N.Y. Comp. Codes R. & Regs. tit. 10 § 58-1.11 - Reports and Records at Clinical Laboratories

This regulation requires that, when requested, a laboratory submit reports containing information and data related to its technical operation, and that such reports must be signed by both the owner and director of the lab.  The regulation requires that each lab or blood bank have records indicating daily acquisition of specimens, and specifies certain minimum requirements for the contents of such records.  The regulation further requires that each lab or blood bank report and supply this report to the physician submitting each specimen for analysis.  These pathology reports are required to use an accepted system of disease nomenclature, and the regulation includes a list of things that the report must contain including, but not limited to the patient’s identifying information, results of tests, information about the collection of specimen, and reports including numerical results.
 
The regulation requires that all the records and reports of test performed and duplicates of reports received from other laboratories be kept on premises of both laboratories and be made available to representatives of department of health on request.  The regulation specifies that records must be retained in their original form for at least 3 months, after which they may be stored in microfilm or other photographic records or in an electronic processing system.  The regulation requires that these records be adequately protected against destruction.  The regulation allows those records that need to be stored over 2 years to be stored in a separate location after 2 years provided they can be retrieved when requested within 24 hours.  The regulation further requires that specific reports be retained for specific numbers of years, and lists them in detail.