Laboratorio Clinico Marie E

Summary Statement of Deficiencies D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Human chorionic gonadotropin (hCG) manufacturer's instructions, worksheet records review and laboratory director interview on April 2, 2024 at 12:35 PM, it was determined that the laboratory failed to follow manufacturer's instructions to document the internal control each day of patient testing when processing hCG samples. The findings include: 1. The laboratory performed (hCG) human chorionic gonadotropin by OSOM hCG Combo Test kit. 2. Review of the manufacturer's instructions on April 2, 2024 at 12:30 PM showed that the laboratory must monitor and document the internal control to ensure the validity of the hCG test performed. 3. The hCG test worksheet records showed on April 2, 2024 at 12:35 PM, that the laboratory did not document the observed results of the internal procedural control with each day of patient testing when processing hCG samples. 4. The laboratory processed and reported 290 hCG patient samples from January 1, 2023 to April 2, 2024. 5. The laboratory director confirmed on April 2, 2024 at 12:40 PM, that the laboratory did not monitor and document the internal control with each day of patient testing when processing hCG samples. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established 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 -- and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on endocrinology quality control records review, it was determined that the laboratory director did not ensure that hCG quality control procedures were performed as established by the manufacturer's instructions. Refer to D5479. -- 2 of 2 --

Summary Statement of Deficiencies 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)

Summary Statement of Deficiencies D2082 GENERAL IMMUNOLOGY CFR(s): 493.837(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 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 Puerto Rico Proficiency Testing Program (PRPTP) records review (year's 2016, 2017 and 2018) and laboratory director interview on May 3, 2018 at 9:25 AM, it was determined that the laboratory failed to take and document