Catalina Island Medical Center

Summary Statement of Deficiencies D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing records, and interview with the laboratory technical consultant on July 6, 2023, at 2:45 pm, the laboratory failed to attain a score of at least 80 percent of acceptable responses for free thyroxine in 2021 3rd event and is unsatisfactory free thyroxine analyte performance for the testing event. The findings include: 1. The laboratory participated in the API proficiency testing program for the year 2021. The laboratory received a 60% score for the free thyroxine analyte in 2021 3rd event which resulted in an unsatisfactory analyte performance. Therefore, the accuracy of the patient test results reported by the laboratory during the proficiency testing event cannot be assured and might have harmed patients. 2. The laboratory technical consultant on July 6, 2023, at 2:45 pm, affirmed that the laboratory received a 60% score for the free thyroxine analyte in 2021 3rd event. 3. The laboratory's testing declaration form, signed by the laboratory director on 6/30/2023 stated that the laboratory performs approximately 1,350 tests in endocrinology, annually. D2105 ENDOCRINOLOGY CFR(s): 493.843(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing records, and interview with the laboratory technical consultant on July 6, 2023, at 2:45 pm, the laboratory failed to take remedial action after receiving an unsatisfactory free thyroxine analyte performance in 2021 3rd event. The findings include: 1. The laboratory participated in the API proficiency testing (PT) program for the year 2021. The laboratory received a 60% score for the free thyroxine analyte in 2021 3rd event. However, the laboratory did not take any remedial action for the failure except re-running the PT sample. Therefore, the accuracy of the patient test results reported by the laboratory during the proficiency testing event cannot be assured and might have harmed patients. 2. The laboratory technical consultant on July 6, 2023, at 2:45 pm, affirmed that the laboratory did not take any remedial or

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records for evaluation of proficiency testing performance and an interview with laboratory personnel (LP) on 11 /19/2020 between 11:00 a.m. and 12:30 p.m, it was determined that the PT and PTT proficiency scores were below acceptable for one event (Event 1 2020). Findings include: 1. On 11/19/2020, an inspection was conducted between 11 a.m. and 12:30 p. m. 2. During a review of the laboratory documentation from AAB (agency providing the proficiency specimens), it was noted at approximately 11:45 a.m. that the laboratory had unacceptable PT and PTT results for samples 1 and 2. The LP recognized these four atypical results. 3. The findings and acceptable ranges were as follows: Sample Test Actual Result Expected Result (range) 1 PT 14.2 32.6-44.2 2 PT 42.4 11.5-15.5 1 PTT 27.2 44.5-60.2 2 PTT 52.6 23.3-31.6 4.

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review third quarter (Q3-2016) of the American Association of Bioanalysts (AAB) proficiency testing records and interview with the testing personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for PO2 blood gas analyte. The findings included: a. Q3-2016, AAB reported an unsatisfactory proficiency testing score of 0% for PO2 analyte. b. Based on the laboratory's testing declaration submitted for 2017-2018, the laboratory analyzed and reported 22 Blood gases tests which included PO2 analyte. c. The testing personnel affirmed (6/19/2018, 14:30) that the laboratory failed in the proficiency testing for the above analyte. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review and the lack of quality control (QC) records, and interview with the testing personnel, it was determined that the laboratory failed to document 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 -- performs each quantitative procedure, include two control materials of different concentrations. The findings included: a. The laboratory uses iStat instrument (Abbott) for Lactate and blood gases analytes. The laboratory does not analyze and perform each quantitative procedure, include two control materials of different concentrations. b. Based on the laboratory annual testing declaration submitted for 2017-2018, the laboratory analyzed and reported 121 Lactate, and 22 Blood gases tests. c. The testing personnel affirmed (6/19/2018, 14:30) that the laboratory did not have documentation to show of each quantitative procedure, include two control materials of different concentrations. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review and the lack of quality control (QC) records, and interview with the testing personnel, it was determined that the laboratory failed to document and performs each qualitative procedure, include a negative and positive control material. The findings included: a. The laboratory analyzed and reported infectious Mononucleosis (Mono), Influenza A & B (Flu), and Serum Human gonadotrophin (HCG) tests. The laboratory has no documentation to show that daily quality control (QC) materials are performed and documented. b. Based on the laboratory annual testing declaration submitted for 2017-2018, the laboratory analyzed and reported 19 Mono, 206 Serum HCG, and 89 Flu tests. c. The testing personnel affirmed (6/19 /2018, 14:30) that the laboratory did not have documentation to show of each qualitative procedure, include a negative and positive control material. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory's Critical Values policy and procedure, random patient test result and interview with the testing personnel, it was determined that the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the post analytic systems. The findings included: a. The laboratory's Critical Values policy and procedure stated: "All laboratory tests have reference ranges associated with them. If values are determined to be critical, the ordering physician or the on-call physician must be notified STAT. If the ordering provider is a non-staff physician, the CLS on duty must call the Physician's office and verbally relay the critical result." b. For one (1) out of one (1) random patient test result reviewed with Complete Blood Count (CBC) ordered on 10/330/2016 with a high -- 2 of 3 -- White Blood Cell (WBC) count. The laboratory has not established, follow, monitor and other mechanism when indicated correct problem problems that are identified. c. The testing personnel affirmed (6/19/2018, 14:30) that the laboratory has not established, follow, monitor, assess when indicated, correct problems identified in the post analytic systems. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records, quality control (QC) records, Critical Values policy and procedure, random patient test result and interview with the testing personnel, it was determined that the laboratory director failed to ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. See D2087, D5447, D5449, and D5891. -- 3 of 3 --