Summary:
Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to ensure the time the laboratory received specimens was documented for 11 (Patients 6130, 35010, 30176, 33222, 35072, 33688, 33723, 33289, 32593, 12956, and 31875) of 11 patient test records reviewed. Findings include: 1. A review of the laboratory's test records revealed a lack of time the laboratory received specimens for patients 6130, 35010, 30176, 33222, 35072, 33688, 33723, 33289, 32593, 12956, and 31875. 2. An interview on 3/17/22 at 10:47 am with the Laboratory Director confirmed the laboratory did not document the time the laboratory received specimens. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 2 -- . Based on record review and interview with the Laboratory Director, the laboratory failed to indicate the specimen source on the mohs map as part of the test report for 3 (Patients 33289, 31875, and 30176) of 11 patient test records reviewed. Findings include: 1. A review of the laboratory's patient test reports revealed patients 33289, 31875, and 30176 receiving histopathology testing did not have the specimen source on the mohs maps as part of the test report. 2. An interview on 3/17/22 at 10:47 am with the Laboratory Director confirmed the laboratory did not indicate the specimen source on the mohs maps for the patients listed above. -- 2 of 2 --