Care Bioclinical Laboratory

Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) (a) The laboratory must be constructed, arranged, and maintained to ensure the following: (a)(1) The space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on the observations during the laboratory tour, lack of service report, review of four patient records from July 10, 2026, and interview with the manager on August 12, 2026, The laboratory failed to ensure that the ESCO Class II biological safety cabinet (BSC) used for patient sample processing was properly maintained and functioning within acceptable manufacturer specifications prior to use. The findings include: 1. Observations during the tour revealed that except for the ESCO Class II BSC, all equipment were calibrated and maintained by an external service company. 2. The laboratory provided only four patient records for review, which represented all patient specimens processed since the start of testing. All four specimens were processed in the ESCO Class II BSC during a period when the BSC filter was already known by the laboratory to be outside acceptable performance thresholds. 3. During an interview on August 12, 2026, at approximately 11:06 a.m., the manager stated that when the laboratory received the ESCO Class II BSC, the external service company arrived in June 2026 and determined that the BSC filter was not within acceptable threshold. The manager further stated that the service company could not perform the preventive maintenance because the laboratory did not have a replacement filter available. Despite this knowledge, the laboratory continued to use the ESCO Class II BSC to process patient specimens for PCR testing. D3005 FACILITIES CFR(s): 493.1101(a)(3) 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 -- (a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on direct observation of the facility layout and of the laboratory's Polymerase Chain Reaction (PCR) testing for the presumptive detection of SARS CoV-2 (COVID19), RSV A/B and Influenza A/B and interview with the manager on August 12, 2026, the laboratory failed to ensure that the PCR procedures which are not contained in closed systems have a unidirectional flow with separate areas for specimen preparation, master mix and reagents preparation, amplification, and product detection. The findings include: 1. The laboratory performed PCR testing for the detection of COVID19, RSV A/B and Influenza A/B using manual and automated methods for specimen processing, preparation of the master-mix, controls, reagents, and addition of template. 2. During the laboratory tour on August 12, 2026, at approximately 11:06 a.m., the surveyor observed that access to the ESCO Class II biosafety cabinet (specimen processing area) was limited to a single shared doorway, which served as both the entrance and exit. This arrangement caused staff to move bidirectionally through the same space. After specimen processing, testing personnel proceeded through the same doorway to another area used for master-mix and reagent preparation and extraction procedures. Personnel were then required to retrace their steps through the same shared hallway before entering a different room containing the Applied Biosystems 7500 Fast Real-Time PCR System for amplification and detection. This repeated forward-and-back movement through multiple testing steps did not provide unidirectional flow, contrary to CLIA requirements for molecular procedures. 3. During an interview on August 12, 2026, at approximately 11:06 a.m., the manager confirmed that the laboratory's physical design did not support the unidirectional workflow required by CLIA for molecular amplification procedures. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's competency assessment policy and procedure, four patient records, lack of personnel competency documentation, and an interview with the testing personnel on August 12, 2026, as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to follow the written personnel competency assessment policy and procedure. The findings include: 1. The laboratory's policy and procedure for testing personnel competency assessment aligned with CLIA requirements but was not followed. 2. Record review showed that the testing personnel lacked competency assessment documentation prior to testing the four patient samples on July 10, 2026, which represented all the patient specimens processed since testing began. a. Patient samples processed and tested on July 10, 2026: i. G126-00122 ii. G126-00119 iii. G126-00120 iv. G126-00121 3. During an interview on August 12, 2026, at approximately 11:06 a.m., the testing personnel confirmed that the laboratory failed to conduct and document the initial competency -- 2 of 3 -- assessment prior to testing patient samples on July 10, 2026. 4. No

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on 09/08/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) records (2025-1 and 2025-2), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the specialty of Hematology and analyte Prothrombin Time (PT) resulting in unsuccessful performances. See D2130 & D2131. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for three consecutive events (2025-1 and 2025-2) for the specialty Hematology and analyte Prothrombin Time (PT): PT 0% - 2025 first testing event; PT 0% - 2025 second testing event. A review of the 2025 scores from API confirmed the above findings. D2131 HEMATOLOGY CFR(s): 493.851(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API report, the laboratory failed to achieve satisfactory performance for two of three consecutive events (2025-1 and 2025-2) for the specialty of Hematology: Hematology 0% - 2025 first testing event; Hematology 0% - 2025 second testing event. A review of the 2025 scores from API confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and API records for 2025-1 and 2025-2 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 of 3 -- (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and API records for 2025-1 and 2025-2 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2130 and D2131. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on September 30, 2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation (proficiency testing); and 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 the review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D and American Proficiency Institute (API) records (2023-Q3, 2024- Q1, and 2024-Q2), the laboratory failed to successfully participate in a proficiency 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 -- testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the subspecialty of Routine Chemistry for the analyte Bilirubin, Total, resulting in subsequent unsuccessful performance. Refer to D2096. 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 desk review of Certification and Survey Provider Enchanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API evaluation reports, the laboratory failed to achieve satisfactory performance for two of three prficiency events in 2024 for analytes: ALT (SGPT), Albumin, AST (SGOT), Ca-total, Cl, Creatinine, Glucose/non-waived, Mg, K, Na, and BUN. The finding include: 1. The laboratory received the following proficiency testing scores: 0% on the 2024 ALT first event 0% on the 2024 ALT second event 0% on the 2024 Albumin first event 0% on the 2024 Albumin second event 0% on the 2024 Alk Phos first event 0% on the 2024 Alk Phos second event 0% on the 2024 AST (SGOT) first event 0% on the 2024 AST (SGOT) second event 0% on the 2024 Ca first event 0% on the 2024 Ca second event 0% on the 2024 Cl first event 0% on the 2024 Cl second event 0% on the 2024 Creatinine first event 0% on the 2024 Creatinine second event 0% on the 2024 Glucose (non-waived) first event 0% on the 2024 Glucose (non-waived) second event 0% on the 2024 Mg first event 0% on the 2024 Mg second event 0% on the 2024 K first event 0% on the 2024 K second event 0% on the 2024 Na first event 0% on the 2024 Na second event 0% on the 2024 Total Protein first event 0% on the 2024 TotalProtein second event 0% on the 2024 BUN first event 0% on the 2024 BUN second event 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of Certification and Survey Provider Enchanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API evaluation reports, the laboratory failed to achieve satisfactory performance for two of three prficiency events in 2024 for analytes: Triiodothyronine and TSH. The finding include: 1. The laboratory received the following proficiency testing scores: 0% on the 2024 Triiodothyronine first event 0% on the 2024 Triiodothyronine second event 0% on the 2024 TSH first event 0% on the 2024 TSH second event D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 3 -- The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 155 report, API records for 2023-3, 2024-1 and 2024-2 events, the laboratory director failed to provide overall management and director of the laboratory services. 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 a proficiency testing desk review of CASPER 0155D report API records for 2023-Q3, 2024-Q1, and 2024-Q2 events, the laboratory director failed to ensure successful participation in an HHS approved prficiency testing program. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on September 30, 2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation (proficiency testing); and 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 the review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D and American Proficiency Institute (API) records (2023-Q3, 2024- Q1, and 2024-Q2), the laboratory failed to successfully participate in a proficiency 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 -- testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the subspecialty of Routine Chemistry for the analyte Bilirubin, Total, resulting in subsequent unsuccessful performance. Refer to D2096. 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 the desk review of Certification and Survey Provider Enchanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API evaluation reports, the laboratory failed to achieve satisfactory performance for the analyte Bilirubin, Total in two consecutive testing events or two out of three consecutive testing events, resulting in a subsequent unsuccessful performance. 1. The laboratory received the following scores: The finding include: 0% on the 2023 Bilirubin, Total - third event 0% on the 2024 Bilirubin, Total - first event 0% on the 2024 Bilirubin, Total - second event 2. A review of the 2023 and 2024 proficiency testing scores from American Proficiency Institute confirmed the above findings. 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of Certification and Survey Provider Enchanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API evaluation reports, the laboratory failed to achieve satisfactory performance for two of three prficiency events in 2024 for analytes: Triiodothyronine and TSH. The finding include: 1. The laboratory received the following proficiency testing scores: 0% on the 2024 Triiodothyronine first event 0% on the 2024 Triiodothyronine second event 0% on the 2024 TSH first event 0% on the 2024 TSH second event 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 the proficiency testing desk review of the CASPER 0155D report API records for 2023-Q3, 2024-Q1, and 2024-Q2 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. -- 2 of 3 -- 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 a proficiency testing desk review of CASPER 155 report API records for 2023-3, 2024-1 and 2024-2 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096 and D2107. -- 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) -155D and API - American Proficiency Institute (API) records (2023-3 and 2024-1), the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecailty, and test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Bacteriology and the test Bilirubin, Total. Refer to D2020 and D2088. D2020 BACTERIOLOGY 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 -- CFR(s): 493.823(a) 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API - American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for two consecutive events (2023 third testing event and 2024 first testing event) for the subspecialty of Bacteriology: The finding include: 60% on the 2023 third event 0% on the 2024 first event A review of the 2023 and 2024 scores from API - American Proficiency Institute confirmed the above findings. D2088 ROUTINE CHEMISTRY 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API - American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for two consecutive events (2023 third testing event and 2024 first testing event) for the analyte Bilirubin, Total (Bili, T): The finding include: 0% on the 2023 third event 0% on the 2024 first event A review of the 2023 and 2024 scores from API - American Proficiency Institute confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and API records for 2023-3 and 2024-1 events, the laboratory director failed to provide overall management and direction of the laboratory services. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CASPER 0155 report and API records for 2023-3 and 2024-1 events, the laboratory director failed to ensure sucessful participation in an HHS approved proficiency testing program. Refer to D2020 and D2088. -- 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performances. (See D2096) 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 -- 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analytes: ALK PHOS; CA; CHOLESTEROL, TOTAL; GLUCOSE; BUN; and URIC ACID, resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analytes, ALK PHOS; CA; CHOLESTEROL, TOTAL; GLUCOSE; BUN; and URIC ACID, as follows: 2021 Q3 2022 Q2 ALK PHOS 0% 0% CA 0% 20% 2021 Q3 2022 Q2 CHOL, TOTAL 0% 20% GLUCOSE 0% 20% BUN 0% 40% URIC ACID 0% 60% Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analytes, ALK PHOS; CA; CHOL, TOTAL; GLUCOSE; BUN; and URIC ACID. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analytes, ALK PHOS; -- 2 of 3 -- CA, Total; CHOL, TOTAL; GLUCOSE; BUN; and URIC ACID, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performances. (see D2016 and D2096) -- 3 of 3 --

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 review of records, random patient sampling, lack of documentation for the Beckman Coulter Access 2 Calibration verification, and interviews with the technical supervisor (TS) and testing personnel (TP); it was determined that the laboratory failed to perform and document calibration verification procedures for the year 2020. The findings included: 1. On the day of the survey 02/11/2021 at approximately 11: 30, the TS and TP failed to provide documentation for the calibration verification for 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 -- Beckman Coulter Access 2 instrument for the year 2020. 2. For three (3) out of seven (7) random patient sampling test results reviewed, covering period from 02/25/2020 to 2/11/2021, the laboratory analyzed and reported patient's laboratory tests during the time when the laboratory did not perform calibration verification for the Beckman Coulter Access 2. 3. Based on the laboratory's annual declaration submitted for the year 2020, the laboratory analyzed and reported approximately 17,000 immunoassay tests without performing calibration verification every six months or whenever it is needed. 4. The TS and TP affirmed on 02/17/2021 at approximately 1:25 p.m. that the laboratory failed to perform calibration verification every six months or whenever it is needed. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on observation, lack of documentation, random patient sampling, and interview with the technical supervisor (TS) and testing personnel (TP); it was determined that the laboratory failed perform quality control on the Kirby-Bauer (KB) antimicrobial susceptibility testing method each day the test was performed. The findings included: 1. On the day of the survey, February 17, 2021, the laboratory lacked the documentation for KB antimicrobial susceptibility use of control organisms for each day the KB antimicrobial susceptibility test was performed. 2. The laboratory did not provide an Individualized Quality Control (QC) Program for KB susceptibility testing a procedure which may be used in the laboratory to detemine organisms QC frequency for the antimicrobial susceptibility testing method. 2. For two (2) out of seven (7) random patient sampling test results reviewed, covering period from 2/25 /2020 to 2/11/2021 the laboratory analyzed and reported patient test results for KB antimicrobial susceptibility during the time when the laboratory did not use control organisms for each day the KB antimicrobial susceptibility tests method was performed. 3. The TS and TP affirmed on 02/17/2021 at approximately 2:00 p.m. that the laboratory was not performing quality control organisms for each day the KB antimicrobial susceptibility test was performed. D6119 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(6) The technical supervisor is responsible for ensuring that patient test results are not reported until all