Conditions and standards for grant of certificate of registration for tissue banks.

A. Facility and premises: (1) Facilities must conform to the standards and guidelines laid down for the purpose and the States and Union territories may have separate registration fee and procedure to keep track of their tissue bank activities. (2) The respective State or Union territory Appropriate Authority may constitute an expert committee for advising on the matter related to tissue specific standards and related issues. (3) The tissue bank must have written guidelines and standard operating procedures for maintenance of its premises and facilities which include- (a) controlled access; (b) cleaning and maintenance systems; (c) waste disposal; (d) health and safety of staff; (e) risk assessment protocol; and (f) follow up protocol. (4) Equipments as per scientific requirements specific to tissue (s) being procured, processed, stored and distributed and the tissue bank should ensure the availability of the accessories, spare-parts and back-up, maintenance and service support for all equipments. (5) Air particle count and microbial colony count compliance shall be ensured for safety where necessary. (6) Storage area shall be designated to avoid contact with chemicals or atmospheric contamination and any known source of infection. (7) Storage facility shall be separate and distinguish tissues, held in quarantine, released and rejected. B. Donor screening: (8) Complete screening of donor must be conducted including medical or social history and serological evaluation for medical conditions or disease processes that would contraindicate the donation of tissues and the report of corneas or eyes not found suitable for transplantation and their alternate use shall be certified by a committee of two Ophthalmologists. C. Laboratory tests: (9) Facility for relevant Laboratory tests for blood and tissue samples shall be available and testing of blood and tissue samples shall begin at Donor Screening and continue during retrieval and throughout processing. D. Procurement and other procedures: (10) Procurement of tissue must be carried out by registered health care professionals or technicians having necessary experience or special training. (11) Consent for the procurement shall be obtained. (12) Procurement records shall be maintained. (13) Standard operating procedure for following shall be followed, namely :- (a) procurement or Retrieval and transplantation; (b) processing and sterilisation; (c) packaging, labeling and storage; (d) distribution or allocation; (e) transportation; and (f) reporting of serious adverse reactions. E. Documentation and Records: (14) A log of tissue received and distributed shall be maintained to enable traceability from the donor to the tissue and the tissue to the donor and the records shall also indicate the dates and the identities of the staff performing specific steps in the removal or processing or distribution of the tissues. F. Data Protection and Confidentiality: (15) A unique donor identification number shall be used for each donor, and access to donor records shall be restricted. G. Quality Management: (16) The Quality Management System shall define quality control procedures that include the following, namely:- (a) environmental monitoring; (b) equipment maintenance and monitoring; (c) in -process controls monitoring; (d) internal audits including reagent and supply monitoring; (e) compliance with reference standards, local regulations, quality manuals or documented standard operating procedures; and (f) monitoring work environment. H. Recipient Information: (17) All tissue recipients shall be followed up and prompt and appropriate corrective and preventive actions taken in case of adverse events.