| (ii) every six months for high-risk level compounding.
(C) Pharmacy personnel who fail written tests or whose
media-fill tests result in gross microbial colonization shall:
(i) be immediately re-instructed and re-evaluated by
expert compounding personnel to ensure correction of all aseptic practice
deficiencies; and
(ii) not be allowed to compound sterile preparations
for patient use until passing results are achieved.
(D) The didactic and experiential training shall include
instruction, experience, and demonstrated proficiency in the following
areas:
(i) aseptic technique;
(ii) critical area contamination factors;
(iii) environmental monitoring;
(iv) structure and engineering controls related to
facilities;
(v) equipment and supplies;
(vi) sterile preparation calculations and terminology;
(vii) sterile preparation compounding documentation;
(viii) quality assurance procedures;
(ix) aseptic preparation procedures including proper
gowning and gloving technique;
(x) handling of hazardous drugs, if applicable;
(xi) cleaning procedures; and
(xii) general conduct in the clean room.
(E) The aseptic technique of each person compounding
or responsible for the direct supervision of personnel compounding
sterile preparations shall be observed and evaluated by expert personnel
as satisfactory through written and practical tests, and challenge
testing, and such evaluation documented. Compounding personnel shall
not evaluate their own aseptic technique or results of their own media-fill
challenge testing.
(F) Media-fill tests must be conducted at each pharmacy
where an individual compounds low or medium risk sterile preparations.
If pharmacies are under common ownership and control, the media-fill
testing may be conducted at only one of the pharmacies provided each
of the pharmacies are operated under equivalent policies and procedures
and the testing is conducted under the most challenging or stressful
conditions. In addition, each pharmacy must maintain documentation
of the media-fill test. No preparation intended for patient use shall
be compounded by an individual until the on-site media-fill tests
indicate that the individual can competently perform aseptic procedures,
except that a pharmacist may temporarily compound sterile preparations
and supervise pharmacy technicians compounding sterile preparations
without media-fill tests provided the pharmacist completes the on-site
media-fill tests within seven days of commencing work at the pharmacy.
(G) Media-fill tests must be conducted at each pharmacy
where an individual compounds high risk sterile preparations. No preparation
intended for patient use shall be compounded by an individual until
the on-site media-fill tests indicate that the individual can competently
perform aseptic procedures, except that a pharmacist may temporarily
compound sterile preparations and supervise pharmacy technicians compounding
sterile preparations without media-fill tests provided the pharmacist
completes the on-site media-fill tests within seven days of commencing
work at the pharmacy.
(H) Media-fill testing procedures for assessing the
preparation of specific types of sterile preparations shall be representative
of the most challenging or stressful conditions encountered by the
pharmacy personnel being evaluated and, if applicable, for sterilizing
high-risk level compounded sterile preparations.
(I) Media-fill challenge tests simulating high-risk
level compounding shall be used to verify the capability of the compounding
environment and process to produce a sterile preparation.
(J) Commercially available sterile fluid culture media
for low and medium risk level compounding or non-sterile fluid culture
media for high risk level compounding shall be able to promote exponential
colonization of bacteria that are most likely to be transmitted to
compounding sterile preparations from the compounding personnel and
environment. Media-filled vials are generally incubated at 20 to 25
degrees Celsius or at 30 to 35 degrees Celsius for a minimum of 14
days. If two temperatures are used for incubation of media-filled
samples, then these filled containers should be incubated for at least
7 days at each temperature. Failure is indicated by visible turbidity
in the medium on or before 14 days.
(K) The pharmacist-in-charge shall ensure continuing
competency of pharmacy personnel through in-service education, training,
and media-fill tests to supplement initial training. Personnel competency
shall be evaluated:
(i) during orientation and training prior to the regular
performance of those tasks;
(ii) whenever the quality assurance program yields
an unacceptable result;
(iii) whenever unacceptable techniques are observed;
and
(iv) at least on an annual basis for low- and medium-risk
level compounding, and every six months for high-risk level compounding.
(L) The pharmacist-in-charge shall ensure that proper
hand hygiene and garbing practices of compounding personnel are evaluated
prior to compounding, supervising, or verifying sterile preparations
intended for patient use and whenever an aseptic media fill is performed.
(i) Sampling of compounding personnel glove fingertips
shall be performed for all risk level compounding. If pharmacies are
under common ownership and control, the gloved fingertip sampling
may be conducted at only one of the pharmacies provided each of the
pharmacies are operated under equivalent policies and procedures and
the testing is conducted under the most challenging or stressful conditions.
In addition, each pharmacy must maintain documentation of the gloved
fingertip sampling of all compounding personnel.
(ii) All compounding personnel shall demonstrate competency
in proper hand hygiene and garbing procedures and in aseptic work
practices (e.g., disinfection of component surfaces, routine disinfection
of gloved hands).
(iii) Sterile contact agar plates shall be used to
sample the gloved fingertips of compounding personnel after garbing
in order to assess garbing competency and after completing the media-fill
preparation (without applying sterile 70% IPA).
(iv) The visual observation shall be documented and
maintained to provide a permanent record and long-term assessment
of personnel competency.
(v) All compounding personnel shall successfully complete
an initial competency evaluation and gloved fingertip/thumb sampling
procedure no less than three times before initially being allowed
to compound sterile preparations for patient use. Immediately after
the compounding personnel completes the hand hygiene and garbing procedure
(i.e., after donning of sterile gloves and before any disinfecting
with sterile 70% IPA), the evaluator will collect a gloved fingertip
and thumb sample from both hands of the compounding personnel onto
contact plates or swabs by having the individual lightly touching
each fingertip onto the testing medium. The contact plates or swabs
will be incubated for the appropriate incubation period and at the
appropriate temperature. Results of the initial gloved fingertip evaluations
shall indicate zero colony-forming units (0 CFU) growth on the contact
plates or swabs, or the test shall be considered a failure. In the
event of a failed gloved fingertip test, the evaluation shall be repeated
until the individual can successfully don sterile gloves and pass
the gloved fingertip evaluation, defined as zero CFUs growth. No preparation
intended for patient use shall be compounded by an individual until
the results of the initial gloved fingertip evaluation indicate that
the individual can competently perform aseptic procedures except that
a pharmacist may temporarily physically supervise pharmacy technicians
compounding sterile preparations before the results of the evaluation
have been received for no more than three days from the date of the
test.
(vi) Re-evaluation of all compounding personnel shall
occur at least annually for compounding personnel who compound low
and medium risk level preparations and every six months for compounding
personnel who compound high risk level preparations. Results of gloved
fingertip tests conducted immediately after compounding personnel
complete a compounding procedure shall indicate no more than 3 CFUs
growth, or the test shall be considered a failure, in which case,
the evaluation shall be repeated until an acceptable test can be achieved
(i.e., the results indicated no more than 3 CFUs growth).
(M) The pharmacist-in-charge shall ensure surface sampling
shall be conducted in all ISO classified areas on a periodic basis.
Sampling shall be accomplished using contact plates or swabs at the
conclusion of compounding. The sample area shall be gently touched
with the agar surface by rolling the plate across the surface to be
sampled.
Cont'd... |
