Summary:
Summary Statement of Deficiencies D0000 A Certification Survey was performed on June 11, 2019 at Eric N. Tabor, MD APMC, CLIA ID # 19D2133284. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 observation and interview with personnel, the laboratory failed to ensure marking dyes have not exceeded their expiration date. Findings: 1. Observation by surveyor during laboratory tour on June 11, 2019 revealed the following expired items: a) Tissue Marking Dye Blue, Lot # 054076, Expiration Date: 04/2019, Quantity: one (1) bottle b) Tissue Marking Dye Red, Lot # 053223, Expiration Date: 03/2019, Quantity: one (1) bottle c) Tissue Marking Dye Black, Lot # 052345, Expiration Date: 01/2019, Quantity: one (1) bottle d) Tissue Marking Dye Yellow, Lot # 053213, Expiration Date: 02/2019, Quantity: one (1) bottle e) Tissue Marking Dye Green, Lot # 054525, Expiration Date: 05/2019, Quantity: one (1) bottle 2. In interview on June 11, 2019, the Laboratory Director stated he was unaware the identified marking dyes had an expiration date. The Laboratory Director confirmed the identified dyes were expired. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. 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 observation and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed testing as required. Refer to D5417. -- 2 of 2 --