Metro Pavia Clinic - Aguadilla

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Metro Pavia Clinic - Aguadila on October 17, 2025. 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 October 17, 2025. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (1) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. This STANDARD is not met as evidenced by: A. Based on a review of rapid plasma reagin (RPR) quality control records (year 2025) and an interview with the laboratory general supervisor on October 16, 2025, at 12:00 PM, it was determined that the laboratory failed to evaluate the new lot of RPR test kits for positive and negative reactivity prior to placing the lot in routine use on September 30, 2025. The findings include: 1. The laboratory performed RPR tests for syphilis using the ASI RPR Card Test. 2. The RPR quality control records were reviewed from January 1, 2025, to October 16, 2025, and showed that the laboratory did not evaluate the new lot of RPR test kits for positive and negative reactivity prior to use in patient testing. Lot Number: 5C07R6 Expiration date: December 31,2026 Date opened: September 30,2025 3. The laboratory performed and reported 26 out of 26 RPR patient tests from September 30, 2025, to October16, 2025. 4. The laboratory general supervisor confirmed on October 17, 2025, at 12:05 PM, that the laboratory did not evaluate the new lot of RPR tests for positive and negative reactivity prior to 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 -- placing it into routine use. B. Based on the review of human chorionic gonadotropin (hCG) test quality control records (year 2025) and an interview with the laboratory general supervisor on October 17, 2025, at 12:10 PM, it was determined that the laboratory failed to evaluate the new lot of hCG test kits for positive and negative reactivity prior to placing the lot in routine use on September 24, 2025. The findings include: 1. The laboratory performed hCG testing using the Alere hCG Combo Cassette method. 2. The hCG quality control test records were reviewed from January 1, 2025, to October 16, 2025, and showed that the laboratory did not evaluate the new lot of hCG test kits for positive and negative reactivity prior to use in patient testing. Lot Number: 953985 Expiration date: January 1, 2027 Date opened: September 24, 2025 3. The laboratory performed and reported 18 out of 18 hCG patient tests from September 24, 2025, to October 16,2025. 4. The laboratory general supervisor confirmed on October 17, 2025, at 12:20 PM, that the laboratory did not evaluate the new lot of hCG test for positive and negative reactivity prior to placing it in routine use. 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 the review of RPR and hCG quality control records (year 2025) and an interview with the laboratory general supervisor on October 17, 2025, at 12:30 PM, it was determined that the laboratory director failed to ensure that the general supervisor monitored compliance with analytic system requirements for new lots of RPR and hCG test kits for positive and negative reactivity prior to placing them in routine use. Refer to D6144. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on the review of RPR and hCG quality control records review and an interview with the laboratory general supervisor on October 17, 2025, at 12:30 PM, it was determined that the laboratory general supervisor failed to verify the new lots of RPR and hCG test kits for positive and negative reactivity prior to placing them in routine use. Refer to D5471 (A) and (B). -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the Urinalysis quality control review and interview with the laboratory general supervisor on October 25, 2023 at 11:45 AM; it was determined that the laboratory did not include or document any negative microscopic sediment control material when 712,909 patient's were processed and reported under the microcope since January 2022. The findings include: a. The Urinalysis quality control was reviewed on October 25, 2023 at 11:45 AM, and showed that the laboratory did not include or document any negative microscopic control for sediment. b. The laboratory testing personnel confirmed on October 25, 2023 at 11:50 AM that no microcopy control was implemented since January 2022 when 12.909 patient's were processed and reported under the microcope since January 2022. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) 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. 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 -- This STANDARD is not met as evidenced by: Based on urinalysis quality control records review (years 2022-2023) and laboratory general supervisor interview on October 25, 2023 at 11:45 A. M, it was determined that the laboratory director failed to ensure that the laboratory included a negative microscopic sediment control material when 12,909 patient's samples were processed and reported under the microscope since January 2022. The finding include: 1. The laboratory did not include or document any negative microscopic sediment control material when 12,909 patient's were processed and reported under the microcope since January 2022. Refer to D5445. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on urinalysis quality control records review (years 2022-2023) and laboratory director interview on October 25, 2023 at 11:45 A. M, it was determined that the laboratory general supervisor failed to ensure that the laboratory included a negative microscopic sediment control material when 12,909 patient's samples were processed and reported under the microscope since January 2022. Refer to D5445. -- 2 of 2 --

Summary Statement of Deficiencies D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, general immunology quality control records review in years 2017-2018 and laboratory general supervisor interview at 10:10 a.m. on May 18, 2018, it was determined that the laboratory failed to follow manufacturer's instruction when patient's samples were tested for qualitative C-reactive protein (CRP) by Detector-crp method. The findings include: 1. The laboratory uses Detector- crp method to perform C-reactive protein (CRP) patient's samples. 2. The Detector- crp manufacturer's instructed the laboratory to check all negative seras by retesting at 1:10 glycine dilution due to a prozone phenomena. 3. Review of records from November 20, 2017 to May 17, 2018, the records showed that the laboratory did not dilute fifty nine (59) patient's specimens before it reported as negative C-reactive protein. 4. The laboratory general supervisor confirmed on May 18, 2018 that the laboratory did not dilute fifty nine (59) patient's specimens before it reported as negative C-reactive protein. 5. The laboratory processed and reported fifty nine (59) negative patient's samples without 1:10 glycine dilution retest. 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. (c) The 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 -- laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on quality assessment (QA) records review in years 2017-2018 and laboratory general supervisor interview on May 18, 2018 at 10:10 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for analytic systems. The findings include: 1. The laboratory failed to follow manufacturer's instructions when patient's samples were tested for qualitative C-reactive protein (CRP) by Detector-crp method. Refer to D5479. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, general immunology quality control records review in years 2017-2018 and laboratory general supervisor interview at 10:10 AM on May 18, 2018, it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. Refer to D5479. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, general immunology quality control records review in years 2017-2018 and laboratory general supervisor interview on May 18, 2018 at 10:10 AM, it was determined that testing personnel failed to follow quality control procedures. The findings include: 1. The laboratory uses Detector-crp method to perform C-reactive protein (CRP) patient's samples. 2. The Detector-crp manufacturer's instructed the laboratory to check all negative seras by retesting at 1:10 glycine dilution due to a prozone phenomena. 3. Review of records from November 20, 2017 to May 17, 2018, the records showed that the laboratory did not dilute fifty nine (59) patient's specimens before it reported as negative C-reactive protein. 4. The laboratory general supervisor confirmed on May 18, 2018 that the laboratory did not dilute fifty nine (59) patient's specimens before it reported as negative C-reactive protein. 5. The laboratory processed and reported fifty nine (59) negative patient's samples without 1:10 glycine dilution retest. Refer to D5429. D6144 GENERAL SUPERVISOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, general immunology quality control records review in years 2017-2018 and laboratory general supervisor interview on May 18, 2018 at 10:10 AM, it was determined that the general supervisor failed to follow quality control procedures. Refer to D5479. -- 3 of 3 --