HomeMy WebLinkAbout160802 CITY OF GLENDALE
PLANNING&DEVELOPMENT SERVICES
5850 W.GLENDALE AVE.,2ND FLOOR
GLENDALE,AZ85301
Alenda1e 623.930.2800 SPECIAL INSPECTION CERTIFICATE
.930,2
ARIZONA www.GlendaleAZ.com STRUCTURAL
(0,wiNER.isi OITPFI.-gi-rIL godSPEC►Lsmi SI:EC�iTII,�N)
To be completed and signed by the Owner before a building permit is issued
In accordance with Sections 1704 and 1705 of the 2018 International Building Code which requires that certain construction work be placed under inspection
of a registered design professional.I,as owner/legal agent,do hereby certify that I have retained Alta Arizona to be
responsible for the special inspections on this project. ite Stered(oe$igrl professionaUFir feria ornttl
Signature:, CER
113,130JEC7T1tVAlU1 REGISTiEREDIDESI.GNIPRiaFES51.0NAL�/F{RMINAME:
PHOENIX HEART James Floyd,PE/Alta Arizona
•
IP"O1JELTii�;D'DRESS) REGISTERED DESIGN OI�AUF.IRIVI►ADDRESS:
5;g9 W.Talavl BLVD 1800 W Broadway Road,Suite 5,Tempe,Az 85254
Glendale, AZ 85306
(0-01001JEGTiN,UMBER4 231733 COG PERMIT NUMBER: 160802
•
GERTIFI'GATE4I F RESPO.N5IF ILITY CERTIFICATE OF COMPLIANCE
To be filled in and signed by the professional in charge of Special Inspections To be filled in and signed by the professional in charge of Special Inspections
before a building permit is issued. before a certificate of occupancy is issued.
As registered design professional in I certify that,to the best of my
charge of special inspections of the l' knowledge,the requirements of the
above named project,I certify that I Q�� � , 2018 International Building Code
am familiar with the design of the a /�1 P and the approved plans and
project and hereby assume full � s� specifications have been complied •
responsibility for carrying out the �rw q g609 with,insofar as the portion of the
required special inspections in o DAMES F v work requiring special inspection
accordance with Sections 1704 and FLOYO under Section 1704 and 1705 is
1705 of the 2018 International O 08/23/2. concerned.A guarantee that the
Building Code. �fe Signed Q contractor necessarily constructed
/ ON A the building in full accordance with
the plans and specifications is
neither intended nor implied.
(024,Sig a tire glidfp -) (Seal,Signature,and Date)
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SPECIAL INSPECTOR QUALIFICATIONS APPROVAL BY BUILDING OFFICIAL/PLANS EXAMINER(1704.2.1): .11 _.&' ,,Il,__M — DATE: 08/24/2023
WORK WHICH REQUIRES SPECIAL INSPECTION QUALIFIED INOIUINUAL OR FIRM1
❑ CONCRETE CONSTRUCTION/REINFORCING STEEL/POST-TENSION(1705.3)
❑ MASONRY CONSTRUCTION(1705.4)
❑ WOOD CONSTRUCTION(1705.5)
❑ STEEL CONSTRUCTION(1705.2&AISC 360)
❑ SOILS(1705.6)
❑ FOUNDATIONS(1705.7,1705.8&1705.9)
❑ESDECIAL GASES:POST�INSTALLEDIZEP.OXY/EXPANSIONI)ANO-HORSI(r1b7j0551.1) Alta Arizona
❑ SEISMIC RESISTANCE(1705.12)
• "1 SPRAYED FIRE-RESISTANT MATERIALS(1705.14)
❑ EXTERIOR INSULATION AND FINISH SYSTEMS(EIFS)(1705.16)
❑ STORAGE RACKS(1705.12.7)
❑ OTHER:
Ce DRA CCCCf+TIVC flA/7R/',r a D
c �
Ca7
1 CITY OF GLENDALE
PLANNING&DEVELOPMENT SERVICES
5850 W.GLENDALE AVE,2ND FLOOR
GLENDALE,AZ85301 SPECIAL INSPECTION CERTIFICATE
GlendaleGlendale623.930.2.930.2800
ARIZONA www.GlendaleAZ.com STRUCTURAL
OWNER'S NOTIFICATION OF SPECIAL INSPECTION
To be completed and signed by the Owner before a building permit is issued
In accordance with Sections 1704 and 1705 of the 2018 International Building Code which requires that certain construction work be placed under inspection
of a registered design professional.I,as owner/legal agent,do hereby certify that I have retained James Floyd w/Alta Arizona to be
responsible for the special inspections on this project (Regstered Design ProfessionaVFem-please print)
Owner's name: Owner's Signature: Date:
PROJECT NAME: REGISTERED DESIGN PROFESSIONAL/FIRM NAME:
Interior Remodel For:Phoenix Heart Alta Arizona
PROJECT ADDRESS: REGISTERED DESIGN PROFESSIONAL/FIRM ADDRESS:
5859 W,Talavi Blvd. 1800 W.Broadway Rd.,Suite 5
Glendale,AZ 85306 Tempe,AZ 85282
COG PROJECT NUMBER: COG PERMIT NUMBER: 160802
CERTIFICATE OF RESPONSIBILITY CERTIFICATE OF COMPLIANCE
To be filled in and signed by the professional in charge of Special Inspections To be filled in and signed by the professional in charge of Special Inspections
before a building permit is issued. before a certificate of occupancy is issued.
As registered design professional in I certify that,to the best of my
charge of special inspections of the knowledge,the requirements of the
above named project,I certify that I 2018 International Building Code
am familiar with the design of the a :ion, £n and the approved plans and I e pion• f
project and hereby assume full Q �/ specifications have been complied o,
responsibilityforcarrying out the a/GJ�; TF �P� with,insofar as the portion of the a D� CEP
required special inspections in i�iF�_/ work requiring special inspection m�F'.
accordance with Sections 1704 and �� 48609 under Section 1704 and 1705 is a i' 48609 - c_---
1705 of the 2018 International — JAMES r concerned_A guarantee that the '� JAMES P•
Building Code. FLOYO - contractor necessarily constructed FL0'
QS/15/202' the building in full accordance with °` 92/15/20
e Sq11 the plans and specifications is fe Si rt5 P
/ZON A - neither intended nor implied. qR/ZO N A
(Seal,Signature,and Date) (Seal,Signature,and Date)
SPECIAL INSPECTOR QUALIFICATIONS APPROVAL BY BUILDING OFFICIAL/PLANS EXAMINER(1704.2.1): DATE:
WORK WHICH REQUIRES SPECIAL INSPECTION QUALIFIED SPECIAL INSPECTOR INDIVIDUAL OR FIRM
❑ CONCRETE CONSTRUCTION/REINFORCING STEEL(1705.3)
❑MASONRY CONSTRUCTION(1705.4)
❑ WOOD CONSTRUCTION(1705.5)
❑ STEEL CONSTRUCTION(17052&AISC 360)
❑ SOILS(1705.6)
❑ FOUNDATIONS(1705.7,1705.8&1705.9)
KI SPECIAL CASES:POST-INSTALLED(EPDXY/EXPANSION)ANCHORS(1705.1.1) Alta Arizona
❑ SEISMIC RESISTANCE(1705.12)
❑ SPRAYED FIRE-RESISTANT MATERIALS(170514)
❑ EXTERIOR INSULATION AND FINISH SYSTEMS(EIFS)(1705.16)
❑ STORAGE RACKS(1705.12.7)
❑ OTHER:
Ai+- A hl.. ')21n01
ARRA-3 Page 1 of 6
I .\\-8%;r71:;"
ARIZONA DEPARTMENT OF HEALTH SERVICES
BUREAU OF RADIATION CONTROL
RADIOACTIVE MATERIAL LICENSE
Pursuant to Chapter 4,Tide 30,Arizona Revised Statute,,and Title 9,Chapter 7 tithe ArizZIOa Administrative Code,aid in reliance on statements and representations made to the Department
by the licensee,a license is hereby isurd authorizing the acgn sitiaa,reception,possession,use and transfer of the radioactive material li4cd in this license for the'imposes and at the places
specified. This license is sal*ct to ail applicable rules nail Department osiers now or hereafter in effect and to the coodit<eacs specified_ in accordance critic letters dated May 31,2023 and
December IS,2023,signed by Rajn1 Pat 1,MD.mad Scott GeatberiimE,CEO,repecthcty,License`_amber 07-437 is hereby amended is its entirety to read as Mims:ALL
CHANGES ARE IN HOLD
r
LICENSEE
3.a. LICENSE NUMBER: 07-437
1. NAME: Phoenix Heart,P.L.L.0 b. AMENDMENT NO.: 18
2. ADDRESS: 5859 West Talavi Boulevard 4. EXPIRATION DATE: May 34,2027
Suite 100
Glendale,Arizona 85306 5. CATEGORY: B3(2) - MEDICAL MATERIALS
CLASS B -^
6. Radioactive material 7. Chemical or physical form 8. Maximum quantity licensee may
(element and mass number) possess at any time
A. Technetium-99m A_ Technetium labeled A. 74 GBq(2,000 millicuries)
radiopharmaceuticals
B. Thallium-201 B. Thallium Chloride B. 14.8 GBq(400 millicuries)
C. Technetium-99m C. Sodium Pertechnetate C. 111 GBq(3,000 millicuries)
D. Cobalt-57 D. Sealed Source in D. 1.85 GBq(50 millicuries)
accordance with Sealed
Source and Device Registry
in 10 CFR 35.2
E. Strontium- E. Generator(manufactured E. 37 GBq(1,000 millicuries)
82/Rubidium-82 by Jubilant DraAimage or
Bracco Diagnostic)
F. Strontium-85 F. Any F. 74 GBq (2,000 millicuries)
G. Germanium-68 G. Sealed Source,in G. 1.85 GBq(50 millicuries)
accordance with Sealed
Source and Device Registry
in 10 CFR 35.2.
IL Flourine-18 H. Any FDA approved H. 3.7 GBq(100 millicuries)
radiopharmaceutical-Not to
include investigational new
drugs(END).
POST IN ACCORDANCE WITH R9-7-1002
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ARRA-3 (Cont.)- Page 2 of 6
ARIZONA DEPARTMENT OF HEALTH SERVICES
BUREAU OF RADIATION CONTROL
RADIOACTIVE MATERIAL LICENSE
SUPPLEMENTARY SHEET License Number: 07-437
Amendment Number_ 18
9. Authorized Use:
•
A.&B. For diagnosis of cardiac disease.
C. Ultra tag kit preparation for diagnosis of cardiac disease.-
D,G,and IL For instrument calibration purposes and shall be used under the supervision of a Certified Nuclear
Medicine Technologist
E. For the production of Rubidium-82 that will be used in the diagnosis of heart disease.
F. For the storage as a contaminate in a Sr-82/Rb-82 generator.
CONDITIONS
10. A. Radioactive material listed under sub items A through H of Items 6,7 and 8 may be possessed and used only
at the licensee's address stated in Item 2 above.
B. Radioactive material listed under sub items A through D of Items 6,7 and 8 may be possessed and used only
at the licensee's address located at:
Site 1: Phoenix Heart,P.L.L.0 Site 2: Phoenix Heart,P.L.L.0
10293 N.92nd Street 17301 East Spring Valley Road
Scottsdale,Arizona 85258. Mayer,Arizona 86333.
11. The licensee shall comply with the provisions of Title 9,Chapter 7,Arizona Administrative Code;Article 3,
"Radioactive Material Licensing"; Article 4, "Standards for Protection Against Ionizing Radiation"; Article 7,
"Medical Uses of Radioactive Material";and Article 10,"Notices,Instructions,and Reports to Radiation Workers;
Inspections".
12. A. Radioactive material listed under sub items A through H of Items 6,7,and 8 shall be used by or under the
supervision of:
Alfred C.Rossum,M.D. Rajul Patel,M.D.
B. The Radiation Safety Officer for this license shall be Rajul Patel,M.D.
13. Technologists using radioactive material under the supervision of the authorized user on the license shall be a
Certified Nuclear Medicine Technologist.
14. A. The licensee shall not change or modify a PET facility,or operations involving radioactive material,
authorized under this license so that individuals exposed to radiation in or around the facility are
exposed to radiation in excess of the levels in A.A.C.9-7-408 and A.A.C.97-416. .
B. The licensee shall be informed at all times of activities in areas surrounding the PET facility to ensure
that personnel occupancy does not change,resulting in radiation exposure in excess of the levels in
A.A.C.9-7408 and A.A.C.9-7-416.
POST IN ACCORDANCE WITH R9-7-1002 '
ARRA-3 (Cont) Page 3 of 6
ARIZONA DEPARTMENT OF HEALTH SERVICES
BUREAU OF RADIATION CONTROL
RADIOACTIVE MATERIAL LICENSE
SUPPLEMENTARY SHEEP License Number: 07-437
Amendment Number: 18
14.Cont.
C. As part of the annual ALARA review required under R9-7-407,the licensee shall review the PET
patient workload to ensure that personnel in unrestricted areas are not exposed to radiation in excess of
the limits in A.A.C.9-7-408 and A.A.C.9-7-416.
D. The Licensee shall not image more than 60 PET patients in a five-day work week.
15. When using the CardioGen-82®rubidium-82 generator with the Infusion System manufactured by CTI,Inc.:
A. Use only additive-free Sodium Chloride Injection USP to elute the CardioGen-82®generator.The use
of any other type of saline is prohibited.
1. If the additive-free 0.9%Sodium Chloride Injection USP is replaced during a day of clinical
use,the licensee shall perform an additional quality control test with the new saline.
B. The licensee shall follow all of the requirements in manufacturer's CardioGen-82®Infusion System
User Guide,its supportive documents and updates.The licensee shall maintain and follow updates to
the manual provided by the manufacturer. Copies of this manual, its supportive documents and
updates shall be available to each person using and persons having responsibility for the use of,the
device and shall be available for inspection by the department.
C. The licensee shall comply with the safety precautions and limitations established in the package insert
for the generator.
D. For each generator,the licensee shall maintain an on-going record of all eluate volumes (washing,
testing and patient infusions)including a summary of the cumulative volume of cluate.The on-going
daily records of volume usage shall be maintained for at least three years and be available for
inspection by the department.
E. The licensee shall measure and calculate the strontium-82/rubidium-82 and strontium-85/rubidium-
82 concentrations by using a dose calibrator set on the rubidfum-82 or cobalt-60 setting (with
correction formula if using cobalt-60)and on its most sensitive microcurie scale and recording all
values with at least one significant figure and at least two places to the right of the decimal place
according the schedule as detailed below.Records of these tests shall be kept in accordance with the
manufacturer's user manuals,and its supportive documentation.
1. Daily eluate tests on days of use prior to administration;and
2. Additional daily eluate tests performed at every 750 milliliters eluate use for that day(i.e.,one
additional test when 750 milliliters of elnate is used during the day,a second additional test
when 1,500 milliliter of elnate is used during the day and an additional test for each 750
milliliters of eluate used during the day)when:
a. the initial test concentrations of strontium-82 reach 0.002 microcuries per millicurie of
rubfdium-82;or
POST IN ACCORDANCE WITH R9-7-1002
ARRA-3 (Cont.) Page 4 of 6
ARIZONA DEPARTMENT OF HEALTH SERVICES !�
BUREAU OF RADIATION CONTROL
RADIOACTIVE MATERIAL LICENSE
SUPPLEMENTARY SHEET License Number: 07-437
Amendment Number_ 18
15.Cont.
b. the initial test concentrations of strontium-85 reach 0.02 microcuries per millicurie of
rubidium-82;or
c. 14 liters of total elution volume has passed through the generator column.- -
F, The licensee shall immediately stop using the generator to treat patients at the expiration limits listed
below:
1. 17 liters for the generator's cumulative eluate volume;or
2. 42 days post generator calibration date;or
3. An eluate concentration of strontium-82 of equal to or greater than 0.01 microcuries per
millicurie of rubidium-82;or -
4. An eluate concentration of strontium-85 of equal to or greater than 0.10 microcuries per
millicurie of rubidium-82.
G. The licensee shall follow the manufacturer's annual preventative maintenance schedule for the
CardioGen-820 Infusion System and complete all of the recommended corrective actions.This shall
include checks on infusion pump flow rate for consistency and accuracy and the performance of the
radiation detector as compared to the manufacturer's specifications.The licensee shall retain copies of
all infusion system calibration records,preventative maintenance checks,corrective actions taken and
any manufacturer's quality review audits for inspection by the department.
H. The licensee shall participate in the manufacturer's generator and CardioGen-82®Infusion System
monitoring programs to determine use or stability of these products.
L The licensee shall immediately report to the department each occurrence when the eluate concentration
of strontium-82 equals or exceeds 0.02 microcuries per millicurie of rubidium-82 or the eluate
concentration of strontium-85 equals or exceeds 0.20 microcuries per millicurie of rubidium-82.
J. The licensee shall use the activity measured by the detector on the infusion cart as the activity of the
administration. This activity determination will be acceptable to satisfy the activity determination
requirements.
16. When using the RUBY-FILL®rubidium generator and RUBY Rubidium Elution System:
A. Use only additive-free 0.9%Sodium Chloride Injection-USP to elute the rubidium-82 generator.The
use of any other type of saline is prohibited.
1. If the additive-free 0.9%Sodium Chloride Injection USP is replaced during a day of clinical
use,the licensee shall perform an additional quality control test with the new saline.
B. The licensee shall follow all of the requirements in the manufacturer's RUBY Rubidium Elution System
User Manual,its supportive documents,and updates.The licensee shall maintain and follow updates to
the manual provided by the manufacturer. Copies of this manual, its supportive documents, and
updates shall be available to each person using,and persons having responsibility for the use of,the
device and shall be available for inspection by the department.
POST IN ACCORDANCE WITH R9-7-1002
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ARRA-3 (Cont) Page 5 of 6
ARIZONA DEPARTMENT OF HEALTH SERVICES
BUREAU OF RADIATION CONTROL
RADIOACTIVE MATERIAL LICENSE
SUPPLEMENTARY SHEET License Number: 07-437
Amendment Number: 18
16.Cont.
C. The licensee shall comply with the safety precautions and limitations established in the package insert
for the generator.
D. For each generator, the licensee shall maintain an on-going record of all eluate volumes (flushing,
testing,and patient infusions)including a summary of the cumulative volume of eluate.The on-going
daily records of volume usage shall be maintained for at least three years and be available for
inspection by the department
E. The licensee shall use the dose calibrator that is integrated into the RUBY Rubidium Elution System to
perform mandatory eluate testing(i.e.quality control tests)to determine rubidium-82,strontium-82,
and strontium-85levels:
1. Daily,before administering rubidium-82 chloride injection to the first patient each day;
2. Immediately after detection of the volume alert limit(20 L);and
3. After every 4 patients when an alert limit has been detected.Alert limits are:
a. 20 L total elation volume has passed through the generator column;or
b. The strontium-82 level reaches 0.004 uCi per mCi(kBq per MBq)of rubidium-82;or
c. The strontium85 level reaches 0.04 nCi per mCi(kBq per MBq)of rubidium-82.
F. The licensee shall immediately stop using the generator to treat patients at the expiration limits listed
below:
1. A total elution volume of 30 L has passed through the generator column;or
2, The expiration date of the generator(60 days post-manufacturing)has passed;or
3. An eluate concentration of strontium-82 of equal to or greater than 0.01 nCi per mCi
(kBq/MBq)of rubidium-82;or
4. An eluate concentration of strontium-85 of equal to or greater than 0.10 uCi per mei
(kBq/MBq)of rubidium-82.
G. The licensee shall follow all manufacturers'guidance for use,maintenance,and disposal of activities
related to the RUBY-FILL®generator and elution system.This would include all commitments in the."
Jubilant system user manual,package insert,and any associated current and future amendments to the
documents including product recalls.The licensee shall keep records for all system quality and safety
requirements as required by the manufacturer and be able to produce them within a reasonable time
frame during an inspection.The licensee is responsible for all adverse event reporting requirements
related to the use of the Jubilant system.
POST IN ACCORDANCE WITH R9-7-1002
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ARRA 3 (Cent.) Page 6 of 6
ARIZONA DEPARTMENT OF HEALTH SERVICES
BUREAU OF RADIATION CONTROL
RADIOACTIVE MATERIAL LICENSE
SUPPLEMENTARY SHii License Number: 07-437
Amendment Number: 18
16.Cont.
IL The licensee shall immediately report to the department each occurrence when the eluate concentration
of strontium-82 equals or exceeds 0.02 nCi per mCi of rubidium-82 or the eluate concentration of
strontium-85 equals or exceeds 0..0 uCi per mCi of rubidium-82.
I. The licensee shall use the activity measured by the detector on the elution cart as the activity of the
administration. This activity determination will be acceptable to satisfy the activity determination
requirements.
17. For purposes of ending the principal activities authorized under this radioactive material license:
A. The license stays in effect beyond the license expiration date. Beyond the expiration date The licensee shall
store radioactive material only, until the Department authorizes its use by license amendment, or the
Department notifies the licensee in writing that the license is terminated.
B. The licensee shall ensure the timeliness of decommissioning of facilities where principal activities are
conducted under this license in accordance with Department requirements.
C. The licensee shall continue to control public access into restricted areas and pay the annual licensing fee until
- - the license is terminated.
18. Except as specifically provided otherwise by this license,the licensee shall possess and use the radioactive material
described in Items 6, 7 and 8 of this license in accordance with the statements, representations and procedures
contained in:
1. Application dated May 25,2022,signed by Kyle Matthews. . V
2, , Letter with attachments dated May 31,2023,signed by Rajul Patel,M.D. V
3, Letter with attachments dated December 18,2023,signed by Scott Gemberling,CEO.
The most recent statements,representations,and procedures shall govern if they conflict with previously submitted
documents,unless otherwise specified by a license condition;and the Department's rules shall govern the licensee's
statements in applications or letters.
B N b tLTa KL BUREAU CHIEF
DATE ISSUED: FEB 0 7 2024 TOM SALOW,ASSISTANT DIRECTOR
KJL:BDGcr)
POST IN ACCORDANCE WITH R9-7-1002