T Off Mens Health Fort Worth

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: No deficiency details available. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: No deficiency details available. 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 --

Summary Statement of Deficiencies D0000 Based on an announced validation inspection, the laboratory was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493 CLIA requirements. The conditions not met were: D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F. R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the proficiency testing records and interview, the laboratory failed to attain an acceptable score of 80% or higher for the analyte Thyroid Stimulating Hormone (TSH) in the 1st event of 2023 resulting in unsatisfactory analyte performance. Findings follow. A. Review of the American Proficiency Institute (API) proficiency testing records from the 1st event of 2023, the 1st, 2nd, and 3rd events of 2022, and the 3rd event of 2021 showed in the 2023 Chemistry Core 1st Event the laboratory obtained a score of 60% for TSH. B. Interview with testing personnel #1 on June 29, 2023 at 1625 hours confirmed the laboratory repeated the samples, but didn't re-evaluate the results. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 22 -- This STANDARD is not met as evidenced by: Review the CMS 155, proficiency testing records, and interview showed that the laboratory failed to attain a satisfactory score of at least 80% in the 1st event of 2023 resulting in unsatisfactory performance for Endocrinology. Findings follow. A. Review the CMS 155 proficiency testing scores found that the laboratory obtained an overall testing event score of 60% for Endocrinology. B. Review of the American Proficiency Institute (API) proficiency testing records showed in the 2023 Chemistry Core 1st Event the laboratory obtained a score of 60% for Thyroid Stimulating Hormone (TSH) when the laboratory failed to submit acceptable results for 2 of 5 specimens. C. Interview with testing personnel #1 on June 29, 2023 at 1625 hours confirmed the laboratory repeated the samples, but didn't re-evaluate the results. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the maintenance logs, and interview, the laboratory failed to retain all maintenance logs for the Beckman Coulter UniCel DxI 600 for four of 23 months reviewed. Findings follow. A. Review of the Beckman Coulter UniCel DxI 600 Maintenance Logs from July 2021 to May 2023 showed missing logs: 1. August 2021 2. September 2021 3. December 2021 4. February 2022 B. Interview with testing personnel #1 on June 30, 2023 at 1100 hours confirmed the findings. 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 review of the proficiency testing records and interview, the laboratory failed to verify the accuracy of its testing when the laboratory failed to attain an acceptable score of 80% or higher for the analytes Vitamin B12, PSA (Prostate Specific Antigen) Folate, Prolactin, and Vitamin D in the 1st event of 2023, and for Vitamin B12 in the 1st event of 2022, and for Vitamin B12 and Prolactin for the 3rd event of 2021: three out of five testing events reviewed. Findings follow. A. Review of the American Proficiency Institute (API) proficiency testing records from the 1st event of 2023, the 1st, 2nd, and 3rd events of 2022, and the 3rd event of 2021 showed: 1. 2023 Chemistry Core 1st Event the laboratory obtained a score of 50% for the analytes: a. Vitamin B12 b. PSA c. Folate d. Prolactin and e. Vitamin D 2. 2022 Chemistry Core 1st Event the laboratory obtained a score of 50% for: a. Vitamin B12 3. 2021 Chemistry Core 3rd Event the laboratory obtained a score of 50% for: a. Vitamin B12 the laboratory obtained a score of 0% for: b. Prolactin. B. Interview with testing -- 2 of 22 -- personnel #1 on June 29, 2023 at 1625 hours confirmed the failures. Phone interview with testing personnel #1 on July 21, 2023 at 1040 hours confirmed the failures and confirmed the laboratory never ceased testing. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the manufacturer's instructions, observation, query of testing records, and interview, the laboratory failed to monitor and evaluate the overall quality of the preanalyitic systems and correct identified problems in Chemistry and Endocrinology(see D5311). D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, observation, query of testing records, request of collection date and times, and interview, the laboratory failed to ensure specimens were stored at the appropriate temperature for Ferritin, Folate, Prolactin, Prostate Specific Antigen (PSA), Total Testosterone, Vitamin B12, and Sensitive Estradiol on the Beckman Coulter UniCel DxI 600 from July 19, 2023 - July 27, 2023. Findings follow. A. Review of the Beckman Coulter Access Instructions for Use for: 1. Ferritin (C64647A Dec 2021) under Specimen stated, "If the assay will not be completed within 48 hours, or for shipment of samples, freeze at -20 degrees Celsius or colder." 2. Folate (B03897H Dec 2021) under Specimen stated, "If the assay will not be completed within 48 hours, or for shipment of samples, freeze at -20 degrees Celsius or colder." 3. Prolactin (C64671A Dec 2021) under Specimen stated, "If the assay will not be completed within 48 hours, or for shipment of samples, freeze at -20 degrees Celsius or colder." 4. Prostate Specific Antigen (A85067P Feb 2022), under Specimen stated, "Specimen Collection and Preparation...If the serum sample is to be assayed within 24 hours after collection, the specimen should be stored in a refrigerator at 2 to 8 degrees Celsius. Specimens held for longer times (up to 5 months) should be frozen at -20 degrees Celsius or colder." 5. Total Testosterone (C64673A April 2022) under Specimen stated, "If the assay will not be completed within 48 hours, or for shipment of samples, freeze at -20 degrees Celsius or colder." 6. Vitamin B12 (C64657B Oct 2022) under Specimen stated, If the assay will not be -- 3 of 22 -- completed within 24 hours, or for shipment of samples, freeze at -20 degrees Celsius or colder." 7. Estradiol (A56077T May 2020) under Specimen stated, "If the assay will not be completed within 48 hours, or for shipment of samples, freeze at -20 degrees Celsius or colder." B. Surveyor observed on June 30, 2023 at 1030 hours in the laboratory, half a rack of tubes stored in the refrigerator waiting to be tested: no specimens were stored in the freezer. C. Review of a query of patient testing performed and request of collection date and times showed for testing performed on 06 /24/2023 and 06/27/2023 the following samples listed by accession #, time of collection in hours, analyzer reported time in hours, total elapsed time: Accession # Collection Time Reported Time Elapsed time 1. Ferritin: Manufacturer required specimens not tested within 48 hours be frozen a. 99052404 06/21/2023 @ 0738 06/27 /2023 @ 1421 6 days, 6 hours b. 99052417 06/22/2023 @ 0841 06/27/2023 @ 1504 5 days, 6 hours c. 99052409 06/21/2023 @ 0945 06/27/2023 @ 1438 6 days, 4 hours d. 99052424 06/21/2023 @ 1320 06/27/2023 @ 1458 6 days, 1 hour e. 99052401 06/20 /2023 @ 0903 06/27/2023 @ 1445 7 days, 5 hours f. 99052386 06/19/2023 @ 1033 06 /27/2023 @ 1406 8 days, 3 hours g. 99052399 06/20/2023 @ 0826 06/27/2023 @ 1457 7 days, 6 hours h. 99052405 06/21/2023 @ 0819 06/27/2023 @ 1454 6 days, 6 hours i. 99052410 06/21/2023 @ 0925 06/27/2023 @ 1406 6 days, 4 hours j. 99052419 06/22/2023 @ 0906 06/27/2023 @ 1442 5 days, 5 hours k. 99052426 06/22 /2023 @ 0834 06/27/2023 @ 1453 5 days, 6 hours l. 99052434 06/23/2023 @ 0715 06 /27/2023 @ 1424 4 days, 7 hours m. 99052437 06/23/2023 @ 0858 06/27/2023 @ 1431 4 days, 5 hours n. 99052379 06/19/2023 @ 0737 06/24/2023 @ 1137 5 days, 4 hours o. 99052384 06/19/2023 @ 1010 06/24/2023 @ 1211 5 days, 2 hours p. 99052385 06/19/2023 @ 0827 06/24/2023 @ 1155 5 days, 3 hours q. 99052387 06/19 /2023 @ 0940 06/24/2023 @ 1305 5 days, 3 hours r. 99052388 06/19/2023 @ 1336 06 /24/2023 @ 1147 4 days, 22 hours s.99052393 06/19/2023 @ 1527 06/24/2023 @ 1323 4 days, 21 hours t. 99052395 06/19/2023 @ 1011 06/24/2023 @ 1305 5 days, 2 hours u. 99052397 06/20/2023 @ 0731 06/24/2023 @ 1137 4 days, 4 hours v. 99052398 06/20/2023 @ 0908 06/24/2023 @ 1227 4 days, 3 hours w. 99052400 06/20 /2023 @ 0922 06/24/2023 @ 1204 4 days, 2 hours x. 99052402 06/20/2023 @ 1134 06/24/2023 @ 1234 4 days, 1 hour y. 99052403 06/21/2023 @ 0720 06/24/2023 @ 1330 3 days, 6 hours z. 99052406 06/21/2023 @ 0853 06/24/2023 @ 1138 3 days, 2 hours aa. 99052407 06/21/2023 @ 0914 06/24/2023 @ 1203 3 days, 2 hours bb. 99052408 06/21/2023 @ 0930 06/24/2023 @ 1205 3 days, 2 hours cc. 99052411 06/21 /2023 @ 1030 06/24/2023 @ 1220 3 days, 1 hour dd. 99052412 06/21/2023 @ 1351 06/24/2023 @ 1130 2 days, 21 hours ee. 99052432 06/21/2023 @ 0845 06/24/2023 @ 1148 3 days, 3 hours ff. 99052414 06/22/2023 @ 0822 06/24/2023 @ 1314 2 days, 4 hours gg. 99052418 06/22/2023 @ 0857 06/24/2023 @ 1328 2 days, 4 hours hh. 99052428 06/22/2023 @ 1016 06/24/2023 @ 1255 2 days, 2 hours 2. Folate: Manufacturer required specimens not tested within 48 hours be frozen. a. 99052404 06 /21/2023 @ 0738 06/27/2023 @ 1421 6 days, 6 hours b. 99052417 06/22/2023 @ 0841 06/27/2023 @ 1504 5 days, 6 hours c. 99052409 06/21/2023 @ 0945 06/27 /2023 @ 1438 6 days, 4 hours d. 99052424 06/21/2023 @ 1320 06/27/2023 @ 1458 6 days, 1 hour e. 99052401 06/20/2023 @ 0903 06/27/2023 @ 1445 7 days, 5 hours f. 99052386 06/19/2023 @ 1033 06/27/2023 @ 1406 8 days, 3 hours g. 99052399 06/20 /2023 @ 0826 06/27/2023 @ 1457 7 days, 6 hours h. 99052405 06/21/2023 @ 0819 06/27/2023 @ 1454 6 days, 6 hours i. 99052410 06/21/2023 @ 0925 06/27/2023 @ 1406 6 days, 4 hours j. 99052419 06/22/2023 @ 0906 06/27/2023 @ 1442 5 days, 5 hours k. 99052426 06/22/2023 @ 0834 06/27/2023 @ 1453 5 days, 6 hours l. 99052434 06/23/2023 @ 0715 06/27/2023 @ 1424 4 days, 7 hours m. 99052437 06/23 /2023 @ 0858 06/27/2023 @ 1431 4 days, 5 hours 3. Prolactin: Manufacturer required specimens not tested within 48 hours be frozen. a. 99052404 06/21/2023 @ 0738 06 /27/2023 @ 1421 6 days, 6 hours b. 99052417 06/22/2023 @ 0841 06/27/2023 @ -- 4 of 22 -- 1504 5 days, 6 hours c. 99052409 06/21/2023 @ 0945 06/27/2023 @ 1438 6 days, 4 hours d. 99052424 06/21/2023 @ 1320 06/27/2023 @ 1458 6 days, 1 hour e. 99052401 06/20/2023 @ 0903 06/27/2023 @ 1445 7 days, 5 hours f. 99052386 06/19 /2023 @ 1033 06/27/2023 @ 1406 8 days, 3 hours g. 99052399 06/20/2023 @ 0826 06/27/2023 @ 1457 7 days, 6 hours h. 99052405 06/21/2023 @ 0819 06/27/2023 @ 1454 6 days, 6 hours i. 99052410 06/21/2023 @ 0925 06/27/2023 @ 1406 6 days, 4 hours j. 99052419 06/22/2023 @ 0906 06/27/2023 @ 1442 5 days, 5 hours k. 99052426 06/22/2023 @ 0834 06/27/2023 @ 1453 5 days, 6 hours l. 99052434 06/23 /2023 @ 0715 06/27/2023 @ 1424 4 days, 7 hours m. 99052437 06/23/2023 @ 0858 06/27/2023 @ 1431 4 days, 5 hours 4. PSA: Manufacturer required specimens not tested within 24 hours be frozen. a. 99052404 06/21/2023 @ 0738 06/27/2023 @ 1421 6 days, 6 hours b. 99052417 06/22/2023 @ 0841 06/27/2023 @ 1504 5 days, 6 hours c. 99052409 06/21/2023 @ 0945 06/27/2023 @ 1438 6 days, 4 hours d. 99052424 06/21/2023 @ 1320 06/27/2023 @ 1458 6 days, 1 hour e. 99052401 06/20 /2023 @ 0903 06/27/2023 @ 1445 7 days, 5 hours f. 99052386 06/19/2023 @ 1033 06 /27/2023 @ 1406 8 days, 3 hours g. 99052399 06/20/2023 @ 0826 06/27/2023 @ 1457 7 days, 6 hours h. 99052405 06/21/2023 @ 0819 06/27/2023 @ 1454 6 days, 6 hours i. 99052410 06/21/2023 @ 0925 06/27/2023 @ 1406 6 days, 4 hours j. 99052419 06/22/2023 @ 0906 06/27/2023 @ 1442 5 days, 5 hours k. 99052426 06/22 /2023 @ 0834 06/27/2023 @ 1453 5 days, 6 hours l. 99052434 06/23/2023 @ 0715 06 /27/2023 @ 1424 4 days, 7 hours m. 99052437 06/23/2023 @ 0858 06/27/2023 @ 1431 4 days, 5 hours n. 99052379 06/19/2023 @ 0737 06/24/2023 @ 1137 5 days, 4 hours o. 99052384 06/19/2023 @ 1010 06/24/2023 @ 1211 5 days, 2 hours p. 99052385 06/19/2023 @ 0827 06/24/2023 @ 1155 5 days, 3 hours q. 99052387 06/19 /2023 @ 0940 06/24/2023 @ 1305 5 days, 3 hours r. 99052388 06/19/2023 @ 1336 06 /24/2023 @ 1147 4 days, 22 hours s.99052393 06/19/2023 @ 1527 06/24/2023 @ 1323 4 days, 21 hours t. 99052395 06/19/2023 @ 1011 06/24/2023 @ 1305 5 days, 2 hours u. 99052397 06/20/2023 @ 0731 06/24/2023 @ 1137 4 days, 4 hours v. 99052398 06/20/2023 @ 0908 06/24/2023 @ 1227 4 days, 3 hours w. 99052400 06/20 /2023 @ 0922 06/24/2023 @ 1204 4 days, 2 hours x. 99052402 06/20/2023 @ 1134 06/24/2023 @ 1234 4 days, 1 hour y. 99052403 06/21/2023 @ 0720 06/24/2023 @ 1330 3 days, 6 hours z. 99052406 06/21/2023 @ 0853 06/24/2023 @ 1138 3 days, 2 hours aa. 99052407 06/21/2023 @ 0914 06/24/2023 @ 1203 3 days, 2 hours bb. 99052408 06/21/2023 @ 0930 06/24/2023 @ 1205 3 days, 2 hours cc. 99052411 06/21 /2023 @ 1030 06/24/2023 @ 1220 3 days, 1 hour dd. 99052412 06/21/2023 @ 1351 06/24/2023 @ 1130 2 days, 21 hours ee. 99052432 06/21/2023 @ 0845 06/24/2023 @ 1148 3 days, 3 hours ff. 99052414 06/22/2023 @ 0822 06/24/2023 @ 1314 2 days, 4 hours gg. 99052418 06/22/2023 @ 0857 06/24/2023 @ 1328 2 days, 4 hours hh. 99052428 06/22/2023 @ 1016 06/24/2023 @ 1255 2 days, 2 hours ii. 99052429 06/22 /2023 @ 1512 06/24/2023 @ 1318 1 day, 22 hours jj. 99052430 06/22/2023 @ 1556 06/24/2023 @ 1140 1 day, 19 hours 5. Total Testosterone: Manufacturer required specimens not tested within 48 hours be frozen. a. 99052404 06/21/2023 @ 0738 06 /27/2023 @ 1421 6 days, 6 hours b. 99052417 06/22/2023 @ 0841 06/27/2023 @ 1504 5 days, 6 hours c. 99052409 06/21/2023 @ 0945 06/27/2023 @ 1438 6 days, 4 hours d. 99052424 06/21/2023 @ 1320 06/27/2023 @ 1458 6 days, 1 hour e. 99052401 06/20/2023 @ 0903 06/27/2023 @ 1445 7 days, 5 hours f. 99052386 06/19 /2023 @ 1033 06/27/2023 @ 1406 8 days, 3 hours g. 99052399 06/20/2023 @ 0826 06/27/2023 @ 1457 7 days, 6 hours h. 99052405 06/21/2023 @ 0819 06/27/2023 @ 1454 6 days, 6 hours i. 99052410 06/21/2023 @ 0925 06/27/2023 @ 1406 6 days, 4 hours j. 99052419 06/22/2023 @ 0906 06/27/2023 @ 1442 5 days, 5 hours k. 99052426 06/22/2023 @ 0834 06/27/2023 @ 1453 5 days, 6 hours l. 99052434 06/23 /2023 @ 0715 06/27/2023 @ 1424 4 days, 7 hours m. 99052437 06/23/2023 @ 0858 06/27/2023 @ 1431 4 days, 5 hours n. 99052379 06/19/2023 @ 0737 06/24/2023 @ -- 5 of 22 -- 1137 5 days, 4 hours o. 99052384 06/19/2023 @ 1010 06/24/2023 @ 1211 5 days, 2 hours p. 99052385 06/19/2023 @ 0827 06/24/2023 @ 1155 5 days, 3 hours q. 99052387 06/19/2023 @ 0940 06/24/2023 @ 1305 5 days, 3 hours r. 99052388 06/19 /2023 @ 1336 06/24/2023 @ 1147 4 days, 22 hours s.99052393 06/19/2023 @ 1527 06/24/2023 @ 1323 4 days, 21 hours t. 99052395 06/19/2023 @ 1011 06/24/2023 @ 1305 5 days, 2 hours u. 99052397 06/20/2023 @ 0731 06/24/2023 @ 1137 4 days, 4 hours v. 99052398 06/20/2023 @ 0908 06/24/2023 @ 1227 4 days, 3 hours w. 99052400 06/20/2023 @ 0922 06/24/2023 @ 1204 4 days, 2 hours x. 99052402 06/20 /2023 @ 1134 06/24/2023 @ 1234 4 days, 1 hour y. 99052403 06/21/2023 @ 0720 06 /24/2023 @ 1330 3 days, 6 hours z. 99052406 06/21/2023 @ 0853 06/24/2023 @ 1138 3 days, 2 hours aa. 99052407 06/21/2023 @ 0914 06/24/2023 @ 1203 3 days, 2 hours bb. 99052408 06/21/2023 @ 0930 06/24/2023 @ 1205 3 days, 2 hours cc. 99052411 06/21/2023 @ 1030 06/24/2023 @ 1220 3 days, 1 hour dd. 99052412 06/21 /2023 @ 1351 06/24/2023 @ 1130 2 days, 21 hours ee. 99052432 06/21/2023 @ 0845 06/24/2023 @ 1148 3 days, 3 hours ff. 99052414 06/22/2023 @ 0822 06/24/2023 @ 1314 2 days, 4 hours gg. 99052418 06/22/2023 @ 0857 06/24/2023 @ 1328 2 days, 4 hours hh. 99052428 06/22/2023 @ 1016 06/24/2023 @ 1255 2 days, 2 hours 6. Vitamin B12: Manufacturer required specimens not tested within 24 hours be frozen. a. 99052404 06/21/2023 @ 0738 06/27/2023 @ 1421 6 days, 6 hours b. 99052417 06 /22/2023 @ 0841 06/27/2023 @ 1504 5 days, 6 hours c. 99052409 06/21/2023 @ 0945 06/27/2023 @ 1438 6 days, 4 hours d. 99052424 06/21/2023 @ 1320 06/27 /2023 @ 1458 6 days, 1 hour e. 99052401 06/20/2023 @ 0903 06/27/2023 @ 1445 7 days, 5 hours f. 99052386 06/19/2023 @ 1033 06/27/2023 @ 1406 8 days, 3 hours g. 99052399 06/20/2023 @ 0826 06/27/2023 @ 1457 7 days, 6 hours h. 99052405 06/21 /2023 @ 0819 06/27/2023 @ 1454 6 days, 6 hours i. 99052410 06/21/2023 @ 0925 06 /27/2023 @ 1406 6 days, 4 hours j. 99052419 06/22/2023 @ 0906 06/27/2023 @ 1442 5 days, 5 hours k. 99052426 06/22/2023 @ 0834 06/27/2023 @ 1453 5 days, 6 hours l. 99052434 06/23/2023 @ 0715 06/27/2023 @ 1424 4 days, 7 hours m. 99052437 06/23/2023 @ 0858 06/27/2023 @ 1431 4 days, 5 hours 7. Estradiol: Manufacturer required specimens not tested within 48 hours be frozen. a. 99052404 06 /21/2023 @ 0738 06/27/2023 @ 1421 6 days, 6 hours b. 99052417 06/22/2023 @ 0841 06/27/2023 @ 1504 5 days, 6 hours c. 99052409 06/21/2023 @ 0945 06/27 /2023 @ 1438 6 days, 4 hours d. 99052424 06/21/2023 @ 1320 06/27/2023 @ 1458 6 days, 1 hour e. 99052401 06/20/2023 @ 0903 06/27/2023 @ 1445 7 days, 5 hours f. 99052386 06/19/2023 @ 1033 06/27/2023 @ 1406 8 days, 3 hours g. 99052399 06/20 /2023 @ 0826 06/27/2023 @ 1457 7 days, 6 hours h. 99052405 06/21/2023 @ 0819 06/27/2023 @ 1454 6 days, 6 hours i. 99052410 06/21/2023 @ 0925 06/27/2023 @ 1406 6 days, 4 hours j. 99052419 06/22/2023 @ 0906 06/27/2023 @ 1442 5 days, 5 hours k. 99052426 06/22/2023 @ 0834 06/27/2023 @ 1453 5 days, 6 hours l. 99052434 06/23/2023 @ 0715 06/27/2023 @ 1424 4 days, 7 hours m. 99052437 06/23 /2023 @ 0858 06/27/2023 @ 1431 4 days, 5 hours n. 99052379 06/19/2023 @ 0737 06/24/2023 @ 1137 5 days, 4 hours o. 99052384 06/19/2023 @ 1010 06/24/2023 @ 1211 5 days, 2 hours p. 99052385 06/19/2023 @ 0827 06/24/2023 @ 1155 5 days, 3 hours q. 99052387 06/19/2023 @ 0940 06/24/2023 @ 1305 5 days, 3 hours r. 99052388 06/19/2023 @ 1336 06/24/2023 @ 1147 4 days, 22 hours s.99052393 06/19 /2023 @ 1527 06/24/2023 @ 1323 4 days, 21 hours t. 99052395 06/19/2023 @ 1011 06/24/2023 @ 1305 5 days, 2 hours u. 99052397 06/20/2023 @ 0731 06/24/2023 @ 1137 4 days, 4 hours v. 99052398 06/20/2023 @ 0908 06/24/2023 @ 1227 4 days, 3 hours w. 99052400 06/20/2023 @ 0922 06/24/2023 @ 1204 4 days, 2 hours x. 99052402 06/20/2023 @ 1134 06/24/2023 @ 1234 4 days, 1 hour y. 99052403 06/21 /2023 @ 0720 06/24/2023 @ 1330 3 days, 6 hours z. 99052406 06/21/2023 @ 0853 06 /24/2023 @ 1138 3 days, 2 hours aa. 99052407 06/21/2023 @ 0914 06/24/2023 @ 1203 3 days, 2 hours bb. 99052408 06/21/2023 @ 0930 06/24/2023 @ 1205 3 days, 2 -- 6 of 22 -- hours cc. 99052411 06/21/2023 @ 1030 06/24/2023 @ 1220 3 days, 1 hour dd. 99052412 06/21/2023 @ 1351 06/24/2023 @ 1130 2 days, 21 hours ee. 99052432 06 /21/2023 @ 0845 06/24/2023 @ 1148 3 days, 3 hours ff. 99052414 06/22/2023 @ 0822 06/24/2023 @ 1314 2 days, 4 hours gg. 99052418 06/22/2023 @ 0857 06/24 /2023 @ 1328 2 days, 4 hours hh. 99052428 06/22/2023 @ 1016 06/24/2023 @ 1255 2 days, 2 hours D. Interview with the owner on June 30, 2023 at 1520 hours acknowledged they were freezing tubes prior to the new technical consultant's arrival who started June 10, 2023, and stopped around June 19, 2023 when the new testing person (hired by the technical consultant) told them they didn't need to freeze the samples, and now only tested once a week on Saturdays. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, review of the verification of performance specification records, manufacturer's instructions, laboratory's policies and procedures, maintenance logs, quality control (QC) records, query, pre-survey paperwork and interview, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct problems in testing performed in Chemistry and Endocrinology. Findings follow. 1. The laboratory failed to have a written procedure for the performance of