Cheyenne County Hospital

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 review of proficiency testing records the laboratory failed to successfully participate in proficiency testing from American Proficiency Institute for the analyte: Free thyroxine for two out of three consecutive proficiency testing events: 2020 event 1 and 2020 event 2 (refer D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review for proficiency testing from the provider API for Chemistry, the regulated analyte free thyroxine revealed the following performance scores for PT: 1.First testing event 2020 revealed a score of 60% for Free thyroxine 2. Second testing event 2020 revealed a score of 0% for Free thyroxine. The laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the analyte:Free thyroxine -- 2 of 2 --

Summary Statement of Deficiencies 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 review of Kendro CO2 incubator Hercell 150 operating manual and interview with the General Supervisor #2 and Testing Personnel #3, the laboratory failed to follow the manufacturer's instructions for operating the CO2 incubator in Microbiology. Findings included: 1. Review of the operator's manual for the Kendro CO2 incubator Hercell 150 indicated a CO2 comparison measurement has to be performed every three months to determine the exact measured value of the device- integral CO2 sensor. 2. Review of the Microbiology maintenance logsheet indicated no comparison measurement of CO2 for the incubator. 3. Interview with General Supervisor #2 and Testing Personnel #3 confirmed the laboratory failed to follow the manufacturer's instructions for the correct maintenance of the CO2 incubator. 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 on direct observation and interview with General Supervisor #2, the laboratory 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 -- failed to ensure reagents and stains were used before they had exceeded their expiration date. Findings Include: 1. Direct observation of the laboratory testing area on the date of survey at 1:30 PM found a bottle of Potassium Hydroxide (KOH) solution with the lot number of 63028985 and expiration date of September 30, 2018. 2. General Supervisor #2 confirmed the bottle of Potassium Hydroxide (KOH) solution was expired and was currently used in patient testing. The interview occurred February 19, 2019 at 1:35 PM. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's immunohematology policies and procedures and 30 patient test records, the laboratory failed to document all immunohematology control procedures performed in one out of 30 instances. Findings include: 1. Review of the laboratory's immunohematology policy titled "Blood Bank Quality Control" found the following instructions for Quality Control (QC). DAY OF USE Perform QC once each day of use that a Blood Bank procedure is performed. 2. Review of the Transfusion Service Testing Log indicated a patient was typed and crossmatched for two units on February 9, 2019. The two units were not transfused. 3. Review of the Laboratory's Blood Bank Assessment Form in the LIS found no quality control (QC) documentation for ABO/Rh and antibody screeing cells on Febraury 9, 2019. 4. Interview with the General Supevisor #2 on February 9, 2019 at 11:30 AM confirmed that there was no documentation of QC for ABO/Rh and antibody screening cells in the LIS on February 9, 2019. -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: A review of proficiency testing records from American Proficiency Institute (API) (a year consists of three testing events) and interview with laboratory Supervisor revealed the laboratory failed to verify the accuracy of analytes for which the proficiency testing program does not obtain the agreement required for scoring. Findings were as follows: a. Proficiency testing records form API for the third event of 2016, revealed that the proficiency testing program failed to obtain the agreement required for scoring the Urine ID , Susceptibility Testing and Thyroid Stimulating Hormone). : At the time of survey (04/02/2018), there was no evidence of verification activities of accuracy by self grade (comparison to the published expected results) for any of these analytes available for review. An interview with the Testing Person #2 from the CMS form 209 on 04/02/2018, at 10:20 hrs confirmed that no verification of accuracy. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based upon a review of the laboratory's proficiency test reports performed through the provider American Proficiency Institute (API) laboratory policy/procedures and staff interview, the laboratory failed to ensure that evaluation of an unacceptable proficiency testing event was documented. Findings were: a...Based upon proficiency testing results for API 2-2016, Chemistry .Acetaminophen specimen CH-10 reported 33.0 acceptable range 27.4---32.5 no