Lab Clin Borinquen - Las Lomas

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Borinquen - Las Lomas on July 3, 2025. 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 July 3, 2025. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on urinalysis quality control records review (years 2024-2025) and laboratory supervisor interview on July 3, 2025 at 11:02 AM, it was determined that the laboratory failed to verify the stated value of the new lot of control materials (normal and abnormal controls), when the laboratory processed and reported 951 patient urinalysis samples from January 1, 2025 to January 31, 2025. The findings include: 1. The laboratory performs urinalysis tests with the iChem VELOCITY instrument and uses IRISpec urine control material. 2. The urinalysis quality control records reviewed (years 2024-2025) on July 3, 2025 at 11:02 AM, from January 1, 2025 to January 31, 2025, showed that there was no evaluation of the manufacturer's stated values for the normal and abnormal kit control material lot number 614-24 prior to placing them in 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 -- routine use on January 31, 2025. 3. The laboratory director stated on July 3, 2025 at 11:02 AM, that no evaluations of the stated lot of control materials were performed prior to placing them in routine use. 4. The laboratory director confirmed on July 3, 2025 at 11:10 AM, that the laboratory failed to evaluate the stated value of the new lot of control materials for urinalysis tests performed by the iChem VELOCITY instrument, when they processed and reported 951 patient samples from January 1, 2025 to January 31, 2025. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established 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 urinalysis quality control records review (years 2024-2025), it was determined that the laboratory director did not ensure that quality control procedures related to urinalysis quality control procedures were performed as established by the urinalysis quality control requirements. Refer to D5469. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of validation records of the new hematology system (Coulter DXH 600) for complete cell count (CBC) tests and general supervisor interview on July 23, 2019 at 1:45 PM, it was determined that the laboratory failed to verify that the manufacturer's CBC reference intervals (normal values) are appropriate for the laboratory's patient population before reporting 15,728 CBC tests during the year 2018. The findings include: 1. On July 23, 2019 at 1:45 PM, the validation records of the Coulter DXH 600 system showed that the laboratory laboratory performed the validation procedures for this new system on January 29, 2018. However, the validation records showed that the laboratory did not verify that the manufacturer's CBC reference intervals (normal values) are appropriate for the laboratory's patient population. 2. The general supervisor confirmed that the the validation records of the Coulter DXH 600 system did not include the verification of the manufacturer's CBC reference intervals. She stated that this performance characteristic was verified but the records were not available. 3. The laboratory processed and reported 15,728 CBC tests during the year 2018. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) 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 -- The laboratory director must ensure that the quality control programs are established 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 review of validation records of the new hematology system (Coulter DXH 600) for complete cell count (CBC) tests and general supervisor interview on July 23, 2019 at 1:45 PM, it was determined that the laboratory director failed to comply with the requirements for CBC tests. Refer to D 5421 (The laboratory failed to verify that the manufacturer's CBC reference intervals (normal values) are appropriate for the laboratory's patient population before reporting 15,728 CBC tests during the year 2018). D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: Based on review of validation records of the new hematology system (Coulter DXH 600) for complete cell count (CBC) tests and general supervisor interview on July 23, 2019 at 1:45 PM, it was determined that the technical supervisor failed to follow quality control procedures (verifying the performance specifications of new instrument) before reporting 15,728 CBC tests during the year 2018. Refer to D 5421. -- 2 of 2 --