N.Y. Comp. Codes R. & Regs. Tit. 10 § 58-2.8 - Standard operating procedures
(a) Current standard operating procedure
manuals or other procedural guides specific to the facility shall be available
at all times in the immediate work area of personnel engaged in the collection,
processing, testing, storage, distribution and administration of blood, blood
components or derivatives for autogeneic or allogeneic use, and for
therapeutic, prophylactic or diagnostic purposes. There shall be a written
protocol for all procedures performed at the facility. Manuals shall contain a
protocol for writing, maintaining and periodic review of standard operating
procedures by user personnel and management staff. Procedure manuals shall have
the following features:
(1) a standardized
format;
(2) a system of numbering
and/or entitling individual procedures;
(3) a clearly written description of purpose
for each procedure;
(4) a reference
section listing appropriate scientific literature;
(5) clearly defined areas of personnel
responsibility by title;
(6)
documented approval of procedures and procedural modifications by the director,
and annual review by the director or authorized supervisor;
(7) instructions for the completion of
reports and forms, including examples;
(8) effective date and date of review for
each procedure; and
(9) a system of
archiving earlier versions of procedures and forms.
(a) Discontinued procedure documents and
forms shall be retained and be available for inspection for at least seven
years. Dates of initial use and discontinuance shall be recorded.
(b) The standard operating procedure manual
shall include a written procedure for documenting errors or accidents in
collection, testing, processing, storage or distribution that may affect the
safety or purity of any product, or health of the donor or recipient. All such
errors and accidents not detected prior to product distribution shall also be
reported to the department's Wadsworth Center within seven calendar days of
discovery and, if required, to Federal authorities.
(c) The standard operating procedure manual
shall include written policies and procedures regarding the following, for
activities performed at the site:
(1) use and
maintenance of blood warming devices;
(2) type of infusion sets and filters for all
components;
(3) issuance of
components, which must include visual inspection prior to issuance;
(4) type of personnel authorized to issue
components;
(5) for collecting
facilities, obtaining blood or components from other institutions during
emergency situations;
(6) all
transfusion-related testing, prenatal testing, and neonatal testing;
(7) prompt evaluation of reported transfusion
reactions and other adverse events;
(8) emergency release of uncrossmatched
blood, which must include compatibility testing performed after
release;
(9) method validation
requirements;
(10) professional
qualifications of personnel who may collect blood specimens for pretransfusion
testing;
(11) specimen and labeling
requirements for pretransfusion samples;
(12) release of blood and blood components to
limited transfusion services and ambulance transfusion services; and
(13) administration of blood components,
including prevention of transfusion reactions.
(d) The policies and procedures specified in
the standard operating procedure manual shall be followed at all times. If
deviations are identified, appropriate corrective action shall be taken and
documented.
(e) The blood bank
director or the director of transfusion services shall establish and maintain a
planned and periodic internal review program for monitoring and evaluating the
quality and appropriateness of standard operating procedures in the performance
of blood bank and transfusion service activities. Included in the program shall
be a system for designing and implementing corrective action for any problems
identified. Quality assurance deficiencies shall be documented, and evidence
shall be available that problems are reported to the appropriate individuals in
a timely manner and that corrective action is implemented and subsequently
followed-up.
Notes
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