Saint Francis Hospital Vinita

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/24,25,2021. The findings were reviewed with the quality coordinator, current laboratory supervisor, and incoming laboratory supervisor during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1447; D6108: Technical Supervisor 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 records, written policy and interview with the laboratory supervisor, the laboratory failed to follow their written technical consultant and general supervisor competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) On 06/25/2021, surveyor #2 reviewed personnel records for competency assessments performed during 2019 and 2020. There was no evidence competencies had been performed for the technical consultant and general supervisor, based on their job responsibilities; (2) Surveyor #2 asked the laboratory supervisor if a written policy to evaluate the technical consultant and general supervisor based on job responsibilities was available. The general supervisor provided the policy for the surveyors review; (3) Suveyor #2 reviewed the policy titled, PERSONNEL COMPETENCY ASSESSMENT", which stated, "7.1. Competency of the technical or general supervisor is assessed via annual performance review."; (4) Srveyor #2 asked the laboratory supervisor if annual competencies based on job responsibilities had been performed during the review period. The laboratory supervisor stated on 06/25/2021 at 09:50 am, annual competencies had not been performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- 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: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to evaluate the accuracy of testing when proficiency results had not been graded by the proficiency program for one of five Hematology events reviewed. Findings include: (1) On 06/25/2021, surveyor #2 reviewed proficiency testing records for the first 2019, second 2019, first 2020, second 2020, and third 2020 event. The following was identified for one of five Hematology events: (a) First 2020 Hematology Event for Blood Cell Identification - One of five results had not been graded by the proficiency testing program: (i) ECI-01- Under "Expected Results" it stated, "See Data Summary". There was no evidence the laboratory reviewed the commentary contained in the "Participant Summary Report" to evaluate their result. (2) Surveyor #2 reviewed the records with the laboratory supervisor who stated on 06 /25/2021 at 02:27 pm, the laboratory had not evaluated the result that was not graded by the proficiency testing program and

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/25/19 through 02/28/19. The findings were reviewed with the technical consultant and general supervisor at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1210; D5016: Routine Chemistry 493.1403; D6000: Laboratory Director, Moderate Complexity 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: Based on a review of records and interview with the technical consultant and general supervisor, the laboratory failed to ensure proficiency testing attestation statements had been signed by the laboratory director or designee. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017, 2018, and 2019 proficiency testing records. The following was identified for 1 of 22 testing events: (a) Second 2017 Chemistry Miscellaneous Event (i) The attestation was not signed by the laboratory director or designee. (2) The findings were reviewed with the technical consultant and general supervisor who stated the attestation had not been signed as indicated above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 18 -- D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records and interview with the technical consultant and general supervisor, the laboratory failed to ensure the requirements were met for the subspecialty of Routine Chemistry for Troponin I and ABG (G3+ cartridge: pH, pCO2, pO2) testing. Findings include: (1) The laboratory failed to perform two levels of quality control materials each day of patient Troponin I and ABG (Arterial Blood Gas G3+ cartridge: pH, pCO2, pO2) testing. Refer to D5447; (2) The laboratory failed to have an ongoing mechanism for performing analytic quality assessment. Refer to D5791. 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 records, written policy and interview with the general supervisor, the laboratory failed to follow their written technical consultant and general supervisor competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) On the first day of the survey, the surveyor reviewed personnel records for competency assessments performed during 2017, 2018 and 2019. There was no evidence competencies had been performed for the technical consultant and general supervisor, based on their job responsibilities; (2) The surveyor asked the technical consultant and general supervisor if a written policy to evaluate the technical consultant and general supervisor based on job responsibilities was available. The general supervisor provided the policy for the surveyors review; (3) The surveyor reviewed the policy which required annual competencies be performed for the technical consultant and general supervisor based on job responsibilities. (4) The surveyor asked the technical consultant and general supervisor if annual competencies based on job responsibilities had been performed during the review period. The technical consultant and general supervisor stated annual competencies had not been performed. 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: Based on a review of records and interview with the general supervisor, the laboratory -- 2 of 18 -- failed to review and evaluate proficiency testing results. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017, 2018, and 2019 proficiency testing records. The following failures were identified, in which