Summary:
Summary Statement of Deficiencies D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on P, uerto Rico Proficiency Testing Program records reviewed ( 2021-2022) and laboratory general supervisor interview on January 26, 2023 at 10:00 A.M., it was determined that the laboratory failed to participate in the routine chemistry second testing event performed in June 2022. The findings include: 1. Proficiency testing records were reviewed from February 2021-December 2022. 2. The laboratory did not participate in the second testing event of routine chemistry ( routine chemistry, urinalysis, urine sediment) performed in June 2022, a testing score of 0 % was obtained . ( review on 1/26/23 at 10:10 a.m. ) 3. The laboratory general supervisor confirmed on January 26, 2023 at 10:20 A.M., that the laboratory failed to participate in the second testing event of routine chemistry specialty in June 2022. 4. The laboratory processed and reported 9,708 routine chemistry patients samples from February 2022 to October 2022. D2100 ENDOCRINOLOGY CFR(s): 493.843(c) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program records reviewed ( 2021-2022) and laboratory general supervisor interview on January 26, 2023 at 10:15 A.M., it was determined that the laboratory failed to participate in the endocrinology second testing event performed in June 2022. The findings include: 1. Proficiency testing records were reviewed from February 2021-December 2022. 2. The laboratory did not participate in the second testing event of endocrinology performed in June 2022 , a testing score of 0 % was obtained . ( review on 1/26/23 at 10:20 a.m. ) 3. The laboratory general supervisor confirmed on January 26, 2023 at 10:25 A.M., that the laboratory failed to participate in the second testing event of endocrinology sub- specialty in June 2022. 4. The laboratory processed and reported 209 endocrinology patients samples from February 2022 to October 2022. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)