Schweiger Dermatology, Pllc - Pathology Lab

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 direct observation, review of the current, approved standard operating procedures (SOP), and interview with the general laboratory supervisor (GLS), the laboratory failed to maintain adequate ventilation and air quality in the areas where patient specimen processing occurred. FINDINGS: 1. Surveyors detected Xylene odor in suite 1606 on January 30, 2024, at 9:57 A.M. a. Three HEPA 1,000 CFM grade Air Scrubbers were observed in the main laboratory area. 2. Current, approved Vapor Monitoring SOP specified, "the laboratory monitors staff and/or workstations for formalin and xylene vapor exposure." Monitoring was performed on an annual basis or requested by personnel and reports were retained in the Histology laboratory. a. Stat Lab Medical Products formaldehyde and xylene vapor concentration detection badges were utilized to evaluate air quality for an eight hour period. The Stat Lab Medical Products vendor was not indicated in the current, approved SOP. b. Air quality test was performed for the main laboratory, outdoor air 65 Broadway 1606, grossing area, and histology area on September 6, 2022, and May 26, 2023. Test results included carbon monoxide, carbon dioxide, humidity, total volatile organic compound (TVOC), volatile organic compound (VOC) including acetone, benzene, ethanol, formaldehyde, styrene, toluene, turpentine, and xylene. 3. Detection badges were processed by Leica Biosystems on January 3, 2024, and results were reported January 15, 2024. 4. On January 30, 2024, at 9:30 A.M., the surveyors observed two, ten gallon drums featuring flammable/solvent waste labels as well as one, five gallon drum labeled with a barcode dated January 29, 2024, phone 646-604-4341, address 65 Broadway Suite 1606 retained in Storage Area Room #4. a. No hazardous materials or chemical safety labels were adhered to the respective drums. 5. GLS confirmed that 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 -- one ten gallon drum contained formaldehyde and alcohol waste and the second ten gallon drum contained xylene and alcohol waste. The five gallon drum contained stain waste. 6. Surveyors observed one red biohazard container contained specimen bottles and vials. The LS explained that specimens were retained for weeks and subsequently discarded. Two boxes of container and vial specimens were located on a shelf. 7. Surveyors observed that Tanner Scientific Cryostat TN50 S/N E225006 was located beside the waste drums. 8. GLS confirmed that the respective Cryostat was utilized for processing frozen sections. Refer to D6083 and D6084. 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: Based on direct observation, review of the SOPs, and interview with the GLS, the laboratory failed to maintain adequate ventilation and air quality in the areas where patient specimen processing occurred. FINDINGS: 1. Surveyors detected Xylene odor in suite 1606 on January 30, 2024, at 9:57 A.M. a. Three HEPA 1,000 CFM grade Air Scrubbers were observed in the main laboratory area. b. Three grossing areas included three fume hoods located over the workbenches. 2. Current, approved Vapor Monitoring SOP specified, "that every 4 weeks/monthly charcoal filter is changed out by Degmor Inc. (112 St. Brooklyn)." 3. On January 30, 2024, at approximately 11:00 A.M., GLM confirmed that filters were changed every four weeks/monthly and invoices were sent to SDG Corporate office located at 27-01 Queens Plaza, 10th Floor, Long Island City, New York 11101. The following invoices were reviewed: DET11879, date of service August 31, 2022; DET1906, date of service September 21, 2022; DET1943, date of service October 25, 2022; DET2006, date of service December 14, 2022; DET2082, date of service January 26, 2023; DET22139, date of service March 1, 2023; No documentation for February 23, 2023 filter change; DET2176 date of service March 28, 2023; DET2301, date of service April 28, 2023; DET2331, date of service May 31, 2023; No documentation for June 23, 2023 filter change; DET2365, date of service July 6, 2023; DET-22301, date of service July 25, 2023; DET2398, date of service July 28, 2023; Last day of filter change indicated survey date. 4. No documentation of July 2023 through January 2024 filter changes. 5. Fume hoods S/N 90630, S/N 90640, and S/N 90112 velocity and uniformity annual testing was performed by Avantik Co. Air Flow. Results were satisfactory. Refer to D6083 and D6084. 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 review of the current, approved SOPs, and interview with the GLS, the -- 2 of 4 -- laboratory failed to perform monthly quality assurance (QA) as well as annual evaluation in compliance with QA policy. Findings: 1. There was no documentation of November 2023 and annual 2023 QA review. This is contrary to instructions included in the Schweiger Dermatology policy S304 Quality Management Plan. 2. Confirmed findings by interview with the GLS on January 30, 2024, at approximately 12:00 P.M. 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 direct observation, the laboratory failed to document aliquot bottle reagent concentrations, lot numbers, preparation dates, and expiration dates. Findings: 1. There was no documentation of 1 - EZ Prep aliquot bottle dilution concentration, lot number, preparation date, and expiration date. 2. There was no documentation of 1 - Buffer Wash aliquot bottle concentration dilution, lot number, preparation date, and expiration date. 3. Confirmed findings by interview with the GLS on January 30, 2024, at approximately 11:00 A.M. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on direct observation and interview with the GLS, the laboratory director (LD) failed to ensure that the laboratory physical and environmental conditions were suitable for testing personnel. Refer to D3001 and D3011. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on review of the Vapor Monitoring SOP, air quality reports, and interview with the GLS, the LD failed to ensure that the laboratory physical and environmental conditions were safe for laboratory personnel. Refer to D3001 and D3011. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) -- 3 of 4 -- The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of monthly and annual 2023 QA documentation as well as interview with the GLS, the LD failed to comply with current, approved QA policy S304 Quality Management Plan. Refer to D5415. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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 direct observation, review of the current, approved SOPs, as well as interviews with the GLS and data entry personnel, the LD failed to perform and document employee competency evaluations. FINDINGS: 1. GLS confirmed that data entry personnel occasionally assisted with accessioning of patient specimens. 2. Lab aides responsible for patient specimen accessioning completed an accessioning knowledge assessment quiz and sign-off sheet. There was no documentation of knowledge assessment quiz or completed sign-off sheet for data entry personnel performing patient specimen accessioning. 3. It was noted that data entry personnel initialed and dated "Specimen Receiving" as per S103 in the SOP. 4. The findings were confirmed by interview with the GLS on January 30, 2024, at 2:00 P.M. -- 4 of 4 --

Summary Statement of Deficiencies 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 of the bottle of Xylene and interview with the general supervisor, the laboratory failed to label the prepared Xylene with the required information. FINDINGS: Xylene Prepared 10-29-19 exp 6/1/21/was prepared by TH, did not have the concentration and the storage range for room temp on the label. a. The manufacturer requires a room temperature of 15-30 C for the storage of the Xylene. 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 of the Hematoxylin stain in the laboratory's storage area, inks for histology specimens in the grossing area and interview with the general supervisor, the laboratory failed to review reagent, solutions stains and inks for expired dates. FINDINGS: The surveyor observed the following: Hematoxylin stain 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 -- and inks used for histology specimens: Hematoxylin Stain- Surgipath- #115068 exp 8 /31/22- 2 bottles 500 ml Black Ink- 1 bottle #065705 exp 4/20 Yellow Ink-1 bottle #065586 exp 4/20 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 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 review and observation of test requisition, lack of a written procedure for retention of both original and amended reports, and interview with the general supervisor, the laboratory failed to establish a procedure for differentiating between original report and amended report and retention of the original report and amended report. FINDINGS: 1. Pathologist #1 recorded the result date on her original report but modifies the date on the orginal report to reflect the amended report date. a. SD22- 34348 Original 6/16/22 amended 6/17/22 b. SD22-36618 Original 6/23/22 amended on 6/27/22 2. Laboratory director/pathologist performed it correctly that when an amended report was generated only the amended information was dated with the amended date, leaving the original date reported and electronic signature dates constant with the original report a. SD22-32082 Original 6/3/22 amended 6/13/22 b. SD22-32582 Original 6/10/2 amended 6/15/22 c. SD21-53802 Original 10/6/21 amended on 11/12/21 3. The general supervisor confirmed on September 12, 2022, at approximately 2:30 PM that the laboratory failed to establish a procedure for differentiating between original report and amended report and retention of the original report and amended report. The procdure must define th following: a. Time frame as to when the corrected reports are sent to the authorized person. b. Retention of the original report and corrected reports. c. Maintain duplicates of the original report, as well as the corrected report d. Ensure that incorrect original results are not reissued. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) 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)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on review and observation of test requisition, lack of a written procedure for retention of both original and amended reports and interview with the general -- 2 of 3 -- supervisor, the laboratory director failed to ensure that the histology reports differentiate between original report and amended report and retention of the original report and amended report. Refer to D5821. -- 3 of 3 --

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of the response to the

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 direct observation, review of the laboratory standard operating procedure (SOP) manual and the procedure titled "Vapor Monitoring", lack of air quality reports and an interview with the general laboratory manager, the laboratory failed to maintain adequate space in the accessioning area and laboratory ventilation and air quality in the laboratory area. FINDINGS: 1. The surveyors observed the accessioning area on May 10, 2022, at 10:10 AM, had the received specimen in several containers on the floor next to the three lab aides in the aisle. Surveyors had to step over these containers to walk through the laboratory. 2. The laboratory failed to have adequate space on the accessioning workbench for accessioned specimens, send out specimens and racks grossing specimens to be entered into Novopath laboratory information system (LIS). a. Histology Slide Boxes are stacked in the aisle, by front door, the slide storage room was full. 3. Reviewed the Vapor Monitoring SOP, "states the laboratory monitors staff and/or workstations for formalin and xylene vapor exposure." Monitoring is performed on an annual basis or requested by personnel and the reports are on file in the Histology laboratory. a. No records that this procedure was performed in the laboratory. b. The general laboratory manager on May 10, 2022, at 11:00 AM, stated, "that no previous or current records for vapor monitoring was located." 4. The vapor monitoring procedure using formaldehyde and xylene vapor concentration detection badges to evaluate the air quality for 8 hour period was performed using a vender, which is not the vender listed in the current procedure. a. The badges were sent to the current vender for processing and the report was sent to Schweiger Dermatology Group (SDG) management. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 review of the Competency Assessment policy and an interview with the general laboratory manager, the laboratory failed to establish and follow the Competency Assessment policy. FINDINGS: 1. The laboratory failed to follow their establish competency assessment policy an perform an evaluation for the technical consultant, general laboratory manager a. No documentation was available for review at this survey. 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 review of the Quality Assessment (QA) policy, lack of QA documentation, the laboratory failed to follow and maintain their established QA policy. FINDINGS: The QA policy stated, "that the quality system must be designed to assess and continuously improve the delivery of services to meet the needs of patients and all clinical personnel responsible for patient care. And that the quality manual will contain documentation of ongoing efforts by the Quality Management System Committee to fulfill the quality system elements including agenda, minutes to the meetings and monthly QA checklist." a. No documentation was available currently for surveyors to review. THIS IS A RECITED STANDARD DEFICIENCY FROM THE SURVEY CONDUCTED ON DECEMBER 1, 2021. 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 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's review of the laboratory's Quality Assessment (QA) policy, lack of QA records for the calendar years 2019 through November 2021 and an interview with the general supervisor, the laboratory failed to follow their established QA policy for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. Refer to D6094 FINDINGS: 1. The general supervisor confirmed on December 1, 2021 at approximately 3:15 PM, that the laboratory failed to follow their established QA policy for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. 2. The laboratory's QA policy requires a monthly review of all phases of the laboratory's histology testing. a. the laboratory failed to perform and document the monthly QA review for the calendar years 2019, 2020 through November 2021. 3. The laboratory failed to identify and take