Ponce Clinical Laboratory Inc

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on August 19, 2025 to Laboratorio ClinicoPonce Clinical Lab, Inc., the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1441 Laboratory Director, High complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024-2025) and CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for Red Blood Cell (RBC) tests. Refer D2130. 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024) and CASPER Report 0155D score, it was determined that the laboratory obtained an initial unsuccessful performance in two out of three consecutive testing events for Red Blood Cell (RBC). The finding includes: 1. The Puerto Rico Proficiency and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Red Blood Cell (RBC) a. Second testing event year 2024 - 40% b. First testing event year 2025 - 60% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025) and CASPER Report 0155D scores, its was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for Red Blood Cell (RBC) tests. Refer to D6089. 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; This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024-2025) and CASPER Report 0155D score, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for Red Blood Cell (RBC) tests during the second testing event of the year 2024 and first testing event of the year 2025. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Proficiency Test (PT) Desk Review off site survey was performed on June 2, 2025 to Laboratorio Clinico Ponce Clinical Lab, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1403 Laboratory Director, Moderate Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of proficiency testing records (years 2024-2025) and Casper Report 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 -- 0155D scores, it was determined that the laboratory failed an unsuccessful participation in a Proficiency Testing Program for routine chemistry subspecialties. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory obtained an initial unsuccessful performance in two out of three consecutive testing events for the routine chemistry tests. The finding includes: 1.The Puerto Rico Proficiency Testing and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Urea Nitrogen Blood (BUN) a.Second testing event year 2024 - 0% b.First testing event year 2025 - 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for routine chemistry tests. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory has a satisfactory participation for routine chemistry test during the second testing event 2024 and first testing event 2025. Refer to D2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Ponce Clinical Lab, Inc. on March 26, 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 March 26, 2025. D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) (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 review of Puerto Rico Proficiency Testing scores (year 2024), CASPER Report 0155D scores and laboratory director interview on March 26, 2025 at 10:30 AM, it was determined that the laboratory failed to participate in the routine chemistry second testing event performed on May 2024. The findings include: 1. The proficiency testing records were reviewed from January 2023 to December 2024. Reviewed on March 26, 2025 at 10:30 AM. 2. The laboratory did not participate in the second testing event for routine chemistry (routine chemistry, urinalysis, urine sediment) performed in May 2024, a testing score of 0 % as obtained. Review on March 26, 2025 at 11:00 AM. 3. The deadlineof the second testing event report of routine chemistry was May 23, 2024. 4 The laboratory director confirmed on March 26, 2025 at 11:10 AM, that the laboratory failed to participate in the second testing event of routine chemistry specialty in May 2024. D2104 ENDOCRINOLOGY CFR(s): 493.843(d) 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 -- (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 review of Puerto Rico Proficiency Testing scores (year 2024), CASPER Report 0155D scores and laboratory director interview on March 26, 2025 at 10:30 AM, it was determined that the laboratory failed to participate in the endocrinology second testing event performed on May 2024. The findings include: 1. The proficiency testing records were reviewed from January 2023 to December 2024. Reviewed on March 26, 2025 at 10:30 AM. 2. The laboratory did not participate in the second testing event for endocrinology (human chorionic gonadrotopin (hCG), thyroid stimulating hormone (TSH), thyroxine (T4), triiodothyronine (T3) and Free T4 (thyroxine) performed in May 2024, a testing score of 0 % as obtained. Review on March 26, 2025 at 11:00 AM. 3. The deadlineof the second testing event report of endocrinology was May 23, 2024. 4 The laboratory director confirmed on March 26, 2025 at 11:10 AM, that the laboratory failed to participate in the second testing event of endocrinology subspecialty in May 2024. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing scores (year 2024), CASPER Report 0155D scores and laboratory director interview on March 26, 2025 at 10:30 AM, it was determined that the laboratory director failed to ensure that the technical consultant would participate during the second testing event of year 2024 of proficiency testing samples.. Refer to D2093 and D2104. -- 2 of 2 --

Summary Statement of Deficiencies D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Microscan manufacturer's instructions, incubator temperature chart records (year 2018) records review and laboratory technical supervisor interview on February 22, 2019 at 10:30 AM , it was determined that the laboratory failed to ensure compliance with the analytic system requirements of bacteriology. The finding includes: 1. The laboratory did not follow the Microscan manufacturer's instruction when 289 out of 289 patients culture specimens were processed and reported for the microorganisms identification and susceptibility panels by the Microscan system from January 2, 2018 to December 29, 2018. Refer to D 5405. 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 Microscan manufacturer's instructions, incubator temperature chart records (year 2018) records review and laboratory technical supervisor interview on February 22, 2019 at 10:30 AM , it was determined that the laboratory failed to follow 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 5 -- Microscan manufacturer's instruction when 289 out of 289 patients culture specimens were processed and reported for the microorganisms identification and susceptibility panels by the Microscan system from January 2, 2018 to December 29, 2018. The findings include: 1. The Microscan's manufacturer instructed the laboratory to incubate the microorganisms identification and susceptibility panels at temperature of 35 C +/- 1 C. 2. On February 22, 2019 at 10:30 AM, the incubator temperature chart records (year 2018) showed that the laboratory incubated the Microscan's microorganisms identification and susceptibility panels at temperatures out of the manufacturer's range in 308 out of 365 days from January 2, 2018 to December 29, 2018. 3. The laboratory technical supervisor confirmed on February 22, 2019 at 10:30 AM, that the laboratory incubated the Microscan's microorganisms identification and susceptibility panels at temperature range of 37 C +/- 1 C from from January 2, 2018 to December 29, 2018. 4. The laboratory processed and reported 289 out of 289 patients culture specimens for microorganisms identification and susceptibility tests by the Microscan system from January 2, 2018 to December 29, 2018. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on Sysmex CA-500 manufacturer's instructions for maintenance and supplies replacement, Sysmex CA-500 preventive maintenance records (years 2017 and 2018) review and interview with the testing personnel on February 22, 2019 at 11:25 AM, it was determined that the laboratory failed to follow written instructions for the monthly and yearly preventive maintenance of the Sysmex CA-500 system when 643 of of 643 Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) patients specimens were processed and reported from January 2, 2018 to December 29, 2018. The findings include: 1. The laboratory processed the PT and PTT by the Sysmex CA- 500 system. 2. The Sysmex CA-500 manufacturer instructed the laboratory to perform the monthly preventive maintenance (verification of the LED calibration) and the yearly preventive maintenance (replenish rinse filter). 3. On February 22, 2019 at 11: 25 AM, the Sysmex CA-500 preventive maintenance records showed that the laboratory did not perform the required preventive maintenance (monthly and yearly) from January 2, 2018 to December 29, 2018. 4. The testing personnel stated on February 22, 2019 at 11:25 AM, that the LED calibration was verified but not recorded in the preventive maintenance record. Also she confirmed that the laboratory did not perform the yearly preventive maintenance since January 2, 2018. 5. The laboratory processed and reported PT and PTT patients specimens tests by the Sysmex CA-500 system from January 2, 2018 to December 29, 2018. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 -- 2 of 5 -- (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on syphilis serology testing records(years 2017, 2018 and 2019) review and testing personnel interview on February 22, 2019 at 10:45 AM, it was determined that the laboratory failed to include at least once a day, a negative control material besides a control material with tittered reactivity when 4 out 4 patients specimens were tested for syphilis serology by rapid plasma reagin (RPR) quantitative tests by ASI method from June 6, 2018 to December 14, 2018. The findings include: 1. The laboratory processed and reported the RPR quantitative tests by ASI method. 2. On February 22, 2019 at 10:45 AM, the syphilis serology testing records showed that the laboratory did not include at least once a day, the negative control material besides the control material with tittered reactivity when 4 out 4 patients specimens were tested for RPR quantitative tests by ASI method from June 6, 2018 to December 14, 2018: on June 6, 2018, July 3, 2018, September 13, 2018 ad December 14, 2018. 3. The testing personnel confirmed on February 22, 2019 at 10:45 AM, that the laboratory did not include the negative control material when it performed the quantitative RPR test. She stated that the laboratory includes this control material when it processing the qualitative RPR test. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on Individualized Quality Control Plan (IQCP) record for the Microscan microorganisms identification and susceptibility tests system, Microscan manufacturer's instructions, incubator temperature chart records (year 2018) records, Sysmex CA-500 manufacturer's instructions for maintenance and supplies replacement, syphilis serology testing records(years 2017, 2018 and 2019) review, interview with the testing personnel and the laboratory technical supervisor on February 22, 2019 at 11:25 AM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory analytical system. The findings include: 1. Refer to D 6079 ( The laboratory director failed to ensure to evaluate effectively the Risk Assessment of the IQCP of the Microscan tests system). 2. Refer to D 6093 (The laboratory director failed to ensure compliance with the requirements for analytic systems). 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 -- 3 of 5 -- 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 Individualized Quality Control Plan (IQCP) record for the Microscan microorganisms identification and susceptibility tests system, Microscan system manufacturer's instructions, incubator temperature chart records (year 2016) and technical supervisor interview on February 22, 2019 at 10:30 AM, it was determined that the laboratory director failed to ensure to evaluate effectively the Risk Assessment of the IQCP of the Microscan tests system from January 1, 2016 to December 30, 2016. The findings include: 1. On February 22, 2019 at 10:30 AM, the IQCP for the Microscan tests system records showed that it was implemented on May 22, 2017. The laboratory evaluated the Risk Assessment components with the quality control data of the year 2016. The Risk Assessment evaluation showed a potential failure for the environmental component due to the laboratory did not follow the Microscan manufacturer's instructions for the incubation's temperature from January 1, 2016 to December 30, 2016. 2. The Microscan manufacturer instructed the laboratory to incubate the Mycroscant identification and susceptibility system at 35 C +/- 1 C. The incubator temperature records(year 2016) showed 280 out of 365 days with temperature out of the manufacturer's temperature range. 3. The laboratory technical supervisor confirmed on February 22, 2019 at 10:30 AM, that the laboratory incubated the Microscan's microorganisms identification and susceptibility panels at temperature range of 37 C +/- 1 C from from January 1, 2016 to December 30, 2016. 4. The laboratory did not follow the Microscan Manufacturer's instruction when it processed 289 patients specimens for microorganisms identification and susceptibility tests by the Microscan system from January 2, 2018 to December 29, 2018. Refer to D 5405. 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 Microscan manufacturer's instructions, incubator temperature chart records (year 2018) records, Sysmex CA-500 manufacturer's instructions for maintenance and supplies replacement, syphilis serology testing records(years 2017, 2018 and 2019) review, interview with the testing personnel and the laboratory technical supervisor on February 22, 2019 at 11:25 AM , it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. Refer to: D 5002 (The laboratory failed to ensure compliance with the analytic system requirements of bacteriology). D 5429 ( The laboratory failed to follow written instructions for the monthly and yearly preventive maintenance of the Sysmex CA-500 system). D 5451 (The laboratory failed to include at least once a day, a negative control material besides a control material with tittered reactivity for syphilis serology by rapid plasma reagin (RPR) quantitative tests by ASI method). D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES -- 4 of 5 -- 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 Microscan manufacturer's instructions, incubator temperature chart records (year 2018) records, Sysmex CA-500 manufacturer's instructions for maintenance and supplies replacement, syphilis serology testing records(years 2017, 2018 and 2019) review, interview with the testing personnel and the laboratory technical supervisor on February 22, 2019 at 11:25 AM , it was determined that technical supervisor failed to ensure compliance with the requirements for analytic system. Refer to: D 5405 (The laboratory failed to follow the Microscan manufacturer's instruction when patients culture specimens were processed and reported for the microorganisms identification and susceptibility panels by the Microscan system). D 5429 ( The laboratory failed to follow written instructions for the monthly and yearly preventive maintenance of the Sysmex CA-500 system). D 5451 (The laboratory failed to include at least once a day, a negative control material besides a control material with tittered reactivity for syphilis serology by rapid plasma reagin (RPR) quantitative tests by ASI method). D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high 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 Microscan manufacturer's instructions, incubator temperature chart records (year 2018) records, Sysmex CA-500 manufacturer's instructions for maintenance and supplies replacement, syphilis serology testing records(years 2017, 2018 and 2019) review, interview with the testing personnel and the laboratory technical supervisor on February 22, 2019 at 11:25 AM , it was determined that the testing personnel failed to follow quality control procedures. Refer to: D 5405 (The laboratory failed to follow the Microscan manufacturer's instruction when patients culture specimens were processed and reported for the microorganisms identification and susceptibility panels by the Microscan system). D 5429 ( The laboratory failed to follow written instructions for the monthly and yearly preventive maintenance of the Sysmex CA- 500 system). D 5451 (The laboratory failed to include at least once a day, a negative control material besides a control material with tittered reactivity for syphilis serology by rapid plasma reagin (RPR) quantitative tests by ASI method). -- 5 of 5 --