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Educate leadership on USP expectations with this excerpt


January 23, 2020

Help your leadership understand the upcoming accreditation survey process once new USP protections for hospital workers handling hazardous drugs go fully into effect (see article above) with this excerpt from HCPro’s, “USP <800>: How to Prepare for the New Hazardous Drug Requirements.,” written by written by Kurt Patton, MS, RPh, a pharmacist and former director of accreditation services for The Joint Commission (TJC), as well as founder of Patton Healthcare Consulting, in Naperville, Illinois.

Chapter 10: The Accreditation Survey Process

All accrediting bodies assign teams of individuals to assess hospitals. These teams include physicians, nurses, administrators, Life Safety Code® (LSC) specialists, and sometimes pharmacists. The very first survey activity is document review, which will include a review of policies, plans, performance data, and external inspection reports. This is usually performed by the surveyors in isolation from hospital staff. You have risk if the documents you place in front of the surveyors are not self-explanatory or hood or room certifications were not conducted on schedule. Pharmacy directors should review these documents before they are provided to The Joint Commission. Quality or facilities directors should also review these documents to make sure they agree the documents are self-explanatory and everyone should understand them. Since surveyors conduct their document review in isolation, they may draw conclusions that you are noncompliant if the documents are not clear. The life safety and clinical surveyors will independently examine documents including these same primary engineering control (PEC) and secondary engineering control (SEC) certifications and any state inspection reports. The LSC surveyor may be asking questions about these documents from the facilities lead, and the clinical surveyors may be asking the quality staff about the documents. You don’t want your answer to be either “I don’t know,” “I am not sure what we did about that problem,” or “Our compounding supervisor is on vacation this week.”

An example of a problem you might encounter during this document review might be if the inspection of the SEC identified that the viable surface sampling exceeded United States Pharmacopeia (USP) thresholds. If you put such a report in front of a surveyor, they will immediately want to know what you did regarding education, re-cleaning, and retesting. Thus, the inspection report should be annotated with simple information such as “staff reeducation xx/xx/xx,” “recleaning of SEC xx/xx/xx,” and “retested no growth noted xx/xx/xx.” Be careful of your dates on the corrective action. The corrective action should not start weeks after you receive your vendor report; it should start immediately with retesting taking place as soon as education and recleaning are completed. If you wait multiple weeks to get improvement started, the accrediting body is going to question the safety of the products you prepared until corrective action took place. In addition, the evidence that all the corrective action was done should be attached to the original inspection report, including sign-in sheets and training materials for the education, documentation of the cleaning performed, and the repeat surface sample report. In addition, you should document that hospital quality and/or infection control (IC) was promptly notified of the problem and remediation.

Both life safety and clinical surveyors will also be visiting hazardous medication receiving, storage, and preparation areas and observing hand hygiene, garbing, gloving, product movement into the sterile compounding area, compounding, and the physical environment in which this is done. They will observe staff to verify they are free of any jewelry, makeup, and cell phones. They will observe for proper use of alcohol swabs, one per port, and proper use of alcohol during compounding for glove disinfection. They will look at the product labeling for the gloves being worn and verify staff compounding hazardous medications are wearing two pairs of chemo gloves and shoe covers and removing them appropriately when exiting the compounding area. They may observe for the use of plastic-backed pads and closed-system transfer devices (CTSD) (both “shoulds” in USP <800>, sections 5.4 and 12) used during the compounding of hazardous sterile products. Surveyors will also look at the compounding environment, making sure that the floors are seamless and that there is a hard ceiling in the SEC. If suspended ceiling tiles are used, they must be washable and caulked into place. Surveyors will even look for room-specific mops using disposable heads and records of cleaning. Surveyors will look at the room pressures and ask staff to explain those to verify positive spaces and negative spaces are meeting their required pressures.

Surveyors as part of the patient tracer activity will also be observing hazardous drug administration practices on the inpatient units or infusion clinics. Surveyors will observe for proper use of CSTD, including examining the drug product being prepared or administered to verify it can be safely used with your CTSD. The use of a CTSD, which is optional during compounding in a PEC, is not optional during product administration. During administration, the use of a CTSD is a “must” in section 5.4 of USP Chapter <800>. Be forewarned that surveyors learn new facts from each other and hospital staff on each survey and they utilize that new information on subsequent surveys and share it with their peers. If there is a hazardous drug they have learned is incompatible with a specific CSTD, they will ask about how you manage this at your hospital.

Both clinical and LSC surveyors will be visiting the area where drug receiving takes place to evaluate the physical environment and work practices. The hospital “must” have policies and procedures for conducting the receiving function relative to safe handling of hazardous medications. The drug products received should be (preferred) contained inside of plastic bags to contain any contamination. But it is not mandatory that manufacturers or wholesalers provide the shipment inside of plastic bags. If the hazardous products are not shipped in plastic bags, USP <800> in section 7.5 states that staff “should” wear an elastomeric half mask with a multigas cartridge and P-100 filter until they have verified products were not damaged in transit. Staff must be wearing chemo gloves when unpacking hazardous medication in accordance with your policies and procedures. Products must be taken from the receiving area to the hazardous drug storage room immediately after unpacking the shipment. In this setting, surveyors are likely to ask staff a hypothetical question about what to do in the event of a spill or delivery of a broken package. Staff will need to describe the actions to be taken and be able to identify where all the required personal protective equipment (PPE) is located and any after-action reports should be filed.
Both the clinical and LSC surveyors may ask about preventive maintenance requirements for the PEC and SEC and what aspects the hospital may perform versus the vendor. Surveyors may use the term instruction for use (IFU). Medical equipment and devices comes with detailed advice from the manufacturer about how to maintain this complex equipment. You want to know that the IFU is adhered to 100% and who does it. It may be assigned to the biomedical department, it may be assigned to the pharmacy staff, or it may be assigned to the vendor, but either way the documentation of adherence to filter changes, cleaning, manufacturer alerts, recalls, etc., must all be immediately available.

Continuing the tracer path, surveyors are likely to ask about the staff that cleans and decontaminates hazardous drug compounding areas. They may also ask about the chemicals used for cleaning and decontamination, and staff should be able to verbalize the precise steps they take when conducting cleaning and decontamination. The last phase of this discussion will be examination of competency files for these staff during the HR system tracer. The Joint Commission has published an FAQ on this subject stating that any environmental services (EVS) staff members who perform cleaning and decontamination in compounding areas should have their competency assessed by the compounding supervisor, not just the EVS manager.

There are also multiple system tracers where questions may arise about hazardous medication compounding. This may occur during the environment of care (EC) interview, IC, medication management (MM), data use system tracer, and the human resource system tracer. Someone needs to be present who knows exactly what is being done at your hospital to be compliant with all of the requirements and any corrective actions. For example, if there was a PEC or SEC certification failure, you might anticipate follow-up discussion at the MM, IC, and EC sessions about the corrective actions taken and the timeline to completing the corrective action. Should any defects be identified by your certification vendor, it is imperative that the corrective action not be taken in isolation. There should be hospital reporting to quality, EC, and IC so everyone is aware of the problem, everyone can help with the analysis about risk to patients or staff, and the hospitalwide involvement can help mobilize the resources to get it taken care of expeditiously. Any issues that occurred in the year prior to your survey should be well known to leaders, and these leaders should be able to state the case about the hospital’s effective management of the problem. In addition, you want to pay particular attention to issues that come up during the morning briefings with surveyors, as some may come up for more detailed discussion at different system tracers. Also note that in the sample questions below, some repeat in multiple sessions. This simply means they could be repeated but does not mean they always will or must be repeated. In addition, some questions posed relate to items only identified as a “should” in USP <800>. This does not mean the accrediting body is seeking you to be stricter than USP requirements. They are only inquiring to determine whether you ever considered the issue. Stating you evaluated the issue and made a decision not to implement is satisfactory, providing you also state your process to evaluate and rationale. Stating “I don’t know” or “We never considered it” is a survey vulnerability. If you don’t know, but someone else in your hospital will know, it is of course satisfactory to connect that person with the surveyor to close the loop.

(Here is an Environment of Care system tracer. Infection control, human resources, data use system, medication management and patient tracers available in the book.)

Environment of Care System Tracer

Show me what you added to your hospital’s safety plan and/or hazardous materials plan in preparation for implementation of USP <800>.

Describe for me the process of maintaining or managing alarms for areas that require positive or negative air pressure.

Does your hospital perform any wipe sampling for residual hazardous drug contamination, and how are these data evaluated?

Who is the designated person for hazardous drug management in your hospital?

Describe what is said during your orientation for new employees about hazardous drug spills and how to manage them.

Describe the training provided to housekeeping staff who have to clean the hazardous compounding area.

Who provided that training and who signs off on their competency for that process?

Describe the training provided to staff who pick up hazardous medication waste from patient care areas.

How many hazardous drug spills were reported in the prior year?

Is the air handling equipment in the PEC and SEC connected to emergency power?

Survey decisions

At the end of every survey, there is an outcome decision. Usually that outcome is a passing grade, like accredited, with some issues that must be responded to, or standards identified as noncompliant. In about half of all surveys today, surveyors find multiple performance problems that correspond to a particular Medicare Condition of Participation (CoP), e.g., the physical environment or pharmaceutical services CoP. This will result in a follow-up survey to reassess the problems identified within 30–45 days. These are usually successful, as while there may be multiple standards that have to be corrected, they are focused in a few CoP-related areas only. In a smaller number of situations, there are so many standards identified as noncompliant and multiple CoPs identified as noncompliant that The Joint Commission or other accreditors will determine that this is not a passing grade. In the case of The Joint Commission, this may be accreditation with a follow-up survey or preliminary denial of accreditation. Both are significant and both require extensive corrective actions and a follow-up survey, but you have a few months to get it together. There is one survey outcome to be on the lookout for because it is so significant and develops so rapidly it is a significant management problem, and that is the “immediate-threat situation” with The Joint Commission or “immediate jeopardy” in Centers for Medicare & Medicaid Services (CMS) terms. This happens overnight, and you can see your accreditation status change almost immediately. You may have heard there were multiple issues identified by your surveyors dealing with sterile compounding or hazardous drug management. Say, for example, your testing report for the primary engineering control was a failure, or there was viable microbiologic growth above a USP threshold that was not reacted to swiftly and effectively remediated. If this occurs, you will note your surveyors not keeping to their usual schedule, and/or calling back to their corporate office for advice from leadership there. These are bad signs that something is brewing and you are at risk. In the end, a senior leader from The Joint Commission will contact the hospital CEO and inform them that an immediate-threat situation has been identified and the decision has been reached. By then, it is too late to stop, and you must abate the immediate threat as soon as possible.

There are two key concepts to consider relative to immediate threat. The first is can we prevent this outcome by supplying the surveyors with additional information. If you think trouble is developing and there are extenuating circumstances, reality is not as bad as staff stated during their tracers, or something else was being done that provided equivalent safety, you need to get this information to the surveyors proactively. If you can’t stop it, you will need to eliminate the threat in 72 hours and advise The Joint Commission to return to verify the elimination of the problem. Unfortunately, even if you successfully abate the problem, The Joint Commission will come back in four to six months to verify the problem has remained corrected and not returned. CMS in their immediate-jeopardy situation places the organization on a termination track, and only your corrective action can prevent that result.

For a copy of the book, USP <800>: How to Prepare for the New Hazardous Drug Requirements.,” written by Kurt Patton, MS, RPh, go to http://hcmarketplace.com/usp-800.

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