Pedroso Pediatrics Pa

Summary Statement of Deficiencies D0000 A recertification survey conducted from 09/25/2024 to 09/30/2024 found the PEDROSO PEDIATRICS PA clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have all testing personnel (TP) rotate through the testing of Proficiency Testing (PT) for Hematology specialty in one out of two years reviewed. Findings included: Review of FORM CMS-209 signed and dated by the Laboratory Director (LD) on 09/24/2024 revealed the laboratory had three TP listed (TP#A, TP# B and TP#C). -Review of personnel records revealed that TP#A, TP#B, TP#C had annual competencies during 2022 and 2023. -Review of College of American Pathologists (CAP) PT records for 2023 (first, second and third event) and 2024 (first and second event), revealed that TP#C had no PT participation during 2023 for Hematology specialty. During an interview on 09/25 /2024 at 11:30 AM, the Lead Technician confirmed that the laboratory failed to rotate the PT between all TP for the period of reference. D2123 HEMATOLOGY CFR(s): 493.851(c) 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 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 -- 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 record review and staff interview, the laboratory failed to participate in Proficiency Testing (PT) that resulted in a score of zero (0) percent for Hematology in first event of 2023. Findings included: -Review of College of American Pathologists (CAP) PT records for 2023 (first, second and third event) and 2024 (first event and second event), revealed that for the first event of 2023 for Hematology specialty the laboratory had a 0 score. -Review of instrument print outs revealed that the PT samples were tested on 02/21/2023 at 02:14 PM. - Review of CAP instructions revealed the following: "Results are due no latter than midnight, Central Time February 20, 2023" During an interview on 09/25/2024 at 11:30 AM, the Lead Technician confirmed that the laboratory failed to test the PT samples in time for the event of reference. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform at least two levels of quality control (QC) each day of patient testing on the Complete Blood Cell Counter (CBC) Medonic M Series for one out of three patients reviewed. Findings included: -Review Complete Blood Cell Count for three patients : Patient (P) #1 tested 04/11/2023, P#2 tested on 09/18/2023 and P#3 tested on 06/06/2024 -Review of QC records revealed that the laboratory failed to run quality control before patient testing on 09/18/2023, that day one patient was tested. During an interview on 09/25 /2024 at 11:35 AM, the Lead medical assistant confirmed that the laboratory failed to run QC before patient testing on the day of reference. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (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 record review and staff interview, the Technical Consultant (TC) failed to perform the six-month Complete Blood Count (CBC) competency for one out of three -- 2 of 3 -- Testing Personnel (TP) in 2023. Findings included: -Review of FORM-209 (01/2021) signed and dated by the Laboratory Director (LD) on 09/24/2024, revealed that the LD, Clinical Consultant (CC), and TC was the same person and there were three Testing Personnel (TP) (TP#1, TP#2 and TP#3) -Review of personnel records revealed that the TP#C had initial competency evaluation signed by the TC on 12/21 /2022 with a statement that said: 'Re Evaluation 6 months." No six-month competency found between the Initial and the annual on 12/19/2023. During an interview on 09/25 /2024 at 11:40 AM, the Lead Medical Assistant confirmed that the TC failed to document the six-month competency for TP#C. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 12/02/2020 found that the Pedroso Pediatrics PA clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview with testing person (TP) A, the laboratory failed to perform calibration verification procedures of the Medonic M Series 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 -- Analyzer at least every 6 months from 12/30/2019 to 10/23/2020. Findings include: - Review of the Medonic M Series Analyzer calibration records revealed that the laboratory performed calibrations on 12/28/18, 6/28/19, 12/30/2019 and 10/23/20. During an interview on 12/02/2020 at 3:00 p.m., TP A confirmed that the laboratory failed to perform instrument calibration every 6 months in the period of 12/30/2019 to 10/23/2020. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with testing person #1, the hematology laboratory had expired blood collection tubes and hematology controls. The findings include: Observation on November 28, 2018 at 2:00 pm revealed; A)Microtainer brand blood collection tubes for send out bilirubin test: 8 blood collection tubes expiration date 2018-3-31 4 blood collection tubes expiration date 2018-4-30 8 blood collection tubes expiration date 2018-8-31 B) Boule Con -Diff- Tri level multi parameter hematology control lot # 21806-2K, expiration date 2018-10-30. During an interview on November 28, 2018 at 2:45 PM, testing person # 1confirmed that the Microtainer brand blood collection tubes for send out bilirubin test had expired and they were in use. Boule Con -Diff- Tri level multi parameter hematology control lot # 21806-2K had expired and they were not in use. 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 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 -- acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to enter the correct test results manually as the scanned instrument test result print out for 2 out of 4 patients reviewed. The findings include: On November 28, 2018 at 2:00pm, surveyor reviewed 4 patient test reports (#1 to # 4) for hematology tests that included copy of the scanned instrument test result print outs and the manually entered test results (final report)in computer. 1- For patient #1, manually entered results (final report) did not match with the scanned instrument test result print out for LYM% (lymphocyte %) and RBC (red blood cell). 2- For patient # 2, manually entered results (final report) did not match with the scanned instrument test result print out for RBC. 3- The manually entered test results for all 4 patients (final reports) did not include the units of measurement or the normal ranges for the test analytes. During an interview on November 28, 2018 at 2: 45pm, testing person #1 confirmed findings 1 to 3. -- 2 of 2 --