Salinas Pediatric Medical Group

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on -10/23/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and Medical Laboratory Evaluation (AAB) records (2025-1 and 2025-2), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the analyte Hematocrit (HCT) resulting in unsuccessful performance. See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation (AAB) report, the laboratory failed to achieve satisfactory performance for two out of three consecutive events (2025-1 and 2025-2) for the analyte Hct: The finding include: Hct 60% - 2025 first testing event; Hct 40% - 2025 second testing event; A review of the 2025 scores from AAB confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and AAB records for 2025-1 and 2025-2 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and AAB records for 2025-1 and 2025-2 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on observation of the Celldyn Emerald hematology analyzer, review of proficiency testing (PT) reports from CMS (report 155D, Individual Laboratory Profile) and AAB (American Association of Bioanalysts) and laboratory proficiency testing records, and interview with Laboratory Personnel (3, 7), the laboratory failed to attain an acceptable score of 80% or better for RBC (Red Bood Cell Count) and Hematocrit for Q1/2022. Findings included: 1. The laboratory reported 2 unacceptable results (*) out of 5 for the score of 60%, signifying unacceptable testing for RBC, as follows: PT sample Lab result Intended Grading Range -------------------------------------------------------------- 2 *5.99 5.627 5.29 - 5.96 3 *5.06 4.595 4.32 - 4.87 2. The laboratory reported 2 unacceptable results (*) out of 5 for the score of 60%, signifying unacceptable testing for Hematocrit, as follows: PT sample Lab result Intended Grading Range -------------------------------------------------------------- 2 *58.3 54.77 51.5 - 58.1 3 *45.5 41.01 38.5 - 43.5 3. Laboratory Testing Persons (3, 7) affirmed (8/16/23 at 11:00 am) the aforementioned unacceptable scores for RBC and Hematocrit proficiency testing in 2022/Q1. 4. The reliability and quality of RBC and Hematocrit results reported for 104 pediatric patients during the timeframe January - April 2022 could not be assured (CMS116, 8/15/23). Test records selected from February 2022, are as follows: DATE SEQ ------------------------- 2/01/22 00006 " 00007 2/02/22 00006 2/03/22 00010 " 00011 " 00012 2/04/22 00005 " 00006 " 00007 2/07/22 00006 " 00007 " 00009 2/08 /22 00006 2/09/22 00006 " 00007 . D2128 HEMATOLOGY 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 -- 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 review of 2022/Q1 CMS and AAB PT reports and laboratory PT records, the lack of laboratory document, and interview with Laboratory Personnel (3, 7), the laboratory failed to document investigation, determine the root cause, and

Summary Statement of Deficiencies D6067 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Each individual performing moderate complexity testing must have training to ensure that the individual has-- (A) the skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (B) the skills required for implementing all standard laboratory procedures; (C) the skills required for performing each test method and for proper instrument use; (D) the skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed; (E) a working knowledge of reagent stability and storage; (F) the skills required to implement the quality control policies and procedures of the laboratory; (G) an awareness of the factors that influence test results; and (H) the skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on staff interviews, review of 10 randomly selected patient test reports (medical records) from 01/11/2019 to 08/14/2020 and quality control data, and lack of training verification documentations on 10/06/2020 (survey date), it was determined that the laboratory failed to document training appropriate for the testing performed prior to analyzing patient specimens which must include: 1. The skills required for proper specimen collection, including patient preparation, if applicable; labeling, processing or preparation, transportation and storage of specimens. 2. The skills required for implementing all standard laboratory procedures; 3. The skills required for performing each test method and for proper instrument use; 4. The skills required for performing preventative maintenance, troubleshooting and calibration procedures; 5. A working knowledge of reagents stability and storage; 6. The skills required to implement the quality control policies and procedures of the laboratory; 7. An awareness of factors 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 -- that influence test results; 8. The skills required to assess and verify the validity of patient test results through the evaluation of quality control (QC) samples values prior to reporting patient test results. 1. The laboratory had no documentation to show that an ongoing competency evaluation and training for the testing personnel performing moderate complexity testing. b. The laboratory testing personnel affirmed 10/06/2020 (survey date)at 11:30 a.m. that the laboratory had no documentation to show competency evaluation and training for the personnel performing moderate complexity testing for eight (8) testing staff noted on the CMS-209 Laboratory Personnel Report (CLIA) form. c. Based on the laboratory testing declaration submitted on 06/21/2016, the laboratory performed approximately 5,000 hematology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on Surveyor review of proficiency testing (PT) records from American Association of Bioanalysts (AAB) and interview with the laboratory staff, the laboratory failed to attain at least 80% score for erythrocytes in the 3rd event of 2017, and is determined unsatisfactory analyte performance. The findings include: a. The PT records of the 3rd event of 2017 shows that the laboratory obtained "60%" score for the analyte erythrocytes. b. PT sample results review and an interview with the laboratory staff on 02/27/2018 at 11:10 am confirmed that the laboratory received the following scores: Sample Reported Expected ID Result Result 1 5.8 4.22 - 4.76 2 2.09 2.05 - 2.32 3 5.32 5.1 - 5.75 4 2.11 2.06 - 2.33 5 5.0 5.1 - 5.75 c. The laboratory's testing declaration form signed by the lab director on 2/27/2018 shows that the laboratory runs 50,000 samples annually in Hematology. 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. 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 Surveyor review of proficiency testing procedure, policy and records, and interview with the laboratory staff, the laboratory failed to take any action to correct problems associated with the proficiency testing failure, and any remedial action. The findings include: a. The laboratory did not provide any records to prove any action was taken after receiving the unsatisfactory proficiency test score for erythrocytes. b. The laboratory staff, on 2/27/2018 at 11:20 am, affirmed that no remedial action was taken. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on Surveyor review of PT records from American Association of Bioanalysts (AAB) and interview with the laboratory staff on 2/27/2018 at 11:25 am, the laboratory failed to review and evaluate the results obtained on proficiency testing performed. The findings include: a. The laboratory did not have any evidence of review and evaluation of the laboratory's proficiency testing (PT) results. b. The laboratory participates in AAB proficiency testing events however, it does not review and evaluate its performance by reviewing the PT results. c. The laboratory staff, on 2 /27/2018 at 11:25 am, affirmed that no review of PT results were done. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require