Southeast Georgia Pediatrics, Llc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on September 15, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 review of the Abbott Cell-Dyn Emerald (Emerald) Hematology Analyzer 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 -- and staff interview, the laboratory failed to calibrate the Emerald every six months from March 2021 to March 2022. Findings: 1. Review of the Emerald calibration documents, the laboratory calibrated the Emerald on March 5, 2021, and the next documented calibration was March 10, 2022. The emerald was not calibrated during the 12 month period. 2. Interview with staff #1, (CMS 209 form), on September 15, 2020 at approximately 1:30pm, in the office, confirmed the aforementioned statement. D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) 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. (c) The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed. This STANDARD is not met as evidenced by: Based on review of the Abbott Cell-Dyn Emerald (Emerald) Hematology analyzer documentation, , the laboratory director failed to provide oversight for the overall operation and administration of the laboratory. The laboratory failed to perform calibrations for a 12 month period from March 2021 thru March 2022. Findings: 1. Review of the Emerald Calibration documentation, the laboratory did not document calibration performance from March 5, 2021 thru March 10, 2022. The laboratory director is responsible for the overall operation of the laboratory. 2. Interview with staff #1 (CMS 209 form), on September 15, at approximately 1:30 pm, in the office, confirmed the aforementioned statement. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 7, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 review of proficiency testing (PT) records, review of the Laboratory Personnel Report Form (CMS 209), and staff interview, the laboratory failed to rotate performance of proficiency testing samples among all personnel who test patient samples. Findings include: 1. Review of PT attestation statements and PT testing records revealed all hematology PT samples in 2019 and 2020 were tested by staff # 3 (see CMS 209). All bacteriology PT samples in 2019 and 2020 were tested by staff # 3 and #4 (see CMS 209). 2. Review of the CMS 209 revealed 4 total employees listed as testing personnel. 3. Interview with staff #3 (see CMS 209) on October 7, 2020 at approximately 12:15 pm confirmed testing personnel # 3 performed testing on all PT samples in 2019 and 2020. **REPEAT DEFICIENCY** D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 proficiency testing (PT) records, review of the Laboratory Personnel Report Form (CMS 209), and staff interview, the laboratory failed to note

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 31, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 review of proficiency testing (PT) records, review of the Laboratory Personnel Report Form (CMS 209), and staff interview, the laboratory failed to rotate performance of proficiency testing samples among all personnel who test patient samples. Findings include: 1. Review of PT attestation statements and PT testing records revealed all PT samples in 2017 and 2018 were tested by testing personnel # 1 (see CMS 209). 2. Review of the CMS 209 revealed 3 additional employees listed as testing personnel. 2. Interview with testing personnel #1 (see CMS 209) on July 31, 2018 at 11:30 am confirmed testing personnel # 1 performed testing on all PT samples in 2017 and 2018 and the other three testing personnel perform testing on patient samples... D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on observation by the surveyor during a tour of the facility and staff interview, the laboratory failed to have a biohazard sign and "no food or drink allowed" signage on the refrigerator located in the employee break room which is used to store biohazardous material. Findings include: 1. Observation by the surveyor during a tour of the facility revealed the refrigerator used to store laboratory supplies including biohazard material is located on top of a counter in the break room. No biohazard label or sign stating no food or drink should be placed inside the refrigerator is visible. 2. Interview with testing personnel # 1 (See CMS 209) on July 31, 2018 at 10:30 am in the break room confirmed the refrigerator contains biohazardous material and no warning notices are posted. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure for performing throat cultures for group A streptococcus, observation of culture plates in the incubator, observation of uninoculated media in the refrigerator, review of the laboratory's log of media shipments and interviews with the laboratory director and staff, the laboratory failed to follow its written policy for performing throat cultures for group A streptococcus. Findings include: 1. Review of the laboratory's procedure for performing throat cultures revealed Selective Streptococcus Agar (SSA) in conjunction with a bacitracin disk (A disk) is the only acceptable moderate complexity method for performing throat cultures to rule out group A streptococcus. 2. Observation by the surveyor of inoculated culture plates in the incubator and uninoculated media in the refrigerator revealed the laboratory is using trypticase soy agar (TSA) with 5 % sheep's blood instead of SSA as required. 3. Review of the laboratory's log of media shipments with dates & lot numbers revealed the laboratory is receiving TSA with 5% sheep's blood. There is no record of the laboratory receiving SSA. 3. Interviews with the laboratory director on July 31, 2018 at 10:45 am in the laboratory area and with the laboratory director and testing personnel # 1 (see CMS 209) at 1 pm in the break room confirmed the laboratory is using TSA with 5 % sheep's blood agar instead of SSA as required. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in -- 2 of 4 -- 493.1253. (7) Control procedures. (8)