Ocean Skin And Vein Institute Inc

Summary Statement of Deficiencies D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of lack the laboratory's records, and interview with the laboratory staff, it was determined that the laboratory failed to retain all laboratory quality system assessment records for at least 2 years. The findings included: a. The laboratory performed Mohs surgery onsite. b. Interview with the laboratory staff at 8/9 /2022 @ 10:10 am onsite, no laboratory records including but not limited to evaluation of proficiency testing performance/peer review were available onsite. c. The laboratory failed to retain laboratory quality system assessment records for at least 2 years D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory Mohs maps, and interview with the laboratory staff, it was determined that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the post analytic systems The findings included: a. Review of 6 patient Mohs maps as follows: ACCESSION NUMBER = AN, tissue Site = ST L = left, R = 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 -- right DATE AN ST 1) 2/21/22 S22-000617 L Nose 2) 2/21/22 S22-000126 L post scalp 3) 5/23/22 Blank L lateral forehead 4) 5/23/22S22-0007(?)42L cheek- infraorbital 5) 7/18/22 S22-002801 R lower leg-anterior 6) 8/8/22 S22-003407 L inferior eyelid b. One of 6 Mohs maps, the laboratory failed to provide a slide account number in Mohs map, 3) 5/23/22 with Left lateral forehead, to ensure the consistency of the patient-specific data was accurately and reliably recorded or transcribed to Mohs map. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 the laboratory records, Mohs maps, and interview with the laboratory staff, it was determined that the laboratory director failed to ensure and maintain the quality control programs and the quality of laboratory services provided. The findings included: a. The laboratory director failed to ensure and maintain the quality control programs and quality of laboratory services provided. b. The laboratory failed to retain laboratory quality system assessment records for at least 2 years see D-3039. c. One of 6 Mohs maps, the laboratory failed to provide a slide account number in Mohs map, and to ensure the consistency of the patient-specific data was accurately and reliably recorded or transcribed to each Mohs map, see D- 5891. -- 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 onsite survey on May 12, 2021 at Noon, including observation of Mohs slides, review of laboratory records, the lack of 2020 laboratory records and documents, and interview with laboratory personnel, it was determined that in 2020, the laboratory failed to at least twice annually verify the accuracy of Mohs procedures. Findings included: 1. Laboratory records documented four Testing persons performed Mohs procedures in 2020. 2. A laboratory policy stated that the accuracy of Mohs procedures are verified at least twice annually. 3. The laboratory failed to provide for review documents that at least twice annually verified the accuracy of the Mohs procedures performed by each Testing person in 2020, including 6 out of 6 as follows: Date ID Testing person ----------------------------------------------------------------- 2/17/20 JP - R shin SC 6/30/20 AP - R dorsal wrist DS 8/31/20 MM - L ant. lower leg prox AL 10/13/20 JP - R nose ala NT 11/09/20 HW - L chin AL 12/15/20 KH - R ear helix NT 4. A laboratory person affirmed (5/12/21 at Noon) the laboratory failed to maintain the policy for 2020. 5. The reliability and quality of the Mohs procedures performed in 2020 could not be assured when the laboratory failed to at least twice annually verify accuracy. Approximately 200 Mohs procedures were performed by the four Testing persons in 2020. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an 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 -- ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on observation of Mohs slides, review of EMR and laboratory records for Mohs procedures in 2020 - 2021 that revealed inconsistencies, and interview with a laboratory person on 5/12/21 at Noon, it was determined that the laboratory failed to establish and follow written policy/procedure to monitor, assess, identify, and correct problems in postanalytic systems. Findings included: 1. Mohs slides and maps documented 2 Stages were performed for each procedure, as follows: Date ID EMR 6 /30/20 AP - R dorsal wrist (a) 1/18/21 DR - R buccal cheek (b) 3/01/21 JD - L temple (b) 4/12/21 EH - R cheek infraorbital (b) 2. The patient's electronic medical record stated: a) "Total # of Mohs Stages: 1" b) For these three cases -- instead of stating "Total # of Mohs Stages: 2", the EMR stated 1 Stage, twice. For example: "Mohs: Right Cheek - Buccal: 1.3 x 1.1 cm. Total #Mohs Stages: 1", then "Mohs: Right Cheek - Buccal: 1.5 x 1.2 cm. Total # of Mohs Stages: 1". 3. The laboratory person affirmed (5/12/21 at Noon) the EMR were irregular and the failure to have an established internal audit to monitor, assess, identify, and correct problems post- analytically. 4. The reliability and quality of the EMR system could not be assured when the laboratory failed to establish and follow a written policy to perform internal audits post-analytically to monitor, assess, identify, and correct problems. -- 2 of 2 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of patient biopsy slide, patient final testing reports (electronic medical records (EMR), slide labeling, and interview with the laboratory personnel, it was determined that from 06/30/2016 through 01/26/2018 for 1 out of 10 random patient testing records reviewed, the laboratory failed to follow written policies and procedures for specimen collection, labeling and biopsy reports for each biopsy specimen. The findings included: a. Review of patient slide specimen ID K, W (R. Temple dated 10/27/2017), the unique slide identifier (location) found on the slide did not match the location on the mapping chart for patient ID W,K (L nasofacial sulcus) in the final test report (EMR). b. On 02/09/2018 11:00 (survey date), the laboratory personnel affirmed that the unique identifier (location) found on biopsy slide did not match the location on the final test report (EMR). c. Based on the laboratory's annual test volume declaration (01/30/2018) the laboratory performed 250 patient biopsies annually. 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 --