Covenant Medical Group Central Lab

Summary Statement of Deficiencies 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: Citation #1 Based on observation of the Laboratory's two Beckman DxH instruments, lack of documentation of twice a year comparison evaluations for 2022 and upon interview with the Laboratory Manager, determined the laboratory failed to perform and document twice a year evaluations between the two Beckman DxH instruments for performance of Complete Blood Cell Counts (CBCs) in 2022. The findings include: 1. Observation of the Laboratory's Beckman DxH 1 (S#BF12138) and DxH 2 (S#BF12137) instruments in use for performing CBCs in the laboratory for patient testing. 2. Lack of documentation for twice a year comparison evaluations between the two DxH instruments in 2022. 3. Interview at approximately 1:00 p.m. on April 12, 2023 with the Laboratory Manager confirmed the laboratory failed to perform and document twice a year evaluations between the two Beckman DxH instruments for performance of CBCs in 2022. Citation #2 Based on observation of the Laboratory's two Stago instruments, lack of documentation of twice a year comparison evaluations for 2022 and upon interview with the Laboratory Manager, determined the laboratory failed to perform and document twice a year evaluations between the two Stago instruments for performance of Prothrombin time (PT) and Partial thrombolastin time (PTT) analytes in 2022. The findings include: 1. Observation of the Laboratory's Stago 1 (S#7300) and Stago 2 (S#7272) instruments in use for performing PT and PTT in the laboratory for patient testing. 2. Lack of documentation for twice a year comparison evaluations between the two Stago instruments in 2022. 3. Interview at Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- approximately 1:00 p.m. on April 12, 2023 with the Laboratory Manager confirmed the laboratory failed to perform and document twice a year comparison evaluations between the two Stago instruments for performance of PT and PTT in 2022. Citation #3 Based on observation of the Laboratory's Aution Max and Aution Eleven instruments, lack of documentation of twice a year comparison evaluations for 2022 and upon interview with the Laboratory Manager, determined the laboratory failed to perform and document twice a year evaluations between the two Aution instruments for performance of Urinalysis in 2022. The findings include: 1. Observation of the Laboratory's Aution Max and Aution Eleven in use for performing Urinalysis in the laboratory for patient testing. 2. Lack of documentation for twice a year comparison evaluations between the two Aution instruments in 2022. 3. Interview at approximately 1:00 p.m. on April 12, 2023 with the Laboratory Manager confirmed the laboratory failed to perform and document twice a year comparison evaluations between the two Aution instruments for Urinalysis in 2022. Citation #4 Based on observation of the Laboratory's Aution Max/Iris IQ and urine microscope, lack of documentation of twice a year comparison evaluations for 2022 and upon interview with the Laboratory Manager, determined the laboratory failed to perform and document twice a year evaluations between the two methodologies for performance of urine microscopy in 2022. The findings include: 1. Observation of the Laboratory's Aution Max/Iris IQ and urine microscope in use for performing urine microscopy in the laboratory for patient testing. 2. Lack of documentation for twice a year comparison evaluations between the two methodologies for urine microscopy in 2022. 3. Interview at approximately 1:00 p.m. on April 12, 2023 with the Laboratory Manager confirmed the laboratory failed to perform and document twice a year comparison evaluations between the two methodologies for urine microscopy in 2022. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on review of competency assessments for the technical consultants and interview with the Laboratory Manager, determined the Laboratory Director failed to evaluate four of four technical consultants listed on the Centers for Medicare and Medicaid Form 209(CMS 209) in 2022. The findings include: 1. Review of 2022 competency assessments revealed no documentation of competency assessment for four of four technical consultants in 2022. 2. Interview at approximately 1:00 p.m. on April 12, 2023 with the Laboratory Manager confirmed the Laboratory Director failed to evaluate four of four technical consultants in 2022. -- 2 of 2 --

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: _____________________________________ Based on Quality Assurance Plan for Personnel Policy stating "employees are evaluated twice within the first year of employment for competency-may be done at the 6 month evaluation, lack of 6 month competency evaluation for testing person number 3 of 5, hired 3/21/16, and interview with the Laboratory Supervisor and Technical Consultant, determined the laboratory failed to follow policy to assess personnel competency twice within the first year of employment for testing person #3. The findings include: 1. Quality Assurance Plan for Personnel Policy states "employees are evaluated twice within the first year of employment for competency-may be done at the 6 month evaluation". 2. Lack of competency evaluation twice within the first year of employment for testing person number 3 of 5 hired 3/21/16. 3. Interview at approximately 11:00 a.m. February 1, 2018 with the Laboratory Supervisor and Technical Consultant confirmed the laboratory failed to follow policy to assess personnel competency twice within the first year of employment for testing person #3 hired 3/21/16. _______________________________________ D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: _____________________________________ Based on review of package insert and assay sheets for Chemistry Quality Control (QC ) Materials, lack of verification of statistical parameters for QC materials as recommended by manufacturer and interview with the Laboratory Supervisor and Technical Consultant, determined the laboratory failed to verify the criteria for acceptability of Chemistry Control Materials for 2016 and 2017. The findings include: 1. Review of package insert and assay sheets for Chemistry QC materials. 2. Lack of verification of statistical parameters to include mean and standard deviations for Chemistry QC materials as recommended by the manufacturer for 2016 adn 2017. 3. Interview at approximately 2:00 p.m. February 1, 2018 with the Laboratory Supervisor and Technical Consultant confirmed verification of statistical parameters for Chemistry QC materials had not been verified for the 2 year period. ______________________________________ D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: ____________________________________ Based on out of range Lipase Quality Control (QC) results on 1/30/18, laboratory's criteria for acceptable QC results, one patient test result reported on 1/30/18 and interview with the Laboratory Supervisor and Technical Consultant, determined the results of QC materials did not meet the laboratory's criteria for acceptability prior to reporting patient Lipase results on 1/30 /18. The findings include: 1. Out of range Lipase QC results for 2 of 3 quality control materials on 1/30/18. 2. Laboratory's criteria of at least 2 levels of acceptable QC results prior to reporting patient results. 3. One patient Lipase result reported on 1/30 /18. 4. Interview at approximately 2:00 p.m. February 1, 2018 with the Laboratory Supervisor and Technical Consultant confirmed the results of Lipase QC materials did not meet the laboratory's criteria for acceptability prior to reporting one patient test result on 1/30/18. _______________________________________ -- 2 of 2 --