Lab Clinico Ensenadeno

Summary Statement of Deficiencies 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 ImmunoCard Mycoplasma pneumoniae (Meridian) manufacturer's instructions, Mycoplasma pneumoniae testing records review (years 2023-2024) and general supervisor interview on January 26, 2024 at 11:00 AM, it was determined that the laboratory failed to follow the manufacturer's instruction regarding to the established temperature range for Mycoplasma pneumoniae when 152 out of 208 days of year 2023 performed mycoplasma specimens above the established temperature range. The findings include: 1. The laboratory uses ImmunoCard Mycoplasma (Meridian) to perform Mycoplasma patient's samples tests. (Reviewed on January 26, 2024 at 11:00 AM) 2. The ImmunoCard Mycoplasma (Meridian) manufacturer's instructions establish that the Mycoplasma test must be performed at room temperature between 22 C to 25 C. (Reviewed on January 26, 2024 at 11:10 AM) 3. From January 2, 2023 to December 20, 2023, the records of the Mycoplasma pneumoniae testing showed that the laboratory processed and reported 348 out of 481 patient's specimens with a temperature range above 25.0 C. (Reviewed on January 26, 2024 at 11:25 AM) 4.The general supervisor confirmed during an interview, on January 26,2024 at 11:30 AM, that the laboratory processed patient's samples outside the established temperature range. 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 -- 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 manufacturer's instructions, Mycoplasma pneumoniae testing records (years 2023-2024) and laboratory general supervisor interview on January 26, 2024 at 11:30 AM, it was determined that the laboratory director did not assure that the manufacturer's instructions regarding to the established temperature range for Mycoplasma pneumoniae test, when the laboratory processed and reported 348 out of 481 patient's specimens for Mycoplasma pneumoniae. Refer to D5413. 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 Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records (years 2023-2024) and laboratory general supervisor interview on January 26, 2024 at 11:30 AM, it was determined that the general supervisor did not assure that the manufacturer's instructions were followed by the testing personnel regarding to temperature range for Mycoplasma pneumoniae test. Refer to D5413. -- 2 of 2 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on facility records review (2021-2022) and laboratory general supervisor interview on March 15, 2022, it was determined that the laboratory failed to be in compliance with the Puerto Rico State laboratory regulation. The findings include: 1. The laboratory records showed on March 15, 2022 at 9:00 AM that the Biomedical Generator Number (DBR-RP-29-91-02-0216-RN-21) was due since February 14, 2021. 2. The laboratory general supervisor confirmed on March 15, 2022 at 9:20 AM, that the Biomedical Generator Number was due since February 14, 2021 and the laboratory renew the new Biomedical Generator Number on February 2021. 3. The state law establishes that the Biomedical Generator Number must be renew 60 days before the expired date. 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 urinalysis quality control records review (years 2021-2022) and laboratory 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 -- general supervisor interview on March 15,2022, it was determined that the laboratory failed to follow requirements for quality control when manual microscopic urinalysis examination was performed. The findings include: 1. The laboratory uses URS-10 strips and Clinitek 500 urinalysis instrument for urinalysis patient samples tests. 2. Urinalysis quality control records were reviewed from January 2021 to March 14, 2022, on March 15, 2022, at 10:00 AM. 3. On March 15, 2022, at 10:05 AM the records showed that the laboratory did not include a microscopic negative control material when performed manual microscopic urinalysis examination since January 2021. 4. The laboratory performed and reported one thousand five hundred ninety-one (1,591) in 2021 urinalysis patient's samples and four hundred thirty-four (434) in 2022 urinalysis patient's samples. 5. The laboratory general supervisor confirmed on March 15, 2022, at 10:30 AM that the laboratory did not include a microscopic negative control material each day of testing when performed manual microscopic urinalysis examination since January 2021. 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 urinalysis quality control records review (years 2021-2022) and laboratory general supervisor interview on March 15, 2022 at 10:30 AM, it was found that the laboratory director failed to ensure compliance with the urinalysis quality control requirements. Refer to D5449. The findings include: 1. On March 15, 2022 at 10:05 AM, the urinalysis quality control records showed that no negative control material was included. 2. On March 15, 2022 at 10:30 AM the finding was discussed with the laboratory general supervisor. 3. Th laboratory general supervisor stated on March 15, 2022 at 10:40 AM that the laboratory did not include a microscopic negative control material each day of testing when performed manual microscopic urinalysis examinatiion since January 2021. -- 2 of 2 --

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 2016 to December 2017 and laboratory general supervisor and testing personnel interview on January 17, 2018 at 9:48 AM, it was determined that the laboratory failed to maintain the proficiency testing event records. The findings include: 1. Review of PRPTP testing records from February 2016 to December 2017, showed that the laboratory did not maintain the following proficiency testing event records: March 2016, April 2016, June 2016, July 2016, August 2016, November 2016, December 2016 and March 2017. 2. The laboratory general supervisor confirmed on January 17, 2018, that the laboratory did not maintain these proficiency testing event records. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 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 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 2016 to December 2017 and laboratory general supervisor interview at 9:54 AM on January 17, 2018, it was determined that the laboratory failed to take and document