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 Puerto Rico Proficiency Testing Program records reviewed ( 2022-2023) laboratory director and laboratory general supervisor interview on March 28, 2023 at 10:00 A.M., it was determined that the laboratory failed to participate in the routine chemistry second testing event performed in May 2022. The findings include: 1. Proficiency testing records were reviewed from February 2022 toFebruary 2023. 2. The laboratory did not participate in the second testing event of routine chemistry ( routine chemistry, urinalysis, urine sediment) performed in May 2022, a testing score of 0 % was obtained . ( review on 3/28/23 at 11:500 a.m. ) 3. The laboratory general supervisor confirmed on March 28, 2033 at 11:10 P.M., that the laboratory failed to participate in the second testing event of routine chemistry specialty in May 2022. 4. The laboratory processed and reported 47,319 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 2 -- 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 ( 2022-2023) laboratory director and laboratory general supervisor interview on March 28, 2023 at 12:00 P.M., it was determined that the laboratory failed to participate in the endocrinology second testing event performed in May 2022. The findings include: 1. Proficiency testing records were reviewed from February 2022 toFebruary 2023. 2. The laboratory did not participate in the second testing event of endocrinology performed in May 2022, a testing score of 0 % was obtained . ( review on 3/28/23 at 11:50 a.m. ) 3. The laboratory general supervisor confirmed on March 28, 2033 at 11: 10 P.M., that the laboratory failed to participate in the second testing event of endocrinology subspecialty in May 2022. 4. The laboratory processed and reported 20 endocrinology patients samples from February 2022 to October 2022. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Program testing records review ( 2022-2023 ) and interview with the laboratory director on March 28, 2023 at 10:12 P.M., it was determined that the laboratory director failed to ensure that the laboratory participated in an HHS- approved proficiency testing program for routine chemistry and endocrinology sub specialty. Refer to D2089 and D2100. -- 2 of 2 --