Middle Park Medical Center - Granby

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on August 10, 2026, deficiencies were cited for Middle Park Medical Center - Granby in Granby, Colorado. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on a review of the blood bank log, a review of the blood bank quality control (QC) documents, and an interview with the technical supervisors (TS 1 and TS 2), the laboratory failed to perform daily QC for the antibody typing and screening. Findings include: 1. A review of the blood bank patient log revealed that there were 1 patient sample tested on 5/7/2026, 2 patient samples tested on 5/8/2026, 5 units of blood received on 5/8/2026, and 1 patient sample tested on 5/9/2026. 2. A review of the blood bank quality control log revealed that QC was performed on 5/7/2026 at 8 AM and then on 5/10/2026 at 1 PM. 3. An interview with the technical supervisors (TS 1 and TS 2) on 8/10/2026 at 3:05 PM confirmed that there were no quality control performed on 5/8/2026 and 5/9/2026. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) 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 -- (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on a review of the laboratory test menu, a review of the laboratory documents, and an interview with the technical supervisors (TS 1 and TS 2), the laboratory failed to evaluate and define the relationship between test results using the different methodologies, specifically automated cell identification and manual cell identification. Findings include: 1. A review of the laboratory test menu revealed that this laboratory offers both automated cell identification with Siemens Dimension and manual cell identification. 2. A review of the laboratory documents revealed that there is no documentation of comparison between the two methodologies of automated and manual identification. 3. An interview with the technical supervisors (TS 1 and TS 2) on 8/10/2026 at 3:25 confirmed that there were no documentation of comparison between automated and manual cell identification. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) (b)(8)(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and This STANDARD is not met as evidenced by: Based on a review of the testing personnel competency documents and an interview with the technical supervisors (TS 1 and TS 2), the laboratory failed to include the assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing (PT) samples to evaluate the competency of the staff. Findings include: 1. A review of the testing personnel competency documents revealed that the competency for all testing personnel since 2024 have been performed through direct observation of the analytic process. There were no documented blind samples or PT samples included as a part of the competency assessment. 2. An interview with TS 1 and TS 2 on 8/10/2026 at 2:10 PM confirmed that the technical supervisors directly observed competency assessment for all testing personnel and there were no documented blind samples or PT samples included as a part of the competency assessment. -- 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 routine desk audit of CMS-153 and 155 reports of proficiency testing performance and interview, the laboratory failed to achieve satisfactory performance for Prothrombin Time (PTT) for two consecutive events, 2020 event 2 and 3, resulting in unsuccessful proficiency testing performance. See D2130." D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) scores and staff confirmation, the laboratory failed to achieve satisfactory performance for the analyte partial thromboplastin time (PTT) in the specialty of Hematology in 2 consecutive PT events. Findings include: Partial thromboplastin time (PTT): 2nd event 2020 = 40% 3rd event 2020 = 60% -- 2 of 2 --