Summary:
Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's procedures manual, laboratory records, patients test records and slides; the laboratory failed to monitor and evaluate the overall quality of the general laboratory systems and correct problems identified for its histopathology procedures. Findings include: (see D tag 5203) 1. There was no comprehensive procedures manual that described the step by step process in which the laboratory performed its histopathology procedures. 2. Laboratory records show that there were no unique identifiers used when the laboratory collected and documented patients' tissue specimens. 3. Review of 6 patients' test records revealed that 1 of 6 patients' slides was mislabeled with the incorrect specimen. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of survey forms, laboratory's procedures manual, laboratory log, patients' slides, reports and interview with the laboratory director; the laboratory failed to establish and follow written policies and procedures that ensures positive identification and optimum integrity of a patients' specimen from the time of collection or receipt of the specimen through completion of the testing and reporting of results. Findings: 1. Review of survey forms revealed that the laboratory only performs histopathology testing. 2. There were no procedures that described the laboratory process for specimen collecting and testing. 3. Review of the laboratory's log sheets revealed that patients' specimens were not given a unique identifier such as a case number for each different location that a biopsy specimen was collected. In some cases, the same # was given to more than one specimen. 4. On 09/05/19 at 2:30 PM the surveyor selected 6 patients names from the laboratory log. One of which 5 different specimens from 5 different locations were collected and given the same case number for each specimen. 5. 1 of 6 patients' slides was mislabeled with the incorrect specimen location. 6. Review of patients' test reports revealed that a diagnosis was reported for the specimen that was mislabeled. The slide was also sent to the reference laboratory for a 2nd opinion. Records show that the reference laboratory made a diagnosis based on the slide they received from this laboratory. 7. On 09/05/19 at 3:15 PM, the laboratory director confirmed the surveyor's findings. 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)