Feinstein Laboratory

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Laboratory Director, the laboratory failed to ensure testing personnel followed established safety procedures while handling blood specimens for 1 (Testing Personnel #2) of 2 testing personnel observed. Findings include: 1. The surveyor observed Testing Personnel #2 (TP2) perform Complete Blood Count testing on 5/2/23 at 9:12 am. TP2 had one glove on their left hand and mixed the sample with the gloved hand before sampling. TP2 took the glove off and continued to handle the specimen without gloves after the specimen had been sampled. 2. A review of the laboratory's "Universal Precautions" policy revealed a section stating, "All laboratory personnel will wear protective devices to prevent skin and mucous membranes from coming in contact with patient blood and other body fluids. Gloves will be worn when obtaining and handling patient specimens." 3. An interview on 5/2/23 at 9:15 am with the Laboratory Director confirmed TP2 had not observed the laboratory's established safety procedures while handling blood specimens. 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), the laboratory failed to establish written procedures for the testing of sodium, potassium, and chloride for 2 (August 2017 to August 2019) of 2 years. Findings include: 1. A record review of chemistry testing procedures exposed a lack of written procedures for sodium, potassium, and chloride testing using the Mindray BS 200 chemistry analyzer. 2. When requested on 8/1/19 at 9:55 am, the LD failed to provide established procedures for sodium, potassium, and chloride testing. 3. An interview on 8/1/19 at 9:55 am with the LD confirmed the laboratory did not establish written procedures for sodium, potassium, and chloride testing. 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 --