Presentation on theme: "Loyola Medical Laboratories Laboratory Waived Testing Program"— Presentation transcript:
1 Loyola Medical Laboratories Laboratory Waived Testing Program This slide presentation includes an overview of:Loyola Medical Lab’s Waived Testing ProgramFederal Laboratory RegulationsGood Laboratory PracticesGeneral Quality Assurance Requirements for all TestsTo advance slide, click anywhere on blank area of screen.
2 Loyola Medical Laboratories Laboratory Waived Testing Program This slide presentation is provided to you as an educational service by Loyola Medical Laboratories. This presentation should not be used or copied without the express permission of Loyola Medical Laboratories.To advance slide, click anywhere on blank area of screen.
3 Loyola Medical Laboratories Laboratory Waived Testing If you have access to speakers, please turn them on; they will enhance the presentation. If not, the presentation will not be affected.To open presentation to full screen, click on the middle button in the upper most right corner of the screen.To advance slide, click anywhere on blank area of screen.To end show, close the box by clicking on the X in the upper right corner of the box.
4 Loyola Medical Laboratories Laboratory Waived Testing Program As a service to it’s clients, Loyola Medical Laboratories provides technical assistance in the form of a Laboratory Waived Testing Program created and supported by the section of Outreach Services.The Laboratory Waived Testing Program was created to establish standards for all waived testing performed at LUHS in an effort to ensure quality patient testing and compliance with federal laboratory laws.
5 Loyola Medical Laboratories Laboratory Waived Testing Program The Outreach Services Section of the Clinical Laboratory is always looking for better ways to help our clients. We are always willing to answer any questions or help with any problems regarding waived testing here at LUMC.
6 Loyola Medical Laboratories Laboratory Waived Testing Program The Outreach Services Section of the Clinical Laboratory does the following to ensure quality patient testing and regulatory compliance here at LUHS:Coordinates the Point-of-Care Testing Committee. This committeehas the responsibility of regulating all Point-of-Care laboratorytesting here at LUHS and it’s outpatient and satellite facilities. Anyarea which would like to perform new testing must submit anapplication to this committee for review.
7 Loyola Medical Laboratories Laboratory Waived Testing Program Created and supports a Procedure Manual for LaboratoryWaived Testing which is provided to all areas performingwaived testing.Reviews new test methodologies and instruments for use atLUHS. Performs all necessary testing required by law priorto the implementation of any new test to ensure accuracy.
8 Loyola Medical Laboratories Laboratory Waived Testing Program Provides instruction and technical assistance for performingwaived tests here at LUHS through classes, training checklistsand slide presentations.Provides information and assistance with federal laboratorylaws and JCAHO compliance.
9 Where to get Technical Help The Laboratory Procedure Manual - Waived TestsFor any information about waived testing proceduresperformed in your area, you should consult the“Laboratory Procedure Manual- Waived Tests”.This is a large, royal blue binder givento all sites who perform waived testingunder the laboratory’s license.
10 Where to get Technical Help The Laboratory Procedure Manual for Waived TestingThe Waived Testing Procedure manual contains:Written procedures for each testJCAHO regulationsRequired quality assurance for all testsTraining checklists for all testsSample competency logs for maintaining annual competencyHelpful articles about CLIA and JCAHO regulationsMaster quality control logs for all testsTroubleshooting helpSupply and ordering information
11 Understanding Federal Laboratory Regulations While federal laboratory regulations may not be as excitingas a fireworks display,it is important to understand what is required of you to comply with federal laws and JCAHO standards. This slide presentation will try to give you an overview of what the federal laboratory laws require and why they are necessary.
12 Clinical Laboratory Improvement Amendments of 1988 Understanding Federal Laboratory RegulationsAll laboratory testing is governed by a federal law called CLIA.ClinicalLaboratoryImprovementAmendmentsof 1988These laws are administered by HCFA (the Health Care Financing Agency) which is the federal agency that oversees Medicare regulations and funding.Any area that performs laboratory testing for clinical use must abide by federal CLIA laws or risk removal of Medicare funding to the facility.
13 Understanding Federal Laboratory Regulations CLIA was:- enacted in 1988 to standardize and enforce good laboratory practices- created to ensure that patient test results were reported accuratelyCLIA goals are accomplished by:- establishing basic standards of quality assurance- requiring personnel training and competency- requiring patient test result documentation and record retention- requiring the performance of quality control for all tests- requiring two year inspections for all areas performing testing
14 Understanding Federal Laboratory Regulations CLIA regulates all areas that perform testing for clinical use. Areas such as clinical laboratories, satellite facilities, nursing units, mobile health units, and even free testing in shopping malls are all covered under CLIA laws and all must abide by the established regulations.When establishing regulatory requirements for laboratory testing, HFCA recognized that all laboratory tests are not equal. Some are very simple to perform and some are more difficult and need special training. To accommodate this, HCFA had the CDC classify all tests that were on the market and all new tests into categories based on their complexity.
15 Categories of laboratory testing under CLIA These complexity categories were determined using these criteria:Risk of erroneous result on patient healthDegree of knowledge needed to perform the testTraining and experience requiredComplexity of reagent and material preparationComplexity and number of operational steps to perform the testCalibration requirementsTroubleshooting and maintenance requirementsDegree of interpretation and judgment required to report resultsAvailability of proficiency testing materials
16 Purchasing a CLIA certificate (license) In addition to following CLIA regulations, any area that performs laboratory testing must purchase or be covered under a certificate (license) to perform testing. One certificate can be purchased to cover multiple areas at one address. Areas with different street addresses must purchase separate certificates.To purchase a certificate, an application must be completedand sent to the IDPH (Illinois Dept. of Public Health) who administers HCFA’s CLIA laws here in Illinois.
17 Purchasing a CLIA certificate (license) One of four types of certificates must be purchased to comply with CLIA regulations. An area performing testing must purchase a certificate that covers the highest complexity level of test that they perform. For example, if 10 waived tests are performed and one moderate complexity test, a moderate certificate must be purchased. Only the highest level of certificate must be purchased. For example, the moderate level certificate will cover moderate complexity tests and all waived tests. These certificates are offered by test complexity level and include the following:
18 Waived Testing Certificate This category contains tests that are simple and don’t require a high degree of educational background to perform. Waived tests include such instruments and/or tests as glucometers, urinalysis strips, some Strep A tests, pregnancy tests, hemoglobin testing, etc. This category is called “waived” because many regulations have been “waived” or deemed not necessary since the tests in this category are considered simple. Even though waived tests are simple to perform they still require basic quality assurance such as training, annual competency, quality control, etc.
19 Moderate Complexity Certificate This category contains tests that require more educational skills, more complicated steps or can cause a greater degree of harm to a patient if performed incorrectly. This complexity level has more stringent regulatory requirements than waived.
20 High Complexity Certificate This category contains tests that are generally performed only in large hospital or reference laboratories by degreed Clinical Lab Scientists or technicians. This level has the most stringent regulatory requirements.
21 PPM CertificateIn addition to these complexity categories, there is an additional sub-category called PPM or Provider Performed Microscopy. This category is considered a part of the moderate complexity category but is accorded special considerations by CLIA. This category contains a small group of tests that are performed as part of a physical exam by physicians, dentists, nurse midwives, physician assistants or nurse practitioners.
22 PPM CertificateThe tests under this category are not subject to a routine two year inspection but basic quality assurance such as training, quality control, competency, proficiency testing, etc. are still required. This license can only be purchased if testing is performed by the above personnel and only for a small group of tests. This certificate will also cover all waived tests since it is considered a sub-category of a moderate complexity certificate.
23 Tests included in the PPM category Fern testingQualitative (not quantitative) sperm analysisKOH prepsPinworm examsUrine sediment examinationsNasal smears for granulocytes.Direct wet mounts for presence of bacteria, fungi, parasites &human cellular elements.Fecal leukocyte examsPost coital direct, qualitative exams of vaginal or cervical mucousTesting under this license is allowed ONLY if performed by the specified personnel. If staff nurses or technologists perform testing, a moderate complexity license must be purchased and two year inspections are required.
24 Understanding Federal Laboratory Regulations When CLIA was enacted, the federal government realized that they did not have the resources to perform an inspection every two years for all areas performing laboratory testing.To remedy this, they allowed organizations to be “deemed” by HCFA to inspect facilities and report the results back to the agency.Many organizations that were already performing inspections applied to HCFA for deemed status. In order to inspect under the CLIA ‘88 laws, each organization had to submit their inspection standards for review. By proving that their standards were equal to or more stringent than the current CLIA ‘88 regulations, each organization was then allowed to conduct inspections under the CLIA laws.
25 Understanding Federal Laboratory Regulations When a CLIA license is purchased, the facility is allowed to choose which organization will perform their two year lab inspection.Two large organizations that were granted deemed status are:- JCAHO (Joint Commission on Accreditation of HealthcareOrganizations) and- CAP (College of American Pathologists)Both of these organizations have been conducting inspections of hospitals and laboratories for many years and have established their own regulations and requirements.
26 Understanding Federal Laboratory Regulations At the Loyola Medical Center, the laboratory holds all CLIA licenses for waived testing and is responsible for establishing programs that facilitate compliance with CLIA laws.Loyola Medical Labs holds a Waived Testing certificate for the hospital and outpatient facilities and has selected JCAHO to perform our inspection of waived tests.Our Moderate and High Complexity Testing is inspected by CAP (College of American Pathologists) in all areas.
27 Understanding Federal Laboratory Regulations When a facility chooses an organization that will perform their laboratory inspections, they must abide by the standards or regulations that are established by that organization. For example, LUHS has chosen JCAHO to inspect our waived testing program. Therefore, we must abide by all standards that JCAHO has established to regulate this category of testing.
28 Good Laboratory Practices Under CLIA, all categories of testing must meet basic good laboratory practices in regards to quality assurance and safety. In addition, if inspected by an outside agency (JCAHO, CAP), a lab or area must adhere to any additional standards established for each category by the inspecting agency. Some of these CLIA and JCAHO requirements involve:Patient test management - a system must exist for reporting,documenting, and retaining patient results for legal reasons.Quality control. A written quality control program must exist andbe enforced and quality control records must be retained for 2 years.
29 Good Laboratory Practices Quality assurance - must have a written QA program.Procedures - must have written procedures for how to performthe tests and procedures must be reviewed annually.Personnel requirements - must meet CLIA establishededucational requirements and must have an established trainingand competency program. Documentation of training must bemaintained indefinitely.Use of testing - the organization must define how tests are used(either as a screening/monitoring or diagnostic test).
30 Good Laboratory Practices Proficiency testing. At this time this applies only to moderateand high complexity testing. Each area must enroll in a programin which “blind” samples are tested for accuracy. The results arereported to HCFA and maintaining licensure depends onsuccessful performance.Calibration and calibration verification of instruments - formoderate and high complexity testing only.
31 General Quality Assurance Requirements for All Tests These are general QA standards that should be followed for alllaboratory waived tests:Quality control procedures should always be performed accordingto the written procedure. Quality controls MUST be performedBEFORE testing patient samples (only exception are occult bloodcards where quality control is performed after the patient test).Patient testing must never be performed using kits or reagents thathave failed quality control procedures.All waived tests should be performed correctly according to writteninstructions.
32 General Quality Assurance Requirements for All Tests Staff performing testing must have documented training priorto reporting all patient results.Refrigerators or freezers where supplies are kept should bemonitored on a daily basis and a written record maintained forJCAHO (thermometers should be NIST traceable and be able toreport the minimum and maximum temperatures reached sincethe last reading was taken).Whenever a new box, bottle, or kit is opened, the date openedand the date it expires should be written on the box or bottle.Reminder: once a control is opened, the expiration date is NOT thedate stamped on the bottle. Often, a 30 or 60 day expiration dateapplies after opening.
33 General Quality Assurance Requirements for All Tests Test kits and controls should be stored according to manufacturer’sinstructions.NEVER use expired kits or controls to perform testing. Usingexpired kits can result in inaccurate patient test results beingreported. If the expiration date was not written on the item, or afoil pack (example: pregnancy) was left opened and unused, usethe old adage:WHEN IN DOUBT, THROW IT OUT! Otherwise,you may be wasting valuable time trying to make controls performor worse, you may report an inaccurate patient result.Always properly identify patients prior to collection of blood orother body fluids for testing.
34 General Quality Assurance Requirements for All Tests Always label blood tubes, urine specimens, throat cultures, etc.Never assume you will label them later; this can lead tounnecessary recollections and/or results reported on the wrongpatient!When performing waived testing, always label any test device,cassette, Hemoccult card, etc. into which a patient specimen isintroduced to test. If you leave an unlabeled test on the counterand someone else does too, you may not know which is which!Always document results of laboratory waived tests in thepatient’s medical record using established protocol for your area.This is required by federal law!
35 General Quality Assurance Requirements for All Tests Always perform any maintenance such as cleaning that isrequired on instruments prior to performing patient testing andwhen required. A result is only as good as the instrument it isperformed on!Use any and all information that is available to you - theLaboratory Procedure Manual - Waived Tests and anyinformational charts, posters, etc. These are provided to helpyou.
36 Waived Testing and Regulations Review Questions True or False answersTo see the answer, mouse click under the question.1. It’s ok to use kits past their expiration date if it’s just a day or two.False - kits should not be used past their expiration date.2. When a control is opened, it always expires on the date that isstamped on the bottle.False - often, when a bottle is opened the expiration date changes to30 or 60 days past the opening date.
37 Waived Testing and Regulations Review Questions True or False answersTo see the answer, mouse click under the question.3. All tubes of blood, test devices, aliquot specimens, etc. should belabeled with the patient’s medical record number and/or name.True - not labeling tubes, specimens, or test devices can lead to patient recalls or worse, the wrong result reported on a patient.4. You don’t need a certificate (license) to perform only waived tests.False - a waived testing certificate is required to perform waivedtesting.
38 Waived Testing and Regulations Review Questions True or False answersTo see the answer, mouse click under the question.5. Quality controls need only be tested when you think a patient’s testresult is incorrect.False - quality controls (2 levels or positive and negative) must be performed at least once every 24 hours that patient testing is performed.6. Training does not have to be documented - just performed.False - all training and competency must be documented for JCAHO.
39 Waived Testing and Regulations Review Questions True or False answersTo see the answer, mouse click under the question.7. Annual competency is required for all staff performing laboratorytesting.True - competency is a tool to review correct procedures and toensure that testing is being performed accurately.8. Waived testing here at LUMC is inspected by JCAHO.True
40 Waived Testing and Regulations Review Questions True or False answersTo see the answer, mouse click under the question.9. Medical technologists and staff nurses are allowed to perform PPMtests under a PPM certificate.False - only special personnel such as physicians, dentists, nurse practitioners, physician assistants and nurse midwives are allowed to perform testing under a PPM certificate. If medical technologists or staff nurses perform PPM tests, the area must purchase a moderately complex certificate.
41 Waived Testing and Regulations Review Questions True or False answersTo see the answer, mouse click under the question.9. Quality control should be performed and compared againstacceptable ranges before performing patient tests.True - quality control MUST be performed and be acceptable beforeperforming ANY patient tests!10. Competency must be performed annually for all waived tests.True - JCAHO requires competency to be performed & documented.
42 This concludes this presentation on Waived Testing and Regulations Please refer any questions or problems to:Geri Augustine BS MT(ASCP) CLS(NCA)Technical Specialist - Near Patient Testing.Loyola Medical LaboratoriesLoyola University Medical Center(708) or x68044To end show, close the box with the X in the upper right hand corner.