Baylor St Luke's Medical Group

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed March 19, 2025 the laboratory was found to be out of compliance based on the following condition level deficiencies: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) records, the laboratory failed to achieve successful performance in two of two consecutive testing events in 2024 and 2025, resulting in 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 3 -- for 17 of 17 regulated chemistry analytes (D2096), and the specialty of Routine Chemistry (D2097). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) testing records from 2024 and 2025, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two of two consecutive testing events for the 17 of 17 chemistry analytes. Two out of two overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. The findings included: 1. A review of the CASPER Report 155 listed the following scores for the following PT Program analytes: 2024 Event 3 2025 Event 1 ALT 60% 0% ALBUMIN 60% 0% ALK PHOS 60% 0% AST 60% 0% TBILI 60% 0% CA, TOTAL 60% 0% CL 60% 0% CHOL 60% 0% HDL 60% 0% CREA 60% 0% GLUCOSE 60% 0% MG 60% 0% K 60% 0% NA 60% 0% TP 60% 0% TRIGL 60% 0% BUN 60% 0% 2. A desk review of API proficiency testing records for 2024 and 2025 confirmed that the laboratory received the above scores. Key: ALT - Alanine Transaminase ALK PHOS - Alkaline Phosphatase AST - Aspartate Aminotransferase TBILI - Total Bilirubin CA, TOTAL - Total Calcium CL - Chloride CHOL - Cholesterol HDL - Cholesterol, High Density Lipoprotein CREA - Creatinine MG - Magnesium K - Potassium NA - Sodium TP - Total Protein TRIGL - triglycerides BUN - Blood Urea Nitrogen D2097 ROUTINE CHEMISTRY CFR(s): 493.841(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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) records from 2024 and 20205, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two of two consecutive testing events for the specialty of Routine Chemistry. Two out of two overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. The findings included: 1. A review of the CASPER Report 155 listed the following scores for the PT specialty of Routine Chemistry: 2024 Event 3: 60% 2025 Event 1: 0% 2. A desk review of API proficiency testing records confirmed that the laboratory received the above scores for Routine Chemistry for 2024 Event 3 and 2025 Event 1. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for 17 of 17 chemistry analytes and the specialty of Routine Chemistry for two of two consecutive events reviewed in 2024 and 2025. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) records, the laboratory director failed to ensure successful performance in two of two consecutive testing events in 2024 and 2025, resulting in unsuccessful performance for 17 of 17 regulated chemistry analytes (D2096), and the specialty of Routine Chemistry (D2097). -- 3 of 3 --

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on 7/25/2024 found the laboratory out of compliance with 42 CFR Part 493, Requirements for Laboratories. The following condition not met was: D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the laboratory test menu, laboratory documents, and confirmed in interview, the laboratory failed to perform a twice annual comparison of test results, to determine the relationship between two different chemistry analyzers (the Alfa Wasserman ACE Axcel and the iStat), for seven of seven analytes performed on both in 2023. The findings included: 1. Review of the laboratory test menu included the following seven chemistry analytes performed on the ACE Axcel and on the iSTAT Chem8+ cartridge: CO2 Glucose BUN Creatinine Sodium Chloride Potassium 2. Review of laboratory policy and laboratory documentation did not include instructions or documentation for a twice annual comparison to determine the relationship between the two analyzers performing the same chemistry test. Surveyor asked testing personnel (TP) 1 for documentation of a twice annual comparison of test results for 2023, and none was provided. 3. In an interview on 7/25/2024 at 14:00 hours, in the laboratory, confirmed that the laboratory did not perform a twice annual comparison of test results to determine the relationship between the ACE Axcel and the iSTAT for the seven analytes performed on both chemistry analyzers. 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 -- D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the laboratory personnel form 209, personnel records, laboratory policy, and confirmed in interview, the laboratory failed to ensure two of two testing personnel hired in 2024 had documentation of training prior to testing patients, to qualify as a testing personnel which have earned a high school diploma or equivalent under 493.1423(b)(4)(ii). Refer to D6066. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory personnel form 209, personnel records, laboratory policy, and confirmed in interview, the laboratory failed to ensure testing personnel had documentation of training for each test method used in moderate complexity testing, prior to analyzing patient specimens, for two of two testing personnel hired in 2024. The findings included: 1. Review of the CMS209 personnel form included the following two new testing personnel, their hire dates, qualifications. TP3, hired 1/29 /2024, earned a high school diploma or equivalent. TP4, hired 5/16/2024, earned a high school diploma or equivalent. 2. Review of the "Policy and Procedure Manual", section "Technical Consultant Responsibilities" included the following: "The Technical Consultant is responsible for ensuring the following: ... 12. Personnel have been appropriately trained and demonstrated competency prior to testing patient specimens." 3. Review of the moderate complexity testing performed included the following analyzers and the tests performed: Analyzer - Test Sysmex XP300 - CBC's Triage - D-Dimer Tosho AIA-360 - TSH Alfa Wasserman ACE Axcel - BMP, Lipid, Mg iStat - Chem 8+ Surveyor asked for training documentation for TP3 and TP4 to include the training requirements found in 493.1423(b)(4)(ii)(A) through (H) and none was provided. 4. In an interview on 7/25/2024 at 10:20 hours, in the office, TP1 confirmed the laboratory did not have documentation of training, for each test method used, prior to patient testing for TP3 and TP4. -- 2 of 2 --

Summary Statement of Deficiencies D0000 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: I. Based on review of the Centers for Medicare and Medicaid (CMS)-209 form, American Proficiency Institute (API) Proficiency Testing (PT) 2022 records, and staff interview, the laboratory director and testing person failed to attest to the routine integration of proficiency samples into the patient workload for 2 of 2 Hematology proficiency testing events in 2022. Findings Included: 1. Review of the CMS 209 form revealed 1 Testing Person (TP-1) performing moderate complexity hematology testing. 2. Review of API instructions stated the following: "Attestation statement Signatures required- Testing personnel and the laboratory director must physically sign an attestation statement for all PT results and retain the signed statement (or a copy) for a minimum of 2 years. Either the attestation statement below or a printed copy of the form provided online can be used for this purpose." 3. Review of the laboratory's API proficiency testing 2022 records (Hematology 1st and 2nd Events), revealed the laboratory director or designee and testing person, failed to sign the attestation statement for the following events: 2022 API Hematology 1st Event The Laboratory Director and TP-1 failed to attest to the routine integration of proficiency samples into the patient workload. 2022 API Hematology 2nd Event The Laboratory Director and TP-1 failed to attest to the routine integration of proficiency samples into the patient workload. 4. During an interview on 11/08/2022 at 10:16 a.m., in the facility conference room, TP-1 confirmed the above findings. II. Based on American Proficiency Institute (API) Proficiency Testing (PT) 2022 records, and staff 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 7 -- the laboratory director failed to attest to the routine integration of proficiency samples into the patient workload for 1 of 2 Chemistry proficiency testing events in 2022. Findings Included: 1. Review of the CMS 209 form revealed 1 Testing Person (TP-1) performing moderate complexity chemistry testing. 2. Review of API instructions stated the following: " Attestation statement Signatures required- Testing personnel and the laboratory director must physically sign an attestation statement for all PT results and retain the signed statement (or a copy) for a minimum of 2 years. Either the attestation statement below or a printed copy of the form provided online can be used for this purpose." 3. Review of the laboratory's API proficiency testing 2022 records (Chemistry 1st and 2nd Events), revealed the laboratory director or designee and testing person, failed to sign the attestation statement for the following: 2021 API Chemistry 2nd Event The Laboratory Director and TP-1 failed to attest to the routine integration of proficiency samples into the patient workload. 2021 API Chemistry 3rd Event The Laboratory Director and TP-1 failed to attest to the routine integration of proficiency samples into the patient workload. 4. During an interview on 11/08/2022 at 10:16 a.m., in the facility conference room, TP-1 confirmed the above findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: I. Based on direct observation, review of manufacturer's instructions, laboratory environmental records, and confirmed in staff interview, the laboratory failed to ensure the acceptable laboratory temperature range was within manufacturer's specifications for the Bio Rad Liquicheck Immunoassay Plus Control for 3 of 3 months randomly reviewed in 2022 (08/2022-10/2022). Findings Included: 1. During a tour of the facility on 11/07/2022 at 09:30 a.m., the surveyor observed 2 boxes containing Bio Rad Liquicheck Immunoassay Plus Control (Lot Number: 85320) in the freezer. 2. Review of manufacturer's instructions for the Bio Rad Liquicheck Immunoassay Plus Control (Lot Number: 85310), revealed the following: "Procedure: Before sampling, allow this product to reach room temperature (18-25 C). If the product has been stored frozen, allow it to stand at room temperature (18-25 C) until it is completely thawed." 3. Random review of laboratory environmental logs (08/2022- 10/2022) revealed the following acceptable room temperature range: 18-30 C The laboratory failed to ensure the acceptable laboratory temperature range was within manufacturer's specifications for the Bio Rad Liquicheck Immunoassay Plus Control for 3 of 3 months randomly reviewed in 2022. 4. During an interview on 11/08/2022 at 10:20 a.m., in the facility conference room, TP-1 confirmed the above findings. II. Based on direct observation, review of manufacturer's instructions, laboratory environmental records, and confirmed in staff interview, the laboratory failed to ensure the acceptable laboratory temperature range was within manufacturer's specifications for the Eight Check Hematology Control for 3 of 3 months randomly reviewed in 2022 (08/2022 - 10/2022). Findings Included: 1. During a tour of the facility on 11/07/2022 at 10:30 a.m., the surveyor observed 1 container of Eight -- 2 of 7 -- Check Hematology Control in the refrigerator. 2. Review of manufacturer's instructions for the Eight Check Hematology Control, revealed the following: "Instructions for Use: 1. Remove vial from refrigerator and packaging. 2. Allow at least 15 minutes to warm vials to room temperature (18-25 C)" 3. Random review of laboratory environmental logs (08/2022-10/2022) revealed the following acceptable room temperature range: 18-30 C The laboratory failed to ensure the acceptable laboratory temperature range was within manufacturer's specifications for the Eight Check Hematology Control for 3 of 3 months randomly reviewed in 2022. 4. During an interview on 11/08/2022 at 10:20 a.m., in the facility conference room, TP-1 confirmed the above findings. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory policies, quality control (QC) records, patient records, and confirmed in staff interview, the laboratory failed to monitor the accuracy and precision of Bio Rad Liquicheck Immunoassay Plus QC material over time on the Tosoh AIA-360 analyzer for 12 of 12 months (10/2021 through 10/2022) to ensure accurate and reliable test results. Findings Included: 1. During a tour of the facility on 11/07/2022 at 10:30 a.m., the surveyor observed a Tosoh AIA-360 (Serial Number: 879072) on the laboratory work bench. 2. Review of laboratory policies for the Tosoh AIA-360 analyzer revealed the laboratory did not have a procedure for monitoring the accuracy and precision over time to ensure accurate and reliable test results. Further review revealed the only analyte processed on the Tosoh AIA-360 was Thyroid Stimulating Hormone (TSH). 3. The laboratory was asked to provide documentation of monitoring QC over time for analytes tested on the Tosoh AIA-360, using the Bio Rad Immunoassay Plus QC material. No documentation was provided. The laboratory failed to monitor the accuracy and precision of Bio Rad Liquicheck Immunoassay Plus QC material over time on the Tosoh AIA-360 analyzer for 12 of 12 months (10/2021 through 10/2022) to ensure accurate and reliable test results. 4. The following is a random sampling of TSH patients performed in 2022: Patient Identification (ID): #1; #2; #3; #4; #5; #6; #7; #8; #9; #10 (See attached Patient ID chart for corresponding patients.) 5. During an interview on 11/08/2022 at 9:20 a.m., in the laboratory, TP-1 confirmed the above findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations -- 3 of 7 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of laboratory documents, laboratory records, the Centers for Medicaid and Medicare (CMS) form 116, and confirmed in interview, the laboratory failed to complete a Individualized Quality Control Plan (IQCP) to include risk assessment to identify and evaluate potential failures and sources of errors in the testing process, establish a quality control plan (QAP), and a quality assessment (QA) to support a reduction of the QC frequency from every day of patient testing for the i- STAT Chem 8+ cartridge from January to October 2022. The findings include: 1. In a tour of the laboratory on 11/7/2022 at 10:10 am, the surveyor noticed a blue container next to an i-STAT machine labeled "BMP". It contained 19 i-STAT Chem 8+ cartridges out for use with the following lot and expiration date: Lot: H22216A, EXP 1 /31/2021 2. Review of quality control (QC) records from January to October 2022 listed 2 levels of QC performed once a month. 3. Review of the laboratory policy titled "I-STAT Chem 8 Risk Assessment and Quality Control Plan" included a risk assessment and quality control for the test BNP and a Risk Assessment for the CHEM8+ cartridge that was not completed for all areas of potential errors. Surveyor queried testing person (TP) 1, in the conference room, if there was a completed IQCP that included a completed risk assessment, a quality control plan specific to the i- STAT Chem 8+, and a completed QA plan to monitor the effectiveness of the reduction of QC frequency from every day of patient testing to once a month and none was provided. 4. Review of laboratory testing totals provided by TP1 had the annual test volume for the i-STAT Chem 8+ cartridge at 8,064. 5. In an interview on 11/7 /2022 at 11:45 hours, in the conference room, TP1 confirmed that the laboratory did not have a IQCP to support the reduction of QC frequency from every day of patient testing to one a month for the i-STAT Chem 8+ cartridges. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of laboratory documents, quality control records, patient test records, and confirmed in interview, the laboratory failed to run two levels of controls every day of patient testing for the i-STAT Chem 8+ cartridges for 11 of 11 random patients reviewed from January to October 2022. The findings include: 1. In a tour of the laboratory on 11/7/2022 at 10:10 am, the surveyor noticed a blue container next to an i-STAT machine labeled "BMP". It contained 19 i-STAT Chem 8+ cartridges out for use with the following lot and expiration date: Lot: H22216A, EXP 1/31/2021 2. -- 4 of 7 -- Surveyor queried on 11/7/2022 at 11:10, in the laboratory, how often QC was run for the i-STAT Chem 8+ testing. Testing person (TP) 1 stated they run it at the beginning of each month. A review of laboratory QC records titled "iSTAT CHEM 8+ Control Level 1 & 3" confirmed a QC frequency of once a month. 3. Review of laboratory testing totals provided by TP1 had the annual test volume for the i-STAT Chem 8+ cartridge at 8,064; to include the following 11 random sampling of patients tested with the iSTAT Chem 8+ cartridge on days where QC wasn't performed: January: 3 Patients QC performed and documented on 1/4/2022 Patient ID - Date of testing 10110023 -1/10/2022 1011044 -1/11/2022 1011049 -1/11/2022 May 2022: 3 Patients QC Performed and documented on 5/2/2022 Patient ID - Date of testing 10509060 -5/9 /2022 10509061 -5/9/2022 10509057 -5/9/2022 August 2022: 3 Patients QC performed and documented 8/2/2022 10809035 -8/9/2022 10809037 -8/9/2022 10809041 -8/9/2022 October 2022: 2 Patients QC performed and documented 10/4 /2022 1100522003 -10/5/2022 1100522013 -10/5/2022 4. In an interview on 11/7 /2022 at 11:15, in the laboratory, TP1 confirmed that the laboratory did not run 2 levels of QC every day of patient testing for the i-STAT Chem 8+ cartridge. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: I. Based on direct observation, review of the Bio Rad Liquicheck Immunoassay Plus Control instructions for use (IFU), facility policy, and confirmed in staff interview, it was revealed the laboratory failed to establish their own control acceptable ranges for 1 of 1 test performed on the Tosoh AIA- 360 analyzer for 1 of 1 control lot reviewed in 2022. Findings Included: 1. During a tour of the facility on 11/07/2022 at 10:30 a. m., the surveyor observed a Tosoh AIA-360 (Serial Number: 879072) on the laboratory work bench. Further investigation revealed Thyroid Stimulating Hormone (TSH) was the only analyte performed on the Tosoh AIA-360 analyzer. 2. Review of Bio Rad Liquicheck Immunoassay Plus Control (Lot Number:85310) IFU, revealed the following: "Assignment of Values: It is recommended that each laboratory establish its own acceptable ranges and use those provided as guides." Further review of the IFU revealed the following value assignments for TSH: "Thyroid Stimulating Hormone (TSH) Lot Number: 85310; Expiration Date: 02/24/2024 Level 1 Range- 0.560-1.04 Level 2 Range- 4.10-7.62 Level 3 Range- 20.8-38.7" 3. Review of facility policy, "Quality Control Policy" (Reviewed by the Laboratory Director on 07/10 /2019) revealed the following: "The Laboratory Director will ensure that policies and procedures are established to monitor, evaluate, and review: a. Quality Control- establish a mechanism to verify all test confirm to specified performance criteria in -- 5 of 7 -- the quality of laboratory services provided and to identify failures in quality. Further review of the policy revealed: "Procedure: Action- Quality Control a. Quality control material is run in each department. The control material is dependent on the instrument. b. Analytically acceptable ranges are established for the instruments." 4. Review of Bio Rad Liquicheck Immunoassay Plus control records revealed the following acceptable quality control ranges: "Thyroid Stimulating Hormone (TSH) Lot Number: 85310; Expiration Date: 02/24/2024 Level 1 Range- 0.560-1.04 Level 2 Range- 4.10-7.62 Level 3 Range- 20.8-38.7" The laboratory failed to establish their own control acceptable ranges for 1 of 1 test performed on the Tosoh AIA- 360 analyzer for 1 of 1 control lot reviewed in 2022. 5. During an interview on 11/08/2022 at 10:20 a.m., in the facility conference room, TP-1 confirmed the above findings. 45469 II. Based on a review of laboratory quality control (QC) instrument printouts, instructions for use, laboratory documents, and confirmed in an interview, the laboratory failed to have a policy in place for the establishment or verification of control ranges for 19 of 19 chemistry analytes reviewed on the Ace Axcel chemistry analyzer from January to March 2022. The findings include: 1. Review of the QC requisition report from the Ace Axcel instrument had the following acceptable ranges for QC from January to March 2022: Control 1 - Lot 1501UNCM Test - Acceptable Range CA - 8.9 - 10.1 ALT - 46 - 60 GLU - 86 - 60 BUN - 10 - 14 TBILI - 1.3 - 1.9 ALB - 2.6 - 3.2 CREAT - 1.61 - 2.01 AST - 42 - 56 NA - 129.3 - 148.7 K - 0.81 - 7.49 CL - 99.6 - 113.6 TRIG - 84 - 104 DBILI - 0.9 - 1.5 HDL - 34 - 42 ALP - 56 - 74 CHOL - 102 - 116 CO2 - 12.7 - 16.5 MG - 2.2 - 2.8 TP - 4.3 -4.9 Control 2 - Lot 1166UECM Test - Acceptable Range CA - 11.5 - 13.1 ALT - 121 - 157 GLU - 270 - 308 BUN - 43 -57 TBILI - 4.6 -6.0 ALB - 4.1 - 5.1 CREAT - 6.71 - 8.19 AST - 185 - 243 NA - 114.6 - 131.4 K - 7.33 - 7.99 CL - 77.0 - 87.0 TRIG - 159 - 197 DBILI - 2.5 -3.1 HDL - 63 - 77 ALP - 327 - 433 CHOL - 177 -203 CO2 - 25.7 - 33.7 MG - 4.4 - 5.4 TP - 7.3 - 8.3 A review of the QC instructions for use included assayed ranges different than the stated ranges on the Ace Excel chemistry analyzer used for daily acceptability. Surveyor queried testing personnel (TP) 1 for the laboratory policy for the establishment of QC ranges for the Ace Excel chemistry analyzer, and none was provided. 2. Review of the CMS form 116 had a total annual test volume for the specialty chemistry listed at 27,972. 3. In an interview on 11/8/2022 at 14:48, in the conference room, TP 1 confirmed the laboratory did not have a policy for the establishment of QC ranges for the Ace Axcel chemistry analyzer. Key: CA - Calcium ALT - Alanine transaminase GLU - Glucose BUN - Blood Urea Nitrogen TBILI - Total Bilirubin ALB - Albumin CREAT - Creatinine AST - Aspartate transaminase NA - Sodium K - Potassium CL - Chloride TRIG - Triglycerides DBILI - Direct Bilirubin HDL - High Density Lipoproteins ALP - Alkaline Phosphatase CHOL - Cholesterol CO2 - Carbon dioxide MG - Magnesium TP - Total Protein D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. -- 6 of 7 -- This STANDARD is not met as evidenced by: Based on review of the submitted Centers for Medicare and Medicaid (CMS) 116 Application, random review of final patient reports and confirmed in staff interview, it was revealed the laboratory failed to ensure the correct physical address for all tests performed was documented on the final patient reports for 10 of 10 patients randomly reviewed in November 2022. Findings Included: 1. Review of CMS 116 application submitted at the time of survey, revealed the following address for the laboratory: "310 Gaslight Blvd Lufkin, TX 75904" 2. Random review of final patient reports revealed the following 10 of 10 reports in November 2022 that did not include the correct physical address of the laboratory: Patient Identification (ID): #1; #2; #3; #4; #5; #6; #7; #8; #9; #10 (See attached Patient ID chart for corresponding patients.) 3. During an interview on 11/07/2022 at 3:20 p.m., in the facility conference room, TP-1 confirmed the above findings. -- 7 of 7 --

Summary Statement of Deficiencies 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 review of the laboratory's IQCP study for D-Dimer using the Quidel Triage MeterPro and confirmed in interview of laboratory personnel, the laboratory failed to have a complete IQCP study. The findings were: Note: An IQCP must include: - Risk Assessment (to include risks associated with specimen, test system, reagent, environment, and testing personnel) - Quality Control Plan - Quality Assessment (to include policies and procedures for the ongoing monitoring of the effectiveness of the IQCP) 1. Review of the laboratory's submitted IQCP for D-Dimer on the Quidel Triage MeterPro found no documentation of a complete risk assessment, quality control plan, or quality assessment. 2. The laboratory performed a 30 day quality control study, but failed to include a risk assessment, quality control plan, and quality assessment. 3. An interview with the primary testing person on January 25, 2022 at 10: 00 hours in the laboratory confirmed the findings. Key: IQCP - Individualized Quality Control Plan Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the following CONDITION LEVEL DEFICIENCIES: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant. D6063 - 42 C.F.R. 493.1412 Condition: Laboratories performing moderate complexity testing; testing personnel. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. 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 CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). 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 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; laboratory director 493.807 (a) Reinstatement after Failure D2017 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 creatine and sodium. Refer to D2096. 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 proficiency testing scores from API found the laboratory failed to participate successfully for the analytes creatine and sodium. Findings include: 1. The laboratory received the following failing scores (passing = >80%) for the analyte creatine: Second testing event 2018 40% Third testing event 2018 40% First testing event 2019 0% 2. The laboratory received the following failing scores (passing = >80%) for the analyte sodium: Second testing event 2018 60% Third testing event 2018 60% First testing event 2019 40% 3. These three consecutive failures result in a second unsuccessful performance for the analytes creatine and sodium. 4. The laboratory must demonstrate sustained satisfactory performance (>80%) on two consecutive testing events for reinstatement. 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 API records found that the laboratory failed to attain a satisfactory score of at least 80% for the following chemistry analytes. Findings include: 1. API 2018 - 2nd testing event the laboratory received the following unsatisfactory scores: Creatine 40% Sodium 60% 2. API 2018 - 3rd testing event the laboratory received the following unsatisfactory scores: Creatine 40% Sodium 60% 3. API 2019 - 1st event the laboratory received the following unsatisfactory scores: -- 2 of 4 -- Alanine aminotransferase (ALT/SGPT) 20% Albumin 20% Alkaline Phos 20% Aspartate aminotransferase (AST/SGPT) 40% Total Bilirubin 40% Calcium 20% Cholesterol 0% Cholesterol HDL 40% Creatine 0% Glucose 0% Magnesium 20% Potassium 40% Sodium 40% Total Protein 20% Triglycerides 60% Blood Urea Nitrogen 0% 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: Review of the CMS report 155 and API proficiency testing records found that the laboratory failed to achieve a satisfactory score of at least 80% for the overall chemistry testing event score. Findings: 1. API 2019 - 1st event reported an event chemistry score of 28%. 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 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 creatine and sodium. Two out of three unsatisfactory scores results in unsuccessful PT performance. 1. The laboratory received the following failing scores (passing = >80%) for the analyte creatine: Second testing event 2018 40% Third testing event 2018 40% First testing event 2019 0% 2. The laboratory received the following failing scores (passing = >80%) for the analyte sodium: Second testing event 2018 60% Third testing event 2018 60% First testing event 2019 40% 3. These three consecutive failures result in a second unsuccessful performance for the analytes creatine and sodium. 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 -- 3 of 4 -- 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 -- 4 of 4 --

Summary Statement of Deficiencies D0000 Based on the recertification survey, the laboratory is not in compliance with the following conditions of participation required for certification in the CLIA program: D 2016 Successful Particpation-493.803 . 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 American Proficiency Institute (API) proficiency testing (PT) documentation for 2017 and 2018 confirmed by staff interview, the laboratory failed to participate successfully in chemistry testing using the Alfa-Wasserman Ace Axcel analyzer during the second and third events of 2018. Findings: 1. API PT documentation was reviewed. Scores for general chemistry included the following Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- results: 2nd event 2018 Creatinine (mg/dL) Specimen Reported Expected Grade CH- 06 2.27 2.41-3.27 Unacceptable CH-07 1.28 1.23-1.84 Acceptable CH-08 3.24 3.45- 4.68 Unacceptable CH-09 0.88 0.80-1.40 Acceptable CH-10 2.93 3.17-4.30 Unacceptable Event score: 40% Sodium (mmol/L) Specimen Reported Expected Grade CH-06 145 143-152 Acceptable CH-07 127 126-135 Acceptable CH-08 155 159-168 Unacceptable CH-09 123 122-130 Acceptable CH-10 151 155-163 Unacceptable Event score: 60% 3rd event 2018 Creatinine (mg/dL) Specimen Reported Expected Grade CH-11 1.05 0.91-1.52 Acceptable CH-12 2.44 2.46-3.34 Unacceptable CH-13 3.18 3.27-4.44 Unacceptable CH-14 1.82 1.78-2.42 Acceptable CH-15 2.77 2.83-3.84 Unacceptable Event score: 40% Sodium (mmol/L) Specimen Reported Expected Grade CH-11 118 111-119 Acceptable CH-12 133 133-142 Acceptable CH-13 145 149-158 Unacceptable CH-14 125 122-131 Acceptable CH-15 138 140-149 Unacceptable Event score: 60% 2. Scores below 80% in two consecutive testing events for the analytes creatinine and sodium resulted in long term unsuccessful performance. In an interview at the site during the survey, testing person 1 (CMS form 209) 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 review of API PT documentation for 2017 and 2018, confirmed by staff interview, the laboratory failed to achieve satisfactory performance for chemistry testing of the analytes creatinine and sodium using the Alfa-Wasserman Ace Alera analyzer in the second and third events of 2018. Refer to D 2016. . D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on review of quality control (QC) documentation for 2017 and 2018, surveyor observation and staff interview, the laboratory failed to employ control procedures to monitor the accuracy of test performance over time in chemistry testing using the Alfa- Wasserman ACE Axcel analyzer. Findings: 1. During the survey, it was observed that QC documentation for chemistry testing consisted of individual printouts of daily QC testing. A Levey-Jennings plot of the current control lot was requested. Testing person -- 2 of 4 -- 1 stated that she did not know whether the instrument could produce such a report. 2. Review of the manufacturer's introductory documentation revealed that the analyzer could display and print such plots in three different formats and referenced instructions for their generation in the operator's manual. (Alfa-Wasserman Diagnostic Technologies, LLC; ACE Axcel Clinical Chemistry System, Introduction to Quality Control Practices in the Clinical Laboratory, P/N 701419, Rev. A-10/13, page 9) . D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: . Based on review of validation documentation for the Sysmex XP-300 hematology analyzer and staff interview, the laboratory director (CMS form 209) failed to ensure that adequate procedures were employed to verify the performance characteristics of the instrument prior to patient testing. 1. Documentation for the Sysmex XP-300 was reviewed. Validation and correlation studies, dated 03-13-2018 and 03-14-2018, were included. The provided documentation showed no evidence of review by the laboratory director. All spaces provided for signatures of persons performing testing and review were left blank. 2. In an interview at the site on 11-29-2018, testing person 1 stated that the validation data was provided to the manufacturer's service representative for analysis and to her knowledge had not been reviewed by the laboratory director. . D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: . Based on review of the laboratory procedure manual and staff interview, the laboratory director failed to specify in writing the responsibilities and duties of the laboratory technical consultant or testing personnel 1 and 2. Findings: 1. The laboratory procedure manual was reviewed. No document specifyiing the duties or -- 3 of 4 -- responsibilities delegated to the laboratory technical consultant (CMS forrm 209) was found or could be offered during the survey. 2. No document specifying the responsibilities or duties of testing personnel 1 or 2 (CMS form 209) was found or could be offered during the survey. 3. In an interview at the site on 11-29-2018, testing person 1 stated that to her knowledge no such document was available. . D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: . Based on surveyor observation, review of 2018 quality control documentation for the Alfa-Wasserman Ace Accel chemistry analyzer and staff interview, the technical consultant failed to identify training needs for testing personnel in collecting control performance data. Refer to D 5441. . -- 4 of 4 --