Goodland Regional Medical Center

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 a review of the laboratory procedures and interview with technical consultant #3 (TC#3), the laboratory failed to follow written procedures to perform the suspected transfusion reaction work-up on 1 of 1 patients at the time of survey. Findings: 1. Review of the procedure "Blood Bank Policies" revealed under "Transfusion Reactions" the following: "Signs and Symptoms include chills, shock, lower back pain, pain at infusion site, hives, uticaria, abnormal bleeding, temperature +/- 2 degrees from start, Systolic BP +/- 30 minn from start, Dyastiloc BP +/- 20 mm from start and Heart rate +/- 30 beast from start." 2. One patient with a start systolic of 130 before transfusion, a 163 systolic at the end of transfusion. 3. Incorrect documentation from the Registered Nurse (RN) administering the blood of "No Reaction" and did not contact the provider and the laboratory to initiate a suspected transfusion work-up. 4. The packed red blood cells (PRBCs) was administered 5/4 /2025 @ 9:20 p.m. (2120) and finished 5/4/2025 @ 11:21 p.m. (2321). 5. The Laboratory Director did notice the discrepancy and stated on record a "non-hemolytic reaction" with no suspected reaction work-up. 6. Interview with TC #3 on 7/22/25 at 11:55 a.m. confirmed, the laboratory failed to follow written procedures to perform suspected transfusion reaction work-up on 1 of 1 patients meeting criteria. 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 D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Review of 2022, 2023 and to date of survey blood bank temperature monitoring records, lack of procedure, lack of alarm check records, and interview, the laboratory failed to regularly inspect the alarm system for the storage of blood products, specifically Fresh Frozen Plasma (FFP). Findings: 1. Review of the lack of records found no hour monitoring system in place for FFP with temperature graphs for temperature records. Recorded temperature logs reviewed showed acceptable temperatures were maintained. 2. Technical Consultant #3 (TC3) stated that there is no graph monitoring system that monitored the temperatures of FFP and no system to send any hospital staff an alert if the temperature went out of range. 3. Surveyor requested records of high and low alarm checks. TC3 stated the there is no alarm system regularly checked for FFP. 4. Surveyor asked for policy for temperature alarm checks. TC3 stated the laboratory did have a policy for testing the blood bank storage alarm systems for packed Red Blood Cells (pRBCs). No documentation of a quarterly FFP alarm check was provided from 5/50/2022 to 5/23/2023. 5. TC3 stated they contacted North Plains American Red Cross (NP-ARC) when they first received FFP in May 2022 with regards to alarm check on FFP. NP-ARC informed TC3 that alarm checks on FFP was not necessary. 6. No patients were issued any FFP during this time period 7. Interview with TC3 on 5/23/23 confirmed, the laboratory failed to regularly inspect the alarm system for the storage of FFP. 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 D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of performance verification documentation for the Sysmex XN-550 hematology analyzer, EPOC Blood Gas Analyzer and interview, the laboratory failed to verify the reference intervals (normal values) were appropriate for the laboratory's patient population. Findings: 1. Review of the verification documentation of the Sysmex XN-550 hematology analyzer, S/N 20959, for the analytes: White Bloodcell Differential, Red Bloodcell Count, Hemoglobin, Hematocrit, White Bloodcell Count, and Platelet testing showed no verification of normal values at time of survey. Document listed patient testing began March 18, 2021. 2. Review of the verification documentation of the Siemens EPOC Blood Gas analyzer, S/N 28977, for the anyalytes: pH, pCO2, pO2, TCO2, Hematocrit, Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, Lactic Acid, Urea Nitrogen, and Creatinine testing showed no verification of normal values at time of survey. Document listed patient testing began January 23, 2021. 3. Interview with technical supervisor #1 on September 21, 2021 at 2:30 p.m. confirmed, the laboratory failed to verify the reference intervals (normal values) for the Sysmex XN-550 and Siemens EPOC analyzers were appropriate for the laboratory's patient population. D5775 COMPARISON OF TEST RESULTS 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 -- CFR(s): 493.1281(a)(c) (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 review of chemistry Siemens Dimension EXL 200, Siemens EPOC procedures, lack of comparison records and interview, the laboratory failed to evaluate and define the relationship between test results using different methodologies and instruments. Findings include: 1. Review of chemistry analytes Sodium, Potassium, Chloride, Lactic Acid, Carbon Dioxide, Urea Nitrogen, Creatinine and Glucose showed they are performed on the Siemens Dimension EXL 200 S/N DE270815 and the Siemens EPOC S/N 28977. No procedure was available on how to evaluate and define the relationship between the chemistry test results. 2. No comparison testing records from January 23, 2021 to September 21, 2021 were made available at the time of survey. 3. Interview with the technical supervisor #1 on September 21, 2021 at 2:30 PM confirmed the laboratory failed to evaluate and define the relationship between the Siemens Dimension EXL 200 and Siemens EPOC test results for Sodium, Potassium, Chloride, Lactic Acid, Carbon Dioxide, Urea Nitrogen, Creatinine, and Glucose. -- 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 a review of laboratory personnel procedures, competency records and staff interview, the laboratory failed to define by policy/procedure the manner in which competency was assessed for testing personnel. Findings include: 1. A review of the laboratory's policies/procedures showed the laboratory failed to have the six required procedures in their competency assessment for testing personnel. 2. Upon review of the competency assessment documentation from 09/01/18 to 07/23/19 for testing personnel, the forms included only two of the six required procedures. 3. Interview with the Technical Supervisor #2 on 7/23/19 at 1:20 pm confirmed the laboratory failed to define and use the six required procedures in their competency assessment. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on an absence of thermometer records, microscope maintenance records and interview with Technical Supervisor (TS) #2, the laboratory failed to define a function 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 -- check protocol for the thermometers and microscopes. Findings were: 1. No documentation was available for function checks of thermometers for a 24 month period. No documentation was available for the certification of accuracy (NIST traceble) for thermometers, including blood bank storage thermometers for a 24 month period. 2. No documentation was available for the maintenance of microscopes for a 24 month period. 3. Interview with TS #2 7/23/19 1:20 pm confirmed the laboratory had no records of function checks for the thermometers used in the laboratory for the past two years. 4. Interview with TS#2 7/23/19 12:00 pm confirmed the laboratory had no records of microscope maintenance for the past two years. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based upon direct observation during a tour of the laboratory, review of manufacturer's package insert and staff interview, the laboratory failed to ensure that gram stain reagents in use were not being used beyond their open expiration date. Findings were: 1. During a tour of the lab the surveyor observed BD Gram Stain Kits and Reagents with lot # 7340813 that expired 5/31/2019 in use on November 14, 2018. There was no open date or expiration date noted on this gram stain kit. 2. Review of the gram stain quality control (QC) log had lot # 7340813 expired 5/31 /2019 had QC performed and documented for the first time on July 3, 2018. 3. Review of the BD Gram Stain Kits and Reagents stated "The expiration date is for product in unopened bottles stored as direct. Do not open until ready to use. Use the traditional Gram Iodine within 3 months of preparation, not exceeding the Expiration date." 4. Interview with general supervisor (GS) #1 (refer to laboratory personnel report (CMS- 209)) at 2:22 PM on November 14, 2018 they only ordered one grams stain kit at a time when the current kit in use was almost completely gone and that the above kit had been in use since July 3, 2018 as stated on the gram stain log. D5783