Michael G Valpiani Md Az Ltd

Summary Statement of Deficiencies D0000 The Michael G Valpani MD AZ LTD laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of a recertification survey on 2/11/26 and recertification is recommended. Standard level deficiencies were cited. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on surveyor observation, a review of the laboratory's policies, personnel records, and staff interview, the laboratory failed to have documentation of the technical supervisor performing a separate and distinct competency assessment on four of five testing personnel performing toxicology testing in 2025 and 2026. Findings include: 1. Surveyor observation of the laboratory on 2/11/26 at 9:35 a.m. revealed three separate laboratories operating in suite B. 2. A review of the laboratory's policy titled 'Separation of Lab for MultiLab Sites' revealed the following: "Multiple laboratories may operate at the same physical location (e.g. same building or suite, as applicable) with separate CLIA numbers, as long as each laboratory can demonstrate that is is operating as a separate and distinct entity. The following separation must be made in the laboratory in order to comply with this requirement. Personnel Competencies: Competencies for lab staff are to be documented per each lab start date of receiving samples." 3. A review of the laboratory's personnel records revealed the technical supervisor performed competency assessments for the following 4 testing personnel, but there was no 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 -- documentation of which laboratory they were for: a) Testing person #1 - Competency Assessment: LC-MS/MS Quanting and Resulting Performed: 12/29/25 - Competency Assessment: Specimen Processing and Storage Performed: 1/28/26 - Competency Assessment: LC-MS/MS Sample Prep Performed: 1/28/26 b) Testing person #3 - Competency Assessment: Specimen Processing and Storage Performed: 1/28/26 - Competency Assessment: LC-MS/MS Sample Prep Performed: 1/28/26 c) Testing person #4 - Competency Assessment: Specimen Processing and Storage Performed: 1 /10/26 d) Testing person #5 - Competency Assessment: LC-MS/MS Quanting and Resulting Performed: 12/22/25 4. In an interview on 2/11/26 at 11:00 a.m. in the office, after review of the records, the technical supervisor confirmed that the competency assessments performed were intended to be used for all laboratories operating in suite B. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 08/07/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, test establishment studies and staff interview, the laboratory failed to follow its own policy for verification of interfering substances for one of one toxicology testing platforms used by the laboratory, the Sciex 4000 LC-MS/MS. Findings included: 1. Review of laboratory's policy "Analytic Method Validation v2" (approved for use 03/01/2024) revealed: "During the method validation, the analyte will be quantified with other similar drugs or chemical compounds in chemical and physical properties to test if there is an interference exist (sic) and how the interferences affect the quantitation of the analyte being tested." 2. Review of laboratory's test establishment studies for each analyte (completed 03/02/2024) revealed: Sample name: Interference Sample type: Unknown 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 -- Results: Area (cps) = N/A RT (min) = N/A Target concentration (ng/mL): N/A Calculated concentration (ng/mL): N/A There was no documentation of the interfering substances used in the study, nor how it affected the results. 3. In an interview on 08 /07/2024 at 1005 hours in the laboratory, the general supervisor (as indicated on submitted Form CMS 209) confirmed the findings. Key: cps - Counts per second RT - Retention time min - Minutes N/A - Not applicable ng/mL - Nanograms per milliliter CMS - Centers for Medicare and Medicaid D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory's quality assurance/quality control records, policies /procedures and staff interview, the laboratory failed to document evaluation of quality control to detect errors over time for one of one test platforms used by the laboratory, the Sciex 4000 LC-MS/MS. Findings included: 1. Review of laboratory's Sciex 4000 LC-MS/MS quality control and quality assurance records from March to July 2024 revealed the laboratory did not document evaluation of quality control to detect errors over time. 2. Review of laboratory's policies/procedures revealed there were no protocols in place for evaluation of quality control to detect potential errors over time. 3. In an interview on 08/07/2024 at 1145 hours in the laboratory, the general supervisor (as indicated on submitted Form CMS 209) confirmed the findings. -- 2 of 2 --