Laboratorio Clinico Licer

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Licer on January 16, 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 January 16, 2026. D2067 SYPHILIS SEROLOGY CFR(s): 493.835(b) (b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing Service Program (PRPTSP) (years 2024-2025), Certification and Survey Provider Enhanced Report (CASPER), Report 0155 D scores, PRPTSP 2024 schedule and laboratory director interview on January 16, 2026 at 10:00 A.M.; the laboratory failed to report the syphilis serology proficiency testing results within the time frame established by the program. The laboratory processed and report 68 patients samples. The findings include: 1. The PRPTSP and Casper Report were review and showed that the laboratory obtained 0% in the third testing event for syphilis serology in the 2024 year. (Review on January 12, 2026 at 3:10 P.M.). 2. The PRPTSP 2024 schedule, showed that the deadline for the third testing event for syphilis serology score was December 20, 2024. (Review on 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 -- January 12, 2026 at 3:10 P.M.). 3. The laboratory director confirmed on January 16, 2026 at 10:00 A.M., that the laboratory failed to report the syphilis serology proficiency testing results of the third testing event within the time frame established by the PRPTSP. The laboratory processed and report 68 patients samples. D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(c) (c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing Service Program (PRPTSP) (years 2024-2025), Certification and Survey Provider Enhanced Report (CASPER), Report 0155 D scores, PRPTSP 2024 schedule and laboratory director interview on January 16, 2026 at 10:00 A.M.; it was determined that the laboratory failed to report the general immunology proficiency testing results within the time frame established by the program. The laboratory processed and report 16 patients samples. The findings include: 1. The PRPTSP and Casper Report were review and showed that the laboratory obtained 0% in the third testing event for general immunology in the 2024 year. (Review on January 12, 2026 at 3:10 P.M.). 2. The PRPTSP 2024 schedule, showed that the deadline for the third testing event for general immunology score was December 20, 2024. (Review on January 12, 2026 at 3:10 P.M.). 3. The laboratory director confirmed on January 16, 2026 at 10:00 A.M., that the laboratory failed to report the general immunology proficiency testing results of the third testing event within the time frame established by the PRPTSP. The laboratory processed and report 16 patients samples. D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) (e)(4)(ii) The results are returned within the timeframes established by the proficiency testing program; This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing Service Program (PRPTSP) (years 2024-2025), Certification and Survey Provider Enhanced Report (CASPER), Report 0155 D scores, PRPTSP 2024 schedule and laboratory director (sole personnel) interview on January 16, 2026, at 10:00 A.M., it was determined that the laboratory director failed to send the proficiency results for syphilis serology and general immunology within the time frame established by the PRPTSP. Refer to D2067, D2077. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An offsite Proficiency Test (PT) Desk Review was performed on October 16, 2025 to Laboratorio Clinico Licer, 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 the Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025), the laboratory failed to achieve satisfactory performance ( 80% or better ) for two (2) out of three (3) consecutive testing events for the specialty of 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 -- hematology in the analyte Hema Cell Id tests in the subspecialty of hematology. Refer D2130. 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 review of CASPER 0155D and PRPTSP scores (years 2024-2025), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) of three (3) consecutive testing events in a proficiency testing program approved by HHS, for hematology specialty for analyte Hema Cell Id tests. The findings include: 1. Review of the Casper Report 0155D and PRPTSP scores on September 30, 2025, confirmed that the laboratory had a PT failure for the analyte Hema Cell Id tests. The laboratory obtained the following testing scores: Analyte: Hema Cell Id a. Third testing event year 2024 - 0% b. Second testing event year 2025 - 0% 2. A review of the PRPTSP records confirmed the above findings. 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 the CASPER Report 0155D and PRPTSP scores (years 2024- 2025), the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. 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 review of the CASPER Report 0155D and PRPTSP scores (years 2024- 2025), the laboratory director failed to ensure successful participation in an HHS- approved proficiency testing program.. Refer to D2130. -- 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 ImmunoCard Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records and laboratory director interview on October 5, 2023, at 1:18 PM; it was determined that the laboratory failed to follow the manufacturer's instruction when 16 out of 162 patient's specimens were tested for Immunocard Mycoplasma pneumoniae by Meridian Bioscience reagent kit from December 7, 2021, to July 12, 2023. The findings include: 1. The manufacturer's instructions establish to perform the test procedures between 22 to 25C. 2. On October 5,2023 at 1:18PM, the Mycoplasma pneumoniae testing records showed that the laboratory did not follow the manufacturer instructions when it processed the following patient's specimens: Testing Date Sample Id Temperature Processed 11/02 /2022 370272 21C 11/07/2022 370326 21C 11/28/2022 370482 21C 11/28/2022 370483 21C 11/28/2022 370486 21C 11/28/2022 370485 21C 11/29/2022 370495 21C 11/29/2022 370498 21C 12/05/2022 370550 21C 12/05/2022 370556 21C 01/04 /2023 370701 20C 01/04/2023 370705 20C 01/04/2023 370706 20C 01/05/2023 370713 20C 01/09/2023 370725 21C 01/11/2023 370764 20C 3. The laboratory director confirmed during interview on October 5,2023 at 1:35PM, that the laboratory did not follow the manufacturer's instructions related to temperature processing. 4. The laboratory processed and reported 16 out of 162 patient's specimens for Mycoplasma pneumoniae test out of the manufacturer's established temperature range from December 7,2021 to July 12,2023. 5. This deficiency was cited on September 17,2021. 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 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on laboratory room temperature and relative humidity daily log records review (years 2022-2023) and laboratory director interview on October 5, 2023, at 12:00 PM; it was determined that the laboratory failed to monitor the room temperature and relative humidity as established. The finding include: 1. The laboratory room temperature and relative humidity records were reviewed for the year 2022 and 2023. (Reviewed on October 5,2023 at 12:00 PM) 2. The room temperature and relative humidity log records,established that the room temperature and humidity must be documented every day. (Reviewed on October 5,2023 at 12:05 PM) must check and document it every day. (Reviewed on October 5,2023 at 12:05 PM) 3. The records showed that the room temperature and relative humidity were not monitored nor documented since August 4, 2023. (Reviewed on October 5,2023 at 12:07 PM) 4. The laboratory director confirmed on October 5,2023, at 12:10 PM, that the laboratory did not document the room temperature and relative humidity. 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 microscopy urinalysis quality control records (years 2022-2023), microscopy urinalysis written procedure review, and laboratory director interview on October 5,2023, at 12:15 PM; it was determined that the laboratory failed to include two levels of control material, when the laboratory processed five (5) patient specimen for urinalysis sediment on October 3,2023. The findings include: 1. The laboratory used Clinitek 500 instrument to perform urinalysis patient samples. (Reviewed October 5,2023 at 12:15 PM) 2. Review of the microscopy urinalysis quality control records from August 1,2023 to October 5, 2023, showed that the laboratory did not include a positive and negative control material, at least each day of patient testing. (Reviewed October 5,2023 at 12:20 PM) 3. The laboratory director confirmed on October 5,2023 at 12:25 PM, that the laboratory did not include any control material for microscopy urinalysis. 4. The laboratory processed and reported -- 2 of 3 -- five patient's tests for microscopic sediment urine on October 2, 2023. (Reviewed October 5, 2023, at 12:28 PM) 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 Mycoplasma pneumoniae testing, laboratory room temperature and relative humidity, urinalysis quality control records and laboratory director interview on October 5,2023, at 2:30 PM it was determined that the director failed to met with the quality control procedures for Mycoplasma pneumoniae test, urinalysis microscopy test and monitor the laboratory room temperature and relative humidity. Refer to D5405, D5413 and D5445. -- 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 laboratory competence evaluation protocol, personnel records review, lack of technical consultant competency evaluations and laboratory technical consultant consultant interview on September 17, 2021 at 9:00 AM, it was found that the laboratory did not perform the technical consultant competence since January 2020. The findings include: 1. The laboratory competence evaluation protocol showed that personnel competence must be done every year. 2. The personnel records showed that the laboratory director did not evaluate annually the competence of the technical consultant since January 2020. 3. The technical consultant confirmed on September 17, 2021 at 9:00 AM, that her competence evaluations were not performed. 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 QA procedures manual review and technical consultant interview on September 17, 2021 at 9:00 AM, it was determined that laboratory failed to monitor 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 -- and evaluate the following QA activities: Personnel competency. Refer to D 5209 (The competence of the technical consultant was not evaluated since January 2020). 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 manufacturer's instructions, Mycoplasma testing records and technical consultant interview on September 17, 2021 at 9:45 AM, it was determined that the laboratory failed to follow the manufacturer's instruction when six out of six patient specimen were tested for Mycoplasma by Immuno Card Meridian method from May 29, 2020 to September 16, 2021. The findings include: 1. The manufacturer's instruction establishes to perform the test procedures at room temperature from 22 to 25 C. 2. On September 17, 2021, the Mycoplasma testing records showed that the laboratory did not follow the manufacturer instruction when it processed the following patients specimens: Testing Sample ID Temperature Date processed 1. 05/29/2020 359899 20 C. 2. 09/09/2020 360795 21 C. 3. 09/24/2020 360960 20 C. 4. 10/16/2020 361208 21 C. 5. 12/14/2020 361750 21 C. 6. 09/16/2021 365122 not recorded. 3. The technical consultant confirmed on September 17, 2021 at 9:45 AM, that the laboratory did not follow the manufacture's instructions for the temperature of processing. 4. The laboratory processed and reported six out of six patient specimen for mycoplasma test out of the manufacturer's temperature range from May 29, 2020 to September 16, 2021. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) 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 Immuno Card Mycoplasma manufacturer's instructions, Mycoplasma testing records and technical consultant interview on September 17, 2021 at 9:45 AM, it was determined that the technical consultant did not ensure that the temperature required by the manufacturer, for the mycoplasma testing process, was maintained during each day of testing. Refer to D 5405 ( Temperature out of range on six out of six days). 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, -- 2 of 3 -- 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 Immuno Card Mycoplasma manufacturer's instructions, Mycoplasma testing records and technical consultant interview on September 17, 2021 at 9:45 AM, it was determined that the laboratory director did not fulfill her responsibilities to ensure that the technical consultant are competent to perform the mycoplasma test procedures from May 29, 2020 to September 16, 2021. Refer to D 6042 (The technical consultant did not ensure that the temperature required by the manufacturer, for the mycoplasma testing process, was maintained during each day of testing). 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 QA procedures manual review and technical consultant interview on September 17, 2021 at 9:00 AM, it was determined that laboratory director failed to ensure compliance with QA requirements. 1. Refer to D 5291 (The laboratory director did not follow the schedule evaluations in the QA program for the Personnel competency). -- 3 of 3 --