Summary:
Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Fajardo on June 11, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the recertification CLIA survey ending on June 11, 2026. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records (years 2025-2026) and interview with the laboratory director on June 11, 2026 at 12:55 PM, the laboratory failed to evaluate and monitor the general laboratory systems practices related to: patient confidentiality, specimen identification and integrity, complaint investigations, communications, personnel competency, and proficiency testing performance since January 2025. The findings include: 1. On June 11, 2026 at 12:55 PM, the laboratory general system QA 2025-2026 records were requested. The general system QA was not available for evaluation. 2. The laboratory director confirmed on June 11, 2026 at 1:02 PM, that the laboratory QA general system activities records were not available in the laboratory, and that the laboratory failed to monitor the general laboratory systems practices related to: patient confidentiality, specimen identification and integrity, complaint investigations, communications, personnel competency, and proficiency testing performance since January 2025. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.1249(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records (years 2025-2026) and interview with the laboratory director on June 11, 2026 at 12:55 PM, the laboratory failed to evaluate and monitor the pre-analytic laboratory systems related to: patient test requests, specimen submission, handling and referral, since January 2025. The findings include: 1. On June 11, 2026 at 12:55 PM the laboratory pre-analytic system QA 2025-2026 records were requested. The pre-analytic system QA was not available for evaluation. 2. The laboratory director confirmed on June 11, 2026 at 1:02 PM, that the laboratory QA pre-analytic system activities records were not available in the laboratory, and that the laboratory failed to monitor the pre-analytic laboratory systems related to: patient test requests, specimen submission, handling and referral, since January 2025. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records (years 2025-2026) and interview with the laboratory director on June 11, 2026 at 12:55 PM, the laboratory failed to evaluate and monitor the analytic laboratory systems related to: test procedures; test systems, equipment, instruments, reagents, materials, and supplies for accuracy and reliability; specimen and reagent storage condition; equipment or test maintenance and function checks; establishment and verification of method performance specifications; calibration, and calibration verification; control procedures; comparison of test results;