacy – Cascade
G. MMC/Hillcrest Maternal Health
H. Tri-State Surgery
I. Finley Diabetes Center
J. Finley Nursing Service
K. MMC Nursing Service
L. MMC Respiratory Care
M. Clayton Co. VNA
N. MMC Cardiac Cath Lab
3. PXP QC: Quality Control data is uploaded to the QC Manager software and server located at UCL Cathedral Square every time a meter is docked on the network. The data is reviewed on an ongoing basis. Reports are distributed to the testing site periodically.
4. Gem Premier QC: Quality Control is reviewed for each cartridge by the UCL Technical Director. QC results are transferred to a flash drive when the cartridge is finished. The flash drive is sent to the UCL Office of the Technical Director.
5. PXP operator list. The PXP operator list is reviewed and updated as necessary.
Surveys are performed three times a year on:
1. PXP glucose meters at MMC and Finley.
2. ACT testing at MMC Cardiac Cath Lab and Surgery.
3. Gem Premier 3000 at MMC Surgery.
1. Quality Control is performed as listed in individual test procedures.
2. HemoCue Hb: A city control sample is sent to Bellevue & Galena Medical Associates Satellite Offices. The city control sample is run on the HemoCue Hemoglobin analyzer. The result is called to the Instrument Specialist Office and recorded on the daily city control sheet.
3. Semiannual Method Validation includes POCT testing. Refer to “Intersite Analytical Method Parallel (JCAHO Method Validation)”.
Each POCT testing site will maintain its own CLIA certificate. Electronic copies of CLIA certificates for POCT are posted for reviewing on the UCL CLTM web site
1. Supplies obtained through hospital site lab:
A. UA reagent strips, Gastroccult slides and developer, pH paper.
B. Supplies sent are recorded on the POCT Supplies log. Once a month this form is sent to Accounting so supplies can be billed to the POCT site.
2. Supplies obtained from UCL Materials Management: Strep A, Urine hCG, HemoCue Hb control (standing order), Gem Premier 3000 cartridges and controls, Influenza A/B.
3. Supplies obtained from Hospital Purchasing Departments:
A. Departments obtain Precision PXP reagent strips and controls from hospital purchasing department. The purchasing department obtains these supplies from UCL Materials Management.
B. Hepcon HMS Plus cartridges and controls are obtained through MMC Purchasing.
C. At MMC, the Ambulatory and Emergency Departments obtain Strep A and QuickVue hCG kits from the hospital Purchasing Department. The Purchasing Department obtains these supplies from UCL Materials Management.
D. MMC and Finley obtain Hemoccult supplies from the hospital purchasing department.
4. Supplies ordered directly from manufacturer/distributor:
A. Mercy Family Pharmacy orders Coagucheck and Cholestech supplies directly from distributor.
B. Finley Occupational Health orders HemoCue Hb and Cholestech supplies directly from the distributor.
C. Clayton Co. VNA orders HemoCue Hb supplies directly from a distributor.
E. MMC Respiratory Care orders HemoCue Hb supplies through MMC Purchasing.
F. Crescent Community Health Center orders Cholestech and DCA HbA1c supplies directly from the distributor.
G. Finley HomCare orders Alere INRatio 2 supplies directly from the distributor.
POCT procedures must be approved by the director named on the CLIA certificate, or a qualified designee, before use and then once every 3 years. Refer to “POCT Procedure Review” section of the Quality Assurance Manual. The qualified designee for UCL is the Technical Director.
Survey results, temperature logs and patient/QC results logs must be retained for 2 years. All records are stored at the testing site.
Refer to the PA/UCL web page for current version.
1. Steve Raymond; Technical Director/CIO. Pathology Associates. Dubuque, IA.
2. HR.3.10 in the Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing.
i. July 2007 S. Raymond, L. McGovern (Revised: II.3, XI.)
ii. August 2008 S. Raymond/L. McGovern (Revised: I.; XI.table added)
iii. May 2009 L. McGovern (Revised: I.; VIII.4.F.; PXP replaced PCx)
iv. April 2010 L. McGovern (Revised: I.; IV.; VIII.2.,3.A.,4.F.)
v. August 2011 L. McGovern (Revised: for crescent & finley homecare, updated test menu, review list & supply acquisition)
Representative: MMC-DBQ (Nursing Serv.)
Representative: MMC-DV (Nursing Serv.)
Representative: Finley Hosp. (Nursing Serv.)
Representative: Medical Associates Clinic
Representative: Finley Occupational Health
Representative: Mercy Family Pharm (Elm)
Representative: Mercy Family Pharm (Casc)
Representative: Tri-State Surgicenter
Representative: Cascade Immediate Care
Representative: Kehl Diabetes Ctr
Representative: Clayton Co VNA
Representative: Finley HomeCare
Representative: Crescent Com. Health