Forefront Dermatology, Sc

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the regional manager, staff A, the laboratory did not record the time of specimen receipt in the laboratory for six of eight Mohs tissue specimens from two of five randomly reviewed patients. Findings include: 1. Review of laboratory records including patient logs, Mohs maps and patient test reports for five randomly chosen patients showed staff did not record the time of specimen receipt in the laboratory for six of eight Mohs tissue samples from two of five patients. Patient 1: Tissue from four of five stages received. Patient 2: Tissue from two of three stages received. 2. Interview with staff A on October 12, 2022, at 9:45 AM confirmed the laboratory did not record the time of specimen receipt in the laboratory for six of eight Mohs tissue specimens from two of five randomly reviewed patients. 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 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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: Based on surveyor observation of supplies in the laboratory, review of laboratory records, and interview with the regional manager, the laboratory used pink colored embedding media that expired on July 31, 2018 since at least December 13, 2020 and green colored embedding media that expired on May 30, 2020 since at least January 20, 2021. Findings include: 1. Observation of opened colored embedding media on the laboratory counter on February 12, 2021 at 9:45 AM showed two expired bottles: a. The pink media, lot 362350, showed the manufacturer's expiration date was July 31, 2018. The laboratory labeled the bottle with an opened date of December 13, 2020. The media in the bottle appeared discolored and had an orange tint. b. The green media, lot 434620 showed the manufacturer's expiration date was May 30, 2020. The laboratory labeled the bottle with an opened date of January 20, 2021. A second bottle of green embedding media, lot 434620, labeled as received on February 8, 2018 was also available for use in the cabinet under the counter. 2. Review of the Mohs patient log showed testing personnel assign a color to each case. The log shows current use of yellow, green, orange, purple, blue, and white color-coding. 3. Interview with the regional manager (staff A) on February 12, 2021 at 9:45 AM confirmed testing personnel used colored embedding media to color code cases. The manager also confirmed the embedding media on the counter in the laboratory was in current use, and confirmed the pink and green bottles were expired. Further interview confirmed the pink embedding media was discolored. 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 --