Tenafly Pediatrics

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 1/24 /24 at 11:30 am that the laboratory did not maintain a NJCLL for 2024 or any prior years. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Reports (FR) and interview with the Office Manager (OM), the laboratory failed to ensure FR for Overnight Throat cultures 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 -- included all required information from 6/17/21 to the date of the survey. The finding includes: 1. A review of ten FR revealed that five out of ten did not have the date and time the specimen was collected and the date and time results were reported. 2. The OM confirmed on 1/24/24 at 11:50 am that the FR did not include all required information. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on the surveyor review of the Final Report (FR) and interview with the Office Manager (OM), the laboratory failed to have a Reference Range (RR) for Overnight Throat Culture from 6/17/21 to the date of the survey. The OM confirmed on 1/24/24 at 11:15 that the above test did not have a RR on the FR. -- 2 of 2 --

Summary Statement of Deficiencies 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 5/15/19 to the date of survey. The findings include: 1. The OM stated 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 CV calculated for Calibration performed on 5/15/19, 10/3/19 and 11/6/20. 3. The LD confirmed on 6/17/21 at 10:45 AM that the laboratory did not follow the OM. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 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 the Performance Specification (PS) records and interview with the Laboratory Director (LD), the laboratory failed to ensure that all PS procedures were performed for Hematology testing on the Horiba ABX Advia from October 2020 to the date of survey. The finding includes: 1. The laboratory did not verify Patient Normal Range. 2. The LD confirmed on 6/17/21 at 11:15 am that not all PS were performed. -- 2 of 2 --

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (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 and interview with the Laboratory Director (LD), the laboratory failed to verify that assayed QC material was within the acceptable range before it was put into use for all analytes ran on the Horiba ABX Micros 60 analyzer in September 2018 to the date of survey. The finding includes: 1. There were no QC verification records for Horiba Hematology controls Lot# MX413. 2. The LD confirmed on 10/18/18 at 1:00 pm that the laboratory did not verify QC material before use. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests 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, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on the surveyor review of the Final Reports (FR) and interview with the Laboratory Director (LD), the laboratory failed to have a Reference Range (RR) for Hemoglobin parameters on FR from 10/31/16 to the date of the survey. The LD confirmed on 10/25/18 at 11:10 am that the above parameter did not have a RR on the FR. 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 the lack of a Quality Assessment (QA) program and interview with the Laboratory Director (LD), the LD failed to establish a QA program for laboratory testing from 10/31/14 to the date of survey. The findings include: 1)This deficiency was previously cited on 10/31/16. 2) The

Summary Statement of Deficiencies 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 an office review of the CASPER reports 153 and 155 and proficiency testing provider reports, the laboratory failed to achieve a score of at least 80% or more in two out of three events for Hemoglobin test and three out of four events for White Cell Differential tests with the College of American Pathologists. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% for White Cell Differential (WCD) and Hemoglobin (HGB) test. The finding includes: 1. The laboratory scored 60% in 3-16 and 2-17 and 0% in 3-17 for WCD PT events with the College of American Pathologists (CAP). The laboratory failed 3 out of 4 PT events for WCD. 2. The laboratory scored 0% in 1-17 and 3-17 for HGB PT events with CAP. 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 2 of 2 --