Middle Park Health - Kremmling

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manual, and an interview with General Supervisor (GS), the laboratory failed to assess the competency of, or establish a written policy or procedure for assessing the competency of personnel in the positions of Clinical Consultant (CC), Technical Supervisor (TS), and General Supervisor (GS) since the laboratory's last survey on 8/11/2021. The laboratory conducts a total of approximately 30,750 tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual revealed that the laboratory failed to assess the competency of, or establish a written policy or procedure for assessing the competency for the CC, the TS, or for the GS listed on CMS Form-209. The laboratory conducts a total of approximately 30,750 tests annually. 2. Based on an interview with the GS on January 4, 2024, at approximately 11:30 AM, confirmed that the laboratory failed to assess the competency of or establish a written policy or procedure for assessing the competency of personnel in the positions of CC, TS, and GS. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manual, and an interview with the general supervisor (GS), the laboratory director (LD) failed to ensure that the laboratory's policies and procedures manual for quality assurance, chemistry, hematology, and microbiology had been approved, signed, and dated by the current LD before use since the laboratory's last survey on 8/11/2021. The laboratory conducts a total of approximately 30,750 tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual for quality assurance, chemistry, hematology, and microbiology revealed that the current LD had not approved, signed, or dated the laboratory's policies and procedures prior to their use in the laboratory. 2. Based on an interview with the GS on January 4, 2024, at approximately 11:00 AM, confirmed that the current LD had not reviewed, signed, and dated the laboratory's policies and procedures manual for quality assurance, chemistry, hematology, and microbiology prior to their use in the laboratory. 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 an observation, and an interview with the general supervisor (GS), the laboratory failed to follow the manufacturer's instructions for testing coagulation specimens on the Sysmex CA600 since the last recertification survey on 8/11/2021. The laboratory conducts approximately 300 coagulation tests annually. Findings include: 1. An observation on January 4, 2024, at approximately 10:00 AM, revealed the laboratory failed to input the current lot number of the Innovin reagent (Lot #564616A, expiration date: 03/10/2025) into the Sysmex CA600 coagulation analyzer. 2. Based on an interview with the GS on January 4, 2024, at approximately 10:05 AM, confirmed that that laboratory failed to input the current lot number of Innovin reagent (see above) into the Sysmex CA600 coagulation analyzer. -- 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 a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and email communications with the laboratory director, the laboratory failed to achieve satisfactory performance scores for the American Proficiency Institute (API) PT for Virology testing for two out of three PT events, (event 3 in 2022 and event 2 in 2023). See D2056. D2056 VIROLOGY CFR(s): 493.831(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 an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and email communications with the laboratory director, the laboratory failed to achieve a score of 80% for the American Proficiency Institute (API) PT for Virology testing for event 3 in 2022, and event 2 in 2023. Findings include: 1. A review of the CMS-155 Individual Laboratory Profile on 9/13/2023 at approximately 1:15 PM, revealed the API PT for Virology testing scores was 70% for event 3 in 2022 and was 70% for event 2 in 2023. 2. Email communication with the laboratory director on 9/22/2023 at 12:04 PM confirmed the unsuccessful PT scores for Virology. -- 2 of 2 --