Attch 1_SOW_ Allergen Extract_10 Aug 22_FINAL.pdf

USACAEL Allergen Extract Products and Related Ancillary Supplies

1. SCOPE OF WORK: The contractor shall provide allergen extract stock solutions for a wide variety of allergens, including but not limited to trees, grasses, weeds, molds, foods, animals, and other miscellaneous antigens; vials, syringes and other related ancillary supplies as per specifications detailed in the itemized contract listing. Materials are to be provided to the United States Army Centralized Allergen Extract Laboratory (USACAEL), Department of the Army, Kimbrough Ambulatory Care Center, Fort Meade, MD.

Allergen extract products are supplied for fulfillment of the critical Tri-service readiness support mission of the United States Army Centralized Allergen Extract Laboratory which encompasses the provision of quality assured and cost effective patient allergen extract vaccines, diagnostic testing allergens, delayed-type hypersensitivity antigens and related biologicals for the treatment of over 30,000 active duty soldiers, their family dependents and military retirees in over 500 medical treatment facilities worldwide (Army, Navy, Air Force, Veterans Administration Medical Centers and Public Health Service) on an annual basis. Some 95- 100,000 vials of allergy patient treatment vaccines and diagnostic skin testing antigen products are processed and formulated annually.

2. DELIVERY LOCATION: All deliveries of procured allergen extract supplies and materials from the manufacturer placed under this contract are to be delivered to the United States Army Centralized Allergen Extract Laboratory, 9100 Brookville Road, Building 512, Forest Glen, Silver Spring, Maryland 20910.

3. PERIOD OF PERFORMANCE:

01 September 2022 through 31 August 2027

4. GENERAL REQUIREMENTS:

A. Contractor/Manufacturer:

1. The contractor/manufacturer must be approved and licensed by the FDA and have no current outstanding violations with respect to appropriate FDA procedural and regulatory guidelines or policies.

2. The contractor/manufacturer’s facility will be compliant with USP regulations and recommended USP 797 guidelines. Manufacturer USP 797 adherence policies and procedures shall be made available to USACAEL upon request. Issues and concerns involving USP 797 guidelines will be addressed promptly.

3. The manufacturer/contractor shall supply the allergen extract products and ancillary supplies as specified with respect to the desired concentrations and annual USACAEL volume usage requirements as detailed in the itemized contract listing.

4. A representative of the manufacturer/contractor’s medical or scientific affairs team will be available as a point of contact and for support to assist with technical, scientific and clinical inquiries that USACAEL has regarding allergen extract product concentrations and substitutions, species cross-reactivities, cut back dosing recommendations, expiration dating, potency and stability.

5. The FDA approved manufacturer/offeror will be the sole source provider for the listed

STATEMENT OF WORK

United States Army Centralized Allergen Extract Laboratory (USACAEL) Purchase Agreement

Allergen Extract Products and Related Ancillary Supplies allergen extract products and biological supplies for the duration of this contract. Because manufacturing processes and sources of raw materials differ among manufacturers, the interchangeability of extracts from different manufacturers cannot be assured. There is potentially an increased risk of a systemic reaction if the immunotherapy extract is changed because of the possible variability in the composition and potency of allergen extracts. An allergen immunotherapy extract formulation is considered different from a clinical standpoint if there is any change in the constituents of the allergen immunotherapy extract products.

Changes would include differences in lot numbers, manufacturers, concentration and type of extract (aqueous vs glycerinated or standardized vs non-standardized).

B. Allergen Extract Product Specifications:

1. Weight per Volume items must be supplied in the ordered 1:20 W/V, 1:10 W/V or 1:100 W/V concentrations as specified in the itemized contract listing for allergen extract products (trees, weeds, grasses, molds, miscellaneous antigens, foods and special processed antigens). If a 50 ml vial is not available, five 10 ml vials may be substituted. Species as noted and volume usage (vials) per year will also be provided as requested in the itemized allergen extract per Exhibit A / Product Listing.

2. The PNU/ml content shall be provided for requested Weight per Volume allergen extract products. The PNU/ml content shall be clearly labeled for all Alum-Precipitated slow release allergen extract products if supplied to USACAEL.

3. The mg/ml content shall be made available by the contractor upon request..

4. Stock allergen extract solutions will be provided as 50% glycerinated solutions (G) or aqueous solutions (A) as requested by USACAEL and detailed in the itemized allergen extract via the Product Listing (see Exhibit A). New allergen extract products to be added to the inventory will be provided as requested and approved by USACAEL in aqueous or glycerinated solutions. (Concentrate stock solutions contain soluble extracts from source material, 0.5% sodium chloride and 0.54% sodium bicarbonate in water for injection or 50% glycerin. (Aqueous allergen extract solutions contain 0.4% phenol as a preservative. 50% glycerinated stock solutions contain 0.2% phenol).

5. Food items (Weight per Volume) are to be provided in 1:20 W/V concentrations or 1:10 W/V concentration solutions as specific in the itemized listing for allergen extract products. If this is not possible for a specific food product, the highest available concentration will be acceptable. These items shall be supplied as 50% glycerinated solutions.

6. Standardized (BAU/ml and AU) allergen extract products to include cat, mite products and grass 50% glycerinated stock solutions must be provided in the following desired concentrations:

a. Cat: 10,000 BAU/ml

b. Mites: 10,000 AU/ml

c. Grasses: Standardized grasses are to be supplied at a 100,000 BAU/ml concentration except for Bermuda which is available only at 10,000 BAU/ml.

7. All allergen extract products shall be labeled with the appropriate genus/species name as well as the common name of the product as applicable. All changes to the labelling of stock extract products to include nomenclature should be made known to USACAEL in an immediate manner before any deliveries with the labeling change occur.

8. All requested allergen extract stock solutions shall be provided in the appropriate vial sizes (10 ml, 50

ml) as specified in the itemized contract listing. Substitutions may be made if a vial size is not available, for example, five 10 ml vials may be substituted for a 50 ml vial of a particular allergen extract product if the 50 ml vial size of the product is not available.

9. Diluents shall be provided in the specified vial sizes. Annual volume requirements for diluent products are indicated in the itemized contract listing. Human Serum Albumin diluent may be substituted with 10% glycerosaline diluent if necessary or as requested.

a. Sterile albumin saline (HSA) diluent products (9 ml, 1.8 ml and 100 ml) contain 0.9% sodium chloride, 0.03% normal human serum albumin and 0.4% phenol as a preservative in water for injection.

b. Sterile phenol saline (normal saline) diluent products (9 ml and 100 ml) contain 0.9% sodium chloride and 0.4% phenol as preservative in distilled water.

c. Sterile 50% glycerin solution (100 ml) contains 50% glycerin, 0.09% sodium bicarbonate, and

0.166 sodium chloride in distilled water.

d. Sterile 10% glycerin solution contains 10% glycerin, 0.9% sodium chloride and 0.4% phenol.

10. Venom products shall be supplied in the appropriate vial sizes (5.5 ml or multi dose 10 ml) and mcg/ml concentrations as specified in the itemized contract listing.

11. Vial labels for stock allergen extract solutions will have bar coding capability to assist in capturing information (lot number, expiration dating, and item #).

C. Related Ancillary Supply Items:

1. Related ancillary supply items to include syringes, empty vials, vial caps, tamper proof seals, biohazard containers, jiffy bags, empty vial boxes and containers, packing envelopes and Styrofoam mailers are to be supplied in the desired annual amounts as specified in the detailed itemized contract listing.

2. Sterile empty vials and scratch dropper vials to include 10 ml empty vials, 30 ml empty vials, 50 ml empty vials and 5ml scratch dropper vials are to be supplied in the volume indicated as detailed in the itemized contract listing.

D. Allergen Extract Product Availability:

1. USACAEL must be notified immediately (upon receipt of supply order) as to the availability of an allergen extract product. Bio-equivalent or cross reacting species substitutions for an allergen extract product that is no longer available or has been discontinued, will be made in consultation with the manufacturer medical affairs team and technical representatives to prevent the risk of an adverse patient reaction and minimize interruptions to the patient’s treatment regimen. Cross-reactivity data or information will be made available upon request.

2. USACAEL must be notified for any allergen extract product that will have a shortened expiration dating (less than 1 year). These products will be sent upon the approval of USACAEL to assure they will be utilized in a timely fashion.

3. New allergen extract antigens and related ancillary supplies that are requested and may be supplied or added to the itemized contract listing, during the course of the contract (base year and four option years), shall be priced accordingly with respect to manufacturer pricing for current option year.

E. Ordering and Delivery (Invoices and Status):

1. USACAEL shall have the option to place orders electronically (ordering template preferred), by fax. or by phone.

2. All products shall be shipped by the manufacturer in a timely manner- within one week of receipt of submitted USACAEL order. Upon submission of the product order, within 48 hours, USACAEL must be notified as to the availability of the ordered allergen extract products and ancillary supplies. The expected time of delivery for delayed or back ordered products will also be relayed. Appropriate shipping times will be discussed with, and approved by USACAEL to assure staff is on hand to receive the shipped items.

3. Complete and accurate invoices are to be sent with all deliveries. Allergen Extract product information will be sent to include item lot numbers, expiration dating, PNU/ml designation and number of vials shipped.

4. Contactor must provide a current report as well as an annual report for all allergen extract products ordered (number of vials, total cost per item, and total annual cost for all previous orders placed) upon request by USACAEL.

F. Contract Management and Coordination:

The contractor shall coordinate contract requirement changes through the appropriate USACAEL Contract Officer Representative.

G. Legal Holidays:

The following legal holidays are observed by Kimbrough Ambulatory Care Center:

New Year's Day / Martin Luther King's Birthday / President's Day / Memorial Day

Juneteenth / Independence Day / Labor Day / Columbus Day / Veteran's Day

Thanksgiving Day / Christmas Day

H. Security Requirements:

The Medical Treatment Facilities (MTFs) are restricted access military installations. Contracted workers shall not begin performance until the complete documentation for a Personnel Background Investigation has been submitted, if applicable. An identification (ID) badge, the Common Access Card (CAC) and the vehicle registration will not be issued until complete documentation has been submitted to the appropriate Installation, MTF, or other Security Manager (s), as required at the facility. The CAC card is required for access to Government computer databases and also is presented to the security guards when entering the military installation. If a background investigation results in an unfavorable finding, the contracting officer will notify the contractor and the contract employee will not be granted access to the facility, will not be able to perform services at the facility, and must return all identification badges, CAC cards, and other items issued previously issued by the Government.

I. Contractor Services

1. The Contractor shall furnish all personnel and services to comply with the requirements of this contract, except where specifically identified as government-furnished supplies and services.

2. Point of Contact. Three calendar days prior to performance of services, the Contractor HCP shall designate, in writing, and provide to the Contracting Officer's Representative [COR] and Contracting Officer, the name, email address, and telephone number of the point of contact for all actions on this requirement.

5. STATEMENT OF WORK – ADDENDUM FOR ANTI-TERRORISM/OPERATIONS SECURITY

Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within Army controlled installation, facility, or area. Contractor and all associated sub- contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204- 9, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

For contractors requiring Common Access Card (CAC). Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) Both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) Remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) Physical access to multiple DoD facilities or multiple non- DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more.

At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

Threat Awareness Reporting Program. For all contractors with security clearances. Per AR 381-12 Threat Awareness and Reporting Program (TARP), contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

EXHIBIT A

Product Listing

2022 UNITED STATES ARMY ANTIGEN AND ANCILLARY SUPPLY REQUIREMENTS

TREE ANTIGENS

Size

ANTIGEN W/V CC

ACACIA SPECIES (A) 1:20 50

ALDER, RED (A) 1:10 50

ASH, WHITE (A) 1:20 50

ASPEN (G) 1:20 10

BAYBERRY/WAX M (A) 1:10 10

BEECH, AMERICAN (G) 1:20 50

BIRCH MX (RWB) (G) 1:20 50

BOX ELDER (G) 1:20 50

CEDAR, MTN (G) 1:20 50

CEDAR, RED (G) 1:20 50

CEDAR, SALT (G) 1:20 50

COTTONWOOD, CMN (G) 1:20 50

CYPRESS, BALD (A) 1:40 50

ELM, AMERICAN (G) 1:20 50

ELM, SIBERIAN (G) 1:20 50

EUCALYPTUS (A) 1:20 10

GUM, SWEET (A) 1:10 10

HACKBERRY (A) 1:10 50

HAZELNUT, AMER (A) 1:10 50

HICKORY, SHAGBARK (A) 1:10 50

MANGO BLOSSOM (A) 1:20 10

MAPLE, RED (A) 1:10 50

MELALEUCA (A) 1:20 10

MESQUITE (G) 1:20 50

MULBERRY, RED (G) 1:20 50

OAK MX (BL,R,W) (G) 1:20 50

OLIVE, EUROPEAN (A) 1:10 50

PALM, QUEEN/COC (A) 1:10 10

PECAN (A) 1:10 50

PEPPER TREE SP (A) 1:20 10

PINE MX (W,Y,L) (A) 1:10 50

PINE, AUSTRALIAN (A) 1:10 10

PRIVET (G) 1:20 50

RUSSIAN OLIVE (A) 1:20 50

SYCAMORE, EAST (A) 1:10 50

WALNUT, BLACK (A) 1:10 50

WILLOW, BLACK (G) 1:20 50

GRASSES NON-STANDARDIZED

ANTIGEN W/V CC

ALFALFA (G) 1:50 10

BAHIA (G) 1:20 50

BROME, SMOOTH (G) 1:20 50

CORN (G) 1:20 50

JOHNSON (G) 1:20 50

OATS, COMM CULT (G) 1:20 50

GRASSES STANDARDIZED (BAU/ML)

BERMUDA 10,000 K 50

JUNE, KY BLUE 100,000 K 50

MEADOW FESUE 100,000 K 50

ORCHARD 100,000 K 50

RED TOP 100,000 K 50

RYE, PERENNIAL 100,000 K 50

SWEET VERNAL 100,000 K 50

TIMOTHY 100,000 K 50

WEEDS

COCKLEBUR (G) 1:20 50

DOCK/SORREL MX (G) 1:20 50

GOLDENROD (G) 1:20 50

KOCHIA (A) 1:10 50

LAMBS QTRS (G) 1:20 50

MARSHELDER, RO (G) 1:20 50

NETTLE (A) 1:20 50

PIGWEED MX (CPR) (A) 1:20 50

PLANTAIN, ENG (A) 1:10 50

RAGWEED, FALSE (G) 1:20 50

RAGWEED, MIX (G) 1:20 50

RAGWEED, WEST (G) 1:20 50

RUSSIAN THISTLE (G) 1:20 50

SAGE, MUGWORT (G) 1:20 50

SCALE, WING (A) 1:10 50

MOLDS

ALTERNARIA (G) 1:20 50

ASPERGILLUS FUM (G) 1:20 50

CANDIDA ALBICANS (G) 1:20 50

CHAETOMIUM (A) 1:10 10

DRESHLERA/CURVU (A) 1:20 50

EPICOCCUM (G) 1:40 50

FUSARIUM MX (A) 1:20 50

HELMIN/BIPOLARIS (A) 1:10 50

HORMODENDRUM (G) 1:20 50

MUCOR MX (G) 1:20 10

PENICILLIUM CHRYSO (A) 1:10 50

PHOMA (G) 1:40 50

PULLULAR/AEROBA (G) 1:40 50

RHIZOPUS MX (A) 1:20 50

STEMPHYLLIUM (A) 1:20 50

MISCELLANEOUS ANTIGENS

FIRE ANT, INVICTA (G) 1:20 50

FIRE ANT, RICHT (G) 1:20 50

CATTLE (G) 1:20 10

COCKROACH MIX (G) 1:20 50

COTTONSEED (G) 1:20 10

DOG EPI/MIXED (A) 1:10 50

FEATHER MX (CDG) (A) 1:10 10

FLAXSEED (G) 1:40 10

GERBIL HAIR (G) 1:20 10

GOAT (G) 1:20 10

GUINEA PIG (G) 1:20 10

HAMSTER HAIR (G) 1:20 10

HORSE HAIR (G) 1:20 10

MOSQUITO, AEDES (A) 1:20 10

MOUSE (G) 1:20 10

RABBIT (G) 1:20 10

RAT (G) 1:20 10

SMUT, GRAIN MX (G) 1:40 10

CAT AND MITES STANDARDIZED (BAU

AND AU)

ANTIGEN W/V CC

CAT, STANDARD 10,000 K 50

MITES, MX (5000 EA) 10,000 K 50

MITES, FARINAE 10,000 K 50

MITES, PTERONYS 10,000 K 50

FOOD ITEMS

ALMOND 1:20 10

APPLE, RED 1:40 10

APRICOT 1:40 10

ASPARAGUS 1:20 10

AVOCADO 1:20 10

BANANA 1:40 10

BARLEY 1:20 10

BASS 1:20 10

BAY LEAF 1:20 10

BEAN, GREEN 1:20 10

BEAN, PINTO 1:20 10

BEEF 1:20 10

BLUEBERRY 1:20 10

BRAZIL NUT 1:20 10

BROCCOLI 1:20 10

BUCKWHEAT 1:20 10

CABBAGE 1:20 10

CANTALOUPE 1:20 10

CARROT 1:40 10

CASHEW NUT 1:20 10

CATFISH 1:20 10

CAULIFLOWER 1:20 10

CELERY 1:40 10

CHERRY 1:20 10

CHICKEN 1:20 10

CHOCOLATE 1:20 10

CINNAMON 1:20 10

CLAM 1:20 10

COCONUT 1:20 10

CODFISH 1:20 10

COFFEE 1:20 10

CORN 1:40 10

CRAB 1:20 10

CRANBERRY 1:40 10

CUCUMBER 1:40 10

EGG, WHITE 1:20 10

EGG, WHOLE 1:20 10

EGG, YOLK 1:20 10

FLOUNDER 1:20 10

GARLIC 1:20 10

GINGER 1:20 10

GRAPE, WHITE 1:20 10

GRAPEFRUIT 1:40 10

HALIBUT 1:20 10

HAZELNUT 1:20 10

HOPS 1:20 10

LAMB 1:20 10

LEMON 1:40 10

LETTUCE 1:40 10

LOBSTER 1:20 10

MACKEREL 1:20 10

MALT 1:20 10

MILK, WHOLE 1:20 10

MUSHROOM 1:40 10

MUSTARD 1:40 10

NUTMEG 1:20 10

OATS, WHOLE GR 1:20 10

OLIVE 1:20 10

ONION 1:20 10

ORANGE 1:20 10

OYSTER 1:20 10

PEA, GREEN 1:20 10

PEACH 1:40 10

PEANUT 1:20 10

PEAR 1:40 10

PECAN 1:20 10

PEPPER, BLK/WHT 1:20 10

PEPPER, GR 1:40 10

PERCH 1:20 10

PINEAPPLE 1:20 10

PISTACHIO 1:20 10

PORK 1:20 10

POTATO, SWEET 1:20 10

POTATO, WHITE 1:20 10

RICE, WHOLE 1:20 10

RYE 1:20 10

SALMON 1:20 10

SCALLOPS 1:20 10

SESAME 1:20 10

SHRIMP 1:20 10

SOYBEAN, WHOLE 1:40 10

SPINACH 1/100 10

SQUASH 1:40 10

STRAWBERRY 1:40 10

TEA 1:20 10

TOMATO 1:40 10

TROUT 1:20 10

TUNA 1:20 10

TURKEY 1:20 10

VANILLA 1:20 10

WALNUT, BLK 1:20 10

WATERMELON 1:20 10

WHEAT, WHOLE GR 1:20 10

YEAST SACCHAROMY 1:20 10

DILUENTS AND HISTAMINE CONTROL

DILUENT SIZE CC

Human Serum Albumin

YELLOW 9 ML EA

(10-20) 25PK

BLUE 9 ML EA

(10-20) 25PK

GREEN 9 ML EA

(10-20) 25PK

SILVER 9 ML EA

(10-20) 25PK

SILVER 1.8 ML EA

(5-20) 25 PK

SILVER 100 ML 12

Pack

Phenol Saline

PHENOL SALINE 9 ML EA

(10-20) 25PK

PHENOL SALINE 100 ML EA

12 per pack 100-20

Glycerosaline 50% Glycerosaline 100 ML EA 12 per pack 100-20

Positive Controls HISTAMINE PRICK 5 ml EACH

6 MG/ML BASE

HISTAMINE

HISTAMINE ID 5 ML EACH

0.1 MG/ML BASE

STERILE EMPTY VIALS AND SCRATCH

VIALS

STERILE EMPTY (10-20) EA

(CAPPED) SILVER 9 ML 25PK

STERILE EMPTY (10-20) EA

(CAPPED) RED 9 ML 25PK

SCRATCH 5 ML EA

DROPPER Gross 144 vials

STERILE EMPTY (30-20) EA

SILVER 10/PK

STERILE EMPTY (50-20) EA

SILVER 12/PK

SYRINGES AND VIAL CAPS

ANTIGEN SIZE

OPTIMIX MIXING 1 ML CASES

23g X 1/2" (1000 per CASE)

RED VIAL CAPS 25/PK EA

YELLOW VIAL CAP 25/PK EA

GREEN VIAL CAP 25/PK EA

BLUE VIAL CAP 25/PK EA

PACKING SUPPLIES

JIFFY BAGS #1 7 X 12 CASE

100 PER CASE

STYROFOAM MAILERS 5X 10 ml vials

CASE

200 PER CASE

BOX AND TRAY 100/CASE

5/20/2006

EMPTY BOXES

GRIDS 144 SLOTS

DIAGNOSTIC TESTING MATERIALS

SKIN TESTER OMNI OM-EV EACH

EVALUATION

PACKAGE

OMNI SKINTESTER OM-503 EACH

CARRIER TRAY

OMNI SKINTESTER OM-303C EACH

TRAY (20 Well)

OMNI SKINTESTER 0M-203C EACH

10 PACK/BOX

GREER PRICK TRAY GY-5 EACH

ASSEMBLY (60 Well)

GREER PRICK TRAY

LID

GY-LD EACH

(60 Well)

SKIN REACTION

GUIDE

SRG EACH

BULK VERSA VIAL

RACK

VRB-001 EACH