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Cleaning, Disinfection and Sterilization

Cleaning, Disinfection and Sterilization

This issue can’t be stressed enough.  When The Joint Commission identifies one of the five high risk areas for healthcare organizations as the cleaning, disinfection and sterilization process you can bet that the surveyors will zero in on these areas and they have been.  Its July 20 Online newsletter even encouraged leaders to get involved in their organizations practices noting that the surveyors have received additional training on sterilization processes.  So, it is no surprise that feedback I’m receiving from organizations that have recently experienced an onsite accreditation evaluation is the surveyors have more pointed questions about an organization’s practices against the current evidence based guidelines such as the CDC’s HICPAC or AAMI’s (AAMI ST-79) guidelines on steam sterilization.  Although high level disinfection is supposedly next on the surveyor’s formal training agenda, it has already been a targeted focus during surveys.  To prepare for the more in depth discussion of your processes:
• Know the manufacturers recommendations to clean and disinfect scopes used between procedures.  This includes the timeframes involved, validation, storage and testing of the controls.  (Make cheat sheets or have checklists available. Have the manufacturers’ recommendations handy to use as a reference.)
• Check on whether PPE is consistently present and actually utilized by the staff performing this function.
• Whether ventilation is adequate based on what is recommended for the type of agent that is being used to clean equipment.
• The effectiveness of storage and/or packaging of devices after disinfection as to not contaminate the cleaned items.  Think about clean scopes touching the floor in the storage cabinet or respiratory equipment such as laryngoscopes lying around unprotected. 

Involve your infection prevention staff in the evaluation of your current processes as well.  It’s also worth taking a closer look at the CDC’s recommendations related to disinfection for infection prevention and the latest AAMI guidelines to see how your processes stack up.

In addition, review how you are cleaning equipment between patient use.  Many times when I interview floor staff, I’m told that “disposable wipes” are used on thermometers, glucometers, stretchers and other reusable equipment but staff cannot speak to the correct process or “wet time” to effectively disinfect.   It’s important to know the manufacturers recommendations for the products you use.  For example, one organization changed brands of these disposable wipes and went from a 2 minute to a 10 minute wet time.  They didn’t even realize it and staff were not disinfecting correctly.  Some organizations have the Infection Control Committee approve all cleaning products to prevent this from happening as well as to limit the number of unapproved products from cropping up on the floors.  I tend to see this happen in departments that don’t order supplies through the centralized purchasing process such as the ambulatory areas.  Products change and setting up a process of clearly understanding the manufacturers’ recommendations regarding effective cleaning prior to purchase and their impact in the organization keeps everyone in sync.

You want to ensure that you are doing the right thing in preventing infections.

CMS Changes

CMS Updates: Respiratory/Rehab, Blood/IV, Error Reporting

On May 13, CMS released a 14 page memo outlining updates due to Appendix A of the State Operations Manual (SOM) related to:
• Orders for rehabilitation and respiratory services due to regulatory changes
• Clarifications for blood and IV medication administration requirements for nursing
• Reporting of medication errors guidance.
These revisions were immediately effective so it’s a good chance to review what CMS expects in these areas. 

Rehabilitation Services [§482.56 (b)]

Medical Staff policies and procedures should address the types of practitioners that can order rehab services in accordance with your State law. Ensure that they are privileged by you to do so.  CMS emphasized that all services received by the patient should have an order by the responsible provider, be provided by qualified individuals and be reflective in the patient’s care plan. [§482.56 (b)(2)].  Once again, make sure staff competencies are current and appropriate, even if rehab is a contracted provider for you.

Respiratory Services [§482.57 (b)(3)]

The responsible practitioner who orders respiratory care services must be privileged to do so as well.  These privileges must be granted in a manner consistent with your State’s scope of practice law, hospital policies and procedures, developed by the medical staff and approved by the governing body.  The staff qualification criteria should be clearly defined.  Of course, the medical record must demonstrate evidence of the respiratory services received.

Blood Transfusion and IV Medications

Under its Nursing Service regulation [42 CFR 482.23 (c)(3)], CMS clarified its Interpretive Guidelines for staff that administer blood transfusions or IV medications related to the documentation of training received.  (This excludes physicians).  Each employee’s record should contain evidence of these competencies.  Aside from State practice, surveyors will expect to see that staff training is based on recognized practices which minimally include:
• Fluid and electrolyte balance
• Venipuncture techniques (demonstration and supervised practice)
• Blood components
• Blood administration procedures based on hospital policy, State law, and nationally recognized standards of practice
• Requirements for patient monitoring, including frequency and documentation of monitoring
• The process for verification of the right blood product for the right patient;
• Identification and treatment of transfusion reactions.

Consider reviewing your policies’ expectations, training received and documentation requirements in these areas to see if you pass muster.  Too often, the link between all three aspects is broken. Specifically monitor patients who have had transfusions to see if the documentation meets your expectations including completed blood slips, vital sign monitoring, patients’ reactions and staff competencies.  Don’t forget any staff that performs admixing of IVs.   

Medication Error Reporting

CMS requires that hospitals define the circumstances for reporting drug administration errors, adverse drug reactions and incompatibilities including the circumstances and process for physician notification under its Pharmaceutical Services Conditions of Participation.   Surveyors have been instructed to look at your policies and procedures, patient records and to conduct staff interviews about your process. The tricky part will be the use of staff clinical judgment about when not to notify the attending or covering physician such as a missed night time medication dose.  Consider what resources are available for staff to make this determination especially if you don’t have 24 hour onsite pharmacy coverage.  Ensure that all these circumstances are covered under your quality program for reporting and evaluation in consideration of State requirements, even for those circumstances that didn’t cause problems for the patients.

Since this memo reflects an early-release version of the CMS updates, there may be changes whenever the updated Appendix A of the SOM is eventually released.  Since your State surveyors have recently received these details, they may be on their radar screens for additional scrutiny.  This link provides additional details if needed.

The Pressure of “Timely” Medication Passes

The Pressure of “Timely” Medication Passes

Those automated medication administration systems are great, right?  Well, except for when all the nurses are standing in line for access to it while trying to beat the 30 minute window clock for timely medication administration.  I have not met one nurse lately who didn’t acknowledge that she or he was untimely in passing medications at the required times, especially with the morning medication pass and sliding insulin scale coverage.  I recently spoke to one nurse who had a medication pass every half hour except one during her shift.  This is a recipe for disaster and pretty consistent with the outcomes of the research conducted in 2010 by the Institute for Safe Medication Practice (ISMP).

Everyone understands that in its Interpretive Guidelines, CMS has directed its surveyors to determine if drugs are administered within 30 minutes of the scheduled time for administration. [§482.23 (c) (1)]  They have been especially diligent in reviewing this area while onsite.  However, you control the scheduled times for medication administration since the providers generally order a frequency.  Many times old policies hold the staff hostage to the times that are currently noted on the MAR even though practice has changed since they were last reviewed.  A successful medication pass depends on a well thought out process for making it happen as expected. 

You should be regularly monitoring your Medication Administration Records (MAR).  Considering your daily staffing challenges in both nursing and pharmacy, look at what you can do to help yourselves to meet the requirements.   For example, there is no actual standard that says you must immediately deliver a medication after it’s extracted from your automated medication system.  Your medication administration process, though, must ensure that the relevant components of the medication management standards are met.  So, it is okay to pour medications and place them into a secondary dispenser such as a medication cart as long as the meds are properly labeled and secured between pouring and administration.  This avoids the bottleneck at the dispensing machine but only addresses one issue related to medication administration. Take a good look at your practice considering the published guidelines from professional associations such as ISMP and the American Society of Health-System Pharmacists. 

In September 2010 ISMP has issued its Guidelines for Timely Medication Administration.   Simply put, it suggests that hospitals identify a list of medications that are “time-critical” to be administered such as immune-suppressing agents and short acting insulins where a delay would cause the patient harm.  These medications must be given within the 30 minute window.  In these instances, the MAR would state the scheduled time.  Conversely, “non- time-critical” medications should have guidelines established such as the administration of them within 25 percent of the scheduled time.  These can include daily, twice a day and more frequently than 4 hours apart medications which would have an allowable one and two hour window from the scheduled administration time.  Target timeframes also need to be established for “loading” or first- dose medications. 

A pharmacy and nursing team dedicated to evaluating and resolving these types of issues can be beneficial in keeping the medication administration timely.   Get your medical staff on board with the issue and make sure that there are procedures for staff to follow to promote safe and timely administration of medications.  ISMP is still collecting feedback on its guidelines before issuing a final position on this issue but it makes a lot of sense.   You can comment via  ISMP also states that it is working with CMS to discuss the concerns of this rule on patient safety. 

CMS Updates

Noteworthy CMS Updates

Two updates were provided by CMS recently regarding credentialing and privileging of telemedicine providers and health newborn orders if you aren’t already aware of them. 

Telemedicine Providers
On May 2, 2011 CMS announced an update to the Conditions of Participation regarding credentialing and privileging of telemedicine providers for hospitals and critical access hospitals (CAH).  The new CMS rule allows for the credentialing and privileging of these providers by proxy or surrogate which was allowed by The Joint Commission when it held its statutory deeming authority.  CMS regulations had previously required hospitals to grant individual practitioner privileges for those that were already credentialed by their remote entities.  This meant that these practitioners could not provide care via telemedicine unless this process occurred at the recipient hospital.  It added a huge burden on hospitals regarding the resources needed to execute this requirement especially if a large number of remote providers are involved in providing services.
Per CMS, the new rule allows a hospital which has a relationship with a remote entity, such as a hospital or telemedicine provider, to rely upon that providers’ information when making credentialing and privileging decisions for the physicians which are supplying the services.  The link for the press release is attached:

Routine Newborn Orders

In case you missed last October’s CMS memo, you can initiate healthy newborn orders without an immediate physician’s order upon the baby’s arrival to the nursery.  CMS clarified  that there is an option available for a medical staff approved order set to be initiated for a healthy newborn (such as the Hepatitis B vaccine, prophylactic ophthalmic antibiotics and Vitamin K), as it is an example of timely and necessary care needed for the infant.  The responsible provider must still authenticate the orders as soon as possible after their implementation though.  So for all of you struggling to make the order happen prior to administration of the medications to the newborn, there is a CMS-approved solution for you.  Attached is the CMS letter posted by the American Academy of Pediatrics.

CMS, Anesthesia and Sedation

When CMS issued its memo updating the anesthesia interpretive guidelines mid January of this year, I’m sure that folks were hoping that the federal government was finally announcing it had gotten on the same page as The Joint Commission.  But that was wishful thinking.  CMS very clearly articulated that the regulation does not include moderate sedation in its definition of anesthesia services.  However, in its 2011 hospital accreditation manual, The Joint Commission still notes that the relevant Provision of Care standards apply to both moderate and deep sedation as well as anesthesia services.  So, if your organization is Joint Commission accredited, expect the surveyor to look for what they would typically examine under the anesthesia requirements for sedation patients including the patient pre and post assessment process. This includes who is training and determining competencies of staff administering moderate sedation and how these competencies are evaluated.  Be prepared to address how you are assessing the quality of sedation and anesthesia care whether it’s through the review of adverse event reports, the use of reversal agents administered or by retrospective chart review among other ways.  It does not have to be a complex process but it still needs to be in place.  Since anesthesia providers are contracted employees in many organizations, you need to speak to your organization’s demonstration of anesthesia oversight for all sedation services provided as well.  It’s surprising how many staff still cannot confidently articulate their organization’s process. 

In the same memo, CMS also loosened two timeframe requirements: 
• You now have 30 days before the procedure date to collect information on a patient’s anesthesia risk, potential complications, medical and surgical history and the development of an anesthesia plan.  What’s included in the 48 hour clock is a review of the medical history and a patient examination. 
• The 48 hour time frame for the post anesthesia assessment to be completed is still in effect and needs to be completed by a qualified anesthesia provider.  However, the post assessment does not have to occur prior to the patient’s discharge.  So, whether the anesthesia provider is clearing an outpatient pre-discharge from the PACU, making a home call post surgery or just reviewing the PACU or recovery area’s nursing notes, it appears that all will meet the intent of CMS’s directive in this area.   

Keeping up with Verbal/Telephone Order Validation

You are not alone if you are having difficulty getting telephone and verbal orders authenticated within 48 hours.  As consultants, we often are asked how to comply with the requirements when physician coverage changes frequently such as when a practitioner issues a verbal/telephone order and then is either off duty or not on call for a period of time outside of the 48 hour window.  This leaves the order unauthenticated or not validated, resulting in a lot of frustration on the part of staff as well as a non compliance citation.  All the little “sign here” sticky flags is not going to get the order co-signed in these circumstances.  Under requirement §482.24 (c)(1)(ii), CMS allows for another practitioner who is responsible for the patient’s care to authenticate the verbal/telephone of the ordering practitioner.  In addition, if it is within the scope of their practice and the patient is being followed by them, qualified licensed practitioners, such as a physician assistant (PA) or nurse practitioner (NP), may validate licensed practitioner’s verbal orders. The endorsing practitioner must have knowledge of the patient’s care and is really acknowledging that the order is complete by co-signing it.  You also should review whether your Medical Staff rules and regulations or policies prohibit an alternate authenticator.   In other words, you don’t want to push it if your organization or medical staff specifically doesn’t allow it.

This is a temporary allowance expiring on January 26, 2012 when, supposedly, more electronic records will be in place.  So, unless your state prohibits this option, make it a part of your hospital’s policy to help with compliance in these types of situations.  Of course, this is not a guarantee for success but it has improved compliance in hospitals that have implemented this process.  Proper validation includes not only the signature but the date and time as well.

Marcia Hargreaves

Joint Commission Standards Changes Announced

In its January 12 Online newsletter the Joint Commission announced that it was making standards changes in order to remain compliant with its CMS-awarded deeming authority.  Some are being surveyed very soon so be aware of the changes.

Patient Rights

In response to a Presidential memorandum of last April directive of hospitals’ visitation efforts, CMS has added new regulations (located within CoP Patient Rights §482.13(h) (1, 2) for hospitals and Provision of Services §485.635(f) (1, 2) for critical access hospitals) effective January 18, 2011.  CMS is requiring hospital and critical access hospitals to ensure the full and equal visitation rights of individuals consistent with patient preferences.  This includes access for visitation and the designation of a support person for the patient.  The patient must be informed of this right and be fully participative in designating who can and can’t visit if possible.  By the way, CMS accepts oral designations from the patient regarding this “support person”.  Here’s the link to the Federal Register if you missed it:  With over 7,600 responses to its public comment, expect some awareness of these changes from the community.

Pursuant to this change, The Joint Commission announced that it is moving up the implementation date of two previously approved EPs in its Patient Provider Communication standards.  (Remember that they had an estimated implementation date in 2012).  Beginning, July 1, 2011 EPs 28 and 29 will be effective under the RI.01.01.01 standards.  These EPs are “A” scoring categories and focus on access of a “support individual” to be present for the patient as much as possible while prohibiting discrimination.  This is especially applicable when these advocates are not part of a historically typical family grouping. Hospitals should review current written policies on visitor access and restrictions to make any modification taking note of how incapacitated patients’ rights to visitation will be handled.  

In the interim, these new CMS CoPs will be scored under the existing Joint Commission standards located in RI.01.01.01 EPs 1,2,5,6 and LD.04.01.01 EP2 (which is the general meeting licensure requirements) beginning February 18, 2011.

Environment of Care

Changes to the fire safety equipment and building standard, EC.02.03.05 were also announced by The Joint Commission effective July 1, 2011.  
•    Under EP2, valve tamper switches must be tested quarterly, which is up from the previous semi-annually testing frequency bringing Joint Commission standards up to CMS expectations.
•    EP25 was added  to provide a summary of the specific elements required to ensure compliant documentation of the fire alarm and water based fire protection systems’ maintenance, testing and inspection activities.

Expect to see these changes “officially” published in a future issue of Perspectives.  Having lost its statutory or “written into law” deeming authority, The Joint Commission is now required to comply with all CMS changes directly even though they have been trying to minimize the number times that standards updates are processed in a given year.

Not All RFIs to be Publically Posted

If you read the January issue of the Joint Commission’s Perspectives, you might have been as confused as I was regarding some of the new language in the public release of information policy since it was different than what is published in the 2011 standards manual.  What caught my attention was that it appeared The Joint Commission would be reverting back to a previous practice of posting all Requirements for Improvement (RFI) on its website beginning in 2011.  Under the revised, approved policy regarding public information, new language referenced the posting of RFIs for organizations that undergo a survey resulting in an accreditation decision.  The old policy (located in the Accreditation Process chapter of the manual) noted posting of RFIs only for organizations with accreditation decisions requiring certain follow-up surveys.  (You’ll recall that The Joint Commission went away from the practice of posting all RFIs about six years ago.)  If this were indeed true, it would be a major change in position from its current practice and one that would make Joint Commission accredited organizations more prone to detailed public scrutiny of its compliance performance.   

In communications with Joint Commission staff this week to clarify what was written, it was confirmed that the new language was not intended to signify a change to its current policy. My conclusion drawn from the new, approved language was simply, well, incorrect.  Knowing that developing clear, concise language is a focus of Joint Commission, it seems that there are still instances where clarifications are required from its staff in order to be better understood by its customers.      

By the way, the policy is inclusive of all Joint Commission certification programs such as heart failure and stroke as well.

Laure Dudley     

Revisiting the Universal Protocol for simple, one-person procedures

The FAQs are dead.  Long live the rationales.
Did you notice a significant change in the Universal Protocol (UP) recently? No? We’re not surprised. Most of us missed the fact that The Joint Commission removed the UP FAQs from their web site. We’ve been told that there is no intention to re-post the FAQs, relying instead on the UP rationale statements in the Accreditation Manual to clarify the position. Greeley has been thinking about this and working with some clients to understand the implications of this change. So, let’s take a collective step back and see what’s required for simple procedures now that the FAQs are gone.

Before 2010 the Universal Protocol (UP) applied to surgical and non-surgical invasive procedures that placed the patients at risk. Back then, we used to tie the UP with the notion of informed consent: it applied only when informed consent was required. But the 2010 version of the UP says nothing about risk. It now applies to all procedures (both invasive and non invasive). Before they were taken down from the website a few months ago, the FAQs still exempted venipuncuture, peripheral intravenous lines and similar procedures. It now appears that these type and other simple procedures are covered under the UP. Does this mean that there needs to be a time out before a phlebotomist takes a blood sample? Not really. Let’s think about this a little more before jumping into the deep end of the pool.

Pre-procedure verification
The right patient is verified before every procedure. In complex settings such as the operating room the procedure is verified and re-verified a number of times such as in scheduling, pre-surgical assessments and when placing the patient on the procedural table. Verification for simple procedures is a matter of checking the patient’s identify with the order for the procedure (e.g. PICC line order or lab slip). As always, two separate means of identification are used. So, common, safe practice should account for the pre-procedure verification process for all procedures, from venipuncture to cardiac bypass.

Site marking
The issue of “risk for the patient” comes into play for site marking, which is only required when there’s an impact on quality or safety if the wrong site can be selected (UP.01.02.01 EP.1). There are, of course, other exemptions, including situations where the person performing the procedure does not leave the patient between site identification and implementation of the procedure. We can think of very few simple procedures where site marking is required either because there is minimum risk to the patient, the provider selects the site as the procedure commences, or both. By the way, who decides which procedure impact quality or safety? According to The Joint Commission, your organization does (UP.01.02.01 EP.1)

Alternate process (UP.01.02.01 EP.5)
There’s been significant confusion over the years about what sort of alternate to site marking should be in place for patient refusals, neonates, teeth, cardiac catheterizations and the like. The FAQs gave examples, many of which did not work for some procedures and settings. But since the FAQs are gone, so why not simply design a process that calls for documenting the site on a piece of paper or computer screen that is available at the location of the procedure and referring to this document in lieu of a site mark? We believe this would comply with the requirement and reflect a common (and safe) clinical practice for simple procedures. (Banding or flagging may still be appropriate for more complex surgical procedures.)

The one-person time out
Some (not all) simple procedures involves only one person. The FAQs used to clearly require a pause by the provider for one-person procedures. This requirement is not quite as clear now that the FAQs are gone. But let’s assume that a one-person time out is really required. If you review standard UP.01.03.01 carefully you will note it’s really written for the operating room (even though it is applied to other settings). What does a one-person time out look like? The “team” is one person, so active communication and reconciling differences is not an issue. So as long as the provider verifies the patient, the site and the correct procedure prior to starting, the required time out seems implemented.

Documenting the time out
Most of our clients have found that it adds little value to have an OR-like check list filled out for simple procedures. Instead, it’s perfectly acceptable to use your standard procedural documentation to indicate that a time out was conducted. Some organizations use a simple pre-printed statement as part of the procedure note such as “a time out to verify the patient, procedure and site was conducted involving all team members immediately prior to the start of the procedure.”

I don’t think we’ll miss the FAQs. Frankly, we’d love to see a little more clarity in the UP itself, but we feel that most organization will be able to use the UP’s Elements of Performance and Rationale Statements to craft simple, efficient processes that will protect patients while eliminating meaningless operational and paperwork overhead.

What do you think? We’d love to hear your thoughts on this.

Bud Pate

Taking Note of AORN’s Surgical Attire Update

The debate over the effectiveness of the home laundering of scrubs has been ongoing for some time now.  Well, if you were fortunate to be on the webcast on October 27, you know that AORN has reviewed its position on that issue in addition to discussing a few others.  In general, we’ve seen much less restrictions placed on staff in the invasive procedural areas than we used to so I believe that AORN was really focused on both the profession and the accountability aspect in these recommendations.  They include all types of issues from homemade hats or head coverings, the wearing of jewelry to the types of personal items allowed in restricted and semi-restricted invasive procedural areas.   You will want to get yourself a copy of AORN’s latest recommendations since research was cited to support its position in many cases.  This alone should make you pause and take inventory of your organization’s current practices.  Here’s what was discussed on the call:

Surgical Attire

  • To the disappointment of many I’m sure, AORN has not changed its position and does NOT endorse the home laundering of scrubs, cover jackets and hats.  Studies showed that home laundering is not as effective in decontaminating scrub type attire.  Home laundries are also not monitored for safety, consistency or quality which allows pathogens into the home and the community and puts patients at risk.  This includes those homemade or staff-centric hats of team logos and other themes which, by the way, should be laundered daily.
  • Specific recommendations were reviewed on how to appropriately wear scrubs such as buttoning up the warm up jackets and wearing the sleeves down to tucking in too-loose tops into the waist band of the pants in an effort to avoid drag as well as the shedding skin onto the procedural area.
  • Scrubs should be changed if leaving the building or going outside – such as for lunch or smoke breaks.
  • Cover-ups such as lab coats that are not cleaned regularly contaminate the clothing underneath and should be laundered frequently if not daily since the cuffs and pockets contain the most pathogens.
  • Hats or bonnets should cover all the hair and scalp so the hair in front of the ears. So, no bangs and no sideburns are allowed peeking out of the hair covering.

Shoes that are cloth, without non-skid soles or have perforations in them like those popular colored ones in the market are not recommended.  Simply put, only a few types of shoes protected against total penetration of falling objects such as scalpels and those included leather types such as sneakers, suede with a certain type of lining and others made of hard rubber. 

It was made very clear that the wearing of any bracelets should not be allowed since they slide up and down the arm and rub against the skin.  Earrings also had a high bacteria count so anything that can’t be contained under the head covering shouldn’t be worn in these areas.  The dangle earrings have to go and all necklaces must be tucked within the scrub attire.  How many of you are removing your watches for the handwashing and scrubbing?

Briefcases, Fanny packs and the like
Those made of porous materials aren’t allowed because they can’t be properly cleaned or disinfected. 

With the popularity of lanyards for holding identification, it’s not surprising that they show greater bacteria than the regular type badges.  The dangling aspect also poses a hazard risk of getting tangled up on equipment or being clutched by patients.  Badges should be cleaned regularly when soiled and your manufacturer can recommend how to do it.

The teleconference addressed the correct way to wear and remove masks, the importance of cleaning stethoscopes and the merits of utilizing approved laundering facilities.  Supposedly the webcast will be posted on the AORN website so that those who would like to listen to it can access it on demand.

This latest release of information is sure to generate a lot of discussion especially in hospitals where cutbacks have necessitated implementation of some of the current practices.  However, the data was pretty telling.  I’d suggest you take a look at your current practices and do a gap analysis to what is recommended. It will not only better support your position if you need to involve your leadership in making changes but it is the right thing to do in the name of patient safety.