Summary:
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 lack of written laboratory policy and procedure manual and interview with the clinic office manager and testing personnel (TP), the laboratory failed to establish and maintain a written procedure manual for all laboratory testing, to include collecting specimens, performing CBC (Complete Blood Count) testing with the hematology analyzer, or reporting patient test results since the last survey. Findings include: 1. There was no policy and procedure manual available the day of survey, for collecting, performing moderate or waived tests, or reporting test results performed by testing personnel in the laboratory. 2. The laboratory uses the Boule Medonic hematology analyzer to perform CBC testing. The laboratory has an annual volume of 3500 patient samples for CBC and approximately 1000 are waived tests performed. 3. The office manager and testing personnel confirmed in an interview on 5/1/2024 at 10: 30 a.m. that there was no written laboratory policy and procedure available, approved and signed by the laboratory director. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing records, Centers of Medicare and Medicaid Services (CMS) database proficiency testing CASPER report 0155D and interview with office manager, the laboratory director failed to ensure the laboratory was enrolled in an HHS approved proficiency testing (PT) program for CBC (complete blood count) performed on the Boule Medonic hematology analyzer for 1 of 7 testing events. Findings include: 1. Review of the CMS database proficiency testing CASPER report 0155D revealed no scores for CBC for the first event of 2024. 2. Review of the laboratory proficiency records from 1/27/2022 through 5/1/2024, revealed no evidence of proficiency testing participation for the 1st event of 2024. 3. The office manager confirmed in an interview on 5/1/2024 at 12:00 p.m. that the laboratory was not enrolled in proficiency testing for CBC for the 1st event of 2024. 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 lack of a written quality control procedure appropriate for the testing performed and interview with the office manager and testing personnel, the laboratory director did not ensure the laboratory had available a quality control policy manual which should include established parameters for acceptable levels of analytic performance for testing performed on the Boule Medonic hematology analyzer. Findings include: 1. Based on review of the laboratory records, the laboratory did not have available a Quality Control policy that included: A. The levels of control and type of calibration material to be performed B. The frequency of control and calibration performance C. The criteria for determining the acceptability of control results D. The