Advocare Morristown Pediatrics

Summary Statement of Deficiencies D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on surveyor observation of where Bacteriology testing was performed and the lack of decontamination records and interview with the Testing Personnel(TP), the laboratory failed to ensure contamination of laboratory work areas were minimized from 3/23/21 to the date of inspection. The TP #1 as listed on the CMS-209 form confirmed the laboratory failed to ensure contamination of laboratory work areas where minimized. 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 2023. A Surveyor for the Clinical Laboratory Improvement Services (CLIS) confirmed on 6/19/23 that the laboratory did not have a NJCLL license for 2023. D5401 PROCEDURE MANUAL 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 -- 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 follow all procedures written for "Taxo A QC Kit (#3137)" from 3/23/21 to the date of the survey. The findings include: 1. The procedure "Taxo A QC Kit (#3137)," stated "Note: Quality control should be performed and results recorded each week patient tests are done." 2. There was no documented evidence the above mentioned procedure was performed. 3. The TP #1 listed on CMS-209 confirmed on 6/15/23 at 11:00 am that the laboratory did not follow the PM. 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 culture media and interview with the Testing Personnel (TP), the laboratory failed to discard expired culture media used for Bacteriology tests from 05/09/2023 to the ate of survey. The findings include: 1) 1 unopened 10 pack of Hardy Diagnostics Selective Strep Agar, Lot # 150746, Expiration date of 05/09/2023 was observed. 2) The TP #1 listed on CMS-209 form confirmed on 6/15/23 at 12:10 pm that laboratory failed to discard expired culture media. 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 Final Reports (FR) and interview with the Testing Personnel (TP), the laboratory failed to ensure the FR had all the required information from 05/25/16 to the date of survey. The finding includes: 1. The laboratory failed to include a FR date on 10/10 FR 2. The laboratory failed to have a final result in the -- 2 of 3 -- "Result" section in 4/10 FR. 3. The laboratory failed to have a reference range value in 4/10 FR. 4. The TP #1 listed on the CMS form 209 confirmed on 6/15/23 at 12:10 PM that all the required information was not on the FR. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. 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 establish a procedure for verifying manually entered results into the Electronic Medical Record from 06/12/18 to the date of survey. The TP #1 as listed on CMS form 209 confirmed on 6/19/23 at 12:15 pm that the laboratory did not have the procedure mentioned above. Note: This is the third time citation has been observed. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the Procedure Manual and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to establish a Quality Assurance (QA) program for verifying manually entered results into the Electronic Media Record from 6/12/18 to the date of survey. The TP#1 as stated on CMS-209 form confirmed on 6/15 /23 at 11:45 AM that a QA program was not established. -- 3 of 3 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. 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 maintain Attestation Statements (AT) for Throat Culture tests performed with the College of American Pathologists (CAP) for events D1-A 2020 and D1- C 2020. The TP #4 as listed on CMS form 209 confirmed on 3/23/21 at 1:15 pm that the laboratory did not maintain AT for PT. 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: 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 surveyor review of the Test Reports (TR) and interview with the Testing Personnel (TP), the laboratory failed to have accurate Reference Ranges (RR) for Throat Culture (TC), Rapid Flu and Rapid Strep tests from 06/12/18 to the date of the survey. A review of the TR revealed the RR was listed as "Negative, Presumptive, Not Performed" The TP #4 as listed on CMS form 209 confirmed on 3/23/21 at 2:00 pm that these tests did not have accurate Reference Ranges on the TR. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. 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 establish a procedure for verifying manually entered results into the Electronic Medical Record from 06/12/18 to the date of survey. The TP #4 as listed on CMS form 209 confirmed on 03/23/21 at 2:15 pm that the laboratory did not have the procedure mentioned above. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files, Competency Assessment (CA) records and interview with the Testing Personnel (TP), the Technical Consultant (TC) failed to perform CA from 06/12/18 to the date of survey. The findings include: 1. The CA was not performed by the TC. 2. The TP #4 performed CA on TP #1, TP #2, TP #3 and TP # 5. 3. TP #1 performed the CA for TP # 4 4. TP #4 and TP #1 were not qualified to perform CA 5. The TP #4 as listed on CMS form 209 confirmed on 03/23 /21 at 1:15 pm that the CA was not performed by the TC. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to maintain the Throat Culture work record and attestation statement for the A-2018 PT event with the College of American Pathologists (CAP). The OM confirmed on 6/12/18 at 1:15 pm that all PT records were not maintained. 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 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 -- 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 Final Report (FR) and interview with the Office Manger (OM), the laboratory failed to ensure that the Test Report Date (TRD) was indicated on the FR for Throat Cultures from 5/25/16 to the date of survey. The OM confirmed on 6/12/18 at 1:45 pm that the TRD was not on the FR. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed to have a procedure to verify manually entered results into electronic medical records for accuracy from 5/25/16 to the date of survey. The OM confirmed on 6/15/18 at 1:35 pm that the laboratory did not have the procedure mentioned above. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require