Southern Rapid Care

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of Hematology calibration records and an interview with Testing Personnel #1, the laboratory failed to ensure calibration material was utilized before the expiration date on one out of three calibrations reviewed from June 2021 to October 2022. The findings include: 1. A review of the Beckman Coulter AcT Diff 2 calibration records revealed a calibration was performed on 10/13/2022, using calibrator lot number 4757, which expired on 9/17/2022. 2. During an interview on 10 /20/2022 at 11:00 AM, Testing Personnel #1 confirmed the above findings. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. 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 a review of Hematology calibration records, a review of the Beckman Coulter AcT Diff 2 Operator's Manual, and an interview with Testing Personnel #1, the laboratory failed to follow the manufacturer's instructions to perform quality controls after calibrations, and before running patient samples. This was noted for three out of three calibrations reviewed from 2021-2022. The findings include: 1. A review of Hematology records revealed the Beckman Coulter AcT Diff 2 was calibrated on 11/22/21, 5/20/22, and 10/13/22. However, quality control records revealed no documentation of quality controls performed after the calibrations. 2. A review of the Beckman Coulter AcT Diff 2 Operator's Manual revealed under "Calibration", "...17 Verify calibration by running 4C PLUS cell control...". 3. During an interview on 10/20/2022 at 11:00 AM, Testing Personnel #1 confirmed the above findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the IQCP (Individualized Quality Control Plan) for the iStat, a review of quality control (QC) records, and an interview with Testing Personnel #1, the laboratory failed to ensure two levels of quality control (QC) were performed and documented every 30 days of patient testing as per the IQCP. This was noted four out of sixteen months reviewed from 2021-2022. The findings include: 1. A review of the IQCP for the iStat revealed a QC Plan which specified two levels of QC should be performed and documented for the Chem 8 + cartridge every 30 days of patient testing, and with each new lot number and shipment of reagent cartridges. 2. A review of the iStat Chem 8 + QC records revealed no QC was performed in February 2022, March 2022, August 2022, and October 2022; the patient log revealed 23 patients tests were performed during this time. 3. During an interview on 10/20/2022 at 1:00 PM, the surveyor reviewed and confirmed the above findings with Testing Personnel #1. The surveyor then asked how many patient tests were performed during the above months; Testing Personnel #1 reviewed data in the Electronic Medical Record, and determined 23 patients were performed during the four-month inquiry period. -- 2 of 2 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Beckman Coulter AcT diff 2 Hematology analyzer quality control (QC) records and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to ensure at least two levels of quality control were performed and acceptable, prior to analyzing patient specimens and reporting the results one day in 2020. The findings include: 1. A review of the Hematology records revealed no documentation of QC on 3/2/2020. 2. During an interview on 6/23/2021 at 3:20 PM, Testing Personnel #1 reviewed the daily instrument print outs, and confirmed no QC was performed on 3/2/2020. When asked if patient testing was performed, Testing Personnel #1 checked the patient records, and stated two patient CBC's (Complete Blood Counts) were run on the above date. SURVEYOR ID#32258 Licensure and Certification Surveyor 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 D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on reviews of the AAB (American Association of Bioanalysts) Proficiency Testing (PT) records, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to provide the CLIA number on the survey result forms to ensure AAB could forward the laboratory's results to the appropriate government agencies for mandatory review. This affected the period from the previous survey on 12/15/2016 until 4/26/2018 after the laboratory had changed to a new PT provider. The findings include: 1. A review of the laboratory's AAB PT records revealed the rectangle for the CLIA number was blank on the results entry forms from Hematology Q3-2016 thru Q3-2017 (Chemistry and Hematology). The returned AAB survey results with the overall scores for analytes in each specialty included the following comment in bold capitalized letters: "RESULTS CANNOT BE TRANSMITTED TO CMS WITHOUT A CLIA NUMBER.". However, there was no documentation this information was provided until 4/26/2018 when TP #1 received an e-mail stating she needed to provide the CLIA number to API (American Proficiency Institute), their new 2018 PT provider. 2. In an interview on 7/17/2018 at 3:15 PM, the surveyor asked if anyone had noticed the CLIA number was blank on AAB PT result forms, and AAB was requesting this information on the returned results. TP #1 reviewed the PT records, and stated she had not realized the importance of the comment, and did not remember the Technical Consultants giving her directions 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 -- regarding the issue until 2018. Thus the above noted findings were confirmed. SURVEYOR:Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor -- 2 of 2 --