Memorandum of Understanding between the Department of Labor 

Office of Workers' Compensation Programs (OWCP) and the 

Department of Health and Human Services, Centers for Disease Control 

and Prevention, National Institute for Occupational Safety and Health 

(NIOSH) establishing a B reader quality assurance program 

Under the Black Lung Benefits Act (BLBA) and implementing regulations, 30 

U.S.C. §§ 901- 944; 20 C.F.R. Parts 718, 725, the existence of pneumoconiosis 

may be established based on the appearance of specific pulmonary abnormalities 

evident on a chest radiograph. The black lung regulations provide that when two 

or more chest radiograph reports from different physicians conflict, consideration 

must be given to the readers' respective radiological qualifications. Although a 

range of professional qualifications may be considered, a particularly important 

one is B reader certification, which NIOSH grants to physicians who pass a 

specially-designed examination that tests the reader's proficiency to classify chest 

radiographs for the presence and severity of radiographic changes using the 

standardized classification system for pneumoconiosis developed by the 

International Labour Organization (ILO). This qualification is especially 

important, because the ILO classification system is used for the reporting of 

pulmonary abnormalities considered in black lung benefits proceedings. 

Recognizing the important medical, legal, and societal impacts that B readers may 

have, NIOSH has had a longstanding commitment to a B reader code of ethics, 

which encourages B readers to adhere to standards of professionalism, honesty, 

and objectivity in all professional interactions and to report to appropriate 

authorities any individuals deficient in character or competence, or any B Readers 

who are engaging in fraud or deception. As of 2014, prospective B Readers were 

required to sign statements on their applications to take the B Reader certification 

or recertification examinations promising to adhere to the B Reader Code of 

Ethics. 

It is expected that B readers' classifications in a case may differ, despite the B 

Readers' demonstrated proficiency, because the classification of chest radiographs 

is an inherently subjective process. However, a B reader's classifications should 

not markedly deviate from mainstream classifications indicating the presence or 

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severity of abnormalities associated with pneumoconiosis. Such misclassification 

could undermine a fair evaluation of a miner's entitlement to black lung benefits, 

particularly when the classifications relate to the presence or absence of "large 

opacities", which are indicative of severe disease and total disability under the 

BLBA. 

In order to identify B readers who frequently misclassify large opacities associated 

with pneumoconiosis and to minimize, if not eliminate, their impact on the 

evaluation ofblack lung claims, it is the intent ofOWCP, as administrator ofthe 

BLBA, and NIOSH, as the B reader certifying authority, to enter into this 

Memorandum of Understanding (MOU) establishing a B reader quality assurance 

program. 

The B reader quality assurance (QA) program will operate as follows: 

• OWCP will establish and maintain a QA disputed radiograph repository: a 

repository of disputed chest radiographs regarding the presence of large 

opacities consistent with pneumoconiosis submitted in black lung claims. A 

chest radiograph will be considered disputed when one or more B readers 

classify a radiograph as depicting large opacities consistent with 

pneumoconiosis and one or more B readers classify it as not depicting such 

opacities. OWCP will also establish and maintain a QA disputed readings 

repository: an electronic repository of scanned images of all B readings 

(generally submitted on form CM-933, Radiologic Interpretation) dated and 

signed by each B reader of a disputed radiograph. In addition, OWCP will 

establish and maintain a QA database: a database containing the names and 

readings of the B readers interpreting the disputed chest radiographs. 

• OWCP will establish and maintain the QA disputed radiograph repository, 

the QA disputed readings repository and the QA database in accordance with 

designs, procedures and protocols to be established subsequent to this 

MOU' s effective date. The repositories and associated database will contain 

no personally identifiable information (PII) concerning black lung claimants, 

although OWCP will establish procedures to ensure that each Breading can 

be linked to its respective chest radiograph in the absence of the black lung 

claimants' PII. 

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• OWCP will request in writing that NIOSH conduct a quality assurance 

review of each B reader who falls within the terms of the attached protocol, 

developed jointly by NIOSH and OWCP, which sets forth objective criteria 

for referring B readers to the quality assurance program. The quality 

assurance review request will identify the B reader, and include the disputed 

chest radiographs, the B reader's classifications of the disputed chest 

radiographs, the classifications of the disputed chest radiographs by other B 

readers, and other relevant information. 

• After receiving OWCP's request, NIOSH will first determine if the request 

complies with the protocol for initiating a B reader quality assurance review. 

If so, NIOSH will then perform a quality assurance investigation. 

• NIOSH will conduct the investigation in accordance with procedures to be 

established by NIOSH subject to OWCP's agreement. These procedures 

will be developed subsequent to this MOD's effective date. The NIOSH 

policy will include provisions for (1) informing B readers that a quality 

assurance investigation has been initiated; (2) developing and evaluating 

evidence relevant to OWCP's submission; (3) identifying possible actions 

NIOSH may take at the conclusion of an investigation; ( 4) allowing B 

readers an opportunity to challenge the initial investigation findings and 

notifying them of the final results of the investigation; and ( 5) informing 

OWCP whether the investigated B reader's certification remains effective or 

is suspended or revoked. 

OWCP and NIOSH have a long history of working together to administer the 

BLBA. NIOSH, as OWCP' s statutory scientific advisor, continues to provide 

highly relevant advice that assists OWCP in fulfilling the congressional mandate of 

awarding benefits to miners who are totally disabled by pneumoconiosis arising 

out of coal mine employment. The creation of a B reader quality assurance 

program represents an important effort to meet this mandate. NIOSH and OWCP 

anticipate that formal publication of these inter-agency activities, MOU, and 

protocol will help to ensure public trust in the adjudication of black lung claims. 

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Any modification of this MOU will be valid or binding on the parties only if 

agreed to by both parties and made in writing and signed by each of the parties. 

Either party shall provide 30 days written notice to the other party regarding any 

modification of a provision of this MOU. 

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Office of Workers' Compensation Programs 

po September 22, 2015 

Michael A. Chance Date 

Director, Coal Mine Workers' Compensation 

National Institute for Occupational Safety and Health 

September 24, 2015 

David N. Weissman, MD Date 

Director, Division of Respiratory Disease Studies 

Attachment: 

Protocol 

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Protocol for OWCP Referral of B Reader Classifications to NIOSH for 

Evaluation 

ClassifYing the presence of "large opacities" in chest images has a very important 

impact on Black Lung Benefits proceedings, administered by the Office of 

Workers' Compensation Programs (OWCP), because coal miners with large 

opacities are irrebuttably presumed to be totally disabled due to pneumoconiosis as 

provided by 20 C.P.R.§ 718.304(a); 30 U.S.C. § 921(c)(3). Classifications are 

performed by physicians who are National Institute for Occupational Safety and 

Health (NIOSH)-certified B Readers. This quality assurance program, to be 

implemented by OWCP, focuses on OWCP reviewing and reporting classifications 

to NIOSH by NIOSH-certified B Readers whose findings are frequently 

inconsistent with other NIOSH-certified B Readers' classifications of the same 

chest images for the presence or absence of large opacities. 

The quality assurance program involves the following: 

If at least one B Reader classifies a large opacity as present on the chest 

radiograph, OWCP personnel will examine such classification. If the OWCP 

examiners identity NIOSH-certified B Readers- employed by either the claimants 

or defendants in such cases - who provide classifications in 5 or more different 

cases over a 2-year period in which their classifications regarding the presence (or 

absence) of large opacities differ from all other NIOSH-certified B readers 

employed by the opposing side, then the OWCP examiners will refer such cases to 

NIOSH for evaluation. 

The rationale for referring cases to NIOSH where there are significant variations 

among classifications provided by the B Readers involved in a case, is to ensure 

that the B Readers are performing classifications accurately, without bias, and 

based solely on radiographic findings. We recognize that there may be some 

subjectivity in the classification of chest radiographs and B Readers may disagree 

about classification of large opacities - particularly in borderline cases. Thus, this 

program will not focus on cases where at least one B reader on one side of the case 

agrees with the B reader of concern on the opposing side. Instead, this program 

focuses on B readers who frequently disagree with all B Readers on the opposing 

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side of a proceeding. To provide accurate classification of large opacities in chest 

radiographs, NIOSH recommends that OWCP refer B Readers to NIOSH for 

evaluation if the B Reader disagrees with all B Readers employed by the other side 

of the case about the presence (or absence) of large opacities as described by the 

ILO classification system in five or more cases within a 2-year timeframe. 

Materials provided to NIOSH by OWCP for conducting the evaluation will include 

the name of the B Reader; the 5 chest radiographic images in question; and all 

classification reports submitted for each of the 5 images within the 2-year time 

period. 

Example: 1 -The case of B Reader Z 

a. Case 1 

1. Defendant: B Reader Z, reading for the coal mine operator, 

finds no evidence of a large opacity. 

11. Claimant: B Readers S and T, reading for the miner, find 

evidence of a large opacity. 

111. Case assessment: This would count as one of the 5 cases of 

disagreement forB Readers Z, S, and T. 

b. Case 2 

1. Defendant: B Reader Z, reading for the coal mine operator, 

finds no evidence of a large opacity. 

11. Claimant: B Readers U and V, reading for the miner, find 

evidence of a large opacity. 

111. Case assessment: This would count as one of the 5 cases of 

disagreement for B Readers Z, U, and V. 

c. Case 3 

1. Defendant: B Reader Z, reading for the coal mine operator, 

finds a confluence of small opacities but no large opacity. 

11. Claimant: B Readers Wand X, reading for the miner, find 

evidence of a large opacity. 

111. Case assessment: This would count as one of the 5 cases of 

disagreement forB Readers Z, W, and X. 

d. Case 4 

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1. Defendant: B Reader Z, reading for the coal mine operator, 

finds no evidence of a large opacity. 

II. Defendant: B ReaderS, reading for coal mine operator, finds 

evidence of a large opacity. 

111. Claimant: B Readers C, D and G, reading for the miner, find 

evidence of a large opacity. 

IV. Case assessment: This would count as one of the 5 cases of 

disagreement forB Reader Z, but not forB Readers S, C, D, 

and G. 

e. Case 5 

1. Defendant: B Reader Z, reading for the coal mine operator, 

finds no evidence of a large opacity. 

11. Defendant: B Reader T, reading for the coal mine operator, 

finds evidence of a large opacity. 

111. Claimant: B Readers C, D and F, reading for the miner, find 

evidence of a large opacity. 

IV. Case assessment: This would count as one of the 5 cases of 

disagreement forB Reader Z, but not forB Readers T, C, D, 

and F. 

If these 5 cases occurred within a 2-year period, OWCP would refer B 

Reader Z to NIOSH for evaluation, because B Reader Z did not find 

evidence of large opacities in each case and his conclusions were 

inconsistent with all the B Readers' findings who read the same x-rays for 

claimants. 

Example: 2- The case ofB Reader A 

f. Case 1 

1. Claimant: B Reader A, reading for the miner, finds evidence of 

a large opacity. 

11. Defendant: B Readers Band C, reading for the coal mine 

operator, find no evidence of a large opacity. 

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iii. Case assessment: This would count as one of the 5 cases of 

disagreement forB Readers A, B, and C. 

g. Case 2 

1. Claimant: B Reader A, reading for the miner, finds evidence of 

a large opacity. 

11. Defendant: B Readers D and E, reading for the coal mine 

operator, find no evidence of a large opacity. 

111. Case assessment: This would count as one of the 5 cases of 

disagreement for B Readers A, D, and E. 

h. Case 3 

1. Claimant: B Reader A, reading for the miner, finds evidence of 

a large opacity in the upper zone. 

11. Defendant: B Readers F and B, reading for the coal mine 

operator, find the presence of small opacities with a confluence 

of opacities in the upper zone. 

111. Case assessment: This would count as one of the 5 cases of 

disagreement forB Readers A, F, and B. 

1. Case 4 

1. Claimant: B Reader A, reading for the miner, finds evidence of 

a large opacity. 

u. Claimant: B Reader H, reading for the miner, finds a confluence 

of small opacities but no large opacity (in this example, the 

miner employs 2 B Readers). 

111. Defendant: B Readers C, D and G, reading for the coal mine 

operator, find no evidence of a large opacity. 

IV. Case assessment: This would count as one of the 5 cases of 

disagreement forB Reader A, but not forB Readers H, C, D, 

and G. 

J. Case 5 

1. Claimant: B Reader A, reading for the miner, finds evidence of 

a large opacity. 

11. Claimant: B Reader I, reading for the miner, finds no evidence 

of a large opacity (in this example, the miner employs 2 B 

Readers). 

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111. Defendant: B Readers C, D and F, reading for the coal mine 

operator, find no evidence of a large opacity. 

IV. Case assessment: This would count as one of the 5 cases of 

disagreement forB Reader A, but not forB Readers I, C, D, 

and F. 

If these 5 cases occurred within a 2-year period, OWCP would refer B 

Reader A to NIOSH for evaluation, because B Reader A discovered 

evidence of large opacities in each case and his conclusions were 

inconsistent with all the B Readers' findings who read the same x-rays for 

coal mine operators. 

Example: 3 - The case of B Reader K 

k. Case 1 

1. Defendant: B Reader K, reading for the coal mine operator, 

finds no evidence of a large opacity. 

11. Claimant: B Reader AA, reading for the miner, finds evidence 

of a large opacity 

111. Claimant: B Reader BB, reading for the miner, finds no 

evidence of a large opacity. 

IV. Case assessment: This would not count as one of the 5 cases of 

disagreement forB Readers K or BB, but would count as a case 

for B Reader AA. 

1. Case 2 

1. Defendant: B Reader K, reading for the coal mine operator, 

finds no evidence of a large opacity. 

11. Claimant: B Readers CC and DD, reading for the miner, find 

evidence of a large opacity. 

111. Case assessment: This would count as one of the 5 cases of 

disagreement forB Readers K, CC, and DD. 

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m. Case 3 

1. Defendant: B Reader K, reading for the coal mine operator, 

finds a confluence of small opacities but no large opacity. 

11. Claimant: B Reader EE, reading for the miner, finds evidence 

of a large opacity 

111. Claimant: B Reader FF, reading for the miner, finds no 

evidence of a large opacity. 

IV. Case assessment: This not would count as one of the 5 cases of 

disagreement for B Readers K or FF, but would for B Reader 

EE. 

n. Case 4 

1. Defendant: B Reader K, reading for the coal mine operator, 

finds no evidence of a large opacity. 

11. Defendant: B Reader GG, reading for coal mine operator, finds 

evidence of a large opacity. 

111. Claimant: B Readers FF, HH and II, reading for the miner, find 

evidence of a large opacity. 

IV. Case assessment: This would count as one of the 5 cases of 

disagreement for B Reader K, but not for B Readers GG, FF, 

HH, and II. 

o. Case 5 

1. Defendant: B Reader K, reading for the coal mine operator, 

finds evidence of a large opacity. 

n. Defendant: B Reader JJ, reading for the coal mine operator, 

finds no evidence of a large opacity. 

111. Claimant: B Readers LL, MM and NN, reading for the miner, 

find evidence of a large opacity. 

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IV. Case assessment: This would not count as one of the 5 cases of 

disagreement forB Reader K, LL, MM, and NN, but would for 

B Reader JJ. 

OWCP would not refer B Reader K to NIOSH for evaluation based on these 5 

cases within a 2-year period because only 2 "cases of disagreement" occur within 

the five cases. If OWCP identified 3 additional cases of disagreement within the 

same 2-year period where B Reader K provided classifications of large opacities 

that were in disagreement with all B Readers employed by the opposing side, then 

B Reader K would be referred to NIOSH for evaluation. 

The quality assurance program also involves the following: 

If the OWCP examiners identify NIOSH-certified B Readers - employed by 

OWCP- who provide classifications in 5 or more different cases over a 2-year 

period in which their classifications regarding the presence (or absence) of large 

opacities differ from all other NISOH-certified B readers employed by the 

claimant or differ from all other NIOSH-certified B readers employed by the 

employer, then the OWCP examiners will refer such readings by the OWCPemployed B Reader to NIOSH for evaluation. 

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