Avera Hand County Memorial Hospital

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 6/7/22. The Avera Hand County Memorial Hospital laboratory was found not in compliance with the following requirements: D6028. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to ensure competency evaluations for one of seven laboratory staff (A) were completed by qualified personnel (their credentials had not been reviewed to determine if they were qualified to serve as technical consultant) for the nonwaived test methods they had been performing under the laboratory's certificate. Findings include: 1.Review of the personnel file for laboratory staff A revealed his competency assessment was performed on 6/3/21 by laboratory staff B. There was no indication the laboratory director was involved in the competency assessment process. Review of the Center for Medicare and Medicaid Services 209 Laboratory Personnel Report form signed by the laboratory director on 6/2/22 revealed that employee C was listed as a technical consultant. Laboratory staff B was listed only as testing personnel. Review of the laboratory's yearly competency assessment policy stated that "A technologist will complete an evaluation/competency form for the laboratory manager, which will be 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 -- reviewed and signed by the laboratory director." Review of education records for laboratory staff B revealed she had an associates degree. There was no documentation that a higher degree had been obtained. Interview with laboratory staff A on 6/7/22 at 10:30 a.m. revealed: *He confirmed that laboratory staff B had completed his competency assessment. *He was unaware that his competency assessment needed to be completed by personnel who qualified to serve as a technical consultant. *He confirmed that laboratory personnel B had an associates degree for her highest level of education. The laboratory director was unavailable for interview at the time of the survey. -- 2 of 2 --

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 American Proficiency Testing Institute PT events (1st and 2nd 2020 Immunology /Immunohematology testing 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 American Proficiency Institute (API) events (1st and 2nd Immunology/Immunohematology testing events). 1. Review of the laboratory's CASPER Reports 153D and 155D revealed the API 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. 2020 Immunology/Immunohematology 1st event compatibility score = 80% (SER-01 was graded as unacceptable). b. 2020 Immunology/Immunohematology 2nd event compatibility score = 80% (SER-08 was graded as unacceptable). Interview with the laboratory supervisor on 9/10/20 and 9/14/20 confirmed the failure. She stated she had investigated the unsatisfactory results. In both testing events the samples (SER-01 and SER-08) had a positive antibody screen. Laboratory staff did not perform the IgG phase of compatibility testing which was required when a specimen had a postive antibody screen. Laboratory staff performed only an immediate spin compatibility test and reported the result as compatible. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 4/26/18. The Avera Hand County Memorial Hospital Laboratory was found not in compliance with the following requirement: D5471. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the potassium hydroxide (KOH) reagent, review of the annual test volume form, and interview with testing personnel A, the laboratory failed to check each lot number or shipment of the KOH reagent for its positive reactivity prior to patient testing for 19 of 19 patient samples tested during 2017. Findings include: 1. Review of available records revealed no documentation of quality control (QC) having been done on the KOH reagent in 2016, 2017, or 2018. Observation of the bottle of KOH reagent (lot # 4610F117, expiration date 10/2019) at 9:55 a.m. on 4 /26/18 revealed it had been received on 4/3/17. Review of the annual testing volume form indicared nineteen KOH patient procedures had been performed duing 2017. Interview at the above time with testing personnel A revealed she was unaware QC was required of a new lot number or shipment before use on patient samples. 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 --