Tiefenbrunn & Fortin Pediatrics

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records, Manufacturers Package Insert (MPI) and interview with the Laboratory Manager (LM) the laboratory failed to retain Certificates of Analysis (COA) for Uricult media used for Bacteriology tests from 1/3/24 to 8/20/25. The findings include: 1. The MPI for Uricult media states "remove certificates of analysis from package insert for each new lot and attach to QC records." 2. COA for lots 1925761 and 1926104 were not retained. 3. The LM confirmed on 8/20/25 at 11:00 am, the COA for all Uricult media were not retained. Note: This deficiency was previously cited on the survey performed on 1/2/24. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Manager (LM), the laboratory failed to review all unsatisfactory scores and document

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on an in-office review of the laboratory's requirements for a New Jersey State Clinical Laboratory License (NJCLL) under New Jersey Statutes Annotated: N.J.S.A. 45:9-42.28. License; necessity; categories, the laboratory failed to maintain a NJCLL for calendar year 2023 or any prior years. The Laboratory manager confirmed on 1/2 /24 at 11:30 am that the laboratory did not maintain a NJCLL for 2023 or any prior years. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records, Manufacturers Package Insert (MPI) and interview with the Laboratory Manager (LM) the laboratory failed to retain Certificates of Analysis (COA) for Uricult media used for Bacteriology tests from 2/10/22 to the date of the survey. The findings include: 1. The MPI for Uricult media states "remove certificates of analysis from package insert for each new lot and attach to QC records." 2. The LM confirmed on 1/2/24 at 11:00 am that the COA for Uricult media were not retained. 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 -- 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 surveyor review of the Procedure Manual (PM), Uricult Manufacturers Specifications (MS) and interview with the Laboratory Manager (LM) the laboratory failed to have written procedures for resulting urine cultures using Uricult media from 1/2/24 to the date of survey. The LM confirmed on 1/2/24 at 12:00 pm, the laboratory failed to have written procedures for resulting urine cultures using Uricult media. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records, the Procedure Manual and interview with the Laboratory Manager (LM), the laboratory failed to check each new lot number and shipment of Selective Strep Agar (SSA) media for its ability to inhibit specific organisms from 2/10/22 to the date of the survey. The findings include: 1. The laboratory failed to use at least one organism to confirm the inhibitory characteristic of SSA media. 2. The LM confirmed on 1/2/24 at 11:30 am the laboratory did not perform the above mentioned QC on SSA media. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a lack of a Quality Assessment (QA) plan, review of the Procedure Manual and interview with the Laboratory Manager (LM), the Laboratory Director (LD) failed -- 2 of 3 -- to establish a QA program to assure the quality of laboratory services provided from 2 /10/22 to the date of the survey. The LM confirmed on 1/2/24 at 11:00 am that the LD failed to establish a QA program. -- 3 of 3 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the reagents and interview with the Testing Personnel (TP), the laboratory failed to label the reagents used to perform Bacteriology testing with pertinent information required for proper use on the date of survey. The finding includes: 1. The laboratory did not document received date on Bacitracin TAXO discs lot # 0343425. 2. The TP confirmed on 2/10/22 at 10:05 am the laboratory did not document received date on Bacitracin TAXO discs lot # 0343425. 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 --

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Director (LD), the laboratory failed to evaluate results when the laboratory received an unacceptable score in PT for Urine Colony Count Combo performed with the College of American Pathologists (CAP) in 2018. The finding includes: 1. There was no review or evaluation documented when the laboratory received an unacceptable result for MC-02 in the MC4-A, and MC-10 in the MC4-B 2018 events. 2. The TP#2 listed on CMS form 209 confirmed on 4/4/19 at 1:20 pm that the laboratory did not perform and document an evaluation of unacceptable PT performance. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: 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 -- a. Based on surveyor review of the Personnel Files (PF) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to have appropriate education records for all Testing Personnel (TP) on file from 5/10/17 to the date of the survey. The finding includes: 1. 7 out of 8 TP did not have education records. 2. The TP#2 listed on CMS form 209 confirmed on 4/4/19 at 12:00 pm education records were not in the PF. b. Based on surveyor review of the PF and interview with the TP, the LD failed to have training documentation for Throat Culture tests for TP #8 from February 2019 to the date of the survey. The TP #2 listed on CMS form 209 confirmed on 4/4/19 at 12:20 pm training records were not in the PF for TP #8. -- 2 of 2 --