Hampton Clinic

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: . Through a review of policy and procedure manual, temperature records lack of documentation, and interviews with staff, it was determined the laboratory director failed to approve and sign the policy for the change in Humidity conditions. A. A review of policy and procedure manual revealed the Humidity range as 10-85%. B. A review of temperature records for 2022 and 2021 revealed the change in Humidity range as 30-85%. C. Surveyor requested the policy for the change in the Humidity range. None was provided. D. In an interview on 3/15/2022 at 10:30, laboratory personnel #2 (as listed on form CMS 209) confirmed the change in range for Humidity had not been approved, signed, or dated by laboratory director. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 -- This STANDARD is not met as evidenced by: . Through a review of Laboratory test reports and interview with staff it was determined the laboratory test reports failed to include the name and address of the laboratory where the test was performed. Survey findings include: A. A review of laboratory test reports (ten of ten) revealed the of laboratory results reports reviewed failed to include the name and address of the laboratory where testing was performed. B. In an interview at 12:30 on 3/15/2022 the laboratory director (as listed on the form CMS-209) confirmed the laboratory test report did not include the name or the address of laboratory where testing was performed -- 2 of 2 --

Summary Statement of Deficiencies D6067 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Each individual performing moderate complexity testing must have training to ensure that the individual has-- (A) the skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (B) the skills required for implementing all standard laboratory procedures; (C) the skills required for performing each test method and for proper instrument use; (D) the skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed; (E) a working knowledge of reagent stability and storage; (F) the skills required to implement the quality control policies and procedures of the laboratory; (G) an awareness of the factors that influence test results; and (H) the skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. This STANDARD is not met as evidenced by: . Through a review of personnel records for three of three testing personnel, lack of documentation, and interviews with laboratory staff, it was determined two of three testing personnel had no documentation of training, Survey findings include: A. Personnel records for three current laboratory testing personnel (listed as laboratory employees #4, #5, and #6 on the form CMS-209) were reviewed. Personnel files for employees #5 and #6 did not include documentation of initial training on the laboratory instrumentation. B. In an interview at 9:30 a.m. on 7/25/2019, the laboratory director confirmed the initial training of two of three testing personnel had not been documented. 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 No Tags No deficiency details available. 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 --