Dr Prosper Abitbol Pa

Summary Statement of Deficiencies D0000 A recertification survey was conducted on February 26, 2024. Dr Prosper Abitbol PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of temperature logs, and interview, the laboratory failed to maintain documentation of the temperature logs for the room temperature and humidity of the laboratory for seven (August 2023 - February 2024) of 24 months (March 2022 to February 2024) reviewed. Findings: Review of the Laboratory Temperature Logs for the room temperature and humidity revealed the month of August 2023 - February 2024 were missing. On 02/26/2024 at 3:30 PM, Testing Personnel A stated she did not know where the temperature logs were located. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to follow manufacturer's instructions for storing the Schiff's Reagent from 05/18/23 to 2/26/24. (See D5411), failed to document the making of the 70 % and 95 % alcohol solutions used on the Sakura Tissue Tek VIP (Vacuum Infiltration Processor) from 02/08/2022 to 02/26/2024, failed to record the temperature of the refrigerator where reagents were stored from 03/2022 to 02/23/2024 (See D5413), failed to document the making of the 70 % and 95 % alcohol solutions used on the Sakura Tissue Tek VIP (Vacuum Infiltration Processor) from 02/08/2022 to 02/26/2024 and failed to document the making of the 95 % alcohol solution used on the Leica Autostainer XL from 02/08 /2022 to 02/26/2024 (See D5415). 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 observation, review of temperature logs, and interview, the laboratory failed to follow manufacturer's instructions for storing the Schiff's Reagent from 05/18/23 to 2/26/24. Findings: During a tour of the laboratory on 02/26/2024 at 1:30 PM, two bottles of Schiff's Reagent (lot #2308608 expiration date 03/30/2024 and lot #2326129 expiration date 09/21/2024) were found in the refrigerator. The label on the bottle for lot #2308608 noted "Store in refrigerator (2 - 8 degrees. C" (Celsius) and was dated 05/18/2023. The label on the bottle for lot #2308608 noted "Store in refrigerator (15 degrees - 30 degrees C)" and listed an open date of 11/01/2023. On 02 /26/24 at 1:39 PM, the temperature reading on the thermometer was 11.4 degrees C. Review of the Refrigerator Temperature Chart showed the laboratory placed a check mark indicating the temperature was in the range from 1 - 11 degrees C. On 02/26 /2024 at 1:31 PM, Testing Personnel A acknowledged the Schiff's Reagent may not have always been stored according to the temperature ranges on the bottles. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of temperature logs, and interview, the laboratory failed to record the temperature of the refrigerator where reagents were stored from 03/01/2022 to 02/23 /2024. Findings: Review of the Refrigerator Temperature Chart showed the laboratory -- 2 of 5 -- placed a check mark indicating the temperature was in the range between 1 - 11 degrees Celsius. On 02/26/2024 at 1:31 PM, Testing Personnel A acknowledged they put a check mark when the temperature was in range, and did not know they needed to record the actual temperatures. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, review of quality control documents, review of the laboratory's 2022

Summary Statement of Deficiencies D0000 A recertification survey conducted on 01/24/2022 found that clinical laboratory DR PROSPER ABITBOL PA was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review and staff interview, the laboratory failed to document the making of the 75 % and 95 % alcohol solutions used on the SAKURA TISSUE TEK VIP (Vacuum Infiltration Processor) from 03/10/2020 to 01/24/2022. The laboratory failed to document the making of the 95 % alcohol and 3 % Acetic Acid solutions used on the LEICA AUTOSTAINER XL from 03/10/2020 to 01/24 /2022. Findings include: -Examination of the SAKURA TISSUE TEK VIP on 01/24 /2022 at 10:30 AM, showed the processor used the following reagents: Alcohol 100 %, Alcohol 95 %, Alcohol 75 %, Formalin 10%, Safeclear and Paraffin. -Review of the SAKURA TISSUE TEK VIP Maintenance log, showed that the laboratory failed to record the preparation and expiration date for 95 % alcohol and 70 % alcohol and the lot number for the reagents used in the preparation. -Examination of the LEICA AUTOSTAINER XL on 01/24/2022 at 10:35 AM, showed that the stainer used the following reagents: Safeclear, Alcohol 100 % and 95 %, Hematoxylin, Eosin, Bluing, High Def and Acetic Acid 3 %. -Review of LEICA AUTOSTAINER XL Maintenance log, showed that the laboratory failed to record: Preparation and expiration date for 95 % alcohol and the Acetic Acid 3 % and the lot number for 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 -- reagents used in the preparation. During an interview on 01/24/2022 at 11:30 AM, the laboratory manager confirmed that the laboratory failed to keep record of the alcohol and acetic acid solutions preparation used on the SAKURA TISSUE TEK VIP and the LEICA AUTOSTAINER XL. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 03/09/2020 found that Dr Prosper Abitbol Pa clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 competency assessment record review and staff interview, the laboratory failed to have annual assessment competency for testing personnel (TP) B for 1 out of 2 years reviewed. The findings include: -A review of personnel competency assessment records for 2018 and 2019 revealed that there was not annual competency for TP B for 2019. During an interview on 03/09/2020 at 11:30 AM, TP B confirmed that the laboratory missed her annual competency for 2019. 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 record review and staff interview, the laboratory failed to ensure the twice a year accuracy verification for histopathology testing during 2019. Findings include: - Review of patient log revealed the laboratory performed testing from January to May 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 -- 21st 2019. -Review of peer review records revealed that there was no documentation of peer review for histopathology for 2019 -During an interview on 03/09/20 at 11:30 a.m., TP B confirmed that there was no documentation of peer review for histopathology during 2019. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation and an interview with the testing person, laboratory failed to provide adequate testing space and sanitary conditions to the tetsing personnel. Findings included: Observation on March 2, 2018 at 11:00AM revealed that; 1) There was no eyewash station in the laboratory. 2) Ladies purses were kept on Tissue Tek processor. 3) Laboratory back door opened inward, across the Tissue Tek, not leaving testing space for testing person. Back door was used by testing personnel and by other laboratory office employees. 4) No sufficient workbench space for test specimens, requisition slips and record log book. During an interview on March 2, 2018 at 12:00 PM, testing person confirmed that; 1) There was no eyewash station in the laboratory. 2) Ladies purses were kept on Tissue Tek processor. 3) Laboratory back door across the Tissue Tek opened inward, not leaving space for testing person. Back door was used by testing personnel and by other laboratory office employees. 4) No sufficient workbench space for test specimens, requisition slips and record log book. 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. 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 5 -- Based on observation and an interview with the testing person, laboratory failed to provide the safety and sanitary conditions to the patients and personnel. Findings included: Observation on March 2, 2018 at 11:00AM revealed that; 1) There was no eyewash station in the laboratory. 2) laboratory floor had several loose wooden rectangular tiles. 3) Ladies purses were kept on Tissue Tek processor. 4) Laboratory back door across the Tissue Tek Processor opened inward, leaving no testing space for testing person. Back door was used by testing personnel and by other laboratory office employees. During an interview on March 2, 2018 at 12:00 PM, testing person confirmed that; 1) There was no eyewash station in the laboratory. 2) laboratory floor had several loose wooden rectangular tiles. 3) Ladies purses were kept on Tissue Tek processor. 4) Laboratory back door across the Tissue Tek Processor opened inward, leaving no testing space for testing person. Back door was used by testing personnel and by other laboratory office employees. 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 record review and interview with testing person, laboratory failed to assess the competency of clinical consultant for 2 out of 2 (2016 and 2017) years reviewed. Findings included: Competency record review on March 2, 2018 at 3:15PM revealed no competency evaluations for clinical consultant for the years 2016 and 2017. During an interview on March 2, 2018 at 3:30 PM, testing person confirmed that no competencies were completed on the clinical consultant for the years reviewed. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on observation, record review and the interview with the testing person, laboratory failed to follow their owne procedures for the following areas; - monitor grounding check for the microscope, -monitor the refrigerator temperature, - have the computer key boards in the laboratory in the testing area, Findings included: A) Procedure manual review on March 2, 2018 at 3:45PM revealed that; 1- procedures for grounding check for Olympus microscope to be monitored annually were not followed. 2- procedure regarding Computer keyboards was listed under clean areas, and not to be entered with gloves on; which was not followed. A) there were norecords for Olympus microscope maintenance, that would include annual grounding check. B) Thermco external thermometer to monitor Haier refrigerator temperature did not function to show the monitored or stored temperature. C) Thermco external thermometer was not calibrated after February 26, 2014. D) Known positive quality control blocks for Helicobacter pylori( H pylori) test; Periodic acid Schiff(PAS), Alcian Blue ( AB) , stored in Haier refrigerator. E) there was no other thermometer inside Haier refrigerator to monitor the temperature. F) The laboratory specimen -- 2 of 5 -- processing area had a computer and computer keyboard. During an interview on March 2, 2018 at 4:15 PM, testing person confirmed that; (a) there were no records for Olympus microscope maintenance, that would include annual grounding check. (b) at the time of survey, Thermco external thermometer for Haier refrigerator did not show the stored temperatures, as it was supposed to. (c) Thermco external thermometer for Haier refrigerator had calibration date as February 26, 2014, with no other annual calibration dates. (d) Known positive quality control blocks for Helicobacter pylori( H pylori) test; Periodic acid Schiff(PAS), Alcian Blue ( AB) , stored in Haier refrigerator. (e) there was no thermometer inside the Haier refrigerator to monitor temperature. (f) The laboratory specimen processing area had a computer and computer keyboard. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review and interview the laboratory failed to check and monitor room temperature and humidity from January 2016 to March 2, 2018 for the subspecialty of histopathology and cytology testing. Findings included: On 3/2/18 at 1: 00PM, surveyor did not observe humidity check/ room temperature monitoring device in the laboratory. Instrument maintenance records from January 2016 to March 2, 2018 did not show records of humidity check or room temperature for the subspecialty of histopathology and cytology testing. During an interview on 3/2/18, at 1:15 PM, the testing person confirmed that the laboratory did not monitor the room temperature or humidity from January 2016 to March 2, 2018 for the subspecialty of histopathology and cytology testing. And that there were no previous records from year 2014 or 2015 and no humidity check/ room temperature monitoring device in the laboratory. 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 observation and interview, the laboratory had expired reagents. Findings included: Observation on March 2, 2018 at 1:15 PM revealed; 1) Acetone, purified - lot# 1407101, expiration date; 9/9/16. 2) Platinum line xylenes - lot# 1520322, expiration date; 1/18/2018. 3) Acetic acid solution (0.5%) - lot# 31435, expiration date; 2015-12. 4) Hydrochloric acid solution 1.00 Normal- lot # 12119224; expiration date; 7/13/14. 5) Plastic bottle labeled as acetic acid, had date 3/14/14. During an -- 3 of 5 -- interview on March 2, 2018 at 1:30 PM, testing person confirmed that the reagents 1-5 had expired and they were not isolated or labeled as not in use-expired. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to perform and record microscope maintenance from January 2016 to March 2, 2018 for the subspecialty of histopathology and cytology testing. Findings included: On 3/2/18 at 2:30PM instrument maintenance log records from January 1, 2016 to March 2, 2018 showed no documentation of microscope maintenance for the subspecialty of histopathology and cytology testing. During an interview on 3/2/18, at 3:30 PM, the testing person confirmed that the laboratory did not perform yearly microscope maintenance from January 2016 to March 2, 2018 for the subspecialty of histopathology and cytology testing. Also, there were no previous records from year 2014 or 2015 for any microscope maintenance. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on observation, record review and the interview with the testing person, laboratory director failed to be responsible for overall operation and administration, general laboratory systems, pre-analytic systems, analytic systems, and post analytic systems and to establish and maintain the quality assessment program for the histopathology and cytology subspecialty laboratory testing. Findings included: 1- No adequate testing space and no utilities (no eyewash station) in the laboratory. Refer to D3001. 2- Laboratory floor had several loose wooden rectangular tiles- physical safety hazards. Refer to D3011. 3- No yearly competency review for clinical consultant. Refer to D5209. 4- Failure to follow the procedure manual for; (a) proficiency testing protocol, eye wash station, microscope maintenance, and computer key boards. (b) Refrigerator temperature; external thermometer calibration. Refer to D5407. 5- Failure to monitor humidity and room temperature, no monitoring device. Refer to D5413. 6- Expired reagents. Refer to D5417. 7- No microscope maintenance and no records. Refer to D5429. On 2/2/18 at 5:40PM testing person confirmed; A) -- 4 of 5 -- findings 1 to 7. (B) that there was no