Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory director(LD) failed to approve, sign, and date the procedure manual for hematology and chemistry testing processes . Findings are as follows: 1) Interview with a laboratory RN (registered nurse) on 2/9/18 at 11:00 a.m. revealed that the LD had not signed the laboratory manual for usage on patient samples. 2) Record review of the laboratory manual in use at the facility on 2/9/18 revealed that the laboratory manual for the specialties of Chemistry and Hematology had not been signed/approved by the LD prior to usage on patient samples. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory director (LD) failed to maintain the laboratory quality program. Refer to D5407 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 -- D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory director(LD) failed to approve procedure manual for hematology and chemistry testing processes . Findings are as follows: 1) Interview with a laboratory RN (registered nurse) on 2/9/18 at 11:00 a.m. revealed that the LD had not signed the laboratory manual for usage on patient samples. 2) Record review of the laboratory manual in use at the facility on 2/9/18 revealed that the laboratory manual for the specialties of Chemistry and Hematology had not been signed/approved by the LD prior to usage on patient samples. -- 2 of 2 --