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 NJCLL for calendar year 2023. A Surveyor for the Clinical Laboratory Improvement Services (CLIS) confirmed on 9/26/23 that the laboratory did not have a NJCLL license for 2023. 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 laboratory records and interview with the Laboratory Director (LD), the laboratory failed to maintain the patient raw data print-outs from the Horiba Micros 60 used for hematology testing. The findings include 1. The LD stated "after the raw data print-outs have been manually entered into the Electronic Medical Records (EMR) they are shredded". 2. The raw data print-outs containing 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 -- results and data alarm flags were not maintained. 3. The LD confirmed on 9/27/23 at 10:00 am that raw data print-outs containing results and data alarm flags were not maintained 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), and interview with the Laboratory Director (LD), the laboratory failed to have a procedure for Quality control verification (QVC) for Hematology testing from 6/10/21 to the date of survey. The TP confirmed on 9/26/23 at 10:00 am that the laboratory failed to have the above mentioned procedure. 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 493.1253. (7) Control procedures. (8)

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 10/20/20 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 CV calculated for Calibration performed on 10/20/20 and 4/21/21. 3. The LD confirmed on 6/10/21 at 11:45 AM that the laboratory did not follow the OM. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of Hardy Diagnostic Bacitracin Discs (HDBD) and interview with the Registered Nurse (RN), the laboratory failed to discard expired (HDBD) from 2/28/21 to the date of survey. The findings include: 1. On the date of 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 -- the survey the laboratory used expired HDBD Lot # 404704 expired 2/28/21 2. Approximately 323 patients were tested with expired HDBD. 3. The RN confirmed on 6/10/21 at 12:00 pm that the laboratory used expired HDBD. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (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 Laboraotry Director (LD), the laboratory failed to check each lot number and shipment of Bacitracin Discs for positive and negative reactivity from 8/13/20 to the date of the survey. The LD confirmed on 6/10/21 at 11:00 am that QC was not performed. -- 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 Testing Personnel (TP), the laboratory failed to check each new lot number and shipment of Throat Culture and Urine Culture media for sterility from 1/1/19 to the date of the survey. The TP #1 listed on CMS form 209 confirmed on 4/2/19 at 10:30 am the laboratory did not perform the above QC. 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), Procedure Manual (PM) and interview with the Laboratory Director (LD), the laboratory failed to identify the source of the Reference Intervals (RI) used for Hematology tests from 1/1/19 to the 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 -- date of the survey. The findings include: 1. The RI found on the FR and the Result Report (RR) from the ABX Micros 60 did not agree with the established RI in the PM. 2. RI differed as below: a. White Blood Cells (WBC) FR: 5 - 14 RR: 3.5 - 10 PM: 4.5-13 b. Hemoglobin (HgB) FR: 11 - 11 - 14 RR: 11 - 16.5 PM: 11 - 15 c. Hematocrit (HCT) FR: 35 - 45 RR: 35 - 50 PM: 35 - 45 d. Platelets (PLT) FR: 140 - 400 RR: 150 - 450 PM: 150 - 450 e. Lymphocytes % FR: 25.5 - 45 RR: 17 - 48 PM: 25 - 45 f. Granulocytes % FR: 34 - 64 RR: 43 - 76 PM: 30 - 60 g. Monocytes % FR: 1 - 5 RR: 4 - 6 PM: 1 - 15 3. The LD confirmed on 4/2/19 at 12:00 pm that the source of the RI on the FR was unknown. 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: Based on the surveyor review of the Personnel Files and interview with the Testing Personnel (TP), the Laboratory Director failed to have training documented on the AB Micros 60 for four out of five TP from 1/1/19 to the date of the survey. The TP #4 listed on the CMS from 209 confirmed on 4/2/19 at 11:20 am that all TP did not have training documented. -- 2 of 2 --