Integrated Medical Group Pc

Summary Statement of Deficiencies 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 review of the American Academy of Family Physicians (AAFP) and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and interview with Testing Personnel (TP), the laboratory failed to verify the accuracy of the PT results obtained for 7 of 7 events in Chemistry for 2021, 2022 and 2023. Findings include: 1) On the day of survey 09/22/2023 at 10:39 am, review of the laboratory's AAFP and WSLH PT records revealed that the laboratory did not verify the accuracy for the following analytes that were not graded by the PT agencies: - AAFP 2021-C Multichem 21+ Endocrinology HCG: CH-11N, CH-12N, CH-13N, CH- 14N, CH-15N - AAFP 2022-C Multichem 21+ General Chemistry Cholesterol LDL: CH-11N, CH-12N, CH-13N, CH-14N, CH-15N - WSLH 2023A Special Chemistry Immunoassay Chemistry 6+ analytes Ferritin: CS-1, CS-2, CS-3 Folate: CS-2, CS-3 - WSLH 2023A Chemistry/Endocrinology/Therapeutic Drugs 31+ Chloride: CET-1, CET-2, CET-3, CET-4, CET-5 Cholesterol HDL: CET-1, CET-2 GGT: CET-2, CET- 4, CET-5 2) TP confirmed the above findings during interview on 09/22/2023 at 12:05 pm D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the 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 -- manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of Roche Diagnostics Cobas e411 validation study records and interview with Testing Personnel (TP), the laboratory failed to establish criteria for acceptable performance specifications and perform a reference range/normal value study for 1 of 1 analytes performed on the Roche Diagnostics Cobas e411 analyzer from 08/24/2023 to the date of the survey. Findings Include: 1. On the day of the survey, 09/22/2023 at 9:22 am, a review of the Cobas e411 analyzer EP evaluator validation records revealed the validation performed on 08/24/2023 did not include the laboratory's acceptable criteria for performance specifications for reportable ranges for Elecsys Insulin immunoassay. 2. The laboratory could not provide documentation of a validation summary or reference range/normal value study appropriate for the laboratory's patient population. 3. Interview with TP on 09/22 /2023 at 12:05 pm confirmed the findings above. -- 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 review of competency assessment (CA) records and interview with testing personnel (TP), the laboratory failed to establish a complete competency assessment policies and procedures to assess the competency of 1 of 1 testing personnel (TP) for each test metodology performed in the departments of Chemistry, Hematology, and Urinalysis in 2019, 2020, and 2021. Findings Include: 1. On the day of survey, 09/21 /2021 at 09:07 a.m., the laboratory could not provide a CA procedure to assess 1 of 1 TP for 2019, 2020, and 2021. 2. The laboratory could not provide CA records for 1 of 1 TP for 2020. 3. The laboratory could not provide separate CA records for each test metodology performed by the TP in hematology, chemistry, and urinalysis for 2019, 2020, and 2021. 4. The TP confirmed the findings above on 09/21/2021 at 11:30 a.m. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. 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 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the testing personnel (TP), the laboratory failed to establish a maintenance policy to assess the maintenance /function for 3 of 3 traceable thermometers used to monitor the temperature of reagents used on the Beckman Coulter DxH520 hematology analyzer, Roche Cobas Integra 400+, and Roche Cobas e411 chemistry analyzers from 09/21/ 2019 to the day of survey. Findings Include: 1. On the day of survey, 09/21/2021, the surveyor observed 2 of 2 traceable refrigerator thermometers and 1 of 1 traceable room temperature thermometer in use to monitor the temperatures of reagents used on the Beckman Coulter Dix hematology analyzer, Roche Cobas Integra 400+, and Roche Cobas e411 chemistry analyzers. The thermometers were due for maintenance on August 2019. 2. The laboratory could not provide a maintenance policy for the thermometers. 3. TP #1 confirmed the findings above on 09/21/2021 around 09:00 a. m. -- 2 of 2 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Quality Control record review and interview with the Medical Laboratory Technician, the laboratory failed to document all Quality Control procedures performed for Urine Sediment Examination, from 05/01/2018 through the date of the survey (06/06/2019), Findings include: 1.Review of urine Quality Control records revealed the laboratory failed to document Visual Quality Control for 3866 Urine Sediment Examination tests, preformed from 05/01/2018 through 04/30/2019. 2. During the survey (09:45 06/06/2019), the Medical Laboratory Technician confirmed that Visuaal Quality Control was not documented each day of patient testing for Urine Sediment Examination. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --