Summary:
Summary Statement of Deficiencies D0000 The INTEGRIS Baptist Medical Center Portland Avenue was found in compliance with 42 CFR Part 493 requirements for laboratories as a result of a validation survey on 05/27/26. Standard level deficiencies cited. 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 record review and interview with the point of care manager, the laboratory failed to perform Quality Control (QC) as stated in the laboratory's Individualized Quality Control Plan (IQCP) for three of five months. Findings included: 1. On 05/27 /26 at 01:15 pm, the point of care manager verified the laboratory performed blood gas and chemistry testing using the CG8+ cartridge and the CG4+ cartridge with an iSTAT analyzer (serial# 430447) in the critical care unit (CCU3). 2. Record review of the laboratory's Quality Control Plan (QCP) stated the following: a. Activity - "Each lot/shipment of test cartridges is evaluated for acceptance using minimum 2 levels of External Liquid QC; iSTAT TriControl Levels 1&3 ...". b. Frequency - "Each lot /shipment & monthly (minimally every 31 days). Lot-to-Lot (Old/New) as indicated". 3. Record review of QC between 12/01/25 through 04/30/26 revealed the laboratory failed to perform external QC for three of five months as follows: a. CG8+ cartridge 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 -- External QC not performed between 12/20/25 and 02/23/26 External QC not performed between 02/23/26 and 04/22/26 Level 3 external QC not performed on 04 /22/26 (not the minimum of 2 levels of external QC) b. CG4+ cartridge Level 3 external QC not performed on 12/20/25 (not the minimum of 2 levels of external QC) External QC not performed between 12/20/25 and 04/22/26 Level 1 external QC not performed on 04/22/26 (not the minimum of 2 levels of external QC) 4. During an interview on 05/27/26 at 01:15 pm, the point of care manager confirmed the findings above. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of a written policy, record review, and interview with the nurse manager, the facility's written policies failed to ensure the safety of individuals being transfused for two of five transfusion patients. Findings included: 1. Review of the written procedure titled, "IV Therapy: Blood/Blood Product Administration, SYS- PCS-600" stated the following: a."I. vital signs (Blood Pressure, Pulse, Respirations, Temperature and SpO2) are taken:" "1. Prior to initiation of transfusion of each unit, no more than 30 minutes prior to starting the transfusion." "2. 15 minutes after initiation of the transfusion." "3. Hourly until the completion of the transfusion." "4. At the completion of the transfusion, within 30 minutes of stop time." 2. Record review of five patients transfused on 05/06/26, 05/13/26, and 05/16/26 revealed the laboratory failed to follow its policy for two of five patients transfused as follows: a. Patient# 201184602 - Transfused unit# W091026175910 Packed Red Blood Cells (PRBCs) on 05/06/26 Transfusion start time at 06:42 pm, vital signs documented at 07:00 pm and 07:41 pm. Vital signs not documented again until 09:35 pm (one hour fifty-six minutes later not hourly until the transfusion stopped at 10:00 pm). b. Patient# 203475083 - Transfused unit# W091026219139 PRBCs on 05/16/26 Transfusion start time of 11:37 am, vital signs not documented again until 12:04 pm (27 minutes later not 15 minutes after the initiation of the transfusion per laboratory policy). Vital signs taken at 12:37 and 02:10 pm (one hour thirty-three minutes later not hourly until the transfusion was stopped at 02:10 pm per laboratory policy). 3. During an interview on 05/27/2026 at 11:55, the nurse manager confirmed the findings above. 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 -- 2 of 3 -- 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 record review and interview with the point of care manager, the laboratory failed to perform comparison studies at least twice a year for two of two Abbott iSTAT instruments for Troponin I testing for one year (2025). Findings included: 1. On 05/27/26 at 02:30 pm, the point of care manager verified the laboratory performed Troponin I testing using two iSTAT analyzers (serial# 419077 and serial# 419240) in the emergency department. 2. Record review of January 2025 through December 2025 revealed one comparison study (performed on 08/29/25). 3. During interview on 05/27 /26 at 03:00 pm, the second comparison in 2025 was requested and no documentation was provided. -- 3 of 3 --