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 4/30/24 that the laboratory did not have a NJCLL license for 2024. 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), Work Records (WR) and interview with the Laboratory Director (LD), the laboratory failed to follow procedure "Protocol for Horiba when controls fail"on 3/16/24 and 3/28/24. The findings include; 1. The procedure "Protocol for Horiba when the controls fail" states "1. Try running the controls 2X" if controls fail "2. Run another start-up" and "3. run controls again" 2. On 3/16/24 and 3/28/24 Control, lot #MX446 low was run five times consecutively 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 -- on each date. 3. The LD confirmed on 4/30/224 at 11:00 am the laboratory did not follow the PM. 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 4/26/21 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 documented evidence that CV calculated for Calibration. 3. The LD confirmed on 4/30 /24 at 10:45 am that the laboratory did not follow the OM. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to ensure that all Testing Personnel (TP) who performed Hematology tests participated in the College of American Pathologists (CAP) PT events in the calendar years 2019 and 2020. The finding includes: 1. A review of all PT events revealed that only two out of six TP performed PT all events in 2019 and 2020. 2. The TP #1 listed on CMS form 209 confirmed on 4 /29/21 at 1:30 pm that PT events were not rotated between TP. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. 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 -- This CONDITION is not met as evidenced by: Based on surveyor review of the COVID 19 Veritor Plus system, patient test results and interview with the Testing Personnel (TP), the laboratory failed to report COVID 19 test results to the State of New Jersey (NJ) from September 2020 to the date of the survey. The findings include: The laboratory did not report as follows: 1. The Laboratory did not report Negative COVID 19 results to the State of NJ. 2. The Laboratory performed approximately 40 COVID 19 tests per day. 3. The TP #1 listed on CM'S form 209 confirmed at 2:30 pm on 4/29/2021 that the laboratory did not report all COVID test results. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to retain all records from Throat Culture PT events performed with the College of American Pathologists (CAP) in the calendar year 2020. The finding includes: 1. The laboratory did not retain the PT results for D1- B 2020 Throat Culture event. 2. The TP #1 listed on CMS form 209 confirmed on 4/29 /21 at 2:00 pm that PT record was not retained. 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 COVID 19 Veritor System and interview with the Testing Personnel (TP), the laboratory failed to follow the Information for Use (IFU) when performing Covid tests from September 2020 to the date of the survey. The findings include: The laboratory did not follow the IFU as below: 1. The Laboratory did not report negative Covid 19 results to the State of New Jersey. 2. The Laboratory performs approximately 40 tests per day. 3. The TP # 1 as listed on CMS form 209 confirmed at 2:05 pm on 04/29/2021 that the laboratory did not follow the IFU. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Test Report (TR) and interview with the Testing Personnle (TP), the laboratory failed to report Covid 19 testing accurately from September 2020 to the date of the survey. The findings state: 1. The laboratory performed non Food and Drug Administration (FDA) Emergency Use Authorization (EUA) cleared tests and there was no statement stating "This test has not been FDA cleared or approved; The test has been authorized by FDA under an Emergency Use Authorization (EUA). 2. The TP #1 listed on the CMS form 209 on 04/29/2021 at 2: 00 pm that COVID 19 tests were not reported accurately. 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 Testing Personnel (TP), the Laboratory Director failed to have education documented for two out of six TP from 9/24/18 to the date of the survey. The TP #1 listed on CMS form 209 confirmed on 4/29/21 at 1:10 pm that all education records were not available. -- 3 of 3 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to ensure that all Testing Personnel (TP) who performed Hematology tests participated in the College of American Pathologists (CAP) PT events in the calendar years 2019 and 2020. The finding includes: 1. A review of all PT events revealed that only two out of six TP performed PT all events in 2019 and 2020. 2. The TP #1 listed on CMS form 209 confirmed on 4 /29/21 at 1:30 pm that PT events were not rotated between TP. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. 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 -- This CONDITION is not met as evidenced by: Based on surveyor review of the COVID 19 Veritor Plus system, patient test results and interview with the Testing Personnel (TP), the laboratory failed to report COVID 19 test results to the State of New Jersey (NJ) from September 2020 to the date of the survey. The findings include: The laboratory did not report as follows: 1. The Laboratory did not report Negative COVID 19 results to the State of NJ. 2. The Laboratory performed approximately 40 COVID 19 tests per day. 3. The TP #1 listed on CM'S form 209 confirmed at 2:30 pm on 4/29/2021 that the laboratory did not report all COVID test results. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to retain all records from Throat Culture PT events performed with the College of American Pathologists (CAP) in the calendar year 2020. The finding includes: 1. The laboratory did not retain the PT results for D1- B 2020 Throat Culture event. 2. The TP #1 listed on CMS form 209 confirmed on 4/29 /21 at 2:00 pm that PT record was not retained. 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 COVID 19 Veritor System and interview with the Testing Personnel (TP), the laboratory failed to follow the Information for Use (IFU) when performing Covid tests from September 2020 to the date of the survey. The findings include: The laboratory did not follow the IFU as below: 1. The Laboratory did not report negative Covid 19 results to the State of New Jersey. 2. The Laboratory performs approximately 40 tests per day. 3. The TP # 1 as listed on CMS form 209 confirmed at 2:05 pm on 04/29/2021 that the laboratory did not follow the IFU. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Test Report (TR) and interview with the Testing Personnle (TP), the laboratory failed to report Covid 19 testing accurately from September 2020 to the date of the survey. The findings state: 1. The laboratory performed non Food and Drug Administration (FDA) Emergency Use Authorization (EUA) cleared tests and there was no statement stating "This test has not been FDA cleared or approved; The test has been authorized by FDA under an Emergency Use Authorization (EUA). 2. The TP #1 listed on the CMS form 209 on 04/29/2021 at 2: 00 pm that COVID 19 tests were not reported accurately. 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 Testing Personnel (TP), the Laboratory Director failed to have education documented for two out of six TP from 9/24/18 to the date of the survey. The TP #1 listed on CMS form 209 confirmed on 4/29/21 at 1:10 pm that all education records were not available. -- 3 of 3 --

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 Testing Personnel (TP), the laboratory failed to perform CA correctly on six of six TP in 2017 and 2018. The findings include: 1. The CA was not assessed for test performance (procedure 3). 2. An arrow was drawn from Test Evaluation elements 2 to 13, procedures A,B,C and E were used to assess all but they were not all applicable. 3. The TP # 1 listed on CMS form 209 confirmed on 9/24/18 at 1:00 pm that CA was not performed correctly. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure 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 -- accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on surveyor review of the Test Requisitions (TR) and interview with the Testing Personnel (TP), the laboratory failed to ensure that TR included relevant and necessary information for accurate and reliable testing and reporting from January 2018 to the date of survey. The findings include: 1. A review of ten TR revealed ten of ten did not have the specimen source and collection date recorded. 2. The laboratory did not document any efforts made to get the information. 3. The TP #1 listed on CMS form 209 confirmed on 9/24/18 at 2:20 pm that specimen source and collection date was not on the TR. 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 QBC Hematology Control Manufacture Package Insert (MPI), observation of the control and interview with the Testing Personnel (TP), the laboratory failed to follow MPI instructions for stability of QBC Quality Control (QC) material at the time of the survey. The findings include: 1. The MPI stated that controls were stable for 4 days once opened. 2. There was no open or expiration date documented on QC in use. 3. The TP stated the controls were used for one week and then discarded. 4. Approximately 10 to 20 patients were run each day. 5. The TP #1 listed on CMS form 209 confirmed on 9/24/18 at 1:20 pm that the MPI was not followed. 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 Laboratory Director (LD), the laboratory failed to check each lot number of the identification system used for Urine Cultures (UC) for positive and negative reactivity from 9/22/16 to the date of the survey. The findings include: 1. The laboratory used a split media plate with Sheep's Blood Agar and Eosin Methylene Blue (EMB) for UC identification. 2. The laboratory identified organisms at the specie level and did not -- 2 of 3 -- perform any QC or Biochemical reactions. 3. The laboratory reported on the Final Report: a. "Looks like E. coli" b. "Looks like E. coli - not confluent growth (prob just under 100,000)" 4. The LD confirmed on 9/24/18 at 2:35 pm that QC was not performed for positive and negative reactivity on UC 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 the surveyor review of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check QC on each batch of Urine (UC) and Throat Culture (TC) media from 9/22/16 to the date of the survey. The findings include: 1. TC media was not checked for its ability to select or inhibit specific organisms. 2. UC media was not checked for: a. Ability to support growth b. Ability to select or inhibit specific organisms 2. The TP #1 listed on CMS form 209 confirmed on 9/24/18 at 2:10 pm that 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 surveyor review of the Final Report (FR) and interview with the Testing Personnel (TP), the laboratory failed to ensure that the Normal Reference Intervals (NRI) were indicated on the FR for tests performed in the laboratory from 9/22/16 to the date of survey. The findings include: 1. There was no NRI for Throat and Urine Culture results. 2. % Granulocytes and Lymphocytes/Monocytes did not have a NRI. 3. The TP #1 listed on CMS form 209 confirmed on 9/24/18 at 2:25 pm that the NRI were not on the FR. -- 3 of 3 --