Family Medical Center Of Hart County

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing (PT) scores obtained from the national database and verified with the PT company. The laboratory was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 proficiency testing (PT) desk review of the Certification and Survey Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Provider Enhanced Reporting (CASPER)-0155 and American Proficiency Institute 2024 records (3rd event) and 2025 records (1st event), the laboratory failed to successfully participate in a PT program. The laboratory failed to successfully participate in the specialty of Microbiology for Bacteriology for 2 consecutive testing events. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) (e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 and American Proficiency Institute 2024 records (3rd event) and 2025 records (1st event), the laboratory failed to achieve satisfactory performance (80% or greater) for 2 consecutive testing events in Bacteriology. The findings include: 1. Review of the CASPER -0155 report revealed the following: Microbiology 2024- 3rd Event The laboratory received an unsatisfactory score of 67% for Bacteriology. Microbiology 2025- 1st Event The laboratory received an unsatisfactory score of 75% for Bacteriology. 2. A PT desk review from API 2024 and 2025 PT records confirmed the above findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2024 records (3rd event) and 2025 records (1st event), the laboratory director failed to provide overall management and direction of the laboratory services to ensure successful PT participation of testing in Bacteriology during 2 consecutive testing events. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 and American Proficiency Institute -- 2 of 3 -- (API) 2024 records (3rd event) and 2025 records (1st event), the laboratory director failed to ensure that the PT samples were tested as required under Subpart H during 2 consecutive testing events. Refer to D2028. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing (PT) scores obtained from the national database and verified with the PT company. The laboratory was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 proficiency testing (PT) desk review of the Certification and Survey Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Provider Enhanced Reporting-0155 and American Proficiency Institute 2024 (2nd and 3rd event) records, the laboratory failed to successfully participate in a PT program. The laboratory failed to successfully participate in the specialty of Hematology for Red Blood Cell count (RBC) amd Hemoglobin for 2 consecutive testing events. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) 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 proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2024 (2nd and 3rd events) records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in 2 consecutive testing events in Hematology for Red Blood Cell counts (RBC) and Hemoglobin (HGB). The findings include: 1. Review of the CASPER -0155 report revealed the following: Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 40% for RBC. Hematology 2024- 3rd Event Laboratory received an unsatisfactory score of 20% for RBC. Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 40% for HGB. Hematology 2024- 3rd Event Laboratory received an unsatisfactory score of 60% for HGB. 2. A PT desk review from API 2024 PT records confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting-0155 and American Proficiency Institute 2024 (2nd and 3rd events) records, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services to ensure successful PT participation of Red Blood Cell counts (RBC) and Hemoglobin (HGB) testing during 2 consecutive testing events. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting-0155 and American Proficiency Institute 2024 (2nd and -- 2 of 3 -- 3rd event) records, the laboratory director failed to ensure that the PT samples were tested as required under Subpart H during 2 consecutive testing events. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 04/13/2023 and the facility was found not to be in substantial compliance with the laboratory requirements at 42 CFR Part 493, with deficiencies cited. 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 the laboratory's procedure manual, Uricult CLIA Compliance Reference Guide and interview, the laboratory failed to verify the accuracy of 1 of 1 urine colony count procedure performed (Uricult test procedure). Findings included: Review of the laboratory procedure manual revealed there was no test procedure for the Uricult test. Review of the test distributor's "Uricult CLIA Compliance Reference Guide", undated, revealed, "No standard proficiency survey required but must participate in a bi-annual assessment program." During an interview on 04/13/2023 at 11:05 PM, the Laboratory Manager (LM) stated she was unaware the Uricult test was not a moderate complexity test, therefore PT was not done. 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, 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 -- 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 review of the Cell-Dyn 1700 Complete Blood Counts procedure, calibration report and interview, the laboratory failed to calibrate the Cell-DYN hematology analyzer at the frequency indicated for 2 of 2 years reviewed (2021 and 2022). Findings included: A review of the laboratory procedure titled "Complete Blood Counts Cell-DYN 1700" revised on 04/27/2016, revealed "7. Calibration: a. Calibration is required whenever the quality control is out of range or once every six (6) months whichever comes first." A review of the calibration report for the Cell- DYN hematology analyzer revealed the analyzer was calibrated on 12/30/2021 and 10 /18/2022. Another calibration was due 06/2022 but was not performed. During an interview on 04/13/2023 at 1:20 PM, the Laboratory Manager (LM) stated calibrations were only completed annually for the Cell-DYN hematology analyzer. -- 2 of 2 --

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 desk review of Hematology proficiency testing results from the American Proficiency Institute on 01/11/2019, the laboratory failed to successfully participate in the Red Blood Cell certified analyte in two (2) of three (3) consecutive testing events. See D2121 and D2130 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Hematology proficiency testing results from the American Proficiency Institute on 01/11/2019, the laboratory failed to attain a satisfactory score of at least eighty percent (80%) on the Red Blood Cell analyte. Findings include: The laboratory scored an unsatisfactory twenty percent (20%) in the first testing event of 2018 and scored an unsatisfactory forty percent (40%) in the third testing event of 2018. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 desk review of Hematology proficiency test results from the American Proficiency Institute on 01/11/2019, the laboratory failed to successfully achieve satisfactory performance for the Red Blood Cell Count in two (2) of three (3) consecutive testing events. Findings include: The facility scored twenty percent (20%) in the first testing event of 2018 and scored forty percent (40%) in the third testing event of 2018 for an unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 record review and staff interview on 11/13/2018 and 11/14/2018, the laboratory failed to perform and document maintenance procedures as required by the manufacturer of the TOSOH A1A 360 chemistry analyzer. Findings include: The laboratory failed to perform monthly maintenance in January, February, June, September, October, and December of 2017. The laboratory failed to perform six month and annual maintenance from November 2017 through October 2018. An interview with the Technical Supervisor at 11:00 AM on 11/13/2018, revealed the laboratory failed to establish a system to ensure maintenance procedures were performed and documented as required and recommended by the manufacturer. 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 --