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ASC Governance

ASC Policies, Procedures, and Protocols, Oh My!

ASC Policies, Procedures, and Protocols, Oh My!

By ASC Governance, ASC Management, Leadership No Comments

Policies, procedures, and protocols are the lifeblood of an ASC’s operations. These critical guidelines should be clear, concise, and readily accessible to members of the workforce. Sometimes, despite the importance of these standards, locating a comprehensive listing of policies, procedures, and protocols is not easy. When staff members are unable to easily locate a policy for the guidance they need to complete their job duties, they are hampered in their mission to provide efficient and effective service to patients. Frustration arises when time is wasted working through inefficient processes. And, in a surgery center’s fast-paced environment, timeliness is critical to efficiency.

Policies and procedures are written to provide clear and concise context, which in turn promotes consistent performance across teams. Written policies are the guideposts which represent evidence-based practices to be applied in daily functions. When team members cannot locate a policy, mistakes can happen, and clinical care can falter.

The best policies and procedures are well-researched, carefully crafted documents that contain pertinent references. They should also be stripped of bulky words, keeping content current, consistent, and concise. No matter how well written the policy, it is meaningless if it is never read and applied to practice.

How do you know if your staff is knowledgeable of your surgery center’s policies and procedures?

If your staff asks questions which are addressed in the policies and procedures manual, that can be an indicator that they are unfamiliar with your ASC policies and procedures. For example, do they ask, “What policy addresses cleaning point of care devices between patient use?” or “How often must relative humidity be monitored?” These questions indicate your staff either do not know best practices, or your ASC process, or they are unsure where to locate the information.

To address a lack of awareness of policies and procedures, begin by creating open dialogue with your staff. During this process, you may uncover a need for retraining or identify areas in your onboarding process that are insufficient. On the other hand, if your staff reveals competency in the areas where there were questions and they are solely looking for your center’s specific policy, take a step back to review the accessibility of your policies and procedures and determine if they are user friendly. There may be many reasons why staff members do not establish and maintain policy knowledge with ease; communicate with them to find out why.

Are Policies, Procedures, and Protocols Accessible?

Let’s explore the accessibility factor by looking at the history of policies and procedures. In the past, policies and procedures were paper based – typically housed in several large three ring binders. Often, these policy notebooks were strategically placed in the confines of a manager’s office – the person most often responsible for upkeep of written policies. In this model, the binders are not immediately available to the bedside nurse who may benefit greatly if they were in a more convenient, accessible location.

The communication breakdown here can be explained by competing priorities. A manager of a busy ASC is often overwhelmed by the demands of the day. The ongoing task of refreshing policies quickly can easily slip to a lower priority.

A practicing nurse knows to wipe down the gurney and put clean sheets on the bed before the next patient uses it. He or she did not need to read a policy to know this. However, does this same nurse know why only FDA approved disinfectant is used? How much dwell time is needed to kill microorganisms? Which point of care devices need to be cleaned? The answers to these infection prevention practices are critical to current infection control standards and are addressed in written policy. When the policy is read and executed, best practice is displayed by the entire team.

Poor practice, ineffective communication, and inadequate onboarding occur when the cleaning process is vocalized but not provided in written form during the orientation of a new hire. The orientee does their best to repeat what is heard and observed – but a breakdown in the consistency of the function can easily occur. If the employee does not receive enough guidance or resources, he or she may resort to performing the task in the way he or she knows how, relying on previous experience or observations of others. That performance might not adhere to the latest best practices. Alternatively, proper infection control processes are easily achieved as a repeatable task with initial and continuous education resources available.

Sustainable solutions to sharing protocols, policies, and procedures

As ASC leaders, our responsibilities include consistent, reliable management of information. Effective policies contain information that can be easily shared with members of the workforce. Leaders need sustainable solutions that improve how we share policies with staff members.

Here are four goals to consider:

  • Policies are readily available to end users.
  • Policies are accurate and current.
  • Policies are protected from erroneous editing.
  • Policy updates are communicated clearly and in a timely manner to appropriate personnel.

To select a communication platform designed to achieve these goals and secure utilization among all team members, consider the following questions:

  • Does the platform address your identified goals?
  • Can the facility afford the platform?
  • What training is required to launch and implement the platform?
  • What will be gained from using this platform?
  • How will leadership appropriately administer change management?

Not every ASC will be able to adopt the same method, hence the importance of identifying your own goals. Once goals are established, develop leading questions to identify the best tool or process for your surgery center presently and in the foreseeable future.

Is there a better way?

Pinnacle III’s managed facilities recently adopted a technology-based policy management system. This strategic move allows our ASCs to immediately gain access to our surgery center policy library. Placing a clickable icon on every workstation provides employees immediate access to policies. System administration ensures accurate and current content material, maintaining intellectual ownership. To protect policies from incidental tampering, all editing occurs via permissions and a prescribed work flow process.

To facilitate the change management process, staff training was provided upon implementation. Periodic in-services were scheduled following initial implementation. To progress staff adoption, a series of quizzes were prepared for personnel affording them opportunities to practice locating and reading various policies on the platform.

Implementation of this software has decreased employee frustration with inability to locate policies. The software provides a more efficient way to maintain and update policies. Our leadership team is more confident members of the workforce are following policies. This has enhanced the workforce’s ability to achieve compliance to practice standards and defined business operations. The leadership team’s repetitive message, “Let’s view the policy!” and “Did you read the policy?” makes consistency probable.

A technology-based platform may not be the answer for your ASC. However, it is important to understand the pain points and efficiency issues that occur in your center. These critical components are directly tied to patient care. No matter what your solution, make sure you are addressing your policy, procedure, and protocol goals. After all, the best policy ever written is the policy which is accessed, read, and applied to daily practice!

Jean Day, Director, Clinical Education

Running an Effective ASC Board Meeting: Lessons I've Learned

Running an Effective ASC Board Meeting: Lessons I’ve Learned

By ASC Governance, ASC Management, Leadership No Comments

Board meetings are critical to an ASC’s ongoing and long-term success. They designate time to address regulatory issues required to maintain compliance. They serve as an opportunity for leaders to make important financial and strategic planning decisions. An ASC board meeting also allows leadership to address problems or areas in need of improvement.

In my 10-plus years serving as a surgery center administrator, I’ve run my fair share of board meetings. Regardless of how each board meeting turns out, I strive to learn something to help the next meeting go smoother.

Guidance for Conducting a Better ASC Board Meeting

Here are some of the key lessons I’ve learned over the years.

  1. No established rules. There are no firm guidelines for running an ASC board meeting. In fact, board meetings do not need to be formal. What matters is finding a format and approach that allows you to accomplish what’s necessary in the time available.
  2. Get to know your board. Learn about your board members; specifically, what they want to get out of board meetings. Using this information, adapt your approach to cater to these needs.
  3. Be consistent. Once you develop a format that works well for your board meeting, stick with it. This serves several purposes. A template will make developing agendas easier and help ensure you do not omit important topics from one meeting to the next. It will also help focus the meeting – board members will know when certain agenda items are up for discussion. If time is consistently allocated to specific topics, board members are less likely to push for earlier discussion on an issue.
  4. Take command. As the individual running the board meeting, you play a major role in determining the meeting’s effectiveness. Talkative or strongly opinionated board members have the potential to hijack a meeting. Maintain control and keep the meeting on task.
  5. Allow for discussion. Build in time for some discussion of key issues in every board meeting. The key word here is “some.” Most meetings last 60 to 90 minutes. A mere 15-minute discussion will eat up a large percentage of that time. Keep discussions short and focused so you can move through the agenda. If an issue requires lengthy discussion, designate a time following the meeting for interested individuals to continue their conversation.
  6. Focus on key items. Going into an ASC board meeting, know which issues are the most important and make sure to cover them. Good preparation and organization of information will help ensure efficient use of the available time. If you plan to provide details, make sure they are critical to the discussion and any decisions. Do not dive so far into details that you take time away from other key issues.
  7. Keep it high level. When weighing what details to provide, such as financial or quality data, keep in mind that most boards look for a high-level perspective. This would include what’s going right or wrong within the ASC and your recommendation on next steps (more on this below). A high-level perspective typically works well for most topics unless one requires deeper discussion because of its urgency or seriousness.
  8. Come up with solutions. If your agenda includes the sharing of shortfalls or areas of concern, be prepared to outline plans for correction. You want board members to leave the meeting feeling confident that you are already working to address any problems.
  9. Make decisions easier. Agenda items that require board members to vote on an issue or make a decision can quickly derail a meeting. If one board member shares an opinion, others are likely to share their thoughts as well. This can quickly turn into a lengthy, possibly heated, discussion. Avoid this scenario by steering members away from unnecessary confrontations. Rather than asking board members what they think the ASC should do, provide options to choose from. Share your recommendation, with a short explanation of your reasoning. The board may still want to engage in a discussion, but providing a few options rather than presenting an open-ended question should help bring about a faster decision.
  10. Be upfront with bad news. If you have bad news to share or anticipate needing to discuss a difficult subject, don’t shock board members by using the meeting as the first time you present this information. Provide board members with a heads-up that the meeting agenda will include the concerning topic. Make sure the board president is aware of the matter and, when possible, to discuss the issue prior to the meeting. If the matter affects specific board members, hold conversations with them in advance.

Bonus Tips for a Successful ASC Board Meeting

Here are a few additional pieces of advice to help you lead constructive meetings:

  • Efficiency is important, but poor preparation can quickly overshadow its significance. If you don’t present ideas in an organized manner, the board may perceive you as less efficient and knowledgeable.
  • When you don’t know the answer to a question, admit it. You’re better off being transparent than trying to appear knowledgeable about an issue when you simply are not. If the information provided turns out to be incorrect, the board is likely to lose confidence in you. Rather, take the time to research the information and provide a correct response. By taking this approach, when you say you know the answer to a question, board members will trust you.

Considering the infrequency of board meetings – with many ASCs only holding them quarterly – every minute of every meeting is of the utmost importance. To run your next ASC board meeting more effectively and productively, prepare fully and take total advantage of the time allotted.

Diane Lampron, Director of Operations

Selecting the Right Compounding Pharmacy for Your ASC

Selecting the Right Compounding Pharmacy for Your ASC

By ASC Governance, ASC Management 2 Comments

In 2011, a compounding pharmacy repackaged an anti-cancer drug off label into plastic syringes for the treatment of macular degeneration. The pharmacy had no container closure or compatibility studies. Fifteen plus patients sustained injuries, including blindness, due to contamination of the medication during the repackaging process.[1]

In 2012, more than 60 patients died from fungal meningitis when they were given a steroid that was compounded by New England Compounding Center. This medication was prepared and packaged in an environment in which proper sterile techniques were not used.[2]

From 2016 to 2017, Guardian Pharmacy Services compounded an ABO steroid to replace a FDA approved drug that had gone on back order. The medication was compounded with an improperly treated binding agent, causing loss of visual acuity in more than 30 patients.[3]

Unfortunately, surgery centers purchased and administered these preparations to patients under their care. Understanding how these adverse events happened will help you prevent them from occurring at your center. Knowing what regulations were put in place as a result and the best ways to research the compounding pharmacies you order from will aid your center in mitigating risk.

How did these issues happen?

Historically, compounding pharmacies were created for physicians to have specialized preparations made for specific patients. Perhaps they had a patient with an allergy to a binding agent or dye in a medication and needed the medication to be made without those ingredients. Over time, these pharmacies began to batch produce sterile preparations. Unfortunately, this occurred in pharmacies that did not have the proper sterile processes and equipment in place to ensure safety of the medications being compounded. In addition, the FDA had no statutory authority over these facilities. The facilities were not even required to be registered with the FDA. While some of these pharmacies may have been visited by their state board of pharmacy, most of them flew under the radar.

After the New England Compounding Center debacle, Congress acted, creating the Drug Quality and Security Act (DQSA). The act delineated two classes of compounding pharmacies and granted the FDA the authority to regulate these facilities.

503A & 503B Key Differences

Under DQSA, there are two classes of compounding pharmacies – 503A and 503B. A traditional compounding pharmacy (one script for one patient) is a 503A. The 503B, however, is an outsourcing facility intended for batch production.[4] The table below outlines the new regulations under DQSA for both types of pharmacies.

503A Compounding Pharmacy 503B Outsourcing Facility
Regulatory Authority State Boards of Pharmacy

FDA registration & inspection

FDA registration & inspection

Additional State requirements

Applicable Standards USP <797>

FDA 503A Policy Guide

FDA cGMP (21CFR 210 & 211)

Additional State requirements

FDA Inspection Under authority to enforce 503A FDA authority to enforce cGMP regulations
Licensing State Boards of Pharmacy FDA Registration
Inspection FDA

State Boards of Pharmacy

FDA & States if additional State requirements
Limitation on Services Individual prescription only

Limited anticipatory compounding

Batch processing

May maintain inventory

Must sell direct to prescriber


Additional Differentiators


  • Laminar flow hood
  • Lack of aseptic technique
  • No qualification of:
    • Active pharmaceutical ingredients (API) & excipient* vendors
    • Container closure
    • Aseptic operators
    • Environmental controls


  • Full current good manufacturing processes (cGMP) qualified[5]
  • API & excipient* vendors
  • Validated sterile procedures
  • Aseptic technique
  • Aseptic operators
  • Environmental controls
  • Environmental monitoring
  • Release assays
  • Stability testing

Best Practices for ASCs

If you need a product and there is no FDA-approved commercial option, it is best to use a cGMP 503B registered outsourcing pharmacy. If a 503B is not available, you can use a 503A facility, but ensure you perform due diligence on both types of facilities first.

There are several ways to obtain information on compounding facilities:

  1. Regulatory status / licensure. Know the regulatory status of the pharmacy you are ordering from by checking the FDA website. All registered compounding pharmacies are listed here with their status and survey history. Ensure you verify licensure in the state where the compounding takes place.[6]
  2. Query results of your (receiving state) State Board of Pharmacy for any regulatory infractions.
  3. Qualify your provider.
    • Use the questionnaire from the International Academy of Compounding Pharmacists (IACP). This document guides you through a series of questions that provide you with a good picture of the facility and their record of regulatory compliance.
    • Obtain and review an information release. Most pharmacies will give this to you if you ask. The information release will summarize regulatory status, licensure type, survey history, etc.
    • Obtain and review the pharmacy’s quality manual. If you really want to dive in, you can review their QA plans.
    • Obtain the cGMP certification of Product-503B outsourcing pharmacies. Often, they will provide a copy of the current good manufacturing processes that were used in production. This verifies the medication was made using the appropriate processes and verification methods.
    • Ask for proof of the facility’s Pharmacy Compounding Accreditation Board (PCAB) certificate.

Armed with this information, your ASC should be able to secure products from a reputable compounding pharmacy who is diligent about preparing medications in a safe environment. You can rest easier knowing you’ve performed the due diligence necessary to mitigate risk to your patients and maintain your ASC’s reputation of high quality care.

Jovanna Grissom, VP of Operations

[1]Avastin injections are reported to cause blindness.

[2] Killer pharmacy: inside a medical mass murder case.

[3] Patients lose vision after routine cataract surgeries at Dallas Key-Whitman center





ASC Real Estate Ownership v. Leasing – What’s Best for Your Business?

ASC Real Estate Ownership v. Leasing – What’s Best for Your Business?

By ASC Development, ASC Governance No Comments

Surgery center investors, like other business owners, must weigh the pros and cons of leasing or buying the space in which an ambulatory surgery center (ASC) resides. How does one decide which option is best? Investors who understand the financial impact ASC real estate ownership or leasing is likely to have on the short- and long-term development of their business project are better equipped to make sound decisions. Only then can investors thoughtfully examine other reasons for either leasing or owning their ASC space. Let’s explore the considerations of both options.

Leased ASC Space

Leasing space for an ASC from an unrelated third party is typically the most straightforward option. It avoids many of the additional steps required in the ASC real estate ownership model described below. Best practice allows the prospective owners to determine a geographic location that ensures the greatest potential for physician partner participation. The ownership partnership then locates a space that will meet its needs – no more, no less. The ASC partnership evaluates the lease rate of the space as well as the construction costs required to convert it to an operating ASC. Costs are then evaluated against the project pro forma to determine if the space best meets the identified needs and desired financial outcome.

Owned ASC Space

The second option is an ASC real estate ownership model in which the ASC LLC, or some portion of its members, own the space where the facility will be located. This model, while providing equity, presents a few challenges and considerations for the ASC investor group.

  1. Fair market value: Regardless of who owns the space, the terms of the lease must represent fair market value for like-space in the area to ensure the entity does not run afoul of federal Anti-Kickback laws. The health system partner cannot subsidize the ASC partnership with artificially low rent; nor can the ASC partnership pay an inflated rental rate in space owned by some, or all, of its physician investors or a potential referral source.
  2. Location, Location, Location: The old real estate adage holds true in our business as well. The location of the facility is the most important factor when considering ASC real estate ownership. I have seen some centers struggle, and others fail, because fifteen minutes is too far for the partners to drive. I have also worked with partnerships who are convinced a location twenty minutes away is the better option because the ASC real estate ownership deal makes more sense for those physicians. The bottom-line? The best location is the one that will be consistently utilized.
  3. The ASC is the primary business: A business owner once told me he would have been more successful if he had made fewer of his business decisions based on the fact that he owned the building. While real estate ownership may be attractive, if the ASC meets the expectations of a well-vetted pro forma, its returns should far outpace that of the real estate investment. Thus, the primary concern for the ASC LLC partnership should be the location and lease terms that make the most financial and operational sense for the ASC.
  4. Ownership structure: Many times, ASCs include the ASC real estate ownership in the ASC LLC partnership. In every one of these instances, problems arise down the road. Our advice, while not always accepted, is to have a separate LLC own the real estate. The real estate partnership can then lease space to the ASC LLC at fair market value. The real estate entity can be structured in a number of ways – owned by the ASC LLC partners, a subgroup of partners, an individual partner, or another similar arrangement. The benefit is this structure will allow the real estate to be dealt with separately from the ASC.

Owning versus leasing the real estate in which your business operates is never an easy decision. ASC owners must consider a variety of factors, including which option makes most financial sense and what will best serve its customers, physician partners, and patients. Carefully weighing all options will yield the best outcome when deciding if you should lease or buy space for your surgery center.

Robert Carrera, President/CEO

ASC Emergency Preparedness: Checklist for Compliance

ASC Emergency Preparedness: Checklist for Compliance

By ASC Governance, ASC Management, Leadership No Comments

Disasters come in many forms. They can be natural – a hurricane, tornado, flood, earthquake – or man-made – a chemical spill or cyberattack. While the impact of disasters varies greatly, what ultimately matters is how your ASC responds. An effective response, outlined in an ASC emergency preparedness plan, can protect and save lives, reduce facility damage, and make recovery easier.

Critical to such a response is the development of an ASC emergency preparedness program. I witnessed its value firsthand at a Colorado ASC that suffered a significant disaster in 2015. The ASC’s plan was instrumental in containing the damage, ensuring patients received the care they needed, and expediting repairs.

If your ASC is certified by Medicare, meeting emergency preparedness regulations is a requirement. Centers for Medicare & Medicaid Services (CMS) outlined these regulations in their final rule posted in September 2016. While the regulations went into effect in November 2016, providers and suppliers have until November 15, 2017 to comply with and implement them.

Earlier this year, Pinnacle III published a blog on “What the CMS Emergency Preparedness Rule Means for ASCs.” With the implementation deadline fast approaching, I thought it would be helpful to publish the ASC emergency preparedness program requirements below. They are organized for your convenience with the intent of helping you achieve and maintain compliance.

Your program must include, but is not limited to, the following four elements:

1. ASC Emergency Preparedness Plan

Develop and maintain an ASC emergency preparedness plan. The plan must:

  • Include a risk assessment. The plan should be based on a facility- and community-based risk assessment that employs an all-hazards approach. This approach focuses on capacities and capabilities critical to preparedness for a full spectrum of emergencies or disasters specific to the location of your ASC.
  • Factor in the types of hazards most likely to occur in your area. Take into consideration facility damage, care-related emergencies; equipment and power failures, and communication interruptions, including cyberattacks.
  • Include strategies for addressing emergency events identified in your risk assessment.
  • Address the needs of the patient population, including services your ASC can provide in an emergency.
  • Address continuity of operations, including delegation of authority and succession plans.
  • Include a process for cooperation and collaboration with emergency preparedness officials (e.g., local, regional, state, federal) in their efforts to maintain an integrated emergency response.
  • Include documentation of your ASC’s efforts to contact emergency preparedness officials and participate in collaborative, cooperative planning efforts.
  • Undergo a review and update at least annually.

2. Policies and Procedures

Develop and implement ASC emergency preparedness policies and procedures. Base them on the emergency plan and risk assessment discussed above and communication plan discussed below. Review and update policies and procedures at least annually. At a minimum, policies and procedures must address the following:

  • A system to track the location of on-duty staff and sheltered patients in your care during an emergency. Note: If you relocate on-duty staff or sheltered patients during an emergency, document the name and location of the receiving facility/location.
  • Safe evacuation from your ASC, including consideration of care and treatment needs of evacuees, staff responsibilities, transportation, identification of evacuation location(s), and primary and alternate means of communication with external sources of assistance.
  • Means to shelter in place patients, staff, and volunteers who remain in your ASC.
  • A system of medical documentation that preserves patient information, protects information confidentiality, and secures and maintains records availability.
  • Use of volunteers in an emergency and other staffing strategies, including the process and role for integration of state and federally designated health care professionals, to address surge needs.
  • Your ASC’s role in the provision of care and treatment as an alternate care site identified by emergency management officials, in the event of a waiver declared by the U.S. Health and Human Services Secretary.

3. Communication

Develop and maintain an ASC emergency preparedness communication plan. Review and update the communication plan at least annually. The plan must include the following seven components:

  • Names and contact information for staff, organizations providing services under arrangement, physicians, and volunteers.
  • Contact information for emergency preparedness staff (e.g., federal, state, regional, local) and other sources of assistance.
  • Primary and alternate means for communicating with your staff and emergency management agencies.
  • A method for sharing information and medical documentation for your patients with other providers to maintain continuity of care.
  • An appropriate means to release patient information in the event of an evacuation.
  • An appropriate means of providing information about the general condition and location of patients under your care.
  • A means of providing information about your ASC’s needs and its ability to provide assistance to the appropriate authority.

4. Training and Testing

Develop and maintain an ASC emergency preparedness training and testing program based on the emergency plan, risk assessment, policies and procedures, and the communication plan discussed above. Review and update the training and testing program at least annually.

With regard to training, your ASC must:

  • Provide initial training in emergency preparedness policies and procedures to all staff, individuals providing on-site services, and volunteers (consistent with their expected roles).
  • Provide emergency preparedness training at least annually.
  • Maintain documentation of all training.
  • Demonstrate staff knowledge of emergency procedures.

To meet the testing requirements, your ASC must conduct at least two exercises annually to test its emergency plan. You must:

  • Participate in a full-scale community-based exercise. If a community-based exercise is not accessible, participate in an individual, facility-based exercise. Note: If your ASC experiences a natural or man-made emergency requiring activation of your emergency plan, you are exempt from engaging in an exercise for one year following the onset of the event.
  • Conduct an additional facility-based exercise. This can be another individual, full-scale exercise or a tabletop exercise that includes a group discussion.
  • Analyze your response to and maintain documentation of all drills, tabletop exercises, and emergency events.
  • Identify and implement improvement opportunities, revising the emergency plan as needed.

Note: If your ASC is part of an integrated health care system with a unified and integrated emergency preparedness program, you may choose to participate in the system’s coordinated program. If you do so, there are additional requirements your ASC must meet. Review the CMS final rule to identify those requirements.

Quick Tips

To achieve compliance, follow the steps provided above. Some tips that will further assist you in your emergency preparation efforts are:

  • Designate an incident commander. This individual is responsible for the overall management of the emergency response.
  • Pre-assign other incident command roles. This could include a deputy incident commander whose responsibilities include filling the incident commander role in the event the incident commander is not on-site during the emergency. It could also include command staff (e.g., public information officer, safety officer, liaison officer) and general staff (e.g., operations, planning, logistics, finance/administration).
  • Make sure your ASC has the appropriate insurance and coverage for the emergencies and disasters you are likely to face.
  • If financial, patient, and other data is stored on-site, plan for how you will protect servers and other critical information technology.
  • Consider any “what ifs.” If there is something you think could happen during an emergency, plan for it.

Improving Your Emergency Preparedness Program

Development of an ASC emergency preparedness program can help a center achieve a more successful response to a disaster. But disasters are unpredictable. An ASC emergency preparedness program can only account for so much. That’s why it is critical to take advantage of every exercise to identify areas of your plan to revise and improve.

It’s also valuable to study how other health care providers responded to actual disasters. Doing so provides an opportunity to incorporate tried-and-tested processes and practices into your plan. In an upcoming blog, I will share many of the steps the Colorado ASC I mentioned took in response to its disaster. By doing so, I hope to help your ASC prepare for what you may face one day.

Diane Lampron, Director of Operations

outpatient total joint replacement program

Starting an Outpatient Total Joint Replacement Program at Your ASC: 5 Key Questions

By ASC Development, ASC Governance, ASC Management No Comments

Advances to minimally invasive surgical techniques, blood loss management, and anesthetics have led to a rise in total joint arthroplasties (TJA) being performed at ambulatory surgery centers (ASCs). Orthopaedic specialists and patients nationwide are increasingly well-served with the same-day model, in which patients receive their total joint replacement and return home for recovery within 24 hours, typically on the same day as surgery. Many orthopaedic-focused and multidisciplinary ASCs are preparing to offer a same-day TJA program, if they do not already. For ASCs working to initiate a credible total joint program, there are key clinical, business, and marketing elements of a well-developed program to consider.

Five questions ASC board members and investors will want to ask before approving a TJA program follow.

1. How does the ASC determine TJA patient selection criteria?

Well-formed patient selection criteria are important components of a successful TJA program. Key stakeholders will likely query, is there a national standard for outpatient TJA patient selection criteria? Unfortunately, the current answer is no. Outpatient total joints do not have as much history as that of outpatient surgery in general. And few professional societies have yet to publish specific criteria for outpatient total joint replacements. However, publications from institutions doing TJA successfully on an outpatient basis are available.

To form a TJA patient selection criteria that is safe for your patients, lean on your clinical leaders. This includes your clinical nurse manager and head anesthesiologist. Begin with your center’s current patient selection criteria for all patients. Then, consider American College of Surgeons National Surgical Quality Improvement Program (NSQIP) standards and American Society of Anesthesiologists (ASA) standards. Do this before reviewing accepted standards from peer-reviewed publications and other ASCs with successful TJA programs.

2. What is the ASC’s clinical plan for performing total joints?

A thorough clinical plan includes patient selection criteria, pre-operative screening protocols, anesthesia plans (pre-operative, intra-operative, and post-operative), clinical guidelines, discharge guidelines/criteria, and follow-up guidelines. Once again, rely on your clinical leaders to formulate the guidelines. If you are having trouble determining some of the clinical plan components, contact a qualified total joint program consultant and/or your ASC association. You can also perform an internet search to look at what other ASCs are doing. Finally, the clinical plan should also incorporate physical therapy, which many ASCs are arranging for patients to complete at the ASC both pre-operatively and post-operatively on the day of surgery.

3. Is the ASC’s nursing staff prepared for the first TJA case?

The beauty of working with skilled nurses in an ASC is their wide-ranging experience. Their experience often includes total and partial joint surgeries at hospitals and other surgery centers. Still, you will want to work with your Clinical Nurse Manager to prepare your ASC’s nursing staff for the TJA program. Identify individuals on your team with the most experience in orthopaedic surgery and in performing total joint surgeries. If you are lucky, you may even have nurses on staff who have worked on TJA cases with the physicians who will be performing them at your center. Rely on these individuals to serve as your skilled TJA nurses and teachers for the other nurses.

In advance of your first patients, prepare your operating room nurses. Arrange for a TJA walk-through with your device representatives. Prepare your pre-op/PACU recovery nurses by arranging for a lesson with a physical therapist who can teach them safe post-surgery movement and ambulation techniques that will prepare TJA patients for discharge. If overnight patient stays are part of your clinical plan, ensure nursing staff members understand patient care expectations during this extended recovery time.

4. What will be the fiscal impact on the ASC?

If you are projecting a certain number of total joint cases in your first year, identify the market and physicians who you expect will deliver these cases. For example, is there a patient population you are not treating because an outpatient total joint program isn’t currently in place? Or, will your physicians be moving a sector of their current patient population to your ASC? Is there another way to capture market share? Combine projected case counts with information on reimbursements and costs to identify the potential fiscal impact on your ASC.

5. What is the marketing strategy and plan for your TJA program?

To answer this question, one must first gain direction from the ASC’s governing body. Determine their interest in working collaboratively with key stakeholders such as the hospital partner to market a comprehensive total joint program. In some cases, collaborative marketing may be a strong desire of your board. Regardless, it will behoove you to create a marketing plan that divides marketing efforts into consecutive stages.

For example, the initial stage might aim to maintain the current customer base. This can include efforts like marketing to referral sources and direct-to-consumers through patient education, media/public relations, and website enhancements. The next stage could then focus on expanding the customer base by exploring new market areas and referral sources. At each stage, marketing efforts and metrics should be evaluated to determine if program goals are being met. This analysis will help determine future growth opportunities and identify further initiatives for enhancing the TJA program.

One of the key components of a successful outpatient total joint replacement program is early preparation. Completing a clear and concise clinical, business, and marketing plan will not only demonstrate to surgery center board members the ASC is ready for total joint approval, it will also deliver a safe environment for total joint replacements performed in your facility.

Jack Mast – Physician Liaison

asc political landscape

Preparing Your ASC for Political Battle

By ASC Governance, Leadership No Comments

There’s an old saying, “Laws are like sausages, no one wants to see them being made.”  When I was younger, I was fully on board with that analogy.  The last thing I wanted to do was participate in the political process.  Then, about 15 years ago, I was thrust into a position that forced me to get directly involved.

Within the same year, pieces of legislation were introduced in Colorado and Minnesota that would have severely negatively impacted the ambulatory surgery center (ASC) industries in those states.  Neither state had an active or robust state association.

Consequently, neither state was prepared to deal with the threat.  Through a herculean effort, disaster was averted in both instances.   Those of us involved in those fights learned a valuable lesson – the best time to prepare for a disaster is before it occurs.

Fast forward to 2017.  The landscape has changed in many ways.   After a five-year battle, the Wisconsin state association, WISCA, under the leadership of Eric Osterman and the association’s board, narrowly missed getting the state’s gross receipts ASC tax rescinded.  In Oregon, the state association recently pushed forward House Bill 2664, allowing 16 ASCs to introduce an “extended stay” license to committee.  In Colorado, CASCA is fervently addressing yet another attempt to negatively impact our state’s convalescent center license for ASCs.

At the federal level, the Ambulatory Surgery Center Association (ASCA) supported the Ambulatory Surgical Center Quality and Access Act of 2017. This act addresses a flaw in current law that allows the Centers for Medicare & Medicaid Services (CMS) to use different measures of inflation for ASCs and hospital outpatient departments (HOPDs) when setting reimbursement rates.

As demonstrated by that short list of activities in 2017, the ASC industry, both on the state and federal level, is far more equipped to deal with threats.  It is also more proactive than ever before.  That by no measure means every state or individual center should sit back and consider the battle won.  Rather, continual preparation and reform is necessary to avert the next crisis.

Some problems that still exist and are keeping ASCs from being formidable political players include:

  • Lack of organized state response to business threats
  • Embryonic, unsophisticated, or paralyzed state organizations
  • Unaware, unable, unwilling, or disinterested physicians
  • Insufficient funding
  • Nonexistent, minimal, or inconsistent education of key elected officials
  • Failure to engage ASCA on a state level
  • Lack of experience, robust understanding, or discomfort with politics, government, and public policy on the part of surgeons, administrators, and staff
  • Ineffective recruitment of hospital support by ASCs and physicians in joint venture arrangements

To set up your ASC for political survival:

  • Join or work to revitalize your state association.
  • Contribute to political fundraising at the state level.
  • Solicit contributions from facility investors for political fundraising.
  • Encourage key stakeholders in your ASC to join a committee in your state association.
  • Involve your physician investors, leadership team, and staff members in state association activities.
  • Engage ASC hospital partners as an ally with your state association.
  • Utilize the ASC’s staff or investors’ political connections.
  • Access key political players on federal and state levels.
  • Engage ASCA on a state level.
  • Contribute, and secure contributions from key stakeholders, to ASCAPAC.
  • Have key ASC personnel and physicians participate in the ASCA Washington DC Fly In.

The above suggestions are some ways every ASC can improve their own political standing along with the political standing of the industry.

To summarize, let me leave you with three quotes to consider when preparing for your ASC’s political survival.

“All politics is local.” – Tip O’Neil

“Never let a third party define your issues or your identity.” – Steven Covey

“It’s not the size of the dog in the fight that counts, it’s the size of the fight in the dog.” – Dwight D. Eisenhower

Robert Carrera – President/CEO

How Marginal Gains are Crucial for Surgery Center Growth

By ASC Governance, ASC Management, Leadership No Comments

Over the course of many years, Pinnacle III has been tasked with the evaluation and turnaround of numerous failing or drastically underperforming surgery centers.  In each situation, it was relatively easy to identify the pain points and devise solutions to create marked improvement in the ASC’s performance.  

There are many centers, however, that already operate at an elevated level.  Their investors often ask us if it is possible for these facilities to improve.  

To answer this question, I am reminded of a story from the 2012 Tour de France and London Olympics. In 2010, Sir Dave Brailsford was tasked with improving the performance of the professional cycling team, Team Sky.  Eventually, he was asked to do the same for the British National Cycling Team.  At that time, Britain hadn’t had a Tour de France champion nor had they performed well in Olympic Cycling. Brailsford realized major gains in the realm of world class athletics were difficult to achieve.  Therefore, he focused on the concept of marginal gains aggregation.  He explained this concept as a one percent margin for improvement in everything.  He believed if you improved every area related to cycling by just one percent, those small gains would add up to remarkable improvement overall.

Initially, Brailsford and his team focused on the obvious – tire weight, seat ergonomics, and athlete nutrition.  Then they turned their focus on the far less obvious.  This included pillow choice and its impact on sleep quality, personal grooming habits and their impact on propensity to develop saddle sores, and hand hygiene to avoid illness.  Essentially, they searched for a one percent improvement in every area where they could create impact.  The results, despite some recent controversies, speak for themselves.  Britain’s Team Sky was victorious in the Tour de France in 2012, 2013, 2015, and 2016.  The British National Cycling Team also won 70% of the gold medals at the 2012 games.

I realize Team Sky is not the first or only organization to espouse the benefits of such an approach.  However, as a cyclist and a geek for human performance improvement, I gravitated to this example to illustrate my point.  Other examples that have paid dividends to the concept of marginal gain include David Cameron’s Behavioral Insight Team which improved the wording of tax demands to increase responsiveness.  Or Google testing 41 shades of blue for its advertising hyperlinks, which they claimed netted an extra $200 million in annual revenue.  The examples are endless.

So, how does a successful ASC ensure continuous growth?  We believe the best get better by consistently reassessing where there are opportunities to aggregate marginal gains.  I have written a great deal about culture.  This is another cultural characteristic which we work to ingrain in our partnered centers.

Every member of an ASC’s team can look for ways to identify marginal gains in their day-to-day activities.  Materials management can move more items to consignment.  Nursing staff can suggest the removal of unneeded items from custom packs.  The revenue cycle management (RCM) team can suggest changes to a dictation template to reduce the need for payors to request additional medical records.  Or, they may suggest implementing online bill pay to create an easier medium for patients to submit payments thereby expediting the receipt of receivables.  These are just a few examples of marginal gains that can be achieved through diligent management.  

It’s also important to keep in mind the reverse can be true as well.  A one percent decline in aggregated overtime can have significant impact on a facility’s operation.  The diagram below, adapted from James Clear, as referenced in “The Slight Edge” by Jeff Olson, effectively illustrates this point.

In closing, it’s easy to get caught up chasing the “large whales” – implementing bundled payments, a total joint program, or a re-syndication – to enhance facility prosperity.  But don’t forget to attend to the “small fish” by creating a culture around aggregating marginal gains.  The valleys in an ASC’s growth can be filled by marginal gains.  Doing so ensures the declines aren’t as sharp which leads to a steadier upward slope.  Overall, marginal gains are crucial to an ASC’s continuous growth.

Robert Carrera – President/CEO

ASC Equity

Why ASC Equity Should Be in the Hands of Physician Owners

By ASC Governance No Comments

Investopedia defines equity as, “the value of an asset less the value of all liabilities on that asset.”  Or, in plain accounting terms, equity equals assets minus liabilities.

If the assets of ambulatory surgery centers are its surgeon/physician owners, and the surgeon/physician owners believe in themselves and the case volume they project, why would they consider giving up significant equity in their ASC?

I should qualify my previous statement.  In certain cases, physician owners are not the only assets in an ASC.  Joint venture opportunities are one example. Hospital systems can not only make good ASC partners, but also have the potential to be valuable ASC assets.  They can extend leverage in the market and their payor contracting clout can have significant value.   Additional assets health systems can bring to an ASC are found here.

Surgeons sow the seeds of ASC success.  They are the primary volume drivers to the surgery center.  Therefore, it is our belief that as much equity as possible should be in the physicians’ hands.  

Large ASC management companies often request larger portions of equity. Their rationale is typically based on two premises.  First, that they will work harder for the success of the entity if they hold a significant ownership share.  And second, that the services they bring to the center justify this type of equity position.  We’ve found this is not necessarily the case.  Consider the following:

  • Management contracts based on a fee-for service provide the same, or even greater, incentive for the management company to perform. If a management company isn’t delivering results, their own profit margin suffers.  Eventually, ASC ownership will seek management expertise elsewhere.
  • No management company would advise their on-site management team to work harder, or put in less effort, based on the level of ownership held.  
  • The leverage a management company brings in terms of vendor contracts or payer arrangements are not enhanced by equity levels.

There is something else to think about when considering giving up sizable equity.  If the relationship with the management company does not work out, it is very difficult and costly to buy-out or disengage that partner.   A more thorough discussion of the non-equity management model from the perspectives of physician/hospital joint ventures, is available here.

In some cases, giving up additional equity makes sense.   This is true when investing partners need a large amount of capital to build a facility and they simply do not have the financial wherewithal to pull that capital together.  In this case, it behooves physician owners to give up only what’s needed to finance the project – nothing more.   

It may also make sense for the facility to surrender equity when the contracting clout of the large equity partner results in a significant return on that equity in the form of enhanced managed care contracts.  For example, if a center is going to give up 25% of their equity, the contracting clout should return 35% in improved reimbursement.

The success of an ASC comes from physician partners utilizing the facility.  The more equity the surgeons/physicians have, the more invested they are in ensuring the ASC’s success.  This is the best way to maximize ASC prosperity.

Rick DeHart – Principal Partner

Management page header image

A Clinical Approach to Healthcare Business Management & Problem Solving

By ASC Governance, ASC Management, Leadership No Comments

I am a physical therapist (PT) by education and training.  I graduated from Wayne State University in Detroit, Michigan with a Bachelor of Science in PT. Go Warriors!

For over ten years, I practiced in a variety of settings, including my time spent as a clinical faculty member at the University.  After that, I moved full time into the world of management.  I like to think I could still earn an honest living as a clinician if I needed to.

As my career moved away from clinical practice, I retained my clinical approach when dealing with issues related to business practices.

The American Physical Therapy Association uses the following statement to describe what a physical therapist does:

“PTs examine each individual and develop a plan, using treatment techniques to promote the ability to move, reduce pain, restore function, and prevent disability.  In addition, PTs work with individuals to prevent the loss of mobility before it occurs by developing fitness and wellness-oriented programs for healthier and more active lifestyles.”[1]

Essentially, PTs evaluate the situation and assess findings to develop a treatment plan.  Our goal is to return patients to their previous or higher level of function.  In some cases, we develop a plan to prevent or forestall further disability.  Sound familiar?

As is the case with many healthcare disciplines, we learned to evaluate someone and then document our findings in a format called the SOAP note.

Here is what the SOAP note entails:

Subjective – Detailed notes regarding what the patient relays about their status in terms of function, disability, symptoms, and history.

Objective – This is derived from the clinician’s objective observations.  It can include visual observations such as posture and swelling, actual measurements such as range of motion or strength, and hands-on techniques such as palpation.

Assessment – The clinician’s analysis of the various subjective and objective findings yields an assessment.  It explains the reasoning behind the decisions made and clarifies the analytical thinking behind the problem-solving process.

Plan – Conveys how the clinician develops treatment to reach goals or objectives.

As a business leader, I use the clinical approach I learned and practiced to solve management problems.  Here is how:

Subjective – Years ago I read the difference between clinicians heralded at the top of their profession and those considered more average was based on the quality and thoroughness of the clinician’s ability to subjectively capture a patient’s history.  I believe the same is true in business problem solving.

In business, it is important to seek information directly from the source when issues arise.  For instance, I prefer to meet stakeholders in person to obtain the history of the situation and gain an understanding of how it developed.  What areas have been impacted?  What actions have been taken to resolve the issue?  What, if any, impact have those efforts had?  Lastly, I like to ask the stakeholders for their suggestions on resolving the situation.

Objective – When appropriate, I begin the objective portion of my evaluation visually, just like when I treated patients.  This can entail simply walking through the facility or office.  Many times, it involves taking subjective “histories” from stakeholders.  The measurement and hands-on review, in many cases, involves evaluating existing data and reports.  When necessary, and possible, it includes asking for additional information.  This provides me with a complete view of the situation.

Assessment – Again, the assessment is where the expertise and experience of the “clinician” shines through.  Taking all information gleaned from the subjective and objective portions of my evaluation, I can generate a list of problems.  Next, I can prioritize the items on my list.

Plan – Lastly, just as in a clinical setting, I develop a “treatment” plan for the problems in my facility.  The plan addresses not only the symptoms but also their underlying causes.

The business side of healthcare is made up of many clinicians who have transcended their clinical roles into business management and leadership.  I am one of those individuals.  The skills we learned as clinicians allow us to be effective problem solvers in the operational management side of the business as well.

Robert Carrera – President/CEO