Summary:
Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Review of the laboratory test reports and discussion with staff reveals that the laboratory test reports does not indicate the address of the laboratory where the test is performed. Findings are: 1. The surveyor requested a copy of a laboratory test report and the laboratory printed out laboratory test report from the laboratory's information system (LIS). The test reports shows the name of the Laboratory as " Linn County Department of Health" , but no address information of the laboratory. 2. These findings were confirmed by the laboratory Medical Assistant(MA) and Clinic Supervisor on 08/15/2018 @ 11:00 AM. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the 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 -- appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Review of Personnel files and records shows testing personnels not having the required documentions of their educational requirements such as diploma or transcript of records. Findings include: 1. The surveyor requested and the laboratory failed to provide copies of diploma or transcript of records of the 2 new testing personnel hired on 12/14/2017 and 05/01/2018 at the time of survey. 2. These findings were confirmed by the laboratory Medical Assistant (MA) and the Clinic Supervisor on 08 /15/2018 @ 11:00 AM. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Review of Personnel records and discussion with the staff the laboratory's Technical Consultant (TC) failed to evaluate competency of the new testing personnel (TP). Findings include: 1. The surveyor requested and the laboratory failed to provide documentations of competency for the 2 new testing personnel. 2. The testing personnel (TP) one hired 12/14/2017 did not have documentation of initial training and 6 months competency at the time of survey. 3. The testing personnel (TP) two hired 05/01/2018 did not have initial training documentation at the time of survey. 4. These findings were confirmed by the laboratory Medical Assistant (MA) and the Clinic Supervisor on 08/15/2018 @ 11:00 AM. -- 2 of 2 --