Cdt Del Municipio De Canovanas

Summary Statement of Deficiencies 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 January 3, 2022 to December 31, 2022 and interview with the laboratory technical supervisor on February 2, 2023 at 11:20 am, it was determined that the laboratory failed to include each day of testing an external positive and negative control material when 310 out of 310 patients specimens were tested and reported for of Mycoplasma pneumoniae qualitative tests from January 3, 2022 to December 31, 2022. The findings include: 1. On February 2, 2023 at 11:20 am, review of Mycoplasma pneumoniae quality control record showed the following: a. The laboratory use the Immuno Card Mycoplasma Test Cassette to perform the Mycoplasma pneumoniae qualitative tests. b. The laboratory did not include each day of testing the external control materials (positive and negative) when patients specimens were processed for Mycoplasma pneumoniae qualitative tests from January 3, 2022 to December 31, 2022. 2. On February 2, 2023 at 11:22 am, the laboratory technical supervisor confirmed that the laboratory failed did not include each day of testing the external negative and positive control material . She stated that the laboratory run the external control when it received a new lot reagent kit or shipment. 3. On February 2, 2023 at 11:25 am, review of Mycoplasma pneumoniae quality control record showed that the laboratory processed and reported 310 patient samples for Mycoplasma pneumoniae from from January 3, 2022 to December 31, 2022. 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 -- D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on laboratory complete blood cell (CBC) reports records review from January 3, 2022 to December 31, 2022 and laboratory technical supervisor interview on February 2, 2023 at 11:20 am, it was determined that the laboratory failed to indicate the address of the laboratory CDT Canovanas when 4,286 out of 4,286 CBC patient's results were reported from January 3, 2022 to December 31, 2022. The findings include: 1. On February 2, 2023 at 11:00 am, the CBC reports records showed the following: a. The CBC test where performed at the laboratory CDT Canovanas by the Mindray BC-5390 system. b. The laboratory CDT Canovanas did not include the address location in the CBC reports from January 3, 2022 to December 31, 2022. 2. On February 2, 2023 at 11:05 am, the laboratory technical supervisor confirmed that the CBC patient's reports did not include the address of the laboratory CDT Canovanas from January 3, 2022 to December 31, 2022. 3. On February 2, 2023 at 11: 07 am, the CBC reports records showed that the laboratory reported 4,286 CBC patient's results from January 3, 2022 to December 31, 2022. 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, 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 laboratory complete blood cell (CBC) reports records review from January 3, 2022 to December 31, 2022 and laboratory technical supervisor interview on February 2, 2023 at 11:20 am, it was determined that the laboratory director failed to ensure that the CBC reports indicate the address of the laboratory CDT Canovanas from January 3, 2022 to December 31, 2022. Refer to D 5805 (The laboratory did not included the laboratory CDT Canovanas address in the CBC patient's reports). D6093 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- 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 General Immunology (Mycoplasma pneumoniae test) quality control records review from January 3, 2022 to December 31, 2022 and interview with the laboratory technical supervisor on February 2, 2023 at 11:20 am, it was determined that the the laboratory director failed to establish the quality control procedures for the Mycoplasma pneumoniae test from January 3, 2022 to December 31, 2022. Refer to D 5449 (The laboratory did not include each day of testing an external positive and negative control material when 310 out of 310 patients specimens were tested and reported for of Mycoplasma pneumoniae qualitative tests from January 3, 2022 to December 31, 2022). -- 3 of 3 --

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 and laboratory general supervisor interview on May 21, 2021 at 9:24 AM, it was determined that the laboratory failed to take and document

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 lack of Puerto Rico Proficiency Testing Program (PRPTP) records review from February 2017 to December 2018 and laboratory director and testing personnel interview on February 6, 2019 at 9:35 AM, it was determined that the laboratory failed to maintain the proficiency testing event records. The findings include: 1. Proficiency Testing records were reviewed from February 2017 to December 2108. 2. Review of proficiency testing records from February 2017 to December 2018, showed that the laboratory did not maintain the following proficiency testing event records from February 2018 to December 2018. 3. The laboratory director and testing personnel confirmed on February 6, 2019, that the laboratory did not maintain these proficiency testing event records. 4. This deficiency was cited on February 14, 2017. D2128 HEMATOLOGY CFR(s): 493.851(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 6 -- 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 2017 to December 2018 and laboratory director and testing personnel interview on February 6, 2019, it was determined that the laboratory failed to take and document