Summary:
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: Through observation and interview it was determined that the laboratory failed to assure that supplies were not used when they have exceeded their expiration date. Findings follow: A. During a tour of the laboratory on 3/27/18 at approximately 1545 four of four bottles of Potassium Hydroxide Solution ( two bottles Lot # 1224112 with an expiration date of 8/28/13, and two bottles lot # 1222811 with an expiration date of 8/15/13) were observed in a supply cabinet and no unexpired Potassium Hydroxide was observed in the cabinet at that time . B. In an interview on 3/27/18 at approximately 1545 the laboratory director identified as number 1 on the CMS 209 form confirmed that the bottles were available for use, and had exceeded the expiration date. 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 --