Nell J Redfield Memorial Hospital

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 Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the American Proficiency Institute (API) and a telephone interview with the laboratory manger on 8 /21/2025, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) consecutive testing events in 2025 for the specialty of routine chemistry for the analyte creatinine kinase. See D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 -- (f) Failure to achieve satisfactory performance for the same analyte or test in 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 Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Proficiency Institute (API) and an interview with the laboratory manager on 8/21 /2025, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) consecutive testing events in 2025 for the specialty of routine chemistry. The findings include: 1. A PT desk review of Report 155D and graded PT results from API identified that the laboratory failed to achieve satisfactory performance for two of three events for the specialty of routine chemistry for the analyte creatinine kinase. Analyte Year Event Score Creatinine kinase 2025 1 60% Creatinine kinase 2025 2 20% 2. A telephone interview with the laboratory manager on 8/21/2025 at 2:09 pm confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of calibration records, instrument documents for the Beckman Coulter AU480 and i-STAT 1 and an interview with the laboratory manager on 1/10 /2025, the laboratory failed to verify the reportable range at least once every six months for chemistry and blood gas analytes in 2023 and 2024. The findings include: 1. A review of calibration records and a lack of linearities for the Beckman Coulter AU480 identified that the laboratory failed to verify the reportable range for Albumin, Alkaline Phosphatase, ALT, AST, Amylase, Bicarbonate, Bilirubin Direct, Bilirubin Total, Calcium, Chloride, Cholesterol, Creatinine, Glucose, Phosphorus, Potassium, Iron, Lactate, Lipase, Magnesium, Sodium, Total Protein, Triglycerides, Urea 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 -- Nitrogen (BUN) and Uric Acid at least every six months in 2023 and 2024. 2. A review of instrument documents and a lack of linearities for the i-STAT 1 identified that the laboratory failed to verify the reportable range for the blood gas analytes: pH, PO2, PCO2, TCO2, HCO3 and SO2 at least every six months in 2023 and 2024. 3. An interview with the laboratory manager on 1/10/2025 at 8:08 am confirmed that the laboratory had not verified the reportable range of chemistry and blood gas analytes at least once every six months in 2023 and 2024. 4. The laboratory reports performing 173,801 chemistry tests and 193 blood gas tests annually. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. This STANDARD is not met as evidenced by: Based on a random record review of Quality Control (QC) documentation and an interview with the laboratory manager on 1/9/2025, the laboratory failed to successfully perform two levels of QC every eight hours of patient coagulation testing. The findings include: 1. A random record review of QC documents from the ACL Top 300 for 2023 and 2024 identified that the laboratory failed to perform two levels of QC every eight hours for prothrombin time (PT) and partial thromboplastin time (PTT) testing. On 5/9/2023 level one QC was not performed and three (3) patient PT results and one (1) patient PTT result were reported. On 7/12/2024 level one QC was not performed and two (2) patient PT results were reported. 2. An interview with the laboratory manager on 1/9/2025 at 11:24 am confirmed the above finding. 3. The laboratory reports performing 1,041 PT and PTT tests annually. -- 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 Centers for Medicare and Medicaid (CMS) proficiency testing data report (Report 155D), graded proficiency testing results from the American Proficiency Institute (API) and a phone interview with laboratory testing personel one (TP1) the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) proficiency testing events in 2023 and 2024 for the specialty of hematology. See 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 the Centers for Medicare and Medicaid (CMS) Proficiency Testing data report (Report 155D), graded proficiency testing results from the American Proficiency Institute (API) and an interview with testing personnel one (TP1) on 7/19/2024, the laboratory failed to achieve satisfactory performance for two (2) consecutive proficiency testing events for the analytes prothrombin time (PT) and partial thromboplastin time (PTT). The findings include: 1. A review of Report 155D and graded proficiency testing results from API identified that the laboratory failed to achieve satisfactory performance for events two (2) in 2023 and one (1) in 2024 for the specialty of hematology for the following analytes: Analyte Year Event Score PT 2023 2 60% PT 2024 1 60% PPT 2023 2 60% PPT 2024 1 40% 2. An interview with TP1 on 7/28/2022 at 12:08 pm confirmed the above findings. -- 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 an off-site Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the American Proficiency Institute (API) and a telephone interview with the technical supervisor on 03/26/2024 the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events for the subspecialty routine chemistry. Refer to D2089 and D2097. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) 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 participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the American Proficiency Institute (API), and a telephone interview with the technical supervisor on 03/26/2024, the laboratory failed to participate in one (1) of three (3) testing events between 2023 and 2024 for the specialty routine chemistry for the analyte Sodium (Na) The Findings Include: 1. A PT desk review of the laboratory's graded 2023 and 2024 results from API revealed that the laboratory failed to participate in testing for event two (2) in 2023 for the specialty of routine chemistry for the analyte: Sodium (Na) Analyte Year Event Score Sodium (Na) 2023 2 0% Sodium (Na) 2024 1 20% 2. A review of the API PT results from 2023 event two (2) and 2024 event one (1) revealed the laboratory received scores of zero (0%) and twenty (20%) for each event, respectively ,for the analyte: Sodium (Na) 3. A telephone interview with the technical supervisor at 2:40 PM on 03/26/2024 confirmed the results. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Proficiency Institute (API) and a telephone interview with the technical supervisor on 03/26/2024, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) consecutive testing events in 2023 and 2024 for the subspecialty of routine chemistry for the analyte: Sodium (Na) The Findings Include: 1. A PT desk review of the laboratory's graded 2023 and 2024 results from API revealed that the laboratory failed to achieve satisfactory scores for two consecutive testing events in the subspecialty of Routine Chemistry for the analyte: Sodium (Na) Analyte Year Event Score Sodium (Na) 2023 2 0% Sodium (Na) 2024 1 20% 2. A review of the API PT results from 2023 event two (2) and 2024 event one (1) revealed the laboratory received scores of zero (0%) and twenty (20%) for each event, respectively, for the analyte: Sodium (Na) 3. A telephone interview with the technical supervisor at 2:40 PM on 03/26/2024 confirmed the results. -- 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 proficiency testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the American Proficiency Institute (API) and a telephone interview with the technical supervisor on 10/25/2023 at 08:26 AM, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) consecutive testing events in 2023 for the subspecialty of routine chemistry for the analyte Glucose (non-waived). Refer to D2088. D2088 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Proficiency Institute (API) and an interview with the technical supervisor on 10/25 /2023, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) consecutive testing events in 2023 for the subspecialty of routine chemistry. The findings include: 1. A PT desk review of Report 155D and graded PT results from API identified that the laboratory failed to achieve satisfactory scores for the subspecialty of routine chemistry for the analyte Glucose (non-waived) Analyte Year Event Score Glucose 2023 2 0% Glucose 2023 3 60% 2. A telephone interview with the technical supervisor on 10/25/2023 at 08:26 AM confirmed the above findings. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Proficiency Institute (API) and a telephone interview with the technical supervisor on 10/25/2023, the laboratory failed to participate in one (1) of three (3) testing events in 2023 for the specialty of chemistry. The findings include: 1. A PT desk review of Report 155D and graded PT results from API identified that the laboratory failed to participate in testing for event two (2) in 2023 for the specialty of routine chemistry for the analyte: glucose (non-waived) resulting in a score of zero (0). 2. A telephone interview with the technical supervisor on 10/25/2023 at 08:26 AM confirmed the above findings. -- 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 a review of Beckman Coulter AU480 maintenance logs and an interview with the laboratory manager on 1/25/2023, the laboratory failed to perform maintenance as required by the manufacturer. The findings include: 1. A random review of Beckman Coulter AU480 maintenance logs identified that the laboratory failed to perform monthly maintenance which included cleaning the sample probe and reagent probe wash wells, cleaning the mix bar wash wells, cleaning the wash nozzle unit and checking the tube mounting joints and cleaning the DI water tank, DI filter, and sample probe filter in December 2021, April 2022 and November 2022. 2. A random review of Beckman Coulter AU480 maintenance logs identified that the laboratory failed to perform quarterly Ion-Selective Electrode (ISE) maintenance which included replacing the roller tubes for MID solution dispense and mixture aspiration and replacing the pinch valve tubing in November 2022. 3. A random review of Beckman Coulter AU480 maintenance logs identified that the laboratory failed to perform every other week ISE maintenance which included manually washing the mix bars, liquid level sensors, sample pot and sample pot tubes in December 2021, April 2022, September 2022, October 2022 and November 2022. 4. A random review of Beckman Coulter AU480 maintenance logs identified that the laboratory failed to perform weekly ISE maintenance which included enhanced cleaning of the electrode line for three of four weeks in December 2021, four of four weeks in September 2022 and two of four weeks in October 2022. 5. An interview 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 -- with the laboratory manager on 1/25/2023 at 10:39 am confirmed that the laboratory failed to document the above maintenance. 6. The laboratory reports performing 91,845 tests annually on the Beckman Coulter AU480. 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 random record review of chemistry and hematology quality control (QC) documentation and an interview with the laboratory manager on 1/25/2023, the laboratory failed to include two levels of QC each day of patient testing. The findings include: 1. A random record review of chemistry QC performed on the Beckman Coulter AU480 identified that the laboratory failed to document two levels of QC on 6 /8/2021 for high-density lipoprotein (13 patients reported), on 12/2/2021 for total protein (9 patients reported), on 4/22/22 for calcium (17 patients reported) and on 9/12 /22 for alkaline phosphatase (25 patients reported). 2. A random record review of hematology QC performed on the Beckman Coulter DXH identified that the laboratory failed to document two levels of QC on 7/26/2021 for complete blood count (17 patients reported) and on 4/27/2021 and 4/28/2021 for red blood cells (43 patients reported). 3. An interview with laboratory manager on 1/25/2023 at 1:54 pm confirmed the above findings. 4. The laboratory reports performing 98,284 chemistry tests and 38,936 hematology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from American Proficiency Institute (API) and an interview with the laboratory manager on 4/21/2021, the laboratory director or his/her designee failed to sign a statement attesting that PT samples were tested in the same manner as patient specimens. The findings include: 1. A review of PT testing from API for 2019 immunology/immunohematology 3rd event identified the laboratory director or his/her designee failed to sign the attestation statement. 2. An interview with the laboratory manager on 4/21/2021 at 9:40 am confirmed that the laboratory director failed to sign the attestation statement for the 2019 immunology/immunohematology 3rd event. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 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 -- 493.1253. (7) Control procedures. (8)

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 proficiency testing desk review and the laboratory's PT results from the American Proficiency Institute, the laboratory repeatedly failed to successfully participate in proficiency testing for the analyte Thyroid Stimulating Hormone (TSH). Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 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 and the laboratory's graded results from the American Proficiency Institute, the laboratory repeatedly failed to achieve satisfactory performance in three consecutive testing events for Thyroid Stimulating Hormone (TSH). Findings: Analyte Year Event Score TSH 2018 2 0% TSH 2018 3 0% TSH 2019 1 40% 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 the deficiencies cited under the Laboratory Director's responsibilities and the subsequent unsuccessful performance in proficiency testing, the laboratory director failed to provide overall management for the laboratory. See D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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) review and the laboratory's PT results from the American Proficiency Institute, the Laboratory Director failed to ensure the laboratory maintained successful participation in proficiency testing for the analyte Thyroid Stimulating Hormone (TSH). Findings: Analyte Year Event Score TSH 2018 2 0% TSH 2018 3 0% TSH 2019 1 40% -- 2 of 2 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record reviews, patient worksheet reviews, and an interview with the laboratory manager, the laboratory failed to test five immunohematology proficiency samples from the American Proficiency Institute (API) in the same manner as they test patient samples during the API 2018 event 2. Findings: 1. A review of the API 2018 event 2 records revealed the laboratory failed to test immunohematology quality control for antibody detection, ABO/RH, and compatibility testing prior to testing 5 PT samples on April 11, 2018. 2. The laboratory performs approximately 180 immunohematology samples a year. 3. An interview on February 12, 2018 at 9:55 AM, with the laboratory manager, confirmed the laboratory failed to perform immunohematology quality control prior to testing PT samples. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) records review and an interview with the laboratory manager, the laboratory failed to retain instrument print-outs from PT test results from the events reviewed between October 2017 through December 2018. This is a repeat deficiency from the last survey on July 28, 2017. Findings: 1. A review of the American Proficiency Institute (API) test events for the specialties chemistry, endocrinology, toxicology, microbiology, and hematology revealed the laboratory failed to retain instrument data results or manual data results for the proficiency test samples performed during 2017 event 3 through 2018 event 3. 2. The laboratory tests approximately 61,700 analytes per year. 3. An interview on February 12, 2019 at 8:40 AM, with the laboratory manager, confirmed the PT results from the analyzers was not retained. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on an observation, a proficiency testing (PT) records reviews, and an interview with the laboratory manager, the laboratory failed to document any remedial action or

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 proficiency testing desk review, the laboratory failed to successfully participate in proficiency testing for the analyte Thyroid Stimulating Hormone. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review and the laboratory's graded results from the American Proficiency Institute, the laboratory failed to achieve satisfactory performance in two consecutive testing events for Thyroid Stimulating Hormone (TSH). Findings: Analyte Year Event Score TSH 2018 2 0% TSH 2018 3 0% -- 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 proficiency testing desk review, the laboratory failed to successfully participate in proficiency testing for Compatibility Testing. Refer to D2181. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk review and the laboratory's graded results from the American Proficiency Institute (API), the laboratory failed to achieve an overall testing event score of satisfactory performance for two out of three testing events for Compatibility testing. Findings: Analyte Year Event Score Compatibility Testing 2018 1 80% Compatibility Testing 2018 2 0% -- 2 of 2 --