ML19338D255
| ML19338D255 | |
| Person / Time | |
|---|---|
| Site: | Nuclear Energy Institute |
| Issue date: | 12/02/2019 |
| From: | Gross W Nuclear Energy Institute |
| To: | NRC/SECY/RAS |
| SECY/RAS | |
| References | |
| 84FR48750 00017, DG-5040, NRC-2009-0225, PR-026 | |
| Download: ML19338D255 (18) | |
Text
PUBLIC SUBMISSION As of: 12/3/19 9:44 AM Received: December 02, 2019 Status: Pending_Post Tracking No. 1k3-9dn6-c0al Comments Due: December 02, 2019 Submission Type: Web Docket: NRC-2009-0225 Fitness-for-Duty Drug Testing Program Requirements Comment On: NRC-2009-0225-0009 Fitness for Duty Drug Testing Requirements; Request for Comment on Proposed Rule and Draft Regulatory Guide Document: NRC-2009-0225-DRAFT-0043 Comment on FR Doc # 2019-18491 Submitter Information Name: William Gross Address:
1201 F St., NW Suite 1100 Washington, DC, 20004 Email: wrg@nei.org General Comment Industry Comments on Part 26 Proposed Rulemaking, "Fitness for Duty Drug Testing Requirements" noticed in the Federal Register, Vol. 84, No. 179, Dated September 16, 2019, and Draft Regulatory Guide DG-5040, "Urine Specimen Collection and Test Results Review Under 10 CFR Part 26, "Fitness for Duty Programs", dated August 2019, Docket ID NRC-2009-0225 Attachments Part 26 Proposed Rulemaking and DG 5040 NRC Submittal Comment Letter Page 1 of 1 12/03/2019 https://www.fdms.gov/fdms/getcontent?objectId=09000064841d9bbd&format=xml&showorig=false 17 PR-026 84FR48750
WILLIAM R. GROSS Director, Incident Preparedness Facility Security Officer 1201 F Street NW, Suite 1100 Washington, DC 20004 P: 202.739.8123 wrg@nei.org nei.org December 02, 2019 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 ATTN: Rulemaking and Adjudications Staff Submitted via Regulations.gov
Subject:
Industry Comments on Part 26 Proposed Rulemaking, Fitness for Duty Drug Testing Requirements noticed in the Federal Register, Vol. 84, No. 179, Dated September 16, 2019, and Draft Regulatory Guide DG-5040, Urine Specimen Collection and Test Results Review Under 10 CFR Part 26, Fitness for Duty Programs, dated August 2019, Docket ID NRC-2009-0225 Project Number: 689 On behalf of the Nuclear Energy Institutes (NEI)1 members (hereinafter referred to as industry), we provide the attached comments on Part 26 Proposed Rulemaking, Fitness for Duty Drug Testing Requirements noticed in the Federal Register, Vol. 84, No. 179, Dated September 16, 2019, and Draft Regulatory Guide DG-5040, Urine Specimen Collection and Test Results Review Under 10 CFR Part 26, Fitness for Duty Programs, dated August 2019, for consideration by the NRC staff. The proposed rule and DG 5040 closely align the NRCs drug testing requirements with the updates made to the U.S. Department of Health and Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs issued in 2008. The proposed rule and DG 5040 would also incorporate lessons learned from implementation of the NRCs current FFD regulations and would enhance the ability of NRC licensees and other entities to identify individuals using illegal drugs, misusing legal drugs, or attempting to subvert the drug testing process.
1 The Nuclear Energy Institute (NEI) is responsible for establishing unified policy on behalf of its members relating to matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEIs members include entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect and engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations involved in the nuclear energy industry.
Rulemakings and Adjudications Staff December 2, 2019 Page 2 The industry is generally in support of the NRC proposed rule and believes additional changes should also be considered for inclusion into the Part 26 rulemaking, to enhance efficiencies while maintaining the continued reliability of the Fitness-for-Duty program. In summary, the industry recommends that NRC:
Eliminate the need for blind performance testing requirements similar to DOTs proposed changes in Federal Register Vol. 82, No. 217, November 13, 2017.
Adopt the HHS Guidelines for oral fluid testing without the need to submit an exemption or awaiting future rulemaking.
Establish a streamlined process for industry adoption of future HHS Guideline issuance without awaiting future rulemaking.
More details of these proposals are contained in the attachments. We appreciate the opportunities that have been provided to interact with the staff and to provide comments on the revisions.
If you have any questions or require additional information, please contact Lisa Hogg, at (202) 739-8121 or lbh@nei.org, or me.
Sincerely, William R. Gross Attachments:
- 1) Industry Comments on Part 26 Proposed Rulemaking, Fitness for Duty Drug Testing Requirements noticed in the Federal Register, Vol. 84, No. 179, Dated September 16, 2019,
- 2) Industry Comments on Draft Regulatory Guide DG-5040, Urine Specimen Collection and Test Results Review Under 10 CFR Part 26, Fitness for Duty Programs, dated August 2019 c:
Shana Helton, Director, DPCP NRC Document Control Desk Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking 1
Response to specific requests for comment from section V. starting on page 48770 from Federal Register, volume 84, No. 179 dated Monday, September 16, 2019.
Comment
Response
- 1. Alignment with HHS Guidelines The NRC is seeking comment on additional provisions in 10 CFR part 26 that are consistent with the HHS Guidelines and could be eliminated from 10 CFR part 26.
There should be a streamlined process other than rulemaking to incorporate the drug panel for Fitness for Duty (FFD) drug testing for nuclear facilities upon issuance of Department of Health and Human Services (HHS) Guidelines.
- 2. Special Analyses Testing The proposed rule includes new requirements in § 26.163(a)(2) for the special analyses testing of urine specimens for drugs and drug metabolites. The first would require special analyses testing of specimens with dilute validity test results when initial drug testing identifies a drug or drug metabolite within 40 percent of the testing cutoff level. Currently, special analyses testing of dilute specimens is optional. The second new requirement would expand special analyses testing to specimens collected under direct observation as required by § 26.115(a)(1) through (a)(3) and new paragraph (a)(5).
The NRC is seeking comment on whether special analyses testing should also apply to the testing of individuals that already have tested positive on a 10 CFR part 26 test (i.e., denied unescorted access authorization by § 26.75(d) for a first or second drug testing positive result). Requiring special analyses testing in this case would add a level of assurance to follow-up testing required by § 26.69(b)(6), which is conducted to confirm continued abstinence from illegal drug use and/or the misuse of legal drugs.
No. Special analyses testing will not provide additional value to the testing process for personnel in both random and follow up pools. This would make it difficult to allow credit of random tests for follow up tests. However, it is reasonable to conduct special analyses testing for the first observed test.
Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking 2
Comment
Response
- 3. Provide Flexibility To Conduct Additional Specimen Validity Tests The NRC is seeking comment on whether § 26.161(h) should be revised to provide a licensee or other entity with the option to conduct additional specimen validity tests and/ or to utilize lower cutoff levels if the HHS Guidelines are revised in the future to include such testing.
This may result in an inconsistent approach across the industry however, there should be a more streamlined process for adopting future updates to the HHS Guidelines.
- 4. Effective Date of the Final Rule The NRC is seeking comment on whether this implementation time period is appropriate based on the proposed rule changes.
Once the rule is issued licensees will need to evaluate change management plan items to include procedures, union/lab contracts, computer systems, training, etc. To fully and effectively implement the new program utilizing established processes, licensees will need approximately 12 months.
Clarify that during the transition period, any program may accept and rely on another programs FFD-related information as long as the information being shared is compliant with the sharing programs current Part 26 processes.
- 5. Direct Observation of Specimen Collection The proposed rule retains the requirement for direct observation during the collection of a second sample when there are indications of a subversion attempt during the initial collection. The NRC is seeking comment on whether there are any effective alternatives to direct observation that will assist in preventing subversion of the drug testing process.
Oral Fluid Testing should be considered as an effective alternative testing method especially for direct observations and for shy-bladder instances.
The rule should be stated such that the industry can adopt and implement the HHS guidelines for oral fluid testing within their programs without submitting exemptions or awaiting rulemaking.
Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking 3
Comment
Response
- 6. 2017 HHS GuidelinesNew Test Analytes On January 23, 2017, HHS issued its latest revision of the Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine Specimens (82 FR 7920). Subpart C, Urine Drug and Specimen Validity Tests, of the 2017 HHS Guidelines was revised to include additional initial and confirmatory test analytes for certain opioids; specifically, hydrocodone, hydromorphone, oxycodone, and oxymorphone. The NRC is seeking comment on whether §§ 26.31(d)(1) and 26.405(d) should be revised to identify hydrocodone, hydromorphone, oxycodone, and oxymorphone test substances, and whether §§ 26.133 and 26.163(a)(1) and (b)(1) should be revised to require initial and confirmatory testing of these drugs at the cutoff levels recommended in the 2017 HHS Guidelines.
Although testing costs would increase, NEI and its members believe there is a safety benefit to include hydrocodone, hydromorphone, oxycodone, and oxymorphone test substances in the rule.
Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking 4
Comment
Response
- 7. Methylenedioxyethylamphetamine The 2008 HHS Guidelines adds methylenedioxyethylamphetamine (MDEA) as a confirmatory analyte to the drug testing panel in Section 3.4. However, when the HHS revised the mandatory guidelines in 2017, HHS removed MDEA from Section 3.4 stating that [t]he Department has evaluated the comments and has removed MDEA from the Guidelines (i.e., MDEA is no longer included as an authorized drug in Section 3.4). The number of positive MDEA specimens reported by HHS certified laboratories (i.e., information provided to the Department through the NLCP) does not support testing all specimens for MDEA in federal workplace drug testing programs. (82 FR 7920, 7923; January 23, 2017). The NRC is not proposing to adopt the 2008 HHS Guidelines addition of MDEA as a confirmatory test analyte at this time. As a result, the NRC is also proposing to add MDA to the initial testing panel to fully align with the Ecstasy drugs testing panel in the 2017 guidelines. The NRC is seeking comment on these changes.
Although Ecstasy drugs have not been a prevalent issue in the industry, NEI and its members are in favor of aligning with the 2017 HHS Guidelines.
However, if blind specimen testing remains a requirement, consideration should be given to eliminate testing of drugs that are not prevalent issues in the industry.
Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking 5
Comments on proposed rulemaking.
Proposed Rule Section Comments Suggested Wording/Revision Subpart AAdministrative Provisions
§ 26.4 FFD program applicability to categories of individuals.
(g)(6) All persons monitoring a donor during the hydration process described in
§ 26.109(b).
§26.31 only requires monitors to be trained to perform the activity.
Requiring monitors to be covered by the program is an unnecessary expansion that does not improve the effectiveness of the activity. Observers are not required to be Collectors subject to the FFD program and their role is more significant ensuring the proper collection of a specimen.
Requirements for the Hydration Monitor should be consistent with the requirements for an Observer.
Remove proposed (g)(6) from § 26.4 Subpart AAdministrative Provisions
§ 26.5 Definitions.
Federal custody and control form (Federal CCF) means any HHS-approved form, which has not expired, that is published in the Federal Register and is used to document the collection, custody, transport, and testing of a specimen.
Additional clarity is needed for the following which has not expired and additional clarity is needed for the use of equivalent forms.
Recommend to revise definition to read:
Federal custody and control form (Federal CCF) means any HHS-approved or equivalent form, which has not expired, that is published in the Federal Register and is used to document the collection, custody, transport, and testing of a specimen. Expired custody Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking 6
Proposed Rule Section Comments Suggested Wording/Revision and control forms may be used if covered by an active memorandum for the record.
Subpart AAdministrative Provisions
§ 26.5 Definitions.
Potentially disqualifying FFD information means information demonstrating that an individual has (1) Violated a licensee's or other entity's FFD policy; (2) Had authorization denied or terminated unfavorably under §§ 26.35(c)(2), 26.53(i), 26.63(d), 26.65(g),
26.67(c), 26.69(f), or 26.75(b) through (e);
(3) Used, sold, or possessed illegal drugs; (4) Abused legal drugs or alcohol; (5) Subverted or attempted to subvert a drug or alcohol testing program; (6) Refused to take a drug or alcohol test; (7) Been subjected to a plan for Marijuana legalized by state law needs to be addressed.
(7) is in direct conflict with (3) and (4)
Recommend to revise language to read:
(3) Used, sold, or possessed illegal drugs (Including controlled substances determined to be illegal under federal law, such as marijuana, but deemed legal under state law);
Recommend to revise language to read:
Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking 7
Proposed Rule Section Comments Suggested Wording/Revision substance abuse treatment (except for self-referral); or (8) Had legal action or employment action, as defined in this section, taken for alcohol or drug use.
above.
(7) Been subjected to a plan for substance abuse treatment; or Subpart AAdministrative Provisions
§ 26.5 Definitions.
Rejected for testing means the result reported to the MRO by a licensee testing facility or HHS-certified laboratory when no tests can be performed on a specimen.
Consider re-wording for clarity.
Recommend to revise definition to read:
Rejected for testing means the result reported to the MRO by a licensee testing facility or HHS-certified laboratory when a fatal flaw disqualifies a specimen or, any of the required testing cannot be performed on a specimen.
Subpart AAdministrative Provisions
§ 26.5 Definitions.
Substance abuse means the use, sale, or possession of illegal drugs, or the abuse of prescription and over-the-counter drugs, or the abuse of alcohol.
Consider including controlled substances, such as marijuana which has been legalized by some states to provide clarity.
Recommend to revise definition to read:
Substance abuse means the use, sale, or possession of illegal drugs, or the abuse of prescription and over-the-counter drugs, or controlled substances determined to be illegal under federal law, such as marijuana, but deemed legal under state law, or the abuse of alcohol.
Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking 8
Proposed Rule Section Comments Suggested Wording/Revision Subpart BProgram Elements
§ 26.31 Drug and alcohol testing.
(d)(2)(v) Require that individuals who are off site when selected for testing, or who are on site and are not reasonably available for testing when selected, shall be tested at the earliest reasonable and practical opportunity when both the donor and collectors are available to collect specimens for testing and without prior notification to the individual that he or she has been selected for testing; Need to clarify availability of the collector performing in a collector capacity.
Recommend to revise language to read:
(d)(2)(v) Require that individuals who are off site when selected for testing, or who are on site and are not reasonably available for testing when selected, shall be tested at the earliest reasonable and practical opportunity when collection personnel are scheduled to perform collections and the donor is available for testing and without prior notification to the donor that he or she has been selected for testing; Subpart ECollecting Specimens for Testing
§ 26.89 Preparing to collect specimens for testing.
(d) In order to promote the security of specimens, avoid distraction of the collector, and ensure against any confusion in the identification of specimens, a collector shall conduct only one collection procedure at any given time, except as described in § 26.109(b)(1). The urine collection procedure is complete when the urine specimen container has been sealed with Clarity is needed (and in § 26.117(c))
on what constitutes a label versus a seal. § 26.117 refers to an identification label, as well as a tamper-evident seal. Verbiage needs to completely align with other sub-section(s) to avoid future confusion or compliance issues.
Recommend to revise language to read:
(d) In order to promote the security of specimens, avoid distraction of the collector, and ensure against any confusion in the identification of specimens, a collector shall conduct only one collection procedure at any given time, except as described in § 26.109(b)(1). The urine collection procedure is complete when the urine Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking 9
Proposed Rule Section Comments Suggested Wording/Revision tamper-evident tape, the seal has been dated and initialed, and the Federal CCF has been completed or when a refusal to test has been determined under § 26.107(d).
specimen container has been sealed with a tamper-evident seal, the seal has been dated and initialed, and the Federal CCF has been completed or when a refusal to test has been determined under § 26.107(d).
Subpart ECollecting Specimens for Testing
§ 26.109 Urine specimen quantity.
(b) If the quantity of urine in the first specimen provided by the donor is less than 30 mL, the collector shall take the following steps:
(1) The collector shall encourage the donor to drink a reasonable amount of liquid (normally, 8 ounces of water every 30 minutes, but not to exceed a maximum of 40 ounces over 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />) until the donor provides a specimen of at least 30 mL. Alternatively, as specified in the licensees or other entitys FFD program procedures, the collector may assign responsibility for monitoring a donor during the hydration process to another collector who meets the requirements in § 26.85(a) or to a hydration monitor who meets the requirements in § 26.4(g)(6). If another collector or hydration monitor is used, the collector:
The need for the Hydration Monitor to be a Collector is unnecessary and an administrative burden. Guidance and instruction can be provided similar to that given when needed for an observed test when the observer is not a FFD collector.
There is insufficient room on the CCF to record the name of the hydration monitor on the CCF and it is unnecessary. The CCF does not require recording other monitors, nor does it require information when a hydration period is implemented. It is only required to be recorded when a direct observed collection takes place.
Recommend to revise language in § 26.109(b)(1) to read:
(1) The collector shall encourage the donor to drink a reasonable amount of liquid (normally, 8 ounces of water every 30 minutes, but not to exceed a maximum of 40 ounces over 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />) until the donor provides a specimen of at least 30 mL. Alternatively, as specified in the licensees or other entitys FFD program procedures, the collector may assign responsibility for monitoring a donor during the hydration process to another collector who meets the requirements in § 26.85(a) or to a hydration monitor who meets the requirements in § 26.31(b)(1)(vi). If Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking 10 Proposed Rule Section Comments Suggested Wording/Revision (i) Shall explain the hydration process and acceptable donor behavior to the hydration monitor; (ii) Shall record the name of the other collector or hydration monitor on the Federal CCF and then provide the Federal CCF to that individual for the duration of the hydration process; and Recording the name of the other collector or hydration monitor is un-necessary. The CCF should remain with the collector and not the hydration monitor.
another collector or hydration monitor is used, the collector:
And, recommend to add the following language as § 26.31(b)(1)(vi):
(vi) When a donor is unable to provide an acceptable specimen of 30mL, they are encouraged to follow the hydration process in §26.109(b). During the hydration period, a donor may be under the observation of a hydration monitor as follows:
(A) The donor must be continuously monitored by an individual who does not have a personal relationship with the donor.
(B) Individuals who are assigned to monitor donors during a hydration period shall be provided instructions on the monitoring process and control the donors access to any fluids, and control the hydration process in accordance with 26.109(b);
(C) The hydration monitor shall be responsible for documenting the hydration process in accordance with program procedures.
Recommend to delete (ii) Shall record the name of the other collector or hydration monitor on the Federal CCF and then provide the Federal CCF to that individual for the duration of the Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking 11 Proposed Rule Section Comments Suggested Wording/Revision hydration process; and Subpart ECollecting Specimens for Testing
§ 26.115 Collecting a urine specimen under direct observation.
(e) The collector shall ensure that the observer is the same gender as the donor. A person of the opposite gender may not act as the observer under any conditions. The observer may be a different person from the collector and need not be a qualified collector. If the observer is not a qualified collector, the collector shall, in the presence of the donor, instruct the observer on the collection procedures in paragraph (f) of this section before proceeding with the directly observed collection.
Flexibility should be allowed on same gender collections with regards to donors who identify as one gender however still have the physical anatomy of the opposite gender, or those who identify as gender X. In these cases, it should be allowable to have a medical professional of the opposite gender of the donor, such as a doctor or nurse complete the direct observation. This would not be allowed based on the proposed wording.
Recommend to revise language to read:
(e) The collector shall reasonably ensure that the observer is the same gender as the individual donor. The observer may be a different person from the collector and need not be a qualified collector. If the observer is not a qualified collector, the collector shall, in the presence of the donor, instruct the observer on the collection procedures in paragraph (f) of this section before proceeding with the directly observed collection.
Subpart HDetermining Fitness-for-Duty Policy Violations and Determining Fitness
§ 26.185 Determining a fitness-for-duty policy violation.
(f) Review of invalid specimens.
(3) If the MRO and the laboratory agree that further testing would not be useful and there is no legitimate technical or MROs receive the required technical instruction for these situations through their required AAMRO qualification and Recommend to delete (f)(3).
Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking 12 Proposed Rule Section Comments Suggested Wording/Revision medical explanation, and the invalid result is based on pH in the range of 9.0 to 9.5, the MRO shall consider whether there is evidence of elapsed time, exposure of the specimen to high temperature, or both that could account for the pH value. If an acceptable explanation exists for the invalid test result due to pH, based on objective and sufficient information, that elapsed time, high temperature, or both caused the high pH and donor action did not result in the invalid pH result, the MRO shall report a cancelled test result to the licensee or other entity, cancel the test result, and direct the licensee or other entity to collect a second urine specimen from the donor as soon as reasonably practicable. The second specimen collected may not be collected under direct observation.
periodic requalification training.
Mandating one course of action, when the MROs license, training, and qualifications require us to rely upon their knowledge and skills, is contrary to the MROs role. Unless this is also in other Federal programs, it is unnecessary.
Subpart GLaboratories Certified by the Department of Health and Human Services
§ 21.168 Blind Performance Testing Given the rigorous HHS oversight of the laboratories, as well as the business necessity for the laboratories to maintain a reliable record of accuracy, it is not likely that laboratories would relax their standards simply because the relatively small number of blind specimen tests now required was eliminated.
Eliminate the need for blind performance testing requirements similar to DOTs proposed changes in Federal Register Vol. 82, No. 217, November 13, 2017.
Industry Comments on DG 5040, Urine Specimen Collection and Test Result Review Under 10 CFR PART 26, Fitness for Duty Programs 1
Proposed Language Comments Suggested Wording/Revision C. STAFF REGULATORY GUIDANCE
- 1. Monitoring a donor during the hydration process A. General guidance (7) Upon transferring responsibility for monitoring the donor to the hydration monitor, the collector should enter the name of the hydration monitor on the Federal custody and control form (Federal CCF). The area used for hydration should have a working clock visible to the donor(s) and the collector or hydration monitor. The clock that is used should be synchronized with the clock that the collector uses to document the start of the 3-hour hydration process.
There is no benefit or useful purpose in entering the name of the hydration monitor on the CCF.
Synchronizing clocks is difficult to manage and is an un-necessary administrative burden.
Recommend to revise language to read:
(7) The area used for hydration should have a working clock visible to the donor(s) and the collector or hydration monitor. The collector is ultimately responsible for monitoring the clock.
C. STAFF REGULATORY GUIDANCE
- 1. Monitoring a donor during the hydration process B. Monitoring the donor during the hydration process (3) If during the hydration process, the collector or hydration monitor observes any action or behavior by the donor that may indicate an attempt to subvert the testing process, a description of the donors conduct should be immediately documented on the Federal CCF (10 CFR 26.107(b)). If a hydration monitor observes the donor conduct, the Throughout the guidance an excessive amount of information is required to be documented on the CCF. There is not adequate room on the CCF to document such information. Most licensees have internal documentation processes for documenting this information.
Recommend to revise language to read:
(3) If during the hydration process, the collector or hydration monitor observes any action or behavior by the donor that may indicate an attempt to subvert the testing process, a description of the donors conduct should be immediately documented. If a hydration monitor observes the donor conduct, the hydration monitor shall then inform the collector of the observation. The hydration monitor should communicate this information to the collector while maintaining continuous monitoring of the Industry Comments on DG 5040, Urine Specimen Collection and Test Result Review Under 10 CFR PART 26, Fitness for Duty Programs 2
Proposed Language Comments Suggested Wording/Revision hydration monitor shall then inform the collector of the observation. The hydration monitor should communicate this information to the collector while maintaining continuous monitoring of the donor.
donor.
C. STAFF REGULATORY GUIDANCE
- 1. Monitoring a donor during the hydration process D. Providing a specimen during the hydration process (3) If the hydration monitor is not qualified as a collector, the donor shall be transferred to a collector when the donor is ready to attempt to provide a specimen.
Clarify that the collector should be available too.
Revised language to read: (3) If the hydration monitor is not qualified as a collector, the donor shall be transferred to an available collector when the donor is ready to attempt to provide a specimen.
C. STAFF REGULATORY GUIDANCE
- 2. Using mirrors during specimen collections under direct observation (10 CFR 26.115, Collecting a Urine Specimen under Direct Observation)
D. All mirrors should be sufficiently affixed or secured to a wall or structure to prevent injury to the occupants in the room, stall, or private area.
Proposal of permanently affixed mirrors creates a perception that could compromise privacy for non-observed tests. Use of portable mirrors will facilitate temporary collection facilities.
Recommend to revise language to read:
Allow for use of mirrors that are not secured to a wall or structure.
Industry Comments on DG 5040, Urine Specimen Collection and Test Result Review Under 10 CFR PART 26, Fitness for Duty Programs 3
Proposed Language Comments Suggested Wording/Revision C. STAFF REGULATORY GUIDANCE
- 3. MRO consideration of time and temperature for urine specimens with invalid test results due to pH in the range of 9.0 to 9.5 (10 CFR 26.185(f)(3))
MROs receive the required technical instruction for these situations through their required AAMRO qualification and periodic requalification training.
Mandating one course of action, when the MROs license, training, and qualifications require us to rely upon their knowledge and skills, is contrary to the MROs role. Unless this is also in other Federal programs, it is unnecessary.
Recommend to delete section 3.