Hale County Hospital

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the laboratory's proficiency testing provider, American Proficiency Institute (API). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D 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 4 -- 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 100%) in proficiency testing for Unexpected Antibody Detection, an analyte in the specialty of Immunohematology, and Prothrombin Time INR (International Normalized Ratio). The laboratory failed two consecutive PT events for each test in 2024 - 2025, resulting in initial unsuccessful proficiency testing performance. Refer to D2130 and D2172. . 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of at least 80%) in proficiency testing for Prothrombin Time INR (International Normalized Ratio). The laboratory failed two consecutive PT events in 2024 - 2025, resulting in initial unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Reports revealed the laboratory received failing scores for Prothrombin Time INR in two consecutive API PT events, as follows: A) 2024 Hematology Event #3: Prothrombin Time INR with a score of 0 % B) 2025 Hematology Event #1: Prothrombin Time INR with a score of 0 % 2. A review of the laboratory's proficiency testing evaluation reports from the API website confirmed these findings. . D2172 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(e) (e) Failure to achieve an overall testing event score of satisfactory 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 100%) in proficiency testing for Unexpected Antibody Detection. The laboratory failed two consecutive PT events in 2024 - 2025, resulting in initial unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Reports revealed the laboratory received failing scores for Unexpected Antibody Detection in two consecutive API PT events, as follows: A) 2024 Immunology / Immunohematology Event #3: 60 % B) 2025 Immunology / Immunohematology Event #1: 0 % 2. A review of the laboratory's proficiency testing evaluation reports from the API website confirmed these findings. . D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 4 -- 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 (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for Prothrombin Time INR (International Normalized Ratio) in two consecutive 2024 - 2025 API PT events. Refer to D2130. . 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and -- 3 of 4 -- 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for Unexpected Antibody Detection in two consecutive 2024 - 2025 API PT events. Refer to D2172. -- 4 of 4 --

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 the American Proficiency Institute (API) Proficiency Testing (PT) reports, and an interview with the Technical Consultant (TC), the laboratory failed to maintain successful PT participation for: 1) D-dimer and INR (International Normalized Ratio) for the following three consecutive events: a) D-dimer; 2022 Events #2 and #3, and 2023 Event #1. b) INR; 2024 Events #1 and #3, and 2025 Event #1. These failures result in a non-initial unsuccessful PT participation. 2) Urine Sediment, Potassium Hydroxide (KOH), and Prothrombin Time for the following two of three testing events: a) A) Urine Sediment; 2022 3rd event 2023 1st event. B) KOH; 2022 3rd event and 2023 2nd event. C) Prothrombin Time; 2024 3rd event 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 5 -- 2025 1st event. These failures result in a initial unsuccessful PT participation. Refer to D 2130. 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 review of the American Proficiency Institute (API) proficiency test records and an interview with the Technical Consultant (TC), the laboratory failed to achieve satisfactory performance for Urine Sediment, Potassium Hydroxide (KOH), and Prothrombin Time for two of three testing events, and D-dimer and INR (International Normalized Ratio) for three of three testing events. This was noted for proficiency testing records reviewed in 2022 through 2025 for the specialty Hematology. The findings include: 1. A review of the API proficiency test results revealed unsuccessful performance for Urine Sediment, KOH, and Prothrombin Time for two consecutive testing events, as follows: A) Urine Sediment; Hematology 2022 3rd event 50% and 2023 1st event 0%. B) KOH; Hematology 2022 3rd event 50% and 2023 2nd event 50%. C) Prothrombin Time; Hematology 2024 3rd event 0% and 2025 1st event 0%. 2. A review of the API proficiency test results revealed unsuccessful performance for D-dimer and INR for three consecutive testing events, as follows: a) D-dimer; 2022 2nd event 0%, 2022 3rd event 50%, and 2023 1st event 0%. b) INR; 2024 1st event 60%, 2024 3rd event 0%, and 2025 1st event 0%. 2. During an interview on 4-29- 2025 at 11:15 AM, the TC confirmed the above findings. . 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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on a review of Abbott I-stat quality control (QC) records, Blood Bank QC records, Clostridioides difficile (C.diff) QC records, serum hCG (Human Chorionic Gonadotropin) QC records, and an interview with the Technical Consultant (TC), the laboratory failed to retain documentation of daily QC performed. This was noted for 2023 through 2025. The findings include: 1. A review of the QC records revealed no evidence of the following documentation: a) I-stat Chem 8, CG4, and cTnI QC records for February 2023. b) Blood Bank QC records for February 2023. c) C.diff QC records for January through December 2023 and January through March 2025. d) Serum hCG QC records for January through December 2023, January through December 2024, and January through March 2025. 2. During the exit interview on 4- 30-2025 at 3:25 PM, the TC confirmed she could not locate the QC records for the above analyzers. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) -- 2 of 5 -- The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records,

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 the Centers for Medicare and Medicaid (CMS) CASPER 155 reports, American Proficiency Institute (API) Proficiency Testing (PT) reports, and an interview with the interim Laboratory Manager, the laboratory failed to maintain successful PT participation for the White Blood Cell (WBC) Differential for three consecutive events, Events #2 and #3, 2022, and Event #1, 2023. These failures result in a non-initial unsuccessful PT participation. 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 3 -- 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 the Centers for Medicare and Medicaid (CMS) CASPER 155 report, American Proficiency Institute (API) Proficiency Testing (PT) reports, and an interview with the interim Laboratory Manager, the laboratory failed to maintain successful performance in three consecutive events (2nd and 3rd events of 2022, 1st event of 2023), resulting in unsuccessful performance for White Blood Cell Differential (WBC Diff). The findings include: 1. A review of the CASPER 155 report revealed the following scores: a) Event #2, 2022 WBC Differential 60 % b) Event #3, 2022 WBC Differential 4 % c) Event #1, 2023 WBC Differential 0 % 2. The API PT reports confirmed the above mentioned scores, and indicated the laboratory failed to participate in Event #1, 2023. 3. In an interview on 6/27/2023 at 9: 22 AM, the interim Laboratory Manager confirmed the above noted PT failures. At 11: 15 AM, during a follow-up interview, the interim Laboratory Manager agreed to voluntarily cease testing of the WBC Differential. 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and American Proficiency Institute (API) Proficiency Testing (PT) reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) The laboratory director must ensure the results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and American Proficiency Institute (API) Proficiency Testing (PT) reports, and an interview with the interim Laboratory Manager, the Laboratory Director failed to ensure the testing personnel timely submitted the PT results of the Hematology, Event #1, 2023. The untimely submission of the PT values resulted in a "Failure to Participate." The findings include: 1. A review of the CASPER 155 report revealed the following score: a) Event #1, 2023 Hematology = 0 % 2. The API PT reports confirmed the above mentioned score, and indicated the laboratory failed to -- 2 of 3 -- participate in Event #1, 2023. 3. In an interview on 6/27/2023 at 9:22 AM, the interim Laboratory Manager confirmed the former Laboratory Manager did not submit the results by the grading time-lines for Event #1, 2023. -- 3 of 3 --

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 CASPER reports and American Proficiency Institute (API) Proficiency Testing (PT) reports, the laboratory failed to successfully participate in proficiency testing for the White Blood Cell (WBC) Differential for two consecutive events, Events #2 and #3, 2022. These failures result 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 CASPER reports and American Proficiency Institute (API) Proficiency Testing (PT) reports, the laboratory failed to satisfactorily perform in White Blood Cell (WBC) Differential (Hematology) testing for two consecutive events, Events #2 and #3, 2022. The findings include: 1. The CASPER report revealed the following scores for the laboratory: a) Event #2, 2022; WBC Differential = 60 % b) Event #3, 2022; WBC Differential = 4 % 2. A review API PT records confirmed the above noted findings. -- 2 of 2 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (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 a review of the calibration instructions in the DCA Vantage Analyzer Operator's Guide and an interview with Testing Personnel #2, the laboratory failed to perform calibration verification on the Urine Microalbumin / Urine Creatinine twice a year as required by CLIA regulations. This was noted from the previous survey (9/30 /2021) to the current survey (11/10/2022). The findings include: 1. A review of the calibration instructions in the DCA Vantage Analyzer Operator's Guide revealed 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 -- testing personnel performed a two-point calibration by scanning both sides of a calibration card received with each box of Urine Microalbumin / Urine Creatinine cartridges (a moderate-complexity test). Tests calibrated with less than three calibrators require calibration verification every six months, as per CLIA regulations. 2. During an interview on 11/10/2022 at 11:10 AM, when the surveyor requested the Urine Microalbumin / Urine Creatinine calibration verification records, Testing Personnel #2 stated, "We have never performed a calibration verification on the DCA Vantage Microalbumin / Urine Creatinine". . 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 quality control (QC)/patient test records, a review of IQCP (Individualized Quality Control Plan) documents, and an interview with the General Supervisor, the laboratory failed to ensure two levels of controls were run each day of patient testing or at the interval specified by the laboratory's IQCP for C. diff (Clostridium difficile), Urine Microalbumin /Urine Creatinine ratio, and Serum Ketones. This was noted eleven times from October 2021 - October 2022. The findings include: 1. A review of the quality control/patient test records revealed the following: a) C. diff - one patient test was performed on 10/12/2021 with the last QC run on 10/04/2021. One patient was performed on 01/30/2022 with the last QC run on 01/20/2022. b) Urine Microalbumin /Urine Creatinine ratio- patient tests were performed on 5/18/2022, 5/25/2022, and 5/31/2022 with the last QC run performed on 4/15/2022. c) Serum Ketones - Patient tests were performed on 10/06/2021, 10/08 /2021, 10/10/2021, 1/21/2022, 06/11/2022, and 06/27/2022 with no documentation of quality controls. 2. A review of the IQCP documents revealed the following: a) IQCP for C. diff: a positive and negative control should be performed upon opening the kit and with specimen testing at an interval not less than 7 days or with next procedure if interval is greater than 7 days. b) IQCP for Urine Microalbumin /Urine Creatinine ratio: a positive and negative control should be performed upon opening the kit and with specimen testing at an interval not less than 30 days or with next procedure if interval is greater than 30 days. 3. During an interview on 11/10/2022 at 9:53 AM, the General Supervisor confirmed the above findings. . D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a review of the test menu and analyzers, and an interview with the General Supervisor (also the Laboratory Manager), the laboratory failed to implement procedures to ensure test results from different analyzers were compared and evaluated twice a year. This affected four analytes from the previous survey (9/30 /2021) to the current survey (11/10/2022). The findings include: 1. A review of the test menu and analyzers revealed four analytes are performed on more than one instrument in the laboratory as follows: A) Troponin-performed on the Seimens Dimension EXL-200 and the Abbott I-Stat B) Hemoglobin A1c-performed on the Seimens Dimension EXL-200 and Seimens DCA Vantage C) Basic Metabolic Profile- performed on the Seimens Dimension EXL-200 and the Abbott I-Stat D) Glucose- performed on the Seimens Dimension EXL-200 and Accuchek Glucometer 2. During an interview on 11/10/2022 at 11:55 AM, the surveyor requested documentation of comparison studies of test results on the two testing platforms. The General Supervisor was not sure the laboratory had performed any comparison studies, and did not provide any documentation of comparison evaluations. . D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on reviews of personnel files, and an interview with the current General Supervisor (also the Laboratory Manager), the Technical Consultant failed to ensure training was performed and documented before testing personnel began patient testing. This affected six of six new testing personnel listed on the Form CMS-209 (Laboratory Personnel Report). The findings include: 1. A review of personnel files revealed no documentation of training for six new testing personnel hired since the date of the previous survey (9/29/2021). Only an initial competency was performed which included a list of instruments and tests with "Yes" under the "Proficiency" column, along with the date, the testing personnel's initials and observer's initials. There were no details on how the testing personnel were trained, or what the training included (such as maintenance, quality control, calibrations, problem resolution, results reporting and other tasks). The surveyor further noted the laboratory did not specify how personnel were trained to collect arterial blood gases. 2. During an interview on 11/9/2022 at 1:05 PM, the current General Supervisor (hired in August 2022) confirmed the above findings, and explained she had continued to use the same system already in use when she "got here" because it "was all that was available". . D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (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. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on reviews of personnel records and an interview with the General Supervisor (also, the Laboratory Manager), the Technical Consultant failed to implement a mechanism to assess the six minimal competency assessment criteria required for moderate complexity testing. This was noted from the previous survey (9/30/2021) to the current survey (11/10/2022). The findings include: 1. A review of personnel records revealed competency assessments which included a list of instruments and tests with "Yes" under the "Proficiency" column, along with the date, the testing personnel's initials and the observer's initials. There were no details on how employee competency was assessed, or if the six minimal competency assessment criteria required for moderate complexity testing were considered. 2. The surveyor further noted employee files for Testing Personnel #2, #4 and #5 included a "Performance Assessment" sheet which included five of the six competency assessment criteria, however the "Procedure observed" was not specified. 3. As part of the investigation of a complaint, the surveyor also reviewed files to determine if the staff were assessed on their Arterial Blood Gas (ABG) collection proficiency. A review of the Competency Assessment check off sheet (see #1 above) listed, "ABGs" "Performing Arterial Stick" [and] "Check off on skills sheet" with "Yes" under the "Proficiency" column for the General Supervisor, Testing Personnel #6, and one Phlebotomist. However, the assessment of ABG collection skills were not included on the form entitled, "SKILL /ELEMENT OF KNOWLEDGE", under the section "Specimen Collection and Processing". 4. During an interview with the General Supervisor on 11/9/2022 at 1:05 PM, the surveyor reviewed the six competency assessment criteria required for moderate complexity testing in the CMS booklet, "What Do I Need to Do to Assess Personnel Competency?", listed as follows: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting of test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples. f) Assessment of problem solving skills. 5. As the interview continued on 11/9/2022 at 1:35 PM, the surveyor explained the current system failed to specify how the employee competency was assessed, or whether the six required competency assessment criteria for moderate complexity testing were considered for each testing platform. The current General Supervisor (hired in August 2022) confirmed the above findings, and explained the laboratory had continued to use the same system already in use when she "got here" because it "was all that was available". SURVEYOR ID# 32558 and 46292 Licensure and Certification Surveyors -- 4 of 4 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) Proficiency Testing records and an interview with General Supervisor #2, the Laboratory failed to review and evaluate all results less than 100%. This was noted on 4 out of 38 Testing Events from 2019 - 2021. The findings include: 1. A review of Proficiency Testing records revealed the following: a) 2019 Hematology/Coagulation 3rd Event - 80% Blood Cell Identification and 80% Monocytes with no

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 the CMS CASPER Report (#153 and #155) for Proficiency Testing (PT) and API (American Proficiency Institute) PT evaluations, the surveyor determined the laboratory failed to successfully participate in ImmunoHematology for compatibility testing for three out of four consecutive events Event #3 2019, Event #1 2020, and Event #3 2020. The failures of compatibility testing for these three out of four consecutive events resulted in a noninitial unsuccessful participation. The findings include: 1. A review of the CASPER reports revealed the laboratory scored sixty percent (60%) for compatibility testing for Event #3 2019, eighty percent (80%) for Event #1 2020, and eighty percent (80%) for Event #3 2020, three out of four 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 -- consecutive events. 2. The surveyor confirmed the above noted findings with the review of the API PT evaluations: 60% for Event #3 2019, 80% for Event #1 2020, and 80% for Event #3 2020. 3. An initial unsuccessful PT participation for Event #3 2019 and Event #1 2020 for compatibility testing was cited on 06/23/2020. These three out of four consecutive events resulted in the laboratory's noninitial unsuccessful PT participation. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory 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 review of the CMS CASPER Reports (#153 and #155) for Proficiency Testing (PT) and API (American Proficiency Institute) PT evaluations, the surveyor determined the laboratory failed to satisfactory perform in ImmunoHematology for compatibility testing for three out of four consecutive testing events, Event #3 2019, Event #1 2020, and Event #3 2020. The failure of compatibility testing for these three out of four consecutive testing events resulted in a noninitial unsuccessful participation. The findings include: Refer to D2016. 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 review of the CMS CASPER Report (#153 and #155) for Proficiency Testing (PT) and API (American Proficiency Institute) PT evaluations, the surveyor determined the Laboratory Director failed to ensure the laboratory successfully participated in ImmunoHematology for compatibility testing for three out of four consecutive events Event #3 2019, Event #1 2020, and Event #3 2020. The failures of compatibility testing for these three out of four consecutive events resulted in a noninitial unsuccessful participation. The findings include: Refer to D2016. 1. A review of the CASPER reports revealed the laboratory scored sixty percent (60%) for compatibility testing for Event #3 2019, eighty percent (80%) for Event #1 2020, and eighty percent (80%) for Event #3 2020, three out of four consecutive events. 2. The surveyor confirmed the above noted findings with the review of the API PT evaluations: 60% for Event #3 2019, 80% for Event #1 2020, and 80% for Event #3 2020. 3. An initial unsuccessful PT participation for Event #3 2019 and Event #1 2020 for compatibility testing was cited on 06/23/2020. These three out of four consecutive events resulted in the laboratory's noninitial unsuccessful PT participation. -- 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 a review of the CMS CASPER Reports (#153 and #155) for Proficiency Testing (PT) and API (American Proficiency Institute) PT evaluations, the surveyor determined the laboratory failed to successfully participate in ImmunoHematology for compatibility testing for two consecutive testing events, Event #3, 2019 and Event #1, 2020. The failures of compatibility testing for these two consecutive testing events resulted in an initial unsuccessful participation. The findings include: 1. A review of the CASPER reports revealed the laboratory scored sixty percent (60 %) for compatibility testing for Event #3, 2019, and 80 % for Event #1, 2020, two consecutive testing events. 2. The surveyor confirmed the above noted findings with 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 -- the review of the API PT evaluations: the 60 % score for Event #3, 2019 and 80 % for Event #1, 2020. 3. These two consecutive failures resulted in the laboratory's initial unsuccessful PT participation. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory 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 review of the CMS CASPER Reports (#153 and #155) for Proficiency Testing (PT) and API (American Proficiency Institute) PT evaluations, the surveyor determined the laboratory failed to satisfactorily perform in ImmunoHematology for compatibility testing for two consecutive testing events, Event #3, 2019 and Event #1, 2020. The failures of compatibility testing for these two consecutive testing events resulted in an initial unsuccessful participation. The findings include: Refer to D2016. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observations of programmed data in the Sysmex CA-600 Coagulation analyzer, a review of Innovin Protime (PT) reagent "crossover study" records, and interviews with the Laboratory Manager, the surveyor determined the laboratory failed to manually verify the INR (International Normalized Ratio) to ensure all programmed data was entered correctly. This was noted on Innovin reagent in use from 11/9/2017 till the date of the survey on 10/23/2018. The findings include: 1. On 10/23/2018 at 4:05 PM, the surveyor reviewed the programmed data used for the calculation of the INR in the Sysmex CA-600 Coagulation analyzer. The printout listed the normal patient mean as 10.1 seconds, and the ISI (International Sensitivity Index) as 0.98. The Innovin PT reagent lot number (#) was not specified. 2. A review of the "crossover study" records for the Seimens Dade Innovin reagent Lot #539378 (in use since 11/9/2017) revealed the manufacturer's insert specified an ISI of 0.97, and the normal patient mean (for twenty patients) was calculated as 10.7 seconds. 3. During an interview with the Laboratory Manager on 10/23/2018 at 4:20 PM, the above discrepancy was discussed. The Manager explained the Sysmex Technician had assisted her by phone in the entry of the data for the new Innovin lot #539378. The Manager contacted the Sysmex Technician who verified she had assisted in the entry of the data, and theorized the laboratory had failed to save the data as required. A further review of the data in the Sysmex CA-600 revealed the data had actually been saved in the Extended Protime (XPT) channel (used to run abnormally high PT's) only, however it was not entered and saved in the regular PT channel. 4. As the 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 -- interview continued, the surveyor then asked the Laboratory Manager if the laboratory's Innovin "Crossover Study Procedure" included a comparison of the manually calculated INR to the INR calculated by the CA-600 to ensure they are the same. The Manager stated she "had looked at it", however she was unable to provide any documentation of the calculations. Thus the above noted findings were confirmed. . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observations, a record review of the 2016-2018 temperature charts, a review of storage requirements for the Biorad QC (Quality Controls) (used for D-Dimer, Chemistry, Endocrinology and Toxicology assays), and an interview with the Laboratory Manager, the surveyor determined the laboratory failed to define appropriate acceptable ranges (as defined by the manufacturer), and ensure QC was stored at temperatures specified by the manufacturer in 2017 and 2018. The findings include: 1. A review of the October 2016 thru October 2018 temperature records for the "Chest Freezer" revealed the laboratory specified an acceptable range of 0 to -25 degrees C (Celsius) on the charts. 2. During an interview on 10/25/2018 at approximately 5:00 PM, the Laboratory Manager stated the Chest Freezer is used to store the Biorad controls. The surveyor and Laboratory Manager then inventoried the contents of the freezer, which included multiple packages (with six bottles each) of Biorad Chemistry/Toxicology QC, Immunoassay QC (for Prostatic Specific Antigen [PSA] and Hormone assays), and Cardiac QC. An icon on each of the Biorad QC packages specified storage requirements of -20 to -70 degrees C. 3. A review of the 2017-2018 temperature charts with the Laboratory Manager revealed the Chest Freezer had consistently maintained temperatures colder than -20 degrees C until March 2017, and thereafter fluctuated. Approximately 50% of the time between March 2017 to October 2018, temperatures were noted to be outside Biorad's required storage temperatures of -20 to -70 degrees C. Testing personnel recorded temperatures in the range of -14 to -19 degrees C 50% of the time with no documentation of