Dermpath Service

Summary Statement of Deficiencies 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 surveyor review of the Procedure Manual (PM), Biannual Assessment (BA) records and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy and reliability of Histopathology testing twice a year in the calendar years 2020 and 2021. The finding includes: 1. The BA logs did not have dates written when BA was performed. 2. There were no credentials for the physician reviewing the slides for BA. 3. The GS confirmed on 10/6/22 at 10:30 am that the laboratory did not verify the accuracy of Histopathology twice a year. 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 Laboratory Director (LD), the laboratory failed to follow all procedures written for "Microscope Equipment" from 9/19/19 to the date of the survey. The findings include: 1. There was no documented evidence the below mentioned procedure was followed: 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 -- a. "Yearly Maintenance:","1. The microscope must have yearly maintenance done by a pathologist with experience.", "2. The yearly maintenance must be documented" 2. There was no documented evidence that yearly maintenance was performed on the microscope. 3. The LD confirmed on 10/6/22 at 10:30 am that the laboratory did not follow the PM. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor review of the Biannual Assessment (BA) records and interview with the Laboratory Director (LD), the LD failed to verify the accuracy and reliability of Histopathology testing twice a year in the calendar year 2018. The LD confirmed on 9/19/19 at 10:10 am that the laboratory did not verify the accuracy of Histopathology testing twice annually in 2018. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on lack of a Procedure Manual (PM) and interview with the Laboratory Director (LD), the LD failed to have an approved PM for the professional component of Histopathology testing from 5/17/18 to the date of the survey. The LD confirmed on 9/19/19 at 10:00 am that the LD did not ensure an approved PM was available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on lack of Quality Control records and interview with the Laboratory Director (LD), the laboratory failed to document positive and negative reactivity of Immunochemical Stains and the reaction of the Special and Hematoxylin Eosin stains used in Histopathology from 1/1/18 to the date of the survey. The LD confirmed on 5 /17/18 at 2:00 pm that stain reactions were not documented. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --