Marshall County Healthcare Center

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 3/15/22. The Marshall County Healthcare Center laboratory was found not in compliance with the following requirement: D5221. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure proficiency testing (PT) results had been reviewed, evaluated, and those activities documented for five of thirty-six PT events reviewed (College of American Pathologists [CAP] C-A 2020 General Chemistry Therapeutic Drugs, FH9-B 2021 Hematology Auto Differential, CM-B 2021 Clinical Microscopy, CGL-B 2021 Coagulation Limited, and FH9-C 2021 Hematology Auto Differential). Findings include: 1. Review of the 2020 CAP PT events revealed the following unacceptable test results: *C-A General Chemistry Therapeutic Drugs -Bilirubin Direct sample CHM-01 was graded as unacceptable. Review of the 2021 CAP PT events revealed the following unacceptable or ungraded test results: *FH-9 B Hematology Auto Differential -Blood cell identification sample BCP-11 was graded as unacceptable. -Blood cell identification sample BCP-13 was ungraded due to lack of participant or referee consensus. *CM-B Clinical Microscopy -Urine sediment identification sample CMP- 14 was graded unacceptable. *CGL-B Coagulation Limited -Activated partial thromboplastin time sample CGL-8 was ungraded due to lack of participant or referee consensus. *FH9-C Hematology Auto Differential -Blood cell identification sample BCP-24 was ungraded due to lack of participant or referee consensus. Review of the laboratory's PT reports revealed there had been no investigation of unacceptable or ungraded results for the above listed samples. Review of the Laboratory Quality Assurance Program policy (written 1/20/14, last revised March 2021, and signed by 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 -- the laboratory director on 3/10/22) revealed for: *"Proficiency Testing Performance - Verify documentation of investigation/

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 8/28/19. The Marshall County Healthcare Center laboratory was found not in compliance with the following requirement: D5445. 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 review of quality control (QC) records, procedure review, and interview with the laboratory (lab) supervisor, the laboratory failed to ensure QC had been acceptable prior to reporting patient results during two (June and July 2019) of three months of chemistry QC reviewed. Findings include: 1. Review of the lab's Chemistry Quality Control policy (last revised 6/2015) revealed: *Three levels of controls would be run every 24 hours. *Controls must be run and within set ranges before patient results can be reported out. *The acceptable range had been set at 2.0 standard deviations (SD) from the mean, with two values within 2.0 SD and one value within 3.0 SD being acceptable. Review of the May, June, and July QC chemistry records revealed: *6/20/19: Creatinine level 3 QC had a reported value of -0.27 which was -11.950 SD from the mean. "Rerun same result, 2 of 3 levels OK" was documented as the

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 proficiency testing (PT) record review and interview with the laboratory supervisor, the laboratory failed to achieve successful particpation for the compatibility test method. Unsatisfactory results had been received in two of three College of American Pathologists PT events (J-C 2018 and J-A 2019 Transfusion Medicine [Comp] events) resulting in unsuccessful PT participation. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 -- Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER Reports and interview with the laboratory supervisor, the laboratory failed to achieve satisfactory proficiency testing (PT) performance for the compatibility test method in two out of three events College of American Pathologists (CAP) events (J-C 2018 and J-A 2019 Transfusion Medicine [Comp] events). 1. Review of the laboratory's CASPER Reports 153D and 155D revealed the CAP PT scores for the compatibility test method were less than the 100% required to pass the compatibility test per CLIA requirements found at CFR 493.861(a): a. J-C 2018 Transfusion Medicine (Comp) compatibility score = 67% (J-19S was graded as unacceptable). b. J-A 2019 Transfusion Medicine (Comp) compatibility score = 67% (J-04S was graded as unacceptable). Interview with the laboratory supervisor on 4/29 /19 confirmed the failure. She stated she had investigated the unsatisfactory results. In the first event sample J-19S had a postivie antibody screen result. Laboratory staff did not perform the IgG phase of compatibility testing which was required when a specimen had a positive anibody screen. Laboratory staff performed only an immediate spin compatibility test and that result was reported as compatible. In the second event, the laboratory staff reported the cell suspension had been too heavy which lead to a false positive result. The laboratory staff involved had received additional training. -- 2 of 2 --