Ut Health Rgv Clinical Laboratory

Summary Statement of Deficiencies D0000 Based on an announced validation inspection from 4/02/2024 to 04/03/2024, the laboratory was found out of compliance with the CLIA regulations. The condition not met was: D5300 - 42 C.F.R. 493.1240 Condition: Pre-analytic systems D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the laboratory's College of American Pathologist's (CAP) proficiency testing (PT) records from 2023 and 2024, review of the laboratory's personnel records, review of the laboratory policy and confirmed in interview, the laboratory failed to ensure that proficiency testing was performed by all personnel who routinely performed testing for 16 of 24 testing events reviewed. The findings were: 1. A review of the laboratory's College of American Pathologist's proficiency testing records from 2022 and 2023 revealed testing personnel number one as listed on Form CMS 209 performed the analysis of proficiency testing samples for 16 of 24 testing events reviewed. The events documented as performed by testing personnel number one were: CB-2023 General Chemistry/Therapeutic Drugs G-G 2023 Syphilis Serology S-B 2023 Diagnostic Immunology S2-B 2023 Special Immunology K-B 2023 Ligand - General U-B 2023 Urine Chemistry - General GH5-B 2023 HgA1C VM-B 2023 Viral Markers UDS-B 2023 Urine Drug Testing ESR1-A 2023 Erythrocyte Sed Rate Y-A 2023 Sex Hormones CGL-B 2023 Coagulation Limited FHG-B 2023 Hematology Auto Diff GH5-A 2023 HgA1C CM-B 2023 Clinical Microscopy VM-C 2023 Viral Markers 2. A review of the CMS209 revealed seven Testing personnel (TP). TP #1 (hire date 07/2022) TP #2 (hire date 02/2023) TP #3 (hire date (06/2023) TP #4 (hire date 06/2023) TP #5 (hire date 09/2023) TP #6 (hire Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- date 09/2023) TP #7 (hire date 10/2023) 3. In review of the laboratory policy Proficiency Testing (SOP GEN.0020, effective 12/23/2020), it stated "survey specimens will be analyzed by the same primary method used for patient samples and by the personnel that routinely perform patient testing." It did not include that it would rotate surveys amongst testing personnel. 4. An interview with the administration liaison on 4/02/2024 at 1120 hours in the conference room confirmed the above findings. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of manufacturer's instructions, surveyor observation, review of patient test records and staff interview, the laboratory failed to meet the requirements for pre-analytic systems. The findings include: 1. The laboratory failed to ensure coagulation samples were transported to the facility at the temperature required by the manufacturer (refer to D5311 I.). 2. The laboratory failed to ensure thromboplastin samples were tested within 4 hours of collection (refer to D5311 II.). 3. The laboratory failed to have a mechanism in place to ensure chemistry samples were transported to the facility at the temperature required by the manufacturer (refer to D5311 III.). D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: I. Based on a review of the manufacturer's instructions for the Dade Innovin reagent, review of the Dade Actin FSL Activated PTT reagent, review of the laboratory's procedures for PT (prothrombin time) and PTT (partial thromboplastin time) testing, surveyor observation of patient samples received by the laboratory on 04/03/2024, and staff interview, the laboratory failed to ensure samples for coagulation testing were not transported to the facility at refrigerated temperatures. The findings include: 1. A review of the manufacturer's instructions for the Dade Innovin reagent (10873566GU11 Rev.03) under the section titled "Specimen Collection and Preparation" stated: "Do not store on ice or at 2 to 8C." 2. A review of the manufacturer's instructions for the Dade Actin FSL Activated PTT reagent (11541732 Rev.11) under the section titled "Storing the Specimen" stated: "Store in an unopened -- 2 of 13 -- tube at room temperature." And, "Do not store on ice." 3. A review of the laboratory's procedure titled "Prothrombin Time (PT) (Revised 08/31/2023) under the section titled "Handling conditions" stated: "The specimen should be transported at room temperature." And, "Specimens for PT assays can be maintained uncentrifuged or centrifuged with the plasma remaining on top of the cellular component in an unopened tube at room temperature for up to 24 hours." 4. A review of the laboratory's procedure titled "Activated Partial Thromboplastin Time (aPTT) (Revised: 8/31/2023) under the section titled "Handling conditions" stated: "The specimen should be transported at room temperature." And, "Cold temperatures are known to induce platelet aggregation and release platelet factor 4." 5. Surveyor observations on 04/03/2024 at 1415 hours in the laboratory revealed the laboratory received a coagulation sample 56306923 and part of a shipment of multiple samples. Surveyor observed the specimens were transported via a cooler with a minimum temperature of 1.57 C and maximum temperature of 12.88 C. An interview with the courier on 4/03/2024 at 1417 hours confirmed that he brought all specimens in a similar cooler with 2 ice packs daily. He placed them in their biohazard bags onto the cooler. 6. The laboratory reported performed the following number of coagulation tests in 2023: PT: 290 PTT: 219 7. Testing personnel number 5 and number 7 on 04/02 /2024 at 1430 hours in the processing area confirmed all samples were received by the laboratory inside a cooler with ice packs. They could not provide proof that the temperature of the coolers were acceptable for coagulation testing. II. Based on review of the manufacturer's instructions for the Dade Actin FSL Activated PTT reagent, review of the laboratory's procedures for PTT (partial thromboplastin time) testing, review of patient test records from November 2023 to January 2024, and staff interview, the laboratory failed to ensure PTT testing was performed within 4 hours of collection. The findings included: 1. A review of the manufacturer's instructions for the Dade Actin FSL Activated PTT reagent (11541732 Rev. 11) under the section titled "Storing the Specimen" stated: "Store at room temperature and test within 4 hours." 2. A review of the laboratory's procedure titled "Activated Partial Thromboplastin Time (aPTT) (Revised: 8/31/2023) under the section titled "Handling conditions" stated: "The whole blood specimen is checked for clot formation by gentle inversion and centrifuged and tested within 4 hours from the time of specimen collection." 3. A sampling of patient test results from November 2023 to January 2024 identified 16 of 23 samples where the time from collection to receipt by the laboratory exceeded 4 hours and thus, the samples were not tested within the required timeframe. They were: a) November 2023 Patient ID: 73326087 Date: 11/01 Collection time: 09: 06 am Received time: 01:22 pm Elapsed time: 4 hours 16 minutes Patient ID: 45254683 Date: 11/08 Collection time: 08:35 am Received time: 02:48 pm Elapsed time: 5 hours 53 minutes Patient ID: 515834067 Date: 11/08 Collection time: 02:59 pm Received time: 08:17 pm Elapsed time: 5 hours 18 minutes Patient ID: 1552681 Date: 11/16 Collection time: 11:45 am Received time: 07:10 pm Elapsed time: 7 hours 25 minutes Patient ID: 48051790 Date: 11/16 Collection time: 11:30 am Received time: 07:46 pm Elapsed time: 8 hours 16 minutes b) December 2023 Patient ID: 69443370 Date: 12/05 Collection time: 12:56 pm Received time: 07:17 pm Elapsed time: 6 hours 21 minutes Patient ID: 30306754 Date: 12/05 Collection time: 11:30 am Received time: 06:50 pm Elapsed time: 7 hours 20 minutes Patient ID: 30646053 Date: 12/06 Collection time: 11:11 am Received time: 06:35 pm Elapsed time: 7 hours 24 minutes Patient ID: 80445999 Date: 12/08 Collection time: 10:30 am Received time: 06:39 pm Elapsed time: 8 hours 9 minutes Patient ID: 86668067 Date: 12/13 Collection time: 12:31 pm Received time: 06:33 pm Elapsed time: 6 hours 2 minutes Patient ID: 8128086 Date: 12/14 Collection time: 01:45 pm Received time: 06:15 pm Elapsed time: 4 hours 30 minutes Patient ID: 50841581 Date: 12/20 Collection time: 08:48 am Received time: 01:55 pm Elapsed time: 5 hours 7 minutes -- 3 of 13 -- c) January 2024 Patient ID: 86131436 Date: 01/08 Collection time: 11:40 am Received time: 06:01 pm Elapsed time: 6 hours 21 minutes Patient ID: 24781257 Date: 001/09 Collection time: 09:30 am Received time: 01:39 pm Elapsed time: 4 hours 9 minutes Patient ID: 62749109 Date: 01/11 Collection time: 08:00 am Received time: 01:56 pm Elapsed time: 5 hours 56 minutes Patient ID: 26789740 Date: 01/16 Collection time: 10:25 am Received time: 06:34 pm Elapsed time: 8 hours 9 minutes 4. The laboratory director confirmed the findings in an interview conducted 04/04/2024 at 1400 hours in the conference room. 38387 III. Based on review of the manufacturer's instructions, laboratory policies, review of patient records, and confirmed in interview, the laboratory failed to establish and follow the preanalytic requirements for three of three testing observed: urinalysis, chemistry tests and cytology send out testing. A. Urinalysis B. Chemistry C. Cytology Findings included: A. Urinalysis 1. Review of Clinitek Novus Automated Urine Chemistry Analyzer Operator's Guide (11064810 Rev. B) under Testing the Patient Samples, it stated "With unpreserved samples, for the most accurate results, test within 2 hours of collection ...Allow the samples to reach room temperature if they were refrigerated." 2. Review of the laboratory policy Automated Urinalysis on Sysmex UN-Series (SOP Urine.0006, effective 09/01/2022) under Specimen Requirements, it stated, "uncentrifuged urine ...if analysis is not possible within one hour of collection, the urine may be refrigerated ...urine specimens that cannot be analyzed within an hour of collection or refrigerated must be transferred into a urinalysis preservative tube such as BD Vacutainer." 3. Surveyor observations on 04/03/2024 at 1415 hours in the laboratory revealed the laboratory received urine specimens unpreserved in various urine containers. Surveyor observed the specimens were transported via a cooler with a minimum temperature of 1.57 C and maximum temperature of 12.88 C. An interview with the courier on 4/03/2024 at 1417 hours confirmed that he brought all specimens in a similar cooler with 2 ice packs daily. He placed them in their biohazard bags onto the cooler. 4. Random review of urinalysis records from 04/03 /2024 confirmed the laboratory received and performed the following UA specimen received in an inappropriate temperature and beyond the two hours of collection. Patient Acc # 88278 collected 04/03/2024 at 0937 hours, received 1429 hours; elapsed time of 3 hours 52 minutes 5. In review of the laboratory records, the laboratory performed 289700 urinalysis testing annually. B. Chemistry Albumin 1. Review of the package insert for Dimension Albumin (Ref DF13, issue date 04/22/2019) under Specimen Collection and Handling it stated "specimens are stable for 8 hours at room temperature, 2 days at 2-8C. For longer storage, specimens may be frozen at -20 C or colder." 2. Review of the laboratory policy Dimension Albumin (SOP DIM.0001, effective 12/1/2022) under Specimen Requirements, it stated "specimens are stable for 8 hours at room temperature and for 2 days at 2 - 8 C." ALT 3. Review of the package insert for Dimension Alanine Aminotrasnsferase (Ref DF143, issue date 04/0/2019) under Specimen Collection and Handling it stated "separated samples are stable at 7 days refrigerated at 2-8 C. For longer storage, specimens may be frozen for 1 month at -20C or colder." 4. Review of the laboratory policy Dimension Alanine Aminotransferase (SOP Dim.0003, effective 12/01/2022) under Specimen Requirements, it stated "separated specimens are stable for 8 hours at room temperature and for 7 days at 2-8 C." ALP 5. Review of the package insert for Dimension Alkaline Phosphatase (Ref DF150, issue date 04/08/2019) under Specimen Collection and Handling, it stated "specimens are stable for 8 hours at room temperature, 7 days at 2-8 C and 6 months when frozen at -20 C or colder." 6. Review of the laboratory policy for Dimension Alkaline Phosphatase (SOP Dim.0002, effective date 12/01/2022) under specimen requirements, it stated "specimens are stable for 8 hours at room temperature, for 7 days at 2-8 C and for 6 months when frozen at -20 C." 7. Surveyor observations on 04/03/2024 at 1415 hours in the -- 4 of 13 -- laboratory revealed the laboratory received the following chemistry specimens (Patient ID 75361017, 45680567, 32220127). Surveyor observed the specimens were transported via a cooler with a minimum temperature of 1.57 C and maximum temperature of 12.88 C. An interview with the courier on 4/03/2024 at 1417 hours confirmed that he brought all specimens in a similar cooler with 2 ice packs daily. He placed them in their biohazard bags onto the cooler. 8. Random review of laboratory records from 4/03/2024 confirmed the laboratory analyzed the following three specimens for ALB, ALT, ALP. Patient ID 75361017, 45680567, 32220127 C. Cytology 1. Review of the Instructions for Use for the Hologic PreservCyt Collection Medium (AW-23087-002 Rev.001, 03-2021) under Specimen Collection and Preparation, it stated "store PreservCyt Collection medium with gynecologic cytologic samples between 15 C and 30 C for up to 6 weeks." 2. Surveyor observations on 04/03 /2024 at 1415 hours in the laboratory revealed the laboratory received cytology specimens in PreservCyt Collection Medium. Surveyor observed the specimens were transported via a cooler with a minimum temperature of 1.57 C and maximum temperature of 12.88 C. An interview with the courier on 4/03/2024 at 1417 hours confirmed that he brought all specimens in a similar cooler with 2 ice packs daily. He placed them in their biohazard bags onto the cooler. 3. Random review of cytology records from 04/03/2024 confirmed the laboratory received and sent out the following cytology testing to a reference laboratory. Specimen ID DL249161M, DL249139M 4. In in interview with the laboratory director and liaison on 4/03/2024 at 1420 hours in the conference room confirmed the above findings. They acknowledged that the laboratory needed to monitor the temperature of the specimens and ensure they had a process in place to reject specimens not received in the correct temperature and/or within stability. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory client service manual and available policies, review of laboratory records, and confirmed in interview, the laboratory failed to provide documentation of specimen handling and transport for urinalysis, hematology, and chemistry testing. Findings included: 1. Review of the laboratory client service manual revealed no documentation of the required temperature for storage and transport for urinalysis, chemistry, and hematology testing. Cross refer to D5311 I, II- A, B. 2. An interview with the laboratory director on 04/03/2024 at 1320 hours in the conference room confirmed the above 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 may supplement but not replace the laboratory's written procedures for testing or examining specimens. -- 5 of 13 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure for performing platelet poor studies, review of the manufacturer's instructions for Dade Innovin reagent, review of laboratory's procedures for prothrombin testing, platelet poor studies from 2022 to 2024, and staff interview, the laboratory failed to ensure the studies were performed in the same manner as patient samples were processed. The findings included: 1. A review of the laboratory's procedure titled "Platelet Poor Plasma" (revised 8/30/2023) under the section titled "V. Procedure" determined: "Centrifuge for 10 minutes at 3200 rpm." 2. A review of the manufacturer's instructions for the Dade Innovin reagent (10873566GU11 Rev. 3) under the section titled "Specimen collection and preparation" determined: "Centrifuge the blood specimen at 1500 x g for no less than 15 minutes at room temperature." 3. A review of the laboratory's procedure titled "Prothrombin Time (PT)" (Revised:8/31/2023) under the section titled "Handling conditions" determined: "Centrifuge the capped specimen tube for a minimum of 15 minutes at 1500 g to consistently produce platelet poor plasma." 4. A review of the laboratory's platelet poor studies from 2022 to 2024 identified the laboratory processed study samples the following ways: a) 9/26/2022 Speed: no speed stated Time: 5 minutes b) No records for 2023 c) 3/27/2024 Speed: 3200 rpm Time: 10 minutes 5. Testing personnel number 5 (as listed on Form CMS 209) stated in an interview on 04/02/2024 at 1645 hours in the lab that prothrombin time samples were centrifuged at 3500 rpm for 15 minutes. 6. The laboratory reported performing 290 prothrombin time tests in 2023. 7. The Administration Liaison confirmed the findings on 04/03/2024 at 1430 hours in the conference room after her review of the records. She was unaware of the speed and time differences in the procedures and manufacturer's requirements. It was determined the laboratory's centrifuge could alternate between rpms and x g, but she was unable to state if 3500 rpm or 3200 rpm was equivalent to 1500 x g. Key rpm - revolutions per minute 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)