Avera De Smet Memorial Hospital

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 12/6/22. Avera De Smet Memorial Hospital laboratory was found not in compliance with the following requirement: D6125. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on record review and interview, the technical supervisor failed to assess competency through the testing of blind samples or external proficiency samples in the areas of chemistry and microbiology for one of four testing personnel (testing personnel A) in 2022. Assessment of blind testing of specimens and/or external proficiency testing helps ensure competency of staff reporting patient test reports. Findings include: 1. Review of the laboratory staff's annual competency assessment records for testing personnel A revealed: *The annual competency assessment had been completed on the dates of 6/2/22, 6/16/22 and 6/23/22 and had been signed by testing personnel A and the laboratory director. *The competency assessment did not include the testing of blind samples or external proficiency testing for the areas of chemistry and microbiology. Review of the laboratory's Competency Assessment Program policy last revised on 7/1/08 revealed: *"Assessment of test performance through testing previously analyzed, internal blind, external proficiency samples." *" Section specific unknowns will be periodically prepared and administered." *" Monitor staff performance in the proficiency testing program through review of reports." Interview on 12/6/22 at 1:30 p.m. with testing personnel A revealed: *She confirmed she had not completed blind sample testing or external proficiency sample testing in the areas of chemistry and microbiology. *She confirmed that she had 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 -- processed and reported patient testing in chemistry and microbiology in 2022. *She had been unaware the testing of blind samples or external proficiency specimens was required in the competency procedure. *They did not have a system for rotating proficiency testing between staff. -- 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 sodium test method. Unsatisfactory results had been received in two of three PT events (2021 Chemistry-Core-1st and 3rd events) resulting in unsuccessful PT participation. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 satisfactory performance for the same analyte or test in 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 the federal proficiency testing (PT) reports 155D and 153D, the laboratory's American Proficiency Institute (API) PT reports and interview with the laboratory supervisor, the laboratory failed to achieve a satisfactory score of 80% or above for the sodium test method for two of three events (2021 Chemistry-Core-1st Event and 2021 Chemistry-Core-3rd Event). Findings include: 1. Review of the 10/29 /21 federal Unsuccessful PT Report 153D revealed the laboratory had received unsatisfactory scores (less than 80%) for the sodium test method in each of the two events identified above. Review of the 10/10/29/21 federal Individual Laboratory Profile PT report 155D and API PT 2021 Chemistry-Core-1st and 3rd event evaluation reports revealed scores of 60% and 0% respectively for the sodium test method for each event. Review of the individual API sodium test method scores for the two API PT events revealed: a. 2021 Chemistry-Core-1st event: sodium results for samples CH-02 and CH-03 were 114 and 117 millimole/liter (mmol/L) respectively. The range of acceptability was 115-124 and 118-127 mmol/L respectively. b. 2021 Chemistry-Core-3rd event were not available due to failure of the facility to participate. Interview on 10/28/21 with the laboratory supervisor revealed the laboratory had been aware of the failures. The initial failure had been investigated. The second failure was due to the laboratory failing to submit their PT results prior to the data submission date. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 4/25/18. The Avera De Smet Memorial Hospital laboratory was found not in compliance with the following requirement: D5411. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the thromboplastin package insert, observation, interview with laboratory personnel A, and review of the annual test volume form the laboratory, failed to enter the correct International Sensitivity Index (ISI) value in the Sysmex CA- 560 coagulation analyzer to determine an accurate International Normalized Ration (INR) patient results. The laboratory reported 1293 patient INR test results during 2017. Findings include: 1. Observations of the CA-560 coagulation analyzer at 11:35 a.m. on 4/25/18 and review of the thromboplastin package insert revealed the following: *The ISI value documented in the thromboplastin reagent package insert for lot # 539378 expiration date 1/21/19 was 0.97. *The ISI value entered in the Sysmex CA-560 coagulation analyzer for thromboplastin lot #539378 expiration date 1/29/18 was 0.98. Interview with laboratory personnel A at the same time of the observation revealed laboratory staff had been unaware of the discrepant ISI values. In addition there was no documentation as to when the lot # of reagent had been changed and the ISI value had been entered into the Sysmex CA-560 coagulation analyzer. 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 --