The Surgical Eye Center of Morgantown, where I am the managing partner, is located in the university town of Morgantown, WV. It is the only such ASC in a nearly 100-mile radius, where we serve a large geographic, but rural, area in West Virginia and Western Maryland. The ASC has two rooms specializing in ophthalmic procedures.

In 2015, we determined that we needed additional support space to manage our two ORs more efficiently, so we decided to expand our ASC to 8,000 square feet. By late August 2015, the remodel was complete. Our preparations for opening day were thorough. We had anticipated every scenario and held trial runs to identify possible issues, implementing changes in protocol as necessary. Our supplies were stocked, and our newly renovated facility was ready for use.

Our enthusiasm was dampened, however, when five Medicare inspectors from the West Virginia Department of Health and Human Resources arrived for our 5-year inspection. Our staff greeted them with confidence and a positive attitude. The initial introductions and review of our manuals and credentialing went well. Then, things took an unexpected turn early on the first day of the inspection. The nurse reviewers focused on how we administer preoperative eye drops to patients — using a multi-use drop with a sterile technique. They indicated that we were not following appropriate protocol, and explained that each patient requires a separate bottle to comply with the single-use protocol, which applies to every medication in the prep area and in the OR.

We were not convinced that a single-use protocol was the only option. After all, it is acceptable to use a multi-dose approach if safety standards are followed. Furthermore, dispensing multi-dose drops prevents waste and controls costs, especially in the case of ophthalmic medications, many of which do not come in single-use bottles. So, working with our Administrative Nursing Director Heather Huffman, and our Clinical Nursing Director Diane Bolyard, we set out to research our options and petition the result of the inspection. Here is a summary of our research, as well as the outcome of our situation.

ASC Compliance

To receive reimbursement from Medicare and Medicaid, ASCs must comply with Federal requirements in the Medicare Conditions for Coverage. The CMS State Operations Manual¹ states, “The goal of an ambulatory surgical center (ASC) survey is to determine if the ASC is in compliance with the definition of an ASC, ASC general conditions and requirements, and the conditions for coverage (CfCs) at 42 CFR 416 Subparts A through C. Certification of ASC compliance with the regulatory requirements is accomplished through observations, interviews, and document/record reviews. The survey process focuses on an ASC’s delivery of patient care, including its organizational functions and processes for the provision of care. The ASC survey is the means used to assess compliance with Federal health, safety, and quality standards that will assure that patients receive safe, quality care and services.”

An Infectious Outbreak Leads to Stricter Standards

In 2007, an outbreak of hepatitis C, which was the result of unsafe injection practices involving the anesthetic propofol at a Southern Nevada endoscopy center, led to the death of an infected patient and serious illness for dozens of other patients. In 2013, a jury convicted Dr. Dipak Desai of 27 criminal counts related to the hepatitis C outbreak, including second-degree murder, and was sentenced to life in prison. Nevada U.S. Attorney Daniel Bogden said after the sentencing, “We are hopeful this closes a long and sordid chapter of harm caused to the people and businesses of Nevada.”²

In 2009, President Obama signed into law the economic stimulus package known as the Recovery Act. It included an appropriation of $50 million to the Department of Health and Human Services for the healthcare-associated infection reduction strategies. Of that amount, $10 million was provided for State Survey Agencies (SAs) to improve the survey process for Medicare-participating ASCs. In an announcement, CMS stated: “ASCs account for 43 percent of all same-day (ambulatory) surgery in the United States, amounting to about 15 million procedures every year, and have been the fastest-growing provider type participating in Medicare, increasing in number by more than 38% between 2002 and 2007. Typical surgical procedures conducted in ASCs include endoscopies and colonoscopies, orthopedic procedures, plastic/reconstructive surgeries, and eye, foot, and ear/nose/throat surgeries. A 2008 Hepatitis C outbreak in Nevada was traced to poor infection control practices at various ASCs (potentially affecting more than 50,000 people). Follow-up Medicare surveys throughout Nevada found serious deficiencies at 64% of the ASCs surveyed, primarily with infection control practices.”³

CMS made it very clear that, “This initiative will significantly expand the awareness of proper infection control practices among ASCs and SAs, increase the extent to which infection control deficiencies are both identified and remedied, and prevent future serious infections in ASCs by:

1. Improving SA inspection capability and frequency for onsite surveys of ASCs nationwide,
2. Using a new infection control survey tool developed by the CDC and CMS,
3. Improving the survey process through the use of a CMS tracer methodology, and
4. Using multi-person teams for ASCs over a certain size or complexity.”

Although stricter standards are a clear priority, CMS does not have a policy specific to the use of multi-use eye drops. As such, opinions about the standard of care and use differ.

An Argument for Single-use Protocol

In 1998, the Institute for Safe Medication Practices (ISMP) published an article: “Shared Eye Drop Bottles: Danger In Making Every Drop Count.”⁴ It makes a strong argument that eye drops should not be shared:

“It has become practice in some facilities for eye drop containers to be shared among patients. Communal eye drops may be used in both outpatient and inpatient areas to prevent waste, control cost … Some health professionals are concerned that communal containers might be contaminated, which could risk patient infection. … There are few large-scale studies that directly examine the safety of sharing eye drop containers. However, existing literature indicates that ocular cross-contamination will occur. Preservatives ordinarily prevent bacterial growth in the solution. Still, bacteria may be present on bottle top inner surfaces or container grooves and tips. … Additional studies confirm that in-use container contamination occurred, and that serious eye infections can be transmitted from such containers. These studies also refute the belief that doctors, nurses and patients will always apply eye drops properly, without touch contamination. … Medication errors, such as wrong drug and wrong concentration are more likely with communal drops since patients’ names are not on the container label. … Thus, a single dispensing error could result in a series of errors involving numerous patients.

“SAFE PRACTICE RECOMMENDATION: Using communal eye drops increases the risk of infection and medication error. In fact, the CDC considers tears an infectious body fluid and recommends that staff use personal protective equipment whenever the potential for exposure exists. Also, labeling on some ophthalmic products suggests that medications should not be shared among patients. As such, eye drops should not be shared among patients.”

In 2012, ISMP reiterated its position on this issue,⁵ stating, “Sharing eye drop containers between patients and between both eyes of one patient has led to serious eye infections due to cross contamination. While most products include preservatives to prevent growth of bacteria and fungi, organisms can still thrive on the tip of the bottle. Rates of contamination as high as 35% have been noted in some studies; although infections are rare, they can happen and even cause blindness in some cases.

“RECOMMENDATION: To reduce costs, ophthalmic-specialty hospitals often have mandatory training, competency, and monitoring programs to teach and validate safe eye drop administration. Hospitals without this level of training and monitoring should dispense separate containers of eye drops for each patient and each eye.”

The Centers for Disease Control and Prevention (CDC) has also weighed in on this issue, but not specifically for eye drops — the agency evaluated medications in general. It shares the viewpoint of ISMP and states, “Multi-dose vials should be dedicated to a single patient whenever possible.”

On the CDC’s website, they discuss single-use and multi-dose medications as follows: “A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case/procedure/injection. Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative.”⁶

It is noteworthy that CDC is specifically interested in “liquid medication intended for parenteral administration.” There is no mention of eye drops.

Also in 2012, the Association of periOperative Registered Nurses also took a position on this matter: Avoid multi-dose vials in the operating room.

“The use of multi-dose vials in the operating room (OR) has resulted in infection outbreaks and errors. Cross contamination is always a possibility when using multi-dose vials. Also, when medications are supplied in quantities that exceed the amount typically given, practitioners may misinterpret the amount in the vial as a single dose, leading to overdoses.

“RECOMMENDATION: The Association of periOperative Registered Nurses recently released a set of recommended practices that include a recommendation to collaborate with pharmacists to procure and store only single-dose vials in the OR and post-anesthesia unit. Multi-dose vials should be avoided.”⁵

An Argument for Multi-use Protocol

In August 2013, the American Society of Ophthalmic Registered Nurses (ASORN) established comprehensive guidelines for use of multi-dose ophthalmic medications as follows, “In compliance with standards set forth by the Centers for Disease Control, the preferred practice for ophthalmic medication administration is single-use/single-patient medications. However, many medications are available only in multi-dose form. Medications labeled as multi-dose may be used for more than one patient if, and only if, sterile technique, safe injection practices, and standard precautions are followed. Drug shortage or cost savings are never reasons to reuse single-use medications on multiple patients. Any medication labeled as single-use must be discarded immediately after use on a single patient. As always, patient safety and quality of care must come first when caring for the ophthalmic patient.”⁷

In December 2014, Jensen and colleagues published an article in JAMA Ophthalmology,⁸ “Using multidose eyedrops in a health care setting: a policy and procedural approach to safe and effective treatment of patients.” Significantly, the article concluded, “Approval of our policy and processes indicates that The Joint Commission validates our policy and its adherence to accepted preferred practice guidelines of safe handling and administration of multidose eyedrops and establishes precedence that may be followed by other eye care facilities and health care organizations in the future. Our policy provides a safe and effective process for administering eyedrop medications to patients as well as controlling excessive health care costs to both patients and health care facilities.” The article cited substantial cost savings of hundreds of dollars per cataract operation.

In August 2015, the American Society of Cataract and Refractive Surgery (ASCRS), published a position statement, developed by the ASCRS Cataract Clinical Committee, in the wake of some surgery centers being compelled to cease using certain long-accepted topical treatments for preoperative patients.⁹ “Some members reported that surveyors have arbitrarily proscribed these well established and common practices, without any evidence that they pose greater risk,” said ASCRS Past President and Cataract Clinical Committee member David F. Chang, MD. In the position statement, ASCRS said, “Another well-established practice is the use of multidose eye drops on multiple patients as part of the preoperative surgical protocol (i.e., dilating drops, NSAID, etc.). The safety and cost effectiveness of multidose bottles are well recognized in the clinic and in the surgery setting. Safety guidelines have been established for the safe use of these products including: expiration 28 days after initial use, proper dispensing technique, and discarding of any bottle with suspected tip contamination. The ASCRS Cataract Clinical Committee strongly supports the current established practice of utilizing multidose eye drops on multiple patients, when proper protocols are followed.”

Noted Dr. Chang, “The Cataract Clinical Committee is not recommending or suggesting that there is only one best practice. Rather, we want to defend those facilities that choose to use multiuse bottles … based on the best medical judgment of their clinical staff.”

Our Resolution

After the visit from the Medicare inspectors, we received a Summary of Deficiencies that specifically addressed our multi-use protocol. Our initial written response contained our defense and the references mentioned earlier. When the West Virginia Department of Health and Human Resources (WV DHHR) rejected our argument, we appealed directly to the executive director of the WV DHHR. He appreciated our viewpoint, but could not overturn the decision because he was simply following existing federal directives. However, he was willing to discuss our position with the Department of Health & Human Services in Washington, D.C. Surprisingly, the response was a complete reversal. Federal HHS officials agreed with ASORN, the Joint Commission, and ASCRS that if proper training, protocols, and monitoring are in place, an ASC can use multi-dose eye drop bottles.

A Huge Victory

Had we lost our appeal, the added costs of eye drops to provide care would have increased by more than $200 per patient. As we are fixed at an $878 reimbursement for cataract surgery, it was not a cost we could have covered — and I suspect the entire ophthalmic ASC industry would not be able to justify and support the cost of using multi-use bottles under a single-use protocol.

The CDC, ISMP, and AORN presented well-articulated, fact-based, cautious approaches to address potentially life-threatening or blinding healthcare-associated infections. These professional organizations have the best interests of patients in mind, particularly after the scandalous hepatitis C outbreak shined a bright light on the topic. However, with appropriate measures and precautions in place, preoperative multi-use eye drop protocols can be a safe and effective alternative to the single-use approach. ■

References

1. CMS State Operations Manual 100-07, Appendix L – Guidance for Surveyors: Ambulatory Surgical Centers. Available: http://go.cms.gov/1iwDWUl . Accessed Jan. 13, 2017.
2. German J. Hepatitis C Outbreak Dr. Dipak Desai Sentenced To Federal Prison For Fraud. Las Vegas Review Journal, July 9, 2015. Available: http://bit.ly/2jgk7eI . Accessed Jan. 13, 2017.
3. CMS website. Healthcare-Associated Infection (HAI) Initiative. Available: http://go.cms.gov/2isQGFs . Accessed Jan. 13, 2017.
4. Institute for Safe Medication Practices. Shared Eye Drop Bottles: Danger In Making Every Drop Count. November 4, 1998. Available: http://bit.ly/2il7rnk . Accessed Jan. 13, 2017.
5. Institute for Safe Medication Practices. ISMP Quarterly Action Agenda — January - March 2012. April 5, 2012. Available: http://bit.ly/2jgfvoI . Accessed Jan. 13, 2017.
6. Centers for Disease Control and Prevention. Frequently Asked Questions (FAQs) Regarding Safe Practices for Medical Injections. Questions about Single-dose/Single-use Vials. Available: http://bit.ly/2j8ESqH . Accessed Jan. 13, 2017.
7. ASORN Recommended Practice: Use of Multi-dose Medications. August 2013. Available: http://bit.ly/2jguRtw . Accessed Jan. 13, 2017.
8. Jensen, MK, Nahoopii, R, Johnson, B. Using multidose eyedrops in a health care setting: a policy and procedural approach to safe and effective treatment of patients. JAMA Ophthalmol. 2014;132(12): 1476-1479.
9. ASCRS. ASCRS Releases Position Statement on Two Established Ophthalmic Practices. August 15, 2015. Available: http://bit.ly/2jfY9c5 . Accessed Jan. 13, 2017.

Stephen R. Powell, MD, is managing partner at Surgical Eye Center of Morgantown in West Virginia.

Kevin J. Corcoran, COE, CPC, CPMA, FNAO, is president and co-owner of Corcoran Consulting Group.