Source: http://www.nj.gov/health/phel/detail.shtml
Timestamp: 2013-12-11 08:58:35
Document Index: 12227984

Matched Legal Cases: ['art 73', 'art 73', 'art 73', 'art 73', 'art 10', 'art 172', 'art 172', 'art 73', 'art 73', 'art 73', 'art 122']

Laboratory Response Network - NJDOH
Model of Collaboration: Sentinel, Reference and National Laboratories In 1999, the Centers for Disease Control and Prevention (CDC) initiated the concept of a Laboratory Response Network (LRN) through which accredited laboratories with capabilities to detect biological and chemical weapons of mass destruction could deliver their services in an integrated, coordinated way. The LRN is a network of local, state, federal and military laboratories across the United States and internationally which work together for a rapid response to public health emergencies. These laboratories may be categorized as sentinel, reference or national, based on the services they provide, and the biohazard containment they offer. The model of the LRN is a pyramid, with the sentinel laboratories at the base, the reference laboratories in the middle and the national laboratories at the apex. In New Jersey there are currently 64 sentinel (clinical microbiology laboratories) housed in 56 hospitals and 8 commercial laboratory sites. The Public Health and Environmental Laboratories (PHEL) within the New Jersey Department of Health (NJDOH) is the only LRN reference laboratory for the state of New Jersey. This laboratory is located in Trenton. The national laboratories of the LRN are located at CDC and the United States Army Medical Research Institute for Infectious Diseases (USAMRIID).
Additionally, there are 29 New Jersey hospital laboratories, which routinely collect microbiological specimens for analysis and forward them to the sentinel laboratories in the state. All clinical laboratories may be called to prepare and refer samples to reference or national laboratories.
For a more in-depth description of the LRN go to: Facts about the Laboratory Response Network
CDC -- What is the LRN? Sentinel Laboratory Response Plan: Overview/Template
Sentinel laboratories have four main functions within the LRN. These are as follows:
Appropriately collect handle and process specimens for biological and chemical terrorism analyses
Detect select agents using CDC /American Society for Microbiology (ASM) guidelines for sentinel laboratories.
Report these findings to the NJDOH Communicable Disease Service.
Refer isolates and samples to NJDOH PHEL BioThreat Response Laboratory for analysis. NOTE: Other clinical laboratories will also collect, report and refer samples, but lack the microbiology capabilities to detect these agents.
Clinical laboratory administration should, in addition, provide these laboratories with the support to safely and securely handle these and other infectious agents, and for surge capacity in an emergency situation. In order to integrate these functions into their primary care responsibilities the following template may be used: ASM Sentinel Laboratory Readiness Template
All sentinel laboratories within the LRN should have a plan in place for communications. This plan should include the following: Alert limits for agents outlined in CDC/ASM sentinel procedures 24/7 phone directory of key laboratory and hospital staff including laboratory medical director, laboratory administrator, microbiology supervisor and infection control practitioners. A call chain to indicate the internal reporting protocols. An individual(s) should be designated to report findings to the Communicable Disease Service (609)588-7500 or (609)392-2020 (off hours) and to the local health department in the patient’s district. In the event of a public health emergency additional communication information will be provided.
All staff should be trained and demonstrate proficiency on communication protocols. Key staff should be trained by the Communicable Disease Service (CDS) on utilization of the web-based Communicable Disease Reporting and Surveillance System (CDRSS)
CDRSS Website
Detection Procedures for BT Agents
The sentinel laboratory should do the following: Incorporate the CDC/ASM sentinel protocols and procedures for detection of Bacillus anthracis, Brucella spp., Francisella tularensis, Yersinia pestis, Burkholderia mallei and Burkholderia pseudomallei into the microbiology standard operations. These procedures have been developed by the CDC in cooperation with the ASM and are posted on the ASM website.
Train staff on recognition of these pathogens.
Ensure adequate supplies for these procedures.
Enforce immediate referral of all isolates meeting detection criteria to the NJDOH PHEL for rapid confirmation after contacting the NJDOH Communicable Disease Service. If the sentinel laboratory performs viral cultures, ensure that a protocol for safe handling, referral and disposal of unidentifiable viral isolates is in place. To access all the sentinel procedures, go to the ASM website indicated below: ASM Sentinel Laboratory Guidelines
CDC Specimen Selection Guide
Smallpox Collection Guidelines (CDC Guide D)
All clinical laboratories should be prepared to advise physicians and other primary care givers on the collection of samples for smallpox detection utilizing the CDC Guide D.
Only members of the New Jersey Public Health Response Team and other authorized vaccinated individuals are prepared to safely handle high risk specimens. All high risk specimens collected will be packaged by vaccinated individuals and shipped to CDC for analysis.
Clinical laboratories may package and ship samples from patients that are low, moderate, or high risk of smallpox. The PHEL currently has the capacity to test for low and moderate risk agents (eg. Varicella, Vaccinia). Samples that are high risk for smallpox will be referred to CDC. All clinical laboratories should maintain a Smallpox collection kit in their facilities which contains laboratory collection supplies and has been prepared according to Guide D. Ensure that this kit is secured and/or maintained regularly. CDC Smallpox Guide D
Collection Procedures for Other Agents
Other infectious and chemical agents may be tested at either the NJDOH Public Health and Environmental Laboratories or the CDC and collection guidance may be obtained through the CDC links indicated below. However, any clinical laboratory asked to collect and refer such specimens must only do so after contacting the NJDOH Communicable Disease Service at (609)588-7500 regular work hours or (609)392-2020 after hours, for medical consultation regarding the case definition and to obtain testing authorization.
Agent NJDOH CDC Botulinum toxin X Coxiella burnetii X Monkeypox X SARS X Staphylococcal enterotoxin B X Avian Flu X
X Botulinum toxin
Cultures Meeting Criteria for BT Agents Clinical laboratory directors (or their designees) are mandated to report positive laboratory results for communicable diseases listed in the New Jersey Administrative Code Title 8 Chapter 57: Communicable Diseases. Select agents (biothreat agents) are included on the reportable list. If a clinical laboratory isolates an organism in culture, which meets the ASM criteria for the following:
Bacillus anthracis Brucella spp
Burkholderia mallei, Burkholderia pseudomallei Yersinia pestis
It must be reported IMMEDIATELY by calling the following telephone numbers:
609-588-7500 (Monday through Friday 9AM-5PM)
609-392-2020 (all other times)
Patients with Clinical Symptoms resembling Infection with BT Agents
If a physician suspects a patient may have an infection or intoxication with an organism/toxin listed on the 42 CFR part 73 Select Agent List, United States Department of Health and Human Services (USDHHS and OverLap lists) It must be reported IMMEDIATELY by calling the following telephone numbers:
Local health departments in the patient’s jurisdiction must also be notified by the reporting laboratory or physician.
State Reporting Regulations
NJ Directory of Local Health Departments
USDHHS and Overlap Select Agents and Toxins List
Referral Requirements Cultures Meeting Criteria for BT Agents
Upon identification of an organism which meets the ASM criteria for Bacillus anthracis, Brucella spp., Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei or Yersinia pestis, the clinical laboratorian must contact the Communicable Disease Service at 609-588-7500 or 609-392-2020 (after hours). The epidemiologist taking the call will ask the laboratorian a series of questions related to the isolate to confirm satisfaction of the ASM criteria. For Bacillus anthracis the epidemiologist will ask:
Is the isolate a large Gram positive rod?
Did the isolate grow rapidly? (e.g. 15-24 hours on sheep blood agar)
Is the isolate non-hemolytic?
Is the isolate non-motile?
For Brucella spp. the epidemiologist will ask:
Is the isolate a Gram negative coccobacillus or small rod?
Did the isolate produce poorly growing colonies after 24 hours or incubation and better growing colonies after 48 hours on sheep blood agar?
Is the isolate oxidase positive?
Is the isolate catalase positive?
Is the isolate urea positive?
For Yersinia pestis, the epidemiologist will ask:
Is the isolate a slow-growing Gram negative rod?
Is the solate a non-lactose fermenter?
Is the isolate oxidase negative?
Is the isolate urea negative?
Is the isolate indole negative?
For Francisella tularensis, the epidemiologist will ask:
Is the isolate a minute, faintly-staining Gram negative coccobacillus?
Did the isolate produce little to no growth after 24 hours or incubation on sheep blood or chocolate agar and small (1-2 mm) colonies after 48 hours incubation?
Is the isolate oxidate negative?
Is the isolate weakly catalase positive?
For Burkholderia spp.’ the epidemiologist will ask:
Is the isolate a Gram-negative coccobacillus or small rod
Did the isolate produce poorly growing colonies after 24 hours of incubation and better growing colonies after 48 hours on sheep blood agar?
Is the isolate resistant to colistin or polymyxin B?
If the epidemiologist is able to confirm that the isolate meets the ASM criteria, he/she will approve referral of the isolate to the PHEL Biothreat Response Laboratory for confirmation.
The epidemiologist will assign an approval number to the isolate, which the sentinel laboratorian must record on the LAB-5 form which accompanies the culture to Trenton. Cultures, which do not have this approval number on the LAB-5, will not be tested.
Specimens from Patients with Clinical Symptoms Resembling Infection with BT Agents If the patient is suspected of having an infection/intoxication with an agent on the USHHS or Overlap list, the epidemiologist will advise the physician or the sentinel laboratory of the sample collection specifications, transport arrangements and appropriate LRN laboratory which does the confirmatory analysis.
USDHHS and Overlap Select Agents an Toxins List
Securing Specimens
The Select Agent Rule, 42 CFR part 73, affects any academic institutions, biomedical centers, commercial manufacturing facilities, research facilities, and other laboratories whose research or service routinely requires utilization of microorganisms which are identified as biothreat (select) agents by this rule. The major focus of this law is the requirement for registration of a facility that possesses, uses, or transfers a select agent or toxin. For the most part clinical laboratories are exempt from the provisions of Part 73, including the need for registration. Although exempt, all clinical laboratories must however, adhere to the reporting and disposal requirements as described in the Part 73 law. These requirements state that:
Upon identification of a select agent or toxin as the result of diagnosis or verification:
the result must be reported immediately to the HHS Secretary and to the county and/or state health department
the specimen and isolate containing a select agent or toxin must be transferred to a registered facility or destroyed on-site by a method sufficient to cause inactivation, and a record of the identification and transfer or destruction must be prepared and filed. A method for securing these specimens during this process should be implemented.
CDC Form 4 states that "in addition to the reporting requirement, the identified select agent or toxin must be secured against theft, loss, or release during the period between identification and final disposition" NJDOH recommends a lockable storage container to house the specimen.
CDC form 4
Dry Ice (UN 1845) Non-Regulated Materials and Exempt Human Specimens – General Guidelines Method of Transport Determine how you will transport the specimen. Refer to the list below to determine which packaging and shipping regulations apply. United States Postal Service (US Mail)
10.17.4: Category B Infectious Substances (UN3373) 10.17.8: Non-Regulated 10.17.9: Exempt Human or Animal Specimens 10.20.4 : Dry Ice(UN1845) Domestic Mail Manual Section 601, Part 10, Hazardous Materials
US Department of Transportation 49 CFR: 171-178 Category A Infectious Substances (UN2814) 49 CFR 173.196
Dry Ice (UN1845) Packing Instruction 904 IATA Dangerous Goods Regulations (for purchase only)
Shipper’s/Employer’s Responsibilities The shipper is required to classify, identify, package, label, mark, document and make arrangements according to the specified regulation. The employer is responsible for certification of the shippers and maintenance of appropriate documentation.
Classify : Using the criteria outlined in the regulations, determine if the sample should be shipped as a Biological Substance Category B (UN3373), Infectious Substance, Category A (UN2814 or UN2900) or as an Exempt material. Identify : Use internationally recognized name and UN number. Pack : Select the right materials and use them appropriately Label : Use the USDOT hazard labels and handling labels as needed Mark : Mark shipper and consignee information, and sample information. Document : Fill out shipping papers as specified. Make Arrangements :Make sure consignee is notified that a sample is being shipped. Shipper’s Certification According to USDOT and IATA, shippers of HAZMAT, including Category A infectious substances (UN2814 or UN 2900), are required by law to be certified by their employers as shippers. This certification requires that the shipper be trained and tested and that the employer keep a record of the shippers training to include a description of the training, date and time, and proof that the shipper has passed a test.
Shippers of Category B infectious substances must be familiar with USDOT Regulation 49 CFR 173.199, IATA Dangerous Goods Packing Instruction 650 and USPS Regulation 601:10.17.4 IATA and the College of American Pathologists (CAP) requires recertification every two (2) years, USDOT every three (3) years. United States Department of Transportation Training Requirements 49CFR: 172.704
Directions to the Public Health and Environmental Laboratories (Trenton) If a specimen is to be delivered to the laboratory outside of normal working hours, call ahead to make arrangements to ensure someone will be there to receive the sample. If using the post office or commercial carrier, request overnight or same day delivery. Do not relieve the carrier of their delivery responsibilities by signing a waiver. The courier must deliver to an authorized person.
Directions to PHEL Broken or Leaking Samples
The specimen must not arrive at the laboratory in a condition which poses a hazard to the laboratory staff or others who handle the specimen. Broken or leaking specimens will not be tested and if possible, the submitter will be informed. USDOT Sample Shipping Papers for Hospital Couriers
The United States Department of Transportation (USDOT) requires anyone who offers a hazardous material for transportation to describe the hazardous material, in English, on a shipping paper in a manner required by USDOT Hazardous Materials Regulations. The USDOT does not provide an official preprinted shipping paper. The Division of Public Health and Environmental Laboratories (PHEL), New Jersey Department of Health, has developed a shipping paper containing required information. Listed below is a link to the USDOT regulations governing information required on shipping papers:
http://www.myregs.com/dotrspa
Click on Subchapter C Hazardous Materials Regulations Click on Part 172 and refer to the following 49CFR regulations: 172.200: Applicability 172.201: Preparation and retention of shipping papers 172.202: Description of Hazardous Materials on Shipping Paper 172.204: Shipper’s certification
172:604: Emergency response telephone number 173:141: Class 9 (Assignment of Packing Group)Carbon Dioxide, Solid. 173.134 Items excepted from the infectious substance definition USDOT requires shipping papers for transportation of any Category A infectious substance (UN2814 or UN2900). 49 CFR Part 172, Subpart C. USDOT does not require shipping papers for transportation of Category B infectious substances (UN3373). Private courier service such as Federal Express (FedEx) and United Parcel Service (UPS) use shipping papers developed by their respective organizations that meet USDOT requirements and must be used when utilizing the respective courier service. Guidelines for Shipping Agar Plates
Currently United States Department of Transportation (USDOT), International Air Transport Association (IATA) and US Postal Service (USPS) primary container specification preclude the transport of cultures growing on agar plates. NJDOH recognizes the rare need for emergency transport of plates to our facility. Since this transport under ordinary circumstances will occur by ground, there are provisions in the DOT regulation for transport of these materials. It is described in section 49CFR 171.1d5 and states: "Transportation of a hazardous material (is permitted) in a motor vehicle, aircraft or vessel operated by a Federal, state or local government employee solely for noncommercial Federal, state or local government purposes"
Circumstances under which agar plates may be transported by government agents include: When prompt medical treatment is dependent upon confirmatory results available through testing at the state laboratory. When primary culture protocols do not include inoculation of agar slants and immediate analysis of isolates is required for medical, legal or public health purposes. Under circumstances such as these, sentinel laboratories may transport cultures growing on agar plates provided: The transporter is as described above. – DISCUSS THIS WITH LOCAL AUTHORITIES BEFORE TRANSPORT The plates are packaged as described below: NJDOH GUIDELINES FOR PACKAGING CULTURES GROWING ON AGAR PLATES:
Watertight Primary Receptacle shall consist of the following:
Seal the top and bottom of the plate together with parafilm (Stretch the parafilm around the circumference of the agar plate forming a leak proof seal with lid.) Wrap the sealed plate in a paper towel and place the plate inside a leak proof zip lock plastic bag, which displays the international biohazard symbol.
If multiple agar plates are placed inside a single secondary packaging, they must be wrapped individually as stated above to prevent contact between them. Secondary Packaging: (Plastic container with screw top)
Place the leak proof bagged agar plate (s) into a leak proof secondary container and have a list of contents document prepared and placed between the secondary and outer packaging. (Note: Place the list of contents in a clear plastic bag) The primary receptacle or secondary packaging used for Category A infectious substances (UN2814) must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 95 kPa (0.95 bar, 14 psi) and be capable of withstanding, without leakage, temperatures in the range of -40ºC to + 55ºC (-40ºF to +131ºF) Note: UN Certified Packaging for Class 6.2 meets these requirements for the secondary packaging. Outer Packaging: (UN Certified Fiberboard Box for Class 6.2 materials)
Place the secondary container and list of contents into an outer packaging of adequate strength for its capacity, mass, and intended use. (Note: the outer packaging must measure at least 100 mm (3.9 inches) at its smallest overall external dimension. Secure the outer packaging as per manufacturers' instructions.
Label and Mark Outer Package:
The outer package must contain the following information:
Infectious substances, affecting humans (or if applicable animals), UN 2814 for humans or 2900 for animals directly above or below the wording Infectious substances affecting humans or infectious substances affecting animals for UN2900. Shipper and consignee name and address. Responsible Person Phone Number Infectious Substance Class 6.2 Hazard Label. Potential Select Agents: If a culture contains a potential select agent, telephone the Communicable Disease Service at (609) 588-7500 or (609) 393-2020 to obtain a case number prior to transporting the material. Suppliers of UN Certified Products
Listed below are two (2) of numerous commercial suppliers of packaging and shipping supplies that meet USDOT, USPS and IATA hazardous materials regulations: Bureau of Dangerous Goods, DG Supplies Inc. 239 Prospect Plains Road, Suite D201 Monroe Township , New Jersey, 08831 Telephone: 800-347-7879 www.dgsupplies.com
Saf-T-Pak, Inc 101, 17872-106 Avenue Edmonton Alberta, Canada T5SIJ5 Telephone: 800-841-7484 http://www.saftpak.com
Link to Just-In-Time Packaging Requirements
Air Transport Category “A” Infectious Substances (UN2814) [pdf 2.26m]
Courier USDOT Category “A” Infectious Substance (UN2814) [pdf 1.09m]
Air Transport Category “B” Infectious Substances (UN3373) [pdf 1.49m]
Courier USDOT Category “B” Infectious Substance (UN3373) [pdf 1.06m]
Form for Specimen referral (LAB-5)
Directions to NDJHSS PHEL
Prepare samples for shipment to:
New Jersey Department of Health Public Health and Environmental Laboratories Market and Warren Sts. Trenton, NJ 08625-0361
Attention: Nelson Delgado
609-292-3755
Notification, Transfer and Destruction of Select Agents
Within several days of receipt of the referred culture, the BioThreat Response Laboratory will report the results of the confirmatory tests back to the sentinel laboratory. If the confirmatory results are NEGATIVE for the select agent in question, the sentinel laboratory may request the BioThreat Response Laboratory to speciate the isolate and the sentinel laboratory may dispose of the secured samples according to standard medical waste management practices.
If the confirmatory results are POSITIVE for the select agent in question the sentinel laboratory MUST satisfy the clinical laboratory requirements described in the Select Agent Rule 42 CFR part 73.
The Select Agent rule requires clinical laboratories to:
Notify CDC IMMEDIATELY at 404-718-2000.
Destroy and report the destruction of all cultures, diagnostic specimens and their derivatives on Form 4 within 7 days AND/OR
Transfer and document transfer of any cultures, diagnostic specimens or their derivatives on Form 2 Note: Requesting laboratory must supply CDC approval before any transfers occur.
Select Agent Rule 42 CFR part 73
Biosafety: Handling Pathogens in the Laboratory
A fundamental objective of any biosafety program is the containment of potentially
harmful biological agents. The term "containment" is used in describing safe methods,
facilities and equipment for managing infectious materials in the laboratory environment
where they are being handled or maintained. The purpose of containment is to reduce or
eliminate exposure of laboratory workers, other persons, and the outside environment to
potentially hazardous agents. The use of vaccines may provide an increased level of
personal protection. The risk assessment of the work to be done with a specific agent will
determine the appropriate combination of these elements.
There are four biosafety levels (BSLs) that define proper laboratory techniques, safety equipment, and design, depending on the types of agents being manipulated:
BSL-1 labs are used to study agents not known to consistently cause disease in healthy adults. They follow basic safety procedures and require no special equipment or design features. BSL-2 labs are used to study moderate-risk agents that pose a danger if accidentally inhaled, swallowed, or exposed to the skin. Safety measures include the use of gloves and eyewear as well as handwashing sinks and waste decontamination facilities. BSL-3 labs are used to study agents that can be transmitted through the air and cause potentially lethal infection. Researchers perform lab manipulations in a gas-tight enclosure. Other safety features include clothing decontamination, sealed windows, and specialized ventilation systems. BSL-4 labs are used to study agents that pose a high risk of life-threatening disease for which no vaccine or therapy is available. Lab personnel are required to wear full-body, air-supplied suits and to shower when exiting the facility. The labs incorporate all BSL 3 features and occupy safe, isolated zones within a larger building. Summary Of Biosafety Level 1 & 2 for Infectious Agents
OSHA Document: Hazard Communication. - 1910.1200
Safety and Health Topics: Bloodborne Pathogens and Needlestick Prevention
Laboratory Security United States Department of Transportation (USDOT) regulation 49 CFR 172.800 (b) requires each person who offers for transport in commerce or transports hazardous materials ( A select agent or toxin regulated by the Centers for Disease Control and Prevention (CDC) under 42 CFR part 73 or a select agent or toxin regulated by the United States Department of Agriculture (USDA) under 9 CFR part 122) to develop and adhere to a security plan for hazardous materials
USDOT regulation 49 CFR 171.802 refers to required components of a security plan. A security plan must include the following elements : (1) Personnel Security, (2) Unauthorized Access and (3) Enroute Security for couriers. Specific measures put into place by the security plan may vary commensurate with the level of threat.
The Bio-safety in Microbiology and Biomedical Laboratories (BMBL) 5th edition, developed by the United States Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) and the National Institute of Health, February, 2007 provides useful information directed specifically at laboratory security in section VI, Principles of Laboratory Biosecurity
Chain of Custody Physicians, nurses and health professionals document collection of specimens. Couriers document the pick up and delivery of specimens. Laboratories document receipt of clinical specimens. All these documents form the “Chain of Custody.” Chain of custody refers to the physical controls in place and the documentation of the transfer and storage of evidence (overt evidence from a crime scene and specimens from infected animals or other victims). With the assumption that a chain of custody procedure is established at healthcare facilities. The NJDOH LAB-5 is considered a chain of custody document.
USDA Organism and Vector Permits
VS Form 16-3
Select Agents are regulated by USDA (APHIS) and CDC. Diagnostic and clinical laboratories are exempt from the requirement to register (Registration Form: APHIS/CDC Form 1) with the APHIS or CDC Select Agent Program; however, laboratories are required to report the identification of a select agent or toxin, and within 7 days following identification, transfer the material to an entity that is registered for the select agent/toxin or destroy the agent (9 CFR 121.5, 42 CFR 73.5, 7 CFR 331.5, and 9 CFR 121.6, 42 CFR 73.6, 7 CFR 331.6). Certain select agents and toxins require immediate reporting. Refer to the previous regulation citations. The Report of Identification Form (APHIS/CDC Form 4: lab to complete) should be completed, in addition to, completing the Report of Transfer (APHIS/CDC Form 2: lab to complete) and the Veterinary Permit application (recipient should complete). Select agents or toxins may only be transferred to individuals or entities registered to possess, use or transfer that agent or toxin (9 CFR 121.16).
Last Modified: Thursday, 25-Apr-13 10:16:23