# Presentation: 202158

## The  Role of  the Medical Review Officer

- Michelle Alexander, MD
- Assistant Vice President
- Occupational Health Services
- NYC Transit

## Random Drug and Alcohol Testing Rates 2007

**Random Drug and Alcohol Testing Rates 2007**

- Drug testing rate reduced from 50% to 25%
- Alcohol testing rate remains the same at 10%

**Notes:**
49 CFR 655.45 (b): The Administrator has determined
that the random drug testing rate shall
be reduced from 50 to 25 percent for
2007 due to a ‘‘positive rate’’ lower than
1.0 percent for random drug test data
from 2003 through 2005. The random
drug rates for the three preceding
consecutive years are 0.96 for 2003, 0.89
percent for 2004 and 0.79 percent for
2005.

## MRO’s Role

- Independent and Impartial Advocate
- Gatekeeper for the integrity and accuracy of the drug testing process
- Quality assurance review
- Timely Flow
- Confidentiality

## Qualifications

- Licensed physician
- Basic knowledge of SA disorders
- Qualification training
- Certification examination
- Continuing education

## Relationships

- Laboratory
- Designated Employer Representative (DER)
- Collectors
- Substance Abuse Professionals (SAP)
- Third Party Administrators (TPA)

## MRO Functions

- Review of negative tests
-           Personal review of  5% of all CCF and all results that require a corrective action quarterly up to 500 tests

**Notes:**
as a minimum, include the CCF, negative laboratory test result, any accompanying corrective documents, and the report sent to the employer. You must correct any errors that you discover. You must take action as necessary to ensure compliance by your staff with this part and document your corrective action. You must attest to the quality assurance review by initialing the CCFs that you review.(4) You must make these CCFs easily identifiable and retrievable by you for review by DOT agencies. 

## Negative tests

- Immunoassay results are below the initial test cutoffs **or**
- GC/MS results below the confirmatory cutoffs, **and**
- Specimen validity test results in the acceptable range.

## MRO Functions

- Review of all laboratory confirmed drug tests:
- Positives
- Adulterated
- Substituted
- Invalid

**Notes:**
1) Review Copy 2 of the CCF to determine if there are any fatal or correctable errors that may require you to cancel the test (see §§40.199 and 40.203). Staff under your direct, personal supervision may conduct this administrative review for you, but only you may verify or cancel a test.(2) Review Copy 1 of the CCF and ensure that it is consistent with the information contained on Copy 2, that the test result is legible, and that the certifying scientist signed the form. You are not required to review any other documentation generated by the laboratory during their analysis or handling of the specimen (e.g., the laboratory internal chain of custody).

## MRO Miranda

- Explain at the start of the interview that the information provided to you in the course of determining if a legitimate medical explanation exists can be shared with the employer, DOT and other agencies.  In addition, if such information affects workplace safety or indicates that the employee is otherwise not medically qualified the employer can be notified.

## Positive Drug Tests

- Direct contact with the employee or candidate
- Verify the test as negative, positive, or test cancelled

**Notes:**
When, as the MRO, you receive a confirmed positive, adulterated, substituted, or invalid test result from the laboratory, you must contact the employee directly (i.e., actually talk to the employee), on a confidential basis, to determine whether the employee wants to discuss the test result. In making this contact, you must explain to the employee that, if he or she declines to discuss the result, you will verify the test as positive or as a refusal to test because of adulteration or substitution, as applicable.

## Opiate Positive

- 6-AM verify positive
- _In the absence of 6-AM _
- At 15,000  ng/ml or  > verify positive unless legitimate medical explanation
- At levels < 15,000 ng/ml determine if clinical evidence exists

**Notes:**
Personal observation is necessary to make this determination performed by MRO or another physician under your direction. Burden of proof shifts to MRO under 15,000.

## Adulterated or Substituted Tests

- Direct contact with the employee or candidate
- Determine the factual information from the laboratory
- Verify the test as refusal to test

**Notes:**
1) Review Copy 2 of the CCF to determine if there are any fatal or correctable errors that may require you to cancel the test (see §§40.199 and 40.203). Staff under your direct, personal supervision may conduct this administrative review for you, but only you may verify or cancel a test.(2) Review Copy 1 of the CCF and ensure that it is consistent with the information contained on Copy 2, that the test result is legible, and that the certifying scientist signed the form. You are not required to review any other documentation generated by the laboratory during their analysis or handling of the specimen (e.g., the laboratory internal chain of custody).

## Dilute samples

- Creatinine > or equal to 2 and < 20mg/dl **and**
- Specific gravity > 1.0010 but < 1.0030

**Notes:**
Unless the criteria for substituted specimen is met.
Specific gravity is less than 1.003 but greater than  1.001, Creatinine less than 20 mg/dl but greater than 5.
Normal urine specific gravity is between 1.003 and 1.030.
Creatinine a byproduct of protein metabolism is normally > 20mg/dl related to person muscle mass and state of hydration. 
Water loading (consuming large amounts of water), diuretics increase urine flow, putting water in the specimen and medical conditions such as diabetes, kidney disease and psychogenic polydypsia can all dilute specimens.

## Substituted sample

- Creatinine <  2 mg/dl **and**
- Specific gravity < or equal to 1.0010
-     or > or equal to 1.0200

**Notes:**
Specimen does not exhibit the clinical signs & normal characteristic compatible with normal human urine. Lab reports this as “test not performed” and comment that Specimen not consistent with normal human urine. Does not report as negative or positive.

## Adulterated samples

- pH < 3 or > or equal to 11
- Nitrite concentration > or equal to 500 mcg/ml
- An exogenous substance is present

**Notes:**
A constituent not normally found in human urine or endogenous substance at higher than normal concentrations 
Chromium, halogen (bleach, iodine, fluoride), glutaraldehyde, pyridine, surfactant (dodecylbenzene) is present or the specimen contains substance not normally present in human urine or contains an endogenous substance in quantities outside of the physiological range.

## Adulterated or Substituted Tests

- Direct contact with the employee or candidate
- Determine the factual information from the laboratory
- Verify the test as refusal to test

**Notes:**
1) Review Copy 2 of the CCF to determine if there are any fatal or correctable errors that may require you to cancel the test (see §§40.199 and 40.203). Staff under your direct, personal supervision may conduct this administrative review for you, but only you may verify or cancel a test.(2) Review Copy 1 of the CCF and ensure that it is consistent with the information contained on Copy 2, that the test result is legible, and that the certifying scientist signed the form. You are not required to review any other documentation generated by the laboratory during their analysis or handling of the specimen (e.g., the laboratory internal chain of custody).

## Common Adulterants

- Nitrites (Klear, Whizzies)
- Alkylephoxysulfonate (Mary Jane’s Super Clean)
- NaCl (table salt)
- UrinAid (Glutaraldehyde)
- Urine Luck (Pyridine)

## Invalid specimens

- _Creatinine concentration & specific gravity results are discrepant:_
- Creatinine < 2 mg/dl & specific gravity > or equal to 1.0010 and < 1.0200
- Creatinine > or equal to 2mg/dl &
- specific gravity < or equal to 1.0010

**Notes:**
DOT requires that the MRO must discuss each invalid test with the lab. This is so the lab can provide additional info i.e interference with the immunoassay and/or confirmation assay MRO discussion will be dependent on the invalid result and what he/she learns from the lab.

## Invalid specimens cont’d

- _pH outside acceptable range_
- pH is > or equal to 3 and < 4.5; or
- pH > or equal to 9 and< 11
- _Nitrite present_
- Nitrite > or equal to 200mcg/ml

**Notes:**
Ask: Is this specimen consistent with normal human urine?  Are there substances which are foreign or adulterants added to the urine?

## MRO Verification without Interview

- Employee expressly declines to speak with you.
- After 3 unsuccessful attempts to contact the employee (both day and evening) over a 24 hour period and the DER has made such contact and more than 72 hrs have elapsed.
- Neither you or the DER has been able to make contact with the employee and more than 10 days have elapsed

**Notes:**
Attempts must be documented include date and time
Or the both phones are disconnected or wrong
You then contact the DER to contact the employee for you without informing  the DER of the positive, etc. Record this information as well.
If the employee fails to contact you within the next 72 hours

## Common Errors

- Correctable
- _Collector_
- Donor ID number omitted or incorrect on CCF
- (unless refusal)
- Collectors signature missing certification statement
- Incomplete COC block (at least 2 signatures and dates, shipping entry)

**Notes:**
Correct with affidavit memorandum of record from lab  to recover missing information 

## Common Errors

- _Correctable_
- Donor signature missing from certification statement (unless refusal)
- Using incorrect CCF (DOT vs. non DOT)
- _Lab_
- Certifying scientist signature omitted on positives

## Fatal Flaws

- Specimen ID missing from specimen bottle or fails to match
- Volume less than 30 ml
- Specimen seal is broken or shows evidence of tampering
- Specimen shows obvious adulteration
- (color, foreign objects, unusual odor, etc)

**Notes:**
Lab may accept volume between 27- 30  (or below) if they can assure there is sufficient sample for storage and  necessary reanalyses

## Blind Samples

- Submitted with donor samples
- These samples should be verified:
-                          Negative
-                          Drug Positive
-                          Adulterated
-                          Substituted

## Shy Bladder Collection

- After the first failed attempt of less than 45 cc urine (split)
- 3 hour window
- Instructed to drink 40 oz of water over the 3 hours (~8 oz of water/30 minutes)

## Failure to provide sufficient sample for testing

- Obtain a detailed medical history ASAP.
- Refer to an appropriate _trained _physician acceptable to you.
- Consider information provided to you by this physician and make your determination.

**Notes:**
You can cancel the test, if a medical condition exists with a high degree of probability which could have precluded the employee from providing a sufficient amount of urine  or a refusal to test.
In the case of pre employment test you must also determine if a permanent long term condition exists which precludes the employee form providing a sufficient sample. You must also determine if there is clinical evidence of drug use.

## Other samples for testing

- Not currently approved under 49CFR 655
- Oral Fluid
- Sweat
- Hair

## Recommendations

- Education!
- Collectors and DERs
- Physicians used to make medical determinations (shy bladder, lung/refusals)

**Notes:**
Or physicians performing the examination in you stead

## Preventive measures

- Routine
- Forms
- MRO checklist

**Notes:**
When in doubt refer to the regs.

## Interesting websites

- _[http://www.passyourdrugtest.com/](http://www.passyourdrugtest.com/)_
- _[http://www.cleartest.com/](http://www.cleartest.com/)_
- _[http://www.detoks.com/](http://www.detoks.com/)_