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Questions and Answers on USP 797
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RJLG Question 1: Question on fingertip sampling:
I have a question regarding fingertip sampling. On
page 34, the recommended action levels for microbial
contamination states that the action levels for ISO
Class 5 sampling is >3. Yet when I look at the
appendix I for gloved fingertip sampling it states that
"All employees shall successfully complete an initial
competency evaluation and gloved fingertip/thumb
sampling procedure (0 cfu) no less than three times
before initially being allowed to compound CSPs for
human use". I'm confused as to which one applies.
Can you clarify for me? Thanks.
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RJLG Question 2:
What is the minimum time for a settle plate sample. We
are currently using 15 min is this enough.
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RJLG Question 3: I work
in a Nuclear Medicine Department and we use unit dose
for everything but emergency scans. We have changed our
policy to receive multiple separate syringes with
varying activities to produce several single dose kits.
During preparation aseptic techniques will be followed.
The kit will be used within an hour, for only one
patient and no more than two entries into any one vial.
My concern is preparing an Ultra tag kit for a
G.I.Bleed. If we follow the manufacturer's
preparation and use the correct personal protective
equipment are we covered under the immediate use
exemption?
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RJLG Question 4: We are
a privately owned physicians office and do not have
pharmacy or pharmacist. We have (2) RN's that are
trained and certified to mix and give chemo drugs.
We follow NIOSH guidelines. De we have to follow
the USP797 guidelines?
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RJLG Question 5: I read
somewhere in the USP 797 that it was acceptable to mix a
low volume of chemotherapy agents without a separate
negative pressure room as long as CSTD's were used.
Is this correct? Also--what is considered a low
volume?
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RJLG Question 6:
I
have received some conflicting information regarding USP
797 standards related to the presence of a sink in an
anteroom meeting ISO Class 7. In reviewing the
Revision Bulletin (copyright 2008), an ISO Class 7
buffer area shall not contain sinks or floor drains, but
would the presence of a sink in a physically separate,
positive pressure ISO Class 7 anteroom adjacent to a
negative pressure ISO Class 7 buffer area somehow
detract from the anteroom's ISO classification?
Specifically, I have a new hospital pharmacy which has
provided certification documentation that the small
anteroom leading into the hazardous drug preparation
area (negative pressure ISO Class 7 buffer area
containing ISO Class 5 PEC) meets the established
guidelines for ISO Class 7 with the presence of a sink
with a drain (located next to the doorway separating the
anteroom from the buffer area). This was in a
pre-operational, non-dynamic state. There are now
some conflicting opinions about the sink and its impact
on the ISO classification of the anteroom. Any
guidance on this situation would be much appreciated.
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RJLG Question 7:
If a CACI is used as the
PEC (The gloves used are part of the equipment) is
gloved fingertip sampling required? Is
surface sampling required inside a CACI? If so how
frequently?
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RJLG Question 8:
We
are a small home infusion pharmacy. Approximately
2% of our patient base receives chemotherapy medications
(primarily 5FU). Do we need a negative pressure
room if: we compound/mix in a BSC, maintain a
“safety zone” around the BSC within the clean room and
utilize the PhaSeal product line when compounding?
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RJLG Question 9:
Is it acceptable to store a refrigerator in the anteroom
under any circumstance? The only answer I find in
the chapter is “Placement of non-essential items within
buffer and ante areas is determined by the impact on
environmental quality as verified by monitoring.”
Is there a more straightforward answer to this question?
Did I miss the answer? We need a refrigerator in
our anteroom to store thawed premixed bags but don’t
want to purchase if the answer is a definite no.
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RJLG Question 10:
I have a question
concerning the use of two different style hoods in the
same area.
1. Can a biological safety cabinet (BSC) and a laminar
flow hood be in the same ISO 7 room that meets all other
USP 797 requirements (ante-room etc.). The BSC
would not be used for hazardous products and is not
vented to the outside air, but could be used short dated
IV products (with exp</=24 hrs)? We have an extra
BSC and would like to use it in the same room are we
violating any USP standards by using in the ISO 7 room?
2. If the answer to question 1 is yes is there a
specific room arrangement? (i.e. the two hoods can be
next to each other in the same plane vs. opposite each
other, minimum distance apart, etc)
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RJLG Question 11: Is it appropriate to purchase
air sampling equipment and perform our own ISO air
testing for both viable and particle samples in a
hospital setting?
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RJLG Question 12:
If chemotherapy medications
are stored in the negative pressure cleanroom, how are
refrigerated chemotherapy meds supposed to be stored
since refrigerators should not be placed in the clean
room? Do we have to build a separate negative
pressure area for the refrigerator?
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RJLG Question 13:
I need to know what storage requirements of supplies &
drugs stored in the ante room. We purchased metal carts
but not sure weather we can use new plastic bins to
place on the metal carts?
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RJLG Question 14:
We are in the completion stage
of a USP <797> compliant clean room. It will have 4
separate rooms: a preparation room, an ante room, and
two buffer rooms (one for IV therapy and one, under
negative pressure, for chemotherapy). In
addition, we have 2 separate satellites that compound
chemotherapy, separate and distinct from our pharmacy
clean room, on two different floors within the hospital.
My questions relate to chemotherapy storage and are as
follows:
1. Where can we store our chemotherapy
inventory?
2. Can chemotherapy be stored in the main
pharmacy and in the satellites (within its original
carton) if segregated from non-chemo products, but not
in a negative pressure environment?
3. Must they be stored under negative
pressure and if so, removed for the shipping carton and
decontaminated prior to storage?
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RJLG Question 15:
I have a question regarding the preparation of
chemotherapy. I have a negative pressure glove box
that is vented to the outside. It is currently in
the same room as my positive pressure glove box.
If I have verification from the manufacturer that the
glove box does not need to be in a clean room--do I need
to place the chemo glove box in a negative pressure
room? Could I place it in a separate room without
negative pressure. If my room does not have
negative pressure--where is the appropriate area to
store my chemo meds? I would appreciate any
informatiion you can send.
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RJLG Question 16:
Do
you have guidelines for what to do if laminar flow hood
testing surface culture test results are positive?
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RJLG Question 17:
Chapter <797> states that “hazardous drugs shall be
stored separately from other inventory in a manner to
prevent contamination and personnel exposure”. I
work in a hospital with a separate negative pressure
chemo room adjacent to a positive pressure ante room.
We use a separate refrigerator for chemotherapy drugs
and it is only accessed by staff that are involved in
the preparation and distribution of these drugs.
However, this refrigerator is too large to store in our
negative pressure chemo room and would adversely impact
our air quality. Therefore, we store this
refrigerator in a separate storage room. Since the
concern of volatilization of hazardous drugs is at room
temperature and these drugs are refrigerated, is this an
acceptable plan?
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SS1 Question:
I work for a VNA in the community. CVS pt education
material for a multi-use vial (Prolixin) did not give
any guidelines regarding how long the vial could be used
after being opened. We also give Vit B12 injections and
Haldol in the community (IM injections typically). We
always follow sterility procedures and wipe with
alcohol. My question is regarding the stability and
sterility of the drug once the vial is opened. I was
always taught 28 days. We date vials in the hospital
setting and discard after 28 days. My concern in the
community is as follows:
1) Patients pay all or part of the drug expense. The
pharmacy is dispensing vials that can last more than a
year in some cases. Pts are not going to want to incur
the added expense and hassle of refilling every month.
2) I am concerned that some pharmacy programs will not
refill if their guidelines are not following the 28 day
rule.
Then I contacted Bedford Laboratories, they agreed that
the medication expiration date pertains to UNOPENED
vials, but could only cite USP guidelines because their
own material was silent on the subject. Our local (CVS)
pharmacist stated it was the expiration date on the vial
(which I don't believe is correct). Their corporate
written material provided to pts was silent on the
topic, although it did discuss storage.
Do
you have any comments on this subject or anyone I could
check with?
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- SS2
Question:
http://www.usp797.org/Articles-APrimerOnUSP797-IJPC.htm
In the primer article above, in the section titled "What
Were the Main Events Leading Chapter ?"
I'd like to know how to obtain the details of the
comments and data presented.
In addition, I'd like to know how I can find if there
has been comment or participation by any physician
practice organizations like the AMA and ASA.
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- SS3
Question:
For non-sterile CSPs, what are
common methods of sterilization?
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- SS4
Question:
Your website is extremely helpful. My question is
regarding compliance with USP797 in an outpatient
diagnostic imaging facility injecting radiologic
contrast media (either non-ionic or gadolinium based
MRI) The purchase of a laminar flow work station(s)
would not prove cost effective. If the
radiographic contrast media were ordered from the
distributor in pre-filled syringes from the manufacturer
(which confirms the dose was prepared in a sterile
environment) would that be considered compliant with USP
797?SA.
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- SS5
Question:
1. If I have biological safety
cabinet (BSC) or Glove in box within an ISO class 5
environment in a separate rooms does Viable Air Sampling
need to be performed on that room and is garbing
required?
2. Does Proprietary Bag and Vial systems ( ADD-Vantage,
Mini Bag Plus) require an ISO class 5 environment
(Barrier Isolator or glove box) for attachment? Can
someone please give me some clarity on the above 2
questions?SA.
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- SS6
Question:
I have a question regarding oncology offices and the
practice of mixing chemotherapeutic drugs for immediate
use on patients. According to the new June updates
to 797 is this still an acceptable practice or do the
offices need to mix chemo in barrier isolators or a
clean room?
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A1 Question: What is
USP Chapter 797?
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A2 Question: How do I
get a copy of USP Chapter 797?
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A3 Question: Does USP
Chapter 797 provide all I need to know about compounding
sterile preparations?
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A4 Question: What is a
"compounded sterile preparation" according to USP
Chapter 797?
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A5 Question: Is USP
Chapter 797 applicable just to pharmacies that compound
sterile products?
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A6 Question: Are
enforceable sterile compounding standards necessary?
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Answer
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A7 Question: What
can I do now to meet the requirements of USP Chapter 797?
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Answer
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