Altus Baytown Hospital Er

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 07/24/2025. 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. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor's observation, review of manufacturer instructions for use and staff interview, the laboratory failed to document amended expiration date for three of three Medonic hematology analyzer's control vials in use. Findings included: 1. Surveyor's observations on 07/24/2025 at 1255 hours in the laboratory revealed three Boule hematology control vials in use stored in the refrigerator: Abnormal low control lot number: 22504-31 Normal control lot number: 22504-32 Abnormal high control lot number: 22504-33 None of the vials had an open/in-use date or amended expiration date to verify control stability. 2. Review of the "CDS Boule Con-Diff Multi-Parameter Assayed Hematology Control" (document PN201078H R07.30.21) manufacturer's instructions revealed: "Open vial stability 14 days" 3. In an interview on 07/24/2025 at 1255 hours in the laboratory, facility's laboratory director (as indicated on submitted Form CMS 209) confirmed the findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of laboratory's Medonic hematology analyzer's instrument maintenance records, patient test volumes and staff interview the laboratory failed to document the required Monthly Maintenance for six of twelve months reviewed from 2024 and 2025. Findings included: 1. Review of the Medonic hematology analyzer maintenance records revealed the following required Monthly Maintenance documentation: "MONTHLY MAINTENANCE (User Manual, Section 8.2) Boule Cleaning Kit Reagents Monthly Cleaning (Hypochlorite) Clot Prevention (Enzymatic)" 2. Review of random Medonic hematology analyzer maintenance records for 2024 and 2025 revealed the following six of twelve months reviewed did not have documentation of the required Monthly Maintenance: January 2024 February 2024 July 2024 January 2025 March 2025 April 2025 3. Review of laboratory's submitted patient test volumes revealed the laboratory performed approximately 14,500 hematology tests annually. 4. In an interview on 07/24/2025 at 1245 hours in the office, facility's laboratory director (as indicated on submitted Form CMS 209), after review of the records, confirmed the findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of laboratory's Individualized Quality Control Plans (IQCP), quality control (QC) records, patient test records and staff interview, the laboratory failed to follow its own IQCP for documentation of QC every thirty days for two of two test panels used in 2024 and 2025, the Abaxis Piccolo Metlac 12 Panel, and the Alere D- Dimer panels. Findings included: 1. Review of laboratory's IQCP "Quality Control Plan - Abaxis Piccolo Metlac 12 Panel" (last reviewed 07/14/2025) revealed: "Two levels of external controls (low and high) will be run for every new lot number of reagent disc, every new shipment of reagent disc and every 30 days." 2. Review of laboratory's IQCP "Quality Control Plan - Alere Cardiac Panel (CK-MB, Troponin I, Myoglobin)" (last reviewed 07/14/2025) revealed: "Two levels of external controls (low and high) will be run for every new lot number of cartridges and every 30 days." The IQCP document included a handwritten amendment by laboratory director "Also to include D-Dimer in IQCP." 3. Review of laboratory's 2025 (January to June) QC records for the Metlac 12 and D-Dimer panels revealed the laboratory documented QC exceeding the IQCP required thirty days as follows: Metlac 12 Panel QC: QC documented: 02/06/2025 Next QC documented: 03/25/2025 Time elapsed: 47 days QC documented: 05/01/2025 Next QC documented: 06/24/2025 Time elapsed: 54 days D-Dimer: QC documented: 04/30/2025 Next QC documented: 06/24/2025 Time -- 2 of 5 -- elapsed: 55 days 4. Review of laboratory's patient test records revealed the following patients were tested beyond the required thirty days QC: Metlac 12 tested 03/08/2025 to 03/24/2025: Patient's MRN: Tested: M1NO7BBM4714 03/08/2025 M1NO7BBM4713 03/08/2025 M1NO7BBM4712 03/08/2025 M1NO7BBM4763 03 /12/2025 M1NO7BBM4837 03/16/2025 M1NO7BBM4834 03/16/2025 M1NO7BBM4844 03/16/2025 M1NO7BBM4872 03/18/2025 M1NO7BBM4953 03 /22/2025 M1NO7BBM4956 03/22/2025 M1NO7BBM4954 03/22/2025 M1NO7BBM4966 03/23/2025 M1NO7BBM4982 03/24/2025 Metlac 12 tested 06/01 /2025 to 06/23/2025: Patient's MRN: Tested: M1NO7BBM6294 06/01/2025 M1NO7BBM6311 06/01/2025 M1NO7BBM6337 06/03/2025 M1NO7BBM6339 06 /03/2025 M1NO7BBM6361 06/04/2025 M1NO7BBM6357 06/04/2025 M1NO7BBM6389 06/06/2025 M1NO7BBM6392 06/07/2025 M1NO7BBM6428 06 /08/2025 M1NO7BBM6464 06/11/2025 M1NO7BBM6331 06/11/2025 M1NO7BBM6511 06/15/2025 M1NO7BBM6569 06/20/2025 M1NO7BBM6589 06 /21/2025 M1NO7BBM6588 06/21/2025 M1NO7BBM6597 06/22/2025 D-Dimer tested 05/31/2025 to 06/23/2025: Patient's MRN: Tested: M1NO7BBM6283 05/31 /2025 M1NO7BBM6356 06/04/2025 M1NO7BBM6375 06/05/2025 M1NO7BBM6368 06/05/2025 M1NO7BBM6434 06/09/2025 M1NO7BBM6432 06 /09/2025 M1NO7BBM6449 06/10/2025 M1NO7BBM6451 06/10/2025 M1NO7BBM6446 06/10/2025 M1NO7BBM6481 06/13/2025 5. In an interview on 07 /24/2025 at 1150 hours in the office, facility's laboratory director (as indicated on submitted Form CMS 209), after review of the records, confirmed the findings. 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. This STANDARD is not met as evidenced by: Based on review of laboratory's quality control (QC) records, instrument to instrument comparison records, policies/procedures and staff interview, the laboratory failed to document comparison of instrument results for two of two Piccolo analyzers in use in 2024 and 2025. Findings included: 1. Review of laboratory's QC records revealed the laboratory had two Piccolo Xpress analyzers in use, Piccolo 1 and Piccolo 2 on which Metlac 12 panels were tested. 2. The laboratory was asked to provide Piccolo 1 to Piccolo 2 test result comparison records for Metlac 12 panel testing, and no such records were available for review prior to survey exit. 3. Review of laboratory's policies/procedures revealed the laboratory did not have protocols in place for instrument-to-instrument test result comparison every 6 months. 4. In an interview on 07/24/2025 at 1135 hours in the office, facility's laboratory director (as indicated on submitted Form CMS 209), after review of the records, confirmed the findings. D5785

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. 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 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 the laboratory policy, review of laboratory records from March 2021 to November 2021 and confirmed in interview, the laboratory failed to follow its policy for CBC patient analysis on the Medonic M hematology analyzer for three of ten patients reviewed. Findings included: 1. Review of the laboratory policy Complete Blood Count Using Medonic M-series under Handling of Abnormal and Flagged Results revealed "for WBC/WBC DIFF flags, repeat the testing after doing the following: Make sure the EDTA sample has been allowed to sit for 15-20 minutes before it is analyzed. This will allow for the anticoagulant and the blood to equilibrate. Always mix the sample well before analyzing. If WBC [or] WBC DIFF flags are not resolved, DO NOT REPORT PATIENT RESULTS. DE: Small particle interference; re-analyze OM: WBC DIFF - only one WBC population found, slide review advised. Blood sample may be too old or may be an abnormal pathological sample. Make sure the EDTA sample has been allowed to sit for 15-20 minutes before it is analyzed. This will allow for the anticoagulant and the blood to equilibrate. Always mix sample well 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 -- before analyzing. Re-analyze the sample. If the flags are not resolved, do not report patient results. refer the sample to send out laboratory for testing. BD: WBC Diff; high interference between populations. Blood sample may be too old or may be an abnormal pathological sample. Make sure the EDTA sample has been allowed to sit for 15-20 minutes before it is analyzed. This will allow for the anticoagulant and the blood to equilibrate. Always mix sample well before analyzing. Re-analyze the sample. If the flags are not resolved, do not report patient results. refer the sample to send out laboratory for testing." 2. Random review of patient test records from March 2021 to November 2021 revealed three of ten patient test records with one of the above flags with no documentation of the corresponding

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. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on review of the laboratory test logs from 2018 and 2019 and confirmed in interview, the facility failed to document the time and date it received specimens. Findings were: 1. Review of 2018 and 2019 test logs revealed no documentation of the time the facility collects specimens for all nonwaived testing. Specimen time of collection/receipt into the laboratory is vital information in order to ensure specimens are tested within required storage time frames. 2. An interview with the technical consultant on 11/19/19 at 1135 hrs in the conference room confirmed that the facility does not log the time of specimen collection/receipt. 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. 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 -- (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: Based on review of the manufacturer's instructions, review of the laboratory records, patient test records, and confirmed in interview, the laboratory failed to document the correct operating temperature for DDimer, CKMB and Troponin testing on the Quidel Triage Meter per manufacturer's instructions. Findings were: 1. Review of the manufacturer's instructions for the Quidel Triage DDimer test (PN: 26589en Rev. A 2018/04) under warnings and precautions "optimal results will be achieved by performing testing at temperatures between 20-24 C." 2. Review of the laboratory Policy and Procedure Alere Triage DDimer (Policy #15.0) under Reagents and Equipment "before using refrigerated test devices allow individual foil pouches to reach operating temperature (20 - 24 C or 68 - 75 F)...optimal results will be achieved by performing testing at temperatures between 20-24 C." 3. Review of the manufacturer's instructions for the Quidel Triage Cardiac Panel test (PN: 26584en Rev. A 2018/04) under warnings and precautions "optimal results will be achieved by performing testing at temperatures between 20-24 C." 4. Review of the laboratory Policy and Procedure Alere Triage Cardiac Panel (Policy #14.0) under Reagents and Equipment "before using refrigerated test devices allow individual foil pouches to reach operating temperature (20 - 24 C or 68 - 75 F)...optimal results will be achieved by performing testing at temperatures between 20-24 C." 5. Random review of August 2019 - October 2019 revealed 5 of 10 days with documentation of temperature outside of the acceptable range of 20-24 C. Date Temperature (F) 08/05/19 66 10/09/19 66 10 /10/19 66 10/16/19 66 10/26/19 65 6. Review of patient final reports of the above dates revealed Triage DDimer or Cardiac Panel patient testing were performed on the above dates. 8/5/19 Patient ID #16444 10/09/19 Patient ID #418 10/26/19 Patient ID #590 7. An interview with the technical consultant on 11/19/19 at 1135 hours in the conference room confirmed the above findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of quality assessment reports and interview, the laboratory quality assessment policies and procedures failed to identify and correct problems identified in analytical systems. Refer to D5413 -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --