Nestor A.Guerrero,BSMT,RMT,CLS,MT(ASCP) Major (Ret), US Army Medical Service Corps

Nestor A.Guerrero,BSMT,RMT,CLS,MT(ASCP) Major (Ret), US Army Medical Service Corps Point of Care Technical Consultant Kaiser Permanente Medical Center Roseville,California,USA 3/31/2016 1

(POC) Non-Waived Testing Waived Testing PPMP Management Responsibility Personnel Qualifications Training and Competencies Physical Requirements for Testing Regulatory Requirements Benefits and Costs Developement of Procedures and Training Recommended Practices (Before,During & After Testing) 3/31/2016 2

Documents and Records Quality Assessment 3/31/2016 3

What is Point of Care Testing (POCT)? It is defined as a diagnostic testing at or near the site of patient care or bring the test or immediately to the patient. This increases the likelihood that the patient will receive the results in a timely manner thus reducing the turn around time (TAT). POCT is accomplished through the use of transportable and handheld instruments ( ex: glucometer, istat) and test kits ( pregnancy kits, urine dipstick, fecal & occult blood kit,hiv kits). Other POCT devices are smaller,smarter and cheaper have increased the use of these devices due to cost effectiveness. 3/31/2016 4

Tests for POCT: Primary Care / Outpatient Clinics HgbA1c, glucose, HIV, Pregnancy Tests,Urine chemstrip,hemaprompt Emergency Room Troponin, lactate, blood gases, lytes, BNP,Hct, CK, Fecal Occult blood, Hemaprompt Cath Lab- IR ( Interventional Radiology) Activated Clotting Time (ACT-Celite for CVOR) PT-INR Avoximeter ( THb, SO2) ICU, PICU, NICU,Anesthesia/OR Blood gases, glucose, Hct, lytes, ACT (for Anesth,ICU) Labor and Delivery Fern Testing Nitrazine test 3/31/2016 5

What is CLIA? In 1988, congress passed the Clinical Laboratory Improvement Amendments (CLIA) - this is to establish the quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. Clinical Laboratory Improvement Amendment 1988 (CLIA 88) Regulations apply to labs processing human material for medical purposes All labs must be CLIA-registered and certified All labs must comply with basic administrative and operational (technical) requirements 6

POCT is categorized as: CLIA88: Sec.493.5 Non-Waived Testing (high complexity testing) Waived Testing (moderate complexity) Provider Performed Microscopic Procedure (PPMP) 3/31/2016 7

Non-Waived Testing : For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification. The regulations require specific levels of education, experience or both. In general terms, High complexity testing requires an bachelor s degree or higher in a chemical, physical or biological science. Operational steps requires close monitoring or control, and more extensive independent interpretation and judgment are required Non-waived testing must participate in a proficiency testing. 3/31/2016 8

Non-Waived Testing (ISTAT1) 3/31/2016 9

Non-Waived Testing: 3/31/2016 10

Waived Testing (1 of 2) Moderate complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. It requires limited scientific and technical knowledge and training to perform accurately. Operational steps are either automatically executed or easily controlled and require limited interpretation and judgment is required. Under moderate complexity CLIA certificates, waived testing may also be performed. It is defined as a simple that there is a little risk of error. Erroneous results are possible and can produce untoward patient outcomes if acted upon. For waived testing, the federal regulations do not specify the education requirements and the organization may establish their own. The organization should maintain evidence that the testing personnel meet the education requirements established by their job description. As a best practice, the suggested minimum is a high school diploma as this is the minimum education required for moderate complexity testing (the next highest complexity level). 3/31/2016 11

Waived Testing (2 of 2) Laboratories that performs waived testing must meet the following requirements: Enroll in a accreditation program Follow manufacturers test instructions Examples of waived tests: Blood glucose monitoring Urine dipstick Fecal occult blood Hemoglobin A1c Ph determination by ph paper/strip Urine pregnancy 3/31/2016 12

Recommendations for conducting a Quality Waived testing: Continued monitoring of testing with a focus on personnel education and training for introducing waived testing Good laboratory practices for the three phases of testing 1. Before testing / Pre-Analytic ( test ordering & specimen collection) 2. During Testing/Analytic ( control testing, test performance, result interpretation and recording) 3. After testing/post analytic ( result reporting, documentation,confirmatory testing, and biohazard waste disposal) 3/31/2016 13

Waived Testing (Nova glucometer) 3/31/2016 14

Waived Testing (Hemaprompt) 3/31/2016 15

PPMP (1 of 4) Physician Provider Microscopy Procedure (PPMP) PPMP tests are performed using a microscope during the course of a patient visit on specimens that are not easily transportable. Who qualifies as testing personnel under a PPMP certificate? Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider. 3/31/2016 16

PPMP ( 2 of 4) PPMP tests includes (42 CFR Sec.493.19) Wetmounts KOH preparations Urinalysis and microscopic (dipstick/non-automated) Fecal leucocytes Nasal eosinophil count Semen analysis Fern testing Pinworm exams Qualitative semen analysis(limited to the presence or absence of sperm and detection of motility) 3/31/2016 17

PPMP ( 3 of 4) Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable. Procedures are test performed by a provider in his or her own practice during the patients visit on a labile specimen obtained from a patient in his or her own practice. Testing is done by bright-field or phasecontrast microscopy. A PPM site may also perform waived testing. 3/31/2016 18

PPMP ( 4 0f 4) For Provider Performed Microscopy Procedures (PPMP), annual competency assessment is required for all testing personnel, including physicians. When a physician performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the physician for that test. Through the medical staff credentialing process, individual physicians may be privileged for those specific waived tests appropriate to their scope of practice and no further assessment of skills or documentation of competence would be required. At the discretion of the Medical Director of Laboratory Services designated on the laboratory license certificate or organizational policy, more stringent competency requirements may be implemented. 3/31/2016 19

PPMP 3/31/2016 20

PPMP 3/31/2016 21

PPMP 3/31/2016 22

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Management Responsibility: Each testing site should identify at least one person responsible for testing oversight and decision making. The management staff should demonstrate a commitment to the quality of testing service by complying with applicable regulatory requirements and promoting good laboratory practices. 3/31/2016 24

Personnel Qualifications,Training & Competencies: 3/31/2016 25

Personnel Qualifications,Training & Competencies: Personnel: (1 of 3) POCT CLIA Laboratory Director, Clinical Consultant,Technical Consultant, Waived Laboratory Testing Supervisor and Testing Personnel must qualify under California laboratory personnel regulations. Note: Qualifications for certain categories of laboratory personnel is specific to testing location. Examples: a Laboratory Director of any laboratory, including waived laboratories, within an acute care hospital must be a board certified Pathologist. A medical assistant(ma) is authorized to perform waived tests only in a non-hospital setting. A EMT may perform moderate complexity POCT while providing prehospital care but not within the hospital. 3/31/2016 26

Personnel Qualifications,Training & Competencies: Personnel: ( 2 of 3) Testing Personnel, including physicians, are trained and documented for competency prior to performing patient testing. Frequency of competency assessment is consistent with Joint Commission Waived testing chapter, the College of American Pathologists, CLIA and California regulations as possible. 3/31/2016 27

Personnel Qualifications,Training & Competencies: Personnel: ( 3 of 3) The Technical Consultant (TC) and Waived Laboratory Supervisors (WLS) are responsible to evaluate and approve competency of site managers and testing personnel. Competent site manager(s)/testing personnel with one year experience in the applicable POC tests may assist the TC and/or WLS to administer competency assessment to testing personnel within his/her department. The competency of physicians and midlevel practitioners who perform nonperform instrument based waived test (fecal occult blood,urine dipstick) may be established through the credentialing process of the hospital s medical staff. 3/31/2016 28

Personnel Requirements for Waived and Moderate Complexity :Waived Test Testing Location California Qualification Director Acute Care Hospital Other Waive testing site Board of Certified Pathologist CA licensed MD or DO or person licensed as lab director Waived Lab Supervisor NA Waived sup with bachelors degree and 1 yr training or experience in waive tests that he/she is supervising Testing Personnel Acute Care hospital. MA and CAN do not qualify California licensed MD,DO,DPM,DDS CLS,MLT Licensed Physician assistant Certified Nurse Midwife Licensed Nurse Practioner CRNA,RN,LVN,perfusionists,RCP Pharmacist MA (in non-hospital setting) Registered Dietician ** ED / OB Technician ** Patient Care Technician ** CNA ** ( in non-hospital setting) Phlebotomists are not authorized to perform waived test ** Phlebotomy certification is required for blood collection. 3/31/2016 29

Personnel Requirements for Waived and Moderate Complexity : Moderate Complexity Test Testing Location Director Acute Care Hospital California Qualification Board of Certified Pathologist Other Waive testing site CA licensed MD or DO or person licensed as lab director Clinical Consultant NA Possess a CA lab director license or CA licensed MD/DO /DPM Technical Consultant NA CLS possess at least a bachelor s degree or MD/DO/DPM and 2 years of experience in moderate or high complexity testing Testing Personnel CA licensed MD,DO,DPM, DDS CLS, MLT with limitation Licensed Physician assistant Certified Nurse midwife Licensed Nurse Practitioner CRNA, RN Perfusionist Respiratory Care Practitioner Nuclear Medical Technologist Pharmacist 3/31/2016 30

Physical Requirements: Humidity Temperature Lighting Work Space 3/31/2016 31

Regulatory Requirements: Certification DOH and local regulations Safety requirements 3/31/2016 32

Benefits : Evaluate test Intended use Performance Patient population Need for supplemental test or patient follow up Test system 3/31/2016 33

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Costs: Test kits or instruments,supplies not provided with tests Equipment maintenance Safety and biohazard equipment Personal training, competency assessment and need for additional personnel Recordkeeping and information system Supplemental /confirmatory testing Regulatory compliance 3/31/2016 36

Development of Procedures and Training: Written Procedures Personnel Training Competency Assessment Specimen Labeling/ Identification 3/31/2016 37

Written Test Procedures: Use a template to facilitate writing a new procedure and promote ease of use when performing testing. List all materials needed Include instructions for patient preparation and specimen collection Steps in the procedure List time limitations Describe course of actions when the test does not perform as expected Integrate control procedures Include reference intervals and critical values Describe how to record and report results and how to handle critical reports 3/31/2016 38

Personnel Training: Trained and competent personnel are essential to good quality testing and patient care. Training checklists are helpful are helpful to ensure the training process is comprehensive and documented. Training process- training should be provided by a qualified person with knowledge of the test performance, good laboratory practices and able to evaluate the efficiency of training. Training resources- are available from various sources. 3/31/2016 39

Competency Forms (1 of 2) NAME: JOB TITLE: Dept: EEID# Check one box Six Months/New Employee Annual Other (Specify) NOTE: YES means competency is MET, NO means competency is NOT MET, NA means NOT APPLICABLE Method of Assessment i-stat 1 Other Other 1. Direct observation of routine patient test performance, including specimen handling, processing and testing. 2. Monitoring the recording and reporting of test results. 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. 4. Direct observation of performance of instrument maintenance and function checks. 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 6. Assessment of problem solving skills. YES NO YES NO YES NO YES NO YES NO YES NO Date: Date: Date: Date: Date: Date: YES NO YES NO YES NO YES NO YES NO YES NO Date: Date: Date: Date: Date: Date: YES NO YES NO YES NO YES NO YES NO YES NO No Remedial Action Required. MD/Supervisor: Date: Remedial Action Required: Date to be completed: MD/Supervisor: Follow-up/Verification Report: Date completed: MD/Supervisor: Date: Date: Date: Date: Date: Date: Lab Manager Review: Date: After review of training and competency records, I conclude that the above named employee is competent to perform test procedures promptly, accurately and proficiently, unless exceptions are noted above. Assessment Review Performed By: Date: To be completed by employee: I have read/review the procedures/section procedures manuals. I have reviewed this competency assessment. Employee s Signature: Date: 3/31/2016 40

Competency From (2 of 2) Name: Page 2 I. Direct Observation of Patient Testing Procedure Y N NA Critical Procedural Points i-stat1 Accurate specimen handling, collection and processing when applicable Maintains specimen integrity throughout process/procedure Adherence to and correct application of written procedures for elements of procedure(s) observed Accurate interpretation of test reactions and results Thoroughness and accuracy in documenting intermediate and final results Adherence to universal precautions, safety and infection control policies Thoroughness, accuracy, and adherence to procedures in performance and documentation of quality control when applicable Corrective action, documentation and resolution of aberrant results of patient and quality control procedures Appropriate disposal of used materials in appropriate containers Performance Report: Competency Met Competency NOT Met Observed by: Date: II Monitor the Reporting of Test Results: RILIS Reports (see attached) Indicate Result(s) Reviewed Y N NA Critical Procedural Points Accurate results reported upon review Notification of appropriate hospital personnel and physicians of significant results, followed by correct documentation Performance Report: Competency Met Competency NOT Met Observed by: Date: III. Review of Intermediate Test Results, Worksheets, Quality Control, Proficiency Tests, and Preventative Maintenance Records Indicate procedure, QC, or Proficiency test, accession # or QC level Intermediate worksheet results are in agreement with reported result (Y/N) QC results reported within acceptable ranges. Out of control results have been documented and reviewed (Y/N) Comments: (discrepancy noted, suggestions, correlation, followup) Performance Report: Competency Met Competency NOT Met Observed by: Date: IV. Direct Observation of Instrument Maintenance and Function Checks Procedure Y N NA General Criteria for Direct Observation of Instrument Maintenance and Function Checks i-stat1 Performs and documents daily maintenance, if applicable, as per SOP and/or operator s manual Performs and documents weekly maintenance, if applicable, as per SOP and/or operator s manual Properly performs reassembly of analyzer for readiness to perform analytical testing Performs performance/calibration checks, if applicable, as per SOP and/or operator s manual Properly operates and obtains valid results from the instrument as stated in SOP Performs scheduled preventive maintenance as stated in SOP and/or operator s manual Recognizes, troubleshoots and documents problems/corrective action with the instrument according to SOP and /or operator s manual Performance Report: Competency Met Competency NOT Met Observed by: Date: V. Assessment of Test Performance Acceptable results were obtained for the following procedures (check appropriate procedure & attach results) Previous analyzed specimen Post CAP submitted specimen Performance Report: Competency Met Competency NOT Met Observed by: Date: VI. Problem Solving Skills Assessment: Review of documentation on trouble-shooting actions were appropriate Acceptable performance on written, oral or electronic questionnaire (attach results) 3/31/2016 41

Training checklist KFH (Kaiser Foundation Hospital) TRAINING CHECKLIST Name: Date: Operator ID#: Department: Goal: To train a new operator in the use of the i-stat 1 system Evaluator Initials 1. Identifies components of the i-stat System 2. Demonstrates proper specimen collection 3. Handles the sample correctly 4. Fills and closes the cartridge correctly 5. Inserts and removes the cartridge correctly 6. Disposes of contaminated items 7. Explain all prompts and displays 8. Demonstrates access to stored patient results 9. Describes QC procedures for cartridge and analyzer 10. Demonstrates the proper documentation of QC results 11. Demonstrates transferring data to printer, Point-of-Care Central Workstation and/or patient record 12. Explains troubleshooting procedures and documentation 13. Identifies alternatives testing procedures 14. Describes the care of the System. 15. Reads/ Interviews the procedures 16. Knows & documents critical values. The operator has been trained and is competent in the use of the i-stat 1 System. Operator (Trainee) Evaluator: Date: Date: POC Coordinator: Date: 3/31/2016 42

Result Correction Form I-STAT 1 RESULTS CORRECTION FORM (pls. fax to 784-5716) Requestor Name/Title NUID Requestor Signature: Date/Time Department/Unit/Location: Phone Specimen: Draw Date: Time: Accession # ISTAT1 Cartridge/Type: ACT PTINR CG8 + Other CORRECTIVE ACTION REQUESTED: Delete and disregard all results on this specimen Correct the clerical error information on this test specimen as described in the table below. Other: REASON result/s need to be corrected: Specimen Problem: Sample clotted Sample contaminated with air bubbles Blood draw problem Other Test Results Problem: ISTAT error message: Cartridge problem: Clerical Error: Wrong patient ID Other Sample hemolyzed Sample contaminated w/ IV fluid Sample Handling problem Meter problem: Other: Wrong Comment Wrong Specimen Type Clerical Error Corrections Patient Name Patient MR# Patient Age Comment (temp, FIO2,etc) Specimen type Incorrect Information Correct Information Patient Name and MRN# verified by/date: Reviewed by:poc Coordinator /Designee /date: Reviewed by : POC ALAD / date: 3/31/2016 43

Recommended Practices Before Testing Preparations before performing the test are critical element in producing quality results. Paying attention to orders, properly identifying and preparing the patient, collecting a good quality specimen and setting up the test system and testing area contribute to a reliable test results. 3/31/2016 44

Recommended Practices During Testing: (1 of 3) This includes QC testing, test performance, result interpretation and recording. Types of controls Internal or built in controls evaluates whether certain aspects of the test system are working properly. External controls- mimic patient specimens and monitor the testing process, from specimen application to result interpretation, to assure proper test performance. 3/31/2016 45

Recommended Practices During Testing: (2 of 3) Frequency of control testing at a minimum, external controls should be tested with each new shipment of utilized devices, when testing a new lot number, and by each operator performing testing. Corrective Action If controls do not perform as expected, testing should not be performed or results reported until the problem is identified and corrected. Documentation Documentation and monitoring control testing results provides indication that the test was properly performed. Record of results should be periodically reviewed to detect shifts or changes in performance overtime. 3/31/2016 46

Recommended Practices Before Testing: (3 of 3) Recording Results Record results according t o your site s policy. Quantitative test results should be recorded using the units of measurement of the system. Qualitative test results should be recorded using interpretive words such as positive or negative instead of symbols like plus (+) or minus (-). If a test is not acceptable or requires repeat testing, note it as unacceptable, take steps to correct the problem and record correct result. Good laboratory practice include recording what happens, whether acceptable or not, and what is done to correct problems encountered during testing. 3/31/2016 47

Recommended Practices After Testing: Test Report-after completion of the test, results are documented and reported. Verbal reports of test results should be documented and followed by a written report. Results must be recorded in the patient chart/record or flowsheet. Critical /Alert values requires immediate notification to the physician. Procedure must be in place to ensure documentation of the critical values and timely notification of the proper medical personnel. Public Health reporting of results(ex: HIV) Biohazard waste disposal 3/31/2016 48

Documents and Records (1 of 3) Proper documentation is necessary for monitoring and assessing test performance,identifying and solving problems that could affect patient testing, retrieving and verifying information, and maintaining adequate patient and personnel records. The person responsible for testing oversight and decision-making should review records periodically and it is required to retain documents and records for a specific length of time. 3/31/2016 49

Documents and Records (2 of 3) Aspects of testing for which records or documentation are recommended include: Test orders Test procedures or work instructions Records of testing materials used, test system and equipment function checks and maintenance. Daily record of temperatures ( refrigerator, freezer, incubator and testing area ) Lot numbers,dates used, and expiration dates systems and reagents Date and time of equipment function checks and any maintenance performed 3/31/2016 50

Documents and Records (3 of 3) Test results including any confirmatory or supplemental testing QC results and corrective action taken if any if results are unacceptable Date and time of control testing Lot number and expiration date of external control Records of any test failures, troubleshooting or corrective action taken when problems are identified. Personnel training and competency assessment Records of Proficiency testing (PT) or other quality assessment 3/31/2016 51

Quality Assessment (1 of 2) Good laboratory practices can be expanded to include assessment activities to evaluate and improve the quality of site testing. Internal Assessment It offers flexible, low cost options for evaluating quality such as selfconducted inspections, supervisory review of documented problems that occur in the different phases of the testing process, review of QC documentation, and testing and reporting procedures. Test performance can be assessed, if specimens are suitable by exchanging specimens with another testing facility using thesame testing method and comparing results. Result from these assessment should be documented and evaluated noting any irregularities and actions taken to resolve problems or improve processes and procedures. 3/31/2016 52

Quality Assessment (2 of 2) External Assessment Voluntary inspections by peers or consultants can offer additional educational opportunities and feedback on current practices along with ideas for quality improvement. It also evaluate the testing practices and documentation systems, and a more narrowly focused assessment of test performance can be accomplished by participating in performance evaluation or subscribing to PT (proficiency test) programs. 3/31/2016 53

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Conclusion: Continued surveillance and monitoring is needed to determine the effectiveness of the recommendation on protecting and improving the public s health. 3/31/2016 56

It is not necessarily the strongest or most intelligent that survive, it is the one most responsive to change Charles Darwin 3/31/2016 57

Questions??? 3/31/2016 58