Avera Granite Falls Medical Center

Summary Statement of Deficiencies D0000 The Avera Granite Falls Medical Center laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey completed on October 6, 2023. The following standard-level deficiencies were cited: 493.1251 Procedure Manual 493.1256 Control Procedures . D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on observation and interview with laboratory personnel, the laboratory failed to follow the Hematology Stain established procedures in 2022 and 2023. Findings are as follows: 1. The laboratory performed manual differential blood smear testing under the specialty of Hematology as confirmed the General Supervisor (GS) during a tour of the laboratory at 10:10 a.m. on October 5, 2023. 2. The AZER Scientific Easy III Stains used to perform manual blood smears were observed during the tour of the laboratory. It was noted during the tour that the laboratory was staining the slides straight from the three solutions, not making aliquots from a larger stock bottle. 3. Review of the HEM 225 H 11 Hematology Stain procedure found the staff were directed to transfer each solution into staining dishes and keep covered when not in use. 4. In an interview at 11:30 a.m. on October 6, 2023, the GS confirmed the laboratory staff were not transferring the solution to staining dishes and stated that the policy must be out of date with current practice. . D5473 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)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to document Hematology quality control (QC) procedures performed to test AZER Scientific Easy III stain for intended reactivity each day of use from October 2021 through October 2023. Findings are as follows: 1. The laboratory performed manual differential blood smear testing under the specialty of Hematology as confirmed the General Supervisor (GS) during a tour of the laboratory at 10:10 a.m. on October 5, 2023. 2. The AZER Scientific Easy III Stains and Olympus CX43 microscope used to perform manual blood smears were observed as present and available for use during the tour of the laboratory. 3. The HEM 222 H 9 Manual Differential, Peripheral Smear, and-or Slide Review policy, established under section D, Staining and Characteristics, acceptable staining characteristics to ensure were met prior to the interpretation of a slide and if these were not met the laboratory staff were instructed to make a new slide. Documentation of these staining characteristics was not established in policy. 4. The hematology printout for patient account #: GRXXXXXXX408 who had a blood smear performed on May 2, 2023, was reviewed on the day of survey, October 6, 2023. Documentation of acceptable stain characteristics, quality control check, could not be found for the day of patient testing. 5. QC documentation for each day of patient testing was requested and could not be provided by the laboratory for the previous 2 years. 6. In an interview at 11:45 a.m. on October 6, 2023, the GS confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of three 2019 proficiency testing (PT) scores when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Microbiology and Chemistry testing as confirmed by the General Supervisor during a tour of the laboratory at 8:10 a.m. on 10/09/19. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. One Microbiology and two Chemistry results from the first 2019 Hematology PT event were not graded by API due to lack of consensus. See below for sample identifications (ID) and analytes. Sample ID Analyte US-02 Urine Sediment UA-01 Urobilinogen VKP-01 Vaginal Wet Prep 4. The API report referred the laboratory to the expected result data summaries for evaluation of the non-graded test results. The data summaries for the above analytes were not present in laboratory records. Evaluations of the non-graded results were not found in laboratory records. The laboratory was unable to provide evaluations of the non-graded results upon request. 5. In an interview on 10/09/19 at 10:55 a.m., the Technical Supervisor confirmed the above finding. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 a review of proficiency testing reports from the American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for Vitamin D testing under the specialty of Chemistry. Findings are as follows: D2087 - the laboratory failed to obtain a PT score for Vitamin D testing of at least 80 percent in two testing events D2096 - the laboratory failed to achieve satisfactory performance for Vitamin D testing in two consecutive testing events D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API), , the laboratory failed to obtain a PT score for Vitamin D testing of at least 80 percent which resulted in unsatisfactory performance for the analyte. Unsatisfactory PT performance of Vitamin D testing was obtained in the following events. - 2017 2nd event: 67% - 2018 1st event: 33% . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 a review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to obtain a PT score for Vitamin D testing of at least 80 percent in two consecutive PT events. Findings are as follows: The laboratory failed Vitamin D testing in two consecutive PT events. Two consecutive PT failures for the same analyte constitutes unsuccessful performance. PT reports from API listed the following unsatisfactory Vitamin D scores. - 2017 2nd event: 67% - 2018 1st event: 33% . -- 2 of 2 --