Laboratorio Clinico Villa Ana Aguas Buenas Iii

Summary Statement of Deficiencies 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 lack of Quality Assessment (QA) activities records (years 2022-2023) and laboratory director interview on April 24, 2024 at 1:17 PM, it was determined that the laboratory failed to evaluate and monitor the patient confidentiality, specimen identification and integrity, complaint investigation, communication, and personnel competency in the general laboratory system since January 2022. The findings include: 1. On April 24, 2024 at 1:00 PM, the general laboratory system QA 2022- 2023 records were requested. The general laboratory system QA was not available for evaluation. 2. The laboratory director confirmed on April 24, 2024 at 1:03 PM, that the QA general laboratory system activities records were not evaluated or monitored since January 2022. 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 lack of Quality Assessment (QA) activities records (years 2022-2023) and 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 director interview on April 24, 2024 at 1:05 PM, it was determined that the laboratory failed to evaluate Quality Assessment Program and monitor the requirements for pre-analytic systems since year 2022. The findings include: 1. On April 24, 2024 at 1:00 PM, the laboratory pre-analytic systems QA records 2022-2023 were requested. The pre-analytic system QA since year 2022 was not available for evaluation at the time of inspection. 2. Since January 2022 the laboratory did not evaluate practices related to: test request, specimen submission and handling, and specimen referral. 3. The laboratory director confirmed on April 24, 2024 at 1:05 PM, that the laboratory pre-analytic systems QA records 2022-2023 were not evaluated or monitored since January 2022. 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 laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records (years 2022-2023) and laboratory director interview on April 24, 2024 at 1:08 PM, it was determined that the laboratory failed to evaluate Quality Assessment Program and monitor the requirements for analytic systems since year 2022. The findings include: 1. On April 24, 2024 at 1:00 PM, the laboratory analytic systems QA records 2022-2023 were requested. The analytic system QA since year 2022 was not available for evaluation at the time of inspection. 2. Since January 2022 the laboratory did not evaluate practices related to: test procedures, accurate and reliable test system, equipment instruments, reagents, materials, specimen and reagent storage conditions, system naintenance and fucntion checks, verification of method performance specifications, calibration, control procedures, test records,

Summary Statement of Deficiencies D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Mycoplasma pneumoniae quality control records patient records review from February 9, 2021 to May 9, 2022 and laboratory testing personnel interview on May 10, 2022 at 11:14 AM, it was determined that the laboratory failed to meet the requirements in the subspecialty of General Immunology. The finding includes: 1. Refer to D5405 - The laboratory did not monitor and record the room temperature when patient's specimens were tested for Mycoplasma by Immuno Card Meridian method from February 9, 2021 to May 9, 2022 (review on May 10, 2022 at 9:28 AM). 2. Refer to D5449- The laboratory did not include positive and negative control material when performed Mycoplasma pneumoniae each day of patient testing from February 9, 2021 to May 9, 2022 (review on May 10, 2022 at 9:28 AM). 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 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 -- records review from February 9, 2021 to May 9, 2022 and laboratory testing personnel interview, it was determined that the laboratory failed to follow the manufacturer's instruction when 513 out of 513 patient's specimens were tested for Mycoplasma by Immuno Card Meridian method from February 9, 2021 to May 9, 2022. The findings include: 1. The manufacturer's instruction establishes to perform the test procedures at room temperature from 22C to 25C. 2. On May 10, 2022 at 9:28 AM, the Mycoplasma testing records showed that the laboratory did not monitor nor record the room temperature when patient's specimens were tested for Mycoplasma by Immuno Card Meridian method from February 9, 2021 to May 9, 2022. 3. The laboratory testing personnel confirmed on May 10, 2022 at 11:14 AM, that the laboratory did not follow the manufacture's instructions for the temperature of processing. 4. The laboratory processed and reported 513 out of 513 patients specimens for mycoplasma test by Immuno Card Meridian method from February 9, 2021 to May 9, 2022. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on General Immunology (Mycoplasma pneumoniae test) quality control records review from February 9, 2021 to May 9, 2022 and laboratory testing personnel interview, it was determined that the laboratory did not include an external positive and negative control material each day of Mycoplasma pneumoniae patient testing from February 9, 2021 to May 2022. The findings include: 1. General Immunology (Mycoplasma pneumoniae test) quality control records were review on May 10, 2022 at 9:28 AM, from February 9, 2021 to May 9, 2022. 2. Review of Mycoplasma pneumoniae quality control and patient results record showed that the laboratory did not include any control material each day of patient testing since February 9, 2021. 3. The laboratory testing personnel confirmed on May 10, 2022 at 11:14 AM, that the laboratory failed to include a negative and positive control material each day of testing when performed Mycoplasma pneumonia test. The testing personnel confirm on May 10, 2022, that the laboratory only run negative and positive control material when change the lots of Mycoplama pneumoniae kits. 4. The laboratory did not include control material each day of run, when 513 out of 513 patient specimen were processed and since February 9, 2021. 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 general immunology quality control records review from February 9, 2021 -- 2 of 4 -- to May 9, 2022 and laboratory testing personnel interview on May 10, 2022 at 11:14 AM, it was determined that the laboratory director failed to ensure monitor and record the correct room temperature (22C - 25C) when performed Mycoplasma pneumoniae patient's specimens were tested for Mycoplasma pneumoniae by Immuno Card Meridian from February 9, 2021 to May 9, 2022 (513 out of 513 patients specimens for mycoplasma test by Immuno Card Meridian method) and ensure that negative and positive control material, were included by the testing personnel each day of Mycoplasma pneumoniae patient testing from February 9, 2021 to May 9, 2022. The findings include: 1. Refer to D5405 - The laboratory did not monitor and record the room temperature when patient's specimens were tested for Mycoplasma by Immuno Card Meridian method from February 9, 2021 to May 9, 2022 (review on May 10, 2022 at 9:28 AM). 2. Refer to D5449- The laboratory did not include positive and negative control material when performed Mycoplasma pneumoniae each day of patient testing from February 9, 2021 to May 9, 2022 (review on May 10, 2022 at 9: 28 AM). 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: 1. Based on general immunology (Mycoplasma pneumoniae) quality control testing records review from February 9, 2021 to May 9, 2022 and laboratory testing personnel interview on May 10, 2022 at 11:14 AM, it was determined that the laboratory director failed to ensure that the laboratory follow the manufacturer's instruction for monitor and documented the room temperature when the patient's specimens were tested for Mycoplasma by Immuno Card Meridian method. The finding includes: a. The laboratory failed to monitor and documented the the room temperature when patient's specimen were tested for Mycoplasma by Immuno Card Meridian method from February 9, 2021 to May 9, 2022. Refer to D5405. 2. Based on general immunology (Mycoplasma pneumonia) quality control records review from February 9, 2021 to May 9, 2022 and laboratory testing personnel on May 10, 2022 at 11:14 AM, it was determined that the laboratory director failed to ensure that negative and positive control material, were included by the testing personnel each day of Mycoplasma pneumoniae patient testing. The finding includes: a. The laboratory did not include a positive and a negative control material when performed Mycoplasma pneumoniae each day of patient testing from February 9, 2021 to May 9, 2022. Refer to D5449. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on Immuno Card Mycoplasma manufacturer's instructions, Mycoplasma testing records review from February 9, 2021 to May 9, 2022 and laboratory testing personnel interview on May 9, 2022 at 11:14 AM, it was determined that the testing personnel failed to follow the manufacturer's instruction when patient's were tested for Mycoplasma by Immuno Card Meridian Method. The finding includes: 1. The laboratory testing personnel did not follow the manufacturer's instruction for monitor and documented the room temperature from February 9, 2022 to May 9, 2022, when the patient's specimens were tested for Mycoplasma by Immuno Card Meridian method. Refer to D5405. -- 4 of 4 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records review from February 2019 to November 2020 and laboratory testing personnel interview on November 5, 2020 at 9:38 AM, it was determined that the laboratory failed to maintain the proficiency testing event records. The findings include: 1. Review of proficiency testing records from February 2019 to November 2020, showed that the laboratory did not maintain the following proficiency testing event records: October 2019 and November 2019. 2. The laboratory testing personnel confirmed on November 5, 2020, that the laboratory did not maintain these proficiency testing event records. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training 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 -- and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records review from February 2019 to November 2020 and laboratory testing personnel interview on November 5, 2020 at 9:40 AM, it was determined that the laboratory failed to take and document