Tenafly Pediatrics-Paramus Facility

Summary Statement of Deficiencies D5781

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 11:30 am 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 6/30/23 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 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 -- calculated for Calibration performed pm 6/30/23 and 1/29/24. 3. The LD confirmed on 3/13/24 at 10:45 AM that the laboratory did not follow the OM. 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 Reports (FR), and interview with the Laboratory Director (LD), the laboratory failed to have accurate Reference Interval (RI) for Endocrinology tests fom 1/22/20 to the date of survey. The findings include: 1. A review of eight FR revealed as follows: a. Five out of eight FR's had an RI of 12- 18 g for Hemoglobin (HgB). b. One our of eight FR's had an RI of 4.0-6.2% for Red Blood Cell (RBC). c. One out of eight FR's had no RI for all Complete Blood Count (CBC) analytes. 2. The LD confirmed on 3/13/24 at 10:00 am that laboratory failed to have accurate RI. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Laboratory Director (LD), the laboratory failed to perform the CA correctly for seven out of seven Testing Personnel (TP) from 3/23/18 to the date of the survey. The findings include: 1. The laboratory did not document assessment of test performance on seven TP. 2. Seven of seven TP did not have a CA performed in the calendar year 2018. 3. One of seven TP did not have a CA performed in the calendar year 2019. 4. The LD confirmed on 1/22/20 at 10:30 am that the CA was not performed correctly. 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 observation of the incubator and Throat Culture (TC) plates, review of the Procedure Manual (PM), and interview with the Laboratory Director (LD), the laboratory failed to follow the PM for streaking TC specimens from 3/23/18 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 -- to the date of the survey. The finding includes: 1. The PM stated to use one plate for each patient but observation of the incubator revealed the laboratory streaked two patients per plate. 2 The LD confirmed on 1/22/20 at 10:20 am that the laboratory did not follow the PM. 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 sterility from 3/23/18 to the date of the survey. The LD confirmed on 1/22/20 at 10:50 am the laboratory did not perform the above QC. 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 surveyor review of Personnel Files (PF) and interview with the Laboratory Director (LD), the LD failed to have education documented for five out of seven Testing Personnel from 3/23/18 to the date of the survey. The LD confirmed on 1/22 /20 at 10:00 am that all education records were not available. -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisor (GS), the laboratory failed to evaluate a score of 20% for Hematocrit % (Hct%) and 80% for Red Blood Cell (RBS) Count results obtained in FH2-A 2016 Hematology Auto Differentials event with the College of American Pathologists (CAP). The findings include: 1. The laboratory did not evaluate unacceptable results for Hct% for specimens FH2-01, FH2-03 through 05 in FH2-A- 2016 event. 2. The laboratory did not evaluate unacceptable results for RBC for specimen FH2-02 in FH2-A- 2016 event. 3. The GS confirmed on 11/28/17 at 2:30 pm that the laboratory failed to evaluate coded results for PT events in 2017 and 2016. 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: 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 -- 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 or inhibit specific organisms b Sterility of media. c. visual check 2. The LD confirmed on 3/23/18 at 1:00 pm 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 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 four out of five Testing Personnel from 11/13/15 to the date of the survey. The GS confirmed on 2/23/18 at 9:40 am that there were no education records for four out of five TP. -- 2 of 2 --