Valley Citizens' Foundation For Health Care Inc

Summary Statement of Deficiencies D0000 Based on an on-site certification survey conducted on June 18, 2026, deficiencies were cited for Rio Grande Hospital located in Del Norte, 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 laboratory Individualized Quality Control Plan (IQCP), i- STAT quality control (QC) records, and an interview with the general supervisor (GS), the laboratory failed to follow its IQCP for testing external controls on its i- STAT analyzer for the Chem8+ cartridge. One i-STAT Chem8+ test was performed and resulted in April 2026. Findings include: 1. Based on a review of the laboratory's i-STAT Chem8+ IQCP quality control requirements, the laboratory requires external QC to be performed once a month of patient testing, per new lot/shipment, whenever there is a perceived problem, for troubleshooting purposes, and per tech discretion. 2. Based on a review of the laboratory's QC records, the laboratory did not perform QC for the month of April 2026. There was one i-STAT Chem8+ patient test performed and resulted in April 2026. 3. An interview with the GS on June 18, 2026, at 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 -- approximately 1:45 PM, confirmed that the laboratory did not follow its IQCP QC requirements for the i-STAT Chem8+ test by failing to perform QC on the month of April when patient test was performed. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e)(4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. This STANDARD is not met as evidenced by: Based on the laboratory Individualized Quality Control Plan (IQCP), microbiology media quality control (QC) records review, and an interview with the general supervisor (GS), the laboratory failed to document the physical characteristics of the CLSI-exempt media since the last survey performed in September 2024. The laboratory performs approximately 1,597 bacteriology cultures annually. Findings include: 1. A review of the laboratory IQCP for commercially prepared "CLSI- Exempt" media revealed that the laboratory must review manufacturer Certificate of Analysis (CoAs) provided with each batch/lot/shipment of media, perform a visual inspection of media for physical defects or contamination, and mainten logs to record media received, any defects, observed and any interations with manufacturer aobout the defective media. The laboratory supervisor is to review these logs monthly for trends. 2. A review of the microbiology media quality control records revealed that the laboratory does not have a log to record CLSI-exempt media received and any defects observed, as required by the IQCP. 3. Based on an interview with the GS on June 18, 2026, at approximately 2:00 PM, confirmed that the laboratory does not keep a log to record media received and any defects observed as required by the IQCP. -- 2 of 2 --

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 personnel files, policies and procedures manual, and an interview with the laboratory's general supervisor (GS), the laboratory failed to assess the competency of testing personnel (TP) after their initial competency but within their first 6 months of employment; assess or establish a written policy or procedure for assessing the competency of personnel in the position of technical supervisor (TS), and GS. The laboratory conducts approximately 303,659 tests annually. Findings include: 1. A review of the laboratory's personnel files revealed the laboratory was assessing initial and annual competency for TP, but not assessing competency at least 6 months after initial competency was assessed in TP first year of employment since the last survey was conducted on September 24, 2021. 2. A review of the laboratory's personnel files, and 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 one out of one TS, and one out of one GS listed on the CMS-209 Form since the last survey was conducted on September 24, 2021. 3. Based on an interview with the GS, on September 30, 2024, at approximately 11:00 AM, confirmed that the laboratory failed to assess the competency of TP within 6 months of completing their initial competencies, and failed to assess the competency of, or establish a written policy or procedure to assess the competency of personnel in the positions of TS, and GS. 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. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on an onsite records review, a review of the laboratory's policies and procedures manual, and an interview with the general supervisor (GS), the laboratory failed to compare, or establish a policy or procedure to compare their Cepheid SARS- CoV-2 multiplex assay to their Biofire respiratory panel at least semiannually, and failed to compare their Sysmex Hematology analyzer's automated white blood cell (WBC) differential at least semiannually to their manual WBC differential since the laboratory's last survey on September 24, 2021. The laboratory conducts approximately 4,665 microbiology tests, and 80,830 hematology tests annually. Findings include: 1. Based on an onsite records review, the laboratory failed to compare the Cepheid SARS-CoV-2 multiplex assay to the Biofire respiratory panel at least semiannually. 2. Based on an onsite records review, the laboratory failed to compare the automated WBC differential obtained on their Sysmex Hematology analyzer to the results obtained using manual WBC differentials at least semiannually. 3. Based on a review of the laboratory's policies and procedures manual, the laboratory failed to establish a policy or procedure to compare the Cepheid SARS- CoV-2 multiplex assay to the Biofire respiratory panel, and automated WBC differential obtained on their Sysmex Hematology analyzer to the results obtained using manual WBC differentials at least semiannually. 4. Based on an interview with the GS on September 30, 2024, at approximately 2:25 PM, confirmed that the laboratory failed to compare and establish a policy or procedure to compare the Cepheid SARS-CoV-2 multiplex assay to their Biofire respiratory panel, and their automated WBC differential obtained on their Sysmex Hematology analyzer to the results obtained using manual WBC differentials at least semiannually. -- 2 of 2 --