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COVID-19 Surgical / Procedural Case Restart Playbook

AMITA HEALTH

Updated 10/26/20

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Table of Contents

GOAL OF ACTION PLAN ............................................................................................................................. 3 A. STANDARD OPERATING PROCEDURE ................................................................................................. 3

Scope: .................................................................................................................................................. 3 B. CONSIDERATION FOR RE-OPENING SURGICAL CASES ..................................................................... 3

General Considerations: ........................................................................................................................ 3 Personnel Guidelines: ........................................................................................................................... 3 II. Waiting Rooms and Pre-operative Areas: ........................................................................................ 4

C. SCHEDULING OF CASES: PATIENT SELECTION, SCREENING, AND TESTING................................... 5 Patient Selection: .................................................................................................................................. 5 Patient Screening and Testing: .............................................................................................................. 5 II. Patient Testing: .............................................................................................................................. 6

D. ASSOCIATE SCREENING: ...................................................................................................................... 8 E. PRE-ADMISSION CLEARANCE PROCESS:............................................................................................ 8

Pre-Anesthesia Clearance: .................................................................................................................... 8 F. PRE / INTRA / POST PROCEDURE PROCESS ....................................................................................... 9

Pre- Procedure:..................................................................................................................................... 9 Intraoperative: ..................................................................................................................................... 10 Post-Operative / Post Procedure: ........................................................................................................ 10

G. APPENDIX: ............................................................................................................................................ 12

1. IDPH Surgery Recovery Protocols Dated 5/5/2020 ............................................................................ 12 2. Emergent / Urgent Surgery and PPE guidelines................................................................................ 13 3. Medically Necessary Time Sensitive (MeNTS) Triage Tools.............................................................. 14 4. Examples of High Risk Procedures .................................................................................................. 16

5. AMITA Health Tiered PPE Guideline ................................................................................................ 17 6. PPE Conservation Guidelines .......................................................................................................... 18 7. How to Perform Particulate Respirator Seal Check ........................................................................... 19

8. Pain Management Procedural Considerations .................................................................................. 20 9. COVID-19 Patient Screening Checklist............................................................................................. 23 10. Vendor Symptom Monitoring Tool ............................................................................................. 25 VENDOR SYMPTOM MONITORING TOOL........................................................................................ 25 11. References ............................................................................................................................... 26

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GOAL OF ACTION PLAN To provide comprehensive, compassionate care of patients seeking elective surgical procedures with AMITA Health that minimizes the risk of transmission of COVID-19 to patients, families and associates and provides for the best surgical outcome. This framework for reemergence will be disseminated to each facility to locally administer the plan given the resources and supplies available throughout AMITA Health.

A. STANDARD OPERATING PROCEDURE

This is the standard operating procedure of the AMITA Health Surgical Service Line to include, Pain, and AMITA owned Ambulatory Surgery Centers (ASC), These guidelines serve to prevent/address the potential spread of the COVID-19 virus and allows for the restart of elective surgical/procedural cases dependent upon each facility’s ability to maintain staffing, PPE, pharmaceutical and lab testing requirements.

Scope:

This playbook is intended to apply to all surgical / procedural services conducted in the OR; Pain and ASC procedures within AMITA Health locations. This supplements all other COVID-19-related procedures of AMITA Health and provides further instruction related to the care of the surgical/procedural patient population. A separate cardiology and endoscopy playbook are available on the AMITA COVID- 19 website.

This document, prepared by a multidisciplinary team of experts across AMITA, offers a model for consideration that will be expanded and revised over time.

B. CONSIDERATION FOR RE-OPENING SURGICAL CASES

General Considerations:

• Continued decline in COVID-19 cases in a market for 2 consecutive weeks (not currently mandated by IDPH).

• Adequacy of PPE • Adequacy of Equipment • Adequacy of pharmacy and anesthesia supplies • Staff Considerations • Testing considerations • Facility and patient traffic planning: the guidelines may require immediate alteration and shut

down of scheduled essential cases if a surge develops. • In the event the inpatient census is at a level where we need to surge into the overflow

locations, only emergent/urgent procedures will be done.

Personnel Guidelines:

I. Clinical areas should be restricted to essential personnel only:

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• No scheduled meetings or visits with outside vendors/representatives should take place other than clinical support of cases.

• Vendors will be limited and those involved in clinical care will undergo enhanced screening to

include the following: Temperature upon arrival and assessment for symptoms of COVID. Do you have a new or changing cough, shortness of breath, fever >99.5, chills, repeated shaking with chills, muscle pain, headache, sore throat, new loss of taste and smell, increase in shortness of breath, change in cough, known exposure to a COVID-positive patient? Vendors are expected to follow PPE protocols as outlined.

• Medical students, nursing students, or any other individuals in undergraduate training should

not be present in clinical areas. Students will be allowed back in clinical areas once the State of Illinois quarantine restrictions have been lifted. Resident physicians, physician assistants, and surgical assistants that may not be AMITA associates should be approved by the lead surgeon.

• Universal masking will remain in place for all physicians, associates, patients and visitors in

all areas of the facility until otherwise directed.

• Visitation will be aligned with the facility policy. Any exceptions will be at the physician discretion on a case by case basis.

• Surgeons, associates, vendors, or visitors with any sort of illness, cold, upper respiratory

infection, etc. should not be present under any circumstance, even if wearing a mask or protective gear.

• All surgeons and associates should be self-monitoring daily for: fever, chills, repeated shaking

with chills, muscle pain, headache, sore throat, and new loss of taste and smell, any new or changing cough or shortness of breath and should utilize the associate COVID-19 link at http://ascn.io/AscensionScreen

• Recommend a single entrance to be utilized for all surgical procedure personnel.

• Procedural team members are highly encouraged to remain in their department for the entire

shift to decrease exposure.

• Dedicated EVS associates will be assigned for all preoperative, intraoperative and postoperative areas.

II. Waiting Rooms and Pre-operative Areas:

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• Arrange waiting rooms to create optimal distance greater than or equal to 6 feet of distance between chairs.

• Remove all materials such as magazines, puzzles, etc. from waiting areas.

• Frequent cleaning / disinfection of the waiting areas every two hours is recommended.

C. SCHEDULING OF CASES: PATIENT SELECTION, SCREENING, AND TESTING

Patient Selection:

• Hospitals should establish a multidisciplinary triage committee to oversee the appropriateness and scheduling of surgical procedures as market conditions and strategy dictate.

• A Surgical / Procedural Care Review Committee (S/PRC or Surgical Governance Committee)

to include proceduralists, anesthesiology, nursing, pharmacy, and The Resource Group (TRG) shall provide transparent, responsive oversight of the prioritization and selection of cases. Broad representation of surgical specialties and service lines is recommended.

• Additionally, as market conditions evolve and resources allow, this committee should also

guide the decision to expand services to more elective cases.

• Hours of operation, number of rooms running, block utilization / scheduling, and extended procedures on the weekends will be determined by the committee in concert with administration and Surgery / Procedural leadership.

• Decisions for selection of cases should take into consideration ease with discharge

disposition and the recognition that SNF, Rehab, and Post-Acute bed availability may be limited. Plan for home health and home Physical Therapy as needed.

• The local review committee may use a variety of available tools in their case selection process

(see Appendix).

Patient Screening and Testing:

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I. Patient Screening:

• Universal masking will continue and all patients, visitors must wear a mask into the

facility and if they do not have one will be given one upon arrival.

• All patients arriving for preadmission testing or for an elective procedure should be screened for COVID-19. This screening should include the following questions:

o Do you have a new or changing cough, shortness of breath, fever >99.5, chills repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste and smell, increase in shortness of breath, change in cough, known exposure to a COVID-positive patient?

o Upon arrival, patients should also have their temperature directly assessed (preferably using non-invasive means). If the temperature is greater than 99.5 further investigation is warranted, and the procedure may be cancelled.

• If patient screens positive for COVID-19, recommend the following:

o Cancel case. o Refer to PCP for possible further testing and evaluation (including possible

COVID-19 testing). o If unstable, send to ED.

II. Patient Testing:

• Universal Guidance for all patients regardless of vaccination status: o Patients with recent COVID-19 infection should have procedures postponed

until > 10 days after a positive test and until they are asymptomatic. o Patients are considered fully vaccinated two weeks after they have received

the second dose of the Pfizer or Moderna vaccine or two weeks after receiving the Johnson & Johnson vaccine.

o Patients in the process of being vaccinated should be scheduled for their procedure two weeks after they have received the second dose of Pfizer or Moderna or two weeks after receiving the Johnson & Johnson vaccine.

o Patients who have not received any vaccine should be offered an appointment for vaccination and scheduled two weeks after they have received the second dose of Pfizer or Moderna or two weeks after receiving the Johnson & Johnson vaccine.

o Proof of vaccination must be provided in the form of a vaccine card or primary source verif ication in iCARE during the preadmission testing (PAT) process and documented in the electronic medical record.

o At the point of care, if no proof of vaccination is provided and no preoperative COVID-19 PCR testing result is available, the patient should be tested with rapid molecular testing as performed for emergent procedures and appropriate action should be taken based on the result.

o Appropriate personal protective equipment (PPE) is required for all

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procedures regardless of patient vaccination status.

• Pre-procedure testing is required for all patients who are not fully vaccinated prior to the planned procedure.

o Testing must be completed within 72 hours of a scheduled procedure using a test authorized for emergency use by the U.S. Food and Drug Administration (FDA) for the detection of SARS-CoV-2 (PCR/RT-PCR/NAAT).

• Pre-procedure COVID PCR testing is required for all patients under the following

special circumstances, regardless of vaccination status, given the duration of protection from vaccination, and the efficacy against emerging variants is unclear.

o High-risk procedures. Any procedure that involves the upper and lower respiratory tract, the upper and lower GI tract and any procedure that requires or may require any anesthesia administered by mask or intubation. This includes any case with general anesthesia.

o Patients with serious B-cell immunodeficiency (e.g., acute lymphocytic leukemia, lymphoma, rituximab treatment), even if fully vaccinated.

o Patients with symptoms consistent with COVID-19 infection, regardless of vaccination status or prior COVID-19 infection.

• Universal pre-procedure testing is recommended for all patients, regardless of

vaccination status and procedure type o Circumstances that testing is NOT required:

• Asymptomatic patients who previously tested positive for SARS-CoV-2 and are within 90 days of symptom onset or positive test for COVID-19 do not need to be retested.

• Low or moderate risk procedures. Although COVID PCR testing is still the gold standard, due to the decreasing prevalence of COVID-19 in the community, fully vaccinated patients who are having a procedure not classified as high risk, under only local or regional anesthesia, are not required to have pre-procedure COVID testing

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D. ASSOCIATE SCREENING:

• Surgeons, anesthesiologists, and associates will follow the Associate Health screening guidelines.

E. PRE-ADMISSION CLEARANCE PROCESS:

Pre-Anesthesia Clearance:

• Usual PAT questions per routine hospital process.

• Ask Covid-19 Screening questions. The questions are as follows:

o Do you have a new or changing cough, shortness of breath, fever >99.5, new loss of taste and smell increase in shortness of breath, change in cough, or known exposure to a COVID-positive patient?

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• Consider tele-medicine clearance visits with PCP, PAT Clinic, or any other specialty.

• Instruct patient to wear a mask or face covering to the hospital. If they do not have one, provide a mask at the hospital entrance.

• Instruct patient to schedule a COVID-19 PCR test to be completed within 72 hours of surgery. Provide testing center contact information. Instruct the patient to wear a mask to their PCR test and follow rigorous hand hygiene prior to and after their testing and reminder of self- isolation post testing.

• For patients undergoing procedures requiring screening only: Instruct patient it is important to minimize contact with anyone except immediate family for f ive days prior to their procedure. They should remain in self-isolation at home interacting only with immediate family until the day of procedure (provided immediate family are not exhibiting signs and symptoms of COVID-related illness).

• Instruct patient they will need a chaperone if receiving anesthesia. Visitors are encouraged to

wait in the car, will be called post procedure and at the time patient is discharged and ready for pick up.

F. PRE / INTRA / POST PROCEDURE PROCESS Pre- Procedure:

• Enforce social distancing prior to procedure.

• Promote use of ERAS protocol.

• Confirm patient met pre-procedural testing guidance and ensure appropriate PPE available and in use.

• Prior to procedure, patient to provide name and phone number of chaperone for post procedure communication. Visitation to follow individual facility protocol.

• One N-95 mask per day will be issued to all OR team involved in aerosol generating procedures

(AGP) as per the Tiered PPE guidelines or if the patient is tested as COVID-19 positive (). The OR team should cover their N95 with a surgical mask and face shield. The face mask is disposed of at the end of procedure and the N95 can be reused for the next case. If the seal check on the mask isn’t working or the mask becomes soiled, a new mask will be needed. Please refer to PPE and seal check guidelines in the Appendix.

• If this is a non-aerosolizing procedure and patient met pre-procedural testing guidance, then

proceed with usual surgical attire. Face shields are encouraged.

• H&P: History to be completed within 30 days in advance of procedure via telehealth visit or in person. H&P should be updated or verif ied within 24 hours of procedure.

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• Consider how the OR teams are assigned daily to limit associates moving between minor and high-risk procedures given the different testing requirements.

• Limit associates in the procedural rooms during intubation portion of anesthesia procedure

• If a COVID positive patient, post signs on operating/procedural room door AND:

o Use of an anteroom for intubation is optimal if available o Partner with facilities in advance to ensure appropriate measurement and differentials. o If available, have facilities deliver portable hepa filter to the procedure room OR consider

designating a COVID positive procedure room keeping a portable hepa filter in the room. (See AMITA Health play book for operating room guidelines for Persons Under Investigation or Confirmed COVID -19 positive).

• Consent discussion with patients must cover the risk of COVID-19 exposure and the potential

consequences should be documented in the medical record.

Intraoperative:

• Traffic within the OR/Procedure room should be limited.

• If cautery utilized during any procedures, use of suction cautery or house suction to eliminate plume strongly recommended.

• Laparoscopy (per https://www.sages.org/recommendations-surgical-response-covid-19/):

o Incisions for ports should be as small as possible to allow for the passage of ports but not allow for leakage around ports.

o CO2 insufflation pressure should be kept to a minimum and an ultra-filtration (smoke evacuation system or filtration) should be used, if available.

o All pneumoperitoneum should be safely evacuated via a filtration system before closure, trocar removal, specimen extraction or conversion to open

• For COVID negative patients, room turnaround will follow normal post procedure protocols.

• For COVID positive patients, room may need to be vacant for 30 minutes after patient is

transported out of the room before cleaning begins to ensure adequate air exchange to clear the room.

• Touchpoint has defined peracetic acid cleaning / disinfection protocol to be utilized at each site.

If UV light is available, use of this to supplement cleaning protocol is recommended.

Post-Operative / Post Procedure:

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• Patient extubating post procedure (if appropriate) should occur in the OR prior to transfer to post procedure area.

• Results to be provided post-procedure to the chaperone via phone call by physician, or in

person in post op area with physician removing N95 and placing surgical mask used for rounding. Chaperone must have been screened and masked if entry into the facility.

• Consider use of AMITA physical therapy at home to avoid institutional discharge.

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G. APPENDIX:

1. IDPH Surgery Recovery Protocols Dated 5/5/2020

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2. Emergent / Urgent Surgery and PPE guidelines

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3. Medically Necessary Time Sensitive (MeNTS) Triage Tools

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4. Examples of High-Risk Procedures

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5. AMITA Health Tiered PPE Guideline

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6. PPE Conservation Guidelines

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7. How to Perform Particulate Respirator Seal Check

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8. Pain Management Procedural Considerations

Pain Management Procedural Considerations

Procedure / Service Prioritization: Procedures for Phase 1 (local, conscious sedation):

o Lower risk / less invasive local cases* in low risk patient population (younger, no comorbidities)

o Lower risk / less invasive local cases* in elderly population with no comorbidities with significant need for procedure

*May be done under conscious sedation if indicated based on provider judgment.

• Trigger point injections, occipital/supraorbital nerve blocks • Epidural steroid injections (interlaminar, transforaminal) • Intercostal blocks • Facet medial branch blocks/radiofrequency lesioning • Stellate ganglion blocks (only if emergent) • Sympathetic plexus blocks • Obturator nerve block/radiofrequency lesioning • Genicular nerve block/radiofrequency lesioning • Peripheral joint injections • Kyphoplasty • Intrathecal pump (trial implant) (only if emergent, cancer pain with end of life < 3 months)

Procedures for Phase 2 (local, conscious sedation, MAC):

• SCS (trial, implant) • Intrathecal pump (trial, implant) • Interspinous spacer placement, MILD

Phase 3:

• Normal operations

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Testing / Screening Guidelines:

• Follow testing guidelines summarized in the “Patient Testing” section of the playbook • Recommend enhanced screening process in advance of all procedures and services:

o Pre-Screening: Conducted 24-48 hours in advance via phone by Pain Center staff and will include standard list of screening questions

o Day of Procedure / Facility Entry: Conducted upon entry to site and includes screening questions and temperature.

o Day of Procedure / Department: Conducted upon entry to department and includes screening questions, temperature, pulse ox, and listening to lung listening.

• Universal masking guidelines to be followed for all patients.

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Pain Management Procedural Considerations (continued)

PPE Guidelines:

• Tier 1 PPE to be used for non-PUI cases for Phase 1 procedures / services. • Tier 2 PPE to be considered for Phase 2 cases or any cases where patient is supine. • Conserve and reuse N95s per health system guidance. • Staff assisting in procedure / service or in direct contact with patient pre or post to follow the

same PPE guidelines as providers. • All staff and provides should wear protective eye wear such as google or a face shield • Minimize staff in the room to support PPE conservation.

Staffing / Site Operations:

• Plan to space out procedures. Consider incorporating telehealth pain clinic visits

between procedures to maximize efficiency. • Space pre-operative chairs 6 feet apart • No visitors. Call family member when the patient is recovered.

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9. COVID-19 Patient Screening Checklist COVID-19 PATIENT SCREENING CHECKLIST

Patient Name: Procedure Dept. & Date: Name of Screener: _ Covid-19 Testing Date and Time:

Family contact for discharge: Clinical

Features Initial Screening Date:

Pre-op Call Date:

Procedure Date:

Yes

No Yes No Yes No

Fever (≥99.5) ☐ ☐ ☐ ☐ Temp: Sore throat ☐ ☐ ☐ ☐ ☐ ☐ Cough ☐ ☐ ☐ ☐ ☐ ☐ New shortness of breath ☐ ☐ ☐ ☐ ☐ ☐ Muscle pain ☐ ☐ ☐ ☐ ☐ ☐ Headache ☐ ☐ ☐ ☐ ☐ ☐ Chills ☐ ☐ ☐ ☐ ☐ ☐ Loss of taste and smell ☐ ☐ ☐ ☐ ☐ ☐ If patient answers YES to any clinical features, notify provider immediately. Case will be deferred until patient is medically cleared for coronavirus.

Epidemiologic Risk

1. Have you had a close contact with a person who has a confirmed or suspected case of COVID 19 disease?

2. Have you had close contact with a person while they were ill and a healthcare provider is working to determine if they have COVID-19?

If YES to 1 or 2, please notify provider. Patient will need to be asymptomatic for >14 days from time of exposure (with daily temperature checks < 99.5 F) or provider will need to order COVID-19 test to be performed 48 hours prior to procedure being performed.

☐ ☐ ☐ ☐

☐ ☐ ☐ ☐ ☐ ☐

3. Do you reside in a long-term health facility (Nursing home, skilled nursing facility)?

If YES, tier 2 PPE should be utilized by staff and specialist

☐ ☐

4. Do you practice Social Distancing (6 ft of distance in the public areas) if you need to make essential trips? (grocery store or pharmacy)?

If NO, please notify provider. Patient will need to practice social distancing > 10 days (with twice per day temperature checks, report to ordering physician if temp > 99.5 F) and self-isolation > 5 days before procedure date.

☐ ☐ ☐ ☐

Patient Education

Remind patient they will receive a call with COVID 19 results

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Self-isolate for 5 days prior to day of procedure or from the time of COVID 19 test and take temp twice /day, if feasible, and report to ordering physician if temp is >99.5

Practice Social Distancing of 6 feet or greater when leaving the home for essential reasons

Wear a face mask when leaving the home for any reason Must wear a face mask upon entry to hospital or one will be provided upon entry

Hand hygiene education Visitors Restriction/transportation needs addressed prior to arrival for procedure (write contact info at the top of this form)

My signature indicates acknowledgement that I have abided to all Patient Education/Instructions.

Name: Date: _

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10. Vendor Symptom Monitoring Tool

VENDOR SYMPTOM MONITORING TOOL

Please complete and turn in to the Department Manager on each visit

Vendor Name: Date:

Cell#: Company:

Department you will visit:

Yes No Comments

Check -in Temp: F

• If above 99.5, may not enter the facility.

Please answer if you currently have or had any of the following symptoms in the past 10 days. If your answer is “YES” to any questions, please do not enter the facility until symptoms resolve. New or worsening cough

Shortness of breath

New loss of taste or smell

Sore throat

Muscle pain

Fever above 99.5 in the last three days

Signature:

If you have no symptoms, please proceed to the appropriate department and provide this document to the department manager.

Thank you for your cooperation.

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11. References 1. Centers for Medicare & Medicaid Services (CMS), Opening Up America Again:

Recommendations – Re- opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I, March 19, 2020, https://www.cms.gov/files/document/covid-flexibility-reopen-essential-non-covid-services.pdf.

2. American College of Surgeons, COVID-19: Elective Case Triage Guidelines for Surgical Care, March 24, 2020, https://www.facs.org/covid-19/clinical-guidance/elective-case.

3. American College of Surgeons, COVID-19: Guidance for Triage of Non-Emergent Surgical Procedures, March 17, 2020, http://www.facs.org/covid-19/clinical-guidance/triage.

4. Prachand, V.N., Milner, R., Angelos, P., Posner, M.C., Fung, J.J., Agrawal, N., Jeevanandam, V., & Matthews, J.B. (2020). Medically-Necessary, Time-Sensitive Procedures: A Scoring System to Ethically and Efficiently Manage Resource Scarcity and Provider Risk During the COVID-19 Pandemic. Journal of the American College of Surgeons, S1072-7515(20)30317-3. Advance online publication. https://doi.org/10.1016/j.jamcollsurg.2020.04.011.

5. Forrester JD, Nassar AK, Maggio PM, Hawn MT. Precautions for Operating Room Team Members During the COVID-19 Pandemic. JACS Preprint April 1, 2020. https://doi.org/10.1016/j.jamcollsurg.2020.03.030.

6. Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings. CDC April 9, 2020. https://cdc.gov/coronavirus/2019-ncov/hcp/infection-control- recommendations.html?CDC_AA_refVAL=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019- ncov%2Finfection-control%2Fcontrol-recommendations.html.

7. AMITA Health Guidelines for PPE, April 7, 2020. https://www.amitahealth.org/assets/documents/covid- 19-playbook/ppe-usage-guidelines-4.8.2020-v2.pdf.

8. COVID-19: Considerations for Optimum Surgeon Protection Before, During, and After Operation. American College of Surgeons April 1, 2020. https://www.facs.org/covid-19/clinical-guidance/surgeon- protection.

9. SAGES and EAES Recommendations Regarding Surgical Response to COVID-19 Crisis. Society of American Gastrointestinal and Endoscopic Surgeons. March 30, 2020. https://www.sages.org/recommendations-surgical-response-covid-19/.

10. COVID-19 Elective Surgeries and Procedures Frequently Asked Questions. Illinois Department of Public Health. May 5, 2020. http://www.dph.illinois.gov/covid19/community-guidance/elective-surgeries-and- procedures-faqs.