Rawlins County Health Center

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 the review of proficiency testing (PT) records from American Proficiency Institute (API), the laboratory failed to successfully participate in PT under the specialty Routine chemistry for the regulated analyte: total bilirubin. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing (PT) from the provider API for Chemistry, and phone interview, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the regulated analyte: total bilirubin. Findings: 1. Review of API PT scores for 2022 Event 2 revealed a 60% performance score for total bilirubin. 2. Review of the API PT scores for 2023 Event 1 revealed a 40% performance score for total bilirubin. 3. Phone interview with the general supervisor on 4/4/23at 8:20 a.m. confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the regulated analyte: total bilirubin. -- 2 of 2 --

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-450 hematology analyzer, non-waived test lists, and interview, the laboratory failed to verify the reference intervals (normal values) were appropriate for the laboratory's patient population prior to performing patient testing. Findings: 1. Review of the verification documentation of the Sysmex XN-450 hematology analyzer, S/N 12571, for the analytes: White Blood Cell Differential, Red Blood Cell Count, Hemoglobin, Hematocrit, White Blood Cell Count, and Platelet testing showed no verification of normal values at time of survey. Document listed patient testing began 6/23/21. 2. Review of the KS-CLIA-PS02 non-waived test lists showed the XN-450 test volume from 6/23/21 to date of survey to be 19,950 patient test results. 3. Interview with General Supervisor on 11/16/22 at 1:40 p.m. confirmed, the laboratory failed to verify the reference intervals (normal values) were appropriate for the laboratory's patient population prior to performing patient testing. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under 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 -- 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: Based on the review of 2021 and to date of survey blood bank temperature monitoring records without review documentation, lack of acceptable alarm check records, and interview, the laboratory failed to maintain an adequate temperature alarm system for the storage of blood products. Findings: 1. Review of monitoring records found 24 hour monitoring system in place with paper graphs for temperature records. Records examined showed no review documentation to ensure acceptable temperatures were maintained since 11/18/2020. 2. Review of Hi/Lo alarm check records showed the secondary monitoring process (laboratory was not staffed 24 hours a day, 7 days a week) was nonfunctional for the checks performed on 3/31/22 and 9/30/22. The last acceptable alarm check was recorded on 8/10/21. 4. Review of patient records found 10 patients received 22 units of blood from 8/10/21 to 11/16/22. 5. Interview with the general supervisor on 11/16//22 at 11:05 a.m. confirmed, the laboratory failed to maintain an adequate temperature alarm system for the storage of blood products. -- 2 of 2 --

Summary Statement of Deficiencies 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, timer maintenance records and interview with General Supervisor (GS) #1, the laboratory failed to define a function check protocol for the thermometers and timers. 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 GS #1 at 1030 AM on 11/18/2020 confirmed the laboratory had no records of function checks for the thermometers used in the laboratory for the past two years. 4. Interview with GS #1 at 1030 AM on 11/18/2020 confirmed the laboratory had no records of time rmaintenance for the past two years. 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 D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the laboratory's policy and procedure manuals, patient test records and transfusion records, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1271, and 493.1281 through 493.1299. The laboratory failed to document ABO Rh typing of donor units prior to transfusion (refer to D5553) D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a lack of available documentation and confirmed during interview, the laboratory failed to have procedures approved, signed, and dated by the laboratory director before use. Findings: 1. Upon review of the laboratory procedures, the current laboratory director did not approve, sign, and date the laboratory procedures for Hematology, Chemistry, Immunology, Blood gases, Urinalysis. 3. Confirmed during interview with the General Supervisor on February 20, 2019 that the laboratory director had not signed the procedure manuals. 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 -- D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A review of Quality Control and interview with staff revealed the laboratory failed to document quality control of the Differential stain for hematology Findings were as follows: a . Based upon Quality Control of the differential stain for hematology the laboratory failed to produce documentation that the quality control was being performed. This was confirmed in interview with General Supervisor #1 on February 20, 2019 at 11:20 D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (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 selected 2019 patient transfusion records and blood bank procedures reveals that the laboratory fails to comply with 21 CFR 640.5 (b) and (c) No determination of Blood group and Rh factor on donor units are documented. Findings include: 1. Review of the patient transfusion record revealed that no ABO/Rh typing had been documented on two units transfused to patient on February 5, 2019. 2. Interview with General Supervisor #1 confirmed that no ABO/Rh for the two donor units were documented for patient transfused on February 5, 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 Free Thyroxin CHG--13 , Thyroid Stimulating Hormone CH-- 13. b. Proficiency Testing records from API for the first event of 2017 revealed that the proficiency testing program failed to obtain the agreement required for scoring the Triglycerides CH--01 and Free Thyroxine CH--01 At the time of survey (04/04/2018), 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 General Supervisor from the CMS form 209 on 04/04/2018, at 09: 20 hrs confirmed that no verification of accuracy. 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 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 -- 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 the humidity for the laboratory as the XS-1000i hematology analyzer requires and temperature for the drawing room and store room failed to document. Findings were as follows: a. Based upon review of manufacture's operators guide the laboratory failed the humidity 30% to 85% . The laboratory failed to define the acceptable humidity range according to the manufacture's range for 76 of 90 days.. b. Based upon a tour of the laboratory the surveyor observed the drawing room and store room in which BD vacutainer tubes are stored at a temperature of 4 to 25 degrees C no documentation was provided. c. At the time of the survey 04/04/2018 the laboratory failed to produce