As the global COVID-19 pandemic continues to force all of us to find safe paths forward, GCMI continues to remain operational across all service lines including design & development, preclinical services and life cycle advisory. Several states including Georgia are opening businesses and adjusting to life in the COVID-19 era. GCMI remains focused on the health and well-being of our customers as well as our employees. 

 

In that spirit, we are sharing updated guidelines for our customers planning to visit our facilities.

 

Effective 5/12/20, all customers visiting our facility will be required to take this questionnaire prior to visiting GCMI’s facilities. You can scan the QR code to the right to access this visitor screening questionnaire as well. Additionally, we will be utilizing the below guidelines.

 

COVID-19: Considerations for Optimum Employee, Sponsor and Visitor Protection Before, During, and After

 

Sponsor and Visitor Safety and Sickness Communication

GCMI personnel or resident sponsors/incubator clients who are anticipating a visitor or sponsor(s) are responsible for sending these guidelines to the visitor at least 72 hours prior to the visit.

  • All visitors and sponsors will be asked to notify the appropriate GCMI contact of their intent to visit, at least 48 hours prior. 

  • In total, there may be no more than twenty three (23) visitors in the building at one time, based on conference room availability. 

  • Sponsor groups attending a preclinical testing study may not bring any more than five (5) individuals onsite at a time. Additionally, limitations on number of individuals in the OR will apply according to the Operating Room section below. 

  • Sponsor groups attending a preclinical training study may not bring any more than ten (10) individuals onsite at a time. Additionally, limitations on number of individuals in the OR will apply according to the Operating Room section below.

Note: The number of visitors for testing or training may be adjusted according to the maximum visitor capacity as needed.

  • Visitors will be required to take a brief questionnaire regarding their health and for purposes of source and PPE tracking, using a private website where possible at least 24 hours before the visit or entry may not be permitted. The questionnaire will be sent by the appropriate GCMI contact expecting the visitor/sponsor. Signs will be posted on the front door regarding the questionnaire, and a laptop will be made available at the front desk for visitors who have not filled out the questionnaire.


Entry will be evaluated on a case by case basis, and entry MAY be denied. Entry will NOT be permitted to a visitor who was in close contact with someone exposed to or diagnosed to COVID-19 and were NOT self monitoring or wearing PPE.


Entry will be denied to any visitors exhibiting symptoms related to COVID-19: cough, shortness of breath, difficulty breathing, or at least two of the following-fever, chills, repeated shaking with chills, muscle pain, headache, sore throat, new loss of taste or smell.

  • Visitors/sponsors who become ill or develop symptoms related to COVID-19 i.e. symptoms (cough, shortness of breath, difficulty breathing, or at least two of the following (fever, chills, repeated shaking with chills, muscle pain, headache, sore throat, new loss of taste or smell) while at GCMI or in Atlanta, should contact their GCMI program manager. The individual will be asked to leave immediately, or stay at their hotels. If the individuals are too ill to leave on their own, emergency services may be called for assistance. 

  • Upon entry into the facility, Visitors/sponsors will be directed to a hand wash station. Visitors MUST wash their hands prior to leaving the lobby to enter conference rooms, or the operating room. 

  • Visitors are encouraged to bring their own face masks, but will be provided one if they do not have one.

  • During their visit, sponsors must adhere the PPE and Operating room procedures outlined below.
  • GCMI will reserve the right to remove any visitors/sponsors that refuse to follow these guidelines.

 

Use of Personal Protective Equipment, Hand Hygiene and Engineering Controls

The below PPE guidelines have been created keeping in mind ongoing PPE shortages, current GCMI PPE inventory and conservation of disposable PPE for operating room and vivarium use

  • All visitors, sponsors and employees must wash their hands with soap and water upon entering the facility, and after removing any PPE.

  • All employees, sponsors, and visitors, regardless of job responsibilities must use a cloth or disposable mask and other area-appropriate PPE while in the building where a 6ft distancing cannot be maintained. 

  • Employees on the administrative side of the building may be provided with a cloth or disposable mask, which they may carry home, or place in a paper bag to be used as long as the integrity of the mask is not compromised. 
  • In the operating room and vivarium, scrubs and disposable surgical masks must be worn whenever it is a requirement of the job functions. 

  • Personnel who require a surgical mask in the vivarium should wear a disposable mask, which is then stored in a labeled paper bag, and re-used for up to a week, as long as the integrity of the mask is not compromised (and disposed sooner if soiled, wet, ripped, etc.). Alternatively, a cloth mask may also be worn in the vivarium; however, in this case, they should not leave the building, and will be laundered at GCMI according to the laundry guidelines. 

  • In the operating room or vivarium where social distancing may not be possible due to job performance, personnel should also wear a face shield in addition to a mask. 

  • A Plexiglass shield will be placed around the front desk, along with other engineering controls such as contactless door openers etc. 

  • Social distancing will be encouraged throughout the facility by removing sitting arrangements that allow or encourage sitting closer than 6 feet apart. 

  • Only necessary equipment and supplies should be allowed in the surgical suite. Consider factors such as function, ability to decontaminate, dispose, and space.

 

Operating Room Procedures

This section clarifies the procedures inside the operating room where social distancing may not be possible and the type of surgical procedures that are permitted.

  • All employees or sponsors in the operating room must wear appropriate PPE in accordance to the section above. 

  • Additionally, a six foot distance should be maintained where possible. If it cannot be maintained, additional face shields must be worn.
  • The number of individuals (including GCMI employees) with appropriate PPE, in the OR should not exceed: 

  • 5 in the cathlab, 

  • 8 in other operating rooms, 

  • 4 in necropsy and MicroCT room. 

  • Sponsors will be encouraged to take turns in the operating room where possible, and watch remotely. GCMI is working on upgrading its AV system, and every effort will be made to have the procedure available for viewing in the conference rooms. 

  • Surgeons and personnel not needed for intubation and inductions should remain outside the operating room until anesthesia induction and intubation are completed. 

  • Electrocautery should be minimized when possible and a smoke evacuator must be used when electrocautery is used on a cadaveric specimen. 

  • No respiratory tract procedures will be performed for cadaveric specimens. 

  • No laparoscopic procedures will be performed for cadaveric specimens. 

  • All non-disposable surgical instruments shall be processed post-surgery.

 

Facility Cleaning and Laundry Procedures

The 2020 facility cleaning plan will remain in effect, however in light of the COVID-19 pandemic, the additional steps will be implemented for safety and sanitation. These guidelines will be in effect during the period of the COVID-19 pandemic, may be adjusted as necessary, and will be reduced when safe to do so. Additionally, laundry procedures will follow the laundry guidelines.