Elmwood Pediatric Group Llp

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on direct observation, review of Standard Operating Procedures (SOPs), as well as interview with the Testing Person (TP), the laboratory failed to follow manufacturers' instructions for performing the waived test. FINDINGS: 1. The surveyor's observations on December 16, 2025, at approximately 3:00 P.M., confirmed the following Quality Control (QC) materials utilized for monitoring the accuracy of the Quintet AC blood glucose monitor were not removed from inventory when they exceeded their expiration date: a. Quintet AC Blood Glucose Control Solution Level 2, lot: 2WE29A, expiration: April 30, 2025. b. Quintet AC Blood Glucose Control Solution Level 4, lot: 2WE29A, expiration: May 1, 2025. 2. The current, approved SOPs did not include instructions for removal of expired testing and QC materials from inventory. 3. The TP informed the surveyor that the expired QC blood glucose monitoring materials were utilized prior to patient specimen processing. The number of patient specimens processed utilizing the respective expired QC materials could not be determined. 4. The Quintet AC Blood Glucose manufacturer's package insert specified operating ambient temperature range of 10C to 40C (50F to 104F) and humidity range of 10% to 90%. 5. There was no documentation of temperature and humidity for the area where test kits were stored, patient specimens processed, and testing was performed. 6. No thermometer or humidistat were present to monitor ambient room temperature or humidity. 7. The TP confirmed the findings on December 16, 2025, at approximately 4:00 P.M. D2014 TESTING OF PROFICIENCY TESTING SAMPLES 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 -- (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records, as well as interview with the TP, the laboratory failed to complete the attestation statement provided by the PT program, signed by the analyst and Laboratory Director (LD), documenting that PT samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the PT event. FINDINGS: 1. There was no documentation of LD signature and date of signature on the College of American Pathologists attestation statements for events NB-C 2024, NB-A 2025, NB-B 2025, and NB-C 2025. 2. It was noted the analyst signatures were documented on the attestation forms. 3. The TP confirmed the findings on December 16, 2025, at approximately 4:00 P.M. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's training & competency evaluation policy, review of the testing personnel training & education records and an interview with the general supervisor/testing person, the laboratory director failed to follow their establish training & competency assessment policy. FINDINGS: 1. The general supervisor/testing person confirmed on December 9, 2021 at approximately 9:30 AM, the surveyor's findings that the laboratory failed to follow their written competency assessment policy, which included the six required components. a. The laboratory did perform the training, six month and annual competency for the calendar years 2019, 2020 and 2021 using a form titled "Elmwood Pediatric Group Training and Education Record" which only listed the waived and moderate complexity tests that is performed. The laboratory director performed the evaluation and recorded as a check mark along the list of tests. b. However, the form "Elmwood Pediatric Group Training and Education Record" for recording the initial training, six month and annual competency for the three new and nine testing personnel did not include the six required components. The six required components are: 1. direct observation of routine patient test performance, including preparation. specimen handling and testing; 2. monitoring the recording and reporting of test results. 3. review of intermediate results of worksheets, quality control records, proficiency testing results, and preventive maintenance records; 4. direct observation of performance of instrument maintenance and function checks; 5. assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, 6. assessment of problem solving skills. 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 --