Wrmc Medical Complex Laboratory

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of the manufacturer's instruction, the laboratory's procedure manual, patient test records, and interview with staff the laboratory failed to ensure 9 of 42 patient lactate samples were centrifuged within 15 minutes of collection from 1 /28/25 through 2/5/25. A) Manufacturer's instructions ("Instructions for Use Vitros Chemistry Products LAC Slides" Lactate, REF 843 3880, 815 0112, ver 13.0, Pub. No. C-212_EN) for the lactate analysis performed in the laboratory, stated:"centrifuge specimens and remove the plasma from the cellular material within 15 minutes of collection time." B) The Laboratory's QC Policy manual did not contain specfic policies for lactate, but referred to "following manufacturer's instructions and/or package inserts". C) A query of Lactate sample turnaround time records from 1/28/25 through 2/5/25 revealed 9 of 42 samples took longer that 25 minutes from collection to result. Centrifuge times were not documented. D) During interview 2/6/25 at 3: 23pm, the Technical Consultant (as listed on the CMS-209 form) confirmed that the lab documented collection times and report times; but not centrifuge times. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an 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 -- ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure for "Quality Control" (QC), review of quality control Levy-Jennings charts for March 2024 through December 2024, review of QA review notes, lack of documentation, and interview it was determined that the laboratory failed to recognize or take

Summary Statement of Deficiencies D5783

Summary Statement of Deficiencies D5777 COMPARISON OF TEST RESULTS CFR(s): 493.1281(b)(c) (b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available: (b)(1) Patient age. (b)(2) Sex. (b)(3) Diagnosis or pertinent clinical data. (b)(4) Distribution of patient test results. (b)(5) Relationship with other test parameters. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Through review of the laboratory's policy and procedure for quality control (QC), policy and procedure for quality assurance (QA), review of patient results for Albumin (Alb) performed on 8/10/20 and interview it was determined that the laboratory failed to have a functional system to identify patient test results that appear inconsistent with expected distribution. Finding follow: A) Upon review of the laboratory's policies for QC and QA no policy for identifying and assessing patient test results that appear inconsistent with a patients, age, sex, diagnosis or expected distribution was noted. B) Review of patient results for Alb performed on 8/10/20 revealed that 13 of 35 Alb tests performed and reported on 8/10/20 were flagged as abnormally low and 12 , identified as patients numbered 24 through 35 on a separate patient identification list, of the 13 patients flagged as low were performed consecutively between the hours of 1448 and 2231. and were the last Alb tests performed on that day. C) Review of the patient Alb results performed on 8/10/20 revealed that the 12 consecutive with abnormally low Alb results, identified as numbers 24 through 35 on the separate patient identification list, varied as to age and sex. D) In an interview on 4/14/21 at 01:15 the laboratory staff member, identified as number 2 on the CMS 209 form, confirmed that 12 consecutive abnormally low Alb results on patients varying in age and sex would not conform to an expected distribution, that they were not identified and assessed, and that these findings would be used as a inservice topic and example for laboratory testing personnel. 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 -- D5783

Summary Statement of Deficiencies 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: Through a review of the Laboratory Policy and Procedure Manual, a review of Platelet Poor Plasma Studies for 2016 through 2018, and interviews with laboratory staff, it was determined the laboratory failed to follow written procedures for performing Platelet Poor Plasma Studies twice per year. Survey findings include: A. The Laboratory Policy and Procedure Manual includes a policy that requires the laboratory to perform Platelet Poor Plasma Studies twice per year to insure that the speed and time in which the laboratory centrifuges samples for coagulation are adequate to produce platelet poor plasma (which is the required sample) for coagulation testing. B. Through a review of the Platelet Poor Plasma Studies for 2016, 2017, and 2018 it was determined that Platelet Poor Plasma Studies were performed on 12/14/2016, 9/7/2017, and 10/24/2018 (performed three of five due since December 2016). Studies were documented once per year instead of twice per year as required by the written laboratory procedures. C. During an interview at 10:05 on 12 /20/2018, the technical consultant (as listed on the form CMS-209) confirmed the laboratory performed Platelet Poor Plasma Studies once per year instead of twice per year as required by the written procedures. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- 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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of the Individualized Quality Control Plan (IQCP) for the GEM 3000, a tour of the laboratory, and interviews with laboratory staff, it was determined the laboratory IQCP for blood gas testing did not include required components and was not completed for the instrument in use for blood gas analysis. Survey findings follow: A. During a review of the IQCP for blood gas testing it was determined the IQCP risk assessment was missing two of the five required components. The IQCP risk assessment did not include risk assessment for Reagents or for the Test System. During the review it was also noted that the IQCP was written for the GEM 3000 blood gas test system although the blood gas test system is use is the GEM 3500. B. During a tour of the laboratory on 12/20/2018 at 09:25, the surveyor observed the GEM 3500 in use for blood gas testing although the IQCP in the laboratory policy and procedure manual was written for the GEM 3000. C. In an interview at 10:05 on 12/20 /2018 the technical consultant (as listed on the form CMS-209) confirmed the IQCP was not for the current instrument and did not include Reagent and Test System components of the risk assessment. -- 2 of 2 --