we are in the step of making policies for every thing about clean room & tpn preparation.
kindly I need ASPEN PN practice manual book & any reference can help me
thanks a lot
I am requested by hospital management to submit a strategic plan to open a TPN service. Kindly share with me your experience and references for the minimum requirements needed to open a TPN service in our hospital.
I am sure your hospital is big and providing ICU care. For that reason, Admin asked to establish PN service. As the any hospital having neonatal and pediatric, surgical, and critical service, the hospital has to provide PN service. As these patient categories are badly need for PN anytime. in my opinion, there is no minimum number as you may expect unexpected number of PN prescribing depend on the situation.
You have the options to provide either customized or ready made PN but you have neonatal and pediatric service, you may need to focus on customized PN ( standard or tailored formula).
You need to create SOPs related to safe practice for PN and IV fluid first, establishing well defined procedures for safe PN compounding, well trained and skilled pharmacists, expert PN prescriber, and enough manpower either to compound PN manually or by Automated compounding device (ACD)
Roughly, preparation PN manually may take at least 45 minutes to one hour while using ACD may take 10 to 15 minutes per bag.
The option for choosing ACD is depending on the number of PN like more 10 bags, the budget of hospital (the average cost varies depending on the type of machine) Also supplies to ACD like tubing sets and inlets, , and others.
These are below minimum requirement for TPN and Sterile Admixture service in your organization
Cleanroom (IV room) with USP <797> Standardizations
Laminar airflow workbench (LAFW) or Compounding aseptic isolator (CAI)
Qualified and Trained Staff for Aseptic Compounding
Other all accessories used for TPN Compounding and IV- Admixture
– Firstly you should make a strategic plan, based on your hospital bed size, expected patient categories who may need TPN. From that you may estimate how many TPN to be prepared daily, and that is the key factor.
– Put on your mind that TPN service and its infra-structure is not cheap and you will not make it every year or even five. So, if you have future extension plans at your hospital (bed capacity or patient categories), you should consider that while planning your project, otherwise you may need to reconstruct your clean room, replace machines or maybe change the whole workflow.
– You have vendors who can construct your room and sell Laminar Flow Workbenches (Favored if you have a good compliant room), or an Isolator (which is not favored by working personnel).
– If you have a number of preparations > 10-15 bags per day, you should consider having an automatic compounder, rather than the manual preparations.
– You will need trained pharmacists and technicians, who are able to operate in clean environment, and another pharmacists on the Nutrition Support level with solid experience and education in Clinical Nutrition.
– The most important is the design of your clean room and workflow, this will have a deep impact on your work in the soon and far future. So, don’t try to make a room design apart from your workflow plans. (Spend much time on planning this step)
1. The key to success is the exposure to best practices… Workflows and technologies are very important. Consider to spend few days in hospitals with best practices.
2. Competencies-Competencies-Competencies: Are you willing to have a pharmacy-based compounding service or combined with pharmacy-based consulting/ordering PN service? If you develop the experts, your are 80% there!
3. What is your bed number, scope of practice (neonates, peds, adults, critical care, etc.), allocated space in pharmacy, number of pharmacy FTEs and your BUDGET, then we will guide you further on how to proceed! I strongly believe that Experienced Leaders can do MAGIC with any available resources.
4. I truly appreciate seeing such a consult. I have seen few hospitals who started PN services without solid knowledge and confidence, that had failed few months after starting the service. Main reason was lack of competencies and exposure to good practices.
For point no. 2; about whether we are willing to have a pharmacy- based compounding service or combined with pharmacy based consulting/ordering PN service? Kindly if you do not mind, I would appreciate if you could clarify the difference.
For Point no. 3; Current situation
Hospital bed number: 125 beds, 17th in NICU, 4 in PICU, 25 in pediatric and 40 in Maternity.
Scope of Practice: NICU, PICU, Peds
Allocated space in pharmacy:
ante-room: 2.5m x 2.4m
buffer room: 3.7m x 5.7m
FTS: if you meant the pharmacy operating hours, then our pharmacy is 24/7
“TPN service is provided from other hospital in morning weekdays only”
Budget: not decided yet.
If you want the pharmacist to order PN or to offer clinical consults on PN then you require special competencies i.e. BCNSP, clinical PN internship, PGY-2, etc. If your system requires pharmacists to verify and process orders and compounds PN then you require different types of clinical and technical competencies.
With above data, if you plan to prepare all Compounding Sterile Preparations in the Pharmacy, you should expect around 2.5 CSPs per bed day i.e. around 300 CSPs per day + 20 PN per day. The required space is around 50-60 meter square minimum.
Ideally each technician should be able to compound 100 CSPs per shift. You would require 2 FTEs for IV Pharmacists (operational) and 5-6 FTEs Pharmacy Technicians (depend on duty hours, vacation days, male:female ratio, etc.) to cover 24/7. If you plan to have a Clinical Pharmacist to round and order PN then this is an extra FTE.
I’m asking about using other brand names of amino acids for neonates during shortage of AMINOVEN for TPN preparation.
Can we use adult amino acids, hepatic or kidney amino acids?
what are the parameters must be taken in consideration a part from concentration and osmolarity?
if we cannot use adult amino acids , what are the suggested solution during shortage of aminoven? knowing that it’s the only available amino acid product.
Infant or pediatric amino acids formula are recommended for the age under 18 months and strongly recommended for babies under the age of 6 months.
There are major differences between and infant or pediatric amino acids versus adults PN formula or we called standard amino acids and renal and hepatic amino acids formulas:
Infant or pediatric formula has the followings:
1-Low concentrations of methionine, phenylalanine, and glycine. Giving standard or adult amino formula what have very high concentrations of these amino acids and due to immature organ and enzymatic system, they lead to accumulation of these amino acids that have a potential harmful to the babies, like GI upset, affecting blood hemostasis, and possible brain damage.
2- It contains Taurine which plays a role in prevent cholestasis associated with PN and it is important for retinal development
3- It contains Cysteine which enhance the solubility of calcium and inorganic phosphate (if organic phosphate is not in use.
in case of a shortage, it was advised that the standard amino acids should NOT BE used for more than 3 days. There are many pediatric
formula options like Primine, Trophamine, Vaminolact, Aminoven infant in the market.
If PN is to be continued with adult amino acids, standard amino acids formula, you may continue with very low dose 0.5 gm/kg/day, even I Don’t like this approach.
I thought you would be interested to read the recent ASPEN tutorial for Adult PN, include:
1-Determination of energy and volume requirements
4-PN for special situations
5-Daily monitoring and adjustment of PN formula
I have a question about ante room ,should the anteroom be covered with anti rusting panel ? or only it is enough to be painted with anti bacterial painting.
Epoxy-painted walls are fair enough according to the USP 797.
Please do you have any experience or information (with Guideline) towards these topics:-
1. Ketogenic diet in brain tumor, Pediatric patients.
2. Supplementation of vitamins A, E and C prior to chemotherapy, in pediatric
As we are planning to start our TPN unit in our facility, would like
to get help from you all on the following
1. Software for calculation of TPN preparation for Dr’s as
well as pharmacists
2. Auto calculator.
It is highly appreciated if any one of you could help us on the same
at the earliest.
Try doing a google search for the phrase Prescribing and Compounding Software
I have a new iv room setup and there are two helmer refrigerators located inside iv room. Do this helmer refrigerator generate particles?
Can I keep this inside iv room, or should I remove them? Need your kind guidance.
Refrigerators can be placed in ISO classified areas, especially in negative-pressure HD buffer rooms. It is important to check any condenser pans monthly to avoid standing water and to wipe down the coils. If you can place it near or in front of low-wall returns, this be helpful. CriticalPoint has completed a couple of studies (to be published) showing no negative environmental impact when refrigerators are located in ISO classified rooms. I hope this helps.
Thank you so much Rachel for your important conclusion on the impact of siting of refrigerators within ISO classified areas. Sometimes the balance between facts and speculations is a tough game and in such instances nothing beats objective, published evidence.
I would like to mention one aspect which although not necessarily related to refrigerator function per se can also be indirectly linked to such devices. Refrigerator door gaskets can be breeding grounds for microbiological growth, especially fungi (especially if gaskets are black in colour – hard to detect) – so a robust cleaning and disinfection programme that takes this into account would be essential. This is especially important if the refrigerator is used to store vials for aseptic manipulation (any contamination picked up during opening can compromise transfer disinfection of such vials).
Also as Rachel said, siting of refrigerators close to low-floor extracts is also very important as any potential contaminants (including viable particles) will be sucked in and safely extracted without risk of being pushed to areas around the room with the turbulent air-flows. Such siting would therefore also work as a ‘risk containing’ mechanism for such eventualities.
I have two questions regarding the anteroom and what is best according to USP 797 and 800.
1- is it preferable to locate the sink, for hand hygiene, inside the anteroom or before entering the anteroom (in the receiving or working area) to minimize contamination inside the anteroom.
2- in the pharmacy layout design, should the anteroom be the first room to encounter when entering the facility, thus giving access to both work area and buffer area. Or should it be located between the work area and the buffer area, meaning to get to the anteroom you have to pass through the work area.
I have attached a concept plan that might answer many of your questions. Let me know if this helps.
Very helpful, Thanks a lot.
i would like to ask a question about pest control in inpatient pharmacy ,we can spray pesticide in side IV room or not?
We never use pest controls in the clean room.
Pest control materials, if left to volatilize or float in the air, can be as bad or even worse than the pests. But again it is a challenge, and we need to deal with it case by case, by conducting pros and cons analysis.
Below are some hints:
· Focus on preventing pests from getting into clean rooms in the first place.
· Take appropriate supplemental non-chemical steps to eliminate the source or the pest’s route of access to the building and the clean room.
· PMPs must act as consultants for their clients, advising them on sanitation, design, construction, and maintenance improvements that can be made in the building’s surroundings, on the building itself, and inside the building to make the whole area as unfriendly to pests and as impervious to pest invasion as possible.
· The central principle of clean-room Integrated Pest Management is to start from the facility’s outer surroundings; identify pest-conducive conditions and pest populations that are present; and then, working from outside in — from least-sensitive to most-sensitive — block and thwart a pest’s progress into the clean room.
· When it is necessary to apply a pest control device or, in rare cases, a pesticide, inside the clean-room environment, it must be done using materials and methods that reliably preclude the possibility that any contaminants will be added to the particulate load of the air in the clean room.
Is there any specification related to area of IV room, i mean at least 70Sq. meters or else? Or the IV room area can be any size? OR it depends on hospital bed capacity> If hospital bed capacity is 500 beds tertiary care hospital then is 70 sq. meters is o.k ?
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