PWS_for_Medical_Waste_28_Feb_17.docx

Performance Work Statement (PWS) for Medical Waste at Holloman AFB, NM 49th MDG

__________________________________________ Date: _____________________ Contracting Officer Representative BOBBY G. MIDDLETON, GS-09, Civ 49 MDG Service Contract Manager

Functional Commander

EMILY M. DOUGLAS, 1ST LT, USAF, MSC

Commander, 49th Medical Logistics Flight

Quality Assurance Program Coordinator PATTI J. REN, Civ, DAF Quality Assurance Program Coordinator, 49th Contracting Squadron

Contracting Officer KAREN K. MATA, Civ, DAF Contracting Officer, 49th Contracting Squadron

1 June 17

Attachment 1, PWS

1. DESCRIPTION OF SERVICES / GENERAL INFORMATION. The contractor shall provide all the personnel, equipment, tools, materials, supervision and other items and non-personal services necessary to collect, transport, store and dispose of regulated medical waste (RMW), at the 49 MDG, Holloman AFB, New Mexico. The contractor shall perform to the standards in this agreement and in accordance with all federal, state and local regulatory requirements.

1.1. DESCRIPTION OF SERVICES. The contractor shall be responsible for the pickup, transport, storage and disposal of RMW generated by the 49 MDG in accordance with federal, state, and local regulatory requirements. The contractor shall provide and maintain all applicable manifests, certificates, and other documentation in accordance with federal, state and local regulatory requirements (49 CFR 173.197 and 49 CFR 172.202). Attached for reference in section 5 Appendices C and D.

1.1.1. The contractor shall transport, store and dispose of RMW in accordance with federal, state and local regulatory requirements. The waste will be transported in a fully enclosed vehicle (approved by federal, state and local regulatory authorities to transport RMW).

1.1.2. The contractor shall provide shipping papers/manifest and a unique tracking number (i.e., bar code label) for each RMW container to be transported at the time of pick up. The shipping/manifest documents shall be in accordance with applicable federal, state and local regulatory agencies.

1.1.3. The contractor shall provide treatment/destruction certificates within 30 days after scheduled waste pick-up. The treatment/destruction certificates shall account for each shipped container’s identification/ tracking number and provide the date of pickup, date of treatment, method of treatment (i.e., autoclaved) and treatment facility.

1.1.4. The contractor shall maintain all required permits relevant to the transporting and destruction of RMW.

1.2. GENERAL INFORMATION.

1.2.1. QUALITY CONTROL. The contractor shall develop and maintain a Quality Control Program with a written Quality Control Plan (QCP) to ensure the RMW disposal service is performed in conformance to contract specifications. The contractor shall develop and implement procedures to identify and prevent deficiencies from occurring. As a minimum, the contractor shall develop quality control procedures, which address the areas identified in section 2, Service Summary (SS). The contractor shall also identify any applicable commercial and industry Safety Standards and include them in the QCP. The contractor shall provide the government the contact information, to include business telephone, cell phone if necessary, and business email address of a designated Quality Control inspector, who shall be available to respond to the government’s request within twenty-four (24) hours after notification. The QCP shall be submitted to the Contracting Officer and Contracting Officer’s Representative (COR) within fifteen (15) days after contract award and prior to the first scheduled RMW pickup.

1.2.2. QUALITY ASSURANCE. The government will evaluate the contractor’s performance in accordance with the Government’s Quality Assurance Surveillance Plan (QASP), by appointing a COR to monitor performance to ensure the RMW disposal service is performed in conformance to contract specifications. The COR shall inspect each task as completed as considered necessary. Re-performance shall be the typical remedy for nonconformance to standards, but all remedies available to the government under the contract shall be available for use. The COR shall have access to all Contractor Quality Control records related to the contract.

1.2.3. GOVERNMENT REMEDIES. The requirements of FAR 52.212-4, Contract Terms and Conditions for Commercial Items (Feb 2012), shall be the basis for government remedies of the contractor’s failure to correct nonconforming services.

1.2.4. HOURS OF OPERATION. The contractor shall be responsible for conducting the pickup of RMW at the collection locations identified in Appendix A between the hours of 0730 and 1630 on the days scheduled except Federal holidays or when the government facility is closed due to local or national emergencies, administrative closings or similar government-directed facility closings. There will be no pickups at any sites scheduled on Monday or Fridays.

1.2.5. SECURITY REQUIREMENTS. The contractor may be required to obtain a base pass for all vehicles and personnel entering Holloman AFB NM. All vehicles must have current registration and proof of insurance. All vehicle operators must have a valid government issued driver’s license.

1.2.5.1. The contractor shall report security issues to the COR. The COR’s contact information will be provided to the contractor after contract award.

1.2.5.2. The contractor shall be responsible for safeguarding all government property provided for contractor use. At the close of each work period, government facilities, equipment and materials shall be secured.

1.2.6. SAFETY REQUIREMENTS. The contractor shall perform all tasks in a safe manner and be in accordance with all OSHA Standards and federal, state and local safety laws and regulations. Any injuries or accidents shall be reported to the 49th Medical Group Safety Representative. The safety representative’s contact information will be provided to the contractor after contract award.

1.2.7. SPECIAL QUALIFICATIONS. The contractor shall be registered, licensed, and permitted to treat and transport RMW in accordance with all federal, state, and local laws and regulations. All licenses and permits shall be kept current throughout the period of performance of the agreement.

1.2.8. SCHEDULED AND UNSCHEDULED REGULATED MEDICAL WASTE PICKUPS. The pickup of RMW shall be scheduled during the time specified in paragraph 1.2.4. “Hours of Operations”, and all other times shall be coordinated through the COR prior to the pickup.

1.2.8.1. Refer to Appendix A “Pickup Schedule” for the scheduled days and pickup locations.

1.2.8.2. When unscheduled pickups occur, the contractor shall provide out-of-cycle contingency collection services for the locations in Pickup Schedule, as required with a one week notice, to meet unforeseen contingencies or training expansion.

1.2.9. CHARGEABLE ITEMS. Holloman AFB 49 MDG only produces RMW. The regulated waste containers are never weighed when picked up for disposal. We are only assessed by number of containers. Billing Cycles will be submitted Monthly through the (WAWF) Wide Area Work Flow Database

1.2.9.1. The RMW disposal service provided by the contractor shall not exceed total dollar amount on awarded contract.

1.2.10. POST AWARD CONFERENCE / PERIODIC PROGRESS MEETINGS. The contractor shall attend any post award conference convened by the contracting activity or the contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, COR and other government personnel, as deemed necessary, may meet periodically with the contractor to review the contractor’s performance. At these meetings, the contracting officer shall apprise the contractor of how the government views the contractor’s performance and the contractor will apprise the government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.2.11. PERIOD OF PERFORMANCE. The period of performance shall be for a base year and four (4) 12-month option years. The period of performance is as follows:

2. SERVICE SUMMARY.

Performance Objective PWS Reference

Performance Threshold

3. GOVERNMENT FURNISHED PROPERTY AND SERVICES. The government shall provide, the facilities, equipment, materials, and/or services listed below.

3.1. MATERIALS. The Government will provide disposable sharps containers for containment of needles, syringes with needles attached, scalpel blades, and other medical items classified by federal, state, local and DOD authorities as sharp.

3.2. UTILITIES. Any utilities directly involved with the performance of this contract can be utilized by the contractor, if approved by the COR. The Contractor shall instruct employees to use standard industry conservation practices.

3.3. FACILITIES. The Government will designate required space for the contractor’s containers to include operational space to performance services outlined in this PWS.

4. CONTRACTOR FURNISHED ITEMS AND SERVICES. Except for those items specifically stated to be government furnished in section 3, the contractor shall provide containers, boxes and bags for storing and transporting RMW at each site location. The estimated quantity of boxes and containers required is based on the pickup schedule, and should be considered the minimum quantity to be on hand.

4.1. FIBERBOARD BOXES. The boxes shall, at a minimum, meet the requirements of Department of Transportation (DOT) regulations and be marked and labeled to comply with federal, state and local regulatory requirements.

4.2. REUSABLE CONTAINERS. The containers shall be polyethylene construction and appropriate for the type and quantity of waste. The containers shall meet DOT specifications and withstand handling, transfer, and transportation. All containers shall be marked and labeled in accordance with federal, state and local regulatory requirements. The contractor furnished reusable containers and storage units provided shall be clean and disinfected; free of any medical waste, insects and odors.

4.3. The contractor shall provide DOT-approved outer packaging to package large items classified as RMW and provide the appropriate transport and disposal.

4.4. The contractor shall provide 3-mil red bag liners for each contractor provided fiberboard box and reusable container, if required.

4.15. Security Requirements.

4.15.1. Illegal Aliens. The Contractor shall not hire an illegal alien to work or perform any service on HAFB. Employees who are not U.S. citizens must possess a current resident alien immigrant status (green card) or if a non-resident immigrant, must possess a current Employment Authorization Document. While on HAFB, non-U.S. citizen employees must be able to produce for inspection, the appropriate credentials: either a green card or Employment Authorization Document. Any illegal alien found on the installation shall be immediately detained by the base security forces and barred from the installation.

4.15.2. Foreign National Visitor Approval. The contractor must obtain visitor approval for all employees requiring access to HAFB who are not U.S. citizens. The 49th Mission Support Group (MSG)/CC is the approval authority; the 49 MSG/CC may delegate approval authority to the 49 SFS/CC.

4.15.2.1. The contractor must submit visit approval requests for all foreign national employees through the Contracting Officer to the 49 MSG/CC or 49 SFS/CC (if delegated) using the HAFB Foreign Visit Request Form (available at the HAFB Welcome Center).

4.15.2.2. Once coordination through the Contracting Officer has been completed, the HAFB Foreign Visit Request Form shall be forwarded to 49 SFS/S5AV (Welcome Center) for coordination. 49 SFS/S5AV will submit the completed form to the 49 MSG/CC or 49 SFS/CC (if delegated) for approval. The Contracting Officer listed on the Foreign Visit Request Form will be contacted when a final decision has been made.

4.15.2.3. The Foreign Visit Request Form will be maintained by 49 SFS/S5AV and the Air Force Office of Special Investigation until the visit end date.

4.15.2.4. Employees who are not U.S. citizens will not be allowed to enter the installation until properly approved via the procedures outlined above.

4.15.3. Listing of Employees. The Contractor shall maintain a current listing of employees that require access to HAFB. The list shall include the employee's name, Social Security Number and type of investigation if contract work involves unescorted entry to AF restricted areas or other sensitive areas designated by the Installation CC. The list shall be provided to the Contracting Officer, who in turn will supply to the 49 MDG security managers. An updated listing shall be provided when an employee's status or information changes: i.e., terminated for cause, reassignment, retirement, etc., or when a new employee is added.

4.15.4. Security Training. The Contractor ensures all employees receive initial and recurring security education training from the 49 MDG security manager. Training must be conducted IAW Department of Defense (DOD) Manual 5200.01, DoD Information Security Program, and AFI 16-1404, Air Force Information Security Program. Contractor personnel who work in AF controlled/restricted areas must be trained IAW AFI 31-101, Integrated Defense.

4.15.5. Pass and Identification Items. The Contractor shall ensure the pass and identification items required for contract performance are obtained for employees. Upon initial assignment to HAFB, all new contractor employees shall be identified on a HAFB Visit Access Request (VAR). The contractor shall submit a fully completed VAR through 49th Contracting Squadron (CONS)/LGCA to 49 SFS/S5AV NLT seven (7) duty/business days, and for foreign nationals, 14 duty/business days prior to requiring access to HAFB.

4.15.6. Retrieving Identification Media. The Contractor shall return all identification media and/or visitor passes from employees who depart for any reason before the contract expires; i.e., terminated for cause, reassignment, retirement, etc. The contractor will immediately notify the Government (Contracting Officer and Security Forces) within 24 hours, when unable to retrieve identification media from contract employees.

4.15.7. Security Investigation Requirement. Each potential Contractor employee shall be submitted for a Tier 1 (T1) background investigation prior to the start of performance. Potential employees will process, through the 49 MDG security manager, a Standard Form (SF) 85, Security Questionnaire for Positions of Trust upon notification of employment. The 49 MDG security manager will assist the employee in completing the SF 85 and will process all required security documentation pertaining to the investigation request. Upon completion of the SF 85 and required security documentation, the 49 WG/IP Personnel Security Office will schedule an appointment, through the 49 MDG security manager, to submit the investigation request. No employee shall be allowed to work on HAFB without a "favorable" decision from the Air Force Central Adjudication Facility or "favorable" employment suitability determination by the unit CC. The Contractor may temporarily assign a potential employee pending a "favorable" T1 adjudication or a "favorable" employment suitability determination by the unit CC if the potential employee has submitted all required information to the Government and there is no known disqualifying information.

4.15.8. Traffic Laws. The Contractor and its employees shall comply with base traffic regulations. Traffic regulations include, but are not limited to:

4.15.8.1. Employees shall wear a seatbelt when operating or riding in any vehicle (Government, Contractor, or private owned) while on the installation.

4.15.8.2. Speed limits on HAFB are 30 MPH unless otherwise posted. Be aware of reduced speed limits and exercise caution when driving in base housing and school zones.

4.15.8.3. All vehicle operators on the installation shall not use cell phones unless the vehicle is safely parked or unless they are using a hands-free device. The wearing of any other portable headphones, earphones or other listening devices (except for hand-free cellular phones) while operating a motor vehicle is prohibited.

4.15.9. Weapons, Firearms, and Ammunition. Employees are prohibited from possessing weapons, firearms, or ammunition on themselves or within Government, Contractor-owned or privately-owned vehicles while on HAFB.

4.15.10. For Official Use Only (FOUO). The contractor shall comply with DODM 5200.01, V4/E3, DOD Information Security Program: Controlled Unclassified Information (CUI), requirements. This manual sets policy and procedures for the disclosure of records to the public and for marking, handling, transmitting, and safeguarding FOUO material.

4.15.11. Reporting Requirements. Contractor personnel shall report to an appropriate authority any information or circumstances of which they are aware may pose a threat to the security of DOD personnel, Contractor personnel, resources, and classified or unclassified defense information. Employees shall be briefed by their immediate supervisor upon initial on-base assignment.

4.15.12. Physical Security. The Contractor shall be responsible for safeguarding all Government property and controlled forms provided for Contractor use. At the end of each work period, all Government facilities, equipment, and materials shall be secured.

4.15.13. Controlled/Restricted Areas. The Contractor shall implement local base procedures for entry to AF controlled/restricted areas where Contractor personnel will work. An AF Form 2586, Unescorted Entry Authorization Certificate, must be completed and signed by the 49 MDG security manager before a restricted area badge will be issued. Employees must have a completed and favorable T1 investigation before receiving a restricted area badge. Interim access may be granted IAW AFI 31-501, Personnel Security Program Management.

4.15.14. Key Control. The Contractor shall establish and implement methods of making sure all keys/combinations issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized persons. The Contractor shall not duplicate any keys issued by the Government.

4.15.14.1. The Contractor shall immediately report to the COR or SME any occurrences of lost/duplicated keys, compromised lock combinations, or use by unauthorized persons.

4.15.14.2. In the event keys, other than master keys, are lost or duplicated, the Contractor may be required, upon written direction of the contracting officer, to re-key or replace the affected lock or locks without cost to the Government. The Government may, however, at its option, replace the affected lock or locks or perform re-keying and deduct the cost of such from the monthly payment due the Contractor. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the Contractor.

4.15.14.3. The Contractor shall prohibit the use of keys or combinations, issued by the Government, by any person other than the contractor's employees and the opening of locked areas by contractor employees to permit entrance of persons other than contractor employees engaged in performance of contract work requirements in those areas.

4.15.15. Unclassified Network Access (NIPRNET). When required for contract performance, the Government will provide access to AF owned, leased, or controlled unclassified information systems or networks. Contractor employees will be held strictly accountable for actions they initiate on the network and will conduct business IAW USAF, Air Combat Command (ACC), and HAFB instructions and policies. The 49 MDG will ensure contractor employees receive Information Assurance training prior to network access. Contractor employees must have a completed and favorable T1 investigation prior to access being granted. Interim access may be granted IAW AFI 31-501, Personnel Security Program Management.

4.16. Records Management (February 2015). The contractor shall provide accountability and ensure all records and documents generated during the period of this contract are made available to the government at all times. All information may be maintained electronically. All publications and forms will be available for contractor's use through the Holloman Publications Web Site. Any publications or forms that are required for the performance of this contract and are not available electronically are required to be maintained manually.

4.16.1. Freedom of Information ACT (FOIA) and Privacy Act (PA) (July 2015). The contractor shall comply with DOD 5400.7-R, DOD Freedom of Information Act (FOIA) Program and AFI 33-332, Air Force Privacy and Civil Liberties Program. These regulations set policy and procedures for the disclosure of records to the public and for marking, handling, transmitting, and safeguarding Personally Identifiable Information (PII) material.

4.16.2. Contractor Records. The contractor shall maintain all government records IAW AFMAN 33-363, Management of Records, paragraph 6.4., Contractor Support, in order to support the COR who is responsible for all lifecycle record management and all duties assigned to the organization's Record Professional (RP) (Tier-1 (T-1)). [AFI 33-360, Publications and Forms Management, Table 1.1 outlines description of the authorities for T-1.

5. APPENDICES.

APPENDIX A

PICKUP SCHEDULE/ WORK LOAD

NO PICKUPS MONDAYS OR FRIDAYS

New Clinic Bldg. 23, Rm 1D01 “Will take place of building 9 sometime in 2017 and be located in same place of Medical Center on map in Appendix B”.

APPENDIX B

MAP

APPENDIX C

172.202 Description of hazardous material on shipping papers.

(a) The shipping description of a hazardous material on the shipping paper must include:

(1) The identification number prescribed for the material as shown in Column (4) of the § 172.101 table;

(2) The proper shipping name prescribed for the material in Column (2) of the § 172.101 table;

(3) The hazard class or division number prescribed for the material, as shown in Column (3) of the § 172.101 table. The subsidiary hazard class or division number is not required to be entered when a corresponding subsidiary hazard label is not required. Except for combustible liquids, the subsidiary hazard class(es) or subsidiary division number(s) must be entered in parentheses immediately following the primary hazard class or division number. In addition -

(i) The words “Class” or “Division” may be included preceding the primary and subsidiary hazard class or division numbers.

(ii) The hazard class need not be included for the entry “Combustible liquid, n.o.s.”

(iii) For domestic shipments, primary and subsidiary hazard class or division names may be entered following the numerical hazard class or division, or following the basic description.

(4) The packing group in Roman numerals, as designated for the hazardous material in Column (5) of the § 172.101 table. Class 1 (explosives) materials; self-reactive substances; batteries other than those containing lithium, lithium ions, or sodium; Division 5.2 materials; and entries that are not assigned a packing group (e.g., Class 7) are excepted from this requirement. The packing group may be preceded by the letters “PG” (for example, “PG II”); and

(5) Except for transportation by aircraft, the total quantity of hazardous materials covered by the description must be indicated (by mass or volume, or by activity for Class 7 materials) and must include an indication of the applicable unit of measurement, for example, “200 kg” (440 pounds) or “50 L” (13 gallons). The following provisions also apply:

(i) For Class 1 materials, the quantity must be the net explosive mass. For an explosive that is an article, such as Cartridges, small arms, the net explosive mass may be expressed in terms of the net mass of either the article or the explosive materials contained in the article.

(ii) For hazardous materials in salvage packaging, an estimate of the total quantity is acceptable.

(iii) The following are excepted from the requirements of paragraph (a)(5) of this section:

(A) Bulk packages, provided some indication of the total quantity is shown, for example, “1 cargo tank” or “2 IBCs.”

(B) Cylinders, provided some indication of the total quantity is shown, for example, “10 cylinders.”

(C)Packages containing only residue.

(6) For transportation by aircraft, the total net mass per package, must be shown unless a gross mass is indicated in Columns (9A) or (9B) of the § 172.101 table in which case the total gross mass per package must be shown; or, for Class 7 materials, the quantity of radioactive material must be shown by activity. The following provisions also apply:

(i) For empty uncleaned packaging, only the number and type of packaging must be shown;

(ii) For chemical kits and first aid kits, the total net mass of hazardous materials must be shown. Where the kits contain only liquids, or solids and liquids, the net mass of liquids within the kits is to be calculated on a 1 to 1 basis, i.e., 1 L (0.3 gallons) equals 1 kg (2.2 pounds);

(iii) For dangerous goods in machinery or apparatus, the individual total quantities or an estimate of the individual total quantities of dangerous goods in solid, liquid or gaseous state, contained in the article must be shown;

(iv) For dangerous goods transported in a salvage packaging, an estimate of the quantity of dangerous goods per package must be shown;

(v) For cylinders, total quantity may be indicated by the number of cylinders, for example, “10 cylinders;”

(vi) For items where “No Limit” is shown in Column (9A) or (9B) of the § 172.101 table, the quantity shown must be the net mass or volume of the material. For articles (e.g., UN2800 and UN3166) the quantity must be the gross mass, followed by the letter “G”; and

(vii) For hazardous materials in limited quantities, the total net quantity per package must be shown unless a gross mass is indicated in Column 4 of § 173.27 Table 3, in which case the total gross mass per package must be shown. Where different hazardous materials in limited quantities are packed together in the same outer packaging, when a gross mass is indicated Column 4 of § 173.27 Table 3, the net quantity of each hazardous material must be shown in addition to the gross mass of the completed package.

(7) The number and type of packages must be indicated. The type of packages must be indicated by description of the package (for example, “12 drums”). Indication of the packaging specification number (“1H1”) may be included in the description of the package (for example, “12 1H1 drums” or “12 drums (UN 1A1)”). Abbreviations may be used for indicating packaging types (for example, “cyl.” for “cylinder”) provided the abbreviations are commonly accepted and recognizable.

(b) Except as provided in this subpart, the basic description specified in paragraphs (a)(1), (2), (3), and (4) of this section must be shown in sequence with no additional information interspersed. For example, “UN2744, Cyclobutyl chloroformate, 6.1, (8, 3), PG II.” The shipping description sequences in effect on December 31, 2006, may be used until January 1, 2013. Shipping descriptions for hazardous materials offered or intended for transportation by rail that contain all the information required in this subpart and that are formatted and ordered in accordance with recognized electronic data interchange standards and, to the extent possible, in the order and manner required by this subpart are deemed to comply with this paragraph.

(c)

(1) The total quantity of the material covered by one description must appear before or after, or both before and after, the description required and authorized by this subpart. The type of packaging and destination marks may be entered in any appropriate manner before or after the basic description. Abbreviations may be used to express units of measurement and types of packagings.

(2)Hazardous materials and hazardous substances transported by highway considered “household wastes” as defined in 40 CFR 261.4, and not subject to the Environmental Protection Agency's hazardous waste regulations in 40 CFR parts 262 and 263, are excepted from the requirements of this paragraph.

(d) Technical and chemical group names may be entered in parentheses between the proper shipping name and hazard class or following the basic description. An appropriate modifier, such as “contains” or “containing,” and/or the percentage of the technical constituent may also be used. For example: “UN 1993, Flammable liquids, n.o.s. (contains Xylene and Benzene), 3, II”.

(e) Except for those materials in the UN Recommendations, the ICAO Technical Instructions, or the IMDG Code (IBR, see § 171.7 of this subchapter), a material that is not a hazardous material according to this subchapter may not be offered for transportation or transported when its description on a shipping paper includes a hazard class or an identification number specified in the § 172.101 Table.

Appendix D

173.197 Regulated Medical Waste.

(a)General provisions. Non-bulk packagings, Large Packagings, and non-specification bulk outer packagings used for the transportation of regulated medical waste or clinical waste or (bio) medical waste must be rigid containers meeting the provisions of subpart B of this part.

(b)Non-bulk packagings. Except as provided in § 173.134(c) of this subpart, non-bulk packagings for regulated medical waste or clinical waste or (bio) medical waste must be UN standard packagings conforming to the requirements of part 178 of this subchapter at the Packing Group II performance level. A non-bulk packaging used as a sharps container must be puncture-resistant for sharps and sharps with residual fluid as demonstrated by conducting the performance tests in part 178, subpart M, of this subchapter on packagings containing materials representative of the sharps and fluids (such as sterile sharps) intended to be transported in the packagings. Sharps containers must be securely closed to prevent leaks or punctures in conformance with the instructions provided by the packaging manufacturer in accordance with § 178.2(c) of this subchapter.

(c)Large Packagings.Large Packagings constructed, tested, and marked in accordance with the requirements specified in subparts P and Q of part 178 of this subchapter and conforming to other requirements of this paragraph (c) may be used for the transportation of regulated medical waste, provided the waste is contained in inner packagings conforming to the requirements of paragraph (e) of this section. * * * Each Large Packaging design must be capable of meeting the vibration test specified in § 178.819 of this subchapter. Each Large Packaging is subject to the periodic design requalification requirements for IBCs in § 178.801(e) of this subchapter, and to the proof of compliance requirements of § 178.801(j) and record retention requirements of § 178.801(l) of this subchapter. Inner packagings used for liquids must be rigid.

(1)Authorized packagings. Only the following Large Packagings are authorized for the transportation of liquid or solid regulated medical waste:

(i) Metal: 50A, 50B, or 50N.

(ii) Rigid plastic: 50H.

(2)Additional requirements. Each Large Packaging used to transport liquidregulated medical waste must contain absorbent material in sufficient quantity and appropriate location to absorb the entire amount of liquid present in the event of an unintentional release of contents. Each Large Packaging design intended for the transportation of sharps containers must be puncture resistant and capable of retaining liquids. The design must also be tested and certified as meeting the performance tests specified for intermediate bulk containers intended for the transportation of liquids in subpart O of part 178 of this subchapter.

(d)Non-specification bulk packaging. A wheeled cart (Cart) or bulk outer packaging (BOP) is authorized as an outer packaging for the transportation of regulated medical waste in accordance with the provisions of this paragraph (d).

(1)General requirements. The following requirements apply to the transportation of regulated medical waste in Carts or BOPs:

(i)Regulated medical waste in each Cart or BOP must be contained in non-bulk inner packagings conforming to paragraph (e) of this section.

(ii) Each Cart or BOP must have smooth, non-porous interior surfaces free of cracks, crevices, and other defects that could damage plastic film inner packagings or impede disinfection operations.

(iii) Except as otherwise provided in this paragraph (d), each Cart or BOP must be used exclusively for the transportation of regulated medical waste. Prior to reuse, each Cart or BOP must be disinfected by any means effective for neutralizing the infectious substance the packaging previously contained.

(iv) Untreated concentrated stock cultures of infectious substances containing Category A materials may not be transported in a Cart or BOP.

(v)Division 6.1 toxic waste or Class 7 radioactive waste, with the exception of chemotherapeutic waste, may not be transported in a Cart or BOP.

(vi)Division 6.1 or Class 7 chemotherapeutic waste; untreated concentrated stock cultures of infectious substances containing Category B infectious substances; unabsorbed liquids; and sharps containers may be transported in a Cart or BOP only if packaged in rigid non-bulk packagings conforming to paragraph (a) of this section.

(2)Wheeled cart (Cart). A Cart is authorized as an outer packaging for the transportation of regulated medical waste if it conforms to the following requirements:

(i) Each Cart must consist of a solid, one-piece body with a nominal volume not exceeding 1,655 L (437 gallons).

(ii) Each Cart must be constructed of metal, rigid plastic, or fiberglass fitted with a lid to prevent leakage during transport.

(iii) Each Cart must be capable of meeting the requirements of § 178.810 (drop test) at the Packing Group II performance level.

(iv)Inner packagings must be placed into a Cart and restrained in such a manner as to minimize the risk of breakage.

(3)Bulk outer packaging (BOP). A BOP is authorized as an outer packaging for regulated medical waste if it conforms to the following requirements:

(i) Each BOP must be constructed of metal or fiberglass and have a capacity of at least 3.5 cubic meters (123.6 cubic feet) and not more than 45 cubic meters (1,590 cubic feet).

(ii) Each BOP must have bottom and side joints of fully welded or seamless construction and a rigid, weatherproof top to prevent the intrusion of water (e.g., rain or snow).

(iii) Each opening in a BOP must be fitted with a closure to prevent the intrusion of water or the release of any liquid during all loading, unloading, and transportation operations.

(iv) In the upright position, each BOP must be leakproof and able to contain a liquid quantity of at least 300 liters (79.2 gallons) with closures open.

(v)Inner packagings must be placed in a BOP in such a manner as to minimize the risk of breakage. Rigid inner packagings may not be placed in the same BOP with plastic film baginner packagings unless separated from each other by rigid barriers or dividers to prevent damage to the packagings caused by load shifting during normal conditions of transportation.

(vi)Division 6.1 or Class 7 chemotherapeutic waste, untreated concentrated stock cultures of infectious substances containing Category B infectious substances, unabsorbed liquids, and sharps may be transported in a BOP only if separated and secured as required in paragraph (d)(3)(v) of this section.

(e)Inner packagings authorized for Large Packagings, Carts, and BOPs. After September 30, 2003, inner packagings must be durably marked or tagged with the name and location (city and state) of the offeror, except when the entire contents of the Large Packaging, Cart, or BOP originates at a single location and is delivered to a single location.

(1)Solids. A plastic film bag is authorized as an inner packaging for solidregulated medical waste transported in a Cart, Large Packaging, or BOP. Waste material containing absorbed liquid may be packaged as a solid in a plastic film bag if the bag contains sufficient absorbent material to absorb and retain all liquid during transportation.

(i) The film bag may not exceed a volume of 175 L (46 gallons). The film bag must be marked and certified by its manufacturer as having passed the tests prescribed for tear resistance in ASTM D 1922, “Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method” (IBR, § 171.7 of this subchapter) and for impact resistance in ASTM D 1709, “Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method” (IBR, § 171.7 of this subchapter). The film bag must meet an impact resistance of 165 grams and a tearing resistance of 480 grams in both the parallel and perpendicular planes with respect to the length of the bag.

(ii) The plastic film bag must be closed with a minimum of entrapped air to prevent leakage in transportation. The bag must be capable of being held in an inverted position with the closed end at the bottom for a period of 5 minutes without leakage.

(iii) When used as an inner packaging for Carts or BOPs, a plastic film bag may not weigh more than 10 kg (22 lbs.) when filled.

(2)Liquids.Liquidregulated medical waste or clinical waste or (bio) medical waste transported in a Large Packaging, Cart, or BOP must be packaged in a rigid inner packaging conforming to the provisions of subpart B of this part. conforming to the provisions of subpart B of this part. Liquid materials are not authorized for transportation in inner packagings having a capacity greater than 19 L (5 gallons).

(3)Sharps.Sharps transported in a Large Packaging, Cart, or BOP must be packaged in a puncture-resistant inner packaging (sharps container). Each sharps container must be securely closed to prevent leaks or punctures in conformance with instructions provided by the packaging manufacturer. Each sharps container exceeding 76 L (20 gallons) in volume must be capable of passing the performance tests in part 178, subpart M, of this subchapter at the Packing Group II performance level. A sharps container may be reused only if it conforms to the following criteria:

(i) The sharps container is specifically approved and certified by the U.S. Food and Drug Administration as a medical device for reuse.

(ii) The sharps container must be permanently marked for reuse.

(iii) The sharps container must be disinfected prior to reuse by any means effective for the infectious substance the container previously contained.

(iv) The sharps container must have a capacity greater than 7.57 L (2 gallons) and not greater than 151.42 L (40 gallons) in volume.

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