Saginaw Valley Medical Center

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: . Based on observation, record review, and interviews, the laboratory failed to establish procedures to ensure laboratory personnel safety from chemical and biohazardous materials to two (October 2022 to October 2024) of two years reviewed. Findings include: 1. The surveyor observed the laboratory and saw a yellow Gatorade bottle on the chair near the Medica EasyRA qualitative urine toxicology analyzer on 10/17/24 at 9:25 am. 2. An interview on 10/17/24 at 9:31 am with the Testing Personnel revealed they sometimes drink in the laboratory. 3. A review of the laboratory's policies and procedures revealed a lack of established safety procedures. 4. An interview on 10/17/24 at 1:17 pm with the Technical Consultant confirmed the laboratory failed to establish safety procedures. 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. 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 -- This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Testing Personnel, the laboratory failed to follow established specimen labeling policies for 24 of 24 patient urine specimens observed. Findings include: 1. The surveyor observed 24 patient urine specimens on the laboratory counter on 10/17/24 at 9:25 am with patient labels on the caps of the urine containers. 2. A review of the laboratory's "Urine Collection" policy revealed a section stating, "The container must have a label that will adhere under refrigeration. The label must include the patient's identification and the date and time of specimen collection ant the labels must be placed on the container, not on the lid." 3. An interview on 10/17/24 at 9:31 am with the Testing Personnel confirmed specimens are labeled on the lid only. 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 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 record review and interview with the Technical Consultant, the laboratory failed to perform control procedures at least each date of patient testing for one (5/30 /23) of seven patient testing dates reviewed. Findings include: 1. A review of the laboratory's "Quality Control" procedure revealed a lack of information about how often controls are performed. 2. A review of seven patient test records revealed Patient #6, with urine qualitative toxicology testing performed on 5/30/23, had a positive benzodiazepine result. 3. A review of control records for 5/30/23 revealed a lack of documentation of benzodiazepine control results. 4. An interview on 10/17/24 at 10:58 am with the Technical Consultant confirmed controls for benzodiazepine were not performed on 5/20/23 and 24 patients received benzodiazepine testing that date. -- 2 of 2 --

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interview with Technical Consultant (TC) #2, the laboratory failed to verify the toxicology performance specifications for 2 (Buprenorphine [BUP] and Tetrahydrocannabinol [THC]) of 10 tests performed during the 11 (February 2020 to January 2021) months of operation. Findings include: 1. A record review revealed the laboratory failed to verify the performance specifications for 2 (BUP and THC) of 10 toxicology tests. Refer to D5421. 2. An interview on 1/12/2021 at approximately 10:09 am with TC2 confirmed the performance specification were not available on the day of the survey. 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. 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 -- This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant (TC) #2, the laboratory failed to verify the performance specifications for 2 (Buprenorphine [BUP] and Tetrahydrocannabinol [THC]) of 10 toxicology tests during the 11 (February 2020 to January 2021) months of operation. Findings include: 1. A review of the laboratory's patient test reports revealed the laboratory was performing and reporting out 2 (BUP and THC) of 10 toxicology tests with no documentation of performance verification during the 11 months of operation. 2. A review of the laboratory's "Performance Validation Summary" revealed a lack of documentation of verification of performance specifications for BUP and THC testing during the initial performance verification studies. 3. When requested on 1/12/2021 at approximately 10:09 am by the surveyor, the verification of performance specification data for BUP and THC testing was not available. 4. An interview on 1/12/2021 at approximately 10:09 am with TC2 confirmed the verification of performance specification data was not made available to the surveyor. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on document review and interview with Technical Consultant (TC) #2, the laboratory failed to have the final toxicology report maintained as part of the patient's chart or medical record for 1 (#1) of 9 patient charts audited. Findings include: 1. A record review revealed lack of documentation of the final toxicology report for 1 (#1) of 9 patient charts audited in the patient's electronic medical record (EMR) system. 2. On 1/12/2021 at 11:03 am when queried, TC2 was not able to provide the surveyor the final report requested. 3. A interview on 1/12/2021 at 11:03 am, TC2 confirmed the final toxicology report was not part of the patient's EMR report. -- 2 of 2 --