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Safe Medication Practices: Understanding CMS' Standard for ASCs

Safe Medication Practices: Understanding CMS’ Standard for ASCs

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Highly publicized instances of patient complications associated with compounded sterile preparations (CSPs) have increased scrutiny of safe medication practices in ambulatory surgery centers.  Citations are being issued related to safe medication preparation and administration, and there is confusion, even among surveyors, on the use of some multi-dose medications, such as eye drops.

Centers for Medicare and Medicaid Services (CMS) clarifies with CfC 416.48 that we must provide drugs and biologicals in a safe and effective manner, in accordance with accepted professional practice and under the direction of an individual that we have designated responsible for our pharmaceutical services.  In addition, CMS adds in the same CfC that drugs must be prepared and administered according to established policies and acceptable standards of practice. Below is a list of safe medication practice guidelines to prepare ASC Clinical Directors to meet the standard set forth in CfC 416.48.

Safe Medication Standards of Practice:

  1. Designate a licensed staff member to oversee your pharmacy program, and make sure this individual is routinely present in your facility. You must also follow your state regulations as it relates to the need for a registered pharmacist, as regulations vary from state to state. Some states do not require a registered pharmacist and some, like Texas, require a weekly consult.
  2. Keep the appropriate records for the ordering, receipt of, and disposition of scheduled II, III, IV, and V drugs.
  3. Understand that single-dose medications/vials (SDV) are to be used immediately upon opening, on one patient only, and then discarded. Once opened, they cannot be stored for any period of time.
  4. For multiple-dose medications/vials (MDV) – date upon opening with the beyond use date and do not take a MDV into an immediate patient care area; if this occurs, that MDV becomes a SDV for that particular patient.
  5. Make sure that staff are aware of the definition of a MDV. “A vial of liquid medication intended for parenteral administration that contains more than one dose of medication”.  This does not apply to eye drops.  Adherence to this guideline will prevent confusion in a survey.
  6. Create a policy and procedure for the administration of eye drops and conduct staff training on this process.
  7. Review and be knowledgeable of the questions on the CMS infection control surveyor worksheet. Exhibit 351.

United States Pharmacopeia Chapter 797 (USP 797) provides you with guidelines on compounding sterile preparations in your ASC.  It is acceptable for a center to compound for immediate use, but the following rules apply:

  1. The CSP must be intended for immediate use or an emergency situation.
  2. The CSP cannot be stored for the purpose of anticipated need or batch compounding.
  3. No more than (3) commercially available sterile products in original container and no more than (2) entries into any container/package/device can occur.
  4. Continuous process must be completed within (1) hour.
  5. Adhere to aseptic technique.
  6. Administer within (1) hour, or discard CSP.

Examples of immediate use CSPs are antibiotic solutions, blocks, irrigating solution, and even dilating solutions may fall into this category.  The development of best practices for immediate use CSPs is important and should be included in training and competencies for those licensed staff that are involved in the preparation, transportation, and administration of CSPs.

The area where CSP takes place should be quiet and free from distractions. The designated staff member should disinfect the area, complete proper hand hygiene, and wear appropriate personal protective equipment (PPE).  Make sure the entry ports are disinfected and calculations are verified so that accurate mixing takes place.  Proper labeling must also be done prior to taking the CSP for administration.

ASC clinical leaders may refer to the lists above to ensure safe medication practices and compound sterile preparations are compliant with CMS regulations.  For further information on CMS guidelines, visit the CMS infection control surveyor worksheet referenced above or the CMS website.

Part two of this blog series will focus on compounding pharmacies – problems and understanding the differences between the types of compounding pharmacies.

Advancing ASC Technology: The Industry's Next Big Move

Advancing ASC Technology: The Industry’s Next Big Move

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Healthcare is a field that is heavily vested in advancing technology. Physicians and their practice locations, including ASCs, are under great pressure to invest in new technology. Patients are expecting their healthcare facilities not only look modern but deliver an experience that also feels modern. A recent Black Book survey found, for their next healthcare purchase, 83% of consumers will seek providers offering the following four technologies: digital scheduling, online payment options, online portal and engagement capabilities, and results reporting tools.[1]

It’s not just patients who desire healthcare facilities using electronic solutions. Prospective physicians and staff may also find the prospect of using non-electronic solutions unappealing. This is most likely to be true for “digital natives” – those raised during the age of digital technology. Telling them they must use non-electronic solutions or outdated technology may be all it takes to lose physicians and/or job candidates.

Guidance on How to Effectively Add ASC Technology

Despite the growing pressure to add new ASC technology, surgery centers will want to be careful not to try to do too much, too fast. Here is some advice to help you make smart decisions.

Understand your options. As the demand for ASC technology has grown, so have the types of technology available. Our ASC recently implemented two new technologies. One was a texting program managed through an online patient portal vendor (read more about this program in my previous blog). The other was a surgery scheduling application. It allows any authorized personnel logging into the application – whether it be physicians, schedulers, staff or vendor reps – to see our current schedule. The application provides real-time updates when scheduling information changes.

These are just two of the many new technology options to hit the ASC market in recent years. There are also many vendors offering similar technologies. This makes it vital for ASCs to carefully research their technology choices. One way to find out about new solutions is by attending ASC conferences and visiting the booths of exhibiting vendors. Afterwards, you may find it advantageous to schedule demos and speak with other users of the technology. Remember, you should get all questions answered before moving ahead with an investment.

Resist hype. Refrain from implementing technology just because it is the latest trend. You may choose a solution that fails to fill a need as effectively as another option. Rather, consider developing a technology strategy with target initiatives that support specific organizational goals. Benefits of aligning with goals include stronger process efficiencies, cost savings, added functionality, and increased safety.

Involve end users. To help ensure successful adoption, I involve end users from the beginning of the research process. Users are typically more accepting of a new system when they understand how it will positively impact their jobs.

At our ASC, we focus on providing the appropriate amount of training for the appropriate length of time. We get staff feeling comfortable using the new system and avoid overwhelming them with unnecessary details about functionality. You can always provide additional training once staff grasp basic functions of the system.

Anticipate pushback. Resistance to a change of any sort is almost inevitable. That is true with the addition of new ASC technology, even if the technology has the potential to improve existing processes. Reasons for pushback can vary. Some staff may question changing a process if that process seems to still work well. Others may express concern about their comfort with using technology. Some physician owners may wonder whether the financial investment is worthwhile. Factor in resistance in your technology planning and be prepared to address it (see the tips at the end of this article).

Learn from experiences. Every new ASC technology implementation presents opportunities for learning that can be applied to future implementations. Following an implementation and initial use of a new solution, it can be helpful to assess the experience. What obstacles encountered – internally or with the vendor – could have been avoided? If strong resistance remained even after implementation, what can be done to better address it? If staff struggle to use the technology, where can training be improved? The lessons you learn can help make the addition of your next ASC technology a little easier.

Tips for Overcoming ASC Technology Resistance

As noted, you should expect resistance from at least some staff to the addition of a new ASC technology. I already highlighted the value of involving end users, which can play a critical role in overcoming resistance. Here are some other quick tips:

  • Be clear. Even before you select a solution, it is helpful to inform staff about your plans for the new technology. You may consider explaining your plan’s purpose and the benefits you anticipate achieving and letting staff know the decision has board support. As you move forward with the selection process, keep staff in the loop. This will help secure buy-in and build excitement.
  • Lean on your champions. When encountering resistance, identify team members most excited about the new technology and ask them to be your champions and cheerleaders for the project. Think about encouraging your champions to speak with peers about why they are excited and why everyone should share this feeling. Peer pressure can be a valuable tool.
  • Adjust training. Your staff will likely need different levels of training to become comfortable with a new solution. Be prepared to adjust training accordingly. Let staff know that training will be individualized, where necessary. You will likely need to spend more time with those less tech-savvy individuals on your staff. Their training should focus on building a basic understanding of and comfort with the solution. This can help alleviate fears of transitioning to the new ASC technology.
  • Lean on the vendor. You may want to invite vendor representatives to your ASC if they weren’t planning to visit already and ask them to present on the benefits of their technology. The vendors should allow staff time to ask questions. Some staff may be less hesitant to ask questions and express concerns to vendor representatives than to ASC leadership.
  • Celebrate milestones. The more positive energy you can associate with the adding of a new technology, the better. Celebrate significant milestones achieved during the project. These can include choosing a solution, beginning implementation, and go-live. Ways to celebrate include email announcements, posters, snacks, and catered lunches. By building enthusiasm, you may even bring your most rigid naysayers on board.

The addition of technology can transform ASC operations and bring about improvements throughout the organization. But if decisions are rushed, new technology can create significant problems with processes and personnel. Approach potential ASC technology additions with care and purpose. Doing so will better help ensure the solution you choose delivers on its promise.


Michaela Halcomb, Director of Operations


[1]https://blackbookmarketresearch.newswire.com/news/19-recent-healthcare-tech-start-ups-attract-instant-consumer-appeal-20556737

When a Screening Colonoscopy Becomes Diagnostic: Educating Patients on Financial Responsibility

When a Screening Colonoscopy Becomes Diagnostic: Educating Patients on Financial Responsibility

By | ASC Management, Uncategorized | No Comments

A patient comes into your ASC and undergoes a screening colonoscopy. Polyps are found during the procedure and are removed. Considering the circumstances, this sounds like good news. The screening served its purpose. You detected and removed cancer precursor lesions, hopefully helping to prevent the disease.

There’s just one problem: The patient is angry. Not about the successful removal of the polyps, but about how a change in type of procedure also changed the patient’s financial responsibility. A scheduled screening colonoscopy has become a diagnostic colonoscopy. Rather than being a preventative service provided at no cost to the patient after their insurance has processed the claim, the patient now owes a payment – possibly one considered quite significant.

Guidance for Screening Colonoscopy Education

By taking a proactive approach to colonoscopy education, your ASC can help reduce its number of upset patients. You may even improve their satisfaction in the process. Here are some recommendations on how to help patients understand their potential financial responsibilities before undergoing a colonoscopy.

Develop Documentation

Alleviate some of the confusion about colonoscopies by providing patients with documentation explaining possible outcomes of their screening colonoscopy. Share background on preventative services, noting limitations on this provision. Explain how the definition of a preventative service is adjusted due to changing (and strict) insurance guidelines. Elaborate on how this may affect patients scheduled for a screening colonoscopy and their financial responsibility. Define the categories of colonoscopies: screening/preventative, diagnostic/therapeutic, and surveillance/high-risk.

This background information will hopefully help patients gain a better understanding of colonoscopies. Then summarize what can happen when patients receive a screening colonoscopy referral. Describe how categorization can change based on information captured during the scheduling and pre-procedure processes. Consider addressing some frequently asked questions, such as whether physicians can change a diagnosis so a procedure can qualify as screening and why insurance companies may seem to indicate that your ASC can alter a CPT or diagnosis code.

Share Benefits Information

Along with this documentation, provide patients with information about their colonoscopy benefits. Give your benefits coordinator a form to fill out when they review coverage information online and/or contact patients’ insurance carriers. This form would include details on patients’ covered benefits concerning screening and diagnostic colonoscopies. It would also state patients’ financial responsibilities (or potential responsibilities), broken down by co-pay and deductible.

You may want to include details about payment plans your ASC offers on this form. This can help patients start planning how they will pay for their care if the colonoscopy categorization changes. Include this form with the background documentation.

Speak Directly With Patients

While these documents should better prepare patients for their colonoscopy and possible financial outcomes, calls to patients are also worthwhile. Use this opportunity to review the information in the documentation and form. Ensure individuals at your ASC who speak with patients can explain the difference between screening and diagnostic colonoscopies. Staff should receive training to help them effectively communicate with patients and accurately answer questions.

Quick Tips for Dealing With Upset Patients

Despite your best educational efforts, you may still receive phone calls from upset patients following their colonoscopy. Consider following these steps to help address their concerns:

  • Let them vent. If patients sound animated, give them time to share their thoughts and feelings. Avoid interrupting and try to respond only when asked a question. Giving patients this opportunity to vent can help them calm down and become more focused on the discussion to follow.
  • Remain polite. Throughout your conversation, strive to remain polite, listen carefully and remain calm. If patients believe you are becoming frustrated, not listening closely, or failing to take their concerns seriously, they are likely to become angry.
  • Review case history. Help patients feel like you take their concerns seriously by discussing the details of their situation. Pull up their chart and bill. Talk through the procedure: what was scheduled and found, and how that affected information submitted to their insurance carrier. Verify that your ASC properly coded and billed the procedure.
  • Explain insurance rules. After discussing the case history, patients may still question what they owe. Describe health insurance rules and how they dictate changes in colonoscopy categorization. Provide education on diagnosis codes and your ASC’s requirements to code based on the procedures performed, not scheduled. Discuss the claims submission process and how that triggers the health insurance reimbursement process. Note: If patients spoke with their insurance before you, they may have been told that had you coded the procedure as a screening colonoscopy, it would have been covered. Be prepared to explain the potential fraud implications of improper coding and billing.

Going through these steps can provide comfort to patients and help them better appreciate your ASC’s responsibilities. Once you address any outstanding questions, move to the discussion about how patients will cover what they owe. Be cognizant that patients may be in a delicate state as they come to accept their financial responsibility. Help relieve some stress by informing them of payment options that can spread their financial responsibility over time. While patients may express displeasure with what they’re hearing, patience and compassion can move the situation toward a positive resolution.


Catherine Sayers, Director of Operations

Managing a Non-Compliant Patient in an ASC

Managing a Non-Compliant Patient in an ASC

By | ASC Management, Uncategorized | No Comments

ASCs fortunate to remain in business long enough are likely to have the unfortunate experience of a non-compliant patient. When non-compliance occurs, patient and staff safety may be jeopardized.

Patient non-compliance in an ASC can take many forms. These include not taking medications, personal removal of an oxygen mask, and getting out of a wheelchair or bed without caregiver approval. A non-compliant patient can disrupt the delivery of care and an ASC’s workflow. They can also injure themselves as well as individuals around them, including staff. In most cases, that harm is unintentional, such as a patient fall due to a failure to follow instructions. However, an aggressively resistant patient may intentionally hurt caregivers.

To help prepare your ASC to respond effectively and appropriately to a non-compliance scenario, follow these steps.

1. Simulate non-compliant patient events.

If you don’t practice your response to an incident, you can’t emulate what you want to achieve. That’s why it is critical to practice non-compliant events. You can do so through drills or use of “mock patients” where an employee acts like a difficult patient. Consider scripting the experiences to more accurately represent what may happen. Emphasize the importance of remaining calm. Evaluate the response to each simulation and determine opportunities for improvement.

When brainstorming scenarios to simulate, consider possible situations specific to your ASC. For example, if you have a convalescent center, patients staying with you for an extended period can present unique risks. An extended care patient on bed watch may determine it’s safe to ambulate independently without first alerting a nurse. This non-compliance could lead to a devastating fall.

2. Secure the situation.

Regardless of whether patient or staff safety is threatened, make sure to “secure” the situation. Securing the situation can range from calling in security to deal with a threat of violence to informing people around the non-compliance incident what is occurring. If staff members do not feel comfortable responding to a situation on their own, bring in a manager or physician to assist with the situation.

3. Empower staff.

ASC staff, particularly nurses, often have a patient-first mentality. As employees of the ASC, their work focuses on providing the best possible experience for patients. But sometimes the customer isn’t always right. Leadership should emphasize it is not only acceptable but encouraged for staff to speak up when faced with a non-compliant patient.

Empower staff to make decisions they feel are in the best interest of patient and staff safety. This may include transferring a patient to the hospital – a decision not to be made lightly, but one that staff should know is an option if the situation warrants it.

4. Engage family and friends.

Once you encounter a non-compliant patient, you’re no longer just dealing with the patient. The situation also indirectly involves those individuals accompanying the patient. It is important to be upfront about what is occurring with family and/or friends. When you are honest and respectful, conversations about the issue are typically easier. These individuals may have recommendations for how to help diffuse a situation and obtain compliance.

5. Determine level of seriousness.

After you address the non-compliant patient incident, asses its severity. If the incident was minor, including a note in the patient’s chart may suffice as documentation of the experience. However, if the incident led to a more significant patient and/or staff safety issue, consider involving your medical advisory committee and governing board. Also consider whether to involve your risk management and legal team.

If the incident resulted in serious patient harm, patient unconsciousness, or patient transfer, it may require reporting to your state. Understand your state specific reportable event policy and process.

6. Analyze the non-compliant patient incident.

Regardless of the incident’s severity, set aside time to analyze what occurred. Perform a root cause analysis if the incident is significant. Even a minor non-compliant patient incident is worth formally discussing with staff. The key is obtaining feedback on the response and determining if there are opportunities for future improvement.

7. Don’t overlook possible effect on staff.

Dealing with a non-compliant patient is typically not easy. The experience, particularly one which jeopardized safety, may cause distress for your staff and physicians. It is important to evaluate how these “second victims” respond to the incident. If anyone appears traumatized, offer professional support. One-on-one conversations with team members may bring trauma to light.

The More You Know

A non-compliant patient situation can escalate very quickly, going from a seemingly minor incident to one that risks patient and staff safety. By allocating time for education on non-compliance, you will put staff members in a better position to act responsibly when an incident occurs. Following an incident, take advantage of the negative development and turn it into a positive by evaluating the situation. Hopefully what staff members learn will improve their response during the next experience.


Jebby Mathew, Regional Director, Operations

Introduction to ASC Data Analytics

Introduction to ASC Data Analytics

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Part 1: Introduction to ASC Data Analytics

In this three-part series, I will explore the topic of ASC data analytics. Part 1 introduces the topic of data analytics as it applies to ASCs. Part 2 provides examples of how analytics can benefit ASCs. Part 3 walks through the evaluation process to determine if data analytics is a good fit for your surgery center. Let’s dive in!

To succeed in today’s competitive business environment, every organization requires knowledge and understanding of its performance. This fact is especially true in the rapidly evolving world of healthcare, perhaps even more so for ambulatory surgery centers (ASCs). For some, a simple informal review of monthly financial statements may present a sufficient picture of the overall health of the organization. A review of standard accounting reports can provide the information necessary to guide general decision making. However, basic reporting and analysis may not provide sufficient insight to maintain pace with the constantly changing, fast-paced ASC market.

To gain a competitive market advantage, a deeper understanding of an ASC’s performance may be required. The emerging field of ASC data analytics focuses on providing nuanced introspections that surgery center leaders can rely upon as critical tools for decision making.

If you’re not familiar with ASC data analytics, don’t worry. You are not alone. While utilized extensively in financial and retail sectors, ASC data analytics has only recently gained traction. While many factors play into this rapid growth, they all essentially boil down to rising costs, tightening reimbursement, and the influx of integrated health networks. ASC data analytics is increasingly utilized to identify actionable areas of improvement and model the impact of potential changes before they are implemented. As the ASC arena continues to become more competitive internally, along with growing outside pressure – an aging population, payment model shifts, and fluctuating legislation, for example – the ability to identify core problems and predict the success of proposed solutions is an essential tool for organizations looking to gain a competitive edge.

Utilizing data analytics may sound like a panacea for struggling ASCs looking to get back on track or for successful ASCs seeking to further strengthen their position. However, before jumping on the ASC data analytics bandwagon, it’s important to fully understand what analytics entails in the ASC world. Once a basic comprehension is achieved, only then can one ascertain whether implementing an ASC data analytics program is likely to produce a suitable return on investment.

Stay tuned to gain additional understanding of ASC data analytics! My next post in this series will provide examples of how data analytics can be leveraged by ASCs. I will wrap-up the series in my third post by delving into how to determine if an ASC data analytics program is a good fit for your organization.


Cody Carlin, Director, Data Analytics

We are very excited to welcome you to our new blog/content gallery!

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If you are a health care professional in the ambulatory surgery center arena, we hope this blog serves as a valuable resource for you. Our mission at Pinnacle III is to help your surgery center thrive. The heart of everything we do is solving ASC problems. Whether you are involved in developing a new surgery center, managing one, or handling revenue cycle management, our goal is to provide helpful information. As we build on the content in this blog, we hope you will obtain answers to your most important questions optimizing your surgery center efforts as a result.

You already know the health care industry encompasses a rapidly changing landscape. Now more than ever, health care executives are required to be flexible in their efforts to evolve while simultaneously maintaining their organization’s profitability. ASCs are not immune to these changes. The way you operate your facility, recruit physicians, and engage your patients in increasingly competitive communities requires you to be proactive in thinking about new ways to operate if you want to stay ahead of the curve. Revenue cycle management is a more daunting task than ever before with the arrival of ICD-10 and increased financial responsibility being borne by patients.

We understand all of that. We have been working in the ASC industry for over 20 years and have seen every trend imaginable. We help outpatient surgery centers stay flexible, forward-thinking, focused in the face of turmoil, and successful no matter what the health care marketplace brings. Now, we want to take our help to the next level. It’s not enough to have productive conversations with you. It’s not enough to shake your hand at a conference and give you advice. It’s not enough to tackle your questions as you ask them. Rather, we aim to be an ongoing resource for you. We need to capture those conversations, that advice, those key moments when your knowledge was enhanced, and provide it in a way you can easily access and refer back to. We want to be your go-to resource on all things ASC.

Through it all, your surgery center excellence is why we exist, why we do what we do. In the spirit of being your guide in this ever-changing health care world, we give you this blog. In time, we hope answers to all your questions will be found in our gallery of ASC content. We will start with some of your most common questions and build from there. We hope you receive a lot out of this resource. We hope to solve your problems and help you prosper greatly. Welcome to Pinnacle III’s new blog – enjoy!