Middle Georgia Chest & Medical Center, Llc

Summary Statement of Deficiencies D0000 A recertification survey was performed on .May 1, 2025. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the Calibration Verification documents for the Horiba Micros60 (Horiba) Hematology analyzer and staff interview, the laboratory did not perform the Calibration on the Horiba as stated in the Manufacturer Manual that calibrations should be performed every six months. Findings: 1. Review of the Calibration documents for the Horiba confirmed the laboratory failed to perform a Calibraton 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 -- between April 2023 and March 2024, a period of 11 months. 2. Staff interview with Testing Personnel (TP) 1, in the upstairs office, at approximately2 pm., confirmed the aforementioned statements 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: Document review of the Quality Control (QC) documents for the Specialty Chemistry, Sub-specialty Blood Urea Nitrogen (BUN) and Creatinine(Creat), and staff interview, confirmed the laboratory failed to cease testing when QC results for both analytes and levels of QC were outside 3SD (Standard Deviations). Findings 1. Review of the QC documents for May 16 thru May 19, 2023 revealed that between May 17 and May 18, 2023, both levels of the BUN QC was outside of 3SD. Review of the test log, on May 17 revealed that 71 patients had BUN results reported when the QC was out of the acceptance range. 2. Review of the QC documents for May 16 thru 19, 2023 and March 6 thru March 8, 2024 revealed that the Creat QC was outside the acceptable range. Review of the test logs for May 16 thru 19, 2023 and March 6-8, 2024 confirmed that 168 patients had CREAT results reported when the QC was out of the acceptance range. 3. Interview with Testing Personnel(TP) #1 in the upstairs office on 5-1-25 at approximately 3pm confirmed the aforementioned statements D6024 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(7) (e)(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratorys established performance specifications are identified, and that patient test results are reported only when the system is functioning properly; This STANDARD is not met as evidenced by: Based on review of the Patient's Requisition and staff interview the Laboratory Director (LD) failed to prevent patient test results from being reported when the system is not functioning properly. Findings: 1. Review of Quality Control documents and Patient's Requisition, the laboratory released patient results when the QC for BUN and CREAT during May 16 thru May 18, 2023 patient results were released when the QC values were outside acceptable range. On March 6 thru March 8, 2024 CREAT results were released when the QC values were outside acceptable range. 2. Interview with Testing Personnel (TP) 1, as listed on the Centers for Medicare and Medicaid (CMS) 209 Personnel form, on 5/1/2025, in the upstairs office, confirmed the aforementioned statement. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on July 22, 2024. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory 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 -- failed to successfully participate in proficiency testing (PT) in 4 consecutive events for white blood cell differential (WBC Diff) resulting in the subsequential non- initial unsuccessful participation for WBC Diff. Refer to D 2130 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 the review of the CMS CASPER 155 report and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to demonstrate satisfactory performance in 4 of 4 testing events for White Blood Cell Differential (WBC Diff) for the year 2023 - 2024. Findings: 1.A review of Report 155 revealed the laboratory failed to score at least 80% for the analyte WBC Diff during the following events: 2023 Event 1 Score 53% 2023 Event 2 Score 67% 2023 Event 3 Score 53% 2024 Event 1 Score 33% 2.A review of the API reports revealed and confirmed the following WBC Diff PT scores: 2023 Event # 1 Total WBC Diff score- 53% Lymphocyte- 20% Monocyte - 40% 2023 Event # 2 Total WBC Diff score- 67% Lymphocyte - 40% Monocyte- 60% 2023 Event # 3 Total WBC Diff score - 53% Lymphocyte- 20% Monocyte-40% 2024 Event # 1 Total WBC Diff score - 33% Lymphocyte- 20% Monocyte-40% Granulocytes-40% 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 review of the CMS CASPER 155 report and review of the API reports, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on review of the CMS CASPER Report 155 and the API 2023 events 1, 2, and 3; 2024 event 1 PT evaluation reports, the laboratory director failed to ensure successful PT participation in 4 consecutive testing events. Refer to D 2130 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 14, 2024. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory 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 -- failed to successfully participate in proficiency testing (PT) in 3 consecutive testing events for White Blood Cell Differential (WBC Diff) resulting in the non-initial unsuccessful participation for WBC Diff . Refer to D 2130 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 the review of the CMS CASPER 155 report and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to demonstrate satisfactory performance in 3 of 3 testing events for White Blood Cell Differential (WBC Diff) for the year 2023. Findings: 1.A review of Report 155 revealed the laboratory failed to score at least 80% for the analyte WBC Diff during the following events: 2023 Event 1 Score 53% 2023 Event 2 Score 67% 2023 Event 3 Score 53% 2. A review of the API reports revealed and confirmed the following WBC Diff PT scores: 2023 Event # 1 Total WBC Diff score- 53% Lymphocyte- 20% Monocyte - 40% 2023 Event # 2 Total WBC Diff score- 67% Lymphocyte - 40% Monocyte- 60% 2023 Event # 3 Total WBC Diff score - 53% Lymphocyte- 20% Monocyte-40% 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 review of the CMS CASPER 155 report and review of the API reports, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the CMS CASPER Report 155 and the API 2023 events 1, 2, and 3 PT evaluation reports, the laboratory director failed to ensure successful PT participation in 3 consecutive testing events. Refer to D 2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 3, 2023. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on the standard operating procedure (SOP) and staff interview, the laboratory director failed to approve, sign, and date the procdure and changes for the procedure manual before use. The Finding include: 1. SOP revealed the laboratory director failed to approve, sign, and date the procedure and changes for the procedure manual before use. The procedure manual was last signed in 2019. 2. During an interview with Testing Personnel #1 (CMS-209) on May 3, 2023 at approximately 11:20 AM, confirmed the laboratory director failed to approve sign, and date the procedure manual. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to 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 -- identify any problems that require

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on May 23, 2022. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecative events (3rd event of 2021 and 1st event 2022), 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 -- resulting in the first unsuccessful occurrence for Cell ID or WBC Diff #765. Findings include: Refer to D2130 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to maintain satisfactory performance in two consecutive events (3rd event of 2021 and 1st event of 2022), resulting in the first unsuccessful occurrence for WBC Diff, analyte # 765. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #765 WBC Diff on event 3 of 2021 with a score of 73% and event 1 of 2022 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from API confirms the laboratory failed WBC Diff on events 3 of 2021 and event 1 of 2022 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive events (3rd events of 2021 and 1st event of 2022), resulting in the first unsuccessful occurrence for WBC Diff, analyte # 765. Findings include: Refer to D 6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's -- 2 of 3 -- proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive events ( 3rd event of 2021 and 1st event of 2022), resulting in the first unsuccessful occurrence for WBC Diff, analyte # 765. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #765, WBC Diff on event 3 of 2021 with a score of 73% and event 1 of 2022 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed WBC Diff on Event 3 of 2021 and Event 1 of 2022, resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on February 25, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Quality Control (QC) documents for the Horiba ABX Micro 60 (ABX60) hematology analyzer, the laboratory failed to document acceptable QC for three days in January, 2021, for the analyte Hemoglobin (Hgb), and Mean Corpuscular Hemoglobin. Patient results were reported on these three days Findings: 1. Review of the QC documents for January 2021, the laboratory failed to document acceptable Hgb and MCH, for January 11, 12, 13, 2021. Review of the patient logs showed that there was 54 patients which had a Complete Blood Cell Count (CBC) performed on January 11, 12, 13, 2021. The Hgb and MCH are part of the CBC panel. 2. QC documents showed that on January 11, and 12, Hgb was out of range for the Low, and Normal control. On January 13, Hgb was out of range for the Normal and 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 -- High control. On January 12, for MCH, the Low, Normal, and High controls were all out of acceptable range. On January 13, and 14, the Normal and High controls for MCH were out of acceptable range. 3. Interview with the Laboratory Director (LD), on 05/25/2021, at approximately 1:45 pm in the laboratory, confirmed that the above aforementioned QC was out of range, and that 54 patient CBC results was released on those three days. 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 review of the Quality Control (QC) procedure and QC documents for the Opti CCA TS Blood Gas Analyzer (Opti) for testing Arterial Blood Gasses (ABG's), and staff interview, the laboratory failed to document two controls of different concentrations at least once each day, patient specimens are assayed. Findings: 1. Review of the QC procedure and QC documents for the Opti, the laboratory did not document two controls of different concentrations each day of patient testing for ABG's. 2. Interview with the Laboratory Director (LD) on 05/25/2021 , at approximately 1:30 pm in the Laboratory , confirmed that the laboratory was not performing two levels of different concentrations at least once each day, patient specimens are assayed. It was also confirmed that an Individualized Quality Control Plan (IQCP) had not been performed. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the Quality Control (QC) procedure and QC documents for the Opti CCA TS Blood Gas Analyzer (Opti) for testing Arterial Blood Gasses (ABG's), and staff interview, the Laboratory Director (LD) failed to verify that the laboratory documented two controls of different concentrations at least once each day, patient specimens are assayed. Findings: 1. Review of the QC procedure and QC documents for the Opti, the laboratory did not document two controls of different concentrations each day of patient testing for ABG's. 2. Interview with the Laboratory Director (LD) on 05/25/2021 , at approximately 1:30 pm in the Laboratory , confirmed that the laboratory was not performing two levels of different concentrations at least once each day, patient specimens are assayed. It was also confirmed that an Individualized Quality Control Plan (IQCP) had not been performed. -- 2 of 3 -- D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of the Quality Control (QC) procedure and QC documents for the Opti CCA TS Blood Gas Analyzer (Opti) for testing Arterial Blood Gasses (ABG's), and staff interview, the Technical Consultant failed to verify competency of the staff for performing Quality Control(QC). The testing personal failed to document two controls of different concentrations at least once each day, patient specimens are assayed. Findings: 1. Review of the QC procedure and QC documents for the Opti, the laboratory did not document two controls of different concentrations each day of patient testing for ABG's. 2. Interview with the Laboratory Director (LD) on 05/25 /2021 , at approximately 1:30 pm in the Laboratory , confirmed that the laboratory was not performing two levels of different concentrations at least once each day, patient specimens are assayed. It was also confirmed that an Individualized Quality Control Plan (IQCP) had not been performed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 17, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) evaluation reports for the 2017 3rd event, and staff interview, the laboratory failed to provide acceptable