Southern Family Health

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Testing Personnel 1 (TP1), the Laboratory Director failed to sign the PT attestation statements for the specialty in Hematology. This was noted in three of the six events reviewed from the date of the last survey, 11- 29-2022 to the date of the current survey, 01-07-2025. The findings include: 1. A review of the API PT records revealed no signature by the Laboratory Director on the attestation statements for the following surveys: a) 2023 Hematology 2nd Event b) 2024 Hematology 1st Event. c) 2024 Hematology 2nd Event. 2. The TP1 confirmed the above findings during the exit conference on 01-07-2025 at 2:45 PM. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on reviews of the environmental records, the Beckman Coulter (BC) DxH 500 Instructions For Use manual, and an interview with Testing Personnel 1 (TP1), the laboratory failed to monitor and record the room humidity where the BC DxH 500 analyzer was in operation. The surveyor noted no documentation of humidity from the date of the last survey, 11-29-2022 to the date of the current survey, 01-07-2025. The findings include: 1. A review of the laboratory's environmental records revealed a lack of humidity documentation in the room where the BC DxH 500 Hematology analyzer was in operation. 2. A further review of the BC DxH 500 Instructions For Use manual page 1-7 revealed the manufacturer's required environmental parameters, as follows, "The instrument meets performance when operated at a maximum of 80% relative humidity...". 2. The TP1 confirmed the above findings during the exit conference on 01-07-2025 at 2:45 PM. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on reviews of the laboratory's maintenance records, the Beckman Coulter (BC) DxH 500 analyzer maintenance chart, and an interview with Testing Personnel 1 (TP1), the laboratory failed to perform and document the required maintenance as per manufacturer specifications for seven out of the twelve months in 2023. The findings include: 1. A review of the laboratory's maintenance records revealed no documentation of the daily and weekly maintenance on the BC DxH 500 analyzer from June to December 2023. 2. A further review of the BC DxH 500 operator's manual revealed the manufacturer had a chart published specifying daily and weekly maintenance requirements. 2. The TP1 confirmed the above findings during the exit conference on 01-07-2025 at 2:45 PM. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(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 (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Hematology records, the analyzer operator's manual, and an interview with the Testing Personnel 1 (TP1), the laboratory failed to perform -- 2 of 4 -- calibration on the Beckman Coulter DxH 500 Hematology analyzer per manufacturer's requirement. The surveyor noted one missing calibration from the date of the last survey on 11-29-2022 to the date of the current survey of 01-07-2025. The findings include: 1. A review of the Beckman Coulter DxH 500 Hematology analyzer calibration records on 08-22-2024 revealed the calibration was performed but no final report was printed and retained to show the calibration had passed or was acceptable. 2. A further review of the analyzer operator's manual indicated manufacturer's requirement of at least every 6-month calibration. 3. The TP1 confirmed the above findings during the exit conference on 01-07-2025 at 2:45 PM. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on a review of the daily Quality Control (QC) records for the Beckman Coulter DxH 500 Hematology analyzer, and an interview with Testing Personnel 1 (TP1), the surveyor determined the laboratory failed to implement mechanisms to track for QC shifts and trends over time. The failure occurred in 25 out of the 25 months surveyed from 2022-2025. The findings include: 1. A review of the QC records revealed the laboratory had not implemented a mechanism to track for QC shifts and trends over time from 11-29-2022 to 01-07-2025; the laboratory only retained printouts of the daily QC runs. 2. The TP1 confirmed the above findings during the exit conference on 01-07-2025 at 2:45 PM. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. The technical consultant is not required to be onsite at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide consultation, as specified in paragraph (a) of this section. This STANDARD is not met as evidenced by: Based on reviews of Proficiency Testing (PT), Beckman Couter DxH 500 Hematology analyzer, environmental records, Personnel Competency Assessment records, Quality Control records, the surveyor determined the Technical Consultant (also the Laboratory Director) failed to provide technical and scientific oversight and direction from the date of the previous survey, 11-29-2022 to the date of the current survey, 1-07-2025. The findings include: 1. A review of laboratory records revealed a lack of technical and scientific oversight and direction contributed to the following deficiencies: A) Failure to ensure PT attestation statements were signed. (Refer to -- 3 of 4 -- D2009) B) Failure to ensure the laboratory staff recorded the room humidity when the Beckman Couter DxH 500 Hematology analyzer was in operation. (Refer to D5413) C) Failure to ensure maintenance of the Beckman Couter DxH 500 Hematology analyzer was performed according to the manufacturer's required specifications. (Refer to D5429) D) Failure to perform the manufacturer's required calibration frequency. (Refer to D5437) E) Failure to implement a mechanism to track for Quality Control shifts and trends overtime. (Refer to 5441) 2. The TP1 confirmed the above findings during the exit conference on 01-07-2025 at 2:45 PM. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with Testing Personnel 1 (TP1), the Technical Consultant (TC) failed to perform competency assessments for two of the two TP from the date of the last survey, 11-29-2022 to the date of the current survey, 01-07-2025. The findings include: 1. A review of the Laboratory Personnel Evaluation records revealed semi-annual and annual competencies were performed and signed by an individual not listed on the CMS-209 (Laboratory Personnel Report). 2. During an interview with TP1, TP1 stated the owner who has a Certified Registered Nurse Practitioner license completed the TP competencies but did not perform moderate complexity testing in the laboratory. 3. TP1 confirmed the above findings during the exit conference on 01-07-2025 at 2:45 PM. -- 4 of 4 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on a review of the Hematology records, the Quality Assurance (QA) plan, and an interview with Testing Personnel #1, the Laboratory failed to perform calibrations on the AcT diff Hematology analyzer every six months as per the QA policy. The laboratory failed to perform one of two calibrations due in 2021. The findings include: 1. A review of the Hematology calibration records revealed the AcT Diff was calibrated 2/9/2021 and then thirteen months later on 3/25/2022. There was no documentation of a calibration the second half of 2021. 2. A further review of the QA plan revealed on page 2 B.5 "Calibrations are done according to manufacturer's recommendations and at least every six months." 3. During an interview on November 29, 2020, at 10:57 AM, Testing Personnel #1 confirmed the calibration due in August 2021 was not performed. 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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of CMS (Centers for Medicaid and Medicare Services) CASPER reports and API (American Proficiency Institute) Proficiency Testing (PT) Evaluations, and a telephone interview with laboratory staff, the surveyor determined the laboratory failed to successfully participate in PT for RBC (Red Blood Cell) testing for two of three consecutive testing events. These failures resulted in an initial unsuccessful PT participation. The findings include: Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of CMS (Centers for Medicaid and Medicare Services) CASPER reports and API (American Proficiency Institute) Proficiency Testing (PT) Evaluations, and a telephone interview with laboratory staff, the surveyor determined the laboratory failed to successfully participate in PT for RBC (Red Blood Cell) testing for two of three consecutive testing events, Event #2, 2021 and Event #1, 2022. These failures resulted in an initial unsuccessful PT participation. The findings include: 1. A review of the CASPER reports and API PT evaluations revealed the following scores: a) RBC Event #2, 2021 0 % b) RBC Event #1, 2022 60 % These failures resulted in an initial unsuccessful PT participation. 2. In a telephone interview on 5/10/2022 at 4:40 PM, the laboratory staff confirmed the zero score for Event #2, 2021, explaining the staff failed to enter the results. The laboratory staff was unaware of the 60 % failing score for RBC. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of 2017-2018 American Proficiency Institute (API) proficiency testing records, CMS-209 form, and an interview with Testing Personnel (TP ) #1, the laboratory failed to ensure proficiency testing samples were rotated among all personnel who routinely perform moderate complexity testing on patients. This was noted on four of four surveys. The findings include: 1. A review of the API attestation statements revealed TP #2 performed all of the proficiency testing surveys from the first event in 2017 until the first event in 2018 the most current survey. No surveys had been performed by TP #1 in 2017-2018. 2. A review of the CMS-209 form revealed TP #1 was part-time and had been qualified to perform moderate complexity testing since the last survey conducted on 8/3/2016. 3. In an interview conducted on 6 /14/2018 at 11:07 AM, TP #1 reviewed the attestation statements with the surveyor and confirmed TP #2 performed all surveys in 2017 and the first survey in 2018. 4. This is a repeat deficiency. Jeremy Westry, BS, MT (ASCP) 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 --