36C24218R0169-051.pdf

RFP 36C24218R0169

D.23 PACKAGING AND SHIPPING OF SPECIMENS FOR ANALYSIS

VA Western New York Healthcare System Pathology and Laboratory Service

PACKAGING AND SHIPPING OF SPECIMENS FOR ANALYSIS

I. PURPOSE

Specimens are subject to the minimum packaging requirements of government and international regulations and must withstand leakage of contents, shocks, pressure or temperature, change and other conditions incident to ordinary handling in transportation.

II. SCOPE

A. This procedure applies to all staff that package laboratory specimens for transport to a remote site.

B. At the time of original training and at least every two years thereafter, the following training shall occur and be appropriately documented.

1. All Send Out staff, as well as certain other selected lab staff in micro, and/or pathology shall receive certified training on shipping infectious substances and diagnostic specimens.

2. All other Blood Bank staff and local CBOC staff (includes Batavia) receive local training.

3. Overnight CBOC staff receives expanded local training.

C. VA Staff shuttle/courier drivers shall be trained and competency assessed annually. See ATTACHMENT A.

D. At the Buffalo site during administrative hours, final packaging and shipping of lab specimens must be done by the Send Out lab. During non-ad shifts the Blood Bank tech is responsible for packaging and shipping with local courier only.

III. BASIC PREPARATION/PACKAGING OF SPECIMENS

A. Primary leak proof container:

1. All liquid specimens must be in labeled tubes/containers made of plastic with skirted tight-fitting caps exhibiting good integrity. If screw top caps are used for samples traveling by US Postal Service or commercial courier service (UPS, Fed Ex, Taxi etc.), they must be reinforced with adhesive tape or parafilm. This is considered the primary leak proof container.

2. Specimens to be transported by Fed Ex, UPS must not contain more than 500 mL in this primary container.

NOTE: Primary containers that contain a Dangerous Class 3: Flammables (such as the preservative in thin prep vials), Class 8: Corrosives (such as bleach) and class 9 Environmentally Unfriendly Substances (such as lithium batteries) must contain 30mL or less.

3. Labels on primary containers should contain:

a) The patient’s full name and full social security number

b) The specimen type

c) Date/time of collection

d) If the computer generated accession/barcode label is available is must be used. It contains all of the requirements in a – c above.

e) If the lab order label (un-accessioned/non barcode label) is available it can be used but you must write date/time of collection, and your initials on the label.

f) If a specimen has been aliquoted from the original collection container, it should also include the initials of the staff member who aliquoted the specimen.

4. Glass slides will be labeled on the frosted edge and placed in hard cased container to protect from breakage.

5. Paraffin blocks will be labeled on the plastic collar and wrapped in gauze.

B. Secondary leak proof container:

1. The labeled specimen(s) must be placed into a secondary leak proof container.

2. This secondary container may be a ziplock bag or leak proof plastic bin.

C. Absorbent material :

1. Adequate absorbent material must be placed between the primary and secondary leak proof containers. There should be sufficient absorbent material to absorb two times the volume of the specimen(s) in the secondary leak proof container.

2. Foam racks serve as the absorbent material when utilized.

D. Shipping manifest:

1. A shipping manifest (lab request slip, worklist, etc.) must accompany all shipments and contain the following:

a) Originator of the shipment (Who is sending the shipment)

b) Listing of specimens contained in the package

c) Date and time of packaging

d) Initials of the packager

2. The paperwork should not be allowed to be in direct contact with specimens. Place paperwork inside a separate ziplock bag.

E. Outer container:

1. The secondary container and shipping manifest must be placed into a sturdy outer container which maintains specimen integrity and is appropriate for the mode of transportation being utilized and for the specific category of specimen (A or B). See Section IV below for details.

2. The outer container contains required labels depending on mode of transportation utilized and for the specific category of specimen (A or B). See Section VI: Completion of Forms and Labels.

3. Bubble wrap or other packing material should be used to fill in any empty space in the outer shipping container so that specimen(s) will not shift during transport.

4. Pre-labeled coolers are used as the outer container in shipments that are transported by VA shuttle/courier from CBOC’s or the VAWNY Batavia site.

5. After the outer container is packed it must be sealed. VA coolers must be zippered completely and secured with supplied zip locks to ensure all Protected Health Information (PHI) is transported safely. All other boxes should be sealed with packaging tape.

NOTE: When packaging shipments that contain dry ice, DO NOT completely seal all the container seams with tape. You must allow space for the release of gases from the dry ice.

6. Tube mailers or other small containers can be placed in the Fed Ex or UPS plastic mailing envelope designed for lab specimens.

NOTE: The Fed Ex or UPS plastic mailer is considered the outer container and IS NOT to be used as the Primary or Secondary Leak proof container.

IV. PACKAGING OF INFECTIOUS SUBSTANCES- CATEGORY B (DIAGNOSITIC SPECIMENS) BY

FED EX, UPS, TAXI, VA COURIER OR US POSTAL SERVICE.

A. Category B Infectious Substances (Diagnostic Medical Specimens) are defined as human material including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluids, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment or prevention and do not meet the criteria for inclusion in Category A. They fall under the UN shipping code UN 3373 (Diagnostic specimens or Clinical specimens). They must be packaged to comply with IATA Packing Instruction 650. The shipper must ensure that shipments are prepared in such a manner that they arrive at their destination in good condition and that they present no hazard to persons or animals during shipment.

B. Routine patient laboratory specimens being sent for diagnostic testing are included in this category.

C. Specimens must be properly packaged as per Section III above. Specimens, which do not fall into this shipping category must be packaged according to Category A substances and follow IATA Packing Instruction 602, which is addressed later in this policy. See Section V.

D. Category B specimens packaged for transport by Fed Ex, UPS or US Mail may contain no more than 500 mL in the primary container and no more than 4 liters of total volume.

NOTE: A dangerous good that falls under Class 3: Flammables (such as the preservative in thin prep vials), Class 8: Corrosives (such as bleach) and Class 9 Environmentally Unfriendly Substances (such as lithium batteries) must contain 30mL or less in the primary container with no more than 4 liters of total volume in outer packaging.

E. Room Temperature Shipments:

1. Specimens that must remain at room temperature must be kept separated from any refrigerated items in a shipment.

2. Ensure that the specimen is not placed near cold/frozen gel packs. If placed in same outer container with gel packs the room temperature sample must be insulated with packing material to maintain integrity of the sample.

3. Outer shipping containers must be sturdy to protect specimens from breakage. Use a Styrofoam or other sturdy material box for the outer shipping container.

4. Fed Ex or UPS plastic mailing envelopes may be used if specimens are placed in a sturdy rigid container that will fit in the envelope to protect the specimens against breakage. Paper bags are NOT acceptable.

5. The outer shipping container for local CBOC’s and Batavia site is the VA supplied cooler.

F. Refrigerated Shipments:

1. If sending refrigerated serum/plasma/urine: place two or three FROZEN gel packs on top of packaged specimens. If sending whole blood, place packaged specimen between two REFRIGERATED gel packs. During summer months a frozen gel pack should then be placed on top of the upper refrigerated gel pack.

2. Any necessary packing material should be placed on top of gel packs.

3. Use a Styrofoam box or other sturdy material box.

4. The outer shipping container for local CBOC’s and Batavia site is the VA supplied cooler.

G. Frozen Shipments:

1. If a frozen specimen can be allowed to thaw but remain cold in transit, then place two to four frozen gel packs on top of packaged specimen(s).

2. For specimens that must remain frozen during transport, place 2-3 lbs of dry ice on top of packaged specimen(s).

NOTE: When packaging shipments that contain dry ice, DO NOT completely seal all the container seams with tape. You must allow space for the release of gases from the dry ice.

3. Use a Styrofoam box or other sturdy material box with Styrofoam liner.

H. The shipping form and labels to be used will depend on the mode of transportation to be used. See instructions Section VI “COMPLETION OF FORMS AND LABELS”.

V. PACKAGING OF INFECTIOUS SUBSTANCES- CATEGORY A, FOR DELIVERY BY FED EX

A. Category A Infectious Substances are those that are transported in a form that, when exposure to it occurs, it is capable of causing permanent disability, life-threatening or fatal disease to humans or animals. They fall under UN shipping code UN 2814 (Infectious Substances affecting humans) or UN 2900 (Infectious substances affecting animals)

B. Shipping of certain bacterial or viral isolates fall into this category. See Table 3.6.D in the current IATA Dangerous Good Regulations for a full list of infectious substances which fall into Category A. All Category A substances must be packaged under IATA Packing Instruction 602.

C. UPS is not certified to ship Category A substances. All shipments must be sent through Federal Express.

D. Specimens are prepared in the same manner as described in Section III above. The secondary leak proof container MUST be certified to pass a 95kPa (13.8PSI) pressure test.

E. Packaged specimens are then placed in specially labeled “approved” outer shipping containers. These containers may be supplied by NYSDOH Wadsworth Center or purchased. To be “approved” the box must have been certified for Class 6.2. They must have the full name and address of the shipper and consignee, 24 hour Emergency Contact Information, and Class 6 label. A supply of approved boxes is kept in the Microbiology laboratory along with detailed instructions on the use of the packaging material currently in use.

F. A “Shippers Declaration of Dangerous Goods” document is also required. It MUST be generated using Fed Ex Software that is only available on the Microbiology Laboratory Lead Technologist’s computer. One copy must be placed into the box before it is sealed and 3 copies should be placed with the Fed Ex Shipping label on the outside of the box.

G. The Microbiology laboratory sends all isolates to Wadsworth at ambient temperature.

H. See Section VI below for specific instructions for completion of required forms and labels.

VI. COMPLETION OF FORMS AND LABELS

A. General labeling requirements:

1. If the package contains 50 mL or more of fluid, then a Package Orientation Label must also be attached to the outer box (arrows pointing to the top of box)

2. For all Category B shipments, via UPS/Fed Ex, a UN 3373 label and a Biological Substance Category B/ air eligible label must be applied to the outer shipping container.

3. For all Category A shipments a UN 2814 label and a Class 6 Infectious Substance label must be attached to the outer shipping container (see instructions located with the current supply of approved boxes)

4. If the outer container contains DRY ICE:

a) Fed Ex requires a properly completed Class 9 label attached to the outer box.

b) UPS requires a properly completed UPS Dry Ice label attached to the outer box.

B. Taxi/VA Courier shipments:

1. Labels for local use, such as delivery to local reference labs or shipments from Batavia and local CBOCs to the Buffalo laboratory, must include the following:

a) Biohazard label

b) Address and phone # of sending facility

c) Address of testing facility

d) Instructions for the driver of number to call in case of emergency or leakage of package contents.

e) Shipping name: Diagnostic Specimen

2. Pre-printed transport instruction form/labels can be used. See Attachments B and C

a) Place a red/orange biohazard label in the appropriate location on form.

b) Place pre-printed testing lab address/phone number label in the appropriate location on form.

c) Attach to outside of the properly prepared and packaged specimen for transport.

d) For VA Shuttle/Courier coolers, place a completed label in the see thru pocket located on the top of the cooler

C. Fed Ex Shipments:

1. Fed Ex shipments are limited to the following:

a) Category B shipments that are being paid for by the RECEIVER.

(Ex: US Labs)

b) Category A shipments.

c) As a backup service provider to UPS.

2. To generate the air bill go to: WWW.FedEx.com and sign in with your User ID and Password

(administered by the Section Supervisor)

a) Choose address of Receiver from the address book (under “My Lists”)

b) Select Service Type of : Priority Overnight

c) Select Package type , # of packages and estimated weight of package

d) Click in Saturday Delivery box to select if needed

e) If Dry ice is needed you must edit Special Services and enter estimated weight

f) If Category A specimens are being sent you must edit Special Services by selecting

Dangerous Goods and then select type INACCESSIBLE

g) Ship and Print Label

NOTE: a manual airbill may be utilized if internet access is not available during computer downtimes.

See example in Send Out lab file cabinet.

3. If a Fed Ex “Lab Pak” plastic mailer is used, a UN 3373 label and a Biological Substance Category B/ air eligible label must be applied to mailing envelope if it is not already pre-printed on the envelope by the shipper. Lab Paks cannot be used for Category A shipments.

4. Attach the completed air bill to the outside of the outer shipping container in a see-through pouch.

5. For Category A shipments, 3 copies of the “Shippers Declaration of Dangerous Goods” will be generated and brought to the send out lab by the Microbiology Lab staff. Place them in the pouch with the air bill – do not seal the pouch.

D. UPS Shipments

1. UPS cannot be used for Category A shipments.

2. To generate the air bill go to: www.campusship.ups.com and sign in with your User ID and Password (administered by the Section Supervisor)

a) Select the receiving address from the Corporate Address Book

b) Select Packaging Type and enter estimated weight

c) Select UPS Next Day Air for Service

d) Click in “Deliver On Saturday” box to select if needed

e) If Dry ice is needed you must click in the Dry Ice box and enter estimated weight

f) Review entered data and ship

g) Print label http://www.fedex.com/ http://www.campusship.ups.com/

NOTE: a manual airbill may be utilized if internet access is not available during computer downtimes.

See example in Send Out lab file cabinet.

3. If a UPS “Lab Pak” plastic mailer is used, a UN 3373 label and a Biological Substance Category B/ air eligible label must be applied to mailing envelope if it is not already pre-printed on the envelope by the shipper.

4. Attach the completed air bill to the outside of the outer shipping container in a see-through pouch.

VII. TRANSPORTATION

A. VA Courier Service: Specimens should be prepared and packaged as described above. Monday through Friday at approximately 10am, VA Courier will pick up specimens for local delivery in room 218E. (no Holidays). VA courier is also used to transport specimens from the local CBOC sites to the Buffalo or Batavia VA Lab sites.

B. Shuttle Service: Specimens should be prepared and packaged as described above. Deliver to the designated shuttle pick-up area located in Central Processing for the Buffalo site, or the Lab at the Batavia site. Service is available between the Rochester OPC, the Batavia site, certain CBOC sites and the Buffalo site of VAWNYHS.

(See CM 137-14 for shuttle schedule)

C. Cab Service: Specimens should be prepared and packaged as described above. Call the Cab Service being utilized by Lab Service. Inform dispatcher who you are, where you are from, the room location for the package pickup, and where you wish package to be delivered. Cab service is to be used for local deliveries that cannot wait for the next VA Courier Service. All signed cab slips should be forwarded to the Blood Bank and entered into the Blood Bank Cab Service Logbook.

D. Federal Express:

1. Federal Express routinely picks up packages Monday thru Friday in Room 218E after 3:30 pm.

E. UPS:

1. Routine scheduled pickups at the CBOC’s located outside the regular VA Courier route will occur Monday thru Friday at each site (Dunkirk, Jamestown & Olean).

2. UPS routinely picks up packages Monday thru Friday in Room 218E after 3:30 pm.

VIII. SPECIMENS REQUIRING UNIQUE HANDLING

A. Blood Products: All blood products will be transported according to Blood Bank standard operating procedures found in the Blood Bank SOP manual.

B. Anatomic Pathology biopsies will be prepared, packaged and transported according to the written procedure unique to the specimen type and destination of analysis. These procedures will be kept on file in the Pathology Office.

IX. ATTACHMENTS

A. Staff shuttle/courier drivers training B. Transport Instruction Form/Label -Generic C. Transport Instruction Form/Label – Buffalo

X. REFERENCES

A. International Air Transport Association (IATA), Dangerous Goods Regulations Current Edition

B. CM 113-13 – Guidelines for the Collection, Handling, and Transport of Laboratory Specimens C. CM 137-14 – VA Provided Patient Transportation D. Laboratory SOP Manuals for Blood Bank, Send-out Testing, and Anatomic Pathology procedures

XI. HISTORICAL RECORD

DATE

(Enter date put into Service, revised, reviewed or removed)

WRITTEN/

REVISED

BY

STAFF

EDUCATION

METHOD

SUPERVISOR

REVIEW

MD REVIEW

Put into Svc: April 1999 See manual sign-off sheet for original signatures

Revised: Oct 22, 2001 C.Allen, D.Walser

Read SOP

Revised: Feb. 2004 D Walser Revised: March 2005 D. Walser Revised 12/3/08 to include non-ad responsibilities, competencies, how to seal containers and Classes 3, 8, and 9 requirements

J. Minderler, D. Landes, D. Walser

E-mail, Competency Assessment

Rana Samuel, MD

Reviewed 12/30/08 Manola DeMunda Reviewed 3/12/10 Manola DeMunda Reviewed 4/14/11 Manola DeMunda Revised: June 2011 To include new Category A software requirement, UPS use and courier training.

Reformatted

D.Landes E-mail, read SOP, applicable quiz

Manola DeMunda Rana Samuel, MD

Reviewed 10/5/12 Manola DeMunda Revised 2/2014: Added PHI bag lock

D. Landes B.Heim

E-mail

Reviewed 10/7/14 Manola DeMunda Revised 8/2015: Updated Attachment A

D.Landes J.Vona

E-mail

ATTACHMENT A: VAWNYHS Courier Service Specimen Transport Training

Self-Learning Module

Directions: It is the expectation of the VA, OSHA and TJC that all employees who handle or transport specimens have adequate training to perform this task. This is for your safety and also for the integrity of the patient’s sample.

1. Please read the following information on safe Specimen Transport.

2. Complete the attached Competency Assessment form (10 true and false questions)

3. Hand in completed form to your Supervisor.

Laboratory Specimens- WHAT ARE THEY?

They can be vials of blood, containers of urine, fluids, stool or anything being sent to the clinical lab for analysis. Every specimen is contained in a properly sealed container, labeled with the patient’s full name and social security number and bagged in a secondary zip-lock bag. These may or may not be placed into a rigid outer container with an orange biohazard symbol.

Are Laboratory Specimens infectious?

Much is known about the transmission, prevention and treatment of bloodborne viruses such as Hepatitis B, Hepatitis C and HIV (Human Immunodeficiency Virus) infections. Because we do not necessarily know if a patient is infected with these viruses or other infectious agents, it is recommended by the Centers for Disease Control (CDC) and Occupational Safety and Health Administration (OSHA), that all employees who have contact or potential contact with blood or body fluids take the necessary precautions to prevent a possible exposure. Further information on bloodborne pathogens and precautions to be taken are contained in Center Memorandum 11-47 “Exposure Control Plan for Bloodborne Pathogens”.

What Precautions do I need to take?

• Hepatitis B vaccine: Because of your potential exposure to blood/body fluids when transporting specimens, you should consider taking the Hepatitis B vaccine (series of 3 injections given over a 6 month period), if you have not already received it. Please contact Employee Health for more information- ext. 8802 at the Buffalo site

• The transport cooler should be intact, closed and without leakage.

• Do not enter the transport cooler once packed by the clinic or lab.

• Make sure the cooler has an orange biohazard sticker on it such as the one pictured here

• If the biohazard sticker or transport instruction label with delivery addresses is missing or worn off OR if the transport cooler is broken or soiled, tell the lab person immediately, so it can be replaced.

• Specimens should be directly delivered to the clinical laboratory at Buffalo 2B (Automated Lab/Histology)and specimens should be removed from the cooler by laboratory personnel only.

• Do not stop along the way at the restroom, canteen or lunchroom. Even though the outside of the cooler is not contaminated, it is not appropriate for these coolers to be near food or in public places.

• Timeliness of delivery of the specimens and a constant temperature (not too hot and not too cold) is important for the proper management of clinical samples. Do not expose transport coolers to extreme heat or cold by leaving them in vehicles for long periods of time. If anything unusual happened during the transport- (ex van broke down and specimen unable to be delivered for prolonged period), please communicate such transport difficulties to the laboratory personnel upon delivery of specimen.

• If you use the elevators at the Buffalo site when transporting specimens, please use the Service Elevators and not the Patient Elevators

• You do not need to wear gloves when transporting the cooler. If you choose to wear gloves, it is recommended that you glove the hand transporting the cooler and that you keep the other hand ungloved, so as to not touch door handles and surfaces with gloved hand. Always wash your hands after the removal of gloves.

• YOU MUST Clean YOUR HANDS after delivering the specimen to the lab. As long as your hands aren’t visible soiled, you may use the antiseptic foamed alcohol available in wall mounted dispensers. If visibly soiled you must wash with soap and water at any available sink.

• Should the cooler drop or become damaged in anyway, do not open the cooler to inspect for breakage. Take to the laboratory and explain what happened.

• If the cooler should leak due to spillage of its contents, you should cover and/or block off the spillage, and report the spill to the supervisor of the area where it occurred.

• If any spillage of body fluids should get on your skin, wash the affected area immediately with soap and water and report the incident to your supervisor and the Employee Health unit for the proper medical follow-up.

• Kits with protective wear (gloves, mask, spill kit, etc) and an alcohol- based waterless handwashing agent are available in every vehicle that may transport lab specimens.

If you have any questions regarding transport of specimen, please don’t hesitate to call Laboratory QA at 862-8688 or Infection Control Nurses at 862-8813 or 862-8814.

THANK YOU!

ATTACHMENT B:

FROM: Place sending location address/phone # here Lab: Place BioHazard Sticker Here

TO: Place testing lab address/phone sticker here

CONTENTS: HUMAN BODY FLUIDS DO NOT HEAT OR COOL

DIAGNOSTIC SPECIMEN DO NOT OPEN PACKAGE

IN CASE OF EMERGENCY OR LEAKAGE, CONTACT THE VA HOSPTIAL AT THE NUMBER LISTED

ABOVE.

GO IMMEDIATELY TO THE DESTINATION LISTED. DO NOT PASS PACKAGE TO ANYONE ELSE TO

DELIVER.

DELIVER WITHIN 60 MINUTES.

FROM: Place sending location address/phone # here Lab: Place BioHazard Sticker Here

IN CASE OF EMERGENCY OR LEAKAGE, CONTACT THE VA HOSPTIAL AT THE NUMBER LISTED

ABOVE.

GO IMMEDIATELY TO THE DESTINATION LISTED. DO NOT PASS PACKAGE TO ANYONE ELSE TO

DELIVER.

DELIVER WITHIN 60 MINUTES.

ATTACHMENT C:

FROM: VA Western NY Healthcare System Lab: Place BioHazard Sticker Here Send Out Lab 3495 Bailey Ave.

Buffalo, NY 14215 862-7836

IN CASE OF EMERGENCY OR LEAKAGE, CONTACT THE VA HOSPTIAL AT THE NUMBER LISTED

ABOVE.

GO IMMEDIATELY TO THE DESTINATION LISTED. DO NOT PASS PACKAGE TO ANYONE ELSE TO

DELIVER.

DELIVER WITHIN 60 MINUTES.

FROM: VA Western NY Healthcare System Lab: Place BioHazard Sticker Here Send Out Lab 3495 Bailey Ave.

Buffalo, NY 14215 862-7836

IN CASE OF EMERGENCY OR LEAKAGE, CONTACT THE VA HOSPTIAL AT THE NUMBER LISTED

ABOVE.

GO IMMEDIATELY TO THE DESTINATION LISTED. DO NOT PASS PACKAGE TO ANYONE ELSE TO

DELIVER.

DELIVER WITHIN 60 MINUTES.