N.Y. Comp. Codes R. & Regs. Tit. 10 § 58-5.9 - Quality assurance and safety requirements
(a) Quality assurance.
(1) The hematopoietic progenitor cell
procurement service and hematopoietic progenitor cell processing facility shall
keep records which indicate that a quality assurance program is maintained in
the following areas:
(i) preventive
maintenance, periodic inspections and testing for proper operation of
equipment;
(ii) monitoring of all
temperature-controlled spaces and equipment to ensure proper
performance;
(iii) validation of
microprocessor-controlled equipment and associated software, including test
plan protocols, results of parallel testing, and supervisory review;
and
(iv) validation of
hematopoietic progenitor cell processing and testing methodologies.
(2) Hematopoietic progenitor cell
processing, laboratory and storage facilities shall be maintained in a clean
and orderly manner, and shall be of suitable size, construction, and location
to assure product and personnel safety.
(3) All reagents and solutions shall be
in-date, stored properly, and labeled to indicate identity and, as appropriate,
titer, strength or concentration, recommended storage requirements, preparation
and/or expiration date, and other pertinent information. All such materials
shall be removed from use on the expiration date. Materials of substandard
reactivity and deteriorated materials shall be discarded regardless of
expiration date.
(4) All specimens
accompanying the collected hematopoietic progenitor cells shall be sufficiently
stable to provide accurate and precise test results suitable for clinical
interpretation. The hematopoietic progenitor cell procurement service shall
ensure that specimens are collected, preserved and transported to the
laboratory in such a manner as to meet this requirement. Specimens for analysis
shall be identified fully and accessioned in a log book. The accessioning
system shall be designed to allow tracing of the hematopoietic progenitor cells
to a specific donor, and to identify the date and, if applicable, the time of
retrieval.
(5) Current standard
operating procedure manuals specific to the facility shall be available at all
times in the immediate work area of personnel engaged in retrieval, processing,
testing, storage, distribution, or other hematopoietic progenitor cell
procurement activity. There shall be a written protocol for all procedures
performed. Manuals shall contain a protocol for development, maintenance, and
periodic review of standard operating procedures by facility personnel and
management staff. Procedure manuals shall have the following features:
(i) a standardized format for
procedures;
(ii) a system of
numbering and/or titling individual procedures;
(iii) a clearly written description of
purpose for each procedure;
(iv) a
reference section listing appropriate scientific literature and industry and/or
corporate standards espoused by the hematopoietic progenitor cell procurement
service and/or processing facility;
(v) clearly defined areas of employees or
technical staff responsibility by position/title;
(vi) documented approval of procedures and
procedural modifications, including annual review by the director of the
hematopoietic progenitor cell procurement service and/or processing facility,
or authorized supervisor;
(vii)
instructions for the completion of reports and forms, including
examples;
(viii) effective date and
date of review for each procedure; and
(ix) a system for archiving earlier versions
of procedures and forms.
(6) The policies and procedures specified in
the procedure manual shall be followed at all times. If deviations or
deficiencies are identified, appropriate corrective action shall be taken and
documented.
(7) The director of the
hematopoietic progenitor cell procurement service and/or processing facility
shall establish and maintain a planned and periodic internal review program for
monitoring and evaluating the quality and appropriateness of the hematopoietic
progenitor cell banking services. Included in the program shall be systems for
evaluating errors, and designing, implementing and documenting corrective
action for any deficiencies identified. Quality assurance deficiencies shall be
documented, and evidence shall be available that any operational or procedural
problems are reported to supervisory personnel in a timely manner, and that
corrective action is implemented, documented and subsequently followed
up.
(8) The director of the
hematopoietic progenitor cell procurement service and/or hematopoietic
progenitor cell processing facility shall be responsible for developing
policies, procedures and/or standards for the qualifications, training,
certification and continuing education of technical staff. Documentation of
compliance with this requirement and with the policies developed shall be
maintained.
(b) Safety.
(1) The hematopoietic progenitor cell
procurement service and/or processing facility shall implement written safety
and infection control policies and procedures to ensure protection from
unnecessary physical, chemical and biological hazards, as follows:
(i) Decontamination and disposal techniques
for regulated medical waste shall be utilized. All hazardous and regulated
medical waste materials shall be handled, stored and discarded pursuant to Part
70 of this Title.
(ii) If
sterilization equipment is used, the pressure, temperature and duration of each
cycle shall be recorded, and such records maintained for one year. For each
run, these parameters shall be within the manufacturer's recommended operating
standards. If any one or more of these parameters fall(s) outside the
manufacturer's standards, all material shall be resterilized. Chemical,
biological and physical detection systems should be used in conjunction with
these other measurements of performance.
(iii) Eating, drinking, smoking, or the
application of cosmetics or contact lenses shall not be permitted in work
areas. Refrigerators or freezers used for storing specimens or reagents shall
not be used for any other purpose.
(iv) Gloves and laboratory coats, gowns or
other protective clothing shall be worn as necessary while handling blood
specimens or hematopoietic progenitor cell tissue. Such protective clothing
shall not be worn outside the work area and shall be disposed of in an
appropriate receptacle.
(2) The hematopoietic progenitor cell
procurement service and/or processing facility shall have written policies and
procedures in the following areas:
(i)
infection control;
(ii)
biosafety;
(iii) chemical and
radiological safety;
(iv) emergency
response to worksite accidents; and
(v) medical waste disposal.
(3) The safe collection of
peripheral blood hematopoietic progenitor cells by apheresis shall be the
responsibility of the medical director of the apheresis service. Collection
shall be performed in full compliance with section
58-2.15
of this Part.
(4) Hematopoietic
progenitor cell transplantation facilities shall report suspected cases of
infectious disease transmission in recipients to the hematopoietic progenitor
cell bank providing the tissue.
(5)
The hematopoietic progenitor cell bank shall have a written procedure for
documenting any errors or accidents in retrieval, testing, processing, storage
or disposition of hematopoietic progenitor cells that may affect the safety of
the cells, and for reporting such errors or accidents to the medical advisory
committee of the bank. If the error or accident is detected after issuance of
the cells, the error or accident shall be reported to the receiving facility
immediately upon detection by the distributing facility. All errors with the
potential for serious adverse effects on the recipient shall also be reported
to the department's Wadsworth Center within seven calendar days of
discovery.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.