Rutgers Diagnostic Services

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on the lack of Biannual Assessment (BA) records and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy of Histopathology testing from 8/1021 to the date of survey. The LD confirmed on 11/14 /23 at 1:30 pm that the laboratory did not perform BA for Histopathology. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. 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 document Hematoxylin and Eosin (H&E) control slide reactions for Histopathology testing on the date of survey. The findings include: 1. The laboratory did not document H&E stain QC reactions. 2. 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 -- laboratory read and reported approximately 200 patients annually,. 3. The OM confirmed on 11/14/23 at 1:30 pm that the laboratory did not document H&E QC stain reactions. 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 Test Reports (TR) and interview with the Laboratory Director (LD), the laboratory failed to ensure that the TR included all the required information on the date of survey. The finding includes: 1. The TR did not have the name and address of where the Techincal Component for histopathology was performed. 2. The LD confirmed on 11/14/23 at 1:30 pm that the TR failed to include all the required information. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual, interview with the Laboratory Director (LD), the laboratory failed to establish acceptable written procedures for Biannual Assessment (BA) calendar years 2018 and 2019. The findings include; 1) The BA did not have the current licence for the Physician reviewing the slides. 2) The BA did not state that slides were being sent to the reviewing physician without the diagnosis. 3) The LD confirmed on 8/6/19 at 10:30 am that the LD failed to establish acceptable written procedures for BA. 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. 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 Test Report (TR) and interview with the Laboratory Director (LD), the laboratory failed to include the name and address of the laboratory where the Technical Component (TC) for Histopathology tests were performed from 1 /25/2018 to the date of survey. The LD confirmed on 9/24/19 at 10:00 am that the TC laboratory name and address was not on the TR. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Laboratory Director (LD), the laboratory failed to establish a written procedure for Biannual Assessment (BA) from October 2017 to the date of survey. The LD confirmed on 1/25 /18 at 11:00 am that a BA procedure was not established. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. 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 record the reaction of a QC slide for 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 -- Hematoxylin and Eosin stains used in Histology Testing from October 2017 to the date of survey. The LD confirmed on 1/25/18 at 11:10 am that a QC reaction was not documented. -- 2 of 2 --