RFP 75N98020R00014 Final.docx
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RFP Number 75N98020R00014 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 "Streamlined Procedures for Evaluation and Solicitation for Commercial Items," as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.
This solicitation is a request for proposal (RFP) under RFP Number 75N98020R00014. The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-05, dated March 30, 2020. The associated North American Industry Classification System (NAICS) code for this procurement is 541380-Testing Laboratories Services with a size standard of $15,000,000. This RFP is set aside for small business.
LINE ITEMS
a) This is an Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $TBD nor more than a total of $TBD for successful performance of this contract.
b) The prices set forth in this ARTICLE will cover the contract period TBD through TBD .
c) The Government will issue Task Orders based on the work described in the Statement of Work of this contract and the following schedule. Upon delivery and acceptance of the item(s) described in each Task Order, the Government shall pay to the Contractor the prices set forth below
Please see attached price list for line items (Solicitation Attachment #1).
Contract Type It is contemplated that a single award performance based indefinite delivery/indefinite quantity type contract that allows for Firm Fixed Price Orders. Award will be made on an all or none basis.
Description of requirements for the services to be acquired Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work.
Performance Work Statement (PWS)
ARTICLE 1 BACKGROUND
The National Institutes of Health (NIH) is a large biomedical research facility with approximately 900 radioactive materials laboratories and a 200-bed research hospital. The NIH possesses a Broad Scope license issued by the U.S. Nuclear Regulatory Commission (NRC) to use a wide variety and appreciable quantities of radioactive materials in biomedical research, medical diagnosis and treatment. Additionally, the NIH possesses a Cyclotron Production license enabling the NIH to create a number of radionuclides for clinical and research applications. These licenses require NIH to establish and implement a comprehensive radiation safety program under the Division of Radiation Safety (DRS), Office of Research Services.
The majority of the radioactive material laboratories and use areas are located in Bethesda, MD; however, some laboratories are located at other licensed locations in Gaithersburg, MD, Rockville, MD, Poolesville, MD, Frederick, MD, and Baltimore, MD. In addition to routine radioactive materials laboratories, NIH has a number of special-use laboratories in the Nuclear Medicine Department, the Building 21 hot lab facility, the cyclotron facility, a cGMP facility, BSL-3 and BSL-4 labs. NIH has approximately 1,000 radiation safety instruments in service in the various laboratories and facilities used for work with radioactive materials.
The purpose of this procurement is to contract for qualified technical assistance to be provided to support the DRS in carrying out selected elements of the radiation safety program.
The scope of the work is as follows:
· Comprehensive Radiation Safety Surveys of Radionuclide Use Areas
· Corridor Radiation Safety Surveys
· Monthly Surveys of Radionuclide Use Areas
· Weekly Surveys of Radionuclide Use Areas
· 10 CFR 35 Weekly Surveys of Radionuclide Use Areas
· Alpha Surveys of Radiopharmaceutical Areas
· Naturally Occurring Alpha Surveys
· Clearance Surveys of Radionuclide Use Areas
· Checks on Security of Radioactive Materials (during and after normal work hours)
· Preparation and Decontamination of Patient Therapy Rooms (full decon and resets)
· Field Calibration of Survey Meters Used for Contamination Monitoring
· Calibration of Instruments Used to Measure Exposure or Dose Equivalent Rates
· Decommissioning
ARTICLE 2 GENERAL REQUIREMENTS
The purpose of this Contract is for the Contractor, independently and not as an agent of the Government, to perform:
| 1. | Comprehensive radiation safety surveys of all NIH posted laboratories and storage areas |
| 2. | Corridor surveys |
| 3. | Monthly surveys of NIH posted laboratories and storage areas |
| 4. | Weekly surveys of NIH posted laboratories |
| 5. | 10 CFR 35 Weekly surveys |
| 6. | Alpha Surveys of Radiopharmaceutical Areas |
| 7. | Naturally Occurring Alpha Surveys |
| 8. | Clearance surveys of NIH posted laboratories, storage areas, and corridors |
| 9. | Checks on security of radioactive materials |
| 10. | Preparation and Decontamination of Patient Therapy Rooms |
| 11. | Field calibrations and inspections of survey meters used for monitoring of radiological contamination |
| 12. | Calibration of instruments used to measure exposure or dose equivalent rates |
| 13. | Decommissioning of NIH owned or leased buildings in which radioactive materials were |
| used |
These services shall be performed in compliance with:
| a. | 10 CFR 19 |
| b. | 10 CFR 20 |
| c. | 10 CFR 30 |
| d. | 10 CFR 35 |
| 263-2006P(BD)-0012 | Section C |
Revised 5/18/2020 10:00 AM Page C - of 12
e. 10 CFR 37 263-2006P(BD)-0012 Section C f.
Revised 5/18/2020 10:00 AM Page C - of 12
| f. | 21 CFR 1010 | ||
| g. | 29 CFR 1900-1910 | ||
| h. | Conditions of NIH's NRC licenses | ||
| i. | NIH Radiation Safety Web Site | ||
| http://drs.ors.od.nih.gov/Pages/default.aspx | |||
| j. | NIH policy on security of radioactive materials | ||
| Section C |
| k. | DRS Policy on Personnel Monitoring | ||||
| l. | NIH Waste Calendar | ||||
| m. | NUREG-1556, Volumes 9, 11, and 21 | ||||
| n. | The following National Council on Radiation Protection and Measurements | (NCRP) reports: | |||
| 49 - Structural Shielding Design and Evaluation for Medical Use of X-rays | and Gamma Rays of Energies up to 10 MeV (1976) |
57 - Instrumentation and Monitoring Methods for Radiation Protection (1978)
144 - Radiation Protection for Particle Accelerator Facilities (2003)
147 - Structural Shielding Design for Medical X-ray Imaging Facilities (2004)
148 - Radiation Protection in Veterinary Medicine (2004)
160 - Ionizing Radiation Exposure of the Population of the United States (2009)
180 - Management of Exposure to Ionizing Radiation: Radiation Protection Guidance for the United States (2018)
182 - Radiation Safety of Sealed Radioactive Sources (2019)
ARTICLE 3 LOCATION/HOURS OF WORK/SPECIFIC REQUIREMENTS
1. The Contractor shall perform comprehensive radiation safety surveys on approximately 900 laboratories, storage areas, and corridors in facilities that operate under the auspices of NIH's NRC licenses. Most of these facilities are located in Bethesda, MD. There are, however, satellite locations in Gaithersburg, MD, Rockville, MD, Poolesville, MD, Frederick, MD, and Baltimore, MD. The surveys will be spread relatively evenly throughout the month in which they are due.
2. The Contractor shall conduct approximately 5700 monthly surveys each month, spread evenly throughout the month. Having the Contractor perform all monthly surveys is a new DRS service provided to all research labs under this contract. The DRS is responsible for arranging for performance of and payment for this service in all NIH posted labs. The Contractor shall monitor (using the appropriate meters) and take contamination surveys in each lab, regardless of radioactive material use history during the month.
3. In accordance with DRS standard operating procedures, the Contractor shall prepare all contractor-generated swipes and load them into the appropriate counter in the DRS analytical laboratory or at a backup location designated by DRS. If possible, these swipes will receive priority processing by the analytical lab and results will be returned to the contactor as soon as possible. Swipes from the patient therapy rooms shall also be analyzed in the analytical lab. They can be prepared and loaded any time during the day they were collected. All other contractor-generated swipes shall be prepared and loaded between 12:00 p.m. and 5:00 p.m. on the day they were collected. DRS will analyze these swipes and report the results to the Contractor by 2:00 p.m. on the day the surveys are due.
4. The Contractor shall perform checks on security of radioactive materials based on a computer-generated list that specifies areas to be checked weekdays, some to be checked weekday evenings (between 6:00 p.m. and 6:00 a.m.), and some to be checked on weekends. The frequency of security checks in a particular area is based on the history of that area's compliance with the DRS security policy, and in some cases, the presence of perimeter security systems. Frequencies are determined by DRS staff.
5. Complete decontamination of the patient therapy rooms for release as an unrestricted area is required approximately 70 times per year. Ordinarily, the decontamination can be completed over 2 or 3 days. However, it shall be completed within 1 work day if directed by the COR or designee.
6. Decontamination and preparation of the patient therapy rooms between patient therapy patients is required approximately 100 times per year and shall be completed within 1 work day of notification.
7. The Contractor shall inspect and calibrate (on-site) survey meters used only for contamination monitoring. The method of calibration must be submitted and approved by DRS. Any changes to the method must be approved by DRS before they are implemented. There are approximately 900 such survey meters located at the facilities specified on NIH's NRC broad scope license.
8. The Contractor shall calibrate approximately 100 instruments which are used for measurement of exposure or dose equivalent rates at the facilities specified on NIH's NRC license. Most of these instruments can be taken off-site for calibration. However, a few are non-portable instruments, e.g., wall-mounted alarms that must be calibrated on-site.
9. The Contractor shall provide to the COR telephone numbers by which Contractor staff can be reached during the workday.
10. All contract personnel are required to wear appropriate personnel dosimeters. These dosimeters will be supplied by DRS unless other arrangements are made with the COR. The dosimetry service must be National Voluntary Laboratory Accreditation Program (NVLAP) certified and the dose data must be provided to DRS to assure compliance with NRC license conditions.
11. Each contract staff member is required to carry a mobile device capable of receiving and delivering phone calls and email while performing duties required under this contract.
12. Contract staff will receive initial on the job training in some aspects of the contractual requirements (e.g. data entry mechanisms, use of internal Oracle database, report generation, report filing, etc.). In the event that, after receiving the NIH provided instruction, any of the Contractor's employees is replaced, the Contractor shall provide training for the replacement employees.
ARTICLE 4 COMPREHENSIVE SURVEY PROCEDURES
A. Background
| 1. | Most labs are currently on a semi-annual frequency for comprehensive surveys, and about 5% require more frequent comprehensive surveys. The percentage of labs on a particular survey frequency may change at any time. | ||
| 2. | An estimated 1,730 comprehensive radiation safety surveys shall be performed per 12-month period. | ||
| 3. | Each month, the Contractor shall download data on the laboratories and corridors due for comprehensive surveys to devices such as tablet PCs or ipads. The Contractor shall use these devices in the field to collect survey data electronically. In the event that a device is not functioning properly or is unavailable, the Contractor shall document survey results on paper forms and enter the data into the DRS database. | ||
| 4. | Routine comprehensive surveys at NIH are unannounced. Surveyors shall conduct thorough surveys without unduly disrupting work being performed in the area. If the Surveyor is unable to gain access to an area which needs to be surveyed, the Surveyor shall contact the Authorized User (AU) or other researcher familiar with radioactive material usage in the lab and schedule a survey during the month in which it is due. | ||
| 5. | DRS Form 603, "Radiation Survey Report" (Attachment 1) shall be the basis and guide for comprehensive surveys of laboratories and other areas. This form may be revised by the DRS at any time; the COR shall inform the Contractor of any revision and instruct the Contractor in its proper use. In general, a comprehensive survey shall include an inspection covering all areas on the form. However, the survey procedure may be modified by the COR. | ||
| 6. | Comprehensive surveys, whose frequencies are defined by NIH’s NRC license commitments and vary among annual, semiannual, quarterly, bimonthly, and monthly, encompass 25 compliance and other items and consist of contamination smear surveys, monitoring using the appropriate survey meters, and dose rate measurements. However, the scope of the surveys may be modified by the COR. | ||
| 7. | Security of radioactive material is extremely important at NIH. Contract personnel shall provide the necessary surveillance and security for check sources and/or calibration sources in their possession. Also, Contract personnel shall adhere to the current NIH policy on security of radioactive materials. | ||
| 8. | The Contractor shall typically submit completed comprehensive survey reports electronically, using hardware and software provided by the Government. However, in the event that a device is not functioning properly or is unavailable, the Contractor shall submit survey results on paper forms. The surveys shall be submitted to the COR by 4 p.m. of the second workday following the survey, unless there was no appropriate person to interview. In such a case, the Contractor shall notify DRS if any contamination was found, but not submit the survey until the interview has been completed. The survey still needs to be completed and submitted within the month in which it is due (see Attachment 1, section A, item 3). | ||
| 9. | If survey results were documented on paper instead of electronically, the Contractor shall enter the data from surveys that have been approved by the COR or designee into the database within 1 work day. | ||
| 10. | In the event that the Electronic Survey System is offline or not operating properly, the Contractor shall give the appropriate DRS Area Health Physicist (HP) and Authorized User a copy of the survey within 2 days of completion of the survey. The HP will then give the reviewed and completed survey back to the Contractor. | ||
| 11. | On a daily basis the Contractor shall maintain the master listing of areas requiring comprehensive surveys on the DRS database, including corrections, additions, and deletions. Information for corrections may come from observations by the Contractor when performing surveys, or from DRS. Note, however, that all changes, including those proposed by the Contractor, shall be approved by DRS through a “green sheet” before the Contractor enters them into the database. The Contractor shall process “green sheets” within one work day. | ||
| 12. | If a comprehensive survey showed a violation of Item 20 (contamination levels), the Contractor shall send the AU the appropriate "fact sheet" created by DRS to inform the AU how to correct the violation. | ||
| 13. | The Contractor shall enter or transmit data from comprehensive surveys into the database within one work day. |
B. Detailed Technical Requirements (Attachment 1)
1. Specific Requirements
2. "Radiation Survey Report" (DRS Form 603) explained
ARTICLE 5 CORRIDOR SURVEYS
| 1. | Most corridors are currently performed on a semi-annual frequency. Less than 1% require more frequent corridor surveys. The percentage of corridors on a particular survey frequency may change at any time. | ||
| 2. | An estimated 1,000 corridor radiation safety surveys shall be performed per 12-month period. | ||
| 3. | Each month, the Contractor shall download data on corridors due for surveys to devices such as tablet PCs or iPads. The Contractor shall use these devices in the field to collect survey data electronically. In the event that a device is not functioning properly or is unavailable, the Contractor shall document survey results on paper forms and enter the data into the DRS database. The Contractor shall also download the list of active labs and compare it to corridors nearby to ensure they are active and on at least a semiannual survey frequency. | ||
| 4. | Corridor surveys at NIH are unannounced. Surveyors shall conduct thorough surveys without unduly disrupting reseachers or the general public in the corridor area. If the Surveyor is unable to gain access to a corridor which needs to be surveyed, the Surveyor shall contact the Area Health Physicist, Authorized User, or other researchers familiar with radioactive material usage in a posted lab on that corridor and determine if they can schedule the corridor survey either later that month or the following month after it is due. If the construction will last for longer than a month, the Surveyor shall ensure the Area Health Physicist has been notified in order to determine if the posted labs off the corridor need to be inactivated. | ||
| 5. | DRS Form 603, "Radiation Survey Report" (Attachment 1) shall be the basis and guide for corridor surveys of laboratories and other areas. This form may be revised by the DRS at any time; the COR shall inform the Contractor of any revision and instruct the Contractor in its proper use. In general, a corridor survey shall include an inspection covering “Procedures for Corridor Radiation Safety Surveys” on the form. However, the survey procedure may be modified by the COR for corridors and other special cases. | ||
| 6. | Security of radioactive material is extremely important at NIH. Contract personnel shall provide the necessary surveillance and security for check sources and/or calibration sources in their possession. Also, Contract personnel shall adhere to the current NIH policy on security of radioactive materials. | ||
| 7. | Corridor surveys, whose frequencies are defined by NIH’s NRC license commitments, encompass four compliance and other items and consist of contamination smear surveys and dose rate measurements. However, the scope of these surveys may be modified by the COR. | ||
| 8. | The Contractor shall typically submit completed corridor survey reports electronically, using hardware and software provided by the Government. However, in the event that a device is not functioning properly or is unavailable, the Contractor shall submit survey results on paper forms. The surveys shall be submitted to the COR by 4 p.m. of the second workday following the survey. | ||
| 9. | If survey results were documented on paper instead of electronically, the Contractor shall enter the data from surveys that have been approved by the COR or designee into the database within 1 work day. | ||
| 10. | In the event that the Electronic Survey System is offline or not operating properly, the Contractor shall give the appropriate HP a copy of the survey within 2 days of completion of the survey. The HP will then give the reviewed and completed survey back to the Contractor. | ||
| 11. | On a daily basis the Contractor shall maintain the master listing of corridors requiring surveys on the DRS database, including corrections, additions, and deletions. Information for corrections may come from observations by the Contractor when performing surveys, or from DRS. Note, however, that all changes, including those proposed by the Contractor, shall be approved by DRS through a “green sheet” before the Contractor enters them into the database. The Contractor shall process “green sheets” within one work day. | ||
| 12. | If a corridor survey showed a violation of Item 20 (contamination levels), the Contractor shall inform the HP for that area to correct the violation. | ||
| 13. | The Contractor shall enter or transmit data from corridor surveys into the database within one work day. |
B. Detailed Technical Requirements (Attachment 1)
1. Specific Requirements
2. "Radiation Survey Report" (DRS Form 603) explained
3. Procedures for Corridor Radiation Safety Surveys
ARTICLE 6 MONTHLY SURVEYS
1. Each month, the Contractor shall conduct monthly surveys in all NIH posted labs. A monthly survey is not required in the month a comprehensive survey is due. The DRS Database codes as requiring a monthly (determined by DRS).
2. An estimated 5,650 monthly radiation safety surveys shall be performed per 12-month period.
3. The Contractor shall monitor using appropriate survey meters and perform contamination surveys in all posted labs during monthly surveys, regardless of whether or not radioactive materials have been used in each lab since the last survey.
4. The Contractor shall document the results of each monthly survey on an NIH Form 88-12, "Monthly Laboratory Contamination Survey", or electronic equivalent, ensuring that the designation of the modules matches those in DRS's database.
5. Security of radioactive material is extremely important at NIH. Contract personnel shall provide the necessary surveillance and security for check sources and/or calibration sources in their possession. Also, Contract personnel shall adhere to the current NIH policy on security of radioactive materials.
6. Monthly surveys consist of a determination of whether or not radioactive materials were used in a given month, contamination smear surveys and monitoring using the appropriate type of survey meters for the material typically used in the lab. However, the scope of the surveys may be modified by the COR.
7. The Contractor shall monitor the lab with appropriate survey meters and take 10 swipes per module in various areas, such as but not limited to, the floor, benches on which radioactive materials are used, sinks, and refrigerators in which radioactive materials are stored.
8. The Contractor shall submit each monthly survey to the COR or designee by 4:00 p.m. the second workday following the survey.
9. The Contractor shall enter or transmit data to the DRS database within one workday.
ARTICLE 7 WEEKLY SURVEYS
| 1. | The number of labs on weekly survey frequency may change at any time. | ||
| 2. | An estimated 830 weekly radiation safety surveys shall be performed per 12-month period. | ||
| 3. | Each month, the Contractor shall download data on the laboratories due for weekly surveys to devices such as tablet PCs or iPads, and conduct weekly surveys in all relevant NIH posted labs. The Contractor shall use these devices in the field to collect survey data electronically. In the event that a device is not functioning properly or is unavailable, the Contractor shall document survey results on paper forms and enter the data into the DRS database. | ||
| 4. | Routine weekly surveys at NIH are unannounced. Surveyors shall conduct thorough surveys without unduly disrupting work being performed in the area. If the Surveyor is unable to gain access to an area which needs to be surveyed, the Surveyor shall contact the Authorized User or other researcher familiar with radioactive material usage in the lab and schedule a survey during the month in which it is due. | ||
| 5. | DRS Form 603, "Radiation Survey Report" (Attachment 1) shall be the basis and guide for weekly surveys of laboratories and other areas. This form may be revised by the DRS at any time; the COR shall inform the Contractor of any revision and instruct the Contractor in its proper use. In general, a weekly survey shall include an inspection covering all areas on the form. However, the survey procedure may be modified by the COR. | ||
| 6. | Security of radioactive material is extremely important at NIH. Contract personnel shall provide the necessary surveillance and security for check sources and/or calibration sources in their possession. Also, Contract personnel shall adhere to the current NIH policy on security of radioactive materials. | ||
| 7. | Weekly surveys encompass three compliance and other items, including a smoke test performed in the Cyclotron vault, and consist of contamination smear surveys and dose rate measurements. However, the scope of these surveys may be modified by the COR. | ||
| 8. | The Contractor shall typically submit completed weekly survey reports electronically, using hardware and software provided by the Government. However, in the event that a device is not functioning properly or is unavailable, the Contractor shall submit survey results on paper forms. The surveys shall be submitted to the COR by 4 p.m. of the second workday following the survey, unless there was no appropriate person to interview. In such a case, the Contractor shall notify DRS if any contamination was found, but not submit the survey until the interview has been completed. The survey still needs to be completed and submitted within the month in which it is due (see Attachment 1, section A, item 3). | ||
| 9. | If survey results were documented on paper instead of electronically, the Contractor shall enter the data from surveys that have been approved by the COR or designee into the database within 1 work day. | ||
| 10. | In the event that the Electronic Survey System is offline or not operating properly, the Contractor shall give the appropriate HP and Authorized User a copy of the survey within 2 days of completion of the survey. The HP will then give the reviewed and completed survey back to the Contractor. | ||
| 11. | On a daily basis the Contractor shall maintain the master listing of areas requiring weekly surveys on the DRS database, including corrections, additions, and deletions. Information for corrections may come from observations by the Contractor when performing surveys, or from DRS. Note, however, that all changes, including those proposed by the Contractor, shall be approved by DRS through a “green sheet” before the Contractor enters them into the database. The Contractor shall process “green sheets” within one work day. | ||
| 12. | If a weekly survey showed a violation of Item 20 (contamination levels), the Contractor shall send the AU the appropriate "fact sheet" created by DRS to inform the AU how to correct the violation. | ||
| 13. | The Contractor shall enter or transmit data from weekly surveys into the database within one work day. |
ARTICLE 8 10 CFR 35 WEEKLY SURVEYS
10 CFR 35.70 no longer requires daily contamination surveys; however, it still requires daily ambient radiation dose rate measurements only where written directive type activities are conducted (dose preparation and administration rooms). DRS license commitments require weekly contamination surveys of those areas.
The revised 10 CFR 35 has deleted most survey requirements that were previously specifically required. For example, 10 CFR § 35.70 no longer requires daily contamination surveys of all areas where radiopharmaceuticals are routinely prepared for use or administered, weekly surveys of radiopharmaceutical storage or radiopharmaceutical waste storage areas, or weekly surveys for removable contamination. Also, the revised 10 CFR § 35.315 deletes the requirement to survey the radiopharmaceutical therapy patient's room and private sanitary facility for removable contamination before assigning another patient to the room.
Some survey requirements have been retained in the revised 10 CFR 35. For example, a) revised 10 CFR § 35.70 does require radiation dose rate surveys at the end of each day in areas where unsealed byproduct material requiring a written directive is prepared for use or administered; b) 10 CFR 35.315 requires either monitoring material and items removed from the patient's room or handling the material and items as radioactive waste. Note that 10 CFR § 35.70(a) provides that the surveys to be performed under that provision are in addition to Part 20 survey requirements. Other survey requirements can be found in 10 CFR § 35.75 (possible surveys), § 35.92, § 35.315(a)(3), § 35.404, § 35.415, § 35.604, and § 35.652.
1. The number of labs on weekly 10 CFR 35 survey frequency may change at any time.
2. An estimated 180 10 CFR 35 weekly surveys shall be performed per 12-month period.
3. Each month, the Contractor shall download data on the laboratories due for 10 CFR 35 weekly surveys to devices such as tablet PCs or ipads and conduct these weekly surveys in all relevant NIH posted labs. The Contractor shall use these devices in the field to collect survey data electronically. In the event that a device is not functioning properly or is unavailable, the Contractor shall document survey results on paper forms and enter the data into the DRS database.
4. The Contractor shall monitor using appropriate survey meters and perform contamination smear surveys, taking 10 swipes per module in various areas such as but not limited to the floor, benches on which radioactive materials are used, sinks, and refrigerators in which radioactive materials are stored, in all relevant posted labs during 10 CFR 35 weekly surveys, regardless of whether or not radioactive materials have been used in each lab since the last survey.
5. The Contractor shall document the results of each 10 CFR weekly survey on an NIH Form 88-12, "Monthly Laboratory Contamination Survey", or electronic equivalent, ensuring that the designation of the modules matches those in DRS's database.
6. The Contractor shall submit each 10 CFR 35 weekly survey to the COR or designee by 4:00 p.m. the second workday following the survey.
7. If a 10 CFR 35 weekly survey showed a violation of Item 20 (contamination levels), the Contractor shall send the AU the appropriate "fact sheet" created by DRS to inform the AU how to correct the violation.
8. The Contractor shall enter or transmit data to the DRS database within one workday.
ARTICLE 9 ALPHA SURVEYS OF RADIOPHARMACEUTICAL AREAS
1. Each month, the Contractor shall conduct surveys in all NIH posted labs. The contractor may also need to conduct a (following alpha therapy administration) survey in a dose preparation and patient administration rooms following alpha therapy administrations.
2. An estimated 30 alpha lab surveys shall be performed per 12-month period.
3. The Contractor shall monitor using appropriate survey meters and and take 10 swipes per module in various areas, such as but not limited to, the floor, benches, chairs, or beds on which radioactive materials are used, sinks, and refrigerators in which radioactive materials are stored in all posted labs during monthly surveys or following therapeutic administration of alpha emitters when alpha emitters have been used since the last survey.
3. The Contractor shall document the results of each survey on an NIH Form 88-12, "Monthly Laboratory Contamination Survey", or electronic equivalent, ensuring that the designation of the modules matches those in DRS's database.
4. The Contractor shall submit each alpha lab survey to the COR or designee by 4:00 p.m. the second workday following the survey.
5 If an alpha survey showed a violation of Item 20 (contamination levels), the Contractor shall send the AU the appropriate "fact sheet" created by DRS to inform the AU how to correct the violation.
6. The Contractor shall enter or transmit data to the DRS database within one workday.
ARTICLE 10 NATURALLY OCCURRING ALPHA SURVEYS
1. Annually, the Contractor shall conduct surveys for naturally occurring alpha emitters in all NIH labs using such compounds (i.e. Uranyl Acetate, Uranyl Nitrate, Thorium Nitrate or any other naturally occurring alpha radioactive material). If the lab is also posted for radioactive material use, this survey should be included as part of a comprehensive survey.
2. An estimated 40 naturally occurring alpha surveys shall be performed per 12-month period.
3. The Contractor shall monitor using appropriate survey meters and perform contamination surveys in such NIH labs during annual surveys, regardless of whether or not radioactive materials have been used in each lab since the last survey.
3. The Contractor shall document the results of each naturally occurring alpha survey on an NIH Form 88-12, "Monthly Laboratory Contamination Survey", or electronic equivalent, ensuring that the designation of the modules matches those in DRS's database.
4. The Contractor shall monitor the lab with appropriate survey meters and take 10 swipes per module in various areas, such as but not limited to, the floor, benches on which radioactive materials are used, sinks, and refrigerators in which radioactive materials are stored.
5. The Contractor shall submit each naturally occurring alpha survey to the COR or designee by 4:00 p.m. the second workday following the survey.
6. If a naturally occurring alpha survey showed a violation of Item 20 (contamination levels), the Contractor shall send the AU the appropriate "fact sheet" created by DRS to inform the AU how to correct the violation.
7. The Contractor shall enter or transmit data to the DRS database within one workday.
ARTICLE 11 LAB CLEARANCE SURVEYS
The contractor shall perform enhanced clearance surveys on individual laboratory and partial building floors that DRS has determined do not warrant a full Multi-Agency Radiation Survey and Site Investigation manual (MARSSIM) style final status survey. However, the scope of the surveys may be modified by the COR. The COR may also designate DRS personnel to perform these surveys instead of the contractor. An estimated 100 lab clearance surveys shall be performed per 12-month period. The contractor shall complete lab clearances within 5, 10, or 14 business days (longer if agreed upon by COR, since there may be a specific expected date outside 10 business days), depending on the classification of the survey: Urgent, Standard, or Other. However, a lab clearance shall be completed within 1 work day if directed by the COR or designee. A typical lab clearance (single module) is expected to require 10 smears, with 10 additional smears in high RAM use areas within the lab, and 10 more if long-lived RAM was used. Lab clearance surveys shall be of sufficient quality that the laboratory space would no longer be considered impacted by MARSSIM standards. Laboratory spaces that undergo this enhanced clearance survey shall be considered approved for unrestricted use or renovation. These enhanced surveys shall typically be performed on laboratory space that will be renovated and do not have the potential for long-lived contamination to be present in inaccessible spaces: behind cabinets, in hood ductwork, or underneath floor tiles, etc. Labs that are not free of equipment and fully vacant are not subject to this type of clearance survey. Instead, these lab clearances will be performed by a DRS HP for the sole purpose of down-posting the laboratory; however, such labs will require an enhanced clearance or MARSSIM survey in the future. A DRS HP will perform a historical site assessment (HSA) by compiling the data below and a preclearance inspection to ensure the lab is free from radioactive materials and waste, empty and free of clutter, a closeout survey was performed, DRS database reflects no remaining RAM inventory or outstanding orders and a Green Sheet has been submitted to reflect the lab inactivation.
The DRS HP HSA shall consist of the following prior to the contractor conducting the enhanced clearance survey:
1. A history of radionuclides used in the laboratory by authorized user
2. A history of radionuclides by building and laboratory location
3. A history of radionuclides by waste pick up
4. A history of the laboratory’s contamination events
5. A search of spills and events
6. A search of lab comments for any relevant information related to a different room designation, or historic information
The contractor shall document the enhanced clearance survey which must include a lab diagram, the room designation, and room measurements. The survey shall include, as an attachment, the findings from the data review conducted prior to the enhanced clearance survey.
The contractor shall perform scan surveys with radiological detection equipment capable of detecting beta and gamma emitting radionuclides at screening level of 220 dpm/100cm2 and alpha emitting radionuclides at a screening level of 22 dpm/100cm2. The scan MDC and total efficiency shall be calculated using the method described in MARSSIM 6.7, NUREG-1507 3.1 and Chapter 6. The scan survey must include the following:
1. 100% survey of the floor
2. 100% survey of bench tops
3. 100% survey of chemical fume hood horizontal surface and 50% of vertical surface
4. 50 % survey of casework and walls to five feet above the floor
5. 100% survey of all sink drains
The contractor shall perform a removable smear survey using health physics industry standards to cover at least 100 cm2 per smear. Each laboratory shall have a smear sample over no greater area than 10 ft2 on floors, benches and casework and generally be equally spaced. The following areas require additional smears over no greater than 4 ft2 and generally equally spaced:
1. Under the counter waste storage areas
2. Chemical fume hoods, whereby an additional two smears or swabs behind the baffle are required
3. Bench surface(s) and lip(s) that were demarcated with “Caution Radioactive Material” labels/tape.
ARTICLE 12 SECURITY CHECKS
1. Using a computer-generated list, the Contractor shall do a walkthrough of each facility scheduled for security checks to ensure compliance with the current DRS policy for securing radioactive materials.
2. An estimated 55 normal business hour and 190 after-hours security checks shall be performed per 12-month period.
3. Regardless of whether or not a particular lab is posted for the use and/or storage of radioactive materials, the Contractor shall determine if the lab is locked or occupied. If it is neither locked nor occupied, the Contractor shall determine whether or not any unsecured radioactive materials are present.
4. In addition to looking for unsecured radioactive waste and other radioactive materials in plain view, the Contractor shall carefully open labeled refrigerators and freezers to check for unsecured radioactive materials. However, the Contractor shall not rummage through refrigerator/freezers.
RFP Number 75N98020R00014
5. The Contractor shall also check for unsecured radioactive materials in corridors and other unrestricted areas in each facility scheduled for security checks. In unrestricted areas, the Contractor shall check refrigerators and freezers for unsecured radioactive materials and shall be alert for unattended packages of radioactive material.
6. The Contractor shall document the results of security checks on DRS Form 003 "Laboratory Surveillance Program" or electronic equivalent.
7. If unsecured radioactive materials are present, the Contractor shall describe them in detail (i.e., radionuclide, physical form, activity, number of containers, labeled or unlabeled, how full if unsecured waste containers) in the section labeled "Violations Noted." In addition, the Contractor shall describe any interactions he/she had with lab personnel regarding the violation and how access was gained to the lab. The Contractor shall also note the name and DRS number of the Authorized User associated with the laboratory, if applicable.
8. The Contractor shall not cite as a violation, unsecured, unattended radioactive waste containers or other labeled items, which appear to be empty.
9. Whenever possible the Contractor shall correct the apparent violation by securing the area or the materials. If the Contractor is unable to correct the violation and it involves source vials, he/she shall immediately notify the DRS by calling the main number, 301-496-5774 (workdays), or if after hours, via the emergency call list provided to the Contractor by the COR. The Contractor may be directed to confiscate the source vial(s) and place them in secure storage in Building 21. The Contractor shall be given specific instructions for each satellite building for the event of finding unsecured source vials that cannot be secured at the satellite facility.
10. The Contractor shall submit "Lab Surveillance Program" forms to the NIH COR by 4:00 p.m. of the first workday following the security checks.
11. With a minimum of 8 hours of advance notice, the Contractor shall conduct emergency security checks of specified areas within a time frame established by the COR or designee. The time frame may include daytime, evenings, or weekends.
12. The Contractor shall enter or transmit data to the DRS database within one workday.
ARTICLE 13 PREPARATION AND DECONTAMINATION OF PATIENT THERAPY
ROOMS
The NIH Clinical Research Center (CRC) maintains an inpatient I-131 therapy program in which greater than 33 millicuries of I-131 is administered to patients orally or intravenously. NIH also performs Lu-177, Th-227, Ra-223 and Y-90 patient therapies in other locations including the CRC Intensive Care Unit, NCI Molecular Imaging Program and any other location that the NIH Radiation Safety Committee approves for therapeutic administrations. While I-131 therapies are systemic, whereby all body fluids are contaminated; primary contamination from Lu-177, Th-227, Ra-223 and Y-90 therapies will come from urination. In some cases, the I-131 patient is kept in isolation until eligible for release in accordance with NRC regulations; however, most Lu-177, Th-227, and Y-90 patients will be released from either of the two designated isolation rooms with instructions relating to members of the public. These rooms are not currently solely dedicated for patient therapies, and will be used interchangeably between the different types of therapies in addition to housing the typical clinical non-radioactive patients in the interim. Therefore, unless another therapy is imminent, the rooms need to be decontaminated for unrestricted use following release of the patient within one working day of notification if between patient therapies (i.e.
approximately 100 therapy room resets for restricted use per 12-month period) or 2 or 3 days (approximately 70 full therapy room decontaminations for unrestricted use per 12-month period) unless directed to be completed within one day by COR or designee if for complete decontamination relating to unrestricted area release. The Contractor shall properly prepare the rooms prior to therapies to prevent surface contamination in accordance with the radionuclide therapy being planned, and then monitor and decontaminate the rooms after the therapy patients have left or been released in accordance with NRC regulations. Preparation and decontamination of the rooms after Iodine-131 therapy patients have been released shall be in accordance with Attachment 2.
| ARTICLE 14 | SURVEY METER CALIBRATIONS | |
| A. | Background | |
| 1. | All survey instruments used for contamination monitoring only or for measuring exposure or dose equivalent rates shall be calibrated annually in accordance with ANSI standard N323A-1997 (and any subsequent updates) and Appendix K of the latest revision of NUREG-1556, Volume 9. Results shall be documented in accordance with Appendix K of the latest revision of NUREG-1556, Volume 9. | |
| 2. | An estimated 890 contamination meter calibrations and 120 exposure instrument | |
| calibrations shall be performed per 12-month period. |
| 3. | Each calibration shall be performed between 11 and 12 months from the previous calibration date. New survey instruments must be inspected and calibrated by the Contractor prior to initial use. | |
| 4. | The Contractor shall locate, inspect, and calibrate for contamination (on-site) meters that are called in for calibration or due for calibration based on the DRS computerized database. | |
| 5. | Contractor personnel shall contact someone in each of the laboratories to verify the information (Custodian name, DRS number, telephone number, location of meter) from the database and update the database as needed. | |
| 6. | If the Contractor is unable to locate a meter following two thorough searches performed in two consecutive months, the Contractor shall inactivate that meter on the database after entering the dates of the searches. A thorough search is one in which the Contractor searches the last reported location of the meter, searches surrounding labs, requests assistance in finding the meter from the Custodian to whom the meter is assigned, and requests assistance from other researchers in the surrounding areas. | |
| 7. | An adequate calibration, including inspection, replacement of batteries and cables as necessary, labeling, and completion of the calibration form is estimated to require about 30 minutes of time, exclusive of data entry. | |
| 8. | For calibration of instruments for exposure or dose equivalent rate typically performed off-site, the Contractor shall collect each instrument with the permission of the Custodian or designee, calibrate it, and return the instrument to the Custodian or designee within five work days. Calibration forms shall be submitted to the COR or designee for review/approval within 1 work day after calibration. | |
| 9. | If there is no check source on the meter, the Contractor shall fasten an appropriate (Tl-204 for GM probe, I-129 for NaI probe, Cs-137 for either probe) check source to the meter case with adhesive. The contractor shall also use one of the two available DRS Cs-137 check sources to complete a source check information sticker for each DRS exposure or dose equivalent rate meter immediately after bringing the instrument back to NIH. For ZnS probes, the Contractor shall place a gas lantern mantle in a plastic bag and tie the bag to the meter. | |
| 10. | The Contractor shall check the batteries and replace them if necessary. | |
| 11. | If the cable is damaged, badly worn, or appears to be malfunctioning, the Contractor shall replace it. | |
| 12. | The Contractor shall tag inoperable meters, describe the problem on the form, and notify the Custodian. The Contractor shall NOT affix a calibration sticker to the survey meter if an INOPERABLE tag is required. | |
| 13. | The strengths of the sources for this calibration shall be commensurate with the calibration task. Any source system used in the field shall be constructed to be portable, yet totally self-contained and sufficiently shielded so that a member of the public could not receive 100 mrem in a year or 2 mrem in any one hour. The Contractor shall keep such sources under constant surveillance or secure them from unauthorized access. |
14. The method of calibration must be approved by DRS prior to its implementation. Any change in the method must be approved by DRS before being used.
15. The Contractor shall also calibrate and maintain upkeep of three DRS floor (gas proportional) monitors (windowless tritium probes) so that they are deployable when needed. DRS floor monitors may be used on an ad hoc basis by contractor personnel as directed by DRS to perform close-out surveys of a lab, specifically where long-lived radionuclides were used.
16. The Contractor shall enter or transmit all associated data into the DRS database within one work day.
17. On a daily basis the Contractor shall maintain the master listing survey meters requiring calibrations on the DRS computer, including corrections, additions, and deletions.
| ARTICLE 15 | DECOMMISSIONING |
| 1. | The contractor shall design and conduct MARSSIM style final status surveys for decommissioning selected facilities under the NIH’s NRC license. |
| 2. | Following MARSSIM guidance, the Contractor shall perform a Historical Site Assessment (HSA) to identify potential radiological contaminants. |
| 3. | Based on the results of the HSA and in accordance with MARSSIM, the Contractor shall develop a Survey Plan describing the scanning, sampling, and analytical approach of the survey, creating data quality objectives, setting derived concentration guideline levels, identifying survey units and classifications for impacted areas, and determining the number of sample and/or measurement locations required in each survey unit for non-parametric statistical hypothesis testing. |
| 4. | Before commencing the survey, the Contractor shall brief the Contracting Officer’s Representative, the Project Manager and the NIH Radiation Safety Officer (RSO) on the Survey Plan and submit a draft of the plan for review and approval. |
| 5. | The Contractor shall conduct the survey and analyze the results using the Contractor’s survey and analytical equipment in accordance with the approved Survey Plan. |
| 6. | Within 2 weeks of the survey the Contractor shall submit a draft Final Status Survey report as described in MARSSIM. When finalized, this report shall serve as a stand-alone, technically-defensible record of the radiological status of the site, which assuming that the survey results demonstrate that no remediation is needed, would satisfy NRC decommissioning requirements. |
| 7. | The Contractor shall advise and assist with other tasks relating to decommissioning, e.g., periodically update the Decommissioning Funding Plan. |
ARTICLE 16 QUALITY ASSURANCE
The Contractor shall develop and implement a comprehensive quality assurance plan to ensure compliance with the requirements in the Performance Work Statement (PWS), including procedures and deadlines. The Government will evaluate the Contractor’s performance in accordance with the Quality Assurance Surveillance Plan (QASP) (Attachment 5) starting on the date the contract is awarded.
As part of the Government Evaluation of Contractor performance, DRS may accompany Surveyors performing comprehensive surveys, conduct a separate survey following a comprehensive survey, or interview the Authorized User of a lab that the Contractor has recently surveyed. The Government may implement additional QA evaluations at its discretion. In all cases, the Contractor shall coordinate with DRS as needed to accomplish the evaluation.
Monthly Quality…
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