Metro Pavia Clinic Bayamon

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Metro Pavia Clinic Bayamon on August 5, 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 August 5, 2025. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing (year 2025), CASPER Report 0155D scores, and interview with the laboratory supervisor on August 5, 2025 at 9:54 AM; it was determined that the laboratory failed to attain a score at least 80 percent in the triiodothyronine (T3 uptake) in the second proficiency testing event in the 2025 year. The finding includes: 1. The Puerto Rico Proficiency and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Sodium a. triiodothyronine (T3 uptake)- 0 % 2. The laboratory supervisor confirmed on August 5, 2025 at 9:54 AM; that the laboratory failed to attain a score at least 80 percent in the triiodothyronine (T3 uptake) in the second proficiency testing event in the 2025 year. D6116 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(3) (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; 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 review of Puerto Rico Proficiency Testing scores (year 2025) and CASPER Report 0155D scores; it was determined that the technical supervisor failed to ensure that the laboratory achieved satisfactory participation in the second proficiency testing event of the year 2025. Refer to D2098. -- 2 of 2 --

Summary Statement of Deficiencies D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on Immuno Card Mycoplasma pneumonia manufacturer ' s instructions, Mycoplasma pneumoniae patient testing records review on September 29, 2021 at 11: 33 AM, it was determined that the laboratory failed to follow the manufacturer ' s instructions regarding temperature range when patient's specimens were tested for Mycoplasma pneumoniae by Immuno Card Meridian method from January 3, 2021 to September 24, 2021. The findings include: 1. The manufacturer ' s instruction establishes to perform the test procedures at room temperature from 22 C to 25 C. 2. The Mycoplasma testing records showed that the laboratory did not follow the manufacturer's instruction. 3. The quality control records showed that 120 days out of 265 days the laboratory temperature was out of the manufacturer's temperature established range ( 22C-25C ) . 4. A total of 332 out of 677 patient's test were performed outside the established manufacturer's temperatures range. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (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 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 -- materials must be defined and available. (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. (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on routine chemistry ( GlycoHemoglobin, Microalbumin test) and Endocrinology (T4, TSH, T3 UP, FT4, PSA test) quality control record random review and the general laboratory supervisor interview on September 29, 2021 at 9:00 a.m. it was determined that the laboratory did not take and document any

Summary Statement of Deficiencies D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records reviewed ( years 2018 and 2019) and general supervisor interview on August 6, 2019 at 12:00 PM, it was determined that the laboratory failed to report within the time frame specified by the program, the hematology proficiency testing results of the first event of the year 2019. The findings include: 1. On August 6, 2019 at 12:00 PM, the PRPTP records showed that the laboratory obtained a score of 0 percent for the first hematology proficiency testing (PT) event (March, 2019) due to the laboratory did not report the PT results within the time frame specified by the program. 2. The general supervisor confirmed on August 6, 2019 at 12:00 PM, that the the laboratory obtained a score of 0 percent for the first hematology proficiency testing (PT) event (March, 2019) . He stated that he reported the PT results on time but he forgot to submit the results to the PRPTP. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: 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 -- Based on lack of preventive maintenance of the laboratory centrifuge and interview with the general supervisor on August 6, 2019 at 10:20 AM, it was determined that the laboratory failed to retain the centrifuge's preventive maintenance records since January, 2018. The findings included: 1. The laboratory did not have available the laboratory centrifuge's preventive maintenance (cleaning or preventive maintenance as needed) records since January, 2018. 2. The general supervisor confirmed on August 6, 2019 at 10:20 AM, that the laboratory did not have available the centrifuge's preventive maintenance records. 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 personnel file records review and general supervisor interview on August 6, 2019 at 12:30 AM, it was determined that the laboratory failed to follow the written policies to assess the competency of the 2 shift testing personnel since January 2018. The findings include: 1. On August 6, 2019 at 12:30 AM, the 4 out 4 personnel file records of the 2 shift testing personnel showed that the laboratory did not evaluate the competence of these personnel since January 2018. 2. The general supervisor confirmed on August 6, 2019 at 12:30 AM, that the laboratory did not evaluate the the competence of the 2 shift testing personnel. 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 Quality Assessment (QA) records review and general supervisor interview on August 6, 2019 at 12:30 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirements for general laboratory systems: personnel competence. Refer to D 5209 (The laboratory did not evaluate the competence of the 2 shift testing personnel). 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. -- 2 of 6 -- This STANDARD is not met as evidenced by: 1. Based on review of validation records of the Vitros 5600 system and general supervisor interview on August 6, 2019 at 9:15 AM, it was determined that the laboratory failed to verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population before reporting 1,786 patient results for follicle-stimulating hormone (FSH) test and reporting 1,041 patients results for leuteinizing hormone (LH) test from March 18, 2019 to August 5, 2019. The findings include: a. On August 6, 2019 at 9:15 AM, the Vitros 5600 system validation records showed that the laboratory laboratory performed the validation procedures for FSH and LH tests on October 30, 2018. However, the laboratory did not verify that the manufacturer's FSH and LH tests reference intervals (normal values) are appropriate for the laboratory's patient population before reporting patient results from March 18, 2019 to August 5, 2019. b. The general supervisor confirmed on August 6, 2019 at 9:15 AM, that the laboratory did not verify that the manufacturer's FSH and LH tests reference intervals (normal values) before reporting patients results. c. The laboratory processed and reported 1,786 patients specimens for FSH and 1,041 patients specimens for LH from March 18, 2019 to August 5, 2019. 2. Based on review of validation records of the Vitros 5600 system and general supervisor interview on August 6, 2019 at 9:15 AM, it was determined that the laboratory failed to complete the verification of the performance specifications for the new ALT-V tests before reporting 19, 106 patient test results from March 6, 2019 to August 5, 2019. The findings include: a. On August 6, 2019 at 9:15 AM, the Vitros 5600 system validation records showed that the laboratory maintained the raw data of the ALT-V tests validation that it was performed on January 24, 2019. However, the laboratory did not verify statistically the following performance characteristics of this new test: accuracy, precision and reportable range before reporting patient test results from March 6, 2019 to August 5, 2019. b. The general supervisor confirmed on August 6, 2019 at 9:15 AM, that the laboratory did not have available the evaluation of the ALT- V tests validation. c. The laboratory processed and reported 19, 106 patient specimens for ALT-V test from March 6, 2019 to August 5, 2019. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on lack of preventive maintenance of the laboratory centrifuge and interview with the general supervisor on August 6, 2019 at 10:20 AM, it was determined that the laboratory director failed to ensure that the laboratory retained preventive maintenance record for at least 2 years. Refer to D 3031. -- 3 of 6 -- D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) The laboratory director must ensure the results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records reviewed ( years 2018 and 2019) and general supervisor interview on August 6, 2019 at 12:00 PM, it was determined that the laboratory director failed to ensure that the PT results are returned within the timeframes established by the proficiency testing program. Refer to D 2127. 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. This STANDARD is not met as evidenced by: Based on review of validation records of the Vitros 5600 system and general supervisor interview on August 6, 2019 at 9:15 AM, it was determined that the laboratory director failed to ensure compliance with the requirements for the following tests: FSH, LH and ALT-V from March 6, 2019 to August 5, 2019. Refer to D 5421 (1) (The laboratory did not verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population before reporting 1,786 patient results for follicle-stimulating hormone (FSH) test and reporting 1,041 patients results for leuteinizing hormone (LH) test from March 18, 2019 to August 5, 2019). Refer to D 5421 (2) (The laboratory did not complete the verification of the performance specifications for the new ALT-V tests before reporting 19, 106 patient test results from March 6, 2019 to August 5, 2019). 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 and general supervisor interview on August 6, 2019 at 12:30 AM, it was determined that the laboratory director failed to ensure compliance with quality assessment (QA) requirements. Refer to D 5291 (The laboratory did not follow the established Quality Assessment Program to monitor and evaluate the requirements for general laboratory systems: personnel competence). D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) -- 4 of 6 -- The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on personnel records files review and general supervisor interview on August 6, 2019 at 12:30 PM, it was determined that the laboratory director failed to ensure that 3 out of 4 testing personnel of the 2 shift have the appropriate training prior to testing patients' specimens since January 2018. The findings include: 1. On August 6, 2019 at 12:30 PM, the personnel file showed that 3 out of 4 testing personnel of the 2 shift did not have have the appropriate training prior to testing patients' specimens since January 2018. 2. The general supervisor confirmed on August 6, 2019 at 12:30 PM, that those personnel file did not include the in service training documented. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel records files and interview with the general supervisor on August 6, 2019 at 12:30 PM, it was determined that the laboratory director did not specify in writing the duties of the clinical consultant since November 2, 2018. The finding includes: 1. The new clinical consultant was hired on November 2, 2018. However, her personnel files did not include written duties and responsibilities. 2. The general supervisor confirmed on August 6, 2019 at 12:30 PM, that the clinical consultant personnel file did not include the written duties and responsibilities. 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 review of validation records of the Vitros 5600 system and general supervisor interview on August 6, 2019 at 9:15 AM, it was determined that the general supervisor failed to perform day-to-day supervision for the personnel that performing testing and reporting the following tests results: FSH, LH and ALT-V from March 6, 2019 to August 5, 2019. Refer to D 5421 (1) (The laboratory did not verify that the manufacturer's reference intervals (normal values) are appropriate for -- 5 of 6 -- the laboratory's patient population before reporting 1,786 patient results for follicle- stimulating hormone (FSH) test and reporting 1,041 patients results for leuteinizing hormone (LH) test from March 18, 2019 to August 5, 2019). Refer to D 5421 (2) (The laboratory did not complete the verification of the performance specifications for the new ALT-V tests before reporting 19, 106 patient test results from March 6, 2019 to August 5, 2019). -- 6 of 6 --