Laboratorio Clinico Meditech 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 personnel records review (year 2022-2024) and laboratory technical supervisor interview on May 8, 2024, at 9:30 A.M., it was determined that the laboratory failed to follow the established schedule for competence evaluation of the following personnel: the technical supervisor, the general supervisor, and the clinical consultant. The findings include: 1. The laboratory schedule for technical supervisor, general supervisor and clinical consultant competency evaluation showed that it must be done every year. (Reviewed on May 8, 2024, at 9:35 A.M.) 2. The personnel records of the technical supervisor showed that the last competence was performed on October 1,2021. (Reviewed on May 8, 2024, at 9:40 A.M.) 3. The personnel records of the general supervisor showed that the last competence was performed on July30, 2021. (Reviewed on May 8, 2024, at 9:45 A.M.) 4. The personnel records of the clinical consultant showed that the last competence was performed on March 1,2022. (Reviewed on May 8, 2024, at 9:50 A.M.) 5. The laboratory technical supervisor confirmed on May 8, 2024, at 10:15 A.M., did not perform the annual competency evaluations for the personnel during year 2022 and 2023. 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 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 -- 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 manufacturer's instructions, Mycoplasma pneumoniae testing record review (years 2023-2024), and laboratory technical supervisor interview on May 8,2024, at 12:40 P.M., it was determined that the laboratory failed to follow the manufacturer's instruction regarding to the established temperature range for Mycoplasma pneumoniae when 81 out of 1346 patient's specimens were processed and reported for Mycoplasma pneumoniae from January 26, 2023, to May 7,2024. The findings include: 1. The laboratory uses the ImmunoCard Mycoplasma Test Kit to perform the Mycoplasma pneumoniae qualitative tests. (Reviewed on May 8, 2024, at 12:40 P.M.) 2. On May 8, 2024, at 12: 45 P.M., the ImmunoCard Mycoplasma manufacturer's instructions were reviewed. The manufacturer's instructions established to perform the Mycoplasma pneumoniae test procedures between 22C to 25 range temperature. 3. On May 8, 2024, at 1:00 P. M., the Mycoplasma pneumoniae testing records review showed that the laboratory processed and reported 81 out of 1346 patient's specimens for Mycoplasma pneumoniae test from January 2,2023 to April 23,2024, with a temperature range within 19.0C to 21.0C 4. The laboratory technical supervisor confirmed during interview on May 8, 2024, at 1:15 P.M., that the laboratory processed patient's samples outside the established temperature range by manufacturer. 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 and laboratory technical supervisor interview on May 8,2024, at 1:30 P.M., it was determined that the director did not assure that the manufacturer's instructions regarding to the established temperature range for Mycoplasma pneumoniae test were followed, when the laboratory processed and reported 81 out of 1346 patient's specimens for Mycoplasma pneumoniae. Refer to D5413. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on personnel records review and technical supervisor interview on May 8, 2024, at 9:57 A.M., it was determined that the laboratory director did not assure that, the general supervisor offer training to the new testing personnel, prior to testing patient's specimens. The findings include: 1. The laboratory hired a new testing personnel on February 20,2023. (Reviewed on May 8,2024 at 9:57A.M.) 2. The personnel records of the new testing personnel did not include any documented training for the type and complexity of the services offered in the following laboratory's areas: hematology, chemistry, urinalysis, endocrinology, syphilis, and general serology. (Reviewed on May 8,2024 at 10:00 A.M.) 3. During interview with the laboratory technical supervisor, on May 8, 2024, at 10:15 A.M., she stated that the laboratory director delegated in general supervisor the training procedures for the new personnel. The technical supervisor confirmed that the training was not performed. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on personnel records review and laboratory technical supervisor interview on May 8, 2024, at 9:55 A.M., it was determined that the technical supervisor failed to provide at least semiannually, the competence evaluation to the new testing personnel (MT #8495) that performed the high and moderate complexity. The findings include: 1. The laboratory hired a new testing personnel on February 20,2023. (Reviewed on May 8,2024 at 9:55 A.M.) 2. On May 8, 2024, at 10:00 A.M., review of the new testing personnel (MT #8495) records did not include semiannul competence evaluations; that include at least the following requirements: a. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing. b. Monitoring, recording, and reporting of test results. c. Review of intermediate test results or worksheets, quality control records, proficiency testing results and preventive maintenance records. d. Direct observation of performance of instrument maintenance and function checks. e. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 3. On May 8, 2024, at 10:18 A.M., the laboratory technical supervisor confirmed that the semiannually competence is not performed. 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 and laboratory technical supervisor interview on May 8,2024, at 1:30 P.M., it was determined that the general supervisor did not assure that -- 3 of 4 -- the manufacturer's instructions were followed by the testing personnel regarding to temperature range for Mycoplasma pneumoniae test. Refer to D5413. 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 Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records and laboratory director interview on May 8,2024, at 1:30 P.M., it was determined that the testing personnel did not follow the manufacturer's instructions regarding to the established temperature range for Mycoplasma pneumoniae test, when she processed 81 out of 1346 patient's specimens for Mycoplasma pneumoniae. Refer to D5413. -- 4 of 4 --