Altus Baytown Hospital

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 09/18/2025. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on review of laboratory's submitted Form CMS-209, personnel records and staff interview, the laboratory director failed to ensure the laboratory documented completion of training for its test platforms and initial verification of competency prior to start of patient testing for one of eight testing personnel (TP) employed by the facility in 2024 and 2025, TP number six (TP6). Findings included: 1. Review of laboratory's submitted Form CMS-209 revealed the laboratory employed eight testing personnel. 2. Review of laboratory's personnel records revealed TP6 (as indicated on submitted Form CMS-209) was employed and started training on 10/10/2024. There was no documentation of training completion for all laboratory's test platforms or initial competency evaluation for this TP. 3. In an interview on 09/18/2025 at 1000 hours in the conference room, the facility's Laboratory Director (as indicated on submitted Form CMS-209) confirmed the findings. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory's submitted Form CMS-209, personnel records and staff interview, the laboratory's Technical Consultants failed to document semiannual evaluation of competency in the first year of testing for one of eight testing personnel (TP) employed by the facility in 2024 and 2025, TP number six (TP6). Findings included: 1. Review of laboratory's submitted Form CMS-209 revealed the laboratory employed eight testing personnel. 2. Review of laboratory's personnel records revealed TP6 (as indicated on submitted Form CMS-209) was employed and started training and patient testing on 10/10/2024. There was no documentation of semiannual competency evaluation within the first year of patient testing for this TP. 3. In an interview on 09/18/2025 at 1000 hours in the conference room, the facility's Laboratory Director (as indicated on submitted Form CMS-209) confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 01/09/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). STANDARD LEVEL DEFICIENCIES were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory's submitted Form CMS (Centers for Medicare and Medicaid) 209, personnel records, policies/procedures and staff interview the laboratory failed to document competency assessment for one of two clinical consultants employed by the facility. Findings included: 1. Review of submitted Form CMS 209 revealed the laboratory employed two clinical consultants. 2. Review of personnel records revealed Clinical Consultant number 1 (as indicated on submitted Form CMS 209) did not have documentation of competency assessment. 3. Review of policy "Lab2.0 - Quality Control Program" (effective date: 2024-01-07) revealed the policy did not address competency assessment for Clinical Consultant or Technical Consultant positions. 4. In an interview on 01/09/2024 at 1035 hours in the conference room, the laboratory's Testing Person number 1 (as indicated on submitted Form CMS 209) confirmed the findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks 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 -- may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures and staff interview, the laboratory failed to define one of one procedure/protocol for when the laboratory cannot perform proficiency testing (PT) due to technical difficulties, or alternate means for assessing test accuracy after technical difficulties have been resolved, in order to comply with the requirement of at least twice yearly PT/test accuracy verification of results. Findings included: 1. Review of policy "Lab2.0 - Quality Control Program" (effective date: 2024-01-07) revealed the policy did not address protocols for when the laboratory cannot perform proficiency testing (PT) due to technical difficulties, or alternate means for assessing test accuracy after technical difficulties have been resolved to ensure compliance with the frequency of PT/test accuracy verification regulatory requirements. 2. In an interview on 01/09/2024 at 1105 hours in the conference room, the laboratory's Testing Person number 1 (as indicated on submitted Form CMS 209) confirmed the findings. Key: CMS - Centers for Medicare and Medicaid -- 2 of 2 --

Summary Statement of Deficiencies D0000 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. The facility was found in compliance with applicable Conditions of Participation in the CLIA program, 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 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. 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. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, 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 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. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, laboratory test results, and confirmed in interview, the laboratory failed to follow manufacturer's instructions to confirm preliminary positive drug screen results using the CLIA waived Integrated E-Z Split Key Cup II. 1. A review of the package insert for the Integrated E-Z Split Key Cup II (DN: 1156117001, effective 3/16/17) revealed "This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result." 2. Random review of drug screen laboratory test results from 10/2017 to 03/2018 revealed 6 of 7 patient results with test results as preliminary positive (POS) with no documentation of confirmatory results. date ACT Number Results 10/03/17 24617 Benzodiazepines - POS 11/14/17 25206 Opiates - POS; THC -POS; Oxycodone - POS 12/05/17 25206 Opiates - POS 01/03/18 TC 04/1/70 Benzodiazepines - POS; Opiates - POS; Methamphetamine - POS; Amphetamine - POS 02/13/18 26361 Benzodiazepines - POS; THC - POS; Opiates - POS; Oxycodone 03/10/18 21792 Benzodiazepines - POS; Opiates - POS; Methadone - POS 3. An interview with the technical consultant on 05/10/18 at 1150 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 -- hours in the conference room confirmed the above findings. She was aware that the preliminary positive results needed to be sent out for confirmation. She is working with the facility to find a laboratory to perform the confirmation. key: THC - Tetrahydrocannabinol POS - positive 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 review of the laboratory's American Proficiency Institute (API) Chemistry proficiency testing records from 2016, and staff interview, the laboratory failed to attain a satisfactory score of at least 80% for the analyte pO2. The findings were: 1. A review of the laboratory's API from 2016 revealed the laboratory failed to attain a satisfactory score of at least 80% for the analytes pO2 on 1 of 3 events: 2016 Event 3 pO2 (60%) lab result acceptable result IB12 116 45 - 90 IB13 135 59-96 2. An interview with the technical consultant on 5/15/18 at 1015 hours in the conference room confirmed the above findings. -- 2 of 2 --