Appendix-A_MeetingMinutes.pdf

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Meeting Minutes

Project: FDA Cincinnati FCC Building Modernization Project

Subject: Bi-weekly teleconference

Date: Tuesday, April 14, 2020

Location: Tele-conference

Prepared by: Sarunas Rumsa, HDR

Attendees: GSA

Steve Carbery

Nathan Ingersoll

Anthony Walton

Demian Go

Bob Collins

Harana Griggs

Jennifer Hammell

David Zeeb

FDA

Raymond Byrd

Mehryar Ebrahimi

Bryan Gamble

Doug Heitkemper

NKB

Glenn Woodbury

HDR

Sarunas Rumsa

Warren Hendrickson

JJ Tang

Clare Swanson

William Zavatkay

Mark O’Grady

Dale Peterson

Mark Meaders

Meeting Objective:

Bi-weekly status teleconference

Discussion Points:

The following were discussed:

1. HDR presented the Status of the project and schedule:

a. The project is in week 4 of the design schedule as presented at the kick-off meeting.

The initial Pre-Design Phase (Information Gathering) is complete and the project is starting the 7 week long Concept Design Phase. Lab user group meetings will begin on

April 16 and continue for 7 consecutive Thursdays.

b. The project schedule has shifted about one week to accommodate restructuring the design effort with the users to a virtual platform in response to Covid 19 travel restrictions. Some of the internal activities to at the end of the design process have hdrinc.com 30 W. Monroe StreetSuite 700Chicago, IL 60603-2425 been realigned to the middle of the schedule so that the project is anticipated that would conclude at a similar time as the original schedule indicated in the beginning of

June.

c. Laboratory User Group meetings will be scheduled for Laboratory User Group meetings will be scheduled for the next 7 Thursdays, beginning April 16. Proposed time is from 1:00pm – 3:00pm EST. HDR will provide a schedule of meetings and general outline and agenda for topics to be addressed at each meeting, based on the following schedule:

• April 16 Finalize any information gathering

• April 23 Benchmarking tour (virtual)

• April 30 Initial Presentation of Options

• May 7 Open meeting Agenda

• May 14 Peer Review

• May 21 Open meeting Agenda, select finalize option(s)

• May 28 Final Option(s)

d. Additional meetings will be scheduled for: CATEX discussion, LEED discussion, Engineering issues, Security, as well as for any other issues, as required.

2. The HDR team is in progress of completing the GSA security clearance process.

3. GSA introduced NKB as the peer review firm. NKB was represented by Glenn Woodbury.

4. The following are issues related to Covid 19 impact to the project schedule and design process.

a. There are no on-site meetings or field investigations planned within the FCC building, in response to Covid 19 protocols and travel restrictions.

b. For the safety of the FCC staff and facility, FDA would prefer not to have any outside consultants inside the FCC, at this time. Investigations and photography of exterior and adjacent site would be permitted with proper advanced notice to the lab.

c. HDR believes that based on two separate previous tours of the FCC facility and the

POR (prepared by Exp.), no additional field investigations, or in-house meetings will be required for the initial scope of work through concept/schematic design.

d. If field investigations become necessary during the period of travel restrictions, HDR has established relationships with local engineering firms from work on previous

Cincinnati based projects and could solicit their services. The scope of any additional, Cincinnati based, consulting engineering serviced is not currently in the contracted scope of work.

5. It is recognized that some of the sustainability and net-zero requirements, as defined in the GSA P-100 document will not be achievable since the project is only a partial renovation of the building. GSA provide blank waiver forms and deviations will be proactively identified throughout the concepts phase.

6. FDA stated that entropy wheels should not be considered viable options for sustainability.

7. RO/DI requirements and specifications should be as identified in the DRM.

8. GSA peer review – advanced notice of up to 3 -4 weeks will be required for the Peer

Review. The peer review is currently scheduled for May 14.

9. GSA prepared a modification to the contract to include design work for the Peck building.

The Peck modification was issued on April 14, 2020. HDR is developing pricing for the design services.

10. GSA meeting space will be the video conference platform for future virtual FCC project meetings.

11. HDR will provide schedule and outline agenda of topics for the duration of the Lab User

Group meetings. Any required break outs for any other disciplines or additional meetings can occur during the Thursday 1-3 time slot, or schedule an additional meeting.

12. Construction schedule – FDA stated that minimal closures of the labs during construction/renovation are preferred and that long closures are unacceptable. It was recognized that shorter closures would result in higher construction costs. Lowest construction costs would be realized if the labs could be shut down (or relocated) for the duration of the construction.

13. The next bi-weekly FCC meeting is scheduled for April 28, 2020 at 12:30/1:30pm CST/EST.

30 W. Monroe Street, Suite 700, Chicago, IL US 60603-2425

Subject: Lab Planning Breakout Meetings 1-4

Date: Meeting #1 – April 16, 2020, Meeting #2 – April 17, 2020, Meeting #3 – April 20, 2020

Meeting #4 – April 21, 2020

Location: Virtual Tele-conference

Prepared by: Sarunas Rumsa & Clare Swanson

Attendees: GSA

Stephen Carbery

Nathan Ingersoll

Demian Go

Cheryl Flurer

Kirk Gaston

Mike Smithisler

Doug Albright

FDA cont’d

Mehryar Ebrahimi

Bryan Gamble

Doug Heitkemper

Mark Witkoski

Sara Kern

Jonathon Litzau

Dave Crockett

Catherine Dasenbrock

Robert Wilson

Robert Byrd

Brian Kirk

Clare Swanson

Randy Prescott

Topic Facilitator Start End

1 Meeting #1 – Lab Planning Breakout

Separation Labs

Sarunas Rumsa, Clare Swanson, Randy Prescott

Time Time

2 Meeting #2 – Lab Planning Breakout

Trace, Biology/Micro Molecular

Biology, Elemental Analysis

Sarunas Rumsa, Clare Swanson, Randy Prescott

Time Time

3 Meeting #3 – Lab Planning Breakout

Administration, Dock & Storage Area, Glasswash Space

Sarunas Rumsa, Clare Swanson, Time Time

4 Meeting #4 – Lab Planning Breakout

Photo Documentation Lab, Analytical

Sample Prep, Standards Prep Lab, Mass Spec Group

Sarunas Rumsa, Clare Swanson, 1:00 EDT 2:00 EDT

Meeting #1 - Lab Planning Breakout

Meeting Notes

Introduction by Sarunas Rumsa

• Starting 7 week process of collecting info & meeting with users.

• Virtual meeting in lieu of face to face.

• Meetings with users every 2 weeks originally, can now meet weekly virtually.

• Today is initial kickoff.

• April 23rd Bench marking virtual tour due to travel restrictions.

• April 30th (VC2) will present options.

• May 7th open meeting.

• May 14th (VC3) Peer review

• May 28th (VC4) Final option selected.

• May 28-June 11 Production of final documents.

PROCESS

• WHAT?

o Clarification on previous documents that were prepared. How much space, how many users.

• WHY?

o Working relationships & adjacencies. Flexibility.

• HOW?

o Schedule - how long can current lab operations be shut down for remodel?

Introduction by Clare Swanson

• Current lab sections & spaces have been divided into 9 different groups for online user meetings.

• Previously provided equipment lists need to be evaluated to determine if the information is up to date. Groups will determine what needs updating.

• All RDS will be verified throughout process. Prior to next meeting, User’s to review RDS for accuracy.

• 5 W’s- What is the basic high level information for each group. How will process and flow change with additional opioid work? What are ideal adjacencies, collaboration requirements? Can groups share space/expertise/equipment? What do you want to change, what don’t you want changed.

• What is the current utilization of existing spaces? Are there bottle necks?

• Need current and future head counts for each group. Need to know where they should be located. Near labs? Admin area? Inside or outside of security?

• Will be reviewing a couple of different documents during the user meetings. Space list which compares existing requirements vs. new requirements and existing and concept floor plans

• After this round of user meetings HDR will come up with additional concepts that are different from EXP POR report.

SEPARATIONS LABS

• Discussed existing plan. Separation Labs 1, 2, 3.

• Describe function of each lab.

o Sara Kern o All 3 labs do similar testing but are separated due to size of supervisory groups, size of available space, history of lab. All impacted current lab layout.

o Labs perform multiple tests in each lab.

o Equipment includes GCMS (headspace), HPLC, LCMS o A lot of what Sara does in her group is very similar to the testing done in the other groups. Each group may be looking for different factors.

o Specimens include dietary supplements, food and drugs looking for substances that shouldn’t be there.

o Both quantitative (how much) and qualitative (what) work.

o These labs are all opioid related. It’s possible that all labs can be working with opioids. .

• Will new Separations Labs 1 & 2 be doing the same type of work?

o Yes o It is ok that the labs have been separated because there is no cross work. Each supervisory group is self-sufficient and has a variety of different tools in their space. This maintains flexibility within each Separations Lab.

• How do specimens flow through the building and the lab? How is it determined where samples will go?

o Jonathon Litzau o Most samples come in via a common carrier (UPS) to the dock at shipping & receiving. Go through security (x-ray) then it goes to the evidence suite across the hall. The evidence techs will verify the paperwork with the sample. Samples are then sent to the appropriate storage area. Samples are picked up in the Vault

Room (058). Transfer of chain of custody occurs in this area. The sample is assigned to a lead analyst and not to a particular lab. Supervisors meet weekly to assign cases to lead analysts depending on what needs to be done. Supervisor’s divide up amongst their group based on analyst’s availability and expertise. Some specimens will go to multiple labs for testing and some may only go to one section. Lead Analysts shepherd the original sample through the various labs.

o A sample can go to any lab section initially.

o Samples come to 2 evidence techs (there is an opening for a 3rd) in Supply Clerk

(057). They are responsible for sample storage, but do not determine which lab it goes to. They keep track of the shelf or location it’s stored in. They are responsible for the paperwork handling as well and uploading it to the network.

Sample are logged into the FDA system (FACS) as well as the FCC system.

Supervisors of each group are then responsible for delegating work. Supervisors meet weekly with a list of new samples or older samples that haven’t been processed yet to prioritize and assign to analysts. Supervisor meeting happens in the FCC Library (142).

o Once a lead analyst is assigned, they will go pick up the sample from evidence storage. Pick up times are arranged with the evidence techs. This process is the same for all sections.

o The lead analyst determines what testing needs to be done on each specimen o Every analyst maintains chain of custody for their assigned samples once the analyst takes the sample into their lab. Each analyst has a lockable cabinet and shared ref/freezer for sample storage within their labs. Samples are not taken back to the vault every day.

o Once the specimens have been logged in analysts work off of paperless worksheets on their laptops as well as right up their reports

• Are there any groups that you typically collaborate with? Sample sharing? Space?

Equipment?

o Dave Crockett o Some samples are only tested in the Separation Labs (approx. 70%). Other samples need to be tested by multiple sections (approx. 30%).

o Typically work with Mass Spec, Elemental and Trace equally.

o Separation labs don’t necessarily have to be located together, sometimes they do more work with other sections than each other. However, the Separation labs have a lot of the same equipment, so it does help to have them fairly close because instrumentation is interchangeable and if needed they can use instruments in other Separation labs.

o 60-70% of all the analysts work in the Separations section

• General question: What do you really like about your current lab space, how you work within your group? Things you don’t want to change. Other question is What DOESN’T work?

o Brian Gamble - some instruments have stringent vibration criteria. The vibration in the new lab areas above the existing garage will need to be considered. Some microscopes, Mass spec and NMR should not be located here o Dave Crockett - Flexibility of benches is desired. Instruments have changed over time. Power requirements also change which is tough to accommodate. Noisy vacuum pumps have a negative impact on the lab.

o Sara Kern – would like to see better ideas for cord management behind instruments o Jonathan Litzau – would like the flexibility to add or relocate knee spaces at instruments and computer workstations

• What will happen to the staff and equipment in the current Separation Lab 3?

o Equipment and staff will be redistributed to the other labs and analysts workspaces o There are currently 3 supervisors and one will be added for a total of 4 supervisory groups o New Labs 1 & 2 will be Separation Labs for a total of 4 Separation labs.

o Renovation of current Separation Lab 3 will occur after new labs are built and staff and instruments have been relocated.

o FCC will send HDR an existing headcount list as well as a future headcount list. If possible, they will identify where people are sitting today.

• If possible, identify smaller support labs and their function in the Concept plan. Labs 1-4 are noted. What are some of the adjacent support spaces?

o Lab 3 – Photo Documentation Lab o Lab 4 – Sample Prep Lab o Smaller support labs are not necessarily required but could be used storage for equipment, chillers, rough pumps, gas cylinders, etc.

• General Discussion o General Lab Storage (158) is currently used for file, lab supplies etc. The need for this type of storage will increase in the future.

o There are 3 categories of staff located in the FCC. FCC lab staff that have shared offices directly adjacent to the lab. FCC (non-lab) admin staff that should be located on the secure side of the building in the office area and non-FCC, non-lab staff that are located in the building and should be outside of the secure side of the building.

o The non-FCC, non-lab staff will change over time o The current conceptual layout does not work well with the security requirements.

There are too many doors.

Meeting #2 – Lab Planning Breakout

TRACE

• Describe function of each lab.

o Doug Albright o Trace group does a variety of different analysis for other groups (Separations, Microbiology, and Elemental). Look for evidence of tampering and counterfeit drugs o Myriad of different microscopes and instruments. Stereoscopes, digital imaging, FTIR, 3-D scopes, Raman spectroscopy (Adam Lanzarotta uses), GCIR (Adam

Lanzarotta uses), CDX (Mark Witkoski uses), polarized light o They do a lot of authenticity work with samples (counterfeit tablets) o Use infrared spec on whole tablets to scan the inside o GCIR – combination of separation and infrared techniques o Use a lot of solid state equipment – no rough pumps, no noise o Need to control ambient light for imaging o CDX – counterfeit detection device. Look at drugs and packaging. Needs room with adjustable lighting that can be completely darkened. Take low light images.

Sensitive to fluorescent lights. LED lights preferred. May need additional lighting types

Nathan- Can we reach out to manufacturer to see if they have suggestions on light levels?

o Don’t do a lot of wet chemistry.

o Need a lot of instrumentation bench space. Ideally lab benches are configurable

(mobile) and height adjustable.

o Need layout space for viewing samples. May get 50 to 60 cartons that need to be spread out and scanned. Light screening of samples. Then small quantities are sent for testing o They would like a new space for hand held portable field instruments. They ship and receive these instruments from 4-5 mail facilities as well as develop protocols and trouble shoot problems. Goal is to get the devices in this lab to calibrate and fine tune before shipping out to satellite labs.

o Stefanie o Trace photographs initial sample and documents in their lab when they are the lead. This is unique to their section. They also do additional photography techniques that may require special lighting o Samples are stored in their labs. Don’t have a lot of space to store large samples such as bags of tablets, vaping devices etc. Currently store samples in a basecabinet. Any additional storage is done in a cabinet in a different lab space.

o Need more space to layout and photograph as well as store samples.

• Will new opioid work change current requirements?

o Group will be doing same type of work but more of it.

• Do you collaborate with other groups?

o Like other groups, Trace works with all other groups. Trace is centrally located with all groups currently which is good.

• What are new space requirements?

o The new Trace Lab needs to be adjacent to the FTIR lab. Both need positive pressure to prevent contamination of samples from the environment. Potential airlock required from corridor to FTIR and Trace labs.

o 087- Microscopy /Photography - Initial samples come into this room for photography and processing. CDX, hand held instruments, 3d imager located here also. From here it could go to any of the other Trace labs.

o 086- Scanning electron microcopy - SEM to remain. Anticipate a table top SEM in addition to current SEM. SEMs are vibration sensitive. Also have an Alicona 3d imaging system (needs dark environment). Light Microscope in 086 for prepping

SEM samples. Sample prep can stay in 086 so no movement of sample would be needed. Samples moved in a sealed container.

o 080- Fingerprint Lab - will be another photo documentation space. FTIR & XRD instruments also located here.

o 082- Dark Room – no longer used for film processing. Equipment in this room will move to 097A. The space would be used for storing the hand held instruments.

o 081- Data Room – Is now used as a lab with a benchtop tablet press. May need a snorkel (100cfm) for dust issues. There will need to be a water source for cleaning.

o 091- FTIR – Digital scopes are located on the west end of this lab. FTIR, GCIR instruments are located on the east side of the lab. The 2 RAMAN microscopes will move to 097A.

o 097A -Trace Lab Addition would be used for microscopy sample prep. 2 RAMAN instruments will be located here as well. Lighting control zones will be required o Extra space is more critical than flow for the users. There is not a required directional flow through the labs or between instruments.

o All spaces need a form of light control. An open lab concept is not preferred. LED lights in lieu of fluorescent.

o Separated rooms are required for flexibility so that multiple analysts can work simultaneously on different instruments with different light requirements o Rooms 080, 091 and 097 all have instruments that require light control o None of the trace labs should have exterior windows. Sometimes light coming through the Data Rooms can be a problem

• FCC will send HDR an existing headcount list as well as a future headcount list. If possible, they will identify where people are sitting today.

• Currently Trace has 1 supervisor and 10 analysts. With increased opioid work, there will be new hires. There will be an increase in staff but want to maintain a ratio of 1 supervisor to 10 analysts.

• Opioid work is done in all of the Trace Labs.

BIOLOGY/MICRO MOLECULAR BIOLOGY

• Describe function of each lab.

o Katie o Most of the work involves narcotics tampering from hospitals, EMT and nursing homes.

• They also test plants, food (fish & crustaceans) etc.

o o Testing includes:

Biology - staining, gram staining, plating & culturing bacteria, sterility testing

Microbiology – Real time PCR, whole genome testing o They do PCR (Pre (Rm 075) and Post (Rm 076)). Current space is adjacent with door in between.

• How much is currently opioid work?

o 20%. Should remain the same in the future.

• Where do samples come from?

o Same process for Micro as other groups.

o They have items with chain of custody. Need lockable cabinets in labs.

• Is there a group they collaborate the most with?

o Mostly Trace, but work with all sections.

o Share some samples with other groups. Other samples only require micro work that only they do.

• Staff o 1 supervisor o 4 microbiologists – sit in 2 offices o 6 chemists – sit in 3 offices. 2 are part of SSMBS (Special Separation Molecular

Biology Section) and 2 are from the Separations section

The chemists are separate from the separations group for historical reasons. They could be thought of as another supervisory group.

Could the 063 Chemistry lab be incorporated into one of the 4 separations labs?

o One new hire coming soon.

• Some of the testing in the Chemistry Lab (063) is specific to the Biology group, such as

ELISA testing

• What are new space requirements?

o (2) New data rooms in Micro Molecular Biology lab 075.

o Lab addition 066 divided into Post PCR space and Micro Isolator/Sterility testing.

Glove box isolator is used for a sterile environment. Vaporized hydrogen peroxide

(VHP) is used for sterilizing the isolator. Will need to be ducted out of the building.

o Remaining space on 075 would be prep space and Pre-PCR o Samples go to Pre PCR and Prep lab first before going to Post PCR or Micro

Isolation.

o The existing glass wash room is used by all sections. Dishwashing is usually done by evidence tech or receiving clerk. There is also a sealer in the glass wash room that will have to be relocated. Currently the only available autoclave is in the BSL-

3 lab. Biology uses it for glassware and media sterilization and waste decontamination.

o Glass wash discussion will occur at a later time. More disposable items are used now so glass wash might not need to be as big. 50:50 media prepared vs. bought.

Less glassware needs to be stored.

o Pretty much on top of each other right now. Extra square footage will help decompress the lab. Currently only have one BSC would like to add a second one.

The 2 fume hoods in 075 may not be needed.

ELEMENTAL ANALYSIS

• Kathy, Robert Wilson, Tony

• Function of group is separations, elemental analysis (metals detection)

• Staff o 7 Analysts o Supervisor position is currently open

• Equipment includes ICPMS, Optical ICP o Equipment puts out a lot heat, need chillers, exhaust

• Work with other lab sections

• Section does no opioid work. This will not change in the future

• Metals group has a separate prep space (Rm 120) which is currently being renovated.

Need metals free environment so there is no sample contamination. Would like to remove the door to the corridor and enter the lab from Rm 117

• Lab 113 – Ion Chromatography. This is a specialty separation area with 2 analysts working in the adjacent data room.

• Specialty Separations

• Lab 117 - ICPMS, Optical ICP, Isotope Ratio (no AAs) – analysis lab. No changes planned

• Lab 121 – ICP mass spec room. Analysis lab, same type of equipment as 117. Ability to add separations. Equipment on carts that can be moved from instrument to instrument.

(2) ICPMS chromatography carts. No prep in this room.

• 117 and 121 could be combined into one room if the space was available.

• Use Analytical Sample Prep Room 096 for grinding and messier part of specimen prep.

Mixed use shared with other sections. Currently has a large canopy hood in the middle that they would like to replace with a double sided fume hood. Other groups use grinding prep room as well. Whole fish, carrots for example. Ventilation is required for odors not chemicals although some tampered samples could be dangerous

• Some analysts currently do drug work. Most specimens are food.

• Work with all of the other groups equally

• Samples come through same process as other sections.

• Use Photo Document Lab. Every group uses this space.

• Ideally data rooms 114 and 122 would be on an exterior wall.

• May need large work space (top) to work with.

Meeting #3 - Lab Planning Breakout Administration:

• Staff o Existing FCC admin space in yellow on existing plan.

o Office counts and locations to be updated when we get updated head count.

o Currently some supervisors have offices in the admin area. The preference is to have supervisors near their primary lab space.

o After renovation, some of the existing office spaces can return to their original functions like the Mail/File/Copy Rm 153. Currently the admin area is overcrowded.

o Assuming supervisors can be moved out near their labs, people who will occupy this space will only be people who support FCC and have security clearance.

o New FDA Admin offices will need to be located outside of secure laboratory area.

Not all people will need lab access.

o Difficult to get an accurate headcount for the FDA Admin area since the office staff changes frequently.

o Who or what determines who occupies the new admin space? Often it is staff that live near the lab and are assigned offices here for convenience o POR Appendix H shows who might be in the building.

o Associate Director of OMPTSLO is part of FDA. Prefer them to be outside of lab space with access to labs.

o 170 sf/person is the metric that must be achieved. Having an accurate headcount is important since this will determine SF of office and office support space o DOF to be outside of FCC o DPU is the IT staff. Currently have 1 person with OIMT but helps with their IT needs. Trying to find an IT that would be lab IT specific and not business IT specific like they currently have.

o Keep LAN room where it is. IT support does not need to be next to LAN Room.

o Data Processing Unit (DPU). Same as LAN room.

o Currently there is 1 IT person, time is split between business network and lab

(scientific) network. Current desk is in FCC Admin. There will be 1 person dedicated to scientific computers. Business IT person would be moved to another building or would be on the other side of security.

o OBSO are industrial hygienists and should stay on FCC side of security.

o DFA should be located on FCC side of security

• Conference and Amenity Space o Food Service Area is occupied for lunch and breaks. Is current space adequate? It can get crowded.

o FCC Library Rm 142 and FCC Conference Room 141 - only other spaces for meetings. These 2 spaces are used frequently o Library has some books but not a typical library.

o It would be nice to have an additional smaller conference space. Room for 10-12 people.

o Currently training is done in Conference / Training Room 003 and is booked for a week at a time approximately 6 times a year. It is also used for monthly all staff meetings (70 people now, 100 in the future) 15sf/person o Perhaps room 003 could be subdivided with a mobile partition o Option – combine FCC Conference Room 141 and Director’s Office 145 to create a larger sub-dividable conference/training room

• Locker Rooms o FCC locker rooms are 159/61. Full size lockers. Ideally they would be ½ size. Used to store personal items. It is not a requirement for all employees to have a locker o Investigators currently use locker rooms 010/011. This will be available when the district staff moves o Men’s locker room on district side is used by the security guards.

o FCC will provide the size and number of lockers. It is believed that there are 15 lockers/room or 30/women and 30/men total o The showers in the locker rooms are rarely used

• Any issues with lobby / reception area?

o David King may need to weigh in on the area with security guards and whether there is sufficient flow. Will need to have a separate meeting to discuss.

o There may be an issue with the location of the magnetometer. In the future there will be random employee inspections

• DPU

o There needs to be access to the DPU equipment without entering the secured area o Need info on how much server space is needed. 2 racks?

o The 3 racks of lab servers in the Tele Closet 084 should move to the DPU equipment room 037 so that scientific distribution comes from the DPU and runs to the entire building o FDA Business LAN o FCC Scientific Network o Tele Closet 084 is a switch closet for Business Lan currently o There is wireless internet in the building but it is not good

DOCK & STORAGE AREA:

• Evidence Storage Area o There should be sufficient space for current and future needs.

o 055 is a document storage closet for sample custodians or supply clerks. Needs to be cleared out.

o Looking to hire a 3rd evidence technician. May not have enough room for desk o The Vault (Rm 058) is the sample custody transfer room. There is a pick up window adjacent to door to the Evidence Techs office.

• Glass wash o The core function of the glass wash area has changed. Not as much glassware cleaning required anymore. New location of glass wash is okay as shown.

o Washer and dryer for lab coats

• Currently Office/Storage (#052) is a nursing room. Let’s find a better location for the nursing room. Approximately 80 sq. ft.

• On the dock side, there are various storage rooms. Are they adequately sized for current and future work?

o Chemical storage room is small but probably ok.

o Solvent storage room is adequate o Cylinder storage is for empty and new cylinders. 2 Dewars of liquid nitrogen; one for filling cryostorage containers and one is rolled to the NMR lab. Layout of space is not ideal but adequate o Lab Equipment Storage Room 067 is full of old equipment o Ideally relocate stored lab equipment in room 067 elsewhere and make that dock space.

• Storage o Current General Lab Storage (158) is for consumables, gloves, etc. as well as lab case file storage (this should be moved elsewhere).

o Existing parking level

Caged storage room.

Small Storage Room is where the water treatment tank is.

o Industrial Hygienists currently have supplies in the Admin Office Area and Rm 158.

They service FCC as well as other facilities. These should be moved elsewhere.

o Electrical Repair Rm 166

No longer used for electrical repair

1/3 of room currently used for PIV badging. This is outside of the security area and should remain outside. Non-lab people come to the building for badges. Needs to be in a secured room but can be office space. Both the

Peck building and the FCC building should have PIV badging stations in the future

Scientific staff notebook computer storage o Machine Shop Rm 165

No longer used as a machine shop

Canopy hood on one wall. Used for sample destruction. IH determines what waste stream destroyed samples go to. Bulk containers are filled and shipped out for disposal when full. A space ½ the size of the current room would be sufficient.

o Storage Requirements:

Document or file storage - archived case files, instrument logs and manuals, QA, time keeping records. Still some paper based documents that they keep. Items not worth scanning but need to keep. 1/3 to ½ of

Rm 158 would be an approx. size needed

Lab consumables and office supplies – ¼ of Rm 158 would be an approx.

size needed

Old equipment – Space the size of Rm 167 + 1/3 more would be adequate.

This should not be located on the garage level since some items are large and wouldn’t fit into the elevator

IH & Safety supplies – Also store shipping containers. 1/3 to ½ of Rm 158 would be approx. size needed

PIV Station – 1/3 Rm 165 would be adequate

Document destruction – ½ of Rm 165 would be adequate o Currently all storage in on open racks. High Density storage would be good alternative for efficiency and minimizing storage footprint.

GLASSWASH SPACE

• Requirement for glass wash not as big as it used to be due to an increase in the use of disposables.

• Only one dishwasher, no need for another.

• Only one autoclave in the building. Adjacent to BSL3 suite.

• Scullery sink with garbage disposal.

• Washer and dryer for lab coats and towels.

• Need storage for glassware. Tall storage cabinets.

• Currently have an island with a sink and counter space.

• Stainless steel casework. Perhaps the existing casework could be reused

• Large heat seal machine that can be relocated. (For resealing evidence before it gets turned back in).

• Small ice machine - used for micro prep and some protein work (Mass Spec).

• Safety showers - no floor drains. NIH DRM does not allow floor drains.

Meeting #4 - Lab Planning Breakout

PHOTO DOCUMENTATION LAB

• Existing Rm 109. New Lab #3

• Have overhead fluorescent lights and halogen lights. Light fixture with 100W LED bulb to illuminate ceiling for diffused light.

• The wall shelving in the room is not required

• Currently room has a sink in it. Do not need a sink in new lab. Maybe a hand wash sink

• They need good light control. Overhead LED lights that are dimmable. Too much glare currently when items are shrink wrapped or in plastic bags.

• Need different light types.

• Maybe a couple of mobile tables to move around in lieu of fixed casework at walls.

• All samples are photographed when they are received

• Need places to lay samples out.

• Currently stations set up for 2 people. There will need for more stations as staff grows.

• Ideal number of photography stations would be 6 total including the new photo documentation lab. Each station would be 6 to 8 feet wide.

• Would be great to get rid of large format printer and copiers in room to accommodate 3rd station in existing lab.

• Want to see a couple of different layouts of the space. Center mobile tables would be great for laying out samples.

• Trace group has a couple of photo doc stations in their lab. Wouldn’t need to take up space in new photo doc lab.

• Daylight is definitely not wanted. Not using flash photography which is why the lighting component is critical.

• Robert Byrd—Indirect and direct lighting on different switches would be ideal.

ANALYTICAL SAMPLE PREP

• Existing Rm 096.

o The lab is used to prep large quantities of samples that they can’t do in the lab.

The work can be messy o Island bench with canopy hood above, plastic enclosure around table, and a center trough sink. Want to replace with this with back to back floor mounted hoods.

o This change is opioid related.

o Rest of the room is okay as is. Just the center arrangement needs to be updated.

o They need a garbage disposal in this room.

o Washable floors and walls needed.

o Sample Prep Labs could be used by all sections.

• New Lab #4 o This new lab would have a similar set-up to the existing lab

STANDARDS PREP LAB

• This lab is okay as it is.

• Short on freezer storage

• Some casework on the west wall could be taken out to make room for freezers or refrigerators.

MASS SPEC GROUP

• Brian Kirk’s overview of the existing space:

o Mass spec group handles a variety of samples o LCMS, GCMS - Similar to Separations.

o Amaldi Mass Spec o Work with a lot of unknowns o Work requires large and expensive instrumentation. Big open space in lab is for floor mounted mass spec equipment. Some equipment has unique table configurations. Need to maintain open space in laboratory.

o Lab Rm 110 - back to back fixed benches with spaces in between for pumps and equipment.

• Large amount of electricity, gases (N2), and exhaust.

• Nitrogen use. Will need a lot of nitrogen with new space. Haven’t gotten into the specifics of quantity and distribution routes.

• New Lab 097B o Future needs are a growth of what they currently have. Nothing radically different than what they currently have.

o When Lab 097 is split in ½ they envision a new bench against the new wall for prep

• What percentage of work is opioid related?

o 30-40% of what is done.

o 3-4 analysts do large molecular work that is opioid related

• Any groups you work more with than others? Adjacencies are fine the way they are. They are centrally located and near Trace which works well.

• Head count will be updated with the rest of the spaces.

• Any changes you would like to see from your current space? Work flow?

o Biggest issue would be storage of old instruments. They repair a lot of their instruments. Want access to old equipment for pulling parts to repair newer instruments.

o Lacking prep space. Would be nice to have an adjustable height table for prep space.

o Sample storage is another issue. Items that need chain of custody. Need lockable or secure cabinets. Lacking storage for large samples. Sometimes 4 or 5 boxes of stuff. Will often end up with boxes piled up in 110. Need room temperature storage.

• Maybe a central space for new instrumentation set up and testing before being swapped out. This could be nice for all groups and not just Mass Spec group. This could also be used as lab swing space if needed for surges in testing.

FOLLOW UP COMMENTS

• For the RAMAN zoned lighting with dimmable LED lights are required

• Conference/Training 003 needs black out shades and not just blinds on West wall. Sun light negatively effects the CDX

• Data drops to be located later in design process.

• Small visitor training near entrance would be helpful.

NOTES from Tele-Conference chat from Doug Albright:

• Gas chromatography–mass spectrometry (GC-MS)

• Liquid chromatography–mass spectrometry (LC-MS)

• A sub is a portion of a sample removed from the whole to conduct a specific analysis

• Large mass-spectrometers cannot be above garage

• NMR cannot be above garage

• Fourier-Transform Infrared Spectroscopy (FTIR)

• Raman microscope is a laser-based microscopic device used to perform Raman spectroscopy

• SLM = Stereoscopic Light Microscopy

• DLM = Digital Light Microscopy

• SEM = Scanning Electron Microscopy

• SSMBS = Spectroscopy Separations Molecular Biology Section

• ANAB is our accreditation body (ISO compliant)

Page 1 | 2

Project: FDA FCC

Subject: Lab Energy Efficiency Methods

Date: Thursday, April 23, 2020

Location: Webex

Attendees: Bill Zavatkay Sarunas Rumsa

Mehryar Ebrahimi Dale Peterson

Doug Heitkemper Nathan Ingersoll

Stephen Carberry Demian Go

Raymond Byrd Rachel Romero

Shawna Ramthun Marty Borenstein

Otto Van Geet Doug Albright

Ryan Livingston Mark Meaders

Robert Wilson Amie Sell

1. Proposed LCCA Options

CHW Plant

Modular chiller – no N+1 anymore (can be air or water cooled). Just need to add a cell for redundancy.

Higher maintenance costs with water-cooled chillers.

Need to be concerned about chiller use especially during the shoulder months.

Water cooled may not be as “simple” as air-cooled, and they have higher maintenance costs (e.g.

chemicals), but generally have lower LCC vs. air-cooled. GSA has a lot of experience with water-cooled chillers.

Intake from AHUs need to be moved to remove issues with smells.

BASELINE: Modular water-cooled chiller w/ heat recovery (need to include chemical treatment costs)

OPTIONS: 1) Modular heat recovery chiller (HRC), 2) Modular Air-Cooled chiller

HW Plant

Currently 2 HW natural-gas boilers.

There is year-round heat demand.

Condensing boilers operate at lower temperatures. Concern existing reheat coils do not need to be replaced (and not currently planned to be replaced) and cannot work with condensing boilers.

BASELINE: New natural gas boilers

OPTIONS: 1) Modular natural gas condensing boilers, change reheat coils, change piping including recovered heat from HRC, 2) Modular natural gas condensing boilers, change reheat coils, and change piping

Humidification

Page 2 | 2

Need details on existing process steam if that can be combined with existing boilers for humidification purposes.

FDA to get details on specific humidification requirements in specific lab spaces and if central humidification is adequate.

Fogging/ spray humidification systems are not acceptable options.

Would be very good to reduce static in lab areas to assist with testing.

BASELINE: Natural gas steam boilers with modulation

OPTIONS: 1) Natural gas humidification at AHU

AHUs

Currently 2 AHUs with 100% outside air for labs, 1 AHU for office

Need to review existing filtration requirements (e.g. use of HEPA filters and where). Use of HEPA filters increase static pressure and energy use. Possible use of higher MERV ratings filters in lieu of HEPA.

BASELINE: 3 AHUs (single-fan) manifolded together for labs and 1 AHU (single-fan) for office

OPTIONS: 1) Fan array for labs, 2) high-efficiency heat recovery loop

4. Projected LEED Status

HDR put together a projected best-case scenario LEED Scorecard.

Do not believe the project can earn any Location + Transportation points (18 total) due to the location of the project and parking not included in the project scope.

Currently using the Prescriptive Approach for Optimize Energy Performance which includes design features that can be included on the project to earn points. The maximum number of points is 12.

Based on these limitations, we are showing 59 Yes points, 2 Likely, and 18 Unlikely (which most will probably turn to No).

GSA/ FDA instructed HDR to put together a Memo with these concerns and send to request a waiver for LEED Gold.

2. GSA Published Findings

This item was tabled due to running out of time. HDR will schedule a call for April 28 at 230-330p

EDT to discuss. A meeting request will be sent by Mark Meaders.

Page 1 | 2

Project: FDA FCC

Subject: Lab Energy Efficiency Methods – Part 2

Date: Tuesday, April 28, 2020

Location: Webex

Attendees: Bill Zavatkay Sarunas Rumsa

Mehryar Ebrahimi Dale Peterson

Doug Heitkemper Nathan Ingersoll

Stephen Carberry Demian Go

Raymond Byrd Rachel Romero

Shawna Ramthun Doug Albright

Otto Van Geet Mark Meaders

Robert Wilson Amie Sell

David Zeeb Glenn Woodbury

Lauren Andrysiak

Reviewed GSA Published Findings with Deployment Potential for possible technologies to review for the project.

Building envelope o Not reviewed due to not being in project scope and only “impacts” to the envelope would be to repair an item (e.g. roof leak).

Chiller plant control optimization o May be already included if modular chillers are implemented in project

Advanced lighting controls with LED o Project is planning to use LED lighting o Advanced controls include dimming (in multi-occupant spaces like conference rooms and labs) and daylight controls (dims lights automatically based on amount of sunlight – depends on requirements of space) will be implemented o Dimming is wanted in the labs o Occupancy sensors that turn off lights may not be desired in certain lab spaces for safety purposes. HDR needs to work with FDA to specifically identify such spaces.

Dual sensors (not just based on occupancy) could be used

Need to ensure there are no “dead zones” with use of such sensors.

Power strips with occupancy sensors o Required per ASHRAE 90.1 o Hesitant to use in labs due o Open for use in office workstation and conference rooms

Demand control ventilation (DCV) o Required per ASHRAE in certain spaces (e.g. conference rooms) o Need to verify if reheat coils in building can accommodate DCV

Ventilation Risk Assessment https://www.gsa.gov/governmentwide-initiatives/sustainability/emerging-building-technologies/gpgproven-technologies-with-gsa-deployment-potential

Page 2 | 2 o Need to determine what are the correct occupied/ un-occupied ventilation rates for spaces o Need to determine minimum rates for what chemicals are in the space and what is being done in the space

Energy metering o Need to follow GSA Metering Program which states each incoming utility is metered o No GSA requirements for additional sub-metering o Need to evaluate additional sub-metering for LEED purposes

Variable frequency drive (VFD) on chillers o Is VFD included on modular chillers?

o Modular chillers may use something different that modulates the speed and can adjust based on load. Needs to be reviewed.

Renewables o Not currently in the project scope.

o Would like HDR to designate space for inverters and other such equipment for future PVs in the building.

o A simple spreadsheet analysis is requested to see the potential for PVs for the building.

Cooling Towers o Possible methods to treat the water (e.g. advanced oxidation process). Cost impacts needs to be reviewed if such methods will be implemented before it is included in the design.

Free Cooling o Need to explore all methods to use free cooling to reduce loads and energy use.

Lab Air Changes o Need to explore all methods to reduce lab ACH and outside air requirements to reduce energy use and reduce mechanical equipment sizes.

o FDA will utilize NREL Smart Lab Toolkit to understand chemical use and chemical quantities. Must comply with health and safety requirements.

o Can sensible cooling or chilled beams be utilized to reduce loads?

o Need to understand off-hours setbacks in labs to reduce ACH

Air Dispersion Modeling o FDA requested HDR perform such modeling to understand lab exhaust and impacts on

AHUs.

Subject: Bi-weekly teleconference

Date: Tuesday, April 28, 2020

Location: Tele-conference

Prepared by: Sarunas Rumsa, HDR

Attendees: GSA

Steve Carbery

Nathan Ingersoll

Katherine Williams

Anthony Walton

Demian Go

Bob Collins

Harana Griggs

Mehryar Ebrahimi

Bryan Gamble

Doug Heitkemper

Warren Hendrickson

JJ Tang

Clare Swanson

William Zavatkay

Mark O’Grady

Dale Peterson

Mark Meaders

Amie Sell

1) Project Status Update

a) Project Schedule - currently 1/3 of was through Concept Design

b) HDR presenting concepts for first time with feedback from previous User Meetings

i) Presentation of Options on 4/30

ii) finalized programming info

c) Virtual Tour & Benchmarking meetings complete on 4/23

d) Verified Head Count & staff

e) Identified every room

f) Process of basic organization of space.

2) Users on Virtual Tour on 4/23 liked:

a) separating Labs from offices

b) flexibility with casework & Overhead carriers

c) Windows into Labs, while maintaining separation

3) HDR will share documents to share after the meeting. FDA Central office will want to see documentation. Also needed for cost estimating and exhibit preparation, then they can be shared. A record of the topics will happen, they will be diagrammatic.

4) Photos from the virtual tour to be shared with Lab people. HDR will share a PDF of the presentation.

5) Meeting Minutes need to be released.

a) Clare to send minutes and site plans.

6) Updated space list to be issued.

a) First round of User meetings was 4 days, tremendous amount of information and intense focus from each group.

7) No concerns with virtual meetings.

8) Finding holes of information?

a) HDR anticipates we will have some, mostly picky questions for clarification. Clare Swanson sees nothing major and the headcount list provided was easy to use.

9) Schedule of deliverables is needed from HDR by the next meeting for FDA to review.

10) Covid19 caused changes? None noted

11) Revit models are ready.

12) Engineering: Electrical is focusing on generator options and bringing building up to DRM standards

13) Sustainability: Continuing Benchmarking meetings after this meeting.

a) Life Cycle Analysis continuing with drafts will be sent to FDA/GSA for comment.

14) Site: Cultural issues wrapping up in next couple of weeks

15) Security: none

16) GSA/FDA: using to Google drive to share documents.

17) 4/30 Option Meeting:

a) HDR thinks it is best if everyone shows up instead of small groups:

i) Lab users

ii) All stakeholders should be there to see and comment

iii) Feedback during the meeting is critical.

iv) HDR to develop way to capture feedback virtually

18) The next bi-weekly FCC meeting is scheduled for May 14, 2020 at 12:30/1:30pm CST/EST.

Subject: Concept Meeting #1, VC2 Presentation of Options

Date: Thursday, April 30, 2020

Location: Virtual Tele-conference

Prepared by:

Sarunas Rumsa, HDR

Attendees: GSA

Steve Carbery

Nathan Ingersoll

Anthony Walton

Katherine Williams

Keith Kennedy

Demian Go

Bob Collins

Harana Griggs

Mehryar Ebrahimi

Bryan Gamble

Doug Heitkemper

Doug Albright

Jonathan Litzau

Mike Smithhisler

Sara Kern

Cheryl Flurer

Dave Crockett

David Knight

Deshea Rawe

Katherine Penno

Kirk Gaston

Neil Omansky

Pamela Wood

Robert Wilson

Shahid Mubeen

Steven Kuchera

Tom Bruggemeyer

Shawna Ramthun

Clare Swanson

Randy Prescott

William Zavatkay

Mark O’Grady

Dale Peterson

Lauren Andrysiak

Amie Sell

AGENDA: SCHEDULE, PROCESS, ISSUES FOR CONSIDERATION, PRELIMINARY OPTIONS

Sarunas Rumsa presented introduction:

Schedule

1. less than 1/2 way through concept phase

2. Opportunities to meet any time virtually, if needed, before next meeting on May

7th

Process

1. Identify the ISSUES

a. Based on our previous meetings

b. POR

c. Industry standards and trends

2. Identify OPTIONS for the issues

3. Assemble the options into comprehensive SOLUTIONS

4. EVALUATE the options

a. Individual issues

b. Comprehensive solutions

5. REPEAT

Issues

1. PROJECT GOALS

a. Meet Opioid increased testing requirements

b. Upgrade building infrastructure to meets GSA/FDA standards

c. Use energy responsibly – LEED

2. PROGRAM

a. Add laboratory capacity for Opioid response

b. Add laboratory storage capacity

c. Vacate existing admin space for new laboratories

d. Accommodate additional staff

e. align spaces with 170 sf/person requirement

3. STATE-OF-THE-ART LABORATORIES

a. Lab flexibility – respond to testing, equipment, maintenance

b. Environments for sensitive lab equipment – lighting, pressure, air flow, vibration etc.

c. Safe work environments for staff

d. Adequate storage capacity

4. PROCESS FLOW / ADJACENCIES

a. Align building/lab groups with new FCC org chart

b. Maintain chain of custody for samples

c. Supervisors not located near their lab sections

d. Correct legacy moves that were based on space availability not flow or function

5. SECURITY

a. FDA, non-FCC, offices – security and separation

b. Resolve building entry/security/metal detector

c. DPU needs to be located on the non-FCC secured side of the building

6. WORK ENVIRONMENTS

a. Quality work environments

b. Give all employees access to daylight

c. Create safe locations for visitors and tours

d. Coronavirus design paradigm shift

7. COST/SCHEDULE

a. Project COST

b. Prioritize funds (not every lab will be updated or get new casework)

c. Phasing schedule/down time will impact cost/schedule

d. Minimize downtime for the lab during construction

Options

1. BIG picture

a. Location of departments, labs, administration

b. MEP zones, separate air systems

c. LEED/Sustainability

2. MEDIUM picture

a. Remove cross corridors between labs –…