HomeMy WebLinkAboutGateway Arthrex 121311
To:Vail Gateway Building Legal File
From:Town of Vail Community Development Department
Date:December 15, 2011
Subject:Arthrex, Inc. Professional Office- Vail Gateway Building Unit C-10
SUMMARY
The purpose of this memorandum is to provide a summary of the approved use, the zoning regulations, building permit review processes, findings and an overview of the Arthrex, Inc. processes
and procedures.
Arthrex, Inc., a national company, provides products and services for orthopaedic surgeons. Arthrex, Inc. provides new product innovation in arthroscopic surgery and minimally invasive
orthopaedic surgical procedures. The Arthrex, Inc. Vail office is 2,127 in size and consists of two rooms:
A lecture room for presentations on the use of Arthrex, Inc. surgical devices.
A training room with table-like stations used for surgical device training.
As more fully explained below, the Town of Vail has determined the use is consistent with Vail Town Code.
ZONING REGULATION REVIEW PROCESS
Staff determined that Arthrex, Inc. is a professional office use. Staff’s determination is based upon the following findings:
The Vail Gateway Building is located at 12 Vail Road, Vail, Colorado.
Commercial Unit C-10 exists within the Vail Gateway Building.
According to the Official Zoning Map of the Town of Vail, the Vail Gateway Building is located within the Commercial Service Center (CSC) District.
Section 12-7E-3, Permitted Uses, states, in part, the following uses shall be permitted in the CSC district: Professional offices, business offices, and studios.
According to Section 12-2-2, Definitions of Words and Terms, Vail Town Code, the definition of Professional Office is as follows: “An office for the practice of a profession, such as
offices of physicians, dentists, lawyers, architects, engineers, musicians, teachers, accountants, and others who through training are qualified to perform services of a professional
nature, where storage, sale, or display of merchandise on the premises occupies less than ten percent (10%) of the floor area.”
The Arthrex, Inc. building permit application was for a remodel of an existing professional office space within Commercial Unit C-10. The application did not include changes to the exterior
of the building or additional interior square footage.
Pursuant to Section 12-7E-2, Requirements for Establishment; Development Plan, Subsection C, Plan To Be Guide: “The development plan shall be used as a guide for the subsequent development
of sites and the design and location of buildings and grounds within the zone district. All plans subsequently approved by the design review board in accordance with chapter 11 of this
title shall substantially conform to the development plan adopted by the town council.”
Based on the Approved Development Plan for the Vail Gateway Building, a professional office use is permitted in Commercial Unit C-10.
A change in use of Commercial Unit C-10 was not proposed by the applicant, therefore no joint property owner signature(s) or notice was required.
The professional office use complies with the applicable provisions of Article 12-7E, Commercial Service Center (CSC) District, Sections 12-7E-1 through 12-7E-13, Vail Town Code.
Because the land use did not change, no additional parking was required for the new professional office. A parking analysis is included in Attachment B of this memorandum.
Further, Staff conducted a comparative zoning analysis of Arthrex, Inc. locations in Naples, FL, Scottsdale, AZ, Los Angeles, CA, and New York, NY, which is summarized in Attachment
A of this memorandum. In summary, the Staff found that similar Arthrex, Inc. offices are located within zone districts permitting medical offices.
BUILDING PERMIT REVIEW PROCESS
On August 12, 2011, the Town of Vail Community Development Department issued Building Permit B11-0274 for the alteration of Commercial Unit C-10, Vail Gateway Building. The issuance
of the building permit was based on the following findings:
Pursuant to Section 107.1, Submittal Documents, General, International Building Code 2009 Edition, “Submittal documents consisting of construction documents, statement of special inspections,
geotechnical report and other data shall be submitted in two or more sets with each permit application. The construction documents shall be prepared by a registered design professional
where required by the statutes of the jurisdiction in which the project is to be constructed. Where special conditions exist, the building official is authorized to require additional
construction documents to be prepared by a registered design professional.”
Pursuant to Section 107.2.1, Information on Construction Documents, International Building Code 2009 Edition, “Construction documents shall be dimensioned and drawn upon suitable material.
Electronic media documents are permitted to be submitted when approved by the building official. Construction documents shall be of sufficient clarity to indicate the location, nature
and extent of the work proposed and show in detail what it will conform to the provisions of this code and relevant laws, ordinances, rules and regulations, as determined by the building
official.”
Pursuant to Section 107.3, Examination of Documents, International Building Code 2009 Edition, “The building official shall examine or cause to be examined the accompanying submittal
documents and shall ascertain by such examinations whether the construction indicated and described is in accordance with the requirements of this code and other pertinent laws or ordinances.”
Pursuant to Section 304, Business Group B, International Building Code 2009 Edition, the professional office use is classified as a Business Group B occupancy.
Based on Occupancy Type B, the maximum occupant load is 22 people for exiting purposes.
Pursuant to Section 107, Submittal Requirements, International Building Code 2009 Edition, Vail Town Code and standard Vail practices, nothing requires homeowners association signature(s)
or notice for the issuance of a building permit in the Town of Vail.
Building Permit B11-0274 complies with Title 10, Building Codes, Section 10-1-2, Codes Adopted By Reference, Subsections A through J, Vail Town Code.
Pursuant to Section 113.2, International Building Code 2009 Edition, Board of Appeals – Limitations on Authority, “An application for appeal shall be based on a claim that the true intent
of this code or the rules legally adopted thereunder have been incorrectly interpreted, the provisions of this code do not fully apply or an equally good or better form of construction
is proposed. The board shall have no authority to waive requirements of this code.”
ARTHREX, INC. SPECIMEN HANDLING AND DISPOSAL PROCESS
The Town of Vail Community Development Department has researched the specific office processes and procedures of Arthrex, Inc. The following pages summarize the results of our research.
MedCure will provide all cadaver specimens used in this office.
The specimens have a complete serology history, are certified free of pathological diseases, arrive free of blood and are frozen. Testing for HEP B, HEP C, HIV 1 and HIV 2 is completed
and the results are provided.
Prior to shipping, an irrigation process is performed to inhibit bacterial growth and eliminate odors on each specimen.
A tracking number is included with each specimen.
A plastic stamp is attached to the specimen with a number that matches up to the serology report.
As the doctor steps up to a training station, an Arthrex, Inc. representative verifies the tracking number with the doctor.
After training, each specimen is placed in a bag, re-frozen and picked up by Stericycle for incineration.
Stericycle provides Arthrex, Inc. a chain of custody report for each specimen to confirm the incineration.
Below are the chemical cleaning agents proposed to be used at the Arthrex, Inc. facility including two (bold print) used to clean and sanitize instruments and tools using an on site
commercial dishwasher (Hobart Series Dishwasher) typically used in restaurants:
Clorox Regular Bleach
ECO- SAN (dishwasher detergent)
Formula 409 Glass and Surface Cleaner
Jasco Premium Paint Remover
Liquid Spearhead (dishwasher rinse detergent)
Sheila Shine Product Type (Metal Polish)
Simple Green All-purpose Cleaner, Simple Sunshine Makers, Inc.
Green Scrubbing Pad
Virex 256
WD-40 Aerosol
Windex Original Glass Cleaner
All training stations are cleaned, specimens bagged, re-frozen, and disposed of in accordance with Universal Precautions for Bloodborne Pathogen Preventive Procedures. All bio-waste
is picked up by Stericycle, Inc. for incineration.
See Attachment C for the Arthrex, Inc. company policy and Attachment D for the Stericycle service agreement. All MSDS forms for chemicals used at the Arthrex, Inc. facility are in Attachment
E.
SANITATION AND HOUSEKEEPING
ECO-San and Liquid Spearhead are the detergent and rinse used in the “Hobart Series Dishwasher”. The devices surgeons use on specimens are washed in these units using the two detergents.
All devices are rinsed before being placed into the dishwasher. All specimen parts are placed in the designated disposal bags to be picked up by Stericycle and incinerated at their
Dacono, Colorado facility. No specimens are disposed of in the sanitary sewer drain or into the dishwasher. The dishwasher discharges into the sanitary sewer as required by the Vail
Town Code. Based on standards and protocols, there are no odors associated with the use of specimens before or after training exercises. According to Arthrex, Inc., their offices have
not had an odor complaint during their 27-years of business.
WASTE DISPOSAL
All biological waste is disposed in a manner superior to a typical doctor’s office. A doctor’s office previously occupied the Arthrex, Inc. space.In this instance, specimens arrive
with a complete serology history proving there is no pathological exposure. By all standards, this is an extremely clean process which uses no hazardous chemicals and omits no dangerous
or offensive odors.
The specimens used by Arthrex, Inc. arrive in the office certified pathogen free and handled in accordance with bio-hazard handling and disposal requirements. The Arthrex, Inc. biological
disposal process is superior to a doctor’s office since a professional bio-hazardous waste disposal company handles and properly disposes all bio-waste generated from training exercises.
Conversely, patients visiting a doctor’s office for diagnosis and treatment enter the Vail Gateway Building carrying pathogens and/or illnesses.
ATTACHMENTS
Zoning Analysis of Arthrex, Inc. in other locations
Parking Analysis
Arthrex, Inc. company policy
Stericycle service agreements
Applicable MSDS forms
Relevant emails to the Town of Vail regarding Arthrex, Inc.
Attachment A: Zoning Analysis of Arthrex, Inc. in other locations:
Location
Jurisdiction
Local Zone District
Applicable Land Use
Definition of Land Use
Source of Information
1370 Creekside Boulevard
Naples, FL 34108
Collier County, FL
CPUD
Permitted Use:
Manufacturing/office
No definition
Collier County website:
http://www.colliergov.net/Index.aspx?page=128
McDowell Mountain Medical Plaza
9377 East Bell Rd.
Ste 119
Scottsdale, AZ 85260
City of Scottsdale
C-3/ PCD
Permitted Use: Medical or dental office including laboratory.
No definition
Louisa Garbo
480-312-2671
City of Scottsdale
Kerlan-Jobe Orthopaedic Clinic
6801 Park Terrace Drive
Ste 120
Los Angeles, CA 90045
City of LA
C2-1, R1-1
Medical office
No definition
Los Angeles Planning Department website:
http://cityplanning.lacity.org
East Coast Surgical Skills Training CenterSurgiCare of Manhattan, LLC800 2nd Avenue7th FloorNew York, New York 10017
City of NY
C5-2
Offices, business, professional including ambulatory diagnostic or treatment health care, or governmental
No definition
NYC Dept of City Planning:
http://www.nyc.gov/html/dcp
Attachment B: Gateway Parking Analysis:
Commercial unit C-11, Vail Gateway Plaza was previously used as a professional office as defined by Chapter 12-2, Definitions, Vail Town Code. Commercial unit C-10, Vail Gateway Plaza
is proposed to be used as a professional office as defined by Chapter 12-2, Definitions, Vail Town Code. A change of use from one professional office to another professional office
results in no change to the parking requirements for Vail Gateway Plaza building. If there is a proposal to change the use of unit C-10, Vail Gateway Plaza to a land use that requires
more parking spaces than a professional office, there is surplus parking available at the Vail Gateway Plaza that could be utilized to accommodate such a change:
On August 13, 2001 the Planning and Environmental Commission (PEC) approved a conditional use permit (CUP) to allow 39 parking spaces in the 93 space Vail Gateway Plaza garage to become
a for-lease parking club.
On April 12, 2004 the PEC approved amendments to the parking club CUP to allow the 39 for-lease parking spaces to be converted to 13 for-sale spaces, and the remaining 26 parking spaces
would be allocated to specific tenants within the building. The allocation of specific parking spaces to a specific tenant was at the applicant’s request, and not a requirement of the
Vail Town Code. Chapter 12-10, Off Street Parking and Loading, Vail Town Code establishes the minimum number of parking spaces for an entire building and does not require individual
parking spaces to be allocated to specific tenants. In 2004, the applicant also requested that 4 existing parking spaces be converted to ski lockers/storage.
The applicant submitted an analysis demonstrating that if the 13 space for-sale parking club and the 4 parking space conversion to storage were approved, there would be a surplus of
parking at the Vail Gateway Plaza building based upon the existing and potential commercial uses (all office and all restaurant) in the building. The 2004 CUP amendment allocated the
individual parking spaces in the Vail Gateway Plaza garage on a commercial, residential, parking club, and storage use basis. The 2004 CUP amendment allocated a total of 63 parking
spaces to the commercial tenants in the Vail Gateway Plaza building. 47 of the 63 parking spaces were allocated on an individual unit by unit basis, and 16 of the 63 spaces were allocated
to “visitor” for the commercial tenants. The 2004 CUP amendment allocated 4 individual parking spaces to commercial unit C-10. The required number of parking spaces for unit C-10 with
a professional office use is 3.16 parking spaces (2.7 spaces per 1,000 sq. ft. net floor area). The following is a summary of the 2004 allocations of the Vail Gateway Plaza parking
garage:
Unit Type
2004 CUP allocation
All Office scenario
All Restaurant scenario
Required
Commercial
63
37.02
54.83
39.9 (Kelly Liken only restaurant, the rest is office)
Residential
13
9.8
9.8
9.8
Parking Club
13
13
13
13
Storage
4
4
4
4
Total Spaces
93
63.82
81.63
66.7
Surplus Parking Spaces
29.18
11.37
26.3
Commercial Units
Parking Spaces Allocated
C-1,2,3,4, & 5
8
C-6
4
C-7
5
C-8
8
C-9
6
C-10
6
C-10
4
C-13 & 14
5
C-15
1
VISITOR
16
Total
63
Attachment C: Arthrex, Inc. Company Policy
Purpose
Scope
Applicable regulations
responsibilities
exposure determination
implementation of standard controls
sharps containers
work area restrictions
SPECIMENS AND INFECTIOUS MATERIALS
PERSONAL PROTECTIVE EQUIPMENT
HOUSEKEEPING
HEPATITIS B REQUIREMENTS
TRAINING
MEDICAL RECORDS
REVISON HISTORY
aPPENDIX I – CONTROL OF BBP EXPOSURE AND TREATMENT FORM
APPENDIX II – EXPOSURE REPORT TO EMPLOYEE
APPENDIX III – HEPATITIS B VACCINE DECLINATION
APPENDIX IV – BBP AUDIT CHECKLIST
1.0Purpose
1.1The purpose of this policy is to provide minimum guidelines required to prevent possible transmission of the acquired immunodeficiency syndrome (AIDS/HIV), Hepatitis B (HBV), and
other bloodborne pathogens and for providing guidelines for the medical surveillance of employees exposed to these pathogens. Further within this policy, an infection control plan
is outlined for all persons who handle, store, use, process, or dispose of infectious medical wastes. This infection control plan complies with OSHA requirement, 29 CFR 1910.1030, Blood
Borne Pathogens. The plan includes requirements for personal protective equipment, housekeeping, training, needle-stick and sharps safety and a procedure for reporting exposures.
2.0SCOPE
2.1Arthrex employees whose work may involve the treatment of injured employees, exposure to blood, or other potentially infectious materials. This covers all employees who could be
“reasonably anticipated” to face contact with blood and/or other potentially infectious materials as the result of performing their job duties.
3.0APPLICABLE REGULATIONS
3.1The Arthrex Blood-borne Pathogens Policy shall be maintained to comply with all applicable local, state and federal regulations, including OSHA Standard 29 CFR 1910.1030 and the National
Center for Disease Control (CDC) guidelines which set forth enforcement procedures and interpretations of OSHA requirements with respect to the protection of workers who are exposed
to blood or other potentially infectious materials.
4.0RESPONSIBILITIES
4.1The Quality Assurance Manager is responsible for controlling revisions and auditing compliance to this document.
4.2The Director of the Convention and Lab Services and the EHS Manager are responsible for the training and implementation of EHS-0600.
4.3The EHS Manager is responsible for maintaining compliance of this document with the requirements of the documents listed in 3.0.
EXPOSURE DETERMINATION
5.1The job functions of all Arthrex employees have been evaluated to determine which job categories have exposure to infectious materials.
5.2OSHA requires facilities handling possibly contaminated product, to inform employees of the exposure and train them to the standards of CFR 1910.1030.
5.3The following is a list of employees who may have risk of exposure to bloodborne pathogens by way of handling contaminated instrumentation or responding to medical emergencies.
Returns
Director of medical Education
Director of Convention Services and Lab Services
Product Managers
Complaint Group
Regulatory Affairs
Regional Managers
First Aid Responders
EHS Manager
5.4Returns present a unique exposure. All instrumentation returns shall be treated as a possible exposure source.
5.4.1All instrumentation returns shall be in Biohazard bags.
5.4.2All packaging shall then be disposed of as Biohazardous.
5.4.3A standardized complaint or Return Authorization should contain advisories of
5.4.4Biohazardous materials or Infectious Material warnings.
5.4.5Agents or customers must be accountable for materials authorized to be returned.
6.0IMPLEMENTATION OF STANDARD CONTROLS
6.1Areas where there is the potential for exposure to infectious material shall have signs permanently affixed with Biohazard label and Restricted Area- Authorized Personnel Only at
the entrance to area. This includes the laboratory and Returns area.
6.2OSHA requires that this standard plan CFR 1910.1030 include controls such as:
6.2.1Biohazard signs or universal precaution training in areas where a potential biohazard may pass or reside.
6.2.2Personal Protection Equipment (PPE), safety glasses, lab apparel, gloves, etc., etc.
6.2.3Biohazard procedures such as autoclave procedures and cleaning procedures.
6.3UNIVERSAL PRECAUTIONS are defined by OSHA 29 CFR 1910.1030(b) as an approach to infection control according to the concept that all human blood and certain human blood and certain
body fluids are treated as if known to be infectious.
6.3.1Universal precautions will be observed throughout the facility in order to prevent contact with potentially infectious materials regardless of the source.
6.3.2Where occupational exposure remains after institution of the above-mentioned precautions, PPE shall be utilized.
6.3.3Separate freezers, cleaning supplies, instruments, and equipment have specific procedures for maintenance and decontamination of laboratory, educational facilities, and testing
areas.
6.3.4Hand washing stations are installed in areas around the facility; the education laboratory, the machine shop, and all rest rooms. Protective clothing aside, after contact with contaminated
product, hand washing and flushing contact areas with cleanser is appropriate and highly recommended.
6.3.5Antiseptic cleansers and rubbing alcohol are also provided as an added measure when hand wash stations are not available.
7.0SHARPS CONTAINERS
7.1Sharps are defined by Arthrex as any instrument that is, or can be, used to cut, slice, puncture or abrade human tissue. Sharps may be scalpels, needles, razors or any surgical instrument
designed to pierce tissue.
7.2Sharps containers for single use equipment are available in the returns and Laboratory areas and are labeled as single-use.
7.3Reusable equipment that needs to be placed into Sharps containers is labeled appropriately and re-useable. These are checked daily by the Medical Education staff for safe removal
and appropriate use.
7.4Non-contaminated sharps shall be placed in appropriated container labeled “non-contaminated sharps” and disposed by Maintenance.
7.5Contaminated sharps shall be disposed in a red bio-hazard container and disposed by an outside vendor established by the EHS Manager.
8.0WORK AREA RESTRICTIONS
8.1In work areas where there is a reasonable likelihood of exposure to blood or other potentially infectious materials, employees are not to eat, drink, apply cosmetics or lip balm,
smoke, or handle contact lenses. Food and beverages are not to be kept in freezers, refrigerators, cabinets, shelves, counters, or bench tops where blood or other potentially infectious
materials are present. There shall be signage to reflect such.
8.2Under no circumstances shall exposure PPE be worn outside the work area, such as to the break room, rest room or cafeteria.
8.3Mouth pipetting or suctioning of blood or other potentially infectious materials is prohibited.
8.4All procedures shall be conducted with a minimum of splashing, spraying, splattering, or generation of droplets of infectious material.
8.5Methods employed at Arthrex, Inc. to establish control of work area restrictions include:
Universal precautions observed.
Accessible appropriate protective apparel.
ISO and FDA compliance training for all employees.
Rigid enforcement of rules by all employees.
8.6Employees in a position to be witnessing or observing exposure related activity shall be considered potentially exposed and appropriate protection is required to avoid inadvertent
exposure.
9.0SPECIMENS AND INFECTIOUS MATERIALS
9.1Specimens are defined as tissue or derivatives thereof. Associated potentially infectious material is that which has come into contact with specimens.
9.2Specimens and other potentially infectious materials will be placed in a container which prevents leakage during the collection, thawing, handling, processing, storage, and transport
of the specimens/material.
9.3The container used for specimen/material can be labeled or (red) color-coded. The Area Supervisor shall daily ensure that all containers are deposited after usage in receptacle provided
by outside vendor.
9.4Any specimens which could puncture the primary container must be placed inside a secondary container which is puncture resistant. Should a primary container become contaminated,
it also will be placed inside a secondary container.
9.5Contaminated or potentially contaminated items are not to be removed from areas authorized for their use. Under no circumstances shall they contact items in an uncontrolled environment
such as office spaces.
10.0PERSONAL PROTECTIVE EQUIPMENT
10.1The laboratory staff is responsible for ensuring that protective clothing and equipment is available to employees, adequate for the intended use, and effective for its intended purpose
as a barrier to fluids. THE USE OF GLOVES IS A MINIMUM REQUIREMENT.
10.2The Medical Education staff should also take into account the need for various sizes of clothing and various glove types (hypoallergenic and powder-less).
10.3To clean and dispose of personnel protective clothing, all garments must be placed in a container designed to prevent leakage or puncture. Currently, Arthrex, Inc. disposes of all
garments and does not require a laundering facility.
10.4Gloves, which should be worn at all times during possible contact with potentially contaminated materials, are disposable and are not to be re-used. If the protective barrier of
the glove is compromised, the gloves should be discarded and a new set obtained.
10.5Eye protection and masks are required to be worn whenever splashes, droplets of blood, or other potentially infectious material may be generated. This procedure includes transportation
of specimens.
11.0HOUSEKEEPING
11.1General Housekeeping at Arthrex includes cleaning and decontamination with glutaraldehyde or other hospital approved or graded cleaners, and bleach according to the following schedule:
11.1.1Returns: Daily cleaning using glutaraldehyde or other hospital approved cleaners and bleach.
11.1.2Education Lab: After each training session, use glutaraldehyde or other hospital approved cleaners and bleach.
11.2All contaminated work surfaces will be decontaminated after completion of procedures and immediately after spills of blood or potentially infectious materials.
11.3All bins, cans, pails, and receptacles shall be inspected and decontaminated after each use. Each area is responsible for the inspection of the resident receptacles.
11.4Any broken glassware with potential contamination will not be picked up with bare or gloved hands, rather, use a brush to sweep the pieces into an acceptable container.
11.5None of Arthrex, Inc. reusable sharps containers will be handled in such a way as to require an employee to reach into the container to extract equipment.
11.6All mop heads and cloths used to wipe surfaces or flooring (clean) are discarded in a biohazard container. A receptacle provided by outside vendor will hold material until removed
by vendor.
12.0HEPATITIS B REQUIREMENTS
12.1It is a requirement of OSHA Standard 29 CFR 1910.1030 that any company make available to its’ employees a HBV program and post-exposure evaluation/follow-up when those employees
are asked to handle potentially contaminated product.
12.2The Hepatitis B vaccine is available to all employees who provide medical care, work with cadavers or returned instruments as a preventive measure. The vaccine is issued under the
supervision of a licensed physician or healthcare professional. The vaccine is available at no cost to Arthrex employees.
12.3Should an employee decline the vaccine when it is first offered, the Medical Education staff will have the employee sign a statement indicating that the HBV has been declined. At
any point during employment, the employee can ask for the HBV, even after refusing the first offer.
12.4Any future booster shots recommended by OSHA will be offered to employees at Arthrex, Inc. at no cost to the employee.
12.5Any exposure incidents shall be reported, investigated, and documented. The EHS Manager shall investigate the incident. The employee will receive a medical examination and any
required follow-up. The source of possible exposure is evaluated for HBV and HIV infectivity. Results of all investigations and source testing will be made available to the employee
and he or she will be informed of the regulations and applicable laws.
13.0TRAINING
13.1The medical Education staff is responsible for training and initial assignments to employees where exposure may occur. This training shall be repeated every 12 months and tailored
to the educational and language level of the employee. This training is to be offered during work hours.
13.2The training on Bloodborne Pathogens include the following:
13.2.1An explanation of the OSHA standard and Arthrex specific procedures, signs, labels, and color-coding systems..
13.2.2A discussion of epidemiology and symptoms of bloodborne diseases.
13.2.3A discussion of the means of transmission.
13.2.4Recognition of the tasks that may involve exposure.
13.2.5An explanation of the use and limitations of methods to reduce exposure and use of personal protective equipment.
13.2.6A basis of selection for individual PPE and detailed description of how to dispose of PPE.
13.2.7Information on Hepatitis B and availability of vaccines.
13.2.8Discussion of appropriate actions to take, procedures to follow, and persons to contact in an emergency involving blood or other potentially infectious materials.
13.2.9Information on the evaluation and follow-up required after an employee exposure incident.
13.3The person conducting the training shall be knowledgeable in the matter of bloodborne diseases, procedures, and use of personal protective equipment.
13.4Employees who have received training in the past 12 months shall have the training documented and any update in this procedure since the time of training shall require additional
training.
13.5Any change in standard operating procedure will require an impact statement as to its’ effects on this program and training held accordingly.
14.0MEDICAL RECORDS
14.1Medical Records – The EHS Department is responsible for maintaining the following medical information:
Name and social security number of employee
Employee Hepatitis B vaccine status including the date of initial vaccination.
A copy of all results of examinations, medical testing, and follow-up procedures related to exposure incidents, and
A copy of information provided to the medical professional in reference to the duties of the employee and exposure risk.
14.2Training records – The EHS Department is responsible for training records and will maintain these for a minimum of 3 years from the date of training. Training records detail the
following information:
Dates of training sessions
An outline describing material presented
Name of Trainer
Signature of Manager or Supervisor confirming training
14.3Availability
14.3.1All employee records shall be made available to the employee in accordance with 29 CFR 1910. 20.
14.3.2All employee records shall be made available to OSHA officials upon request.
14.4Transfer of Records
If Arthrex is closed and there is no replacement employer, the Director of the National Institute for Occupational Safety and Health shall be contacted for final disposition.
15.0REVISION HISTORY
0.New Document
(2/3/04) Transfer of document to Health and Safety from Quality Assurance.
(6/7/05) 12.2. Revised to include all employees who provide medical care, work with cadavers or returned instruments.
14.1 and 14.2. Replaced “Human Resources” with “The Safety Department”.
Appendix I, II, and III were added.
(5/16/06) Appendix IV added.
4/7/09Added Index and minor format revisions
6/5/09 Revised Section 5.3
(07/15/10) removed “7.4The designated exposure area supervisors shall daily dispose of Sharps containers in Accumulation Receptacle provided by outside vendor.” Added: 7.4 Non-contaminated
sharps shall be placed in appropriated container labeled “non-contaminated sharps” and disposed by Maintenance. 7.5 Contaminated sharps shall be disposed in a red bio-hazard container
and disposed by an outside vendor established by the EHS Manager.
Appendix I
Control of Blood-Borne Pathogens
Exposure and Treatment Notification Form
Exposed Employee's Name:_______________ SSN: ________- _____ - _________
Date Exposed:_________ Exposure Source:_________________________________
SSN:_____________ Department/Workplace _______________________________
Exposure Description: __________________________________________________
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
I ____ request ____ do not request to be evaluated and tested for HIV/HAV/HBV by the Company Physician. I understand this is not mandatory and that all customary expenses will be paid
by Arthrex, Inc. Following the initial HIV/HAV/HBV tests, additional testing will be scheduled at 6 weeks, 12 weeks and 6 months to determine if a blood-borne pathogen has been transmitted.
I understand that I will be provided the test results, counseled by the Company Physician and that all information regarding the exposure, HIV/HAV/HBV testing, and test results will
remain confidential.
___________________________ __________
Exposed Employee's Signature Date
___________________________ __________
Witness' Signature Date
Appendix II
Exposure Report To Employee
TO:___________________________________ Date _________________________
FROM: Safety Manager
SUBJ: Medical Consent for Blood-Borne Pathogens Testing
During the course of your employment, a fellow Employee was exposed to your blood or other body fluids. Following the regulations of the U. S. Department of Labor - Occupational Safety
and Health Administration (OSHA), we request that you submit to blood tests for infectious blood-borne pathogens (HIV, HAV and HBV) that may have been exposed to an Employee. This request
is not mandatory and will not affect your employment. All information gathered will be kept confidential.
Affidavit
I ____ consent ____ do not consent to having blood sample(s) taken to test for infectious blood-borne pathogens (Human Immunodeficiency Virus, Hepatitis A Virus and Hepatitis B Virus)
following an exposure to a health care provider.
I understand that all tests and customary expenses will be paid by Arthrex, Inc., that I will be informed of the test results and that I will be counseled regarding any further necessary
evaluations and treatment (at my expense) if the results are "positive".
_________________________ ___________
Signature Date
_________________________ ___________
Witness Signature Date
Appendix III
Hepatitis B Vaccine Declination
I, _____________________________________, understand that due to my occupational exposure to blood or other potentially infectious materials, I may be at risk of acquiring Hepatitis
B Virus (HBV) infection. I have been given the opportunity to be vaccinated with the Hepatitis B Vaccine, at no charge to myself. However, I decline the Hepatitis B Vaccination at
this time.
Please check one: _____ Due to personal preference
_____ I have previously received and completed the HBV series
I understand that by declining this vaccine, I continue to be at risk of acquiring Hepatitis B, a serious disease. If in the future, I continue to have occupational exposure to blood
or other potentially infectious materials, and I want to be vaccinated with the Hepatitis B Vaccine, I can receive the vaccination series at no charge to me.
Employee Name Printed: _______________________ Date: ___________________
Employee’s Signature: __________________________________________________
Witness Name Printed: _________________________ Date: ___________________
Witness Signature: _____________________________________________________
Appendix IV
Bloodborne Pathogen/ Biohazard
Audit Checklist
Facility
Location
Auditor
Date
Y
N
NA
COMMENTS
A. Contamination Control
1. Proper Decontamination procedures used
B. Exposure Control
1. Sharps handled with caution
2. Sharps disposed of properly
3. PPE provided and used
4. Hepatitis B vaccinations documented
5. Sharps log maintained for all incidents
6. Eating and drinking prohibited in bio-areas.
7. No storage of food or drinks in bio-areas.
C. Inventory & Waste Control
1. Bio-areas properly posted and labeled.
2. Waste packaged and labeled properly.
3. Waste disposed of properly.
4. Documentation available for all specimens.
D. Training
1. Training for BBP exposure.
2. Training for BBP control and prevention.
3. Annual retraining in BBP complete.
E. Engineering Controls
1. Hand washing facilities available.
2. Eye wash station available.
3. Autoclave available and checked for effectiveness.
4. Illumination is adequate for safe activities.
F. Administrative Controls
1. Access to Lab is limited or restricted.
2. Insect and rodent control plan in place.
3. Bloodborne Standard and Policy provided.
Attachment D: Stericycle Agreement
Attachment E: MSDS forms for all chemicals used at Arthrex Vail
Attachment F: Relevant Emails
From: Sealaw [mailto:sealaw@aol.com] Sent: Friday, December 09, 2011 10:35 AMTo: George RutherCc: Wendy Weigler Vail Gateway Atty; rossg@centurytel.net; inovatcreations@aol.com; sealaw@aol.com;
ims@morganreed.com; jim.johnson@russellstandard.com; karenwjohnson@comcast.net; terry@palmos-development.com; rad@morganreed.com; cindy@greenauer.com; jeff@gohighline.com; j.ryan@ryanforestproducts.c
om; jimliken@gmail.com; deighanone@aol.com; kelly@kellyliken.com; loret@greenauer.com; jamesd@gohighline.com; pat@peeplesink.com; avhomes@comcast.net; bluescaster1@gmail.com; irmgardl@aol.comSubject:
Vail Gateway, Suite 300
Dear Mr. Ruther
This is to confirm that the Vail Gateway Condominium Association is strongly opposed to having a wet lab as a tenant in our building. This lab is under construction in violation of numerous
condo docs, rules and regulations for our association. The owner refused to provide our manager with a copy of the lease and it is only by his investigation that we discovered that the
Town of Vail approved this wet lab where we believe body parts will be used in conjunction with a teaching facility. Since the owner and the proposed tenant will not talk to us, we are
putting the pieces together to gather this information.
Wet labs by definition involve the use of chemicals, drugs, biological matter and some types of biological hazards. This is not something the Town of Vail should approve in a high end
commercial and residential building. I can only imagine the effect of this on the Kelly Liken restaurant when it becomes known. Also the venting of this lab will be in very close proximity
to the Vail Plaza Hotel.
This use is totally incompatible with our building and the neighboring building. The building permit issued by the Town of Vail without any notice to our association should be revoked.
The loss of value to the owners in this building will be dramatic. Who would want to buy a condo in a building with this type of work going on. Who would want to go to a fine dining
restaurant in close proximity to a wet lab dealing with cadaver parts and possibly toxic substances. Normally wet labs are in buildings specifically designed to house them per Wikipedia.
Very Truly Yours
Charles R. Lipcon
President
Vail Gateway Condominium Association
From: Sealaw [mailto:sealaw@aol.com] Sent: Friday, December 09, 2011 6:41 PMTo: George RutherCc: sealaw@aol.comSubject: restraining order
Hi George
Attached is a copy of the temporary restraining order entered today
regards
Charles R. Lipcon LIPCON, MARGULIES, ALSINA & WINKLEMAN, P.A.One Biscayne Tower, Suite 1776Miami, Florida 33131tel: 305-373-3016toll free: 800-838-2759fax: 305-373-6204web: www:lipcon.comConfidential
ity Notice: This email message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized
review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply email and destroy all copies of the original message.
This electronic message is also subject to standard copyright/ownership laws. Again, it is not intended to be reproduced, or re-transmitted without the consent of the originator.
From: EF [mailto:bluescaster1@gmail.com] Sent: Saturday, December 10, 2011 7:57 AMTo: George RutherCc: SealawSubject: Gateway Building
Dear Mr. Rither:
As a residential owner in the Gateway Building at 12 Vail Road, I want to express my concern about a new tenant who may be operating a "wet-lab" in our building. If this is true, it
is my opinion that a business of this nature should not be allowed to operate in a residential building, especially one that also includes a high-end restaurant.
I cannot speak to the specific zoning laws within the city of Vail, but common sense tells me that a business of this nature does not belong in a mostly residential building, in Vail
Village.
I have a feeling that if our neighbors at the Sebastion, the Four Seasons and others were made aware of this, they too would be on board to opose the opening of this business, if not
solely for logistical reasons, then possibly for the precedent that is being set. If these people are allowed to operate in the Gateway Building, what is going to keep a like business
from coming to the area and wanting to open in say, Solaris, or The Arrabelle, or maybe The Lodge...I can only imagine how Vail Resorts would react to something like this.
I appreciate your consideration.
Edward Flak
Gateway Building
Unit - 4
From: Sealaw [mailto:sealaw@aol.com] Sent: Saturday, December 10, 2011 1:23 PMTo: George RutherCc: sealaw@aol.comSubject: Vail Gateway Unit 300
Hi George
The rated occupancy for the Wet lab Didactic area is 58 occupants (look at sheet #23 there is a chart for HVAC loading calculations) I spoke to Jerry Hines with R&H who did the air
conditioning work. He said they were told it was a professional office and no mention of a wet lab was made to them.
Charles R. Lipcon LIPCON, MARGULIES, ALSINA & WINKLEMAN, P.A.One Biscayne Tower, Suite 1776Miami, Florida 33131tel: 305-373-3016toll free: 800-838-2759fax: 305-373-6204web: www:lipcon.comConfidential
ity Notice: This email message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized
review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply email and destroy all copies of the original message.
This electronic message is also subject to standard copyright/ownership laws. Again, it is not intended to be reproduced, or re-transmitted without the consent of the originator.
From: Robert Danial [mailto:rad@morganreed.com] Sent: Monday, December 12, 2011 9:58 AMTo: George RutherSubject: FW: Wet lab in Unit 3
Dear Mr. Ruther
I was informed that the building department has approved a permit to build a biological Lab in the unit that is directly under my residential unit. I am shocked and out raged at how
such an approval could have been conferred without the prior approval of the Condo board.
In addition I would like to understand how such use is incompliance with the zoning regulation of the town of Vail. I believe if the existence of such a lab becomes public information
it would damage the economic base of the town significantly.
I understand Gateway Condominium Association is strongly opposed to having a wet lab as a tenant in our building. This lab is under construction in violation of numerous condo docs,
rules and regulations for our association. The owner refused to provide our manager with a copy of the lease and it is only by his investigation that we discovered that the Town of Vail
approved this wet lab where we believe body parts will be used in conjunction with a teaching facility. Since the owner and the proposed tenant will not talk to us, we are putting the
pieces together to gather this information.
The loss of value to the owners in this building will be dramatic. Who would want to buy a condo in a building with this type of work going on. Who would want to go to a fine dining
restaurant in close proximity to a wet lab dealing with cadaver parts and possibly toxic substances.
Thank you
Robert Danial
(305) 867-8484
Please consider the environment before printing this e-mail
From: Sealaw [mailto:sealaw@aol.com] Sent: Thursday, December 08, 2011 1:43 PMTo: rad@morganreed.com; bluescaster1@bellsouth.net; inovatcreations@aol.com; jcjadams@gmail.com; inovatcreations@aol.com;
sealaw@aol.com; ims@morganreed.com; jim.johnson@russellstandard.com; karenwjohnson@comcast.net; terry@palmos-development.com; rad@morganreed.com; cindy@greenauer.com; jeff@gohighline.com;
j.ryan@ryanforestproducts.com; jimliken@gmail.com; deighanone@aol.com; kelly@kellyliken.com; loret@greenauer.com; jamesd@gohighline.com; pat@peeplesink.com; avhomes@comcast.net; bluescaster1@gmail.co
m; irmgardl@aol.comCc: wendy Weigler Vail Gateway AttySubject: Wet lab in Unit 3
Dear Vail Gateway Owners
Our new manager, Ross Graves, has discovered that a proposed tenant for suite 300 is in the business of working with body parts and cadavers. The manager attempted to get further information
from the owner who refused to provide any information whatsoever and refused to provide a copy of the lease. The manager went to the Town of Vail and obtained the building permit which
states that the space will be used for "wet lab" and didactic purposes. Wet lab is a term of art that deals with chemicals, drugs, or other material or biological matter which requires
direct ventilation and specialized piped utilities. Also certain types of biohazard material could also be involved. These types of spaces are normally located within a building specifically
designed to house them.
The manager as a well placed fear that this type of material will go into our air conditioning and plumbing systems. He is getting advise from various specialists on these matters at
this time.
The manager has discovered that unapproved air conditioning systems have been hung in the garage and holes cut in the concrete ceiling. The plumbing system has also been changed without
permission from the Vail Gateway. In fact, none of this has been approved by the Vail Gateway in violation of our condo docs and rules and regulations.
Today a letter has been delivered to the contractor to stop all work due to numerous violations of our condo docs and rules and regulations. The contractor has also been instructed to
not trespass on the common areas of the building including the driveway, entry, stairs, elevator, etc. The contractor signed an acknowledgement of our rules and regulations which also
include a prohibition on doing construction work between Nov 15 and April 15.
Our attorney Wendy Weigler has prepared a lawsuit seeking a temporary and permanent injunction against the use of the space as a wet lab.
The town of Vail is now conducting an investigation into whether or not the use of this space is compatible with the building.
If you have any questions, please contact our manager Ross Graves at 970-445-7188.
If you do not want a wet lab in the building, I suggest you also contact the Town of Vail. You can call George Ruther at 970-479-2145 but probably a letter would be better.
Charles R. Lipcon LIPCON, MARGULIES, ALSINA & WINKLEMAN, P.A.One Biscayne Tower, Suite 1776Miami, Florida 33131tel: 305-373-3016toll free: 800-838-2759fax: 305-373-6204web: www:lipcon.comConfidential
ity Notice: This email message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized
review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply email and destroy all copies of the original message.
This electronic message is also subject to standard copyright/ownership laws. Again, it is not intended to be reproduced, or re-transmitted without the consent of the originator.
From: Hans Willimann [mailto:hans.willimann@fourseasons.com] Sent: Tuesday, December 13, 2011 12:18 PMTo: George RutherSubject: Wet Lab at Gateway
Good morning George, I tried to get in touch with you and left you a message. I guess you might not have received it. Here is my dilemma and I hope you can shed some light on the circumstances
I have been informed that presently there is construction going on at the Vail Gateway complex. Apparently the Town of Vail has approved a wet lab in that building. I believe that a
wet labs use chemicals, drugs, biological matter (body parts) and has potential biological hazards. The proximity of such a facility is totally incompatible with our neighborhood and
our Hotel in particular. I would appreciate your involvement to revoke such a permit, if in fact the purpose of this facility is a "wet-lab" Thank you for giving this you utmost attention.
Hans WillimannGeneral ManagerFour Seasons Resort Vail1 Vail Road, Vail, CO, U.S.A., 81657voice: 1 (970) 477-8601mobile: 1 (970) 306-9033fax: 1 (970) 477-8666email:
mailto:hans.willimann@fourseasons.commailto:hans.willimann@fourseasons.comweb:
http://www.fourseasons.com/vailhttp://www.fourseasons.com/vail
From: Kelly Liken [mailto:kelly@kellyliken.com] Sent: Tuesday, December 13, 2011 2:22 PMTo: George RutherSubject: Arthrex Training Facility
Hi George,
I am sorry to hear that Chuck Lipcon and Ross Graves have made you feel like I am the biggest opponent to the Arthrex project. I do have my concerns, but they are concerns that deal
with making sure the plumbing, waste and ventilation are properly dealt with.
Ross explained to me what a "wet lab" is using a description from wikipedia, not from the company itself. I'm not sure if he wasn't able to get in touch with a representative from Arthrex?
When I researched Arthrex and what they actually do, they seem like a very upstanding company that is a welcome addition to Vail, bringing in the kind of clientele that we all want to
see.
Although I do have concerns as stated above, I am not convinced that the concerns can't be resolved with a few questions answered. I generally feel that Chuck Lipcon has spoken FOR
me in this matter without having spoken TO me. I have NEVER had a conversation with Chuck Lipcon about this matter, only Ross Graves who scared me at first, but after some research
I am less nervous and would only like to be reassured that our notoriously bad plumbing, limited garbage and waste disposal and the HVAC issues are addressed.
I understand that this is new territory for most people and it is scary if you read these things on the internet. It may not be the most ideal usage of the space in many people's opinion,
but it will be a long term, high end tennant, which we need in the building.
It doesn't seem like what Arthrex does coincides exactly with the terror and hysteria that is being distributed. Please feel free to call or email if you would like to talk about any
of my concerns, as I feel that they are valid, but not unresolvable.
Live In Season!
Kelly Liken
Chef/Owner
Restaurant Kelly Liken
(970) 479-0175 office
(970) 343-2348 cell
From: Sealaw [mailto:sealaw@aol.com] Sent: Wednesday, December 14, 2011 9:04 AMTo: George Ruther; Matt Mire ContactCc: sealaw@aol.com; wendy Weigler Vail Gateway Atty; rossg@centurytel.net;
InovatCreationsSubject: Vail Gateway Condo Association letter re Arthrex building permit
Gentlemen:
The Vail Gateway Condo Association would like to appeal the issuance of the Permit # B11-0274, Project # PRJ11-0441 which was issued without notice to our association on 9/21/2011. We
only recently learned about the building permit and the nature of the work Arthrex will be doing there. We have not received information from Arthrex nor anyone else but have attempted
to gather as much information as we can in spite of being refused answers to our questions about what is going on. From Arthrex's web site where they list the Vail location as a surgical
training site and the fact that Arthrex uses cadavers or cadaver parts and the fact that the plans show a training area and multiple lab stations, we have concluded that there will be
surgical training on cadaver or cadaver parts which are considered biohazards.
Please see my attached letter which is preliminary in light of the lack of notice and attempt to put something together in a short time frame.
Charles R. Lipcon
President of Vail Gateway
Condominium Association
Attachment C: Arthrex Policy
Arthrex, Inc.Ref:HASP-0600
Bloodborne Pathogen Preventive ProcedureIssue Date: 02/03/04Rev. Date: 05/16/06
Rev. 5
Attachment C Page 13
Attachment F Page 14
Attachment A
Attachment E Page 49
Attachment A Page 1
Attachment B Page 3
Attachment D Page 4
Town of VailPage 5