2016 CA Building Code Webinar 2 - FINAL · … direct access to surgical suite’s...

1

2016 Update to the California Building Standards Code Webinar Series

Webinar 2 — Administrative, Architectural, MEP Systems and Pharmacy Provisions

May 15, 2017

Welcome

Amber McEwenCalifornia Hospital Association

2

Credit(s) earned on completion of this course will be reported to AIA CES for AIA members. Certificates of Completion for both AIA members and non-AIA members are available upon request.

This course is registered with AIA CES for continuing professional education. As such, it does not include content that may be deemed or construed to be an approval or endorsement by the AIA of any material of construction or any method or manner ofhandling, using, distributing or dealing in any material or product._______________________________________

Questions related to specific materials, methods, and services will be addressed at the conclusion of this presentation.

Overview and Introductions

Cheri HummelVice President, Emergency Management & FacilitiesCalifornia Hospital Association

3

5

Richard Tannahill is a senior architect with OSHPD with more than 28 years of architectural experience — 23 years of which are in health care project management, and building code and construction administration. Mr. Tannahill is a past board member of the Hospital Building Safety Board and continues to be an active staff participant.

Faculty

6

Scott Karpinen, ME, LEED AP, has more than 23 years of experience in the mechanical engineering design of building heating, ventilating and air conditioning systems. His specialized expertise includes design services for hospitals, surgery centers and medical office buildings. Mr. Karpinen is active in OSHPD work and has been a member of the Hospital Building Safety Board since 2009.

Faculty

4

7

Eric C. Johnson, PE, founded ECOM Engineering, Inc., in 1997. Mr. Johnson is the Principal in Charge and oversees the direction and growth of the company along with the overall financial performance of the firm.

Faculty

8

Diana Scaturro has been a plan review supervisor with OSHPD for more than seven years. Ms. Scaturro currently supervises the Facilities Development Division’s Rapid Review Unit, is an OSHPD technical staff consulting member of the Hospital Building Safety Board committees for Technology, and Education and Outreach, and participates in the committee for Administrative Processes, Code Changes and Standard Details.

Faculty

5

Hospital Building Safety Board

Eric Johnson, PEHBSB Member

Diana ScaturroRapid Review Unit Supervisor, OSHPD

Scott Karpinen, ME, LEED APHBSB Member

Richard TannahillSenior Architect, OSHPD

May 15, 2017

Title 24, Part 1 – CAC

Part 2 – CBC

Part 3 – CEC

Part 4 – CMC

Part 5 – CPC

Sterile Compounding Pharmacies for Hospital Facilities

All-Gender Toilet Facilities

Title 24, Part 1

6

7‐131 Incremental design, bidding and constructionEstimated cost associated with each increment of an incremental project as part of a master plan

7‐133 Fees• Incremental projects — invoiced per increment• Seismic examination for SPC/NPC ratings — $250 + time and

materials (T&M)• Alternate Method of Compliance/Protection (AMC/P) filing

fees — $250• If involving examination on the condition of any hospital building,

including, but not limited to, review for equivalency — T&M

• Additional cost Amended Construction Documents (ACDs) — $250• Cost reduction or no cost ACDs— $500

• Exception is Collaborative Review Process remains at $250

• ACDs for change in scope — $250 + T&M• In lieu of new project

11

Title 24 Part 1 –CAC

7‐141 Administration of constructionClarification on responsibility of testing, inspection and observation programs (TIOs) relative to design professionals and inspectors of record (IORs)

7‐144 Inspection“Lead IOR” shall be identified when there are multiple IORs

7‐149 TestsAmended language to reference “construction” documents instead of “contract” documents

7‐153 Amended construction documents• Retitled the section as “Changes in the Approved Work”

• Change in scope of work due to “Value Engineering” may, at the discretion of the Office, use the ACD process in lieu of applying for a new project. Fees for ACD with change in scope — $250 + T&M

12

Title 24 Part 1 –CAC

7

Title 24, Part 2

11B‐202.4 Path of travel requirements in alterations, additions and structural repairs

If the following elements of a path of travel have been constructed or altered in compliance with the accessibility requirements of the immediately preceding edition of the California Building Code, it shall not be required to retrofit such elements to reflect the incremental changes in this code solely because of an alteration to an area served by those elements of the path of travel:1. A primary entrance to the building or facility,2. Toilet and bathing facilities serving the area,3. Drinking fountains serving the area,4. Public telephones serving the area, and5. Signs

14

Title 24 Part 2 –CBC

8

1224.4 GENERAL CONSTRUCTIONRelocate various support areas for common reference

1224.16 ANESTHESIA SERVICE SPACERestructure perioperative support for clarification

1224.28 SUPPLEMENTAL SURGERY SERVICESAdd hybrid operating rooms and electroconvulsive therapy (ECT) rooms

1224.28.6 ELECTROCONVULSIVE THERAPY Add Section 1224.28.6 ECT Therapy Service Space

1224.33 EMERGENCY SERVICEReformat into three tiers — Standby, Basic and Comprehensive Emergency Medical Service — for better alignment with Title 22 and with Facility Guidelines Institute (FGI) Guidelines

1224.34 NUCLEAR MEDICINEAdd sections to cover: Scintigraphy (Gamma Camera) Facilities, Positron Emission Tomography (PET), Single‐Photon Emission Computed Tomography (SPECT) and Radiosurgery (Cyber‐Knife) Suites

1224.39 OUTPATIENT SERVICE SPACEAdd Section 1224.39.5 Hyperbaric Therapy Service Space

15


Added applicability language

CLEAR DIMENSION. An unobstructed room dimension exclusive of built‐in casework and equipment and available for functional use.

LOCATION TERMINOLOGYADJACENT. Located next to but not necessarily connected to the identified area or room.

DIRECTLY ACCESSIBLE. Connected to the identified area or room through a doorway, pass‐through or other opening without going through an intervening room or public space.

IMMEDIATELY ACCESSIBLE. Available either in or adjacent to the identified area or room.

IN. Located within the identified area or room.

READILY ACCESSIBLE. Available on the same floor as the identified area or room.

16

1224.3 DEFINITIONS


9

Added applicability language

PATIENT CARE LOCATIONS

BAY (patient). A space for human occupancy with one hard wall at the headwall and three soft walls (e.g., cubicle curtains or portable privacy screen).

CUBICLE. A space intended for human occupancy that has at least one opening and no door and is enclosed on three sides with full‐height or partial‐height partitions.

PATIENT CARE STATION. A designated space for a specific patient care function. This term does not imply any structural requirement (e.g., a Post‐Anesthesia Care Unit (PACU) can have 10 patient care stations of which three are rooms, three are cubicles and four are bays).

ROOM. A space enclosed by hard walls and having a door. Where the word “room” or “office” is used, a separate, enclosed space for the one named function is intended. Otherwise, the described area may be a specific space in another room or common area. 17

1224.3 DEFINITIONS (CONT.)


Sections relocated from 1224.14 (NURSING SERVICE SPACE) to GENERAL CONSTRUCTION

1224.4.4 Support areas for patient care

1224.4.4.2 Administrative centers or nurse stations

1224.4.4.4 Medication station1224.4.4.4.1 Medicine preparation room

1224.4.4.4.2 Self‐contained medication dispensing unit

1224.4.4.5 Nourishment area

1224.4.4.6 Clean utility/workroom1224.4.4.6.1 Clean supply room

1224.4.4.7 Soiled utility/workroom1224.4.4.7.1 Soiled holding room

18

1224.4 GENERAL CONSTRUCTION (CONT.)


10

1224.4.6.3 Hyperbaric facilities (Pointer to 1224.39.5)

Table 1224.4.6.1 Station Outlets (Med Gas)• Endoscopy procedure room• Hyperbaric suite• Interventional imaging• Electroconvulsive therapy room

19



1224.4.7 Corridors

1224.4.7.6 Departmental boundariesDepartment/service space areas shall be contiguous and include internal circulation to access each of the rooms/spaces associated with it, as identified under the specific Service Space requirements.

1224.4.9.1 Windows (NICU clarification)Newborn intensive‐care units shall also comply with Section 1224.29.2.13 Daylight.

20



11

Preoperative section to be relocated from 1224.15 to 1224.16

1224.16.1 General (perioperative services) … direct access to surgical suite’s semi‐restricted corridor.

1224.16.2 Preoperative patient holding area

1224.16.3 Recovery and Post‐Anesthesia Care Unit (PACU)

1224.16.5 Support areas for patient care• Nurse station• Clinical sink• Medication station• Ice• Storage

21

1224.16 ANESTHESIA/RECOVERY SERVICE SPACE


1224.16.6 Support areas for staffStaff toilets immediately accessible to PACU

1224.16.7 Support areas for patients, families and visitors

1224.16.7.1 Waiting area

1224.16.7.2 Patient change area• (If outpatient procedures provided)

• Changing or gowning area

• Storing patient’s belongings

• Access to patient toilets

22

1224.16 ANESTHESIA/RECOVERY SERVICE SPACE (CONT.)


12

Added general requirements of Imaging Service Space:• Interventional• Image‐guided• Nuclear medicine

1224.18.2.1 Interventional angiography procedures Pointer to interventional imaging requirements (1224.28.4) in Supplemental Surgery and Special Procedures

1224.18.3.2 Intraoperative computerized tomography (CT)Pointer to hybrid operating rooms (1224.28.5) in Supplemental Surgery and Special Procedures

1224.18.4.6 Intraoperative magnetic resonance imaging (MRI)Pointer to hybrid operating rooms (1224.28.5) in Supplemental Surgery and Special Procedures

23

1224.18 RADIOLOGICAL/DIAGNOSTIC IMAGING SERVICE SPACE


1224.28.2.1.1 Emergency response space for electrophysiology studies

1224.28.4 Interventional imaging(Image‐guided interventional procedures performed in procedure rooms)

1224.28.4.1 Space requirements

1224.28.4.2 Pre‐procedure and recovery

1224.28.4.3 Interventional MRI facilities

1224.28.4.4 Control room or area

1224.28.4.5 Scrub facilities

1224.28.4.6 Medication station

1224.28.4.7 Reading room

1224.28.4.8 Electrical equipment room

1224.28.4.9 Clean utility room

1224.28.4.10 Soiled workroom

1224.28.4.11 Housekeeping

1224.28.4.12 Staff changing areas24

1224.28 SUPPLEMENTAL SURGERY SERVICES


13

1224.28.5 Hybrid operating rooms(Surgical procedures supported by intraoperative imaging modalities)1224.28.5.1 Space requirements

1224.28.5.2 Control room

1224.28.5.3 Imaging equipment room

1224.28.5.4 Radiation protection

1224.28.5.5 Requirements for specific types of hybrid operating rooms

1224.28.5.5.1 CT (Intraoperative Computed Tomography)

1224.28.5.5.2 iMRI (Intraoperative MRI)

1224.28.5.5.3 Vascular imaging

1224.28.5.6 Pre‐procedure and recovery

25

1224.28 SUPPLEMENTAL SURGERY SERVICES (CONT.)


1224.28.6 Electroconvulsive Therapy (ECT when provided)

1224.28.6.1 General

1224.28.6.2 ECT procedure room

1224.28.6.3 Pre‐procedure and recovery area

1224.28.6.4 Emergency equipment storage

1224.28.6.5 Patient support areas

26

1224.28 SUPPLEMENTAL SURGERY SERVICES (CONT.)


14

1224.33.1 Definition

Added language to the service space definition

Three levels of emergency medical service:

Standby Emergency —Medical Service with Physician on Call

Basic Emergency —Medical Service with Physician on Duty

Comprehensive Emergency —Medical Service

27

1224.33 EMERGENCY SERVICE


Covered exterior entrance

Ambulance entrances shall provide 6’‐0” clear

Treatment room

Storage

Lobby

Toilet rooms

Communication (Poison control/EMS)

Observation area

28

1224.33.2 STANDBY EMERGENCY SERVICE


15

… at a minimum, all the provisions of Standby Emergency Service under Section 1224.33.2 and the following shall be provided …

1224.33.3.1 Exterior entrance with direct access from public roads

1224.33.3.2 Patient access

1224.33.3.3 Reception, triage and control station(s)

1224.33.3.4 Wheelchair and gurney storage

1224.33.3.5 Public waiting area

1224.33.3.6 Examination and treatment room(s)

1224.33.3.7 Trauma/cardiac rooms

1224.33.3.8 Orthopedic and cast work

1224.33.3.9 Poison Control Center and EMS communications center

1224.33.3.10 Emergency equipment storage space

1224.33.3.11 Patients’ toilet room

1224.33.3.12 Storage (clean and soiled)

1224.33.3.13 Administrative center or nurses’ station

1224.33.3.14 Staff lounge

1224.33.3.15 Housekeeping room 29

1224.33.3 BASIC EMERGENCY SERVICE


… at a minimum, all the provisions of Standby Emergency Service under Section 1224.33.3 and the following shall be provided …

1224.33.4.1 Triage stations

1224.33.4.2 Fast‐track area

1224.33.4.3 Pre‐screening stations

1224.33.4.4 Diagnostic service areas (imaging)

1224.33.4.5 On‐call room(s)

1224.33.4.6 Police and press room

30

1224.33.4 COMPREHENSIVE EMERGENCY SERVICE


16

1224.33.5 Other space considerations

1224.33.5.1 Observation units *… within the emergency department … shall have:

1. Handwashing stations

2. 120 sq. ft. patient stations

3. Toilet — 1 per 6 treatment stations

4. Admin/Nurse station

5. Nourishment area

31

1224.33 EMERGENCY SERVICE


* Does not include requirements for SB 1076 Outpatient Observation Units

1224.34.1.2 Nuclear medicine room

1224.34.1.2.1 Scintigraphy (Gamma Camera) Facilities

1224.34.1.2.2 Positron Emission Tomography (PET)

1224.34.1.2.3 Single‐Photon Emission Computed Tomography (SPECT) Facilities

1224.34.2 Support areas for nuclear medicine services

1224.34.2.6 Pre‐procedure/holding area

1224.34.2.14 Hot lab for scintigraphy (gamma camera), PET and SPECT facilities

32

1224.3 NUCLEAR MEDICINE


17

1224.34.3 Radiotherapy service space

1224.34.3.3 Room sizes (Clarified criteria)

1224.34.5 Additional support areas for cobalt room

1224.34.5.1 Hot lab (Added pointer)

1224.34.6 Radiosurgery suite (Gamma knife & cyber knife)

1224.34.6.1 General (Located near imaging services)

1224.34.6.2 Radiosurgery treatment rooms

1224.34.6.3 Pre‐procedure/recovery accommodations

1224.34.6.4 Support areas for radiosurgery treatment rooms

33


1224.34 NUCLEAR MEDICINE (CONT.)

1224.39.5 HYPERBARIC THERAPY SERVICE SPACE (oxygen therapy service)

1224.39.5.1 General

1224.39.5.2 Hyperbaric chambers

1224.30.5.2.1 Class A chamber (multi‐place facilities)

1224.39.5.2.2 Class B chamber (mono‐place facilities)

1224.39.5.3 Pre‐procedure patient holding area(s)

1224.39.5.4 Medical gas station outlets

1224.39.5.5 Support areas for the hyperbaric suite

1224.39.5.6 Support areas for staff

1224.39.5.7 Support areas for patients

34

1224.39 OUTPATIENT SERVICE SPACE


18

1225.5.1 MEDICAL MODEL

1225.5.1.2 NURSING SERVICE SPACE

1225.5.1.2.1 Patient bedrooms (Amend language to agree with language in 1224.14)

35

1225 [OSHPD 2] SKILLED NURSING FACILITIES


1226.5 OUTPATIENT CLINICAL SERVICES OF A HOSPITAL

1226.5.14 Hyperbaric therapy service space(Point to same sections in Section 1224.39.5)

1226.5.14.1 General

1226.5.14.2 Hyperbaric chambers

1226.5.14.3 Pre‐procedure patient holding area(s)

1226.5.14.4 Medical gas station outlets

1226.5.14.5 Support areas for the hyperbaric suite

1226.5.14.6 Support areas for staff

1226.5.14.7 Support areas for patients

36

1226 [OSHPD 3] CLINICS


19

1226.6 PRIMARY CARE CLINICS

1226.6.1.3 Dental examination and treatment areas

1226.6.1.3.1 Area

1226.6.1.3.2 Pediatric patients

1226.6.1.3.3 Handwashing

1226.6.1.3.4 Imaging

1226.6.1.4 Oral surgery

1226.6.2.6 Sterilization facilities

1226.6.2.7 Laboratory

37

1226 [OSHPD 3] CLINICS (CONT.)


1226.8 SURGICAL CLINICS

1226.8.1.2 Perioperative services(Pointer to revised Section 1224.16)

38

1226 [OSHPD 3] CLINICS (CONT.)


20

Title 24, Part 3

352.12. Uses Not Permitted

• Repeal restriction for [OSHPD 1, 2, 3 & 4]

• Inadvertently added to the 2010 California Electrical Code (CEC)

• Not necessary

40

ARTICLE 352 RIGID POLYVINYL CHLORIDE CONDUIT (PVC)

Title 24 Part 3–CEC

21

517.2 Definitions

Patient Care SpaceAmended to respond to changes in the National Electrical Code (NEC)

517.19 (B) Critical Care Areas – Patient Bed Locations ReceptaclesRepealed — no longer necessary due to changes in the NEC

517.30 (B) Essential Electrical Systems for Hospitals – GeneralRenumbering and editorial changes due to changes in the NEC

41

ARTICLE 517 HEALTH CARE FACILITIES


517.18 General Care Areas

(B) Patient Bed Location Receptacles. Each patient bed location shall be provided with a minimum of four eight receptacles. They shall be permitted to be of the single, duplex or quadruplex type or any combination of the three. All receptacles shall be listed “hospital grade” and shall be so identified. The grounding terminal of each receptacle shall be connected to an insulated copper equipment grounding conductor sized in accordance with Table 250.122.

42

ARTICLE 517 HEALTH CARE FACILITIES (CONT.)


22

517.19 Critical Care Areas

(B) Patient Bed Location Receptacles

(1) Minimum Number and Supply. Each patient bed location shall be provided with a minimum of six 14 receptacles, at least one of which shall be connected to either of the following:

(1) The normal system branch circuit required in 517.19(A)

(2) A critical branch circuit supplied by a different transfer switch than the other receptacles at the same patient bed location.

Exception No.1: [OSHPD 1, 2, & 4] Each intensive care newborn nursery bed equivalent and each bed location in intensive care and coronary care units shall be equipped with at least 10 single or 5 duplex receptacles listed "Hospital Grade" and so identified; each receptacle shall be grounded to the reference grounding point by means of an insulated grounding conductor.

43



517.19 Critical Care Areas (cont.)

(C) Operating Room Receptacles

(1) Minimum Number and Supply. Each operating room shall be provided with a minimum of 36 receptacles, at least 12 of which shall be connected to either of the following:

(1) The normal system branch circuit required in 517.19(A)

(2) A critical branch circuit supplied by a different transfer switch than the other receptacles at the same location

(2) Receptacle Requirements. The receptacles required in C(517.19)(1) shall be permitted to be of the single or duplex types or a combination of both.

All receptacles shall be listed hospital grade and so identified. The grounding terminal of each receptacle shall be connected to the reference grounding point by means of an insulated copper equipment grounding conductor.

44



23

517.30 Essential Electrical Systems for Hospitals

(D) Capacity of Systems

Editorial changes due to changes in the NEC

517.123 [OSHPD 1, 2, 3 & 4] Call Systems

(B) Patient Stations

Added Exception that two‐way voice communication is not required at skilled nursing bed locations

45



700.3 Tests and Maintenance

(A) Conduct or Witness Test

Renumbering editorial changes due to changes in the NEC. Specific editions of NFPA 99 & NFPA 110 repealed for consistency with California Building Code Reference Standards

46

ARTICLE 700 EMERGENCY SYSTEMS


24

Title 24, Part 4

Numerous sectionsRenumbering due to changes in the Uniform Mechanical Code (UMC)

325.1.1 320.1.1 (Air Conditioning and Heating systems)Added requirement for humidifiers to use dry steam

325.1.2 320.1.2 (RE: area heating not shown on Table 320.0)Revised American Society of Heating, Refrigerating and Air‐Conditioning Engineers (ASHRAE) references to “most recent version”

325.1.3 320.1.3 (RE: area cooling not shown on Table 320.0)Revised ASHRAE references to “most recent version”

Table 325.0 320.0 Heating, Cooling & Relative HumidityRevised Table to reflect revisions made to ASHRAE 170

CHAPTER 3 GENERAL REQUIREMENTS

48

Title 24 Part 4–CMC

25

Various sectionsRemoved the edition year from ASHRAE standard references

408.1.5 (Filters)Added reference to ASHRAE Handbook for “dry steam”

416.1 (Alarms)Minimum pressure differential changed to “0.01 of water”

Table 4‐A (Pressure/ventilation requirements) Table 4‐B (Filter requirements)

Numerous room changes to align with ASHRAE 170

49

CHAPTER 4 VENTILATION AIR


Various sectionsMinor editorial changes

602.3.1 602.6.1 Flexible DuctsRenumbering due to changes in the Uniform Plumbing Code (UPC)

50

CHAPTER 6 DUCT SYSTEMS


26

Title 24, Part 5

310.0 Prohibited Fittings and Practices

310.10 Added: … handwashing fixtures shall not be installed in operating and delivery rooms.

321.0 Essential Plumbing Provisions [OSHPD 1, 2, 3 (surgical clinics) & 4]321.1 Domestic water booster pumps321.2 Domestic hot water circulating pumps321.3 Sewage ejector pumps321.4 Sump pumps and drainage pumps321.5 Domestic water heating equipment and controls321.6 Fuel pumps321.7 Grease removal devices requiring electric power

52

CHAPTER 3 GENERAL REQUIREMENTS

Title 24 Part 5–CPC

27

403.3 412.0 Urinals

403.3.1 412.1.3 Nonwater UrinalsRepealed exception for [OSHPD 1, 2, 3 & 4]. Renumbering due to changes in the UPC

413.3.2 Flushometer ValvesRenumbering due to changes in the UPC

Table 4‐2Added footnote 2 (conventional spouts & controls …) to Dialysis patient toilet

53

CHAPTER 4 PLUMBING FIXTURES & FITTINGS


605.3.3.2 605.1.3.2 Pressed FittingsRepealed exception for [OSHPD 1, 2, 3 & 4]

614.0 Dialysis Water‐Distribution Systems614.1 [OSHPD 1, 2, 3 & 4]

Branch lines may be Perfluoroalkoxy (PFA)

54

CHAPTER 6 WATER SUPPLY & DISTRIBUTION


28



TABLE OF CONTENTS

• Sterile Compounding Environment Types

• Code Reference Index

• Definitions

• Title 16, Division 17 Code References — select excerpts

• Title 24, Parts 2, 3, 4 and 5 Code References — select excerpts

• USP <797> — select requirements for sterile compounding

• USP <800> — select requirements for hazardous sterile compounding

• OSHPD Submittal Instructions

• Sterile Compounding Pharmacy Checklist

Sterile Compounding Advisory Guide

56

29

STERILE COMPOUNDING ENVIRONMENT TYPES

Non-Hazardous Sterile Compounding regulations set standards for an appropriate sterile environment for mixing compounded sterile products that present no hazard to the compounding technician/pharmacy staff.

Hazardous Sterile Compounding regulations set standards for an appropriate sterile environment for mixing compounded sterile products that present a health hazard to the compounding technician/pharmacy staff, and must also limit outside environmental exposure to adjoining rooms and at all ventilation discharge locations. Refer to “Hazardous” in the definitions, below, for application of this designation.

RED — Code sections designated in red are direct code requirements supported by California Building Standards Code (Title 24).

PURPLE — Code sections designated in purple are indirect code requirements as standards referenced by the CBSC. These include requirements associated with Board of Pharmacy (BoP) Title 16 §1735 & §1751 and USP <797> & <800>. Although not direct requirements, they are referenced by the CBSC and will need to be in compliance for licensure by the BoP and/or for CMS survey compliance.

BLUE — Items designated in blue are strongly recommended items and/or practical support of submitted project programmatic requirements.

BLACK — Black text is generally provided for reference and context.

CODE REFERENCE INDEX


58

30

BEYOND USE DATE

The date, or date and time, after which administration of a compounded drug preparation shall not begin, the preparation shall not be dispensed, and the preparation shall not be stored (other than for quarantine purposes).

When/How to Get a Number• eCA — electronically• Paper application

What’s Required• Functional program• Checklist (suggested)• Application for Plan Review (if paper submittal)• Construction documents & TIO or preliminary submittal

Length of UseMust submit preliminary or final construction documents within 10 business days or project number will be cancelled


OSHPD SUBMITTAL

Process and Requirements

60

31

PurposeTo achieve compliance with the BoP requirements

Basic Service• Sterile compounding must be located within hospital-compliant

space and within limitations set forth by 1735 and 1751• Interim provisions during construction to be defined, if applicable

Functional Program (CAC 7-119)Defines basis of design and plan review

Mechanical Systems• ISO Class requirement• HVAC equipment & placement


INITIAL PROJECT SCOPINGSetting the Basis of Design

61

Primary Engineering Control (PEC)• Positive/negative• ISO Class 5

Buffer/Clean Room• Positive/negative• ISO Class varies

Ante-Room• Positive/negative• ISO Class varies

Hazardous ExhaustPathway through all levels to roof

Donning/Doffing Provisions

Cleaning Processes/Supply Provisions

Exiting


INITIAL PROJECT SCOPINGKey Design Elements

62

* If modular units are being considered, they must meet all enforceable codes of CAN 1-0.

32


63

INITIAL PROJECT SCOPINGKey Design Elements (cont.)


STERILE COMPOUNDING PHARMACY CHECKLIST

64

33

Types: Laminar Air Flow Hoods (LAFW), Biological Safety Cabinets (BSC), Compounding Aseptic Isolators (CAI), Compounding Aseptic Containment Isolator (CACI)

Ventilation Classification• Minimum ISO Class 5 environment• Laminar airflow/non‐turbulent• Positive or negative pressure per specific environment type• Discharge/exhaust per the specific requirements of intended use

Finishes: Subject to wet cleaning

Accessibility: Employee Work Station [11B‐203.9] Provide common use circulation, turning area & door clearance

Electrical Power: Critical branch power source

Structural — Seismic• PEC stands/bases require OSHPD Preapproval of Manufacturer’s Certification

(OPMs) or structural calculations• All roof‐mounted ventilation/exhaust equipment must be anchored and seismically

certified (refer to PIN 55).


GENERAL REQUIREMENTS

Compounding Work Station (PEC)

65

Mechanical Equipment and Ventilation• ISO Class, pressure differentials and additional ventilation/exhaust per the requirements of the specific environment types

• Laminar air flow with ceiling supply and low‐level return/exhaust• Electrical power — equipment branch power source • Structural — All roof‐mounted ventilation/exhaust equipment must be anchored and seismically certified (refer to PIN 55).

Controlled Room Temperature20‐24 degrees Celsius (68‐75 degrees Fahrenheit) or cooler to be maintained for personnel

Sealed‐Tight Room with Automatic/Self‐Closing DoorsSimilar to an airborne infection isolation room [1224.4.4.1.3] (except for segregated buffer areas)



Buffer Room/Clean Room (SEC)

66

34

Finishes• Ceilings, walls and floors to be non‐porous and cleanable surfaces subject to

wet cleaning.o Shall be smooth, impervious, free from cracks and crevices, and non‐shedding

o The surfaces shall be resistant to damage by disinfectant agents

• Work surfaces shall be constructed of smooth, impervious materials, such as stainless steel or molded plastic, so that they are easily cleaned and disinfected.

• Carts should be of stainless steel wire, non‐porous plastic or sheet metal construction with cleanable casters to promote mobility.

• Storage shelving, counters and cabinets shall be smooth, impervious, free from cracks and crevices, non‐shedding, cleanable and disinfectable.

• The exterior lens surface of ceiling lighting fixtures should be smooth, mounted flush and sealed.



Buffer Room/Clean Room (SEC) (cont.)

67

Sources of Water (Sinks) or Floor Drains are Not Permitted in the Buffer Room/Area

Eyewash Station• Required wherever there is compounding and mixing• May either be placed in Buffer Room or Ante‐area• When placed in the Buffer Room, it should be located just inside the

door and at least one meter from the rim of the sink to the PEC• No drains are permitted within the Buffer Room/Area, thus the

eyewash must be “dry” unless in use

Refrigerator • Essential power required within the Buffer Room or Ante‐area• For segregated environments, refrigerator to be in Ante‐area• Provide critical branch power source




68

35

Dedicated Environmental Services (cleaning materials & supplies for Buffer Room & Anteroom)

• All cleaning materials, such as wipers, sponges and mops, shall be nonshedding, preferably composed of synthetic microfibers and dedicated to use in the buffer or clean area, Ante‐area and segregated compounding areas, and shall not be removed from these areas except for disposal.

• Floor mops may be used in both the buffer or clean area and ante‐area, but only in that order. [USP <797>]

Accessibility — Employee Work Station [11B‐203.9] Provide common use circulation, turning area & door clearance

Egress Through Intervening Spaces [CBC 1016.2] Sterile compounding pharmaceutical spaces located within “I‐2” occupancies are not considered “habitable rooms” and not subject to the requirements regarding direct corridor access. [OSHPD CAN 2‐407.4.1]




69

Mechanical Equipment and Ventilation • ISO Class, pressure differentials and additional ventilation/exhaust per the requirements of the specific environment types

• Electrical power

• Equipment branch power source

• Structural — All roof‐mounted ventilation/exhaust equipment must be anchored and seismically certified (refer to PIN 55).

Controlled Room Temperature 20‐24 degrees Celsius (68‐75 degrees Fahrenheit) or cooler to be maintained for personnel [1751.4(k)]



Ante-Area

70

36

Donning and Doffing AreaRefer to processes in Board of Pharmacy and United States Pharmacopeia (USP) regulations for non‐hazardous and hazardous donning and doffing

• Seating and/or other provisions for gowning at Demarcation Line to restricted area

• Storage for both sterile and contaminated gowns, gloves & booties

FinishesNon‐porous and cleanable surfaces, ceilings, walls and floors, subject to wet cleaning

• 1250.4(2), 1735.6(e)(4), 1751.4(d) — Smooth, seamless, impervious and non‐shedding

• Floors —Wet Cleaning — not affected by cleaning solutions

• Floors and Wall Bases —Wet Cleaning — coved, monolithic without joints (similar to operating room)

• Wall Finishes (similar to sterile supply) —washable, smooth and able to withstand cleaning with chemicals

• Ceilings (restricted area) —monolithic, scrubbable and able to withstand cleaning and/or disinfecting chemicals



Ante-Area (cont.)

71

Eyewash Station• Required wherever there is compounding and mixing• May either be placed in Buffer Room or Ante‐area

Refrigerator • Essential power required within the Buffer Room or Ante‐area [1751(b)(4)]• For segregated environments, refrigerator to be in Ante‐area

Provide critical branch power source. [517(A)(9)]

Dedicated Environmental Services (cleaning materials & supplies for Buffer Room & Anteroom)

• All cleaning materials, such as wipers, sponges and mops, shall be nonshedding, preferably composed of synthetic microfibers and dedicated to use in the buffer or clean area, ante‐area, and segregated compounding areas and shall not be removed from these areas except for disposal. [1751.4(d)(4)]

• Floor mops may be used in both the buffer or clean area and ante‐area, but only in that order. [USP <797> ]



Ante-Area (cont.)

72

37

Accessibility — Employee Work Station [11B‐203.9] Provide common use circulation, turning area & door clearance.

Egress Through Intervening SpacesSterile compounding pharmaceutical spaces located within “I‐2” occupancies are not considered “habitable rooms” and not subject to the requirements regarding direct corridor access. [OSHPD CAN 2‐407.4.1]



Ante-Area (cont.)

73

Hazardous Hazardous Segregated

Hazardous/Non‐Hazardous

Non‐Hazardous SegregatedNon‐Hazardous

SPECIFIC ENVIRONMENT TYPES

74

38



75

Sterile Non-Hazardous

Meets the general requirements

ISO Class 5 — Positive Pressure through non‐turbulent, laminar‐flow, HEPA‐filtered “first air”

• LAFW [USP <797>]

• CAI [1735.1(g)]


Sterile Non-HazardousCOMPOUNDING WORK STATION (PEC)

76

39


ISO‐7 — Positive Pressure HEPA‐filtered [USP <797>4.1]

• Supply air to room to be minimum of 50% (i.e., 15 ACPH) HEPA‐filtered air. Total air changes per hour (ACPH) may be augmented by the ISO Class 5 PEC not to exceed 50% (i.e., 15 ACHP)

• 30 ACPH minimum

• Positive 0.02 to 0.05 in water column (w.c.) vs. all adjacent areas/spaces

• Continuous monitoring


Sterile Non-HazardousBUFFER ROOM / CLEANROOM (SEC)

77

Meets the general requirements with exceptions as noted in Advisory Guide

ISO Class 8 or better — Positive Pressure HEPA‐filtered

• 30 ACPH minimum



Sterile Non-HazardousANTE‐AREA

78

40



79

Segregated Sterile Non-Hazardous


• LAFW [USP <797>]

• CAI [1735.1(g)]


Segregated Sterile Non-HazardousCOMPOUNDING WORK STATION (PEC)

80

41

Meets the general requirements with exceptions as noted in the Advisory Guide

No ISO Class required — Unclassified

Separation between Ante‐Area and Buffer Area shall be a minimum of a one‐meter perimeter around PEC to define Buffer Area

Shall not be in a location that has unsealed windows or doors that connect to the outdoors, with high traffic flow, or that is adjacent to construction sites, warehouses or food preparation

Sealed‐tight room with automatic self‐closing doors not required

Cleanroom finishes applicable within designated buffer area only


Segregated Sterile Non-HazardousBUFFER AREA / CLEANROOM AREA (SEC)

81

Meets the general requirements with exceptions as noted in the Advisory Guide

No ISO Class required —Unclassified

Cleanroom finishes not required


Segregated Sterile Non-HazardousANTE‐AREA WITHIN (SCA)

82

42



83

Sterile Hazardous


Certified Class II Type A or Class II Type B vertical laminar airflow hood with bag in–bag out design

Contaminated air plenums that are under positive air pressure are leak tight

ISO Class 5 —Negative Pressure through non‐turbulent, laminar‐flow, HEPA‐filtered “first air.” Must operate continuously

• Biological Safety Cabinet (BSC)• Containment Aseptic Compounding Isolator (CACI)

Exhaust — 100% dedicated direct exhaust to exterior Recommended one dedicated exhaust per each PEC


Sterile HazardousCOMPOUNDING WORK STATION (PEC)

84

43


Hazardous drug compounding shall be completed in an externally vented physically separate room with fixed walls

ISO 7 —Negative HEPA‐filtered• 30 ACPH minimum

• Negative 0.01 to 0.03 in water column (w.c.) relative to the ante‐room


Exhaust — 100% exhaust to exterior


Sterile Hazardous BUFFER ROOM / CLEANROOM (SEC)

85

Meets the general requirements for Ante‐Area and general requirements for ventilation shown in Buffer Area

Must have fixed walls

ISO Class 7 — Positive Pressure HEPA‐filtered • 30 ACPH minimum

• Positive at least 0.02 in water column (w.c.) relative to all adjacent unclassified areas


Handwash sink capable of washing up to elbows shall be at least one meter away from the door to the Buffer Room


Sterile HazardousANTE‐AREA

86

44



87

Segregated Sterile Hazardous

Meets the requirements of the Sterile Hazardous environment above


Segregated Sterile HazardousCOMPOUNDING WORK STATION (PEC)

88

45

Meets the Buffer Room requirements of the Sterile Hazardous environment, except as noted in the Advisory Guide

Unclassified —Negative pressure• 12 ACPH minimum

• Negative 0.01 to 0.03 in water column (w.c.) relative to all adjacent spaces


• Maintain airflows from clean to less clean areas

Separation between Ante‐Area and buffer area shall be established at a minimum of one meter around PEC to define Buffer Area


Segregated Sterile HazardousBUFFER AREA / CLEANROOM AREA (SEC)

89

Meets the general requirements for an Ante‐Area and the environmental requirements of the shared Hazardous Sterile Buffer Area, except as noted in the Advisory Guide

Cleanroom finishes not required


Segregated Sterile HazardousANTE‐AREA

90

46



91

Hazardous & Non-Hazardous Buffer Rooms with Shared Anteroom

COMPOUNDING WORK STATION (PEC)

For non‐hazardous compounding refer to that environment, above.

For hazardous compounding refer to that environment, above.

BUFFER ROOM / CLEANROOM (SEC)

For non‐hazardous compounding refer to that environment, above.

For hazardous compounding refer to that environment, above.

ANTE‐AREA

Consideration should be given to separate dedicated Ante‐areas for HD and Non‐HD Buffer Rooms, so that contamination affecting one Ante‐area allows the other to remain in use.

Meets the requirements of Sterile Compounding Ante‐Area, above.


Hazardous & Non-HazardousBuffer Rooms with Shared Anteroom

92

47

Use the Guide!!!

Complete and thorough Functional Program

Complete and thorough Checklist with Sheet/Detail Information

Preliminary Submittal (optional)

Complete and thorough Construction Documents

Expedient Back Check responses

Comprehensive Project Schedule

◔ Project scoping and design

◑ Plan review and permitting

◕ Construction duration

● Licensing and acceptance


STEPS TO IMPROVE OSHPD REVIEW, CONSTRUCTION AND LICENSURE

93

www.oshpd.ca.gov/FDD/Training_Education/index.html


94

48

AB 1732 — CHAPTER 818, STATUTES of 2016

95

SIGNAGE — OSHPD FREER MANUAL

*

*Revised 02/01/2017

96

49

The minimum number of required fixtures per user group and accessibility provisions have not changed (see UPC Table 4‐2).

Separate toilet facilities shall be provided for the use of patients, staff personnel and visitors (CPC 422.2.1).

97

All‐Gender Toilet Facilities –PIN 65

OSHPD’S ROLE

DSA BULLETIN — ALL‐GENDER TOILET FACILITIESREQUIREMENTS (AB 1732)

https://www.documents.dgs.ca.gov/dsa/bulletins/BU_17‐01.pdf

98

50

Where existing toilet rooms or bathing rooms do not comply with Section 11B‐603 (i.e., are not accessible), directional signs indicating the location of the nearest accessible toilet room or bathing room within the facility shall be provided per CBC Section 11B‐216.8.

Signs shall comply with Section 11B‐703.5 for visual characters and shall include the International Symbol of Accessibility complying with Section 11B‐703.7.2.1.

99

All‐Gender Toilet Facilities –PIN 65

SIGNAGE

Thank You

Richard TannahillSenior Architect, OSHPD, and former HBSB [email protected]

Scott Karpinen, ME, LEEP APSenior Mechanical Engineer, Frank M. Booth, Inc. and HBSB [email protected]

Eric C. Johnson, PEPresident, ECOM Engineering, Inc., and HBSB [email protected]

Diana ScaturroArchitect and Supervisor, Health Facilities ReviewFacilities Development Division, [email protected]

100

51

Questions

Online questions:Type your question in the Q & A box, hit enter

Phone questions:To ask a question, hit *1

Upcoming Programs

2016 Update to the California Building Standards Code Webinar Series

Webinar 3 — Structural ProvisionsMay 22, 2017, 1:30 – 3:30 p.m., Pacific Time

For additional information, visit www.calhospital.org/2016-CBSC-updates.

52

Thank You and Evaluation

Thank you for participating in today’s seminar. An online evaluation will be sent to you shortly. Full attendance and completion of the online evaluation and attestation are required to receive CEs. CEs are complimentary and available for the registrant only.

For education questions, contact Amber McEwen at (916) 552-7578 or [email protected].

2016 CA Building Code Webinar 2 - FINAL · … direct access to surgical suite’s...

Documents

Transcript of 2016 CA Building Code Webinar 2 - FINAL · … direct access to surgical suite’s...