Premier Dermatology Pllc

Summary Statement of 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: Through observation, review of temperature records, lack of documentation and interview it was determined that the laboratory failed to monitor the temperature on each day of operation in one of two rooms in which supplies with storage temperature requirements were stored. Findings follow: A) During a tour of the laboratory on 9/7 /23 at 2:00 p.m. two separate rooms (main lab, storage room) containing items with a temperature storage requirement were observed. B) During a review of the laboratory's temperature records it was noted that no temperature records were presented for the storage room area. C) During a tour of the laboratory on 9/7/23 at 2: 00 p.m. 3 boxes of Tissue Plus ACT with a storage temperature requirement of 4 degrees C. to 30 degrees C., lot # 4619 , expiration October 2026 and 3 boxes of Parapro LMP embedding media with a storage temperature requirement of 15 degrees C. , to 30 degrees C. , lot # 13195, expiration date 6/2028 were observed in storage room. D) Upon request, the laboratory could not present the temperature records for the storage room in which the supplies identified above were stored. E) In an interview on 9/6/23 at 2:15 p.m., the laboratory staff member (# 1 on the CMS 209) stated " no we don't have temperatures for the storage room". D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- 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: Through observation and interview it was determined that the laboratory failed to assure that supplies were not used when they have exceeded their expiration date. Findings follow: A) During a tour of the laboratory on 9/7/23 at 2:45 p.m, one of one bottles of Potassium Hydroxide Solution , lot # 0083 with an expiration date of 2022- 03-23 was observed in a supply cabinet and no unexpired Potassium Hydroxide was observed in the cabinet at that time . B) In an interview on 9/7/23 at 2:45 p.m, clinic staff member ( number 1 on the CMS 209 form) confirmed that the bottle was available for use, and had exceeded the expiration date. -- 2 of 2 --

Summary Statement of Deficiencies D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: . Through a review of personnel records for two of two testing personnel, lack of documentation, CMS 2567 Statement of Deficiencies from survey conducted on January 30, 2019 and interviews with laboratory staff, it was determined the laboratory director failed to specify, in writing, the procedures each individual is authorized to perform, and whether supervision is required for reporting patient test results. Survey findings follow: A. During a review of personnel records for two of two testing personnel, it was determined that testing personnel #1 and #2 (as listed on form CMS-209) had no written authorization to perform testing without direct supervision. B. Upon request, the laboratory was unable to provide authorization to test for personnel #1 and #2 (as listed on form CMS 209). C. A review of the CMS- 2567 for the CLIA survey conducted on January 30, 2019 revealed the

Summary Statement of Deficiencies 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: Through lack of documentation and interview it was determined that the laboratory failed to assess the competency to perform testing for one of five personnel who perform and report patient testing. Findings follow: A. Upon request, the laboratory was unable to provide annual competency assessment for personnel identified as number four on the CMS 209 form. B. Review of patient medical records revealed that the personnel identified as number four on the CMS 209 form performed and reported KOH preparation testing on the patient identified as number one on a separate patient identification list on 1/23/19. C. In an interview on 1/30/19 at approximately 1400, the histology supervisor identified as number two on the CMS 209 form confirmed that the personnel identified above routinely performs and reports KOH testing and that annual competency assessments had not been performed and documented. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test 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 -- results. This STANDARD is not met as evidenced by: Through review of the CMS 209 form, patient result reports, test logs, lack of documentation and interview it was determined that the laboratory director failed to identify which examinations and procedures personnel are authorized to perform for five of five personnel listed on the CMS 209 form who perform patient testing. Findings follow: A. Upon request, the laboratory was unable to provide authorization to test for personnel listed as numbers one through five inclusive on the CMS 209 form. B. Review of testing logs for KOH preparations revealed that the testing personnel identified as numbers one, four and five on the CMS 209 form performed and reported KOH preparations. C. Review of patient charts revealed that personnel identified as numbers two and three performed and reported gross tissue examinations on pathology reports. D. In an interview on 1/30/19 at approximately 1400, the histology supervisor identified as number two on the CMS 209 form stated that the personnel identified as numbers two and three on the CMS 209 form performed and reported gross tissue descriptions on pathology reports and that personnel identified as numbers one, four and five perform and report KOH preparation examinations and that all personnel lack written authorization from the laboratory director for performing testing. -- 2 of 2 --