Greeley County Hospital / Long Term Care

Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions for Dade Innovin, quality control and quality assessment records for coagulation, observation of the laboratory's Sysmex CA-600 series and interview, revealed that the laboratory did not follow manufacturer's instructions for International Safety Index (ISI) upon utilizing a new lot number from 1/1/2025 to time of survey. Findings: 1. Quality control and quality assessment records for the Sysmex CA-600 Series coagulation analyzer on 3/12/2025 determined the Prothrombin Time (PT) and International Normalized Ratio (INR) for 42 patients could be affected with the current lot of Dade Innovin in use. 2. The laboratory failed to update the ISI in the Sysmex CA-600 series upon the new Lot to Lot completion on 1/1/2025. 3. The manufaturer's current lot of Dade Innovin (564665 Exp: 6/13/2027) listed the ISI for the CA-500/CA-600 series 1.08 is currently being used. 4. The Sysmex CA-600 series operated in the laboratory for PTs and International Normalized Ratio (INR)s utilizing the information of Dade Innovin (564615 3/3/2024) had the ISI listed as 1.04 with a Geometric Mean of 10.8, but using Dade Innovin Lot # 564665. 5. From 1/1/2025 through 3/12/2025 there were 42 PTs /INRs reported on patients with the incorrect ISI on the Sysmex CA-600 series for the current lot number of Dade Innovin. 6. Interview with Technical Consultant and the Laboratory Director on 3/12/2025 at 11:30 a.m. confirmed, the laboratory failed follow manufacturer's instructions for the International Safety Index (ISI) upon utilizing a new lot number of Dade Innovin for the Sysmex CA-600 series from 1/1 /2025 to 3/12/2025. 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 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 the lack of procedures for review and interview, the laboratory failed to have written hematology Sysmex XS-1000i procedure available to and followed by laboratory personnel at time of survey. Findings: 1. No procedures for the Sysmex XS- 1000i was made available for review at the time of survey including the following analytes; white blood cell count (WBC), red blood cell count (RBC), hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MPV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, lymphocyte percentange (LYM %), lyphocyte absolute (LYM #), mixed cell percentange (MXD %), mixed cell absolute (MXD #), neutrophil percentage (NEUT %), neutrophil absolute (NEUT #), red cell distribution weight (RDW) and mean platelet volume (MPV). 2. No hematology procedure or policy indicating reference ranges, linear range, sample limitations, quality control and if necessary dilution protocols. 3. Interview with the Testing Personnel #5 on 2/22/23 at 12:20 p.m. confirmed, the laboratory failed to have a written hematology Sysmex XS-1000i procedure available to and followed by laboratory personnel. 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 D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of available records, the laboratory fails to monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. See .D 5449. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) 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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Review of March 1, 2018 to March 18, 2019 patient test records and quality control (QC) records reveals that the laboratory failed to perform a positive and negative control material each day of patient testing on the Bio-Rad Tox/See Drugs of Abuse Test Kit in 7 out of 98 days of testing. Findings were as follows; a. Based upon 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 -- review of drug testing log sheets revealed the laboratory failed to perform QC testing on each day of use on the following dates: Aug 7, 2018, Aug 18,2018, September 19, 2018 ,November 26,2018, December 21,2018, January 11,2019, January 27, 2019. b. Interview with the General Supervisor on March 18, 2019 @1130 confirmed that the laboratory failed to perform QC testing on each day of use according to the Drug Screen Monitoring Log Sheet and the directions at the bottom of the sheet to perform QC with each day of patient testing and each new lot. No IQCP has been developed to enable the laboratory to reduce the frequency of QC. ***This is a repeat of the deficiency, previously cited on February 19, 2018. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: A review of Temperature and humidity logs and interview with staff revealed the laboratory failed to document the humidity for the laboratory as the Dimension EXL the chemistry analyzer requires. Findings were as follows: a. Based upon review of manufacture's operators guide the laboratory failed to document the humidity 20% to 80% for the laboratory . b. At the time of the survey 02/19/2018 the laboratory failed to produce documentation of humidity, This was confirmed by the Testing Person #1 from CMS 209 form on 02/19/2018 at 10:30 hours. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) 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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. 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: . Review of 2017 and 2018 patient test records and 2017 and 2018 quality control (QC) records reveals that the laboratory fails to performs a positive and negative control material each day of patient testing on the Bio-Rad Tox/See Drugs of Abuse Test Kit. Findings were as Follows; a . Based upon a review of drug testing log sheets revealed the laboratory from failed to perform QC testing on each day of use from 01 /17/2017 to 05/1/2017 24 patients were tested from 05/21/2017 to 06/26/2017 14 patients were tested 06/29/2017 to 09/27/2017 19 patients were tested 09/29/2017 to 02/15/2018 38 patients were tested No IQCP has been developed to enable the laboratory to reduce the frequency of QC. D5783