Bayamon Medical Center

Summary Statement of Deficiencies D0000 The Bayamon Medical Center was found to be in substantial compliance with CLIA regulation (42 CFR Part 493, effective April 24, 2003). No deficiencies were cited as a result of an onsite survey performed on November 4, 2021. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on Covid-19 report records review and general supervisor interview on November 4, 2021 at 1:30 PM, it was determined that the laboratory failed to report the Covid- 19 results as required for six out of ten days reviewed from August 15, 2020 to October 28, 2021. The findings include: 1. The laboratory utilized the Health Department instruction to send the Covid-19 results to the Bioportal. 2. The laboratory processed the Covid-19 test by the following methods: Rapid test , Antigen and PCR. 3. On November 4, 2021 at 1:30 PM, the Covid-19 reports records showed that the laboratory did not send the Covid-19 results in the required frequency (24 hrs) to the Bioportal in six out of ten days reviewed from August 15, 2020 to October 28, 2021: a. On 08/15/2020 ten ot of ten patients Covid rapid reports reviewed were not transmitted to the Bioportal. b. On 08/16/2020 four out of five patients Covid rapid reports reviewed were not transmitted to the Bioportal. c. On 10/22/2021 one out of nine patients Covid antigen reports reviewed was not transmitted to the Bioportal and five out of nine Covid antigen reports were sent to the Bioportal on 10/24/2021. d. On 10/24/2021 two out of nine patients Covid antigen reports reviewed were not transmitted to the Bioportal and 2 out of nine Covid antigen reports were sent to the Bioportal on 10/26/2021. e. On 10/27/2021 one out of four patients Covid-19 PRC reviewed was not transmitted to the Bioportal. f. On 10/28/2021 one out of four patients Covid-19 PRC reviewed was not transmitted to the Bioportal. 4. The general 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 -- supervisor confirmed on November 4, 2021 at 1:30 PM, that the laboratory did not send those Covid-19 results in the required frequency (24 hrs) to the Bioportal. -- 2 of 2 --

Summary Statement of Deficiencies 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 routine chemistry quality control records review and interview with the laboratory director and laboratory general supervisor on May 17, 2018 at 2:0 P.M., it was determined that the laboratory failed to ensure compliance with the analytic system requirements for routine chemistry tests. The findings include: 1. The laboratory failed to follow written instructions to perform the quality control evaluation for Dimension system. Refer to D5403. 2. The laboratory did not perform , at least every 6 months, the calibration verification procedures for the routine chemistry ( electrolytes ) tests processed by the Dimension RxL- Max system. Refer to D5439. 3. The laboratory failed to take and document remedial actions when the normal and abnormal control do not meet the laboratory's criteria for acceptability. Refer to D5783. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of body fluid quality control and patient test records, it was found Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- that the laboratory failed to ensure compliance with the analytic system requirements for hematology. The finding includes: a. The laboratory used body fluids control material beyond the stability date nor include control material . Refer to D5479 and D5543 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)