Julio J Valdes Md Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Julio J Valdes MD PA on 08/14/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain analytic records verifying the performance of new controls for the Hematology analyzer prior to using the new controls from 08/2023 through 12/2024 for data reviewed 08/2023 through 07/2025. Findings included: 1. The lab policy and procedure manual was reviewed. The manual included a policy, with a revision date of 04/20/2018, signed by the Lab Director, that required validating new controls against controls that were currently in use. 2. New control validation records for the months 08/2023 through 07 /2025 were reviewed. No documentation was present for 08/2023 through 12/2024. 3. Testing Personnel #C was interviewed during a tour of the lab beginning at 10:15 a.m. on 08/14/2025. They stated new controls were validated prior to use which occurred approximately every three months. 4. The Lab Director was interviewed on 08/14 /2025 at 12:50 p.m. They confirmed the lab failed to maintain the supporting documentation for new control validations from 08/2023 through 12/2024. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An announced onsite recertification survey was conducted at Julio J Valdes MD PA on 06/21/2023. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 record review and interview, the laboratory failed to report positive and negative Corona Virus Disease (COVID) test results as required by the Florida Department of Health (FDOH) from 01/02/2022 to 06/21/2023. Findings include: The mandatory reporting requirements outlined by FDOH Executive Order 20-013, section 381.0031, Florida Statutes, and Florida Administrative Code Chapter 64D-3, noted laboratories must report both negative and positive COVID-19 test results. Review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated by the Owner of the Laboratory on 06/21/2023, revealed the lab performed waived COVID-19 testing using the QuickVue SARS Antigen Test. Review of the QuickVue SARS Antigen test instructions for use revealed "Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." Review of the list of patients that had COVID testing revealed 1,843 patients were tested from 01/02/2022 to 06/21/2023 without reporting results to the FDOH. On 06/21/2023 at 10:55 AM, the Laboratory Director stated he did not know the laboratory was performing COVID testing and confirmed no records for reporting results to FDOH were present. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing and American Association of Bioanalysts (AAB) proficiency testing results and interview with the Technical Consultant, the laboratory had unsuccessful performance for Erythrocytes and Leukocytes for 2 out of 4 (2nd and 3rd testing event in 2017 and 2nd and 3rd testing events in 2018) testing events reviewed (See D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency and American Association of Bioanalysts (AAB) proficiency testing results and interview with the Technical Consultant, the laboratory had 2 out of 3 unsuccessful testing events for Erythrocytes and Leukocytes in the specialty of Hematology. Findings Included: Review of 2017 API and 2018 AAB proficiency testing results found the AAB 2018 1st Event had a 0% for Erythocytes and Leukocytes and the AAB 2018 3rd testing event had a 0% for Erythrocytes and Leukocytes. Interview on 02/20/2019 at 12:30 PM Technical Consultant stated the lab was late enrrolling for API proficiency testing so the laboratory received 0% for all analytes for the Hematology 2018 1st Event. The Technical Consultant stated that Testing Personnel #C did not know the laboratory tested for erythrocytes and leukocytes so the laboratory received 0% for AAB Hematology 2018 3rd Event for Erythrocytes and Leukocytes. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) and American Association of Bioanalysts (AAB) proficiency testing record review and interview with the Technical Consultant, the Laboratory Director failed to ensure the laboratory was enrolled for Hematology proficiency testing for 2018. Findings Included: Review of API proficiency testing results revealed that the laboratory was enrolled in proficiency testing in 2017 for Hematology. Review of AAB proficiency revealed Hematology proficiency testing records for the 2nd and 3rd Event for 2018. Interview on 02/20 /2019 at 12:30 PM the Technical Consultant stated the laboratory missed the enrollment time for 2018 API Hematology proficiency testing so the laboratory enrolled with 2018 AAB Hematology proficiency testing. -- 2 of 2 --