Ochiltree General Hospital

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Review of manufacturer's instructions, patient final reports and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions when using the Sofia SARS Antigen and the Sofia Flu+SARS Antigen test kits. The findings included: 1. Review of the manufacturer's instructions found on page 19 under the heading CONDITIONS OF AUTHORIZATION FOR LABORATORY " Authorized laboratories using the Sofia SARS Antigen FIA and the Flu+SARS Antigen FIA must include with the test result reports, all authorized Fact Sheets." 2. Review of patient results found no fact sheets included with the final report for three of three patient reports reviewed. 3. Interview of Testing Person one on the CMS report 209 Laboratory Personnel Report conducted August 19, 2021 at 10:50 AM confirmed that the authorized Fact Sheets were not provided to healthcare providers or patients with test results for SARS COV-2 testing. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods 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 9 -- Review of policies and procedures, proficiency testing records and interview of facility personnel found the laboratory failed to ensure that three of three testing personnel who routinely tested patient specimens for Arterial blood gasses participated in testing proficiency specimens in 2019, 2020 and 2021 (three testing events per year). The findings included: 1. Review of the policy titled Proficiency Testing Program found on page "All Proficiency Testing specimens will be treated the same as patient samples to include the following: a. They should be included in the normal analysis workload. b. They should be tested by routine personnel who normally in the A.B.G. lab using routine methods." 2. Review of the American Proficiency I institute (API) proficiency testing records for 2019, 2020 and 2021 found seven of seven testing events between 2019 1st event and 2021 1st event were tested by the same testing person ( no longer employed). 3. Interview of testing person eight conducted on August 18, 2021 at 3:12 PM confirmed that the previous respiratory manager tested all of the proficiency samples in each of the proficiency testing events. 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: Review of the CMS report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found that the laboratory failed to have procedures for performing competency assessments on all supervisors, consultants and testing personnel. NOTE: THIS IS A REPEAT DEFICIENCY FROM THE 08/2017 INSPECTION Findings included: 1. Review of the CMS report 209 Laboratory Personnel Report found the laboratory identified one general supervisor. 2. Review of personnel records found no competency assessments available for review for the general supervisor. 3. Interview of the general supervisor conducted on August 18, 2021 at 10:50 AM confirmed that there were no competency assessments for the general supervisor of the laboratory. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Review of Hematology proficiency testing records, Proficiency testing agency instructions and interview of facility personnel found the laboratory failed to evaluate results not scored by the proficiency testing agency in one of two testing events in 2021. THIS IS A REPEAT DEFICIENCY The findings included: 1. Review of the American Proficiency Institute (API) Hematology proficiency testing records for 2021 found the laboratory failed to evaluate results not graded by the proficiency testing agency in the 2021 Hematology/ Coagulation -1st Event as follows: a. Comment documented under

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Review of policies and procedures, proficiency testing records, patient test records and interview of facility personnel found that the laboratory failed to test proficiency testing samples in the same manner as they tested patient specimens for BNP in one of four testing events reviewed. The findings included: 1. Review of the policy titled proficiency surveys found on page 100 testing procedure - PT samples are run in the same manner as patient samples." 2. Review of proficiency testing records for 2018 and 2019 (three events per year) found that the laboratory tested proficiency specimens for BNP using the Siemens dimension EXL chemistry analyzer in the 2018 testing event two and three and 2019 testing event one. The laboratory obtained and unacceptable score of 40% in the second testing event of 2018.

Summary Statement of Deficiencies D0000 Based on findings made during the onsite revisit conducted on October 25, 2017 the following Conditions remain uncorrected: 493. 803 Condition: Successful Participation 493.1403 Condition: Laboratories Performing Moderate Complexity Testing; Laboratory Director 493.1409 Condition: Laboratories Performing Moderate Complexity Testing; Technical Consultant 493.1421 Condition: Laboratories Performing Moderate Complexity Testing; Testing Personnel 493. 1441 Condition: Laboratories Performing High Complexity Testing; Laboratory Director 493.1447 Condition: Laboratories Performing High Complexity Testing; Technical Supervisor 493. 1487 Condition: Laboratories Performing High Complexity Testing; Testing Personnel Additional Conditions and several standard deficiencies were cited due to non initial unsuccessful participation in a proficiency testing program for Compatibility testing. 493. 807 Condition: Reinstatement of Laboratories Performing Nonwaived Testing ************************ This is a corrected statement of deficiencies. Corrections were made to citation D2016 for CK ISO, previously addressed in a Proficiency Testing Desk Review (PTDR) from November 2015. D2096 was deleted because it had been previously addressed in the 2015 PTDR for CK- ISO. D5293 replaced D5393. **************************** The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493. 803 Condition: Successful Participation 493. 807 Condition: Reinstatement of Nonwaived Laboratories 493.1403 Condition: Laboratories Performing Moderate Complexity Testing; Laboratory Director 493.1409 Condition: Laboratories Performing Moderate Complexity Testing; Technical Consultant 493.1421 Condition: Laboratories Performing Moderate Complexity Testing; Testing Personnel 493. 1441 Condition: Laboratories Performing High Complexity Testing; Laboratory Director 493.1447 Condition: Laboratories Performing High Complexity Testing; Technical Supervisor 493. 1487 Condition: Laboratories Performing High Complexity Testing; Testing 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 --