Summary:
Summary Statement of Deficiencies D0000 A Recertification Survey was conducted at approximately 9:00 am on August 31, 2023 at Delaware Outpatient Center for Surgery. The laboratory was surveyed according to 42 CFR part 493 CLIA requirements. Specific deficiencies are as follows: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: During document review and interview, the laboratory director (LD) failed to sign the attestation page for Proficiency Testing (PT) for 5 of 5 events. Findings include: 1. During document review at approximately 0920 on August 31, 2023 the surveyor determined that the PT attestation page was not signed by the LD for Events 1, 2, and 3 for 2022 and Events 1 and 2 for 2023. 2. During the interview, the PM confirmed that the LD did not sign 5 of 5 PT attestation pages as required for all PTs. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- During document review and during interview, the laboratory did not have a quality improvement process in place for the time period of 11/5/2021 to 8/31/2023. Findings include: 1. At approximately 10:00 am on August 31, 2023 during document review the laboratory failed to provide policies and procedures to monitor, assess and problems identified in the laboratory, to include patient test managment, quality control, proficiency testing, maintenance, inventory, communications, and complaints. 2. During the interview the surveyor determined there were no internal audit when the CD stated that they did them but not "specifically regarding the laboratory". 3. By the end of the survey at approximately 10:00 am no process improvement or quality indicators were provided for the surveyed time period. D5303 TEST REQUEST CFR(s): 493.1241(b) The laboratory may accept oral requests for laboratory tests if it solicits a written or electronic authorization within 30 days of the oral request and maintains the authorization or documentation of its efforts to obtain the authorization. This STANDARD is not met as evidenced by: During document review and interview the laboratory failed to establish a policy for the use of verbal orders for the peiod of 11/5/2021 to 8/31/2023. Findings include: 1. During document review at approximately 9:50 am on August 31, 2023, it was determined that the laboratory had no test requests forms for the surveyed time period. 2. During interview at that same approximate time, the PM confirmed there were no test requests because the laboratory performed its testing based on verbal orders. 3. The surveyor requested a written policy regarding verbal orders, but the laboratory could not provide one as confirmed by the CD. 4. By the end of the survey at approximately 10:30 am the laboratory did provide a copy of a test request, or a written verbal order policy. 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)