El Campo Memorial Hospital

Summary Statement of Deficiencies D0000 The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with American Proficiency Institute (API), 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 3 -- laboratory failed to attain successful performance for two of three consecutive testing events in specialty of Immunohematology/Compatibility Testing for 2023 and 2024, resulting in unsuccessful performance. 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. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and a review of American Proficiency Institute (API) proficiency testing evaluations, the laboratory failed to attain of a score of 100% in two out of three consecutive testing events in compatibility testing between 2023 to 2024. The findings were: 1. Review of the CMS 155 report from 2023 to 2024 revealed the following results: 2023 - 2nd Event laboratory received an overall unsatisfactory score 80% for Compatibility testing. 2024 - 1st Event laboratory received an overall unsatisfactory score of 80% for Compatibility testing. 2. Review of the laboratory's API proficiency testing records for each event revealed the following results: API 2023 Immunology/Immunohematology 2nd Event : 80% for Compatibility testing. Sample: SER-06 Report Result: Compatible/AHG Expected Result: Incompatible Performance: Unacceptable API 2024 Immunology/Immunohematology 1st Event : 80% for Compatibility testing. Sample: SER-01 Report Result: Compatible Expected Result: Incompatible Performance: Unacceptable 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 desk review of laboratory proficiency testing performance, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to 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 desk review of proficiency testing results, the laboratory director failed to -- 2 of 3 -- ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2181. -- 3 of 3 --

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 proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the Certification 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 -- and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with proficiency testing companies American Proficiency Institute (API) and American Association of Bioanalysts (AAB), the laboratory had not successfully participated in a proficiency testing program, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Routine Chemistry for the analyte PCO2 Blood Gas. (Refer to D2096) Key: PCO2 = Partial Pressure of Carbon Dioxide 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) and American Association of Bioanalysts (AAB) evaluation reports, the laboratory failed to achieve satisfactory performance in three of four testing events in 2022 and 2023 for the analyte PCO2 Blood Gas, resulting in non-initial unsuccessful performance. Findings include: 1. A review of the CASPER Report 155 Individual Laboratory Profile for 2022 and 2023 revealed the laboratory received the following unsatisfactory scores for the analyte PCO2 Blood Gas: 2022: Chemistry First Event - PCO2 60% Chemistry Second Event - PCO2 60% 2023: Chemistry First Event - PCO2 0% 2. A review of the API and AAB evaluation reports for 2022 and 2023 confirmed the laboratory received the following unsatisfactory scores for the analyte PCO2 Blood Gas: 2022: Chemistry First Event - PCO2 60% (API) Chemistry Second Event - PCO2 60% (API) 2023: Chemistry First Event - PCO2 0% (AAB) 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute and American Association of Bioanalysts evaluation reports, the laboratory director failed to ensure successful participation in the specialty of Routine Chemistry for the analyte PCO2 Blood Gas for three of four testing events in 2022 and 2023. (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 -- 2 of 3 -- 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute and American Association of Bioanalysts evaluation reports, the laboratory director failed to ensure successful performance in the specialty of Routine Chemistry for the analyte PCO2 Blood Gas for three of four testing events in 2022 and 2023. (Refer to D2096) -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found in compliance with applicable CLIA conditions, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

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 proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a 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 -- proficiency desk review of the American Proficiency Institute (API) proficiency testing records from 2022, it was determined the laboratory had not successfully participated in a proficiency testing program, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of chemistry for the analyte pCO2. 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records from 2022, the laboratory failed to attain 80% (passing) for the analyte pCO2 for 2 of 2 testing events in Chemistry for 2022 resulting in unsuccessful performance for pCO2. Findings included: 1. Review of the CMS database revealed the laboratory scored less than 80% for the analyte pCO2 for the Chemistry Core Event 1 and Event 2. pCO2 Chemistry 1st event - 60% Chemistry 2nd event - 60% 2. Review of the API proficiency test records from 2022 confirmed the above failures for pCO2. Chemistry Core 1st event - 60% pCO2 BG-01 - lab result 42 mmHg (acceptable range 31-41 mmHg) BG-02 - lab result 61 mmHg (acceptable range 64-76 mmHg) Chemistry Core 2nd event - 60% pCO2 BG-07 - lab result 31 mmHg (acceptable range 19-30 mmHg) BG-10 - lab result 60 mmHg (acceptable range 49-59 mmHg) 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the analyte pCO2. 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 -- 2 of 3 -- required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2096 -- 3 of 3 --

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 proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high 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 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 -- (CASPER) Report 155 Individual Laboratory Profile and a proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing (PT) records from 2021 and 2022, it was determined the laboratory had not successfully participated in a proficiency testing program, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of immunohematology for the analyte Antibody ID (identification). Refer to D2190 D2190 ANTIBODY IDENTIFICATION CFR(s): 493.865(e) Failure to identify the same antibody in two consecutive 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 155 Individual Laboratory Profile and proficienty desk review of the laboratory American Association of Bioanalysts (AAB) proficiency test records from 2021 to 2022, the laboratory failed to achieve satisfactory scores (80%) for 4 of 5 consecutive PT events for Antibody ID which constitutes a non-initial unsuccessful test performance. Findings included: 1. Review of the CASPER Report 155 Individual Laboratory Profile from 2021 to 2022 revealed the laboratory failed to attain an acceptable score of 80% for 4 of 5 consecutive testing events for Antibody ID. 2021 1st event - Antibody ID (0%) 2021 2nd event - Antibody ID (0%) 2021 3rd event - Antibody ID (0%) 2022 2nd event - Antibody ID (20%) 2. Review of the laboratory AAB records from 2021 to 2022 confirmed the laboratory failed to attain an acceptable score of 80% for the above testing events for Antibody ID. 2021 1st event - (0% - Failure to Participate) 2021 2nd event - (0% - Failure to Participate) 2021 3rd event - (0% - Failure to Participate) 2022 2nd event - 20% 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 desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to 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: -- 2 of 3 -- Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with the laboratory's American Association of Bioanalysts (AAB) proficiency test results, it was revealed the laboratory director failed to ensure successful participation in a CMS- approved proficiency testing program. Refer to D2190 -- 3 of 3 --

Summary Statement of Deficiencies D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: An unannounced revisit was performed on 7/12/2022 to 7/13/2022. NEW DEFICIENCY Based on review of the laboratory policy, laboratory and patient test records from May and June 2022, and confirmed in interview, the laboratory failed to follow its policy to investigate incompatible blood components for one of one patient reviewed in May 2022. Findings included: 1. Review of the laboratory policy Compatibility Testing (revised 4/28/22) revealed "any agglutination/hemolysis is considered incompatible -- will be sent out to South Texas Blood and Tissue Center (STBTC) for further consultation and evaluation. Technologist will: a. notify the laboratory manager or director b. if an emergency exists, notify the physician of the delay in providing compatible blood. c. Obtain 4 EDTA (purple) or 3 EDTA (pink) tubes from the patient. Always save an extra tube for Blood bank Department as back up and send the rest of the tubes. Copy the work up and send it to the courier. Technologist will follow up for the updates. d. order out units only appropriate for the patient, negative for the antigen corresponding to the antibody detected and compatibility testing must be performed in house." 2. Review of the laboratory blood 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 -- bank records from May and June 2022 revealed on 5/27/2022 Unit W140922027088 was incompatible with Patient 233218 with a notation of "emergency release". Laboratory records revealed a "1+" for the AHG phase for the compatibility testing. 3. Review of the laboratory records revealed no notification to the laboratory manager or director for the above incompatible blood nor the consultation and evaluation from STBCTC per the laboratory policy. 4. An interview with the testing personnel #3 on 7 /12/2022 at 1420 hours in the laboratory confirmed the above findings. She stated that the above unit of blood was not transfused and that STBCTC rejected the specimen because the tube was missing the date of collection and truncated patient name"; therefore, no evaluation was performed. Key: SSTBCTC - South Texas Blood & Tissue Center AHG - AHG phase occurs when anti-human globulin is added to red cells to detect binding of either antibody or complement (or both) to those cells D5781

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 proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 D2016 Condition: Successful participation [proficiency testing] 493.1403 D6076 Condition: Laboratories performing high complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center 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 -- for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB), it was determined the laboratory had not successfully participated in a proficiency testing program approved by CMS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the sub- specialty of ABO AND RHo(D) GROUPS. Refer to D2163. D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) Failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Association of Bioanalysts (AAB) proficiency test results, it was revealed the laboratory failed to attain a satisfactory score of at least 100% for each analyte in each testing event in 2021 and 2022. Findings included: 1. 2021 2nd Event Nc21Q2 (Immunohematology) participant results' evaluation revealed: Analyte: D (Rho) Typing Score: 80.0 Spec:7 Reported Value:* Negative, weak D (Du) not performed Intended Result: Positive 2. 2022 1st Event Nc22Q1 (Immunohematology) participant results' evaluation revealed: Analyte: ABO Group Score: 80.0 Spec:1 Reported Value: * B Intended Result: A Note: Proficiency testing failure for 2021 was cited during the 07/09/2021 onsite survey. D2154 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(b) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Association of Bioanalysts (AAB) proficiency test results, it was revealed the laboratory failed to attain an overall testing score of at least 100% in the sub-specialty of ABO AND RHo (D) GROUPS, resulting in an unsatisfactory performance. Findings include: 1. 2021 2nd Event Nc21Q2 - overall ABO AND RHo (D) GROUPS sub-specialty score of 90% 2. 2022 1st Event Nc22Q1 - overall ABO AND RHo (D) GROUPS sub-specialty score of 90% Note: Proficiency testing failure for 2021 was cited during the 07/09/2021 onsite survey. D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Association of Bioanalysts (AAB) proficiency test results, it was revealed the laboratory failed to achieve an overall satisfactory testing event score for 2 of 3 consecutive testing events resulting in an unsuccessful performance in the Immunohematology sub-specialty of ABO AND RHo (D) GROUPS. Findings include: 1. 2021 2nd Event Nc21Q2 - unsatisfactory overall ABO AND RHo (D) GROUPS sub-specialty score of 90% 2. 2022 1st Event Nc22Q1 - unsatisfactory overall ABO AND RHo (D) GROUPS subspecialty score of 90% Note: Proficiency testing failure for 2021 was cited during the 07/09/2021 onsite survey. 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 desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Association of Bioanalysts (AAB) proficiency test results, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to 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 desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Association of Bioanalysts (AA) proficiency test results, it was revealed the laboratory director failed to ensure successful participation in a CMS-approved proficiency testing program. Refer to D2153, D2154 and D2163. -- 3 of 3 --

Summary Statement of Deficiencies D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: An unannounced revisit was performed on 3/22/2022 to 3/24/2022. Based on review of the manufacturer's instructions for the Siemens Dimension Lactic Acid Flex reagent cartridge, review of patient test records from January 2022 to March 2022, and staff interview, it was revealed the laboratory failed to ensure manufacturer's instructions were followed for specimen handling (refer to D5311). D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: An unannounced revisit was performed on 3/22/2022 to 3/24/2022. *****New 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 -- Deficiency**** Based on review of the manufacturer's instructions for the Siemens Dimension Lactic Acid Flex reagent cartridge, review of patient test records from December 2021 to February 2022, and staff interview, it was revealed the laboratory failed to ensure 113 of 571 (19.7%) specimens were centrifuged within 15 minutes of collection as required by the manufacturer. The findings include: 1. A review of the manufacturer's instructions for the Siemens Dimension Lactic Acid Flex reagent cartridge (Ref DF16, Issue Date 2015-01-30) under the section titled "Specimen Collection and Handling" revealed: "...followed by immediate chilling of the specimen and separation of the cells within 15 minutes." 2. An interview with testing personnel number 4 (as listed on Form CMS 209) on 03/23/2022 at 1645 hours in the laboratory revealed the facility received samples for lactic acid testing from the hospital floors and outpatient facilities. He stated that all samples were received on ice and not spun. 3. A review of patient test records from December 1, 2021 to February 28, 2022 revealed 113 of 571 samples (19.7%) were received more than 15 minutes from the time of collection and thus, could not have been separated from the cells within 15 minutes from collection (see patient alias list). Examples are: Order number: 5358923 Collection: 01/31/2022 06:08 Receipt: 01/31/2022 06:34 Elapsed Time: 26 minutes Order number: 5363016 Collection: 02/06/2022 22:37 Receipt: 02 /06/2022 23:18 Elapsed Time: 41 minutes Order number: 5363693 Collection: 02/07 /2022 17:30 Receipt: 02/07/2022 17:58 Elapsed Time: 28 minutes Order number: 5361905 Collection: 02/03/2022 15:42 Receipt: 02/03/2022 16:25 Elapsed Time: 43 minutes Order number: 5364252 Collection: 02/08/2022 10:45 Receipt: 02/08/2022 11:52 Elapsed Time: 77 minutes Order number: 5362627 Collection: 02/06/2022 06: 53 Receipt: 02/06/2022 07:27 Elapsed Time: 34 minutes Order number: 5372433 Collection: 02/22/2022 03:50 Receipt: 02/22/2022 04:37 Elapsed Time: 47 minutes Order number: 5372722 Collection: 02/22/2022 04:30 Receipt: 02/22/2022 05:08 Elapsed Time: 38 minutes Order number: 5374494 Collection: 02/24/2022 05:49 Receipt: 02/24/2022 06:16 Elapsed Time: 27 minutes 4. An additional interview with testing personnel number 4 (as listed on Form CMS 209) on 03/23/2022 at 1650 hours in the laboratory revealed the facility did not know samples for lactic acid testing were required to be centrifuged within 15 minutes of collection. This confirmed the findings. D5783

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing companies, American Proficiency Institute (API) and American Association of Bioanalysts (AAB) . The facility was found to be out of compliance with the conditions of participation of the CLIA program. The conditions not met were: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D2017 - 42 C.F.R. 493.807(a) - Reinstatement After Failure D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This CONDITION is not met as evidenced by: A. Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Immunohematology for Compatibility Testing . Refer to D2181. B. Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Bacteriology. Refer to D2028. C. Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Chemistry for the analytes Blood Gas PO2, PCO2, CL, NA, K. Refer to D2096. Note: Failure to successfully participate in the specialty of Chemistry for the analyte Blood Gas pH was cited on the 12/11/2018 survey. Key: PO2- partial pressure of oxygen PCO2- partial pressure of carbon dioxide CL- Chloride NA- Sodium K- Potassium D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance the laboratory failed to participate successfully in proficiency testing for the analyte blood gas pH. The laboratory failed to achieve satisfactory performance in the specialty of Chemistry in 2018 for the analyte blood gas pH for two of three consecutive testing events and has not demonstrated sustained satisfactory performance on two consecutive proficiency events since the unsuccessful scores. Findings were: 1. A review of proficiency testing records 2018 (a testing year consists of three testing -- 2 of 6 -- events) revealed that the laboratory attained the following scores: 40% on the first event in 2018 (Unsatisfactory). 0% on the third event in 2018 (Unsatisfactory). 2. A review of proficiency testing records 2019 (a testing year consists of three testing events) revealed that the laboratory attained the following scores: 0% on the first event in 2019 (Unsatisfactory). Key: pH-potential of Hydrogen D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of CMS form 155 and AAB proficiency testing records, it was determined that laboratory failed to achieve satisfactory performance (80% or greater) for the specialty of bacteriology for two out of three consecutive testing events. Findings were: 1. The laboratory received a bacteriology score of 60% on the first event in 2018 (Unsatisfactory). 2. The laboratory received a bacteriology score of 100% on the second event in 2018 (Satisfactory). 3. The laboratory received a bacteriology score of 60% on the third event in 2018 (Unsatisfactory). Two out of three unsatisfactory scores results in unsuccessful PT performance. Key: CMS: Centers for Medicare & Medicaid Services AAB: American Association of Bioanalysts D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and American Proficiency Institute records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry. Findings: 1. API 2018 - 1st testing event the laboratory received the following unsatisfactory scores: pH Blood Gas 40% 2. API 2018 - 3rd testing event the laboratory received the following unsatisfactory scores: pH Blood Gas 0% pO2 Blood Gas 0% pCO2 Blood Gas 20% CL (Chloride) 20% K (Potassium) 0% NA (sodium) 20% 3. API 2019 - 1st testing event the laboratory received the following unsatisfactory scores: pH Blood Gas 0% pO2 Blood Gas 20% pCO2 Blood Gas 0% CL (Chloride) 20% K (Potassium) 20% NA (sodium) 40% Note: pH Blood gas unsatisfactory scores for 2018-1 and 2018-3 were cited on the 12/11/2018 survey. Key: CMS: Centers for Medicare & Medicaid Services API: American Proficiency Institute 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 -- 3 of 6 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS form 155 and American Proficiency Institute proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Chemistry for the analytes Blood Gas pH, PO2, PCO2, CL, NA and K. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings include: 1. A review of API proficiency testing records for 2018 (event 1,2,3) and 2019 (event 1) revealed the laboratory received the following unsatisfactory scores: pH Blood Gas 2018-1 40%(Unsatisfactory). 2018-3 0% (Unsatisfactory). 2019-1 0% (Unsatisfactory). pO2 Blood Gas 2018-3 0% (Unsatisfactory). 2019-1 20% (Unsatisfactory). pCO2 Blood Gas 2018-3 20% (Unsatisfactory). 2019-1 0% (Unsatisfactory). CL (Chloride) 2018-3 20% (Unsatisfactory). 2019-1 20% (Unsatisfactory). K (Potassium) 2018-3 0% (Unsatisfactory). 2019-1 20% (Unsatisfactory). NA (sodium) 2018-3 20% (Unsatisfactory). 2019-1 40% (Unsatisfactory). Note: pH Blood gas unsatisfactory scores for 2018-1 and 2018-3 were cited on the 12/11/2018 survey. Key: CMS: Centers For Medicare & Medicaid Services API: American Proficiency Institute D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a desk review of CMS and AAB proficiency testing records , it was found the laboratory failed to attain an overall compatibility testing event score of at least 100% which constitutes unsatisfactory performance. (2018- 3, 2019-1) Findings: 1. AAB 2018 - 3rd event lab received the unsatisfactory scored of 60% for Compatibility Testing. 2. AAB 2019 - 1st event lab received the unsatisfactory scored of 80% for Compatibility Testing Key: CMS: Centers for Medicare & Medicaid Services AAB: American Association of Bioanalysts 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 desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance for the same analyte in two consecutive testing events or two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance (100 %) in the specialty of immunohematology for Compatibility Testing for 2 of 3 consecutive testing events. (2018-3, 2019-1) Findings were: 1. AAB 2018-3rd Event lab scored 60% for Compatibility Testing. 2. AAB -- 4 of 6 -- 2019-1st Event lab scored 80% for Compatibility Testing. Two out of three unsatisfactory scores results in unsuccessful PT performance. Key: CMS: Centers for Medicare & Medicaid Services AAB: American Association of Bioanalysts 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 desk review of laboratory proficiency testing performance it was revealed that 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; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2096 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 desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to 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. -- 5 of 6 -- This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program (refer to D2028, D2181). -- 6 of 6 --