Marco Gutierrez Md And Associates

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of the laboratory's instrumentation, review of the laboratory's existing Individualized Quality Control Plans, and staff interview, the laboratory failed to have documentation of developing new Individualized Quality Control Plans for 2 of 2 new analyzers. The findings included: 1. A review of the laboratory's instrumentation identified 2 new DCA Vantage analyzers were placed into use: Serial number: S093891 In use: 3/14/2025 Serial number: S097198 In use: 1/23/2026 2. A review of the laboratory's IQCP for the DCA Vantage determined the laboratory failed to perform studies including the new analyzers. 3. The technical consultant confirmed the finding in an interview conducted on 09/30/2026 at 1100 hours in the X ray room. D5781

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory policies, and interview with laboratory personnel, the laboratory failed to follow its infection control policy for one of one observed events occurring on July 26,2022. The findings included: 1. Surveyor observation on July 26, 2022 at 09:10 hours in the laboratory found 2 personal drinking items, one located next to the computer and one located on top of a laboratory refrigerator. 2. Review of the laboratory's policy title 'Infection Control Policy' approved by the laboratory director on September 1, 2016 stated, "Infection Control Policy is to ensure the avoidance of spreading infectious disease. Universal Precautions apply to blood and other body fluids containing blood..." 3. The findings were confirmed in interview with the technical consultant on July 26, 2022 at 11:30 hours in the radiology room. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's verification studies performed on the Medonic M hematology analyzer, and confirmed in staff interviews, laboratory failed to have documentation of completing verification studies on 1 of 1 new analyzers implemented in November 2021. The findings included: 1. A review of the laboratory's verification studies performed on the Medonic M Series hematology analyzer in November 2021 found the laboratory failed to have documentation of verification of patient normal ranges. As of July 22, 2022, the day of the survey, patient normal ranges had not been verified. 2. The laboratory was asked to provide documentation of the missing studies. No documentation was provided. 3. An interviews with the technical consultant on July 26, 2022 at 11:30 hours in the radiology room confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing results from 2016, 2017, and 2018, and confirmed in interview of facility personnel, the laboratory failed to provide documentation of evaluating proficiency testing results returned as 'not graded' by the proficiency testing agency. The findings included: 1. A review of the laboratory's API proficiency testing results from 2016 (event 3), 2017 (events 1, 2, and 3), and 2018 (events 1 and 2) revealed the proficiency agency returned the following results as "Not Graded": 2017 (event 2) Analyte: Monocytes Sample ID: HEM-07, HEM-10 Grade: Not Graded-2 2. The proficiency testing agency defined code "2" as: No Consensus. 3. An interview with the primary testing person on 08/29/2018 at 09:15 hours in the office confirmed the findings. 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 --