Exhibit_3.docx
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- Attached to
- Medical Examination Services
- Solicitation number
- 60RRBH18R0015
- Issued by
-
Railroad Retirement Board
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Exhibit 3
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| File | Type | Posted |
|---|---|---|
| 60RRBH18R0015_Amendment_0001_with_Attachment_H_(Q+A).pdf | ||
| Exhibit_1.docx | DOCX document | |
| 60RRBH18R0015.pdf | ||
| Attachment_B.docx | DOCX document | |
| Exhibit_2.docx | DOCX document | |
| Attachment_F.doc | DOC document | |
| Attachment_D.pdf | ||
| Attachment_A.docx | DOCX document | |
| Attachment_C.docx | DOCX document | |
| Attachment_G.docx | DOCX document | |
| Exhibit_4.pdf |
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ANCILLARY TESTS
INSTRUCTIONS FOR PULMONARY FUNCTION TEST (Exam 041)
The following guidelines must be adhered to when conducting and reporting on the pulmonary function test:
1. Test should not be performed during or soon after acute respiratory illness or if medically contraindicated.
2. Expired volumes must be expressed in liters BTPS.
3. There must be at least 3 satisfactory forced expiratory maneuvers prebronchodilator.
4. Two of the satisfactory expiratory maneuvers should be reproducible, i.e., do not differ from the largest value by more than 5% or 0.1 L, whichever is greater.
5. Peak Flow must be achieved early in expiration.
6. Spirogram must have smooth contour with gradually decreasing flow throughout expiration.
7. Zero time measurement of the FVC and FEV1, if not distinct, should be derived from linear back-extrapolation of peak flow to zero volume. Spirogram is satisfactory for measurement of FEV 1 if the expiratory volume at the back-extrapolated zero time is less than 5% of the FVC or 0.1 L, whichever is greater.
8. Spirogram is satisfactory for measurement of the FVC if maximal expiratory effort continues for at least 6 seconds, or if there is a plateau in the volume-time curve with no detectable change in the expired volume during the last 2 seconds of maximal expiratory effort.
CALIBRATION -
1. Spirometric tracing must show a recorded calibration of volume units using a mechanical volume input, such as a 3 L syringe, unless the tracing is generated by direct pen-linkage to a mechanical displacement-type spirometer.
2. If the spirometer directly measures flow, and volume is derived by electronic integration, the linearity of the device must be documented by recording volume calibrations at 3 different flow rates:
(3L/6 SEC), (3L/3 SEC), (3L/SEC)
3. Volume calibrations should agree to within 1 % of a 3 L calibrating syringe volume. If accuracy is less than 1% but within 3% of the calibrating syringe-use the following formula:
Volume correction factor = actual syringe volume/measured volume.
The measured FVC and FEV1 should be multiplied by the calibration correction factor. If the FVC and FEV1 tracings are at ATPS, the values should in turn be multiplied by the BTPS factor. When the measured FVC and FEV 1 are at BTPS, the BTPS correction factor should not be applied.
4. Proximity of the flow sensor to the individual should be noted.
5. It should be noted whether a BTPS correction factor was used for the calibration recordings and for the actual test.
TRACINGS -
1. Provide tracings of all three FVC attempts, pre and post bronchodilator.
2. Must be appropriately labeled, showing claimant's name, date of testing, distance per second on the abscissa, and distance per liter on the ordinate.
3. Must have a time scale of at least 20 mm/sec.
4. Must have a volume scale of at least 10 mm/L.
NOTE: Calculation of FEV1 from a flow-volume tracing is not acceptable.
POST-BRONCHODILATOR -
1. Post-bronchodilator studies should be done if the pre-bronchodilator FEV1 is less than 70% of the predicted normal value (unless contraindicated).
2. Include dose and name of bronchodilator administered in the report.
3. Post-bronchodilator testing should be done 10 minutes after administration of the bronchodilator.
OTHER REPORTING INFORMATION -
1. Manufacturer and model number of device used to measure and record the spirogram should be stated.
2. Statement regarding individual's ability to understand directions, as well as effort and cooperation, should be included.
3. If a bronchodilator is not administered, please indicate the reason why.
4. Height of the individual -without shoes- must be recorded.
INSTRUCTIONS FOR DIFFUSING CAPACITY OF THE LUNGS FOR CARBON MONOXIDE (DLCO)(Exam 042)
The following guidelines must be adhered to when conducting and reporting on the DCLO:
1. The DLCO should be measured by the single breath technique with the individual relaxed and seated.
2. At sea level, the inspired gas mixture should contain approximately 0.3 percent carbon monoxide (CO), 10 percent helium (He), 21 percent oxygen (O2), and the balance nitrogen. At altitudes above sea level, the inspired O2 concentration may be raised to provide an inspired O2 tension of approximately 150 mm Hg. Alternatively, the sea level mixture may be employed at altitude and the measured DLCO corrected for ambient barometric pressure. Helium may be replaced by another inert gas at an appropriate concentration.
3. The inspired volume (VI) during the DLCO maneuver should be at least 90 percent of the previously determined vital capacity (VC). The inspiratory time for the VI should be less than 2 seconds, and the breath-hold time should be between 9 and 11 seconds. The washout volume should be between 0.75 and 1.00 L, unless the VC is less than 2 L. In this case, the washout volume may be reduced to 0.50 L; any such change should be noted in the report. The alveolar sample volume should be between 0.5 and 1.0 L and be collected in less than 3 seconds. At least 4 minutes should be allowed for gas washout between repeat studies.
4. A DLCO should be reported in units of ml CO, standard temperature, pressure, dry (STPD)/min/mm Hg uncorrected for hemoglobin concentration and be based on a single-breath alveolar volume determination. Abnormal hemoglobin or hematocrit values, and/or carboxyhemoglobin levels should be reported along with diffusing capacity.
5. The DLCO value used for adjudication should represent the mean of at least two acceptable measurements, as defined above. In addition, two acceptable tests should be within 10 percent of each other or 3 ml CO (STPD)/min/mm Hg, whichever is larger. The percent difference should be calculated as 100x (test 1 – test 2)/average DLCO.
6. The ability of the individual to follow directions and perform the test properly should be described in the written report.
7. The report should include tracings of the VI, breath-hold maneuver, and VE appropriately labeled with the name of the individual and the date of the test. The time axis should be at least 20 mm/sec and the volume axis at least 10 mm/L. The percentage concentrations of inspired O2, and inspired and expired CO and He for each of the maneuvers should be provided. Sufficient data must be provided, including documentation of the source of the predicted equation, to permit verification that the test was performed adequately, and that, if necessary, corrections for anemia or carboxyhemoglobin were made appropriately.
INSTRUCTIONS FOR EXERCISE ARTERIAL BLOOD GAS STUDIES (EXAM 123)
The following guidelines must be adhered to when conducting and reporting on the exercise arterial blood gas study:
1. ABGS should be analyzed in a laboratory certified by a State or Federal agency, or the laboratory must submit evidence of participation in a national proficiency testing program, as well as acceptable quality control at the time of testing.
2. Determine if there are any contraindications. A copy of the claimant’s pertinent medical records will be provided for review to aid in this determination. If there are any contraindications, do not perform the exercise test. The reason for canceling the test should be stated in the report.
3. Provide the date of testing.
4. The height (without shoes) of the claimant must be reported. If the claimant has spinal curvature, the measured span between the fingertips when the upper extremities are abducted 90 degrees should be substituted for height. Also, provide weight and age of claimant.
5. Altitude and barometric pressure of the test site should be reported.
6. Provide the normal range of blood gas values for facility.
7. Test and provide the results of a resting PO2, PCO2 and pH determinations. This testing should be obtained while the claimant is in a sitting or standing position.
8. Exercise the claimant under steady state conditions, preferably on a treadmill, breathing room air, for a period of 4 to 6 minutes at a speed and grade providing an oxygen consumption of approximately 17.5 ml/kg/min (5 METs). If a bicycle ergometer is used, an exercise equivalent of 5 METs (e.g., 450 kpm/min, or 75 watts for a 176 pound (80 kilogram) person) should be used. If the claimant is able to complete this level of exercise and arterial blood gas values are higher than the values specified in the table on page 10, then he or she should be exercised at higher workloads to determine exercise capacity. A warm-up period of treadmill walking or cycling may be performed to acquaint the claimant with the exercise procedure. If during the warm-up period the claimant cannot achieve an exercise level of 5 METs, a lower workload may be selected in keeping with the estimate of exercise capacity.
9. Monitor the claimant by EKG/ECG throughout the exercise and in the immediate post-exercise period. Blood pressure and an EKG/ECG should be recorded during each minute of exercise.
10. During the final two minutes of a specific level of steady state exercise, an arterial blood sample should be drawn and analyzed for oxygen pressure (or tension)(PO2), carbon dioxide pressure (or tension)(PCO2), and pH.
Oximetry and capillary blood gas analysis are not acceptable substitutes for the measurement of arterial blood gases. In addition, arterial blood gas samples obtained after the completion of exercise are not acceptable.
11. If you have the capacity, also measure minute ventilation (BTPS) and oxygen consumption per minute (STPD) and CO2 production (STPD).
12. Include in the report the resting and exercise arterial blood gas values obtained, and attach a copy of the representative EKG/ECG strips taken before, during, and after exercise to provide the heart rate in each minute of exercise. Also report the duration of exercise and the treadmill speed and grade settings. If a bicycle ergometer was used, provide the exercise levels expressed in watts of kpm/min.
13. If the claimant fails to complete 4-6 minutes of exercise, the reason must be given in the report.
14. Provide any observations about symptoms noted during and after exercise.
15. Comment on the correlation between test results and findings on your examination.
The physician or technician performing the test must sign report.
| Applicable at test sites less than 3,000 feet above sea level |
| Applicable at test sites 3.000 feet through 6,000 feet above sea level |
| Applicable at test sites over 6,000 feet above sea level |
| Arterial PCO2 (mmHg) and |
| Arterial PO2 Equal to or Less than (mm Hg) |
| Arterial PO2 Equal to or Less than (mm Hg) |
| Arterial PO2 Equal to or Less than (mm Hg) |
| 30 or below |
| 65 |
| 60 |
| 55 |
| 31 |
| 64 |
| 59 |
| 54 |
| 32 |
| 63 |
| 58 |
| 53 |
| 33 |
| 62 |
| 57 |
| 52 |
| 34 |
| 61 |
| 56 |
| 51 |
| 35 |
| 60 |
| 55 |
| 50 |
| 36 |
| 59 |
| 54 |
| 49 |
| 37 |
| 58 |
| 53 |
| 48 |
| 38 |
| 57 |
| 52 |
| 47 |
| 39 |
| 56 |
| 51 |
| 46 |
| 40 or above |
| 55 |
| 50 |
| 45 |
INSTRUCTIONS FOR RESTING ARTERIAL BLOOD GAS STUDIES (Exam 023)
The following guidelines must be adhered to when conducting and reporting on the resting arterial blood gas study:
1. ABGS should be analyzed in a laboratory certified by a State or Federal agency, or the laboratory must submit evidence of participation in a national proficiency testing program, as well as acceptable quality control at the time of testing.
2. Provide the date of testing.
3. Provide the altitude and barometric pressure of the test site.
4. Test and provide the results of a PO2, PCO2 and pH determinations. This testing should be obtained while the claimant is breathing room air, awake and in a sitting or standing position.
5. Include in the report the resting arterial blood gas values obtained.
6. The physician or technician performing the test must sign report.
INSTRUCTIONS FOR STRESS (TREADMILL OR BICYCLE) TEST (EXAM 043)
The following guidelines must be adhered to when conducting and reporting on the stress (treadmill or bicycle) test:
1. Treadmill or bicycle exercise testing should not be performed for claimants who have the following: unstable progressive angina pectoris, acute myocardial infarction within the past 3 months, New York Heart Association (NYHA) class IV heart failure, cardiac drug toxicity, uncontrolled serious arrhythmia (including uncontrolled atrial fibrillation, Mobitz II, and third-degree block), Wolff-Parkinson-White syndrome, uncontrolled severe systemic arterial hypertension, marked pulmonary hypertension, unrepaired aortic dissection, left main stenosis of 50 percent or greater, marked aortic stenosis, chronic or dissecting aortic aneurysm, recent pulmonary embolism, hypertrophic cardiomyopathy, limiting neurological or musculoskeletal impairments, or an acute illness.
2. Do not perform the treadmill or bicycle exercise test if you determine that there are contraindications. The reason for canceling the test should be stated in the report.
3. The treadmill or bicycle testing is to be performed using a continuous progressive multi-stage regimen such as the Bruce Protocol and results documented as shown on the included form or on a comparable form.
Solicitation No. 60RRBH18R0015 Page 1 of 25 Exhibit 3
BRUCE PROTOCOL
| Claimant’s Name: | Sex: __________________________________________________ | |
| Date of Test: | Height: ________________________________________________ | |
| Age: | Weight: ________________________________________________ |
| STAGE |
| GRADE |
| SPEED |
MPH
TIME
(MIN.)
ELASPED
TEST TIME
BLOOD
SYSTOLIC
PRESSURE
DIASTOLIC
HEART
RATE
REST
| I |
| 10% |
| 1.7 |
| 0-1 |
1-2 2-3 1.
2.
3.
| II |
| 12% |
| 2.5 |
| 0-1 |
1-2 2-3 4.
5.
6.
| III |
| 14% |
| 3.4 |
| 0-1 |
1-2 2-3 7.
8.
9.
| IV |
| 16% |
| 4.2 |
| 0-1 |
1-2 2-3 10.
11.
12.
| V |
| 18% |
| 5 |
| 0-1 |
1-2 2-3 13.
14.
15.
| VI |
| 20% |
| 5.5 |
| 0-1 |
1-2 2-3 16.
17.
18.
| VII |
| 22% |
| 6 |
| 0-1 |
1-2 2-3 19.
20.
21.
RECOVERY
PERIOD
0-1 1-2 2-3 3-4 4-5 5-6 22.
23.
24.
25.
26.
27.
4. If a protocol other than the Bruce is used a description of the protocol that was followed must be provided and must meet the same requirements indicated below. Levels of exercise should be described in terms of workload and duration of each stage; e.g., treadmill speed and grade, or bicycle ergometer work rate in kpm/min watts.
5. EKGs/ECGs should include the original calibrated EKG/ECG tracings or a legible copy. All resting, exercise and recovery EKG/ECG strips must have a standardization inscribed in the tracings. The strips should be labeled to indicate the time recorded and the relationship to the stage of the exercise protocol. Record a 12-lead baseline EKG/ECG in the supine and in the upright position. If the EKG/ECG to document effects of hyperventilation is done, the exercise test should be deferred for at least 10 minutes. A 12-lead EKG/ECG should be recorded at the end of each minute of exercise. Post-exercise EKG/ECG should be recorded using a generally accepted protocol consistent with the prevailing state of medical knowledge and clinical practice.
6. Blood pressure levels during testing must be recorded.
7. Medication that claimant is taking with dosages and frequency should be reported as well as a detailed description of all EKG/ECG abnormalities and an interpretation of test findings.
8. If the test is curtailed prior to attaining 5 METs (End of Stage I in Bruce Protocol), you should report the reason for stopping the test, including limiting signs and symptoms.
9. A physician should supervise testing. The exercise test should be paced to the capabilities of the claimant. The exercise laboratory’s physical environment, staffing and equipment must meet the generally accepted standards for adult exercise test laboratories.
10. The physician administering the test must sign report.
INSTRUCTIONS FOR REPORTING ELECTROCARDIOGRAM (EKG/ECG) (Exam 045)
The following guidelines must be adhered to when conducting and reporting the resting EKG/ECG test:
1. Provide the date of the test.
2. EKG/ECG obtained at rest must be submitted in the original or a legible copy of a 12-lead tracing (namely, leads I, II, III, AVF, AVL, AVR, V1, V2, V3, V4, V5, and V6) appropriately labeled with the standardization inscribed on the tracing. Alteration in standardization of specific leads (such as to accommodate large QRS amplitudes) must be shown on those leads.
3. Report if the patient is taking medication or has an electrolyte imbalance, etc. It should be considered as a possible non-coronary cause of EKG/ECG abnormalities, especially those involving the ST segment.
4. Provide a detailed description of all EKG/ECG abnormalities.
5. Provide an interpretation of EKG/ECG tracings.
INSTRUCTIONS FOR A PERIPHERAL DOPPLER ULTRASOUND TEST
(Exam 046)
The following guidelines must be adhered to when conducting and reporting on the Peripheral Doppler Ultrasound Test:
Technique:
1. Arterial blood flow measurements are to be performed before and, if indicated, after exercise. With the claimant lying down, determine the two brachial systolic blood pressures, and the dorsalis pedis and posterior tibial systolic pressure in both legs, using the Doppler technique.
2. Ankle/brachial (A/B) ratios should be calculated by dividing the higher systolic blood pressure in the ankle by the higher of the two brachial systolic pressures. A/B values are expressed as a ratio of the two numbers.
Exercise:
1. Exercise is to be done on a treadmill for 5 minutes at a grade of 10 to 12 percent elevation at 2 miles per hour. Do not perform this test if medically contraindicated or if one of the following conditions applies.
a. Medically contraindicated; or
b. Exercise poses a significant risk; or
c. The highest A/B ratio (either dorsalis pedis or posterior tibial) is less than 0.5 in either extremity; or
d. The lowest A/B ratio (either dorsalis pedis or posterior tibial) is greater than 0.8 in both extremities.
2. The following specific information should be stated in reporting on the Doppler test:
a. Date of the test.
b. Report of information as shown on the sample format that follows as the end of this section.
3. The physician administering the test must sign report.
SAMPLE FORMAT
BASAL STATE DATA – PRE-EXERCISE
| RIGHT |
| LEFT |
Brachial
Dorsalis Pedis
Posterior Tibial
Dorsalis Pedis/Brachial Ratio
Posterior Tibial/Brachial Ratio
| Exercise Indicated |
| Yes |
| No |
POST EXERCISE DATA
Walking 2 MPH, 10-12% Slope Exercise Duration: 5 min. Other (Explain)
Flow Measured IMMEDIATELY Post Exercise
| RIGHT |
| LEFT |
Brachial
Dorsalis Pedis
Posterior Tibial
Dorsalis Pedis/Brachial Ratio
Posterior Tibial/Brachial Ratio
Flow Measured 10 Minutes Post Exercise
| RIGHT |
| LEFT |
Dorsalis Pedis
Posterior Tibial
Additional Comments:
COMPLETE BLOOD CELL COUNT (CBC) (Exam 030)
CBC includes hemoglobin, hematocrit, WBC count, WBC differential counts, estimate of platelet number, RBC count, description of the blood smear, including RBC morphology and estimate of platelet number.
LIVER FUNCTION STUDIES (Exam 038)
Liver Function Test (LFT) must included Serum Bilirubin (Direct and Indirect), Serum Albumin, and Total Protein LDH, alkaline phosphates, ALT (SGPT) and AST (SGOT).
THYROID EVALUATION (Exam 039)
The thyroid function test should consist of TSH and Free Thyroxine (FT4).
SMA-12 (Exam 036)
SMA-12 should include Glucose, BUN, Creatinine, Uric Acid, Total Protein, Albumin, Globulin, Calcium, Phosphate, Cholesterol, Alkaline Phosphates, SGOT, LDH, and Total Bilirubin.
CHEST X-RAY (Exam 055)
AP and lateral views.
OTHER X-RAYS, CT SCANS and MRIs
Refer to Attachment A or B for views required.
INSTRUCTIONS FOR A PSYCHOLOGICAL EVALUATION, WHICH INCLUDES A MINNESOTA MULTIPHASIC PERSONALITY INVENTORY (MMPI) (Exam 014)
This examination is generally ordered for a claimant who suffers from chronic pain. The examination is to be done by a psychologist. (A psychiatrist may be used if he or she is willing to perform the MMPI.)
The report must enable an independent reviewing psychologist to assess the nature and severity of the claimant’s mental impairment.
The consultative examination report should contain the following elements:
1. Provide a Minnesota Multiphasic Personality Inventory (MMPI). Include the results and an analysis of the test.
2. Provide a complete narrative which includes comments on the following points:
a. A detailed history of the present illness.
b. Pertinent personal, social, family and employment history.
c. General observations (personal appearance, presence of a companion, promptness for the appointment, etc.).
d. Daily activities and level of social functioning (normal routine, habits, pets, self-care, relationships with friends and relatives, independent behavior, etc.).
3. Based on your interview of the claimant and observations during the administration of the MMPI, give a detailed mental status examination which includes a description of the following:
a. Patient’s attitude and behavior.
b. Stream of conversation and psychomotor activity.
c. Mood, affective status, emotional reactions.
d. Sensorium, memory and intellectual resources.
4. Discuss the results of the test and assess their validity. Your opinions and conclusions must be supported by a description of the objective findings based upon which they are based.
5. Based on your findings and on other objective material that may have been furnished to you, provide a diagnosis and prognosis for the claimant’s condition.
A mental residual functional capacity (RFC) assessment, as shown in Exhibit 5, must be submitted along with the narrative report.
INSTRUCTIONS FOR FUNCTIONAL CAPACITY EVALUATIONS (EXAM 200)
The following guidelines must be adhered to when conducting and reporting on the standard Functional Capacity Evaluation’s (FCE’s):
1. The Railroad Retirement Board (RRB) will contact the contractor advising of the need for an FCE. The RRB will provide the claimant’s name, address, impairments and job requirements.
2. The contractor will locate a provider for the FCE as close as possible to the claimant’s home address.
3. The contractor will provide to the RRB the extent of or description for the examination, appointment information, the number of hours required for the FCE and the location of the exam. Depending on the provider selected and its requirements, as well as the claimant’s current health status, a medical release from the claimant’s treating physician may be requested prior to the examination. The contractor will notify the RRB of this requirement at this same time.
4. Upon the RRB’s acceptance of the contractor’s examination details, authorization for the FCE shall be issued.
5. Once the FCE authorization is received by the contractor, an appointment will be made and a notification letter will be mailed to the claimant along with any preparatory requirements of the claimant prior to the examination.
6. Once the claimant attends the examination and a report is generated by the provider the contractor should review the report for quality assurance. The report should then be sent to the RRB.
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