Meghan M Caruso Do

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 2024 or any prior years. The Program Manager for the Clinical Laboratory Improvement Services (CLIS) confirmed on 3/8/24, prior to the recertification survey, that the laboratory did not have a NJCLL license for 2024 or any prior years. The Laboratory Director confirmed on 3/12/24 at 12:00 pm that the laboratory did not maintain a NJCLL for 2024 or any prior years. 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 Testing Personnel (TP), the laboratory failed to have a procedure for the DTM testing from 11/10/22 to the date of survey. The TP confirmed on 3/12/24 at 11:00 am that the laboratory failed to have the aforementioned procedure. 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 -- D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor review of the Taylor thermometers used for incubation and in the refrigerator and interview with the Testing Personnel (TP), the laboratory failed to provide documentation of calibration for the Taylor thermometers used in the laboratory from 11/10/22 to the date of the survey. The findings include: 1. The laboratory could not provide documentation of calibration for the Taylor thermometers used for incubation and in the refrigerator. 2. The TP confirmed on 3/12 /24 at 11:15 am that they could not provide documention of calibration of the Taylor thermometers. -- 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 lack of the Competency Assessment (CA) records and interview with the Testing Personnel (TPGS), the laboratory failed to perform a CA on one out of one TP from 8/16/17 to the date of survey. The TP # 2 listed on CMS form 209 confirmed on 8/14/19 at 10:20 am that CA was not performed on TP. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Testing 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 -- Personnel (TP), the Laboratory Director (LD) failed to establish a Competency Assessment (CA) procedure with the required elements from 8/16/17 to the date of the survey. The PT # 2 listed on CMS form 209 confirmed on 8/14/19 at 10:45 am that CA procedure was not established by LD. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Records (PF) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to specify in detail the duties and responsibilities for one out of one TP engaged in the performance of Dermatophye Test Media testing from 8/16/17 to the date of survey. The TP # 2 listed on CMS form 209 confirmed on 8/14/19 at 10:15 am that the LD did not specify the duties and responsibilities of TP. -- 2 of 2 --