Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based upon the review of confidential patient medical records, 1 of 4 patient records lacked the required documentation of testing and test results. Findings: 1. 1 of 4 randomly selected patient records was unable to be retrieved from the patient's electronic chart. The manual test result form documents the results of the laboratory testing performed by the testing personnel. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based upon a review of laboratory personnel files, review of laboratory written policies and procedures, and interview with Testing Personnel 1 (TP1), the laboratory failed to establish a written policy to assess employee competency. Findings: 1. No written policy to establish the criteria of when and how employee competency is assessed, and who administers the employee competency, could be located. 2. There is a laboratory form to document employee competency. The competencies for current employees were assessed and signed by testing personnel. 3. Interview with TP1, on 6 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- /6/19 at approximately 230 PM, confirmed that there is no written policy for employee competency and that employee competency was evaluated by testing personnel. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based upon a review of the laboratory's policies and procedures and an interview with Testing Personnel (TP1), the laboratory failed to establish a written policy/procedure for Quality Assessment (QA) of the general laboratory systems. Findings: 1. No written policy or procedure for QA of the general laboratory systems could be located. This includes the monitoring and assessment of confidentiality, specimen identification and integrity, complaint investigations, communications, personnel competency, and proficiency testing evaluation. 2. The laboratory is performing QA monitoring of general laboratory systems documented on monthly QA forms. These QA forms are not being signed by the laboratory director. 3. An interview with TP1, on 6/6/19 at approximately 210 PM, confirmed there is no written policy or procedure for QA of the general laboratory systems. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based upon a review of written policies and procedures, and an interview with Testing Personnel 1 (TP1), the laboratory failed to establish written policies and procedures for (4) specimen storage and preservation and (7) specimen acceptability and rejection. Findings: 1. No written policy or procedure for specimen storage and preservation or specimen acceptability and rejection criteria could be located. 2. An interview with TP1, on 6/6/19 at approximately 240 PM, confirmed that there are no written policies or procedures to address specimen storage and preservation, specimen acceptability and rejection criteria. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based upon a review of the laboratory's policies and procedures and an interview with Testing Personnel (TP1), the laboratory failed to establish a written policy/procedure for Quality Assessment (QA) of preanalytic systems. Findings: 1. No written policy or procedure could be located for QA of the preanalytic system, which includes the following: test request and specimen submission, handling, and referral. 2. The laboratory is performing QA monitoring of all preanalytic systems, documented on monthly QA forms. These QA forms are not being signed by the laboratory director. 3. An interview with TP1, on 6/6/19 at approximately 210 PM, confirmed there is no written policy or procedure for QA of the preanalytic system. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)