Laboratorio Clinico Familiar Inc

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 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 facility records review (from January 1, 2018 to October 10, 2019) and laboratory director interview at 9:45 AM on October 10, 2019, it was determined that the laboratory failed to be in compliance with the Puerto Rico State laboratory regulation. The findings include: 1. The laboratory Biomedical Generator Number was due since November 18, 2018. 2. The laboratory director confirmed on October 10, 2019, that the Biomedical Generator Number was due from November 18, 2018. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on facility records review (from January 1, 2018 to October 10, 2019) and laboratory director interview at 9:45 AM on October 10, 2019, it was determined that the laboratory director failed to be in compliance with the Puerto Rico State laboratory regulation. The finding includes: 1. The laboratory Biomedical Generator Number was due since November 18, 2018. Refer to D3009. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --