Monument Health Spearfish Hospital

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. Findings include: Review of unsatisfactory results that had been received in two of three PT events (American Proficiency Institute Immunology /Immunohematology 2018 second and 2019 first 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 American Proficiency Institute (API) testing events (Immunology/Immunohematology 2018 second and 2019 first events). Findings include: 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. 2018 Immunology/Immunohematology 2nd event compatibility score = 60% (AUT-07 and AUT-09 were graded as unacceptable). b. 2019 Immunology /Immunohematology 1st event compatibility score = 60% (AUT-01 and AUT-04 were graded as unacceptable). Interview with the laboratory supervisor on 5/15/19 at 7:00 a. m. confirmed the failure. She stated she had investigated the unsatisfactory results and found the folowing: a. In the first event only anti-human globulin phase crossmatches were performed. Specimens AUT-07 and AUT-09 had been reported as compatible. *Laboratory staff did not perform an immediate spin crossmatch which would have detected the ABO blood type incompatibility. *Technical assistance had been obtained from the proficiency testing company. b. In the second event, the laboratory staff did not perform a crossmatch procedure to determine compatibility for AUT-01 and AUT-04.*The specimens were reported as incompatible due to differences in the recipient and donor Rh blood types. *Repeat testing of the specimens confirmed the crossmatch results to be compatible. c. The testing staff had not followed the laboratory's procedure for crossmatch testing in both events. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 4/4/18. The Regional Health Spearfish Hospital laboratory was found not in compliance with these requirements: D5471 and D5477. 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 reaction prior to patient testing for 23 of 23 months reviewed (5/1/16 to 4/4/18). 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. In addition lot numbers received and opened dates had not been documented in 2016, 2017, or 2018. Observation of the box of KOH ampules (lot # 7074640, expiration date 12/31/18) at 2:05 p.m. on 4/4/18 revealed it had been received on 5/5/17. The box of KOH reagent was approximately half full. During 2017, thirty one KOH patient procedures had been performed. Interview at the above time with testing personnel A revealed she was unaware QC was required upon reciept of a new lot number or shipment. D5477 CONTROL PROCEDURES 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 -- CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of available QC records and interview, the laboratory failed to check three lot numbers of three types of media (BD Bactec aerobic, anaerobic, and pediatric blood culture bottles) for sterility and their optimum ability to support growth. Findings include: 1. Review of available QC records revealed the media identified above had not been checked to ensure the media performed as the manufacturer had stated for sterility or growth characteristics: a. BD Bactec Plus Aerobic/F bottles- lot # 8011748 b. BD Bactec lytic/10 Anaerobic/F bottles- lot # 7332625 c. BD Bactec Pediatrics Plus/F- lot # 8002689 Interview with testing personnel A on 4/4/18 at 2:05 p.m. revealed QC had not been performed on media before use or concurrent with patient specimens. She did not realize the requirement for documentation of physical characteristics of media, sterility, and ability to support growth of microorganisms upon receipt of a new lot number or shipment included blood culture bottles. -- 2 of 2 --