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Point of Care Testing BOPCC May 31, 2011 Beatrice OKeefe, Chief Laboratory Field Services California...
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Transcript of Point of Care Testing BOPCC May 31, 2011 Beatrice OKeefe, Chief Laboratory Field Services California...
![Page 1: Point of Care Testing BOPCC May 31, 2011 Beatrice OKeefe, Chief Laboratory Field Services California Department of Public Health.](https://reader035.fdocuments.us/reader035/viewer/2022070305/551487b5550346b0158b5b67/html5/thumbnails/1.jpg)
Point of Care TestingPoint of Care Testing
BOPCC May 31, 2011
Beatrice O’Keefe, Chief
Laboratory Field Services
California Department of Public Health
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ObjectivesObjectives
Describe “Direct patient Care” in California law
Describe Point of Care testing deviceIdentify the personnel authorized to perform
waived or point of care testingEnumerate requirements for the preceptor
training program
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Direct Patient Care Direct Patient Care
“Direct Patient Care” means medical, psychiatric, nursing or other health care which is legally provided by a care giver or healthcare provider directly to a patient, and which includes observation of the patient’s physical or mental condition to enable the care giver or healthcare provider to report changes in the patient’s condition, CCR 1029.7.
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Legally provided by a care giver or healthcare provider
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Direct patient Care cont.Direct patient Care cont.
Directly to a Patient
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Direct Patient Care cont.Direct Patient Care cont.
Includes observation of the patient’s physical or mental condition
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Includes observation of the patient’s physical or mental condition
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Direct Patient CareDirect Patient Care
To enable the care giver or healthcare provider to report changes in the patient’s condition,
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Point of Care Laboratory Point of Care Laboratory testing device (CBPC testing device (CBPC
1206)1206)
• Portable Instrument• Used within the proximity of the patient • Used in accordance with the laboratory
patient test management system, the quality control program, and the comprehensive quality assurance program
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Point of Care Testing DevicePoint of Care Testing Device
• Portable Instrument• Used within the proximity of the patient
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Point of Care Laboratory Point of Care Laboratory testing device Cont.testing device Cont.
• It meets the following criteria:• Waived or moderate complex tests• No preparation after collection• Results without calculation or discretionary
intervention• No calibration or maintenance required
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Point of Care Testing Device Point of Care Testing Device cont.cont.
Used in accordance with the laboratory patient test management system, the quality control program, and the comprehensive quality assurance program
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Laboratory RequirementsLaboratory Requirements
● State Certificate of Registration or license
Plus
● Federal CLIA Certificate of Waiver or
Certificate of Compliance or Accreditation
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Hospital Licensing of LabHospital Licensing of Lab
One license
-Contiguous buildings on hospital
campus
-Common direction
-Common ownership
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Waived Test RequirementWaived Test Requirement
Simple system– Cleared by FDA for home use– Simple-so erroneous results negligible– Pose no risk of harm if performed incorrectly
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Example of Waived TestsExample of Waived Tests
DrugsHormonesChemistriesBlood ChemistryBacteriaViruses
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Director Requirements-Director Requirements-Waived TestsWaived Tests
● Waived Testing
State-MD, CA Licensed Bioanalyst,
CA licensed PhD-Board Certified
Federal-No specification
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Testing Personnel Testing Personnel Comparison – Waived TestsComparison – Waived Tests
• California• Limited to personnel in BPC 1206.5 (a)
• CLIA • No specific educational requirement
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Waived Laboratory SupervisorWaived Laboratory Supervisor
CCR 1036.3 Requirements– Listed in B&P 1206.5– Minimum BS degree– One year training or experience in tests– Documented competency semiannual 1st year
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Waived Supervisor Waived Supervisor ResponsibilitiesResponsibilities
Select Test methodsEstablish QC program from initial receiptResolve technical problemsEnsure corrective actions takenIdentify training needs
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Waived Supervisor Waived Supervisor Responsibilities cont.Responsibilities cont.
Evaluate and Document Competency– Direct observation – Monitor recording and reporting of test results– Review QC records and preventive
maintenance– Observe performance of instrument – Assess problem solving skills– Document competency semiannual 1st yr.
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Testing Personnel Authorized Testing Personnel Authorized to Perform Waived Tests to Perform Waived Tests
CBPC 1206.5CBPC 1206.5
• Licensed Physician and Surgeon• Licensed Osteopath• Licensed Podiatrist• Licensed Dentist• Licensed B&P Chapter 3• Certified Public Health Microbiologists
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Testing Personnel Authorized Testing Personnel Authorized to Perform Waived Teststo Perform Waived Tests
• Licensed Physician Assistant• Registered Nurse• Licensed Vocational Nurse• Certified Perfusionist• Licensed Respiratory Care Practitioner• Certified Medical Assistant • Others, Providers of Direct Patient Care
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Quality ControlQuality ControlWaived Tests Waived Tests
FOLLOW THE MANUFACTURER’S INSTRUCTIONS
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Waived Tests-Most Frequent Waived Tests-Most Frequent DeficienciesDeficiencies
Follow the Manufacturer’s instructionsInstruction sheet not available to testing
personnel
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Director Requirements-Director Requirements-Moderate ComplexityModerate Complexity
● Moderate Complexity Testing
State-same as for waived testing
Federal-
Must be licensed by state, if required
MD, must have lab training or
1 yr. directing or supervising non-waived or
20 CE units
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Testing Personnel Testing Personnel Comparison- Moderate Comparison- Moderate
Complexity TestsComplexity Tests• California
• Limited to personnel in BPC 1206.5 (b)
• CLIA• Licensed according to state law• Doctor of medicine or osteopathy• Earned doctorate, master’s or baccalaureate in science• High school graduate and military specialty• High school graduate and training.
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Testing Personnel Authorized Testing Personnel Authorized to Perform Moderate to Perform Moderate
Complexity Tests CBPC 1206.5Complexity Tests CBPC 1206.5
• Licensed Physician and Surgeon• Licensed Osteopath• Licensed Podiatrist• Licensed Dentist• Licensed under Chapter 3• Certified Public Health Microbiologists
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Testing Personnel Authorized Testing Personnel Authorized to Perform Moderate to Perform Moderate
Complexity Tests (Cont.)Complexity Tests (Cont.)
• Licensed Physician Assistant• Registered Nurse• Certified Perfusionist• Licensed Respiratory Care
Practitioner
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Testing Personnel Authorized Testing Personnel Authorized to Perform Moderate to Perform Moderate
Complexity Tests (Cont.)Complexity Tests (Cont.)
• Licensed Nuclear Medicine Technologist
• Blood Gas Analyst• Any person within a Physician Office
Laboratory• Pharmacist when performing drug
therapy related laboratory tests.
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Testing Personnel Authorized Testing Personnel Authorized to Perform Moderate to Perform Moderate
Complexity Tests (Cont.)Complexity Tests (Cont.)• Specified providers of direct patient care using a
point of care testing device (CCR1054.7)• Certified EMT II• Paramedic• Psychiatric Technician• Licensed Vocational Nurse• Licensed Midwife • Certified Nurse Assistant • Certified Home Health Aide
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Preceptor Program TrainingPreceptor Program TrainingPoint of Care TestingPoint of Care Testing
Operation of each instrumentMaintenance and calibration Manufacturer’s instructionsReference ranges, critical values, actions for
values outside analytical range
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Preceptor Program cont.Preceptor Program cont.
Reference ranges, critical values, actions for values outside analytical range
Quality control and assurance protocols, including remedial action and reagent and specimen handling
Clinical significance of test results
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Preceptor Program cont.Preceptor Program cont.
Physiological conditions that may affect specimen integrity
Safety and Universal precautions Competency determined by director or technical
consultant
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Preceptor Program cont.Preceptor Program cont.
Participate in a preceptor program over 20 separate testing events covering the entire range of expected values with 90% correct
Proficiency requirement is for each separate instrument
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Preceptor QualificationsPreceptor Qualifications
Laboratory director or technical consultant as defined in CLIA or,
Meets qualifications as technical consultant under CLIA and state to perform tests as moderate complex or,
Any person listed in subsection (b) of 1206.5 except for (10) (11) and (12) with 2 yrs. experience with the specific instrument
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InformationInformation
CMS Web site: www.cms.hhs.gov/clia
State regs: www.leginfo.ca.gov/calaw.html
www.calregs.com
phone: (510) 620-3837
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Questions?Questions?