Simedhealth Llc

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Simedhealth Llc was found to be not in compliance with the CLIA laboratory requirements of 42 CFR 493. 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: Based on record review and staff interview, the facility failed to document

Summary Statement of Deficiencies D0000 A recertification survey conducted on 2-21-2020, found the SimedHealth L.L.C clinical laboratory not incompliance with 42 CFR Part 493, Requirements for Laboratories. The following conditions were not met: D5200- General Laboratory Systems D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Cross Reference D5209 - Personnel Competecy Assesment Policies 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: This is a repeated deficiency from last survey on 3/15/2018. Based on record review and interview the laboratory failed to perform initial and 6-month competency assessments for 2 (TP#F and TP# G) out 7 testing personnel (TP). Annual competency 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 -- assessment for 4(TP#A-D) out of 7 TP, 2 general supervisors (GS), 2 technical supervisors (TS), clinical consultant (CC) and technical Consultant (TC). Findings Include: A review of the CMS 209 Laboratory personnel record displays that TP# A- G are Testing personnel. GS# A and B are general supervisors. TS# A and B are technical supervisors. CC#A is a clinical consultant. TC#A is a technical consultant. A review of 2019 Employee Competency Assessment record is revealed that initial and six-month competencies were not preformed for 2 (TP#F and TP# G) out of 7 TP in 2019. Annual competency assessments were not performed for 4 (TP#A -D) out of 7 TP ,GS#A , GS#B , CC#A ,TS#A , TS#B and TC#A. During an interview on 2-21- 2020 at 3:30pm, The general supervisor A confirmed that initial and 6-month competency assessment were not done for 2 TP and the annual competency assessments were not performed for 2 GS, 2 TS , 4 TP, CC and TC . 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: Based on observation, record review and staff interview, the laboratory failed to monitor room humidity for Beckman Coulter Unicell DXH 800 and Dynex DSX Best 2000 Analyzer for 2018 and 2019 . Finding Include: An observation of the Chemistry and Hematology areas revealed a thermometer in each room with a humidity gauge. A review of Beckman Coulter Unicell DXH 800 manual record displayed the required humidity range of 70 -85% for Beckman Coulter Unicell DXH 800. A review of Dynex DSX Best 2000 Analyzer manual record states a required humidity range 15 -85% for DSX Best 2000 Analyzer . A review of Temperature Log Manual Record displayed that humidity was not recorded from 2018 to 2019. During an interview on 2-21-2020 at 3:30pm, the general supervisor A confirmed that humidity was not recorded for 2018 and 2019. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and staff Interview, the laboratory failed to properly label reagents with name, open date, expiration date and remove expired reagents from refrigerators located in Chemistry and Hematology areas. Findings Include: An observation of the Hematology area revealed a Beckman coulter refrigerator. The -- 2 of 3 -- refrigerator contained small bottles of diluents, A1C linearity, A1A alcohol and Stock wash solution that were missing expiration and open dates. Two small sample diluents bottles had expiration dates of October 2019 . An observation of the Chemistry area reveled a Dynex refrigerator. The refrigerator contained immunology stock wash and auto antibodies reagent in two bottles without an open date, expiration date and no proper label to identify chemical. During interview on 2-21 -2020 at 3:30 pm , The general supervisor A and testing personnel E confirmed that reagents were not labeled with name, open date, expiration date and expired reagents were not thrown away in Dynex and Beckman coulter refrigerators. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory director failed to sign and validate the Beckman Coulter DxH800 and Au680 in 2018. Findings Include: A review of the CMS 209 Laboratory Personnel record displays Employee B as a general supervisor (GS). Employee A is the laboratory director (LD) and technical consultant (TC). A review of Beckman Coulter DxH800 validation record revealed the GS signed on the method approval line on 5-25-2018 . A review of Beckman Coulter Au680 validation record showed the GS signed on the method approval line in 4-16-2018 . During an interview on 12-21-2020 at 3:30pm, the GS confirmed that he had signed the validations for Beckman Coulter DxH800 and Au680 in 2018. -- 3 of 3 --

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 record review and staff interview, the laboratory failed to document annual competency assessment on four out of five testing personnel. The findings include: Review of the competency records showed that the laboratory failed to have documentation of annual competency assessments for four out of five testing personnel. Testing Person #2 last had a competency assessment on 2/10/16; Testing Person #3 last had a competency assessment on 5/19/14; Testing Person #4 last had a competency assessment on 7/8/09, and Testing Person #5 last had a competency assessment on 7/8/09. During an interview with the General Supervisor on 3/15/17 at 1:50 PM, it was confirmed that personal competency had not been performed annually for all testing personnel. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and interview, the facility failed to assess and correct 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 -- problems with verification of accuracy of C-reactive protein (CRP), 25- hydroxyvitamin D (25-OH Vit D), Human chorionic gonadotropin (HCG), erythrocyte sedimentation rate (ESR), and Microalbumin in 2016 and 2017. The findings include: The record review of the 2016-2017 American Proficiency Institute (API) testing results for the laboratory showed the following unsatisfactory grades: The API 2nd Event Immunology 2016 analyte CRP scored 50%. The correction action showed this was due to clerical error. The API 3rd Event Immunology 2016 analyte scored CRP 50% with no correction action documented. The API 1st Event Chemistry 2017 analyte 25-OH Vit D scored 67%. The correction action stated the failure was due to a reconstitution error. The API 1st Event Chemistry 2017 analyte HCG scored 40%. The correction action stated the failure was due to a dilution error. The API 2nd Event Chemistry 2017 analyte Microalbumin scored 0%. The correction action stated the failure was due to a clerical error. The API 3rd Event Hematology 2017 analyte ESR scored 50%. The correction action stated the failure was due to the sample being processed as a patient and not like a quality control sample. There was no documentation to show training of staff or changes in procedure to prevent the failures from occurring in the future. The interview with the General Supervisor on 3 /15/18 at 2:00pm confirmed the lack of documentation to show training of staff or changes in procedure occurred as part of the correction action. -- 2 of 2 --