Drs Titus Hendrix Turner Pahle And

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at the lab of Dr.'s Titus, Hendrix, Turner, Pahle, and Christiansen on November 20, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) documentation, and an interview, the laboratory failed to retain instrument result print outs and attestation statements signed by the laboratory director (LD) and testing personnel (TP) for one (1) of six (6) hematology events reviewed. **REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's 2017 and 2018 Medical Laboratory Evaluation (MLE) hematology PT documentation, a total of 6 events, revealed no Beckman Coulter ACTdiff complete blood count instrument print outs or signed attestation statements for the 2017 Event M2. The inspector requested to review: ACTdiff instrument print outs for the five (5) PT samples resulted (HD 6, HD 7, HD 8, HD 9, 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 -- and HD 10) and the LD and TP attestation documentation. No documentation was available for review. 2. In an interview with the primary TP and LD at approximately 1:00 PM, it was confirmed that the laboratory failed to retain copies of the instrument PT results and attestation statements as outlined above. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a tour, review of the laboratory's policies and procedures, and interviews, the laboratory failed to follow their policy for labeling patient samples using two (2) patient identifiers on eight (8) of 8 urine samples, observed in the sample processing area, on November 20, 2018. Findings include: 1. During a tour with the primary testing personnel, at approximately 11:30 AM, the inspector observed 8 patient urine samples in the laboratory's urine processing area: One (1) urine sample was labeled with patient first and last name; Three (3) urine samples were labeled with patient last name, first initial; Four (4) urine samples were labeled with patient last name; The inspector asked the primary testing personnel (TP) to describe the process of labeling patient urine samples. The TP stated: "our policy requests that the patient's full name be on the urine cup. We have our patients write their names on the cups. We label our urine centrifuge tubes according to the cup label and place at microscope". 2. Review of the policies and procedure manual revealed a quality assurance (QA) procedure that stated: "patient samples will be labeled with two unique identifiers throughout the testing process". 3. In an interview with the primary testing personnel and lab director at approximately 1:00 PM, it was confirmed that the laboratory failed to follow their policy to ensure two (2) unique identifiers were placed on patient samples on November 20, 2018 as outlined above. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of test logs, available proficiency testing (PT) records, and an interview, the laboratory failed to perform split sample comparisons or accuracy verification two (2) times per year for urine sediment microscopy in the twenty-four (24) months reviewed. Findings include: 1. Review of the laboratory's test logs revealed that three (3) testing personnel (TP) performed urine sediment microscopy examination in the laboratory from January 2017 to the date of the inspection on 11/20 /2018. 2. Review of the laboratory's PT records for 2017 and 2018 revealed no enrollment or participation with Medical Laboratory Evaluation PT, split sample comparisons, or other documentation of accuracy verification for urine sediment microscopy results for TP A, B, or C. (See TP Code Sheet attached.) The inspector requested documentation of split sample comparison or accuracy verification -- 2 of 7 -- documentation in calendar years 2017 and 2018. No documentation was available for review. 3. In an interview with the primary TP and lab director at approximately 1:00 PM, it was confirmed that the laboratory failed to perform a split sample comparison or accuracy verification two (2) times per year for urine sediment microscopy in the 24 months reviewed. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of the laboratory's policies and procedures, temperature and maintenance logs, manufacturer's package inserts, operators manual, and interviews, it was determined that the laboratory failed to: 1. ensure that Beckman Coulter manufacturer's instructions were followed for the storage and stability of 4C-ES Cell complete blood count quality control materials on one hundred five (105) days of the twenty-four (24) months reviewed (Cross Reference D 5411); 2. ensure that opened hematology Beckman Coulter 4C-ES Cell Controls materials were not used beyond the manufacturer's expiration date or when the reagent had deteriorated (Cross Reference D 5417); 3. document periodic maintenance checks of the LW Scientific Ultra Centrifuge used to prepare urine sediment for microscopic examination in the 24 months reviewed (Cross Reference D 5431). D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of policies and procedures, temperature logs, manufacturer's package insert, and an interview, the laboratory failed to follow Beckman Coulter's storage and stability instructions for hematology quality control (QC) materials on one hundred five (105) days in the twenty-four (24) months reviewed. Findings include: 1. Review of the policy and procedure manual revealed a quality assurance (QA) policy that stated: "Record daily the temperature of the room, refrigerator, freezer on temperature charts to ensure within range and record