Great Lakes Medical Laboratory

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . A. Based on record review and interview with Technical Supervisor #1, the laboratory failed to follow its policy for its assessment of personnel competency for 4 (Technical Supervisor #3, Testing Personnel #8, #9, and #14) of 21 testing personnel listed on Form CMS-209. Findings include: 1. A review of the laboratory's "Personnel" policy revealed a section stating, "Verify that a formal employee performance appraisal is conducted at the end of the first six months of employment and each year of employment thereafter. Employee performance evaluations consist Of: A review of QC, maintenance, calibration, and proficiency testing (PT) performed. Direct observation of the employee while performing laboratory work. Split-specimen testing. Written tests on instrument theory or laboratory policies and procedures. Having testing personnel not involved in the current PT event test specimens after the cut-off date for filing the report, and the results compared with those returning form the PT program." 2. A review of the laboratory's "Laboratory Competency Assessment Policy and Process" revealed a section stating, "Mandatory elements of competency assessment include: Direct observations of routine patient test performance, including, as applicable, patient identification and preparation; and specimen collection, handling, processing, and testing Monitoring the recording and reporting of test results, including, as applicable, reporting critical results Review of test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records Direct observation of performance of instrument maintenance and function checks Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- testing samples Evaluation of problem-solving skills. This can include communication and activities performed when contacting hotline as well as assigned scenarios of laboratory problems." 2. A review of competency assessments revealed the following performed competency assessments lacked the criteria listed above: a. Technical Supervisor #3 failed to have a direct observation of test performance for the urine and oral fluid toxicology testing and instrument maintenance performance for the COVID- 19 RT-PCR testing for their 2022 competency assessment dated 7/16/22. b. Testing Personnel #9 failed to have the assessment of test performance through testing previously analyzed specimens for their 2021 competency assessment dated 11/24/21. c. Testing Personnel #8 failed to have monitoring of the recording and reporting of test results and the assessment of test performance through testing previously analyzed specimens for their 2022 competency assessment completed on 12/30/22 for the COVID-19 Taqman assay and the COVID-19 and Flu combo testing. d. Testing Personnel #14 failed to have monitoring of the recording and reporting of test results and the assessment of test performance through testing previously analyzed specimens for their 2022 competency assessment completed on 12/30/22 for urine and urine toxicology and saliva COVID-19 testing. 3. An interview on 1/10/23 at 10:37 am with Technical Supervisor #1 confirmed the staff listed above had required components missing from their competency assessments. B. Based on record review and interview with Technical Supervisor #1, the laboratory failed to establish a policy to assess Clinical Consultant competency for 2 (January 2021 to January 2023) of 2 years reviewed. Findings include: 1. A review of the laboratory's "Personnel" and "Laboratory Competency Assessment Policy and Process" revealed a lack of policy for the assessment of Clinical Consultant competency. 2. A review of the Clinical Consultant's personnel records revealed a lack of competency assessments performed for their duties as a Clinical Consultant. 3. An interview on 1/9/23 at 3:11 pm with Technical Supervisor #1 confirmed the laboratory had not established a policy to assess Clinical Consultant competency. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Supervisor #2, the laboratory failed to verify the accuracy of its proficiency testing when a score had not been received for 1 (OFD-C 2022) of 3 oral fluid for drugs of abuse proficiency testing events reviewed. Findings include: 1. A review of the laboratory's College of American Pathologists Proficiency Testing documentation revealed the following events not evaluated by the proficiency testing provider or the laboratory for quantitative toxicology testing for the OFD-C 2022 (Oral Fluid for Drugs of Abuse) event analyte norfentanyl for specimens OFD-11 to OFD-15. 2. A review of the laboratory's "API Analytes Not Graded" policy revealed a section stating, "Results that state not graded appear in API evaluations. Every analyte that is not graded must be review and self-graded. The lab must determine the acceptability of performance." 3. A review of the laboratory's "Great Lakes Medical Laboratory" policy revealed a section titled "PT Report Review" stating, "If there are results which are ungraded, due to insufficient data, these must be evaluated for acceptability." 4. An interview on 1/9/23 at 2:22 pm with Technical Supervisor #2 confirmed the laboratory had not -- 2 of 8 -- followed its policy to assess analytes not graded by the proficiency provider for the event listed above. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Supervisor #2, the laboratory failed to verify the accuracy of its quantitative urine toxicology testing for 3 (UT-A-C 2022) of 3 urine toxicology events performed in 2022. Findings include: 1. A review of the laboratory's College of American Pathologists (CAP) Proficiency testing documentation revealed analytes tested using the urine toxicology events were evaluated for their qualitative results and did not assess their quantitative accuracy for the following events in 2022: a. UT-A 2022 b. UT-B 2022 c. UT-C 2022 2. An interview on 1/9/23 at 11:12 am with Technical Supervisor #2 confirmed the laboratory had not assessed its urine toxicology testing using the CAP urine toxicology events for its quantitative accuracy. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation and interview with Technical Supervisor #1, the laboratory failed to ensure reagents used in QuantiFERON TB-Gold tuberculosis testing for 4 of 4 reagent bottles observed. Findings include: 1. The surveyor observed the laboratory's ThunderBolt analyzer performing QuantiFERON TB-Gold tuberculosis testing on 1/9/23 at 9:12 am. The reagent bottles next to the analyzer had a lack of expiration date for 4 bottles to the left of the analyzer. 2. An interview on 1/9/23 at 9: 11 am with Technical Supervisor #1 confirmed the laboratory had not indicated the expiration dates of the reagents. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test -- 3 of 8 -- system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Supervisor #1, the laboratory failed to perform calibration at least every 6 months for the Sysmex XN-10 analyzer #17768 performing Complete Blood Count (CBC) testing for 1 (10/22/21 to 10/11/22) of 2 years reviewed. Findings include: 1. A review of the laboratory's "Instrument Maintenance and Calibration" policy revealed a section stating, "Instrument maintenance and test calibrations are performed properly at the required frequencies." 2. A review of the laboratory's "Certificate of Calibration" records for its Sysmex XN- 10 hematology analyzers revealed a section stating, "Initial calibration is performed during installation by the Sysmex representative. Following installation calibration, the operator is requested to verify the instrument calibration every 6 months or on an 'as needed' basis, and maintain good QC practices, to ensure the accuracy of the system." and revealed a lack of calibration performed for the Sysmex XN-10 serial # 17768 analyzer between 10/22/21 to 10/11/22. 3. An interview on 1/10/23 at 3:12 pm with Technical Supervisor #1 confirmed the laboratory had not performed calibrations at least every 6 months for the Sysmex XN-10 serial # 17768 analyzer. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Supervisor #2, the laboratory failed to establish a system to evaluate the toxicology testing relationship between its Sciex Triple Quad 4500 and ABSciex QTrap 4500 analyzers for 2 (January 2021 to January 2023) of 2 years reviewed. Findings include: 1. The surveyor toured the laboratory on 1/9/23 at 9:12 am and observed a Sciex Triple Quad 4500 and two ABSciex QTrap 4500 toxicology analyzers. 2. A review of the laboratory's toxicology documentation revealed the lack of a system to evaluate its toxicology testing relationship between its Sciex Triple Quad 4500 and ABSciex QTrap 4500 analyzers. 3. An interview on 1/9/23 at 2:22 pm with Technical Supervisor #2 confirmed the laboratory had no system to evaluate the toxicology testing relationship between its Sciex Triple Quad 4500 and ABSciex QTrap 4500 analyzers established. -- 4 of 8 -- D5783