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COVID-19 Applications and Perspectives

Implementation of Novel Protocols in an Ophthalmic Ambulatory Surgical Center to Resume Surgical Procedures During COVID-19

Berkenstock, Meghan K. MD; Ishii, Lisa MD; Giessler, Brian MBA, MLS; Quaty, John BSN; Biggs, Madalyn MSN, RN; Buck, Pamela; Ebrado, Alfred RN; Kalendek, Laurie CNA, COA; Lazoff, Karen CST; Martin, Michael RN; McCullough, Chanda CST, CNA; Jampel, Henry MD; Scott, Adrienne W. MD

Author Information
Quality Management in Health Care: January/March 2021 - Volume 30 - Issue 1 - p 69-73
doi: 10.1097/QMH.0000000000000285
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Abstract

With the spread of COVID-19, the American Academy of Ophthalmology (AAO) recommended the continuation of only urgent and emergent surgical cases.1 Some reports have been published detailing the use of double gloving, specialized drapes over the ophthalmic microscope, and use of N95 masks in ophthalmic operating rooms (ORs).2–4 With the resumption of elective ophthalmic surgery, the AAO has again outlined procedures for providers and patients to limit transmission.5,6 Specific to cataract surgery, which represents the majority of procedures performed at our 2 ambulatory surgical centers (ASCs), the risk of aerosolization is expected to be low but possible during phacoemulsification in the anterior chamber.6 One of the highest-risk groups for complications related to COVID-19 infection are those older than 65 years or with preexisting health conditions, which describes the demographics of most patients undergoing cataract surgery, including those taking systemic immunosuppressive agents to control ocular inflammation.7

To protect both staff and patients, the ASCs were closed on March 18, 2020, and then reopened on May 20, 2020, after a comprehensive manual of operations was drafted and implemented to allow for a continued incremental increase in case numbers during the COVID-19 pandemic. Herein, we discuss this in-depth protocol to safely allow the restart of elective procedures in a dedicated ophthalmic ASC while adhering to AAO recommendations.

METHODS

This is a 2-center review of protocols and practices designed to limit COVID-19 transmission during the restart of ophthalmic elective procedures at dedicated ophthalmic ASCs. All 4 ORs at both locations were closed from March 18, 2020, through May 20, 2020. The manuscript was approved by the Johns Hopkins Institutional Review Board.

RESULTS

The protocols can be broken down into several categories: preoperative preparation, intraoperative sterilization and protection, postoperative care, and perioperative facility precautions.

Preoperative preparation

All patients are tested within 72 hours prior to the procedure with a COVID-19 nasal swab to assess for active disease. Since our facility does not have negative pressure capabilities in the patient holding and recovery areas, it is essential that patients test negative for COVID-19 preoperatively. The surgeon places the order in the electronic medical record of the patient, and the COVID-19 Ambulatory Response Team (CART) contacts the patient to schedule the patient for testing at one of the Johns Hopkins laboratories. Upon entrance to the facility, a temperature check is performed at the front door along with assessment of screening questions pertaining to COVID-19 symptoms—fever in the last 24 hours, unexplained loss of taste or smell, new headache, diarrhea, cough, sore throat, muscle aches, or shortness of breath. This applies to staff and patients. All patients are required to wear a surgical mask while in the facility. The preoperative holding areas of the ASC were altered to allow for 6 ft between each stretcher, and staff was asked to maintain this same distance when possible. Staff and physicians are required to wear disposable surgical or N95 masks and a face shield while working. Masks are disposed of when soiled and face shields are wiped with disinfection wipes at that time or during the day if soiled. Shields are replaced if compromised. Additional personal protective equipment (PPE) including N95 masks and powered air purifying respirators are available to staff at all times. Use of hand sanitizing gel is mandatory when arriving at and leaving a patient's stretcher. Preoperative anesthetizing and dilating eye drops are administered from multiuse bottles. Administration of drops to avoid contact with surfaces is shown in the Figure. The tips of the bottles do not touch any surface, otherwise they are disposed of immediately. The date of opening is labeled on the side of each bottle, and it is disposed of every 28 days. There are 4 ORs within the 2 ASCs, and the surgical volume was restricted to a 50% capacity after reopening, with a gradual increase to 75% over the subsequent months. Dedicated OR time was initially increased on the schedule from 30 minutes to 1 hour to allow for increased turnover time and cleaning of the OR between cases, as discussed in the intraoperative section.

Figure.
Figure.:
Photograph illustrating eye drop administration through pulling down the patient's lower lid without touching the ocular surface.

Intraoperative sterilization and protection

As prior to COVID-19, standard preparation of the surgical site with betadine and use of ophthalmic drapes continued. When in contact with patients, with the exception of using the ophthalmic microscope, providers wore clear wrap around glasses to prevent splashes. The surgeon's depth perception is altered if wearing eye protection when using the microscope. After the time-out is performed and the surgeon is sitting in front of the microscope, his or her eye protection is removed by a staff member, given they have donned a sterile gown and gloves and placed the surgical drape over the patient's face. Patients are required to wear a surgical mask into the OR until the anesthesiologist applies the nasal cannula to deliver oxygen in the case of monitored anesthesia care (MAC).

The algorithms for anesthesia protocols stem from a patient's COVID-19 testing status, as we only perform elective procedures on patients who have tested negative. If asymptomatic and there is a negative nasal swab test within 72 hours of the procedure, the patient's elective procedure using MAC can proceed with the use of either surgical or N95 masks by all staff members and physicians in the OR using low-flow oxygen.

A standard terminal cleanup using a top-down approach is performed between surgical cases for 15 minutes using sanitizing wipes containing 55% isopropyl alcohol and n-alkyl dimethyl benzyl ammonium chloride 0.25%, which is a quaternary ammonium compound. Staff members are required to maintain a 6-ft distance from each other when possible in the OR.

Postoperative care and follow-up

The postoperative areas of the ASC were changed to separate stretchers by 6 ft when possible. The staff again was asked to maintain 6 ft of distance when possible. When recovery is complete and discharge instructions have been discussed, 1 staff member transports the patient by wheelchair outside after contacting the accompanying visitor in the parking lot. The wheelchair is wiped down with sanitizing wipes, as used for terminal cleaning, prior to return to the ASC. To track patient outcomes, the ASCs have a Complication/Infection Control Report Form that all surgeons need to fill out in regard to surgical complications or if a patient develops COVID-19 symptoms during postoperative follow-up. Upon discharge from the ASC, COVID-19 symptoms are discussed with the patient. If any symptoms occur, there is a 24-hour phone number provided to the patient to call to report these symptoms to one of the ASC physicians and obtain COVID-19 nasal swab testing. No cases of COVID-19 were reported in follow-up in the 3 weeks after reopening the ASCs.

Perioperative facility precautions

All waiting room furniture has been removed from the ASC lobby except for 3 chairs, which are 6 ft apart to encourage social distancing. A red sticker was added 6 ft in front of the Plexiglas barrier at the registration desk to provide social distancing. A single pen is available in a cup labeled “clean” for the patient to sign documents and then is placed in a cup labeled “dirty.” The pen and countertop are then cleaned by the front desk staff between patients. If the patient uses the restroom, a staff member immediately cleans the bathroom with the same sanitizing wipes as used for terminal cleaning of the OR.

A safety officer position was created to monitor staff and patients on the proper use of PPE. The safety office also wipes down high-touch surfaces, such as door handles, countertops, keyboards, phones, faucets, and refrigerator handles. This is performed at least 3 times a day. Only 2 staff members are allowed in the break room at a time, given the need to remove masks for eating and the need for 6 ft of social distancing. An additional break room was created, given there are 9 or 10 staff members in the ASC at any given time. Close-quartered spaces, such as small offices for charting, are only permitted to have 1 staff member inside at any time. Staff members are not required to undergo COVID-19 testing unless having the symptoms the symptoms listed in the preoperative preparation section.

Patient communication

The changes made in the ASC and the need for perioperative testing were stressed to patients to increase their comfort in returning for surgical care. One week prior to surgery, patients are called to discuss the need for preoperative COVID-19 testing within 72 hours of the procedure. They are advised that the testing is mandatory and the CART will call to provide the date, time, and place for nasal swab testing. They are encouraged to self-isolate after testing until the procedure. Patients are also made aware of the new protocols in place to prevent transmission of COVID-19, which include symptom screening and temperature check at the entrance and all visitors accompanying patients must remain in their car within the parking lot. Visitors cannot escort the patient into the ASC unless the patient has low vision or ambulatory difficulties. If the latter occurs, the patient is taken from the ASC waiting room by a staff member. Unauthorized personnel are not allowed to remain in the waiting room, and visitors are asked to wait outside for the duration of the procedure.

With the implementation of these procedures in the 3 months prior to this writing no staff or patients tested positive. No patients underwent a procedure without COVID-19 testing. One patient tested positive, but all samples in that batch were read by the laboratory as positive. Since 2 nasal swabs are taken from each patient, the second swab was then tested and found to be negative. Since the patient had not left home in 2 months except to have the nasal swab performed and had no symptoms, the test was felt to be a false-positive and the surgery was performed.

Adjusting to the new protocols allowed turnover time to be decreased from 1 hour between cases to 45 minutes. This allowed the total number of cases performed within a day to increase from 8 to 12. From a financial standpoint, this translates into an increased profit margin. Using the Bel Air ASC as an example, there are 10 working hours a day, 4 days a week, 46 weeks per year, leading to a cost per minute of operation of $14.97. The average net revenue per case during the 2018-2019 fiscal year was $1127.00. Without factoring in the cost of additional PPE and cleaning supplies required to implement these protocols, with only 8 cases initially performed per day, the overhead alone was slightly higher than the generated revenue. However, increased proficiency, while remaining compliant with cleaning procedures, has prevented COVID-19 transmission and created a profit margin.

This has created a self-described “environment of safety” for employees and a continued diligence to strictly follow the protocols moving forward.

DISCUSSION

The restart of elective ophthalmic surgery, especially given the backlog of patients requiring cataract surgery alone, requires the institution of new protocols to decrease transmission of COVID-19 due the unique risks associated with ocular procedures.8 It has been established that COVID-19 spreads through respiratory droplets and tears, and ocular procedures require working near the nasopharynx.3,9,10 Furthermore, close proximity to the patient, as defined by the World Health Organization as less than 6 ft for 15 minutes, is needed to perform ocular procedures.11 It is known that a sneeze can result in particles dispersed over 19 ft.12 However, wearing of face shields and goggles makes looking through the OR microscope very difficult, thus increasing the risk associated with ocular microsurgery.13 While operating through the use of a 3-dimensional monitor has been suggested, not all facilities have this technology.13 Given these constraints and lack of negative pressure capabilities at our center, we determined it was of the utmost importance and necessity that patients undergo COVID-19 testing via nasopharyngeal swab within 72 hours of surgery to allow time for processing and prevent patients with active or asymptomatic infections from entering the OR.14,15 To further screen for symptoms of COVID-19 infection, temperature checks are performed upon patient entry to the ASC. Temperature assessments have previously been used to screen asymptomatic persons during outbreaks of other severe acute respiratory syndrome (SARS) viruses and have started to be investigated during COVID-19.16,17 Currently, the Centers for Disease Control and Prevention (CDC) has recommended temperature screening when entering a clinic with high risk of transmission, including dental practices.18

As with universal precautions in place prior to COVID-19, we continue to use betadine applied to the ocular and periocular surfaces; however, there have been no clinical trials or studies examining its effect on COVID-19. Previous articles have reported that betadine was virucidal against SARS and Middle East respiratory syndrome (MERS) viruses.13,19 Another challenge specific to cataract surgery is preoperative administration of anesthetic and dilating drops from multiuse bottles. To avoid contact with any surface, the drops are instilled at least 3 inches over the patient's eye, with one of the staff's fingers holding down the lower lid.

Further limiting respiratory droplets surrounding the use of general anesthesia, an institutional algorithm was written to wait 20 minutes until other OR staff members and the surgeon can enter the OR was based on CDC guidelines, which recommends allowing an air exchange to remove 99% of airborne particles before opening of the OR doors after intubation or extubation since aerosolized droplets of the virus have been detected up to 3 hours later.20,21 However, all of our cases are performed under MAC and we have implemented low-flow oxygen and suction under the drape to again limit airway aerosolization.3

Cleaning of inanimate surface is of the utmost importance, given COVID-19 has been reported to persist on surfaces for up to 72 hours, including stainless steel and plastic.20,22 In accordance with surface disinfection studies with MERS, SARS, and other human coronaviruses, we use disinfectants for terminal cleaning of the ASC using a top-down approach for a minimum of 15 minutes using agents comprising quaternary ammonium chloride and alcohol.21,23

Finally, we have implemented multiple policies to practice social distancing within all areas of the ASC. Our center, which can accommodate up to 16 cataract surgical procedures per 8-hour day, decreased surgical case numbers to allow for patient distancing by time and allow for existing patient stretchers to be separated by 6 ft, given a combined preoperative holding and postoperative recovery area. The opening of a new break room and removal of all but 3 chairs from the waiting room force staff and visitors to avoid close proximity.11 While it is difficult to maintain 6 ft of distance at all times, all staff members were reminded daily on the importance of social distancing by the safety officer and in real time if staff members were in close proximity.

While these protocol changes have been implemented to prevent the transmission of COVID-19, they also address patient concerns about returning for medical care.24 Safety has been continuously cited by patients at our ASC as the primary concern in returning for medical care during COVID-19. Details of the safeguards implemented in the new protocols were discussed with patients prior to surgery during phone calls to review preoperative instructions. Allaying patient safety concerns needs to be included in all protocols for resumption of elective surgical procedures. Patient hesitation to return for medical care precludes the restart of procedures and needs to be balanced with the effect of untreated ocular disease on their quality of life.24

There are several limitations to this report. Studies are needed to assess the best disinfection techniques, anesthesia practices, and screening algorithms specific to COVID-19 to inform evidence-based guidelines. Many of our current practices are based on literature published during outbreaks of other coronaviruses. Even with this knowledge gap, we still need to provide safe and reliable patient care now. The procedures and workflows described in this article implemented to reinstitute ophthalmic surgical care and limit transmission may be generalizable to other ASCs. Moving forward, ASC protocols will need to evolve as our understanding of the COVID-19 virus increases.

REFERENCES

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Keywords:

ambulatory surgical center; COVID-19; ophthalmic surgery

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