IN THE CASE OF:	  

		BOARD DATE:	  27 March 2012

		DOCKET NUMBER:  AR20110017927 


THE BOARD CONSIDERED THE FOLLOWING EVIDENCE:

1.  Application for correction of military records (with supporting documents provided, if any).

2.  Military Personnel Records and advisory opinions (if any).


THE APPLICANT'S REQUEST, STATEMENT, AND EVIDENCE:

1.  This case comes before the Army Board for Correction of Military Records (ABCMR) on a remand from the United States District Court for the Middle District of Pennsylvania.  The court stayed the applicant's complaint pending his application to, and final determination by, the ABCMR.

2.  The applicant requests removal of his name from the National Practitioner Data Bank (NPDB).  

3.  The applicant states his name was submitted to the NPDB as a provider culpable of malpractice for a case that occurred while he was on active duty.  He believes the decision was an unjust decision and one for which he had little opportunity to defend himself.  An amendment to chemotherapy orders was made by others without his assent.  By the established standing operating procedure (SOP) the chemotherapy should not have been prepared or infused without discussion with him and his assent to changes.  This did not occur because the pharmacist deviated from the SOP and did not discuss any issues with the orders with him.  He states he is not culpable of malpractice and there was a complete lack of due process in the proceedings that led to the submission of his name to the NPDB.

4.  The applicant provides:

* Three DA Forms 4256 (Clinical Record - Doctor's Orders); however, only one is completed, dated 4 March 2002
* his Curriculum Vitae, dated 5 August 2011
* complaint of the estate of Colonel (COL) T_____s against the United States of America
* his complaint against the U.S. Department of Health and Human Services (HHS), U.S. Army Medical Command (MEDCOM), COL L_______y, and The Surgeon General
* Memorandum of Law in Support of Defendants' Motion to Dismiss or in the Alternative for Summary Judgment
* an unsigned statement, dated 27 August 2011

CONSIDERATION OF EVIDENCE:

1.  On 24 August 1995, the applicant was commissioned a lieutenant colonel (LTC) in the Regular Army Medical Corps.  He had previously served 12 years,
2 months, and 10 days of active service in a commissioned status.

2.  In early 2002, COL T_____s (hereafter referred to as the patient), a retired Army dentist, was diagnosed with stage III colorectal cancer.  As the staff physician, the applicant was required to verify the patient's chemotherapy treatment regimen prior to its implementation.  Captain (Dr.) Da_____, a Hematology-Oncology fellow and the patient's treating physician, presented the applicant her proposed chemotherapy order for the patient.  The order called for the patient to receive two drugs: Leucovorin and 5 Fluorouracil, which is also referred to as 5 FU and is the actual chemotherapy drug.  It stops cell division. Leucovorin increases the potency of the 5 FU by allowing it to stay in the body longer and it also lessens the adverse side effects of chemotherapy.  The patient was to receive a five-day course of the drugs.

3.  The order the applicant signed contained "a multiplication error."  The patient’s body surface area (BSA) was 1.96 square meters.  In the case of Leucovorin, he was to receive 20 mg per square meter of BSA.  In the case of 
5 FU, the patient was to receive 425 mg per square meter of BSA.  The Leucovorin calculation rounded the patient’s BSA to 2 square meters leading to a dosage of 40 mg, i.e., 20 mg X 2 = 40 mg.  The 5 FU calculation left the patient’s BSA at 1.96 square meters and resulted in a dosage of 980 mg.  However, the correct dosage should have been 833 mg, i.e., 425 mg X 1.96 = 833 mg, not 980 mg.  The applicant signed the order as correct, despite the multiplication error that it contained.

4.  After Dr. Da_____ and the applicant signed the patient's chemotherapy order, LTC Do, the oncology pharmacist, reviewed the order and noticed the multiplication error.  She brought it to Dr. Da_____'s attention and based on their conversation and a review of the literature appended to the order increased the 
5 FU dosage factor from 425 mg per square meter of BSA to 500 mg per square meter of BSA.  The applicant did not sign the modified order.

5.  On 15 March 2002, the patient began his first cycle of chemotherapy, receiving a daily dose of 5 FU that was approximately 18% higher than intended over each day of the five-day cycle.  On 23 March 2002, the patient reported to Walter Reed Army Medical Center (WRAMC) displaying various symptoms consistent with "severe toxicity from adjunctive 5FU.”  Over the next several days the patient continued to deteriorate and failed to respond to supportive measures.  On 28 March 2002, the patient progressed to multi-organ failure and died.  His immediate cause of death was neutropenic enterocolitis.  

6.  On 9 December 2002, after a series of updates, the WRAMC Patient Care Assessment Committee (PCAC) found that the standard of conduct (SOC) was not met by the applicant, Dr. Da________, LTC Do_____, and a second pharmacist.  The PCAC attributed this deviation from the SOC to the institution because of "systems error."  The PCAC recommended changing WRAMC’s SOP to require the staff physician’s countersignature on any changes to chemotherapy orders.  As a result, WRAMC’s SOP was changed to require the attending physician’s countersignature before altering a patient’s medication dosage.  

7.  On 24 January 2004, the patient’s family filed an administrative claim for personal injury/wrongful death with the US Army Claims Service (USARCS).  The claim asserted that WRAMC’s failure to timely diagnose and treat the patient's colon cancer led to internal burns caused by chemotherapy which led to neutropenic enterocolitis.  

8.  On 30 June 2004, the applicant retired from the Regular Army.  He had completed 21 years and 17 days of active service.

9.  On 14 February 2005, the patient’s family filed a malpractice suit against WRAMC in the U.S. District Court for the District of Columbia.  The family alleged that the care the patient received at WRAMC was negligent and the proximate cause of his death. 

10.  On 29 April 2005, WRAMC’s Consultation Case Review Branch (CCRB) reviewed the family’s claim.  The CCRB found that the patient received an incorrect dosage of 5 FU due to a multiplication error which was confusing to the pharmacist.  The CCRB determined that the SOC was not met, but that, due to insufficient file data, it could not determine to whom to contribute the chemotherapy drug overdose. 
11.  In September 2007, the patient’s family and the United States settled the malpractice claim for one million dollars.  On 27 November 2007, the Army Litigation Division notified the U.S. Army Medical Command (USAMEDCOM) of the settlement and forwarded relevant documents from the case file.

12.  On 6 September 2008, the USAMEDCOM Chief of Quality Management Division (QMD) notified the applicant in writing that the Government had paid a one million dollar medical malpractice claim on behalf of the patient, and that he was identified as a significantly involved provider in the care of this patient.  USAMEDCOM QMD further informed him that a USAMEDCOM QMD Special Review Panel (SRP) would convene to evaluate the case in order to determine if the SOC was met in his management of the patient.  USAMEDCOM QMD explained that one potential outcome of the SRP could be a report to the NPDB.  

13.  USAMEDCOM QMD provided the applicant with all of the documents relevant to the case, including the entire case file, all of the patient's medical records and the lower level reviews.  USAMEDCOM QMD invited the applicant to provide, in writing, any additional clinical or other extenuating information on his behalf for consideration by the SRP.  He was given 2 weeks to review the documents and submit a response.  He was also advised that any information he provided may significantly impact the decisions rendered by the SRP.

14.  The notification memorandum is dated 28 June 2008; however, the applicant did not receive it until 6 September 2008.  It was originally sent to the wrong address, because he had relocated after retiring from the Army.

15.  On 8 September 2008, the applicant mailed his response to USAMEDCOM QMD for the SRP’s consideration.  Among other things, he asserted that he committed no error in the management of the patient and that while an error in chemotherapy did indeed occur it occurred because of modifications to the original order after he had already reviewed and signed it.  These modifications occurred without his knowledge, support, or co-signature.  

16.  On 10 December 2008, the SRP convened to review the case.  It had all relevant documents as well as the applicant's response letter.  In addition, the SRP reviewed the response letters of five other individuals identified as significantly-involved providers.  After considering the evidence before it, the SRP unanimously determined that the applicant did not meet the SOC with respect to the chemotherapy dosage the patient received.  Although additional errors occurred after the applicant signed the original order, the original order itself was in error and called for the administration of the higher dosage ultimately given.

17.  On 4 March 2009, an attorney in the MEDCOM Staff Judge Advocates General's (JAG) Office conducted a legal review of the SRP’s findings and of the case file.  Noting that the applicant "signed off on orders containing a multiplication error that he failed to notice," the JAG found the SRP’s determination to be legally sufficient to support a report to the NPDB.  

18.  On 26 March 2009, after reviewing all the evidence, The Surgeon General (TSG) approved the SRP’s findings and determined that a report to the NPDB was warranted.  On 2 April 2009, TSG notified the applicant of his decision, explaining that "after careful consideration of the entire record, to include those issues noted in your response letter received on 19 September 2008, I have determined that submission of your name to the National Practitioner Data Bank is warranted."

19.  On 28 April 2009, USAMEDCOM QMD notified the applicant in writing that his name had been submitted to the NPDB.  He was advised the Health Care Quality Improvement Act (HCQIA) of 1986 requires the report of monetary payment for a provider in a case where it is determined that the standard of care was not met and the payment was made by the Government on behalf of a provider.  

20.  USAMEDCOM QMD explained that in the applicant's case the medical treatment facility Risk Management Committee at WRAMC determined the standard of care was not met.  In addition, a professional review by the USAMEDCOM QMD SRP and TSG found the standard of care was not met. USAMEDCOM QMD enclosed a copy of the medical malpractice payment report, which stated “Specific Allegation:  Wrong dosage ordered of correct medication and Description: on or about 15 March 2002, at WRAMC [the applicant] breached the standard of care by negligently failing to ensure that a chemotherapy drug dosage was correctly calculated, resulting in the death of a patient."

21.  On 15 July 2009, the applicant filed a dispute with the NPDB concerning the information contained in his report and added a subject statement to his report. He requested that HHS conduct a review of his NPDB report. 

22.  On 23 June 2010, HHS notified the applicant that his request to have the NPDB report voided had been denied.  HHS explained to the applicant that the Army’s reporting requirements to the NPDB are governed by a Memorandum of Understanding (MOU) between the Department of Defense (DOD) and HHS, and that HHS did not have the authority to overturn the DOD decision, void the report, or remove his name.

23.  In the processing of this case an advisory opinion was received from an attorney advisor, Office of the Staff Judge Advocate, HQ, USAMEDCOM based on the applicant's request for relief because he asserts he was not culpable of malpractice and because he was not provided due process in the proceedings.  The attorney advisor recommends denial of his request.

	a.  After a thorough review of the process and decision to report the applicant to the NPDB for his role in the paid medical malpractice claim, the attorney determined the action taken complies with DOD Directive 6025.13-R, the MOU Between the HHS and DOD, and Army Regulation 40-68 (Clinical Quality Management).

	b.  The applicant's role in the case was thoroughly reviewed and he was notified of the pending review and allowed to provide input as required in the administrative review of the paid medical malpractice claim.

	c.  The final decision to report the applicant to the NPDB was made by TSG.

	d.  When notified of the applicant's filing suit in the U.S. District Court for the Middle District of Pennsylvania, the case was again reviewed by TSG who confirmed his original decision to report the applicant to the NPDB.

	e.  The reviewing health care providers applied the administrative procedure in good faith and in substantial compliance with the directive to provide TSG with facts and recommendations to allow him to make the decision to report the applicant to the NPDB.

24.  The applicant's counsel submitted a 5-page rebuttal to the advisory opinion.

	a.  The report of the applicant to the NPDB was improper because:

		(1)  His care was not at issue and it was never at issue to the underlying malpractice action settled by the United States without any consultation or involvement with him; and

		(2)  If the patient's care was at issue, with resolution of the case affecting his right and ability to practice medicine, he should have been afforded the opportunity of notice of the pending lawsuit and the right to be heard in his own defense before the Army settled the case.

	b.  The United States never sought his input or opinion regarding the defensibility of the lawsuit and never consulted with him before paying one million dollars that was later determined to be necessary in part because of his purportedly negligent conduct.

	c.  The Army committed one of two possible constitutional violations:

		(1)  Failure to provide him with any notice and opportunity to be heard prior to settlement of the patient’s family’s litigation if his conduct truly was at issue; or

		(2)  If his conduct was not at issue in the family’s litigation, the Army acted contrary to law in reporting him to the NPDB when his conduct was never criticized, at issue, or could be found by a jury to be substandard.

	d.  The Federal Tort Claims Act, together with the United States Constitution, assures the applicant of the right of notice and opportunity to participate in the defense of an action criticizing his care.

	e.  The plaintiff did not name the applicant as a defendant, did not criticize his care, or identify him anywhere within the complaint.  Nonetheless, the Army reported him to the NPDB after settling the action.

	f.  In the absence of any written claim or demand based on the applicant's act, or failure to act, reporting him to the NPDB was improper.  Although the Army relies on the MOU between HHS and DOD as the basis for the report, the MOU improperly applies the standards established by Congress for the reporting of professionals to the NPDB.  

	g.  The HCQIA does not provide HHS, DOD, the United States Army, or any other health care provider with the authority to independently examine all of the patient's health care providers to reach an independent determination of who should be reported to the NPDB.

25.  References:

   a.  The NPDB was established by the HCQIA of 1986, Pub. L. No. 99-660, 100 Stat. 3784 (codified as amended at 42 U.S.C. § 11101-11152 (2007)).  
The NPDB functions as a repository for information relating to the professional competence and conduct of physicians, dentists, and other health care practitioners.  This statute is implemented within the DOD by DOD Directive 6025.13-R and within the Army by Army Regulation 40-68.  TSG is required to report adverse privileging actions against a provider to the NPDB. 


	b.  Desiring DOD’s participation in national reporting of medical malpractice incidents, Congress included language in the HCQIA encouraging the Secretary of HHS to enter into an MOU with the Secretary of Defense to address how DOD would implement provisions of the HCQIA.  Congress could have required DOD to strictly comply with all of the terms of HCQIA; instead, Congress created a mechanism through which DOD’s participation in the NPDB is defined by an MOU with the Secretary of HHS and DOD guidance and regulations. 

	c.  On 21 September 1987, DOD and HHS signed an MOU outlining DOD participation in the national reporting system.  That MOU provided that within DOD and per DOD policy, all malpractice claims would be analyzed through peer review, assigned a category of responsibility, and reported as follows: "Met standard medical care, "Minor deviation from standards care," or "Major deviation from standards of care."  The MOU further stated that where the peer review found minor or major deviation from the standards of care, a separate report shall be submitted to the NPDB for each practitioner found to have provided substandard care.  Moreover, the MOU provided that each report must include the diagnosis for which the patient received care and the nature of the alleged negligence leading to the malpractice claim and settlement.

	d.  The current rules governing DOD’s policies for NPDB reporting are found in DOD Directive 6025.13 and DOD Instruction 6025.13-R.  Army Regulation 
40-68 implements DOD’s directives and details NPDB reporting procedures within the Army.

	e.  Army Regulation 40-68, paragraph 14-3 states TSG is the sole reporting authority to the NPDB, State regulatory authorities, the Federation of State Medical Boards, and/or other appropriate central clearinghouses.  TSG is responsible for reporting malpractice history information and adverse privileging actions and unprofessional conduct or behavior.

		(1)  PL 99–660 (The Healthcare Quality Improvement Act of 1986) provides for reporting to the NPDB malpractice claims resulting in monetary settlements and certain professional review actions.  Healthcare providers/professionals will be reported whether licensed or pending licensure. 

		(2)  In a malpractice case, the following criteria will be used by the USAMEDCOM QMD SRP to support a recommendation to TSG to report the provider in question to the NPDB for events involving personal injury or death of a military member as a result of medical care.

			(a)  The provider/professional or trainee deviated from the standard of care in the act of commission or omission.
			(b)   Monetary payment was made and the provider/professional or trainee was responsible for an act of commission or omission that was the cause of a harm that gave rise to payment.

			(c)  In instances involving a healthcare trainee, his/her act(s) of omission or commission were not reasonably foreseeable by the supervisor, or the trainee acted outside his/her established scope of practice.

			(d)  In instances involving a healthcare trainee, the supervising provider failed to meet reasonable standards of supervision.

		(3)  The SRP recommendation to TSG, based on a majority vote, and any supporting comments, including the recommendations of the clinical expert participants, will be prepared by the USAMEDCOM QMD.  The USAMEDCOM Staff Judge Advocate (SJA) will be consulted for legal sufficiency before NPDB or Defense Practitioner Data Bank (DPDB) reporting.  The DPDB is composed of the various data/reports released to DOD via the Centralized Credentials Quality Assurance System (CCQAS).

		(4)  The individual will be provided written notification that a report was, or was not, submitted to the NPDB or DPDB.

		(5)  The reporting of healthcare personnel (privileged or non-privileged) is an administrative process; therefore, full due process procedures are not applicable.

	f.  DOD Directive 6025.13-R (Military Health System (MHS) Clinical Quality Assurance Program Regulation) implements the policy guidance concerning quality assurance in the MHS.  

		(1)  C10.2.1. A quality of care review shall occur in every case involving a potential instance of medical malpractice. This includes every claim of alleged malpractice filed under the Federal Tort Claims Act (reference (c)), the Military Claims Act or the Foreign Claims Act (10 U.S.C. Chapter 163) (reference (d)) relating to healthcare provided by a DOD facility or provider.  It also includes every report from a Medical Evaluation Board operating under DOD Instruction 1332.38 of a case in which disability of a military member appears to have resulted from medical or dental care.

		(2)  C10.2.2. Except in cases clearly lacking a substantive basis for evaluation, the quality of care review shall include a professional review of the care and an opinion as to whether the SOC was met or not met, an evaluation of any other processes and factors relating to the case, and a reasonable opportunity for the practitioners significantly involved to provide written comments.  The opportunity for a significantly involved practitioner to provide written comments is not part of any formal proceeding or adverse action process and no due process procedures apply to this opportunity to comment.

DISCUSSION AND CONCLUSIONS:

1.  The ABCMR’s jurisdiction extends to any military record of the Army and does not extend to records maintained by other agencies.  However, under NPDB rules, although HHS maintains NPDB reports, the reporting entity alone may direct HHS to modify or revoke the report.  Thus only the reporting entity, in this case the Army acting through the ABCMR, has jurisdiction to grant the appropriate relief.  

2.  The applicant asserts that the Army's decision was factually erroneous, in that the Army improperly concluded that he committed an act that was required to be reported to the NPDB.  He further suggests that the Army’s reporting was procedurally erroneous, claiming that the Army reported him in a manner that was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.

3.  TSG’s decision that he failed to meet the SOC and thus required NPDB reporting was amply supported by the evidence.  Moreover, the Army’s reporting of the applicant to the NPDB was procedurally correct and in accordance with applicable regulation. Therefore, the report of the applicant to the NPDB was rational, lawful, and supported by substantial evidence. 

4.  The applicant asserts that the decision by HHS to maintain his NPDB report was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.  He argues that HHS should have voided his report on the basis that it was not accurate and that it was not submitted in accordance with NPDB reporting requirements.  However, an HHS review of an NPDB report is limited, especially in situations where reports are made by DOD through an MOU with HHS.  HHS reviewed his claims in accordance with its limited review authority and properly concluded that the report could not be voided.

5.  The applicant contends he provided a written statement demonstrating his absolute lack of substandard conduct.  He asserts the patient’s family’s complaint indicated that Dr. Da_____, not himself, failed to follow the proper chemotherapy protocol.  He contends he reviewed the order and agreed with it, and signed off on it.  However, the evidence shows this order contained a multiplication error.   Subsequently, and perhaps unbeknownst to him, the order was changed to increase the 5 FU factor to match the incorrect dosage product.  The CCRB explicitly determined not only that the patient had received an incorrect dosage of 5 FU, but that he had received it due to a multiplication mistake.

6.  The applicant has continually failed to address the underlying cause of the dosage error - the multiplication error that rendered facially inconsistent the chemotherapy order that he signed as correct.  This error on the original chemotherapy orders contributed to the patient receiving an incorrect dosage and arguably resulted in his death.  Had Dr. Da_____done nothing other than take the order to LTC Do ____ and had LTC Do______ done nothing other than fill the dosage as originally ordered, the result would have been the same.  The patient would have received too much 5 FU.  Dr. Da______’s and LTC Do_____’s actions, although failing to meet the SOC, did nothing to exacerbate the original error in which the applicant participated, they simply validated the error. 

7.  The SRP reasonably found that the applicant failed to meet the SOC.  He signed an order that had a math error and he did not notice the math error.  The SRP, noting the facially incorrect mathematical calculation on the order he signed, reasonably concluded that he shared responsibility for the patient receiving the wrong dosage.

8.  The TSG reviewed the entire record and carefully considered the issues the applicant raised in his response memorandum.  The TSG concluded he failed to meet the SOC, thus warranting report to the NPDB.  TSG's decision was both reasonable and supported by substantial evidence.

9.  The applicant and his counsel contend he was not named in the malpractice lawsuit, not criticized within the complaint, and had no notice of or participation in the defense of the malpractice claim.  The Federal Tort Claims Act provides that military practitioners are not individually liable for conduct occurring in the scope of their duties.  Malpractice claims are tort actions against the United States, and the United States is the only proper defendant.  Whether the patient’s family was aware of applicant’s role in the patient’s death or not is irrelevant.  He did play a role and that role was readily apparent.  Had the applicant been named the United States would have substituted itself in his stead as it did for all of its employees and agents in the case.  Further, the facts surrounding the dosing error were apparent from very early on.  A determination was made that he had received more than the intended amount of 5 FU.  The Government had ample medical expertise at its disposal in assessing the case and the merits of settling versus going to trial in the face of a clear breach of the SOC.  The applicant had no right to control or direct the course of the Government’s case.  

10.  He asserts the manner in which he was reported to the NPDB was unlawful. However, when reporting military providers to the NPDB, it is irrelevant that they are not named in the malpractice suit.  Moreover, it is irrelevant that the applicant's name did not appear within the malpractice complaint.  Military reporting guidelines require an independent review of all settled cases of malpractice and an independent determination as to which providers breached the SOC.  Whether the patient’s family recognized the applicant's failure to notice the chemotherapy orders' facial error is irrelevant.  The reporting of healthcare personnel (privileged or non-privileged) is an administrative process; therefore, full due process procedures are not applicable.

11.  In response to the claims filed by the patient’s family the CCRB independently reviewed the details surrounding the patient's treatment.  The CCRB forwarded its assessment to USAMEDCOM QMD and USARCS.   After settling the family’s claim, the Army convened a peer review (under the auspices of the SRP) to render both an SOC and an attribution determination.  Because the CCRB’s assessment had identified the applicant as one of several significantly involved providers, USAMEDCOM QMD properly notified the applicant of the upcoming SRP.  USAMEDCOM QMD provided him a copy of the case file, affording him two weeks to review that file and to submit a response.  Contrary to the applicant's assertions, therefore, he was provided both adequate notice (in documents specifically referencing the multiplication error) and an adequate opportunity to respond (2 weeks, though he required only 2 days). 

12.  After receiving the applicant’s response, the SRP convened.  It carefully evaluated that response prior to rendering a final SOC determination.  The SRP documented its SOC determination and recommendation and forwarded the report to TSG for final review and approval.  As the regulation requires, the USAMEDCOM QMD SJA Office examined the case and found the SRP’s recommendations to be legally sufficient.  TSG then properly reviewed the entire case file, to include the applicant's written response to USAMEDCOM QMD's notification.  Agreeing with the SRP, TSG found that report to the NPDB was warranted.  He properly notified the applicant that the report had been submitted to the NPDB.  Throughout this process the Army abided by procedure and regulation and fully extended the applicant the process due.  

13.  In view of the above, there is an insufficient basis to grant relief in this case.


BOARD VOTE:

________  ________  ________  GRANT FULL RELIEF 

________  ________  ________  GRANT PARTIAL RELIEF 

________  ________  ________  GRANT FORMAL HEARING

____X____  ____X____  ___X_____  DENY APPLICATION

BOARD DETERMINATION/RECOMMENDATION:

The evidence presented does not demonstrate the existence of a probable error or injustice.  Therefore, the Board determined that the overall merits of this case are insufficient as a basis for correction of the records of the individual concerned.



      _______ _   XXX_______   ___
               CHAIRPERSON
      
I certify that herein is recorded the true and complete record of the proceedings of the Army Board for Correction of Military Records in this case.

ABCMR Record of Proceedings (cont)                                         AR20110017927



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ABCMR Record of Proceedings (cont)                                         AR20110017927



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