Coyle S Connolly, Do Pa

Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of Procedure Manual (PM) the lack for Biannual Assessment (BA) records and interview with the Office Manager (OM), the laboratory failed to ensure that quality systems for the analytic phase of Histopathology testing were monitored from 12/12/19 to the date of survey. 1. The laboratory the laboratory failed to verify the accuracy and reliability of Histopathology. Cross Refer to D5217. 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 the lack of Biannual Assessment (BA) records and interview with the Office Manager (OM), the laboratory failed to verify the accuracy and reliability of Histopathology testing twice a year in the calendar years 2020 2021 and 2022. The findings include: 1. The form used for BA was entitled Quality Assurance, proficiency testing. 2. There was no acknowledgment that the reviewing physicians diagnosis agreed or disagreed with the referring physicians diagnosis. 3. The names of reviewing physician and the referring physician were not on the form. 4. The BA was not signed by the reviewing physician or the referring physician. 5. The last BA was 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 -- performed 12/12/19. 6. The OM confirmed on 9/21/22 at 11:00 am that BA was not performed. Note: This was previously cited 2/24/20. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a interview with the Office Manager (OM), the Laboratory Director (LD) failed to provide overall management and direction to the laboratory to ensure that laboratory testing is performed satisfactorily and in compliance with the CLIA regulations from 12/12/19 to the date of the survey. 1. The LD failed to ensure BA was performed to evaluate the laboratory's performance accurately. Cross refer D6091 D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 Office Manager (OM), the laboratory failed to verify the accuracy and reliability of Histopathology testing twice a year in the calendar years 2018 and 2019. The findings include: 1. The form used for BA was entitled Quality Assurance, proficiency testing. 2. There was no acknowledgment that the reviewing physicians diagnosis agreed or disagreed with the referring physicians diagnosis. 3. The names of reviewing physician and the referring physician were not on the form. 2. The BA was not signed by the reviewing physician or the referring physician. 4. The OM confirmed on 2/24/20 at 1:00 pm that BA was not 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 1 --

Summary Statement of Deficiencies 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: a) Based on surveyor review of the Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed to have a policy for the retention of histopathology slides from 12/14/15 to the date of survey. The PM confirmed on 1/18 /18 at 10:00 am that the OM did not have the policy. b) Based on surveyor review of the Biannual Assessment (BA) procedure, PM and interview with the OM, the laboratory failed follow the BA The finding includes: 1.The BA procedure stated that the BA will be performed every six months. 2. BA was performed once in the calendar year 2017 3. The OM confirmed on 1/18/18 at 10:10 am that the BA procedure was not 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 1 --