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HEALTH DISTRICT LETTER.docxLetter of TransmittalMarch 20, 2019Document Delivery Method (internal use only): Electronic Hard CopyProvidenceAttn: Richard BraytonRichard.Brayton@swedish.org206-320-7487Project Info:CRS# 60801278Project location:Local Permit #:21632 Highway 99Edmonds, WA 98026          Swedish Medical CenterPharmacy Chemo Rm HVAC ImprovementsKey People:Assigned DOH Reviewer:Kevin A. Scarlett, RA, HFDPkevin.scarlett@doh.wa.govFacility Administrator: Swedish Health SystemMike Denney     (206) 386-3877 x.      mike.denney@swedish.orgFacility Contact:Providence Real Estate and ConstructionRichard Brayton     (206) 320-7487 x.      Richard.Brayton@swedish.orgArchitect / Engineer:TGB ArchitectsJohn Ginn     (425) 778-1530 x.      jginn@tgbarchitects.comLocal AHJ:City of EdmondsLeif BjorbackEdmonds, WA 98020(425) 771-0220 x. 1380leif.bjorback@edmondswa.govConsultant:Macdonald MillerLogan Ordona     (206) 290-0094 x.      logan.ordona@macmiller.comConsu ltant:Swedish Health SystemDan Murphy, Pharmacist     (206) 215-2562 x.      dan.murphy@swedish.orgContact:N End Svcs Mgr for Swedish Cancer InstituteSwedish Cancer InstituteAliki Burkenbuel(425) 673-8302 x.      aliki.birkenbuel@swedish.orgContact:Swedish Cancer InstituteJim Yates, VP Ops     (206) 215-3535 x.      jim.yates@swedish.org Copies To: Local AHJ: City of EdmondsArchitect / Engineer: TGB ArchitectsConsultant: Macdonald MillerConsultant: Swedish Health SystemContact: N End Svcs Mgr for Swedish Cancer InstituteContact: Swedish Cancer InstituteDOH Child Birth Center LicensingDOH Office of Investigations & InspectionsL&I Electrical Section L&IFactory Assembled Structures     CRS File Facility Data Certificate: Facility Name:Swedish Medical CenterLicensee UBI#: 178049719 Site Address:21632 Highway 99Edmonds, WA 98026Critical Access Facility: Yes No Estimated Date of Occupancy:12/28/2017 ALL FACILITY TYPES      Occupancy Group: Construction Type:       Applicable Code: Number of Beds: Current:N/A Added: N/A Removed: N/ATotal: N/A Automatic Fire Sprinkler System: Yes No Type Automatic Fire Alarm System: Yes No Compartmentation req’d: Yes No Smoke Control System Provided: Yes NoSpecial Delayed Egress Control: Yes No Location:      Certificate of Need Required: YesNo CON Approval Granted: CON Number :       Yes No RESIDENTIAL CARE FACILITIES ONLY Number of units:       Private occupancy:       Two person occupancy:      Based on size of rooms used for sleeping       ResidentsBased on size of common rooms       ResidentsMaximum allowable licensable beds:       Qualifies for Assisted Living Funding Program Yes No Number of qualifying units:      NOTESRenovate existing compounding rooms and supporting HVAC and other building systems to achieve full USP 797/800 compliance in the pharmacy compounding area. -kas The data above is based on the information presented to CRS. Any change in the facility or facility program that causes the above information to be incorrect is subject to review by CRS. Approval for construction is not approval for licensure. A copy of the facility data certificate will be sent to the licensing agency. Project Status:- Authorized to Begin Construction –- Comments Not Approved – This project is not approved for use or licensure.The construction documents have been reviewed and construction can begin, subject to construction permitting from the local building official. This project will not be approved until the comments labeled as “not approved” have been resolved by providing a written response to each of the comments. When referencing drawings or attached materials, provide sheet or page #, revision # and date as applicable. Additional comments may follow based on design team response and site inspections may be required to verify compliance. Please note the following:The stamped “Authorization to Begin Construction” drawings will be delivered to the Facility Administrator. These shall be kept available on site for inspection during construction and post occupancy survey. Any changes/deviations (incl. change orders or addenda) from the stamped documents must be submitted to the Department for review and approval. Beginning construction prior to resolving the attached comments will constitute facility acknowledgement that you are proceeding at your own risk.Please include your CRS number on all communications to Construction Review Services. PROJECT CLOSE-OUT REQUIREMENTSYou must notify the department when construction is complete by completing the following steps:Verify that you have resolved all of the comments on this form and have submitted any revisionsComplete the Notification of Construction Completed at: http://www.doh.wa.gov/NotificationofCompletion.aspxEmail a copy of the approval from the local building department (final permit approval or certificate of occupancy) to: crs-closeout@doh.wa.govEmail a floor plan showing the scope of work to: crs-closeout@doh.wa.gov Once your construction project is complete, you may contact the DOH Office of Customer Service (360) 236-4700 for help with adjusting or amending your license to add this project. You can monitor project status by visiting our website at www.doh.wa.gov/crs or simply by pressing Ctrl+Click on the following link......https://fortress.wa.gov/doh/constructionreviewsearch/ Preliminary CommentsComment ID # Preliminary Conference – 10/24/17 Attendees: Dan Murphy (Dan.Murphy@swedish.org) Jens Frisvold (Jens.Frisvold@swedish.org) Rex Kerby (Rex.Kerby@swedish.org) Jim Grafton (James.Grafton@providence.org) Bobbi Ragland (Bobbi.Ragland@swedish.org) Taunia Fineran(Taunia.Fineran@swedish.org) Logan Ordona (Logan.Ordona@macmiller.com) Bruce Johnson (Bruce.Johnson@macmiller.com) Chris Lee (Chris.Lee@macmiller.com) Kevin A. Scarlett (kevin.scarlett@doh.wa.gov) - - - - - - - - - - Swedish Hospital Swedish Hospital Swedish Hospital Swedish Hospital Swedish Hospital Swedish Hospital MacDonald-Miller MacDonald-Miller MacDonald-Miller WA Department of Health The following are preliminary comments provided as information and for use preparing the construction documents. These preliminary comments may be revised and/or additional preliminary comments may be made during subsequent submissions. Items Received: Photo’s taken On-site GENERAL BACKGROUND The following relates to a phone conference on 10-12-17; The background and engineering intent of the project were outlined, primarily by Chris Lee of Mac Miller, for the benefit of orienting DOH and the entire team to the details of the project. There was discussion of the intent of the project.  The conclusion was that, although the project was initiated by a specific HVAC issue, any issues with compliance with USP 797 should be identified if possible through this project.  There are two areas of concern: regulatory change since construction of the building and some doubt about the original construction of the building, given the issues that have now been uncovered with the HVAC.  Compliance with USP 800 is viewed by the pharmacists as a separate issue.  The compliance deadline has been postponed to December 2019. There was a question about the HVAC diffusers.  The existing, office-type diffusers will be changed to pharmaseal type diffusers with room-accessible filters at room (a USP requirement). The old HEPA filters are on the roof (which is fine for the exhaust filtration).  Some existing details of the chemo room and anteroom were discussed.  The ceiling in the room is hard lid.  The floor is coved sheet vinyl.  The anteroom handwash sink is not a scrub sink.  It is a large handwash sink (too much-excess splash on floor & adjacent surfaces).  It is unknown whether the walls are painted with epoxy paint, but, the final finish must be epoxy. There was discussion of room relative pressures, including pharmacy, anteroom, janitor closet. There was an update of project status: the project has been submitted to DOH and the City of Edmonds.  DOH’s turnaround time is set at 28 days.  The city’s turnaround time for permit review is unknown.  The city is not requiring a building permit despite the need to reinforce the roof, only a mechanical permit. DOH (Kevin Scarlett) is scheduled to visit the project site on October 24 at 9:30 am. The budget was discussed.  It is known that the project is overbudget.  Right now, known issues include: -The rooftop unit needed to provide the code-required air changes is larger than originally anticipated. -The need to reinforce the roof was not identified during the original budgeting process; -More extensive roofing and curb work will be needed for the larger unit. -An issue with the return air ducting was identified subsequent to the original budget; -Additional Swedish system safety requirements during construction have been introduced to the project that have the effect of raising the cost. -Other code noncompliance issues also have potential for increasing the budget.  The budget will be revisited again after the scheduled DOH site visit on October 24. Start of Project Preliminary comments; T1 Full (additional beyond HVAC) Pharmacy compliance issues will become operative in December 2019. T2 Remove the fire extinguisher & cabinet from the Ante room. Okay to place in main pharmacy. An FE & Cabinet are not an allowed element in a clean room unless specifically required (and it’s not required in any of these clean rooms). Also, the Extinguisher (upon any safety assessment) will place it in the main pharmacy for ready access and use. T3 Horn/Strobe – Remove from both clean rooms under the private mode clause of NFPA 72. Kevin will coordinate with City Fire Kevin Zwebber. Note: there is an existing Horn/Strobe in Main Pharmacy and is located just outside of the Ante Room. T4 HD Storage access - Preferred access to the HD Storage room should be from the Pharmacy space, not the Ante room. The Ante should be dedicated to garbing and doffing PPE prior to entering the compounding room. That said, Kevin is checking with DOH Pharmacy (Gordon) to see if access to HD Storage could be permitted for the long term (permanent) basis. T5 Both Clean Rooms - GWB Walls and GWB Ceilings must be epoxy painted (suggest at least 2 coats due to the latex sub-coat & recommend consult with coatings expert for appropriate cover to exist substrate).ALL surfaces in these rooms must be non-friable in use and during cleaning and regular maintenance activities. T6 Ante room sink needs to be a scrub sink. Facility indicated that an existing unit was just salvaged from another recent project. If not a scrub sink - Ante room scrub sink must be deep enough to allow users to scrub up to their elbows without regular splash to floor and adjacent surfaces. T7 Doors &door frames must be fully sealed with no gaps or seams. Wood or metal doors must be epoxy painted. DO NOT use any door seals or door drops of any kind. These cannot be cleaned, are not otherwise required (fire or other codes) and the doors actually operate better without the tighter seal. Also, the room design accounts for this door gap leakage. As a reminder, when you remove door seals they must be prepped for the epoxy paint coating. T8 Recommend fur-out of new walls to cover low wall returns in clean rooms and mount the EA grille about 1ft AFF to rough-in (or ensure 1” minimum clearance between outer edge of EA grille flange at top of cove base. The 8” dimension discussed is from ASHRAE S170 –Ch 7 and regulates Surgery RA (USP just calls for ‘low wall return/exhaust’. Should you choose to re-use the exposed SS duct, it must be totally sealed to wall, ceiling and adjacent duct (I can see at least 5 very problematic seal issues with the existing configuration and I may have missed a couple – ALL of them must be resolved at project approval/final acceptance). T9 Occupancy sensors will NOT be required. Gang all light switching outside the ante room entry. T10 Sprinkler heads – use anti-ligature sprinkler heads because they are easy to clean. Standard sprinkler heads invite disaster when they are cleaned. T11 Pressure monitors; a) Recommend locating all pressure monitors in visual range of Pharmacy personnel where the area is continuously staffed. b) Balance to 5 Pa (0.02”) and alarm at 0.01” at the low range, and 0.03” at the high range after 2 minutes out-of-range. Negative in Chemo Prep & Positive in Ante. c) Recommend setting monitors to indicate Pa (pretty much anyone can tell if the monitor reads 1.8 that they need to call Rex….if it reads 3.3…..still need to call Rex….but, not as urgent. Basically, it’s being able to see the order of magnitude easier…..for even lay-people. d) Pressure monitors, interlocks and air washes are not required for a pass-through, however they are becoming a best practice recommendation. T12 All seams in clean room spaces complying with the new requirements will require different details to be fully sealed. An epoxy sealant with appropriate shore hardness (D70-or approved) is required. Wall protection panels, vinyl floor edges, etc. should all be finished without moldings and must be sealed with a (D70-or approved) epoxy sealant. ALLjoints must be sealed except joints to accessible (required) access such as outlet covers, HVAC Grilles, Light fixture (inner joints (outer to be sealed), themostats and monitors.ALLfixed construction must be epoxy sealed. Joints between door frames and walls, all seams such as the joints in the knock-down door frames, all re-lite frame joints, acrovyn panel joints, floor base to wall joint, any item permanently affixed to the wall such as monitor brackets, bracing to hoods, etc.. An access panel must seal to the ceiling, but, the access panel opening does not (a gaset for this panel may be required (verify w/kevin via cut sheet or inspection). Also, door vision panels to door and any seams. The gaps behind the auto-door operators must be eliminated (epoxy caulk the units’ base & leave the cover ‘free’ or not sealed/caulked). T13 The anteroom should only be used for donning and doffing of clean room PPE and for scrubbing. It should not provide access to other spaces or be used for storage or other purposes. T14 Hood units should be about 1ft (or as determined by Dan/Jens) off the walls for cleaning access. T15 Leading edge of new SA grille suggested to be aligned with the front face of the hoods. Use a type E diffuser (or similar laminar flow) with HEPA filter at ceiling. T16 Do NOT use a handicap boot at the sink waste for scrub sink. T17 REMOVE any item which does not have a specific purpose for ongoing use in these two clean rooms (example – room signs/door stops/similar not required). T18 The only product which may be brought into the room is for prep use within one shift period. No other storage is permitted in either clean room. T19 Haz Storage must be negatively pressurized to 2.5 Pa and have 12 ACH of MERV 14 air and exhaust directly to the exterior through HEPA filtration. T20 Haz Storage has no other finish requirements similar to the 2 clean rooms. Suggest Sheet Vinyl floor with coved base, latex wall paint, lay-in ceiling okay. Cleaning regiment for this storage room does not match the clean rooms. T21 Provide a cleaning supplies small locker just outside the ante room. T22 You may omit the ‘red line’ in the ante room. Since the only personnel entering this room are the highly trained Pharmacy staff working in these rooms. Plan Review Comments: Comment ID # Approved Not Approved 1 Provide a single pdf of Fire Alarm (FA) plans as reviewed and stamped Approved by the local AHJ (City of Edmonds/Snohomish Co. FD#1). Drawings must bear the City Approval Stamp including signature and date of review Approval. Upon review of this ‘stamped Approved’ set of plans this comment will be marked Deemed (effectively same as Approved). The submittal shall include all product data cut sheets and applicable calculations for a complete submittal. 2015 IFC 907.1 Deferred 5/10/18. –kas 2 Provide a single pdf of Fire Sprinkler (FS) plans as reviewed and stamped Approved by the local AHJ (City of Edmonds/Snohomish Co. FD#1). Drawings must bear the City Approval Stamp including signature and date of review Approval. Upon review of this ‘stamped Approved’ set of plans this comment will be marked Deemed (effectively same as Approved). The submittal shall include all product data cut sheets and applicable calculations for a complete submittal. 2015 IFC 903.1 Deferred 5/10/18. –kas 3 Contact CRS Senior Plans Reviewer Kevin A. Scarlett (KAS) at 360.236.2949 to schedule Inspection efforts. Plan one initial, one intermediate and one Final Inspection (Initial-prior to project start and Final within 2 weeks of project completion). This comment will remain ‘open’ until construction is complete. Deferred 5/10/18. –kas Deferred 3/20/19 – the initial was performed on 3/20/19. –kas 4 Revise the FP to include a narrative for drug process path/s for both Hazardous and Non-Hazardous applications. This should indicate process paths from delivery and package breakdown, to initial storage, pull for compounding, storage and/or use after compounding. Based on prior meetings and discussions with Pharmacy staff, Hazardous drugs are expected to transport from compounding rooms directly to point-of-use locations. Approved 5/15/18 – based on revised FP received on 5-10-18. –kas 5 Provide product data cut sheets for the proposed; epoxy sealant, Not Approved-Shore A55 is too soft & is expected friable. Approved 7/10/18 per DynaPoxy EP-1200 submital. -kas Altro Whitrock wall product (indicate finish pattern and thickness), Approved new pass-thru (Atmos-Tech), Approved scrub sink and faucet, Approved SA grilles, Approved gasketed lights and Approved sprinkler heads.Deferred as of 7/10/18. -kas Not Approved 5/16/18 – based on documents received 4-18-18, status is listed by item in bold text above (in body of comment). –kas Not Approved 7/10/18 – based on documents received 6-13-18, 5a is Approved under this review, 5b thru 5f were previously Approved and 5g is Deferred. –kas 6 Air pressurization in the Ante Room and Positive Buffer Room appear to be opposite the intention. The Positive Buffer Room should be the most highly pressurized of the 3 clean rooms. Verify and revise volumes indicated on Sheet TM0.01 (Ante Room +240cfm/Positive Buffer Room ++160cfm) as these two should be reversed. Suggest reducing EA from Ante Room to 190cfm and increasing EA from Positive Buffer Room to 380cfm. Approved 5/16/18 – based on documents received 4-18-18, MacDonald-Miller (MM) indicates that airflows have been revised to make the Positive Buffer Room the most highly pressurized room and reduced the pressurization of the Ante Room. See the revised airflow matrix on drawingTM0.01. -kas 7 Indicate in plan where pressure monitors are physically located (best to place above door-or away from hood). Approved 5/16/18 – based on documents received 4-18-18, MacDonald-Miller (MM) indicates that the details for locating the pressure monitors has been added to drawing TM2.02. Locations for the pressure sensor wall plates are added to the HVACdrawings. While this comment is approved it should be noted that the pressure devices in the Ante room are in odd array. Each device should be installed immediately opposite the other. -kas 8 Provide cut sheets on sinks and faucets used on this project. Suggest reuse of one of the existing scrub sinks in the ante room. Approved 5/16/18 – based on documents received 4-18-18, MacDonald-Miller (MM) indicates to refer to item #5 above. Scrub sink will be reused (Attachment4). -kas 9 Verify/indicate how hands are dried (verify lint free towels) and how/what PPE is applied in ante room. Approved 5/16/18 – based on documents received 4-18-18, Pharmacy - Jens Frisvold and Dan Murphy,Pharmacists): Yes, we use lint free towels in all of our IV rooms. Everyone wears scrubs. We put on hair nets, face masks and beard covers (if needed) as we enter the anteroom and then put on shoe covers as we cross the line of demarcation in the anteroom. Once inside we wash hands, put on a gown and sterile gloves. Those going into the negative pressure buffer room where a chemo certified gown, two pairs of booties and two pairs of chemo certified sterile gloves which are put on in anteroom prior to entering the neg pressure bufferroom. -kas 10 Verify security sealant (shore hardness D) at ALL joints in the ante & 2 clean rooms. Not Approved 5/16/18 – based on documents received 4-18-18, TGB indicates that Finish note # on A2.12 is edited to indicate ALL SEALANT SHALL BE (D-70 OR APPROVED AND COMPLY WITH DOH REQUIREMENTS [REF: COMMENT T12]. PROUCT SPEC: DYNAFLEX SC FLEXIBLE POLYURETHANE OR APPROVED BY DOHCRS. While the ‘note’ is acceptable, the cut sheet defies thenote. Actually the cut submitted indicates it is Shore A55. Suggest following the recommendation on the very cut submitted and supply DynaPoxy in lieu of DynaFlex. -kas Approved 7/10/18 – based on documents received 6-13-18, the supplied cut sheets indicate using DynaPoxy EP-1200 and Sheet A2.12 indicates the same. –kas 11 Verify/indicate where HEPA filters are located for Chemo hood and room exhaust. USP800 Not Approved 5/16/18 – based on documents received 4-18-18, MacDonald-Miller (MM) indicates to 1.SeetheattachedAttachment7ChemoHoodcutsheetforlocationsoftheHEPAfilters. 2.The USP Compounding Expert Committee has eliminated HEPA filtration for the room exhaust (C-SEC) in a revision posted on 15-Apr-2016. See the revision on the USP website: http://www.uspnf.com/notices/hazardous-drugs-handling-healthcare-settings Item #11.1 covers the hood (KAS still needs to verify directly with Jens&Dan) however the room exhaust HEPA must be located/indicated. Item #11.2 has NOT been approved by committee. -kas Not Approved 7/10/18 – based on documents received 6-13-18, the Engineer MM indicates that a roof mounted HEPA filter housing has been added for the Chemo Compounding roomexhaust. the supplied cut sheets indicate an acceptable housing, however, discharge containing ANY hazardous content must follow both requirements of comments # 12 & #17 below (ie-add signage and 10ft discharge). Submit indication of the applicable signage and 10ft discharge on ALL Hazardous Exhaust. The Chemo hood exhaust still must be verified to contain HEPA on the Exhaust side. The common set-up is the HEPA in the hood provides the ‘first air’ to the hood itself creating the ISO 5 from the ISO 7 environment. If there are two HEPA’s on the hood, we will mark which one handles the Exhaust Air and then we’re resolved, otherwise, the hood must be filtered on the exhaust side. –kas 12 Provide permanent signage at roof hazardous exhaust location/s (engraved plastic or similar with text in contrasting color to the sign body) on this project. Approved 5/16/18 – based on documents received 4-18-18, MacDonald-Miller (MM) indicates that Notes to add signage has been added to drawingTM2.03. -kas 13 Provide a copy of the ISO test report final for each of the three clean rooms. Deferred 5/10/18. –kas 14 Provide the Final TAB report once the HVAC work is complete. Deferred 5/10/18. –kas 15 Revise note on Sheet TM2.03 to add the word ‘down’ after slope for the intake duct. Approved 5/16/18 – based on documents received 4-18-18, MacDonald-Miller (MM) indicates that the note has beenrevised. –kas 16 Verify that the 3 clean rooms contain NO FA detection or notification devices. These are immediately adjacent in the main Pharmacy room areas. Approved 5/16/18 – based on documents received 4-18-18, Nowell Ancheta – Stantec confirms there are no FA detection or notification devices in the clean rooms referenced in DOH comment#16. -kas The following comments result from the 4-18-18 submittal. –kas 17 Roof discharge height (above roof) exhaust for EF-05 & EF-06 needs to be 10ft minimum with a vertical discharge and/or verify via WA Licensed Mechanical PE full compliance with 2011 NFPA 45-8.4.12 with exhaust duct construction compliance to NFPA 45-8.5. Not Approved 7/10/18 – based on documents received 6-13-18, the Engineer MM indicates that the exhaust discharge stacks for exhaust fans EF-05 and EF-06 have been extended to 10 ft above the roof. -kas 18 Ref. Sheet A2.12 – Remove ‘06’ from Chemo Workroom, the Haz Gown must discard in ante room (dirty side), the workroom remains sterile process only, nothing stored, especially trash or discarded gowns. Approved 7/10/18 – based on documents received 6-13-18, the Architect has revised sheet A2.12. -kas 19 TAB must indicate/verify that the Main Pharmacy is Positively pressurized to all adjacent spaces (except Ante Room & Positive Buffer Room). Not Approved 7/10/18 – based on documents received 6-13-18, the Engineer MM indicates that airflows on the drawings for the Main Pharmacy and Anteroom have been adjusted so that the Main PharmacyispositivelypressurizedtotheadjacentspacesexcepttheAnteandPositiveBufferRoom. The design table is correct AND Approved, however, the TAB must indicate the same pressurization differentials. This comment will remain ‘open’ until the TAB proves to match the design table. –kas The following comments result from the 6-13-18 submittal. –kas 20 Indicate (on drawings/diagrams) that all exhausts and roof VTR’s are more than 25ft from this new (or any) air intake AND verify that the roof intake is greater than 3ft above the roof deck. ASHRAE 170 – 6 & 7 Compliance with the comments above provided by the Department of Health, Construction Review Services, are necessary for this facility to meet the requirements of the applicable licensing regulations found in the WashingtonState Administrative Code and associated references. These comments do not relieve the facility from the responsibility to meet the requirements of any other applicable federal, state or local regulations. In the event of conflicts between other jurisdictions and these written comments, the most stringent shall apply.