Skip to main content
Tag

Clinical Operations Archives - Pinnacle III

Launching an ASC Staff Certification Program

Launching an ASC Staff Certification Program

By ASC Management, Leadership No Comments

When members of your staff indicate they want to get better at their jobs, your response is probably enthusiastic support. After all, a more competent, skilled staff is better prepared to achieve improved clinical and financial results and higher patient and surgeon satisfaction. These are some of the reasons ASCs allocate time and resources to staff training and in-service education. They are also compelling reasons for developing a program that supports ASC staff certification.

ASC Staff Certification Program Components

Here are some of the essential components to address when developing your ASC staff certification program guidelines.

Eligibility

Determine certification program eligibility. Is the program limited to full-time employees or are part-time employees also eligible to participate? Are staff required to work at your ASC for a specific amount of time (e.g., one year) before they are eligible for the program? Will you restrict participation to employees in good-standing?

Acceptable Certifications

Specify which certifications your program will cover – preferably, those that are essential to your facility’s success. Examples of certifications you may want to include:

  • Certified Perioperative Nurse (CNOR)
  • Certified Post Anesthesia Nurse (CPAN)
  • Certified Ambulatory PeriAnesthesia Nurse (CAPA)
  • Certified Surgical Tech (CST)
  • Certified Gastroenterology Registered Nurse (CGRN)

It’s important to permit staff to propose certifications not included in your program. You can weigh the merits and applicability of each proposal. While you may add to your original program list, consider including only those certifications awarded by nationally recognized professional organizations.

Covered Expenses

Identify which expenses are eligible for reimbursement upon successful completion of the ASC staff certification. You will likely want to cover the certification exam fee. You may want to reimburse certification renewal fees. Other expenses to consider:

  • Educational resources to support exam preparation (e.g., books, webinars, conferences)
  • Practice exams
  • Transportation to and from an exam center
  • Continuing education required to maintain the certification

Include a qualifier noting that reimbursement only applies to the portion of eligible expenses not already covered by other payment sources, such as scholarships. Put a cap on the amount of reimbursement available for a single certification and/or timeframe (e.g., annually).

Documentation

Require documentation at the beginning and end of the program. Employees seeking certification assistance should submit their application/request in writing. Following certification program completion, ensure employees provide documentation demonstrating they earned the certification. If you are covering other expenses, request itemized receipts.

Secure a Return on Your Investment

An ASC staff certification program is one way for your ASC to invest in staff. Help protect your investment by including a reimbursement qualifier in your guidelines. State how long employees are expected to remain with your surgery center following completion of, and reimbursement for, the certification program. Clearly outline the financial penalty for failing to reach this mark.

For example, you might require employees to repay 70% of their assistance if they do not stay with your ASC for one year after achieving certification. While you cannot require employees to remain at your center, financial penalties encourage them to thoughtfully consider the impact leaving prior to completion of the qualifying term will have on them and your ASC. Financial qualifiers also deter individuals not fully committed to staying with your ASC from applying to the program.

ASC Staff Certification Program Expansion

If you launch a program that is successful, consider additional ways to encourage staff members to participate. One way is to add certifications to your list. Ask staff for their recommendations. Monitor the development of new certifications, such as the recently launched Certified Ambulatory Infection Preventionist (CAIP).

Another way to expand the program is to go beyond certifications. Include courses provided through an accredited educational institution of higher learning (e.g. college, university, trade or vocational school). These offerings may attract individuals already holding certification(s) or those not interested in certification.

Here are some additional considerations if you are going to offer reimbursement for course tuition:

  • Require the primary business of the institution attended is education. Academic or college credit hours should be earned upon successful completion of the class.
  • Ensure course work is applicable to the employee’s current position or tied to a degree related to an employee’s career path with your ASC.
  • Require proof of completion, such as a transcript or grade report.
  • Determine whether to reimburse for books and other supplies mandated for course participation.

Offering reimbursement for certifications and courses is a potentially low-cost, high-reward method to improve staff performance and productivity. This investment can encourage greater staff loyalty and appreciation of leadership support. An ASC staff certification and educational course program promotes an ASC’s mission of providing compassionate, high-quality care. That’s a proposition easy to endorse!


Michaela Halcomb, 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

503A:

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

503B

  • 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.

http://www.newsweek.com/2015/04/24/inside-one-most-murderous-corporate-crimes-us-history-322665.html

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

https://www.dallasnews.com/business/health-care/2017/04/27/patients-lose-vision-routine-cataract-surgeries-dallas-key-whitman-center

[4] https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm

[5] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211

[6] https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm378645.htm