Laboratorio Clinico Los Robles

Summary Statement of Deficiencies 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 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 records review and laboratory director interview on December 12, 2023 at 12:50 PM, it was determined that the laboratory failed to take and document

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 and laboratory general supervisor interview at 9:55 AM on February 5, 2020, it was determined that the laboratory failed to be in compliance with the Puerto Rico State laboratory regulation. The findings include: 1. The laboratory Biomedical Generator Number was due since January 9, 2020. 2. The laboratory director confirmed on February 5, 2020, that the Biomedical Generator Number was due since January 9, 2020. 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 review of clinical consultant records and laboratory director interview at 10: 12 AM on February 5, 2020, it was determined that the laboratory failed to follow written policies to assess the Clinical Consultant (MD # 13552) competency. The findings include : 1. Clinical Consultant records were reviewed since November 2018. 2. The laboratory director failed to perform the annual competency evaluation to the Clinical Consultant (MD #13552) since November 2018. 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 -- 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 Quality Assessment (QA) records review from January 2018 to December 2019 and laboratory director interview on February 5, 2020 at 10:12 AM, it was determined that laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirements for general laboratory systems. The findings include: 1. The laboratory quality assessment records showed that Clinical Consultant personnel competence must be performed every year. 2. The laboratory did not evaluate the Clinical Consultant (MD # 13552) competence since November 2018. Refer to D5209. D6011 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) 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)(2) and provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on facility records review (from January 1, 2018 to February 5, 2020) and laboratory director interview at 9:55 AM on February 5, 2020, it was determined that the laboratory director failed to be in compliance with the Puerto Rico State laboratory regulation. The finding includes: 1. The laboratory Biomedical Generator Number was due since January 9, 2020. Refer to D3009. -- 2 of 2 --

Summary Statement of Deficiencies D2021 BACTERIOLOGY CFR(s): 493.823(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program records reviewed ( 2016-2017) and laboratory general supervisor interview on January 19, 2018 at 10:00 A.M., it was determined that the laboratory failed to participate in the Bacteriology first testing event performed in April 2016. The findings include: 1. Proficiency testing records were reviewed from February 2016 to July 2017. 2. The laboratory did not participate in the first testing event of Syphilis Serology ( April 2016) established by the Proficiency Testing Program. 3. The laboratory general supervisor confirmed on January 19, 2018 at 10: 00 A.M., that the laboratory failed to participate in the first testing event of Bacteriology test performed in April 2016. D2026 BACTERIOLOGY CFR(s): 493.823(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) 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 -- 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 records review and laboratory general supervisor interview on January 19, 2018 at 9:30 A.M., it was determined that the laboratory failed to take and document