Camuy Health Services Inc

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Camuy Health Servives Inc. on February 27, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The following standard level deficiencies were found during the unannounced routine CLIA recertification survey ending on February 27, 2026. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024 - 2025), hematology Proficiency Testing (PT) scores (year 2025) and technical supervisor interview on February 27, 2026, at 10:07 a.m., the laboratory failed to evaluate the accuracy of testing in the hematology specialty (Complete Cell Count - (CBC) and White Blood Cell (WBC) 5 Parameters) when the laboratory received an artificially score of 100 percent from the PT provider. The laboratory processed and reported 40,980 patient samples from June 2025 through February 26, 2026. The findings include: 1. PRPTSP were reviewed from February 2024 through December 2025. 2. Review of the hematology PT scores for the third testing event in 2025 showed that the PT provider assigned an artificial score of 100 percent. The results were not evaluated. 3. During interview On February 27, 2025, at 10:10 a.m., with the technical supervisor, the accuracy of the excused hematology specialty (Complete Cell Count - (CBC) and White Blood Cell (WBC) 5 Parameters) was required. The technical supervisor stated that no procedure for accuracy evaluation 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 -- was performed. 4. The technical supervisor on February 27, 2025, at 10:15 a.m, also stated that no written procedure was developed by the laboratory to evaluated the accuracy of test not evaluated by the PT provider. 5. From June 2025 through February 26, 2026, the laboratory processed and reported 40,980 patient samples. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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 urinalysis quality control (QC) and maintenance records file (year 2024) and interview with the technical supervisor (TS) on February 27, 2026, at 11:50 a.m., the laboratory failed to verify the performance specifications for the Mission U500 Urine Analyzer prior to performing and reporting patient test results. The laboratory processed and reported 68 out of 68 urinalysis tests results from July 26, 2024, to August 2,2024. The findings include: 1. On February 27, 2026, at 11:50 a.m., the urinalysis QC and maintenance records file showed that on July 26, 2024, the laboratory began to use a loaned Mission U500 Urine Analyzer. 2. The performance specification of the instrument was requested to the TS on February 27, 2026, at 11:55 a.m. The TS stated that no performance specification verification was performed prior to initiate patient testing on July 26, 2024. (February 27, 2026, at 12:08 p.m.) 3. From July 26, 2024, through August 2,2026, the laboratory performed and reported 68 out of 68 patient urinalysis test results. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on the lack of performance specification records and interview with the technical supervisor on February 27, 2026, at 1:45 p.m., the laboratory director failed to ensure that the technical supervisor verified the performance specifications for the urinalysis test system prior to performing patient testing and reporting patient test results. Refer to D6115. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024-2025), hematology proficiency testing (PT) scores (year 2025), laboratory policies and procedures, and interview with the technical supervisor on February 27, 2026, at 1:30 p.m., the laboratory director failed to evaluate the accuracy of testing in the hematology specialty (Complete Cell Count - (CBC) and White Blood Cell (WBC) 5 Parameters) and failed to ensure that the laboratory had a written procedure for the evaluation and follow-up of proficiency testing events when the laboratory received an artificially assigned score of 100 percent from the PT provider. Refer to: D5215. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) (b)(2) Verification of the test procedures performed and establishment of the laboratorys test performance characteristics, including the precision and accuracy of each test and test system; This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing Service Program (PRPTSP) scores, urinalysis performance specification records and technical supervisor interview on February 27, 2026, at 1:45 p.m., the technical supervisor failed to fulfill her responsibilities and duties to ensure compliance with the Hematology and Urinalysis requirements. Refer to D5215 and D5421. -- 3 of 3 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of general supervisor and clinical consultant records ( year 2022- 2023 ) and laboratory general supervisor interview on February 14, 2024 at 9:57 A. M , it was determined that the laboratory failed to follow written policies to assess the clinical consultant and general supervisor competency. The findings include : 1. The laboratory written procedures establishes that the clinical consultant and general supervisor competence evaluation must be performed annually. 2. General supervisor and clinical consultant records were reviewed since January 2022. 3. The laboratory technical supervisor failed to perform the annual competency evaluation to the clinical consultant since May 2021. 4. The laboratory director failed to perform the annual competency evaluation to the general supervisor ( technical supervisor ) since December 2021. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 quality assessment procedure manual, quality assessment records review Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- (2022-2023) and laboratory general supervisor interview on February 14, 2024 at 9:30 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the following requirements for pre analytic laboratory systems: test request and requisition. The findings include: 1. . Review of the quality assessment procedure manual showed that evaluations to test requisitions must performed each 6 months. 2. Review of the quality assessment records showed that the laboratory did not evaluate the test request and requisitions since April 2023. 3. The laboratory general supervisor confirmed on February 14, 2024 at 9:30 A.M.. that evaluations to test request and requisitions were not performed since April 2023. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: A-Based on white blood cells (WBC) differential results comparison records review ( year 2022-2023 ) and laboratory general supervisor interview on February 14, 2024 at 9:40 AM, it was determined that the laboratory failed to evaluate and define each six month the relationship between the manual cell differential and automatic cell differential. The findings include: 1. The laboratory performed automatic cell differential by Sysmex XN 550 hematology system. 2. The laboratory written protocol establishes that the laboratory must be performed the evaluation and define the relationship between test results using different methods each six month. 2. The WBC differential results comparison records showed that the laboratory did not evaluate twice a year the relationship of the WBC differential results between the manual method and the Sysmex XN 550 system since March 2023. 3. The laboratory director confirmed on February 14, 2024 at 9:42 A.M. that the laboratory failed to evaluate twice a year a relationship between the manual cell differential and automatic cell differential by hematology system since March 2023. B- Based on laboratory written procedures review, comparison test results records review (year 2022-2023 ) and interview with the laboratory general supervisor on February 14, 2024 at 9:39 A.M. , it was determined that the laboratory failed to follow the laboratory written procedure to perform and evaluate, each six month , the relationship of the glucose test performed by the Beckman Coulter AU- 480 system and glucometer system since October 2022. The findings include: 1. The laboratory written protocol establishes that the laboratory must be performed the evaluation and define the relationship between test results using different methods ( glucose ) each six month. 2. The laboratory used the Beckman Coulter AU- 480 system and glucometer to perform glucose test . 3.On February 14, 2024 at 9:39 A..M., review of the laboratory comparison test results showed that the laboratory did not perform the comparison of glucose test since October 2022. 4. On February 14, 2024 at 9:40 A.M., the general supervisor confirmed that the laboratory failed to perform and evaluate twice a year the comparison of glucose test results since October 2022. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) -- 2 of 4 -- 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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on quality assessment (QA) procedure manual, QA assessment records review (year 2022-2023) and interview with the laboratory general supervisor interview on February 14, 2024 at 9:45 A.M., it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the following requirements for postanalytic systems: turn around time and the patient's final test reports. The findings include: 1. Review of the quality assessment program showed that evaluations related to the laboratory turn around time and the patient's final test reports. must be evaluated each six month. ( review on February 14, 2024 at 9:46 a.m. ) 2. Review of the quality assessment record showed that the did not evaluate the turn around time and patient's final test reports since April 2023. ( review on February 14, 2024 at 9:46 a.m. ) 3. The laboratory genral supervisor confirmed on February 14, 2024 at 9:50 A. M., that the laboratory failed to perform the evaluations of turn around time and the patient's final test reports. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the 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 Quality Assessment (QA) records review ( year 2022-2023 ) and laboratory general supervisor interview on February 14, 2024 at 11:45 A.M., it was determined that laboratory failed to ensure compliance with quality assessment (QA) requirements. The findings include: 1. Quality Assessment records ( 2022-2023 ) showed that the laboratory did not evaluate the established Quality Assessment Program to monitor and evaluate the requirements for laboratory general systems, preanalytic, analytic and postanalytic systems. ( review on February 14, 2024 at 11:45 a.m. ) 2. The laboratory general supervisor confirmed on February 14, 2024 at 11:50 A.M. , that failed to evaluate the requirements for laboratory general systems, preanalytic, analytic and postanalytic systems. Refer to D5209, D5391 , D5391 and D5891. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: -- 3 of 4 -- Based on personnel records review and laboratory general supervisor interview on February 14, 2024 at 10:07 A.M. , it was determined that the technical supervisor failed to provide annually the competence evaluation to four out of four testing personnel that performed the high and moderate complexity tests since October 2022. The findings include: 1. On February 14, 2024 at 10:10 A.M, review the personnel records showed that the technical supervisor did not evaluate annually the competence of four out four testing personnel; that include at least the following requirements: a. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b. Monitoring, recording and reporting of test results. c. Review of intermediate test results or worksheets, quality control records, proficiency testing results and preventive maintenance records. d. Direct observation of performance of instrument maintenance and function checks. e. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 2. The personnel records showed that the competence evaluation were performed on October 2022. 3. On February 14, 2024 at 11:30 A.M, the technical supervisor confirmed that the testing personnel competency were not performed in October 2023. -- 4 of 4 --