Summary:
Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of the final histology slide labeling and interview with the laboratory director/testing personnel, it was determined that the laboratory failed to ensure that the histology laboratory provided adequate and proper patient information on the slide label such as the source of the specimen, the date of specimen collection, and any additional information relevant and necessary for histology testing to ensure accurate and timely testing and reporting of results. The findings included: a. This laboratory sends its biopsy specimen to Path MD, a histology laboratory, to process tissue slides. b. A qualified pathology performed professional component onsite and generate the surgical pathology reports using Window Path, a laboratory information system. c. This laboratory provides biopsy specimens and indicates to Path MD histology laboratory for the following information, including but are not limited to, patient name, source of specimen, date of collection, etc. d. Review of 5 laboratory surgical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- pathology reports; S2019-016970, S2019-016980. S2019-016966, S2019-016026, S2019-013872 along with its corresponding slides. e. Each slide label indicates: slide ID, block ID, H&E (special stain), Patient name, Path MD, and a QR code. f. Path MD, the histology laboratory, failed to provide and indicate the specimen collection date, and specimen source on the slide labels. g. This laboratory and the testing pathologist accept the slides with missing important information such as date of collection, source of specimen necessary for histology test to ensure accurate and timely testing and reporting of results D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on review of the laboratory's Surgical Pathology Reports (SPR) and its corresponding slide labels, and interview with the laboratory director/testing personnel, it was determined that the laboratory failed to ensure the accuracy and consistency when transcribing test requisition or authorization information into a record system or a laboratory information system. The findings included: a. Review of 5 laboratory surgical pathology reports; S2019-016970, S2019-016980. S2019- 016966, S2019- 016026, S2019-013872 along with its corresponding slide labels. b. Path MD, a histology laboratory, labels the tissue slide with A, B, C or... with A1, B1, C1...to identify different specimen sources when received. c. The SPR under "DIAGNOSIS" does not show consistent descriptions: Example 1: S2019-016980 Slides labeled: A1 and B1 (without any specimen source) SPR Diagnosis A. COLON, RANDOM, BIOPSY B. DESCENDING COLON, POLY, BIOPSY Example 2: S2019-016970 slides labeled: A1 GIEMSA -HP, A1 H&E, and GIEMSA-ctrl SPR Diagnosis STOMACH, POLY, BIOPSY No A or A1 while the diagnosis description was based on the slides; H&E and GIEMSA A1 d. For Example 1: A vs A1; B vs B1; Example 2: No A or no A1 vs A1 H&E, GIEMSA slides are not consistent. e. The laboratory failed to ensure the accuracy and consistency when transcribe test requisition or authorization information into a record system or a laboratory information 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)