Sterling Heights Medical Center

Summary Statement of Deficiencies 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 Technical Consultant #1 (TC1), the laboratory failed to perform control procedures for hematology testing for 2 days (3/5 /2019 and 3/8/2019) of 20 months reviewed. Findings include: 1. A record review of the laboratory's "Hematology Log" revealed hematology testing was performed on patients for the following days: a. 3/5/2019, 5 patients were tested. b. 3/8/2019, 7 patients were tested. 2. A review of the laboratory's hematology quality control records revealed a lack of quality control documentation for 3/5/2019 and 3/8/2019. 3. An interview on 2/18/2020 at 12:23 pm with TC1 confirmed no quality control was performed for hematology testing for the dates listed above. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if 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 -- applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to maintain a duplicate of the original report along with the corrected report for 1 (Patient #17) of 20 patient charts audited. Findings include: 1. A review of the laboratory's established procedure manual revealed a section stating, "The laboratory technician will be notified when a lab error is found. The technician will then correct the error and initial the report form. The ordering physician will then be notified and he will also initial the report form. All errors will be described on the lab error report form and the records will be saved for two years." 2. An audit of 20 patient charts revealed Patient #17 had a lipid and liver panel report dated 12/30/19 that contained white-out in the date of birth section of the report, hiding the original report. 3. An interview on 2/18/2020 at 9:16 am with TC1 confirmed the original report was not available for Patient #17. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of the CMS database and review of the American Association of Bioanalysts final proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the analyte: Hematocrit. Refer to D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and review of the American Association of Bioanalyts (AAB) final proficiency testing reports, the laboratory failed to achieve satisfactory performance in 2 (1st and 3rd events 2019) of 3 consecutive proficiency testing events for the following hematology analyte: Hematocrit (HCT). Findings include: 1. Unsatisfactory performance in 2 of 3 consecutive proficiency testing events constitutes unsuccessful proficiency testing performance. The initial unsuccessful performance for HCT occurred in the 1st and 3rd events in 2016. The subsequent unsuccessful performance for HCT occurred in the 1st and 3rd events in 2019. HCT PT Event Score 1st event 2016 0% 3rd event 2016 0% 1st event 2019 60% 3rd event 2019 60% -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to test the hematology proficiency testing samples the same number of times that it routinely tests patient samples for two (1st quarter 2017 and 3rd quarter 2017) of six events in 2016 and 2017 reviewed. Findings include: 1. On January 16, 2018 at 10:39 a.m., record review of the American Association of Bioanalysts (AAB) hematology proficiency testing reports revealed for two of six events reviewed in 2016 and 2017 the testing personnel ran the specimens two times each. 2. During a review of the "Proficiency Testing" procedure on January 16, 2018 at 11:46 p.m. revealed "proficiency testing samples will be treated in the same manner as patient specimens". 3. During the interview on January 16, 2018 at 12:36 p.m. testing personnel #1 and the general supervisor as listed on the CMS-209 confirmed the proficiency testing specimens were not treated like a patient specimen. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --