Summary:
Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation, review, and interview; the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1273, and 493.1281 through 493.1299. Findings: 1. Review of laboratory records revealed the following: a. There was no documentation to show that the laboratory verified the accuracy of its histopathology procedures. See D tag 5217. b. There was no documenation to show that tests were actually ordered. See D tag 5305. 2. The laboratory lacked a comprehensive procedures manual that has all required information. See D tags 5403, 5407, and 5409. 3. Test reports did not include the laboratory location where all tests are performed. See D tag 5805 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 review and interview; the laboratory failed to verify the accuracy of its histopathology procedures. Findings: 1. Review of laboratory policies and procedures revealed that there were no procedures that describes how the laboratory verifies the accuracy of it histopathology procedures. 2. There was no documentation to show that 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 -- the laboratory verified its histopathology procedures from June 2017 through July 2018. 3. During survey date 07/19/18 at 2:00 PM, the laboratory manager confirmed the surveyor's findings. 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 observation, record review and interview; the laboratory failed to ensure that the test requisition solicits all required formation. Findings: 1. During survey date 07 /19/18 at 12:30 PM, the surveyor observed how patients tissue specimens were collected, labeled, and sent out for processing. The surveyor observed that a requisition was packed in a biohazard bag, along with the patients' tissue specimen. 2. Review of the requisition revealed that the following information was not included on the requisition when patients' specimens were labeled and sent to the referral lab: a. The test to be performed. b. The source of the specimen 3. During survey date 07/19 /18 at 2:00 PM, the laboratory manager 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)