Summary:
Summary Statement of Deficiencies D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Human chorionic gonadotropin (hCG) manufacturer's instructions, worksheet records review and laboratory director interview on November 9, 2023 at 11:20 AM, it was determined that the laboratory failed to follow manufacturer's instructions to document the internal control each day of control testing when processing patient hCG samples. The findings include: 1. The laboratory performed (hCG) human chorionic gonadotropin by One step kit. 2. The manufacturer's instructions stated that the laboratory must monitor and document the internal control to ensure the validity of the hCG test performed. 3. The hCG test worksheet records showed on November 9, 2023 at 11:20 AM, that the laboratory did not document the observed results of the internal procedural control each day of control testing when processing patient hCG samples. 4. The laboratory processed and reported 461 hCG patient samples from January 1, 2022 to November 9, 2023. 5. The laboratory director confirmed on November 9, 2023 at 11:25 AM, that the laboratory failed to monitor and document the internal control each day of control testing when processing patient hCG samples. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to 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 -- determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on Human chorionic gonadotropin (hCG) manufacturer's instructions, worksheet records review and laboratory director interview on November 9, 2023 at 11:20 AM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the manufacturer's instructions and laboratory quality control requirements. Refer to D 5479. -- 2 of 2 --