Patton Post – December 2022

December 2022

Inside This Issue

Water Management:

This month’s EC News has a good article about the Joint Commission’s water management standard, EC.02.05.02. The authors report that TJC gets many questions about this standard and we know that some of our clients struggle to understand the requirements under this standard.

TJC reports that one of the most frequently asked questions is about the level of detail required for the basic water management diagram (EP 2). They advise creation of a simple diagram such as the one published in the CDC toolkit on legionella.

You will note that this diagram does not identify every sink, shower, or toilet, but rather identifies that their water system distributes to sinks, showers, and toilets on certain floors, as well as other water features in the cold and hot water distribution green and orange sections.

One question we have received from a client is about any mandatory flushing/running of showers in closed sections of the organization. Unfortunately, there is no absolute guidance on this issue, but rather the guidance should come from your internal risk assessment.

This risk assessment should consider all of the factors that tend to contribute to the safety of your water system such as disinfectant levels, temperatures of the water and, if you are testing water quality, the results of that testing. Bottom line, yes flushing or running water systems in closed areas is expected, but the frequency may vary based on your risk assessment.

In addition, your risk assessment should consider the patient populations served, which may include immunocompromised patients who are more vulnerable to potential water borne/aerosolized infections.

This particular standard, EC.02.05.02 has not yet made the top ten, but it is one that should be focused on. The limited scoring at this time may be related to the newness, rather than any perception that compliance with this standard is easy.

We would certainly suggest distributing the article to your facilities leadership for their use.

Business Occupancies Requirements:

EC News has another article on new requirements for 2023 that focuses on the changes made just a few months ago to the LS.05 standards which affect business occupancies. We wrote about these in our October Newsletter. These will likely be challenging as business occupancies have not undergone a lot of scrutiny from an LS/EC perspective in prior years.

This month’s EC News reproduces the new standards and we would certainly suggest conducting a self-evaluation and gap analysis in your ambulatory facilities that are identified as business occupancies. It may take time for scoring of these new standards to ramp up, but it also may take time for healthcare organizations to become compliant. Thus, the self-evaluation and gap analysis might be protective on future surveys.

FGI Guideline:

Lastly, there is an important article in EC News that advises readers that effective January 2023, The Joint Commission is referencing the most current design and construction guidance from the Facilities Guideline Institute, or FGI. This will be the 2022 FGI Guideline – your 2022 TJC accreditation manual references the 2018 FGI guideline.

This is of course important if you are planning new construction, but it is also important if you are planning any renovations, which would require the renovation to be brought up to the most recent standards. This seemingly simple modification to the TJC standards has major implications as the FGI document is an entire book of guidance, not merely a single standard.

Readers will want to verify they have access to the 2022 FGI subscription and are using its standards when preparing for new construction or renovation. The EC News article discusses specific changes in the FGI guidance for emergency departments, burn trauma ICU beds, telemedicine settings, the number of airborne isolation rooms a hospital should have, and lactation rooms.

If you have any renovation or construction plans for these areas you will want to be sure to read the latest FGI guidance.

LTC Covid-19 Therapeutics:

CMS has one new QSO memo, QSO-23-03 issued November 22, 2022 targeted to all provider types, but with particular emphasis on the long-term care industry. The memo discusses the importance of timely treatment with Covid-19 therapeutics including monoclonal antibodies and oral antiviral agents for high-risk individuals.

After reading this CMS memo, we did find multiple internet references discussing the limited utilization of federally purchased Covid therapeutics. This memo clearly seems to target and promote greater utilization of these agents. The CMS memo has two sentences that seems of significant importance to readers.

On page 1 of this memo CMS says, “Every patient who tests positive for Covid-19 should be evaluated to determine whether the use of an available therapeutic is appropriate.” On page 2 they state, “CMS reminds providers and suppliers that, even when a patient’s symptoms may not initially present as severe, individual risk levels should be considered when deciding whether or not to prescribe an appropriate course of treatment.”

Looking at guidance like that from a compliance perspective has the potential to create questions about medical record documentation. The absence of prescribing a Covid therapeutic may mean it was considered and ruled out as not appropriate. However, the absence of prescribing is not the same as a progress note stating the evaluation of appropriateness.  For example, “the patient does not have comorbidities or meet the CDC definition of high risk, therefore a Covid therapeutic was not prescribed.”

We may be over reading this simple two-page memo, but you may reach similar conclusions. We suggest a careful read of this memo to determine your course of action.

Sampling and SOPs:

We did have a chance to review the recently released update to USP Chapter 797 we briefly discussed last month. Obtaining a copy is the first step in the process and you will want to do this as soon as possible to start your analysis. It is available as an online version only from USP.org within their Compounding Compendium; they are not selling PDF or paper copies.

Reading, studying, and understanding how this version compares to earlier version online is very tedious, but if you do it the old-fashioned way and print a hard copy and then use the print/save as function to save the document as a PDF, it is far less challenging.

During our initial read, two issues jumped out at us, the first is additional sampling we mentioned last month and the second was the number of references to SOPs, or standard operating procedures, required.

Essentially you should think of each section in the reference document as requiring its own SOPs, or several, for that section. This is not a complete listing, but we noticed requirements for SOPs on aseptic techniques required for immediate use preparations, training and competency, obtaining, conducting and incubating microbiologic sampling, hand hygiene, garbing, cleaning and disinfection, calibration of automated compounding devices, terminal sterilization and depyrogenation if performed, visual inspection of compounding products, labeling, and management of complaints about prepared products.

In addition, these SOPs will need to be reviewed and modified as needed every 12 months. The presence or absence of a required SOP is an easy and objective finding for an accreditation surveyor. Over time surveyors will likely develop skills at evaluating the quality of the SOP and of course the actual observation of implementation of the SOP by staff. But for now, failure to have a required SOP is an easy find.

New Acronyms and Terminology Changes:

There is also new terminology and acronyms that staff will need to become familiar with. The previous low risk, medium risk, and high-risk compounding definitions have been replaced by what they call category 1, category 2, and category 3 sterile compounds. These categories are to a large extent defined by the compounding area conditions and how long a beyond use date you need to assign to the compounded product.

A new acronym has been described called RABS (restricted access barrier system). This is an enclosure providing ISO 5 clean air and there are two main types of enclosures with two previously known acronyms, CAI (compounding aseptic isolator) and CACI (compounding aseptic containment isolator) for hazardous compounding.

One very important change here is that the CAI must be placed inside an ISO 7 environment  except when used to prepare a short BUD category 1 sterile compound. Today many of these CAIs are found in a segregated compounding area using today’s longer USP beyond use dates. This change may identify renovation needs or potential workload issues if shorter dating is all that can be used.

The new Chapter 797 has multiple references to USP Chapter 800 for hazardous compounding. USP Chapter 800 remains as previously published, but its requirements have not been in effect, so far. However, when the new USP Chapter 797 becomes official in November 2023, that date also becomes the official implementation requirement date for Chapter 800.

Next Steps:

There are 12 months to go before these new requirements take effect. Accreditors and state board of pharmacy surveyors will be learning about the new chapters during the year leading up to next November.

Your pharmacy staff have a much more rigorous task as they will need to expedite the learning process so that they can change existing practices, develop the previously mentioned SOP’s, update training materials, conduct training and competency and either find a vendor to perform and incubate the monthly surface sampling or gear up to take on that responsibility as a staff function.

The first step is of course purchasing the new Chapter to begin the analysis. We anticipate that USP, State, and National pharmacy associations will all be developing in person and online training to help understand the new requirements. You will want to get this initial access and training conducted ASAP so that you can identify time dependent road blocks and work around them prior to November 2023.

FAQs and the One Hour Rule:

In addition to releasing the new Chapter 797, USP also published almost 40 pages of FAQs, totaling 195 questions, adding more details about interpretation of the chapter. We wanted to bring two of these FAQs to your attention. These are # 20 and #21.

FAQ #20 defines that simple functions, such as removing a dose from a sterile container without further manipulation, is not compounding and thus is not covered by USP Chapter 797. This declaration of applicability then leads to FAQ #21 which states that spiking an IV bag is also not compounding, thus any limitations that might currently exist such as the “One Hour Rule,” are not supported by rationale from USP Chapter 797.

We noticed that TJC has now removed their FAQ addressing the “One Hour Rule” on pre-spiking IV bags. If your organization managed to eliminate this practice, we would encourage readers to not restart pre-spiking, but if you had previously been unable to eliminate the process, we offer the following advice: We recommend reviewing the FDA package inserts for IV solutions and administration sets to verify there is no MIFU that prohibits pre-spiking.

We did notice one IV solution manufacturer that advised removal of the outer plastic wrap “immediately prior to use,” which would mean pre-spiking is not an option for their products. In addition, we would also suggest developing a policy if you are going to authorize the process of pre-spiking.

In development of your policy, we would also suggest using an interdisciplinary risk assessment, detailing that you have concluded the action is safe to perform and necessary due to time constraints.