Laboratorio Clinico Fair View Csp

Summary Statement of Deficiencies D0000 An unannounced CLIA Recertification survey was conducted at the Laboratorio Clnico Fair View on December 5, 2024 by the Puerto Rico State Agency. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. During a recertification survey on December 5, 2024, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1250 Analytic systems 42 CFR 493.1441 Laboratory Director, High Complexity Testing D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on lack of hematology, urinalysis and endocrinology quality control records and laboratory technical supervisor interview on December 5, 2024 at 2:29 pm, it was determined that the laboratoty failed to meet requirements for analytic systems. Refer to D5413, D5469 and D5479. 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 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 -- 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 D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records review (years 2017 - 2018), Puerto Rico Laboratory Division Proficiency Testing desk review and laboratory general supervisor interview on March 28, 2019 at 9:45 AM, it was determined that the laboratory failed to enroll in an HHS approved Proficiency Testing Program for hematology white blood cell (WBC) three part differential since January 2017. The findings includes: 1. The laboratory was enrolled only in the Puerto Rico Proficiency Testing Program in 2017 and 2018. 2. The laboratory uses a Sysmex K4500 system to perform hematology patient samples tests. 3. The Puerto Rico Proficiency Testing records were reviewed from years 2017 to 2018, showing that the laboratory failed to enroll and participate in proficiency testing for hematology white blood cell (WBC) three part differential. 4. The general supervisor confirmed that the laboratory failed to participate in proficiency testing for hematology white blood cell (WBC) three part differential in years 2017 and 2018. He also stated that the laboratory was enrolled in the Medical Laboratory Evaluation (MLE) proficiency program on September 28, 2018, for the proficiency testing program year 2019. 5. The laboratory processed and reported 10,855 patients specimens for hematology from January 2, 2018 to December 31, 2018. 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 -- D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records review from January 2017 to December 2018 and laboratory general supervisor interview on March 28, 2019 at 9:45 AM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the proficiency testing requirements. The findings include: 1. The laboratory director failed to enroll in an HHS approved proficiency testing program for the hematology white blood cell (WBC) three part differential since January 2017. Refer to D6088. 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 Testing Program records review and laboratory general supervisor interview on March 28, 2019 at 9:45 AM, it was determined that the laboratory director failed to ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the white blood cell (WBC) three parameters differential since January 2017. The findings include: 1. The laboratory processed and reported patients specimens for the WBC three parameters differential results since January 2017, however the laboratory is not enroll in a an HHS-approved proficiency testing program for this tests. Refer to D 2000. 2. The general supervisor confirmed on March 28, 2019 at 9:45 AM, that the laboratory did not enroll in an approved proficiency program for the WBC three parameters differential testing since January 2017. He also stated, that the laboratory was enrolled in the Medical Laboratory Evaluation Proficiency Testing Program on September 28, 2018. -- 2 of 2 --