Messenger Dermatology - Compass Health

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 record review and interview with Testing Personnel 1(TP1), the laboratory failed to ensure 5 bottles of Tissue Marking Ink were not used beyond their expiration date. Findings include: 1. Review of the Laboratory's Procedure "Quality Management Program," revealed on page 3, section CII, titled, "Reagents, Materials and Supplies," number 2, states "Monitors include .... audits of reagent inventories, outdate and storage conditions ...". 2. An interview on 09/30/2024 at 9:45 am with Testing Personnel 1 confirmed that reagents were expired. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel (TP) #6, the laboratory failed to retain the histopathology Mohs' peer review (verification of accuracy) for 2 (6 /2019 to 3/2021) of 2 years reviewed. Findings include: 1. Record review for the Mohs' physicians peer review revealed a lack of documentation from 6/2019 to 3 /2021. 2. When queried on 6/16/2021, TP6 acknowledged that the supervisor from the Lansing office provided a note that stated "I misplaced his Mt. Pleasant peer review." 3. An interview on 6/16/2021 at 10:14 am, TP6 confirmed the Mohs' physicians peer review was misplaced. 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 --