Partners In Medicine And Surgery Pa D/B/A

Summary Statement of Deficiencies D0000 An onsite announced CLIA recertification survey was conducted at Partners in Medicine and Surgery PA dba 360 Dermatology on 02/08/2024. The laboratory is not in compliance with 42 CFR, Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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 and humidity records, review of the cryostat instrument manual, and interview with the Office Lead, the laboratory failed to document humidity percentage for 68 out of 124 days of testing from the date after the last survey (12/20/21) to the date of the current survey (02/08/24). The findings include: Based upon review of the "Room Temperature" logs, it was revealed that the room's temperature and humidity are required to be documented on the "Room Temperature" log During a review of the "Room Temperature" logs, it was revealed that humidity percentages were not documented on 68 out of 124 days of testing from the date after last survey (12/20/21) to date of the current survey (02/08/24). The specific dates of noncompliance are as follows: 08/30/22, 09/06/22, 09/07/22, 09/27 /22, 10/04/22, 10/05/22, 10/07/22, 10/14/22, 10/18/22, 10/25/22, 11/01/22, 11/08/22, 11/15/22, 11/22/22, 11/30/22, 12/13/22, 12/20/22, 01/03/23, 01/10/23, 01/24/23, 01/31 /23, 02/01/23, 02/07/23, 02/14/23, 02/21/23, 03/28/23, 04/04/23, 04/05/23, 04/11/23, 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 -- 04/18/23, 05/03/23, 05/04/23, 05/09/23, 05/16/23, 05/23/23, 05/30/23, 06/06/23, 06/07 /23, 06/13/23, 07/17/23, 07/18/23, 07/25/23, 08/14/23, 08/15/23,08/22/23, 08/29/23, 09/05/23, 09/06/23, 09/12/23, 09/13/23, 09/19/23, 09/26/23, 10/03/23, 10/04/23, 10/10 /23, 10/17/23, 10/24/23, 10/31/23, 11/01/23, 11/07/23, 11/14/23, 11/21/23, 11/28/23, 12/05/23, 12/06/23, 01/30/24, 02/06/24, and 02/07/24. A review of the Avantik cryostat QS11 QS11UV instrument manual revealed that operating conditions require a humidity of less than 60%. On 02/08/24 at 10:40 AM, the Office Lead stated the percent humidity was not recorded because she had not been told to record humidity. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Partners in Surgery and Medicine PA d/b/a 360 Dermatology on 08/20/19. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 record review and interview with the Director of Operations, the laboratory failed to verify the accuracy of Histopathology testing which included hematoxylin and eosin at least twice annually for 2 out of 2 years (2018-2019) reviewed. Findings Included: Policy and procedures revealed that Quality Assurance Program for Histopathology peer review states "it is suggested to submit 3 cases every 6 months to outside pathologist". Record review of peer reviews revealed that 1 peer review was conducted on 07/19 which included patients from 2018 and 2019. No other peer reviews were performed. Interview on 08/20/19 at 11:00 AM with the Director of Operations revealed she did not know she could not cover two years in one peer review. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures 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 2 -- This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director, the laboratory failed to document the quality of Histopathology hematoxylin and eosin (H&E) control slides for 2 out of 2 years (2018-2019) Findings Included: Review of the policy "Quality Assurance for Routine Stains" revealed the lab director would determine acceptability of the stain each day and the quality control (QC) would be documented on the stain QC chart. Record review of the laboratory logs revealed the logs did not include the stain QC chart for 2 out of 2 years (2018-2019). On 08/20/19 at 12:00 PM, the Laboratory Director stated that the missing quality control documentation was due to an oversight. -- 2 of 2 --