Tenafly Pediatrics-Clifton Facility

Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (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. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check each batch of Selective Strep Agar (SSA) used for Throat Culture (TC) tests for sterility, its ability to support growth and select or inhibit specific organisms and document the physical characteristics of the media no the date of the survey. The findings include: 1. There was no documented evidence the above mentioned QC was performed on SSA lot # 652907. 2. Approximately 5 patients were run and reported. 2. The TP confirmed on 4 /15/25 at 11:00 am that the laboratory did not perform QC as stated above. 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 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 2024 or any prior years. The Laboratory manager confirmed on 3/13 /24 at 12:30 pm that the laboratory did not maintain a NJCLL for 2024 or any prior years. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of the Operators Manual (OM), Procedure Manual (PM), and interview with the Laboratory Director (LD), the laboratory failed to follow the OM for "Preparation for Calibration" from 1/22/20 to the date of survey. The findings include: 1. The OM states to "perform a repeatability/precision study by running one normal patient sample tens times" , "Calculate the Coefficient of Variation (CV) for each of the 5 parameters to ensure repeatability is acceptable ". 2. There was no 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 -- documented evidence that CV calculated for Calibration. 3. The LD confirmed on 3/13 /24 at 12:45 pm that the laboratory did not follow the OM. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the Laboratory Director (LD), the LD failed to ensure that PS procedures performed for Complete Blood Count (CBC) tests performed on the Horiba analyzer were adequate from 1/23/20 to the date of survey. The findings include: 1. There was no evidence that Accuracy was performed. 2. The LD confirmed on 3/13/24 at 12:15 pm that PS records were not adequate. -- 2 of 2 --

Summary Statement of Deficiencies 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 the surveyor review of the Quality Control (QC) records and interview with the Laboratory Director (LD), the laboratory failed to check each new lot number and shipment of Throat Culture media for its physical characteristics and sterility from 3 /23/18 to the date of the survey. The LD confirmed on 1/22/2020 at 12:50 pm the laboratory did not perform the above QC. 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 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 the lack of Quality Control (QC) records and interview with the Laboratory Director (LD), the laboratory failed to check QC on each batch of Urine Culture Media (UCM) from 11/13/15 to the date of the survey. The findings include: 1. The laboratory did not check UCM for: a. Ability to support growth. b. Ability to select or inhibit specific organisms c. Sterility of media. d. visual check 2. The LD confirmed on 3/23/18 at 10:30 am that the laboratory did not perform the above-mentioned QC checks. 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 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 -- perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of Personnel Files (PF) and interview with the General Supervisor (GS), the Laboratory Director failed to have education records for five out of seven Testing Personnel from 11/13/15 to the date of the survey. The GS #1 listed on CMS form 209 confirmed on 2/23/18 at 9:40 am that there were no education records for five out of seven TP. -- 2 of 2 --