Rapid City Medical Center Llp - South

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 9/4/24. Rapid City Medical Center LLP - South laboratory was found not in compliance with the following requirement: D5407. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to ensure two of two reviewed procedure manuals were approved, signed, and dated by the new laboratory director prior to use. Findings include: 1. Review on 9/4/24 at 8:15 a.m. of the following manuals revealed they had not been approved, signed, and dated by laboratory director A before use: *Laboratory Procedure Manual *Quality Assurance Manual Review of the CLIA database revealed laboratory director A had taken over directorship of the laboratory on 4/5/24. An interview on 9/4/2024 at 9:40 a.m. with laboratory personnel B revealed: *She confirmed the listed manuals had not been approved, signed, and dated by laboratory director A, to date. *She had not been aware the manuals had not been signed by laboratory director A. *Laboratory director A had been serving as the interim laboratory director for only a few months. 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 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 3/19/21. The Rapid City Medical Center LLP - South laboratory was found not in compliance with the following requirement: D3031. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the technical consultant, the laboratory failed to retain the results of patient specimen testing performed on the Sysmex XN-330 hematology analzyer for approximately 15 months (January 2019 to 3 /19/21) to ensure the accurate manual entry of patient specimen test results.Findings include: 1. Observation and demonstration on 3/19/21 at 10:45 a.m. of the Sysmex XN-330 hematology analyzer's electronic files revealed: *Laboratory personnel B was able to pull up a record of the analyzers patient specimen results. *The oldest retained patient specimen result was dated 12/12/19. *Patient test specimen results prior to this date were unavailable. *There was no way to verify the accuracy of result entry of patient specimens processed prior to this date. Review of the annual test volume form revealed 6,209 hematology patient test specimens had been reported in 2019. Interview with the laboratory's technical consultant during the survey on 3/19/21 revealed: *The Sysmex XN-330 analyzer had been put into use in January 2019. *The Sysmex XN-330 was interfaced to the laboratory information system. *Only abnormal patient complete blood cell count (CBC) reports or those CBC patient specmens requiring a manual differential were printed and maintained. All other CBC results were shredded. *She believed the Sysmex XN-330 analyzer's memory was sufficient to maintain the required 2 years of patient data. 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 --