Carnegie Tri-County Municipal Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/4,5/2024. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the technical consultant and testing person #1 at the conclusion of the survey. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on a review of records, the nursing transfusion policy and interview with the technical consultant, the facility failed to ensure written policies were followed for preventing transfusion reactions for two of five units reviewed. Findings include: (1) On 06/05/2024 at 11:00 am, the technical consultant stated that the laboratory performed transfusion services for emergency release blood and blood products that have been tested by the Oklahoma Blood Institute; (2) The policy "Administration of Blood Products" defined the parameters for ensuring blood products were transfused safely; (3) The surveyor reviewed the policy which stated, "Blood products must be infused within the recommended timeframe to ensure optimal benefit to the patient and due to the risk of bacterial proliferation in the blood component at room temperature. The list below provides the infusion timeframe's for blood products that may be administered"; (a) Red blood cells (RBC's) - within four hours of initiation. (b) Leukocyte-reduced red blood cells (LRBC's) - within four hours of initiation. (4) A review of transfusion records for five units of blood transfused with the technical consultant identified for two of five units transfused, the policy was not followed by nursing personnel: (a) Unit #W091024198498 - The unit was started at 1:58 pm and was completed at 6:10 pm, exceeding the four hour window. (b) Unit 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 -- #W091024123350 - The unit was started at 9:30 am and was completed at 2:10 pm, exceeding the four hour window. (5) Interview with the technical consultant on 06/05 /2024 at 11:00 am confirmed the facility failed to ensure the policy was being followed as written. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/28,29,30,2022. The laboratory was found out of compliance with the following CLIA Conditions of Participation: 493.1213; D5022: Toxicology 493.1441; D6076: Laboratory Director, High Complexity Testing 493.1487; D6168: Testing Personnel, High Complexity Testing The findings were reviewed with the chief clinical officer, chief executive officer, technical consultant, laboratory manager, testing person #3, testing person #6, and phlebotomist during an exit conference performed at the conclusion of the survey. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, urine drug screen package insert and test kit box, FDA database, email correspondence with an FDA representative, and interview with the technical consultant and laboratory manager, the laboratory failed to ensure the requirements were met for the subspecialty of Toxicology for six of six months of patient testing. Findings include: (1) The laboratory failed to have written policy defining the method to verify the accuracy of the urine drug screen testing at least twice annually. Refer to D5401; (2) The laboratory failed to establish the performance specifications for the Accurate Urine DOA Rapid Test Dipcard test not cleared or approved by the FDA. Refer to D5423; (3) The laboratory failed to perform a negative and positive control material 20 of 22 days of patient urine drug screen testing. Refer to D5449. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 7 -- 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 a review of records, policies and procedures and interview with the laboratory manager, the laboratory failed to have written policy defining the method to verify the accuracy of the urine drug screen testing at least twice annually. Findings include: (1) On 06/29/2022 at 01:33 pm, the laboratory manager stated the Accurate Urine DOA Rapid Test Dipcard had been put into use for patient testing on 01/03 /2022 (refer to D5423 for specific information pertaining to the test kit not being FDA approved and defaulting to a high complexity test system); (2) A review of urine drug screen records, policies and procedures, and proficiency testing for 2022 revealed the laboratory had not enrolled and participated in a proficiency testing program and there was no evidence a policy had been written to ensure a method to verify the accuracy of the testing at least twice annually; (3) The records were reviewed with the laboratory manager who stated on 06/29/2022 at 01:43 pm the laboratory did not have a method to verify the accuracy of urine drug screen testing at least twice annually because it was believed the test kit was categorized as waived; (4) Refer to D5423 for examples of patient testing. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/07,08/2020. The findings were reviewed with the technical consultant, laboratory manager, and testing person #2 at the conclusion of the survey. The laboratory was found in compliance with standard- level deficiencies cited. 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: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager and technical consultant, the laboratory failed to ensure an analyzer and materials were stored as required by the manufacturer for 3 of 9 months. Findings include: (1) On 10/07/2020 at 10:30 am, the laboratory manager stated the following to surveyor #2: (a) CKMB, Troponin I, and D-Dimer testing were performed in the laboratory using the Alere Triage analyzer. (2) Surveyor #2 reviewed the manufacturer's test device environmental requirements for the analyzer: (a) The operator's manual for the analyzer on page 2 under "STORAGE AND HANDLING REQUIREMENTS" required a room temperature of 20-24 degrees Centigrade (C). (3) Surveyor #2 reviewed laboratory room temperature records for 9 months (January 2020 through September 2020) and identified that for 3 of 9 months the room temperatures were colder than the manufacturer's storage requirements as follows: (a) April 2020 - 3 of 30 days (i) 04/25/2020 - The room temperature had been 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 -- documented at 18 degrees C; (ii) 04/26/2020- The room temperature had been documented at 18 degrees C; (iii) 04/30/2020 - The room temperature had been documented at 18 degrees C. (b) August 2020 - 2 of 31 days (i) 08/04/2020 - The room temperature had been documented at 19 degrees C; (ii) 08/19/2020 - The room temperature had been documented at 18 degrees C. (c) September 2020 - 6 of 30 days (i) 09/09/2020 - The room temperature had been documented at 18 degrees C; (ii) 09 /13/2020 - The room temperature had been documented at 19 degrees C; (iii) 09/14 /2020 - The room temperature had been documented at 19 degrees C; (iv) 09/19/2020 - The room temperature had been documented at 18 degrees C; (v) 09/24/2020 - The room temperature had been documented at 18 degrees C; (vi) 09/28/2020 - The room temperature had been documented at 18 degrees C. (4) Surveyor #2 reviewed the records with the laboratory manager and technical consultant. The laboratory manager and technical consultant stated on 10/08/2020 at 02:25 pm to surveyor #2 , the laboratory did not store the manufacturer's test device according to the manufacturer's requirements as indicated above. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and technical consultant, the laboratory failed to ensure the demonstrated reportable ranges were utilized for 2 of 2 new analyzers. Findings include: (1) On 10/07/2020 at 10:30 am, the laboratory manager stated the following to surveyor #2: (a) The laboratory began using a replacement Alere Triage analyzer to perform CKMB, Troponin I, and D- Dimer testing on 02/05/2020; (b) The laboratory began using Beckman Coulter AcT Diff2 analyzer to perform CBC (Complete Blood Count) testing on 02/05/2019. (2) Surveyor #2 reviewed the performance specification records and identified the laboratory had demonstrated reportable ranges as follows: (a) Alere Triage (i) CKMB - 0.07 - 25.1 ng/ml; (ii) Troponin I - 1.7 - 55.7 ng/ml. (b) Beckman Coulter AcT Diff2 (i) Hemoglobin - 1.7 - 20.0 g/dL (ii) Platelets - 27.0 - 962.0 X 10^3/l (iii) Red Blood Cells - 0.6 - 6.85 X 10^6 /l (iv) White Blood Cells - 0.7 - 90.2 X 10^3/l (3) Surveyor #2 requested the reportable ranges that were being utilized by the laboratory. The laboratory manager provided surveyor #2 linearity ranges from the LIS (Laboratory Information System) and stated on 10/07/2020 at 02:45 pm the linearity ranges were the laboratory's reportable ranges: (a) Alere Triage (i) CKMB - 0.05 - 27.9 ng/ml; (ii) Troponin I - 1.0 - 80.0 ng/ml. (b) Beckman Coulter AcT Diff2 (i) Hemoglobin - 2.0 - 27.0 g/dL (ii) Platelets - 10.0 - 2327.0 X 10^3/l (iii) Red Blood Cells - 0.2 - 8.70 X 10^6 /l (iv) White Blood Cells - 0.5 - 122.0 X 10^3/ (4) The surveyor reviewed the findings with the laboratory manager and technical consultant. The laboratory manager and technical consultant stated on 10/07/2020 at 04:14 pm the laboratory was not using the reportable ranges that had been demonstrated by the laboratory. D5441 CONTROL PROCEDURES -- 2 of 5 -- 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 a review of records and interview with the laboratory manager and technical consultant, the laboratory failed to have control procedures that would detect immediate errors that would occur due to test system failure, adverse environmental conditions, and operator performance three of three months for Acetaminophen and two of three months for Sodium testing. Findings include: (1) On 10/07/2020 at 10:00 am, the laboratory manager stated to surveyor #1 Acetaminophen and Sodium testing were performed on the Ortho Vitros 4600; (2) On 10/08/2020 at 11:00 am the laboratory manager stated the following to surveyor #1: (a) The laboratory began performing patient testing using the new analyzer in December 2019; (b) Three levels of Bio-Rad Liquid Assayed Multiqual QC (quality control) materials were performed each day of patient testing. (3) Surveyor #1 reviewed the package insert for the control materials which stated, "The mean values and corresponding +/-3SD ranges in the Assignment of Values Data Charts (available separately) were derived from replicate analyses and are specific for this lot of product. Data from Unity Interlaboratory Program are included in the determination of some ranges. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides"; (4) Surveyor #1 then reviewed QC records for three lot numbers of control materials used from June through August 2020 (level 1 lot #45861, level 2 lot #45862, and level 3 lot #45863). The review showed the laboratory was using ranges wider than the package insert guideline ranges as follows: (a) Acetaminophen (i) Level 3 - The package insert range was 127-146. A range of 124-148 had been used to evaluate QC results. (b) Sodium (i) Level 1 - The package insert range was 110-122. A range of 106.1-124.1 had been used to evaluate QC results; (ii) Level 2 - The package insert range was 136-151. A range of 129.4-151.4 had been used to evaluate QC results; (iii) Level 3 - The package insert range was 154- 171. A range of 148-172 had been used to evaluate QC results. (5) Surveyor #1 reviewed the records with the technical consultant who stated on 10/08/2021 at 12:30 pm ranges wider than the package insert guideline ranges, as indicated above, had been used to evaluate QC results. 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 -- 3 of 5 -- 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 records and interview with the laboratory manager and technical consultant, the laboratory failed to perform quality control testing as required in the IQCP. Findings include: (1) On 10/07/2020 at 10:30 am, the laboratory manager stated to surveyor #2 that D-Dimer testing was performed in the laboratory using the Alere Triage analyzer; (2) Surveyor #2 reviewed records, and identified the laboratory had performed an IQCP (Individualized Quality Control Plan) for this test system, which had been reviewed and accepted by the laboratory director as effective beginning 05/10/2018. The IQCP quality control plan stated two levels of external quality control (QC) materials were to be performed with new lot numbers and every 30 days (this QC frequency was as stringent as the manufacturer's requirements); (3) Surveyor #2 reviewed records from January 2020 through the first day of the survey (10/07/2020). It was identified that the laboratory did not satisfy the IQCP as follows: (a) One level of QC had been performed on 05/03/2019. (4) On 10/08/2020, surveyor #2 reviewed the records with the laboratory manager an technical consultant. The laboratory manager and technical consultant stated on 10/08/2020 at 02:30 pm the laboratory did not performing two levels of QC, as stated in their IQCP. D5783