Attachment_1_SOW_Lab-Cups_and_Lab_services_w-attachments.docx

INMATE URINALYSIS ON-SITE TEST CUP

AND LABORATORY SERVICES

STATEMENT OF WORK

The Federal Bureau of Prisons (Bureau) intends to award a single award firm-fixed price, requirements for inmate urinalysis on-site test cups and urinalysis laboratory services in support of the Federal Bureau of Prisons Inmate Urinalysis Testing Program.

Section A: On-Site Test Cup

The contractor shall provide on-site urinalysis specimen test cups to the BOP for detecting drugs of abuse, which meet the following specifications and other conditions:

I. Cup Design:

The cup must be constructed of clear plastic with a screw top lid which will not leak during air/ground shipping. The test cup must be integrated to allow for collection and testing of urine for multiple drugs simultaneously, without a separate testing device. Once the specimen is collected and the lid installed on the cup, no other manipulation of the urine is required such as pouring, tipping, tilting, turning, inserting and turning a key, or inserting a test card, pipette, dropper, or dipper.

The on-site test cup must have the capability of detecting a minimum of fourteen (14) different drugs at the same time. The BOP requires, at a minimum, a 14-panel cup with the designated drugs outlined in Section B(III), but the Bureau reserves the right to change and specify the type of drugs/test strips and cut-off levels which will be integrated into the on-site cup based on institution inmate drug abuse history and regional trends. If a change is necessary, the BOP will give the vendor 90 days advance notice of the change and an additional 30 days to implement the change.

The cup must have a minimum fill line (at least 30ml) clearly displayed on the outside of the cup to ensure sufficient specimens are collected.

The cup must have a temperature label on the cup, which provides color-coded indication for temperatures ranging from 90°/32°C to 100°F/38°C in 1 or 2 degree increments.

A label or other pull strip in order to conceal the results from inmates at the time of testing and shall not leave a residue or otherwise make the test panel unreadable shall cover the test panel results. The test results must appear within five minutes, then remain stable, and be accurately read up to 30 minutes after the specimen is provided in the cup.

The contractor shall provide four (4) samples of the on-site cup with the Bid for Proposal for the BOP for technical review. Samples will not be returned unless a proper shipping container and prepaid return label is enclosed.

Should new on-site cup technology become available during the contract period, the contractor will make those cups available to the BOP for technical review.

II. Supplies/Report Forms:

Each sterile on-site cup will be provided in a sealed bag with a lot number, an expiration date, the drugs/cut-off levels the on-site cup tests for, desiccant, which maintains relative humidity inside the sealed bag within the manufacturer’s recommended specifications, and instructions for use of the on-site cups on outside of the bag. The product must have a minimum shelf life of 12 months from the date of manufacture.

For all cups read positive and requiring lab confirmation (approximately 3% of all cups), the contractor will provide an identification label (with unique specimen identification number) to seal the lid of the cup, a single donor chain of custody/specimen report form with preprinted and matching specimen identification number, and a sealable clear shipping bag.

The contractor supplied Chain of Custody forms shall consist of two (2) self-carbonized parts (an original and one copy). BOP staff will use the forms to record the positive specimen identification information, retain the original, and send the copy to the confirmation lab, along with the specimen. The Chain of Custody form to be mailed to the confirmation laboratory will not contain any inmate personal information in order to protect the inmate’s identity. The BOP reserves the right to make changes to this form as deemed appropriate.

The contractor supplied chain of custody forms will provide space to document, at a minimum, the following information:

URINE COLLECTION PROCEDURES (Pre-Printed) (collection procedures will be provided by the BOP) COLLECTION SITE NAME, ADDRESS, AND INSTITUTION CODE (Pre-Printed) (all information will be provided by the BOP) SPECIFIC ACCOUNT NUMBER FOR COLLECTION SITE (Pre-Printed) SPECIMEN NUMBER (Pre-Printed) CONFIRMATION ONLY TESTS REQUESTED (Pre-Printed) Cannabinoids (THC) Opiates Amphetamine Methamphetamine Cocaine Barbiturates

Synthetic Cannabinoids (K2/Spice)

SCREEN AND CONFIRMATION TESTS REQUESTED (Pre-Printed) Methadone Benzodiazepines Oxycontin PCP Buprenorphine Other:

TEST REASON (Pre-Printed) (Collector to check one) Random Prior Use Suspect Disruptive Group Saturation Community DONOR’S (Inmate’s) NAME AND REGISTER NUMBER DATE COLLECTED (mm/dd/yy) TIME REQUESTED (24 hour clock – “Military Time”) TIME PROVIDED (24 hour clock – “Military Time”) COLLECTOR’S CERTIFICATION/VERIFICATION (Staff’s) DONOR’S CERTIFICATION/VERIFICATION (Inmate’s) WITNESS SIGNATURE BLOCK (donor refuses or cannot sign)

III. Test Panels, Sensitivity, and Accuracy:

The BOP anticipates an annual requirement for approximately 275,000 test cups capable of detecting, at a minimum, fourteen (14) drugs with documented cut-off levels.

See Attachment F

To prevent reagent leaching, each drug test (one drug per strip) must be in its own individual test strip chamber/channel, have its own test control, and test result lines. Each test strip chamber/channel must have a control line indicator to determine if the test has functioned properly. The BOP will not be charged for cups, which fail to produce a procedural control valid test indication.

The contractor must ensure the BOP Central Office Correctional Services Branch COR is provided with an up-to-date list of cross-reacting drugs, which will be detected by the on-site cup. The contractor must also provide a list of drugs, which will not be detected and will not produce a positive result for the category of drugs specified above. The COR will provide these lists to the Chief Discipline Hearing Administrator, Correctional Services, Central Office and each institution.

The on-site cups must have an accuracy rate of at least 97% as compared to screening tests by DHHS certified Enzyme Multiplied Immunoassay Technique (EMIT) or other DHHS certified comparable testing technology (CERT). Results and documentation must be provided to verify independent tests have been conducted to obtain those accuracy rates. The accuracy rate must not change due to collection site elevation/altitude or humidity levels.

IV. Support:

The contractor must be able to provide free training twice per year for BOP staff administering the test, at the request of any institution for which the cups are provided. This may be accomplished through on-site visits or through video teleconferencing. The vendor may make a training video available to the BOP Central Office, each Regional Office and all BOP institutions. The vendor can use on-line training modules once the Contracting Officer’s Representative gives permission.

The contractor must be able to provide technical assistance 24 hours a day, seven days a week at no additional cost.

For security purposes, and to maintain the integrity of the testing program, the product being offered must not be sold over the counter or over the internet.

The contractor must provide documentation and statistical data indicating accuracy of the on-site test cup and the proposed laboratory from the last fiscal year to the BOP.

The contractor will provide subject matter expert testimony upon request from the BOP Contracting Officer to address issues such as testing methodologies, testing results, testing cut-off levels, accuracy of on-site cups, and other issues. The offer must include the cost of this service.

V. Comparison Testing

The BOP may, on occasion, conduct comparison testing using other alternative testing matrixes (saliva, hair, sweat, lab EMIT screening, etc.) to compare the results of the on-site test cup results with the results of the other matrixes.

VI. Billing:

Costs for all supplies to include on-site cups, lids, absorbent pad, shipping containers, labels, seals, chain of custody forms, help desk, and shipping are to be included in the cost per on-site cup price.

There are 123 collection sites throughout the United States, Hawaii, and Puerto Rico, with the possibility of other locations to be added over the life of the contract. Some institutions have more than one collection site. The contractor must provide each collection site, an exclusive identification (account) number to identify each site from other locations.

Billing for supplies used shall be directed to the specific billing address provided for each collection site. Billing shall be monthly. Approximately 25% of the billing sites will be for multiple collection sites.

A list of BOP facilities can be obtained on the BOP Directory (www.bop.gov/locations/list.jsp). Institutions will be added or deleted by the BOP Contracting Officer. As new institutions are activated, the BOP Contracting Officer will advise the contractor in writing, who will, within 14 days of notification, establish the new account, and provide all the necessary supplies and forms to the new testing site.

VII. Contract Award

The contractor must ship requested supplies and offer full service to the individual testing sites within 30 calendar days of official notification of the contract award. Expenses for shipping supplies will be borne by the contractor.

The three month supply (approximately 120 – 1800 test cups, 100 - 200 Chain of Custody forms and associated seals/labels, and shipping cartons) will be provided to each testing location/collection site. The number per test site will be determined based on the average 3 month supply reported by each institution. After initial delivery of supplies and forms, it will be the responsibility of the collection site to advise the contractor when additional supplies and forms are required. The contractor must be able to replenish supplies and forms within 14 calendar days of e-mail and/or verbal notification from each testing/collection site.

VIII. Quality Control/Manufacturing Practices:

The manufacturer of the on-site cups will be solely responsible for ensuring the institutions receive a quality and properly functioning product. The manufacturer will conduct and document inspections of completed cups to ensure proper packaging, operational parts, label placement, and uniformity. All improperly packaged/labeled, broken, inert, or otherwise defective cups shall be replaced at no cost to the institution. The manufacturer will also reimburse the institution any laboratory expenses incurred by defective cups. The manufacturer must maintain a minimum overall 97% accepted quality at the institution level. If the manufacturer falls below 97% for more than 2 consecutive months, the Contracting Officer may impose penalties up to and including discontinuation of the contract.

The manufacturer will abide by all applicable federal laws and regulations. The manufacturer and manufacturing process is eligible for scheduled and unscheduled inspections by, but not limited to, National Laboratory Certification Program inspectors, the College of American Pathologist inspectors, the Occupational Safety and Health Administration, the BOP Contracting Officer, and/or the BOP Contracting Officer’s Representative.

Section B: Urinalysis Laboratory Services

A National Laboratory Certification Program (NLCP) or College of American Pathologist Forensic Drug Testing (CAPDT) certified lab is to provide confirmation testing for positive on-site urinalysis cups, submitted by the Bureau of Prisons (Bureau), using a scientifically recognized Department of Health and Human Services (DHHS) method of testing. This confirmation testing shall be capable of providing quantitative information and confirmation for the drugs and cut-off levels as specified in this Statement of Work (SOW). Examples of scientifically recognized DHHS methods of testing are gas chromatography/mass spectrometry (GC/MS), gas chromatography/tandem mass spectrometry (GC/MS/MS), two dimensional gas chromatography/mass spectrometry (GC/GC/MS) or LC/tandem mass spectrometry (LC-MS/MS).

The BOP may also request the NLCP or CAPDT certified lab conduct screening tests for on-site urinalysis cups, submitted by the BOP, using DHHS certified Enzyme Multiplied Immunoassay Technique (EMIT) or other DHHS certified comparable testing technology (CERT) and confirmed by a scientifically recognized DHHS method of testing, if found positive for the drugs and cut-off levels as specified in this SOW. All testing will be accomplished by the NLCP or CAPDT certified lab under contract and samples will not be sent to outside labs unless approved by the BOP Contracting Officer.

The NLCP or CAPDT certified lab conducting screening tests must allow institutions to continue to use on-site test cups provided by the previous contractor until stock has been exhausted. The institutions will use the new chain of custody form provided by the contractor beginning on October 1, 2017.

I. Confirmation Only Test Panels and Sensitivity:

The BOP anticipates the annual requirement for approximately 10,000 confirmation tests to be conducted for on-site cups which will be found positive at the institution and sent to the lab for confirmation. The Chain of Custody form, which will accompany each specimen sent by the BOP, will indicate the drug(s) the institution is requesting confirmation. The BOP may request confirmation for more than one drug from a single on-site cup specimen. Confirmation will be accomplished for drugs at the lowest cut-off level scientifically possible by the lab’s equipment and will not be higher than the specified levels listed below. If the lab is capable of conducting lower cut-off levels than those listed below, at any time during the contract period, the BOP must be notified in writing of the new cut-off level capability and the new cut-off levels will be established without additional cost to the BOP. (See Attachment A)

II. Special Screening Tests and Follow-up Confirmation Tests:

The BOP anticipates requesting approximately 2500 special screening tests, with approximately 10% (.10) requiring follow-up confirmation tests for any one or even all of the following drugs listed below; as well as steroids, at the minimum cut-off levels or lower. The drug(s) to be screened for will be indicated on the Chain of Custody form checked under other and the drug to be tested written in the blank space. If an institution requests special screening be conducted for drugs other than those listed below, the BOP COR will determine the appropriate screening cut-off level and confirmation cut-off level as required and notify the lab accordingly. A scientifically recognized DHHS method of testing, or Enzyme Multiplied Immunoassay Technique (EMIT), will be used as the initial screening method and the type method used must be indicated in the proposal.

If an institution fails to identify or mark, on the Chain of Custody form, which drugs it wants confirmation testing, the lab will attempt to contact the institution for clarification on the requested confirmation test(s). If the lab cannot contact the institution, or does not receive a response to the query, the lab will conduct a full screen on the specimen for all the drugs listed in this section and then conduct a DHHS scientifically recognized method of testing on any drug which is positive on the initial screen. The absence of identification of which drugs to be screened and/or confirmed on the Chain of Custody form does not constitute a “no test” criteria as specified in Section XIII. (See Attachment B)

III. Screening for Steroids:

The lab must have the capability to conduct steroid testing and will provide the BOP with a list of those steroids which the lab is certified to test for and the cut-off levels. BOP anticipates requesting approximately 500 special screening tests for Steroids per year. (See Attachment C)

IV. Laboratory Testing/Screening Procedures:

Certification: The lab must be a documented NLCP or CAPDT certified lab, and shall provide the NLCP or CAPDT certification documentation in the proposal. Every specimen will be screened and/or confirmation tested individually; there will be no batch testing and this shall be acknowledged in the proposal.

Adulteration: All samples submitted by the BOP shall be automatically screened for adulteration, substitution, and dilution using DHHS certified laboratory procedures for measuring specific gravity, creatine, and ph. The lab must report to the institution, any specimen suspected of adulteration and the suspected means or procedure used to adulterate the specimen. If the lab suspects a urine sample contains an adulterant; for example, sample smells like bleach or contains foreign objects or discoloration, the BOP does not expect the lab to perform confirmation testing. However, the lab shall submit a report to the institution’s and Central Office’s SIS email box informing BOP staff of the lab’s findings.

Retest: Upon request of the BOP, the laboratory shall retest a specimen previously tested and reported. If the retest fails to confirm the results of the original test, there will be no cost to the BOP and this will be addressed in the proposal. However, if the BOP requests a retest for a different drug other than those, which produced the original results, the BOP will be responsible for the cost of the retest at the same contracted rate of the initial confirmation. The rate of request for retests will be less than 1% (.01) of those specimens submitted for confirmation testing and/or screening and follow-up confirmation testing.

Quality Control: The BOP reserves the right to conduct random announced/unannounced visits to the laboratory, using an industry recognized contractor/person(s) considered to be an expert in the field of laboratory urine testing, to ensure proper NLCP or CAPDT testing procedures are being followed. The proposal shall address this issue. The lab must be certified in accordance with NLCP or CAPDT rules and regulations and documentation of the certification will be provided.

V. Reporting of Results:

At the completion of the laboratory tests, the laboratory shall send the originating BOP facility the results, both negative and positive, to the designated staff member at the respective facility within 24 hours via e-mail to the institution Special Investigation Section (SIS) GroupWise mailbox in PDF format. The laboratory may also make test results available to the designated staff by way of a secured web site. This shall be addressed in the proposal. Results will be maintained in a database by the lab for a minimum three years.

Each specimen will require an individual report, or secure web site entry, from the lab regarding the results, indicating whether drugs were present or not, (positive or negative) based on the cut-off levels stated in Part I or Part II of this SOW, and the type of drug(s). Each result report, or secure web site entry, will have at a minimum, the name and address of the institution, the institution code, account number (provided by the BOP), the unique specimen identification number which is on the Chain of Custody form and on the seal of the on-site cup lid, the drugs which were tested and/or screened and tested for, the positive or negative results of those tests, and reason for no test if applicable. A sample of the report form, or secure web site entry, shall be included in the proposal.

If the lab includes any other identifying information on the results form, or can maintain/present results on a secure website which might enable the institution to better manage the program, this will be at the lab’s discretion in coordination with and with approval of the BOP COR. Suggestions for additional information shall be included in the proposal. The lab, upon request of the BOP COR, shall be able to provide the quantitative concentration levels of each individual positive reading, unless the cut-off level has been previously set at the limit of detection (LOD).

The secured web site will be customized so institutions will only have access to results for the individual institution. Regional access will be made for institution results within a particular region. Central Office access will have access to all results at all institutions.

VI. Retention of Negative Urine Specimen:

All urine specimens sent in for screening, confirmation testing, or both, which confirm negative must be retained for seven days after the 24 hour notification of the results to the respective institution, and maintained in appropriate storage which will ensure the specimen is preserved in a condition suitable for rescreening and/or retesting. This will allow the institution to request a retest of the sample or the BOP COR to request the sample sent to an independent lab for verification testing. If no such request for a retest is made, the negatively confirmed specimen will be discarded. This requirement shall be addressed in the proposal. The contractor will maintain all negative reports for a period of 3 years.

VII. Retention of Positive Urine Samples:

Specimens confirmed positive by a scientifically recognized DHHS method of testing shall be retained for a minimum 60 days by the lab in appropriate storage ensuring the specimen is preserved in a condition suitable for retesting. Approximately 25 specimens a year may require retention for an undetermined length of time in cases of major litigation and/or prosecution. The BOP COR will advise the lab in writing (via fax or e-mail) when this need occurs. This requirement shall be addressed in the proposal. The contractor will maintain all positive reports for a period of 3 years.

VIII.Billing:

Costs for the lab-provided shipping services to ship/mail the on-site cups to the lab for testing shall be included in the testing costs. There are 123 collection sites (institutions) throughout the United States, Hawaii, and Puerto Rico, with the possibility of approximately another five collection sites to be added over the life of the contract. Some institutions may have more than one collection site. The lab will establish separate accounts for each of the collection sites using the account numbers provided by the BOP COR. These account numbers, which will consist of the BOP institution 3-letter code and four numbers will be referenced on all invoices. Those account numbers will already be pre-printed onto the Chain of Custody forms which will accompany each specimen submitted for testing to ensure proper institution billing for payment for services.

Billing for services provided under this SOW will be directed to the specific billing address provided for each collection site. Billing is to be monthly. Approximately 25% of the billing addresses will be for multiple collection sites. Billing for services will occur upon completion of testing and final reporting of specimen results to the collection site by either report or entry onto the secure web site.

A list of BOP facilities can be obtained at the BOP Directory.

See Attachment D: BOP Institutions

Institutions will be added or deleted by the BOP Contracting Officer. As new institutions are activated, the COR will notify the BOP Contracting Officer who will advise the contractor in writing. Within 14 days of notification, the contractor will establish the new account, again using the account numbers provided by the BOP.

IX. Support:

The laboratory shall provide pre-paid shipping services for the BOP to send the on-site cups from the institution to the laboratory for the testing services outlined in this SOW. The lab will use its own preferred cost effective means of shipping and will provide each collection site with laboratory pre-addressed shipping labels and a clear laboratory/clinical pack/outer bag, which is leak-proof and sealable, for each institution to ship the on-site cup shipping boxes to the lab. The bag must meet all Federal guidelines for shipping non-infectious bodily fluids (urine) by ground or air. It will be the responsibility of the lab (shipper) to comply with all federal regulations and keep the BOP COR informed of any regulation changes regarding shipping of urine.

The contractor will provide the BOP on site-cups, two-part bio-bags with absorbent pad which will contain the cups and Chain of Custody forms, and the one or two-cup sturdy cardboard shipping boxes. When an institution ships the containers to the lab, inside the lab provided outer bag, they may ship up to two, two-cup boxes for a total of four cups; however, in most cases the BOP will typically be shipping a single one or two-cup box at a time which contains either one or two cups. The laboratory provided bag must be able to fully contain two shipping boxes which measure a minimum of 4" x 4" x 6” each, but not exceed 6" x 6" x 6"each. If a vendor has shipping boxes within 2 to 3 inches of the measurement list, the BOP would consider the boxes.

The BOP anticipates approximately 10,000 samples BOP-wide to be sent to the lab annually, with the high security institutions averaging 30 samples shipped per month and the other security levels averaging 10 samples shipped per month. The lab must be able to provide 200 shipping bags, pre-addressed self-adhesive shipping labels to each high security institution, 100 shipping bags, and pre-addressed self-adhesive shipping labels to each of the other security level institutions no later than September 10, 2017. Each institution will be responsible for notifying the lab of the need for additional bags and shipping labels. The instructions for use of the lab shipping outer bag must be printed on the outside of the bag itself. The procedure for specimen retrieval and delivery will be addressed in the proposal.

The lab shall provide for mailing/shipping services as requested by the BOP COR to ship/mail a previously tested and retained specimen to a location designated by the BOP COR, such as a specimen sent to another lab for independent lab verification, a specimen sent to a court ordered lab, or other designated location. The BOP anticipates a requirement for an estimated 50 such shipping’s/mailings per year. In this case, the lab will provide a new bio-bag with absorbent pad, new sturdy cardboard container, lab outer bag and will ship the sample according to the lab’s shipping procedures.

The lab shall provide subject matter expert testimony upon request from the BOP COR to address issues such as testing methodologies and accuracy rates, testing results, testing cut-off levels, lab NLCP or CAPDT certification and documentation, and other issues. The BOP anticipates a requirement for an estimated 40 hours of expert testimony per year for the laboratory services and 40 hours of expert testimony for the on-site quick test cup.

X. Confidentiality & Control - Privacy Act

A. The Contractor agrees:

To comply with the Privacy Act of 1974 and the rules and regulations issued pursuant to the Act in the design, development or operation of any system of records on individuals in order to accomplish an agency function when the contract specifically identifies (1) the system or system of records, and (2) the work to be performed by the contractor in terms of any one or combination of the following: (i) design, (ii) development, or (iii) operations.

In the event of violation of the Act, a civil action may be brought against the BOP contractor involved where the violation concerns the design, development or operation of a system of records on individuals to accomplish an agency function and criminal penalties may be imposed upon the officers or employees of the BOP contractor where the violation concerns the operation of a system of records on individuals to accomplish the government agency function.

For the purpose of the Act, when the contract is for the operation of a system of records on individuals to accomplish a government agency function, the contract and any employee of the contractor is held to the same strict standards as an employee of the government agency.

B. The terms used in this clause have the following meanings:

Operations of a system of records mean performance of any of the activities associated with maintaining the system of records including the collection, use, and dissemination of records.

Records mean any item, collection, or grouping of information about an individual maintained by an agency, including, but not limited to, his/her name, (or the identifying particular assigned to the individual, such as a finger or voiceprint or a photograph.

System of records on individuals means a group of any records under the control of any agency from which information is retrieved by name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

XI. Contract Award

The lab shall provide full confirmation testing and screening/confirmation testing services, in accordance with this SOW, to all of the individual testing sites on date of award.

If, at any time during the contract period, the laboratory loses its NLCP or CAPDT certification, the BOP will be notified on the next business day after such loss of certification. Loss of certification may result in contract termination.

XII. Electronic Data Collection:

The contractor shall provide the BOP Central Office Correctional Services Branch COR with a monthly report via e-mail, in a Microsoft EXCEL format, the total number of specimens submitted, the number of Quantity Not Sufficient (QNS) specimens and the reasons for the QNS, the number of lab confirmed positive specimens, the number of negative specimens, the number of special tests requested and tested, the number of steroid tests requested, and the number of specimens which could not be tested for any other reason such as suspected adulterants, dilution, and/or substitution. The data will be transmitted no later than the seventh (7th) day of the next month. (Example: Data for the month of June must be provided to the COR no later than July 7th.) Only specimens which have completed the testing process and have been reported to the collection site will be included.

If an institution has requested a retest, then the original results/findings will not be included in the data, but instead, the retest results will be included in the monthly report. (Example: On June 27th, the lab conducts a confirmation test on a specimen which results in a negative finding and the institution is notified of the results on June 30th, but the institution immediately requests a retest. The retest is conducted on July 1st. The original June 27th negative confirmation test would not be included in the month of June’s data sent to COR instead, the July 1st retest confirmation results would be the data which would be sent to the BOP Central Office Correctional Services Branch COR and it would be for the month of July.

This requirement shall be addressed in the proposal and a sample format which will be used to submit the data to the BOP Central Office Correctional Services Branch COR shall also be included in the proposal.

See Attachment E.

If the BOP collection site submitted an incomplete Chain of Custody form, the lab shall also indicate this when sending the data to BOP Central Office Correctional Services Branch COR. The lab shall also report attempts to contact the testing site to obtain the missing data.

XIII.“No Test” Criteria:

Examples of conditions, which warrant a “no test” condition from the lab, are:

Specimens without the minimum amount of urine required to complete a proper test due to leakage, which occurred during shipment or insufficient level of urine provided by the inmate. If leakage is noted, every attempt will be made to conduct the requested test with the remaining urine in the cup or using the urine, which may have leaked but still contained in the sealed two-part bio bag and/or by extracting the urine from the absorbent pad in the bio bag.

Specimens with a tampered seal (the tamper-resistant seal must be intact for testing to be performed).

Specimens with tamper-resistant seals not dated and initialed by both the collector and donor (tamper-resistant seals must be initialed and dated for testing to be performed).

Specimens in which the BOP requests confirmation test only and the lab determine the specimen visibly appears adulterated, diluted, or substituted will be screened/tested accordingly as outlined in Section IV, but will not be screened for any other drugs or steroids. If the adulteration test proves positive, this will be declared a “no test” because the confirmation testing could not be conducted. The BOP will incur the cost of this adulteration test if the test produces a positive result for adulteration, dilution, and/or substitution since the BOP does not expect the laboratory to conduct this test at no cost. However, if the test is negative, meaning the laboratory’s initial observation/suspect of adulteration was wrong, then the BOP will not be charged for this adulteration test and the laboratory will proceed with the confirmation testing as originally requested.

Specimens which indicate a negative result at the testing site, but the institution has sent in for further screening and confirmation requests will be automatically screened for adulteration, dilution, and/or substitution. If this test produces a positive result for adulteration, this will be declared a “no test” since the screening for the drugs and/or steroids, depending on the institution’s request, could not be completed. The BOP will pay for the cost of this screening test because the BOP requires the simultaneous testing for adulteration for all its special screening requests as outlined in Section IV.

The contractor shall report each “no-test” and the specific reason back to the institution in the same manner as reporting the positives and negative results as outlined in Section V. The “no test” and reason will also be included in the electronic data reported monthly to BOP Central Office Correctional Services Branch COR as outlined in Section XII.

A Chain of Custody form not completely filled out does not constitute a “no test” criteria. Even if no information is filled out on the form, the laboratory will still have the pre-printed institution name and address, the account number, and the unique specimen ID number to send the results back to the institution and send the data to the COR. If the institution failed to identify on the form, the confirmation tests required and/or special screening and confirmations tests required, then the laboratory will conduct screening and confirmation for all the drugs and the cut-off levels as outlined in Section A(II) and Section A(IV), and report those results to the institution and to BOP Central Office Correctional Services Branch COR as previously indicated in Sections A(V) and Section A(XII). The BOP will only incur the cost of these tests if the form was not filled out completely and the laboratory did not receive a response to a query to the institution after 24 hours.

Attachment A: Confirmation Testing Only

Opiates (Codeine, Hydrocodone, Hydromorphone)

Attachment B: Screening and Confirmation Testing

Opiates (Codeine, Hydrocodone, Hydromorphone)

Attachment C: Steroid Testing (All cut-off levels are set at LOD)

Testosterone Epitestosterone 1-androstenediol 1-androstenedione 1-testosterone Androstenedione/6OXO Bolandiol Bolasterone Boldenone/Quinbolone Boldione Calusterone Clenbuterol Clostebol Danazol Dehydrochlormethyltestosterone Drostanolone Fluoxymesterone Furazabol 4-hydroxy Testosterone Mestanolone Mesterolone Methandienone 6B-Hydroxy Methandienone Eplmetendiol Methandriol Methenolone Methdienolone 19-Norandrosterone 19-Noretiocholanolone 19-Norandrostenedione Norbolethone Norclostebol Oxabolone Oxandrolone Oxymesterone Oxymetholone Probenecid Stanozolol Stenbolone Tibolone Zeranol

Attachment D: BOP Institutions

Attachment E: Example COR Monthly Reporting Format

Attachment F: On-site cup panel cut-off levels

Attachment G: Other drugs and Cut-Offs

Methamphetamine

MDA

Phenobarbital

Secobarb

Morphine

Hydrocodone

Hydromorphone

Oxycodone

Oxymorphone

2-Hydroxyethylflurazepam α-Hydroxytriazolam

Lorazepam α-Hydroxymidazolam

Nordiazepam

Oxazepam

7-aminoclonazepam

Temazepam

Methadone metabolite

Ethyl sulfate (ETS)

Nor-Meperidine

Nor-Buprenorphine

Nor-Fentanyl

Meprobamate (metabolite)

SPICE - JWH072 M

SPICE - JWH073 M

SPICE - JWH 203 M

SPICE - AKB48 M

SPICE - AM2201 M

SPICE - MAM2201 M

SPICE - UR144 M

SPICE - UR144 PYRO M

SPICE - 5F-PB-22 M

SPICE - PB-22 M

SPICE - 5F-AKB48 M

SPICE - AB-CHMINACA M

SPICE - AB-FUBINACA M

SPICE - AB-PINACA N5H M

SPICE - AB-PINACA PA M

SPICE - ADBICA N5HP M

SPICE - ADBICA NPA M

SPICE - ADB-PINACA PA M

SPICE - MAB-CHMINACA M11

SPICE - XLR11 M

SPICE - BB-22 M

KRATOM-MITRAGYNINE

DES STIM-Mephedrone

DES STIM-Cathinone

DES STIM-Methcathinone

DES STIM-Alpha PVP

Dextrorphan

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