Laboratorio Clinico Universal

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: 1. Based on Human chorionic gonadotropin (hCG) patient worksheet records review and laboratory director interview on September 15, 2023 at 11:10 AM, it was determined that the laboratory did not document the required information related to the reagent kits used by the laboratory, nor the identity of the personnel who performed the tests. The findings include: a. On September 15, 2023 at 11:10 AM, the laboratory director stated that the laboratory performs hCG tests with the AimStep kit. b. The hCG test worksheet records showed on September 15, 2023 at 11:10 AM, that the following information must be documented on the daily worksheets: kit, lot, expiration date, and the identity of the personnel who performed the tests. c. On September 15, 2023 at 11:15 AM, review of the hCG worksheets from January 2022 to September 2023 showed that none of the required information was documented. From January 1, 2022 to September 15, 2023, the laboratory processed and reported a total of 100 hCG patient tests. d. During Interview with the laboratory director on September 15, 2023 at 11:20 AM, she confirmed that the required information was not included. 2. Based on review of Mycoplasma Pneumoniae IgM worksheet records and interview with the laboratory director on September 15, 2023 at 12:00 PM, it was determined that the laboratory did not document the required information related to the reagent kits used by the laboratory, nor the identity of the personnel who performed the tests. The findings include: a. On September 15, 2023 at 12:00 PM, 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 2 -- laboratory director stated that the laboratory performs Mycoplasma Pneumoniae IgM tests with the Immunocard kit. b. The Mycoplasma Pneumoniae IgM test worksheet records showed on September 15, 2023 at 12:00 PM, that the following information must be documented on the daily worksheets: kit, lot, expiration date, and the identity of the personnel who performed the tests. c. On September 15, 2023 at 12:00 PM, review of the Mycoplasma Pneumoniae IgM worksheets from January 2022 to September 2023 showed that none of the required information was documented. From January 1, 2022 to September 15, 2023, the laboratory processed and reported a total of 591 patient tests. d. During Interview with the laboratory director on September 15, 2023 at 12:15 PM, she confirmed that the required information was not included. 3. Based on review of RPR (Rapid plasma reagin) worksheet records and interview with the laboratory director on September 15, 2023 at 1:45 PM, it was determined that the laboratory did not document the required information related to the reagent kits used by the laboratory, nor the identity of the personnel who performed the tests. The findings include: a. On September 15, 2023 at 1:45 PM, the laboratory director stated that the laboratory performs RPR tests with the AIM RPR Test kit. b. The RPR test worksheet records showed on September 15, 2023 at 1:45 PM, that the following information must be documented on the daily worksheets: kit, lot, expiration date, and the identity of the personnel who performed the tests. c. On September 15, 2023 at 1: 45 PM, review of the RPR worksheets from January 2022 to September 2023 showed that none of the required information was documented. From January 1, 2022 to September 15, 2023, the laboratory processed and reported a total of 2,711 patient tests. d. During Interview with the laboratory director on September 15, 2023 at 2:00 PM, she confirmed that the required information was not included. 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. This STANDARD is not met as evidenced by: Based on the worksheet records review of hCG, Mycoplasma Pneumoniae IgM and RPR tests from January 1, 2022 to September 15, 2023, and laboratory personnel interview on September 15, 2023 at 3:45 PM, it was determined that the testing personnel did not document the required information on the daily patient worksheets. Refer to D5787. -- 2 of 2 --

Summary Statement of Deficiencies D2072 SYPHILIS SEROLOGY CFR(s): 493.835(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable 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 2020 to June 2021 and laboratory director interview on September 14, 2021 at 9:35 AM, it was determined that the laboratory failed to take and document

Summary Statement of Deficiencies 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: Based on urinalysis quality control records reviewed form years 2018 and 2019, and laboratory supervisor interview on October 11, 2019 at 10:30 AM., it was found that the laboratory did not retain the Clinitek 500 quality control printout records since January 2, 2019. . The findings include: a. The laboratory performed the semiquantitative urinalysis procedure by the Clinitek 500 instrument. b. Although the laboratory had a Laboratory Information System (LIS) the urinalysis quality control results were not captured. c. On October 11, 2019 at 10:30 AM the general supervisor stated that the laboratory read the quality control results from the instrument screen and then the results were documented on the quality control (QC) sheet. The laboratory did not print the QC results since January 2, 2019. 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 and interview with the laboratory supervisor on October 11, 2019 at 10:40 AM, it was 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 -- determined that the laboratory failed to meet the requirements in the subspecialty of General Immunology. The finding includes: a. The laboratory did not include an external positive and a negative control material each day of patient testing. Refer to : 5449- The laboratory did not include positive and negative control material 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 review of Mycoplasma pneumoniae IgM quality control results, patient test results records and interview with the laboratory supervisor on October 11, 2019 at 10: 40 AM, it was found that the laboratory did not include a positive and a negative control material each day of patient testing. The findings include: a. The laboratory began to perform patient's test for Mycoplasma pneumoniae on November 30, 2018. b. Review of the quality control and patient test results records, on October 11, 2019 at 10:40 AM, showed that positive and negative controls were included when a new reagent box was opened. c. The quality control and patient test results records showed that from November 30, 2018 to October 10, 2019 the laboratory had a total of 115 days of sample testing. d. During 106 out of 115 days of testing the laboratory did not include a positive not a negative quality control material. e. The laboratory supervisor stated that they included a negative and a positive control material when a new reagent box was opened and documented the procedural control with each patient. f. The patient test records showed that the laboratory performed a total of 183 patient's samples. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the Quality Assessment (QA) Program and interview with the laboratory director on October 11, 2019 at 11:55 AM, it was found that the laboratory did not evaluate the following aspects included in the QA Laboratory Program. The findings include: a. The laboratory QA program was reviewed on October 11, 2019 at 11:55 AM, the program showed that the following evaluations must be done every year: Evaluation of the laboratory turn around time Evaluation of the patient's final test reports b. Review of the laboratory QA program for year 2017, 2018 and 2019 showed that the laboratory did not evaluate the laboratory turn around time nor the patient's test reports since year 2017. c. The laboratory director stated on October 11, 2019 at 12:05 PM that the evaluations were not performed. D6076 LABORATORY DIRECTOR -- 2 of 3 -- 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 quality control and quality assessments records review and laboratory supervisor interview on October 11, 2219, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control and quality assessment requirements. Refer to D6093 and D6094 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 pneumonia IgM quality control records and interview with the laboratory supervisor on October 11, 2019 at 10:40 AM, it was determined that the laboratory director did not make sure to include a positive and a negative control material each day of patient testing for Mycoplasma pneumonia tests. Refer to D5449. 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 laboratory director interview on October 11, 2019 at 12:05 PM, it was determined that laboratory director failed to ensure compliance with quality assessment (QA) requirements. The finding includes: a. The laboratory director did not evaluate indicators of the postanalytic system. Refer to D5891. -- 3 of 3 --