Vicki Rapaport, Md A Professional Corp

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 the survey on September 13, 2024, the surveyor's observations during the laboratory tour and interviews with the medical assistant (MA) and manager, it was determined that the laboratory failed to be in compliance with applicable Federal, State, and local laboratory requirements and guidelines. The findings include: 1. Based on the observations during the laboratory tour at approximately 1:25 p.m., only the diplomas of the laboratory director (LD) were found to be posted, and no State license was found. 2. Based on the interviews with the MA and manager on September 13, 2024, at approximately 1:45 p.m., no State license was found in all files, e-mails, and rooms at the facility. 3. Based on the desk review performed by the surveyor on September 16, 2024, it was determined that the State license of the facility had expired on June 24, 2017. 4. Based on the annual testing declaration submitted at the time of survey, the facility processed, performed, and reported approximately 1,010 patient test results for Mycology and Dermatopathology during the time when the State license was expired. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory tour and interview with the laboratory's medical assistant (MA), it was determined that the laboratory failed to follow established safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. The findings include: 1. Based on the surveyor's observations during the laboratory tour on September 13, 2024, no eye wash station or portable eye wash bottles were found. 2. Based on the observations of the surveyor during the laboratory tour, the fire extinguisher found was tied to the platform on the lower corner of the wall heading into the break room, which cannot be accessed due to a cabinet beside it. No check tag was also found, and when the MA was interviewed, no documentation for maintenance was available for review. 3. Based on the interview with the MA, the facility recently renovated the area that included the eye wash station and none replaced it. 4. The MA affirmed by interview on September 13, 2024, at approximately 1:25 p.m. that the laboratory lacked an eyewash, the fire extinguisher was inaccessible, and that no function check maintenance was performed located near the testing area. 5. Based on the laboratory's annual testing volume declaration signed by the laboratory director on 09/11/2024, the laboratory processed and reported approximately 1,010 patient test samples. 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 the lack of documentation of testing personnel competency assessment records, a review of patient records, and an interview with the medical assistant (MA) on September 13, 2024, as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to establish a written policy and procedure to assess the testing personnel competency for the years 2022, 2023, and 2024. Findings include: 1. Based on the survey on September 13, 2024, it was determined that the laboratory lacked an established and approved policy and procedure for competency assessment, resulting in missed personnel competency assessment for all physician assistants (PAs) and MAs for the for the years 2022, 2023, and 2024. 2. The MA affirmed by interview at approximately 12:45 p.m. on September 13, 2024, that all personnel that collected and processed the samples for the KOH test had no competency assessment for the years 2022, 2023, and 2024. 3. Based on the review of patient records, the laboratory failed to provide documentation of training and competency assessment for all personnel performing KOH sample collection and processing for the years 2022, 2023, and 2024. 4. According to the laboratory's annual testing declaration submitted at the time of the survey, the laboratory performed 10 KOH tests for the subspecialty of Mycology, for which the competencies of the PAs were not performed. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue -- 2 of 4 -- corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on the surveyor's review of five (5) patient records and an interview with the medical assistant (MA), two (2) out of 5 records were discrepant in their log sheet and final report. The findings include: 1. Based on the survey on September 13, 2024, at approximately 12:05 p.m., the surveyor reviewed a total of 5 randomly chosen patient records covering the period from June 23, 2022, to May 20, 2024 for KOH test. 2. Based on the records reviewed, 2 out of 5 KOH patient records were inconsistent as follows: a. Patient #2, DOB-4-18-55, was examined for two sites, namely, the neck and left hip. The assessment notes only stated left hip, while the final report stated neck as the source of the specimen. b. Patient #4 DOB-6-17-55, review of the patient log showed positive result but recorded negative in the reading report. 3. The MA affirmed by interview on September 13, 2024, that the inconsistentcies described in number 1 (a & b) above were recorded erroneously. Further investigation is needed to be performed. No

Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on the lack of an up-to-date policies and procedures manual, policy for documents, reports, and biopsy slides retention, review of six (6) randomly chosen dermatopathology test records, and interview with the laboratory's testing personnel (TP), the laboratory failed to have a policy for documents and biopsy slides retention. The findings included: 1. On the day of survey, February 8, 2022, at approximately 11: 40 a.m. based on review of the policies and procedures (P&P) manual, the laboratory failed to provide an up-to-date P&P on the current practice including a policy for length of retention of documents, patient reports, and biopsy slides. 2. The laboratory TP confirmed by interview on February 8, 2022, at approximately 12: 00 p.m. that the laboratory did not have an updated P&P for document and biopsy slide preparations retention policy. 3. The laboratory reports performing approximately 590 dermatopathology patients' tests annually. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. 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 STANDARD is not met as evidenced by: Based on the surveyors' interviews with the laboratory director (LD) and laboratory testing personnel (TP) and record review of pre-analytic remedial action records on February 8, 2022; the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the laboratory's preanalytic systems when received patient biopsy slides did not meet the laboratory's criteria for acceptability. Findings included: 1. According to laboratory TP, during preanalytic review of patients' processed biopsy slides, if a patient specimen was received that did not meet the laboratory's criteria for acceptability, a description as to why the specimen did not meet the laboratory's criteria for acceptability would be documented, appropriate