IR 07100117/2012011
| ML20217N148 | |
| Person / Time | |
|---|---|
| Site: | 03019679, 07100117 |
| Issue date: | 04/28/1998 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| Shared Package | |
| ML20217N121 | List: |
| References | |
| 30-19679-97-01, 30-19679-97-1, EA-97-626, NUDOCS 9805050239 | |
| Download: ML20217N148 (5) | |
Text
{{#Wiki_filter:- . - . NOTICE OF VIOLATION i l-Ryder Memorial Hospital Docket No. 030-19679
Humacao. Puerto Rico License No. 52-21026-01 EA 97-626
During an NRC inspection conducted on November 17 and December 11. 1997 a violation of NRC requirements was identified.
In accordance with the " General
Statement of Policy and Procedures for NRC Enforcement Actions." NUREG-1600, the violation is listed below: 10 CFR 35.22(a)(1) requires, in part, that the membership of the licensee's Radiation Safety Committee include an authorized user of each type of use permitted by the. license.
Contrary to the above, since January 1. 1987, the membership of the licensee's Radiation Safety Committee did not include an authorized user of strontium-90: such use was permitted by the license.
This is a Severity Level IV Violation (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201 Ryder Memorial Hospital is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission. ATTN: Document Control Desk. Washington. D.C. 20555.
with a co)y to the Regional Administrator. Region II. within 30 days of the date of tie letter transmitting this Notice of Violation (Notice). This reply.
should be clearly marked as a " Reply to a Notice of Violation" and should , include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level. (2) the corrective steps that have been taken and the results achieved. (3) the ! corrective steps that will be taken to avoid further violations. and (4) the date when full-compliance will be achieved.
Your response may reference or include previously docketed correspondence. if the correspondence adecuately
addresses the required response.
If an adequate reply is not receivec within the time specified in this Notice, an order or a Demand for Information may be issued as to why the license should not be modified, suspended, or revoked, or
why such other action as may be proper should not be taken.
Where good cause is shown, consideration will be given to extending the response time.
If you contest this enforcement action, you should also provide a copy of your response to the Director. Office of Enforcement. United States Nuclear Regulatory Commission. Washington, DC 20555-0001.
Because your res>onse will be placed in the NRC Public Document Room (PDR). to the extent possi)le, it should not include any personal privacy. 3roprietary.
or safeguards information so that it can be placed in the PDR wit 1out redaction.
If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information.
If you request i Enclosure 1
PDR ADOCK 03019679 C PDR
r . . . Notice of Violation
withholding of such material, you must s)ecifically identify the portions of your response that you seek to have withleid and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding l confidential commercial or financial information).
If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.
Dated at Atlanta, Georgia this 28th day of April 1998
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HOSPITAL RYDER MEMORIALc INC.
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HUMACAo. PUERTO RICO
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Les/tsd a Dioi/Se'rvicio a la Humanidad h 9 pr 00792
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TELEFoNo 852 0768 Ayer, Hoy y Siempre j
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February 27, 1998
.
United States Nuclear Regulatory Commission, hereinafter "NRC" Region II Atlanta Federal Center 61 Forsyth Street, SW. Suite 23T85 Atlanta, GA 30303-3415 Re: Predecisional enforcement Conference March 2,1998, Hampton Inn, San Juan, Puerto Rico
Dear Sirs:
When the Quality Management Program hereinafter the QMP Rule was established, the Nuclear Regulatory Commission, hereinafter the NRC. wanted to assure that byproduct material was administered by < technologists just as the physician ordered.
There was never any attempt on the part of the NRC to tell the physician what to order.
The NRC was concerned that physicians were not managing their practices carefully enough, with sufficient oversight, and that their l technologists were making mistakes.
In this context, we address the issues before us: l Contrary to what has been stated in the NRC Inspection Report dated January 30, 1998 from the NRC, Ryder Memorial Hospital, hereinafter
the Hospital, does have a QMP established since January 1992 which is directed to "any therapeutic dosage of a . radiopharmaceutical or any dosage of quantities greater that 30 l microcuries of either sodium iodide I-125 or 131."
In 1994, when the NRC notified licensees that the QMP Rule applied to Strontium 90 eye applicators, had the Hospital decided to continue authorizing the two ophthalmologists to use their applicators at the Fundado en 1914 por la Asociaci6n Misionera Americano g9C395979 3 (United Church Board for Homeland Ministries) Iglesia Evangelico Unida de Puerto Rico
- . . l , _ _.. - United States, Nuclear Regulatory Page 2 February 27, 1998 l l Hospital's operating room, the Hospital would have referred the NRC ! 'to our existing QMP and would have requested the two ophthalmologists to implement said program in their practice within l the Hospital's premises.
l However, the Hospital's decision notified on June 28,1994, was to cancel the authorization previously given these two physicians and requested this cancelation from the NRC.
The NRC acknowledged and accepted the Hospital's decision, and the Hospital immediately notified the ophthalmologists, including doctor de Le6n.
Naturally, the Hospital's existing QMP was not extended to the use of Strontium 90 eye applicators within our premises.1 Subsequently and to our knowledge, doctor Enery Navarrete applied for an NRC license but never applied Sr 90 at Ryder after that.
Furthermore, had the Hospital decided to continue the authorization previously granted for the Sr 90 eye applicator use, and had the established QMP been followed to a "T", not a single misadministration would have been prevented, because: 1. The physician who prescribed the dose was the same person who administered the intended dose.
2. Not a single misadministration involved mistaken identify of the patient.
. , . I Refer to Enclosure 1.
Additionally, please note that doctor de Le6n applied no Strontium 90 after th!s notice in June 1994, and until May 1995 after the physician we now know notif!,:d a " Q.M.P. " to the NRC, and he represents that the NRC authorized him to apply Sr 90 at Ryder.
Finally, all misadministrations occurred after this April 1995 date, and until February 1996.
This is when the Hospital discovers and reflects in its committee minutes, that doctor de Le6n had applied Strontium 90 without its knowledge or authorization between May 1995 and February 1996, and once again instructs doctor de Lc6n to discontinue this practice.
No misadministrations ocurred at Ryder after February 1996.
, . .
!. . .. - - ' United States, Nuclear Regulatory Page 3 February 27, 1998 3. The cause of each and every misadministration was a human error made by an outside consultant physicist, which would not have been prevented by any of the " steps" recommended within the QMP Rule.
The concern we wish to present at this point has been voiced before by the American Association of Physicists in Medicine at the National Academy of Sciences Meeting on Medical Use Programs.
It is the < concern with the punitive nature of the enforcement of the QMP l rules.
When a misadministration occurs, the licensee is presented as either not following the submitted QMP or having a defective QMP.
In the situation under our consideration the NRC presents us as not ] having a QMP at all, when, in reality, as we have explained before, ' Ryder Hospital does have one established and in use since January 1992.
Having established that the existence of a QMP which was strictly being followed, would not have prevented cay of the misadministrations here, we would like to point out the three
instances that we know of now, which would have prevented any and all misadministrations here, had either one of these three opportunities been given the attention that was due them.
All three opportunities were available to either the NRC. or to doctor de Le6n, but not to Ryder Hospital.
First, on the part of the NRC, we now have been told that two communications were received from doctor de Le6n, within a period of a few months, one stating that he would administer a dose of ' 2,000 rads during an exposure time of 26 seconds in June,1994, and " a second one stating that he would administer a dose of 2,000 rads during an exposure time of 60 seconds in April 27, 1995.
The NRC, , had, right there in its files, the necessary information that obviously pointed out, either that an undetermined number of , misadministrations (underdoses) had taken place or that
misadministrations (overdoses) were going to take place.
We all f know that in only 9 months Strontium 90 does not loose more than ' half of its strength.
Ryder Hospital did not have this information.
i
- . . .. - United States, Nuclear Regulatory Page 4 February 27, 1998 The NRC did, and failed to realize this; hence, overlooked an opportunity to promptly inquire where the mistake was and prevent all misadministrations.
I Second, on August 25, 1994, Mr. Douglas M. Collins wrote to the undersigned informing us about the review of the written QMP for the Strontium 90 eye applicator, which we were supposed to have submitted to NRC.
This was surprising, in view of what we have already stated above.
On October 10, 1994 we wrote Mr. Collins a letter which, together with its addendum's, gave NRC another opportunity to realize that Sr 90 applicators were no longer authorized at Ryder.
In that letter I asked Mr. Collins to "please be kind enough to clarify this situation."
Mr. Collins did not reply.
Thirdly, on the part of doctor de Le6n: When the physicist he consulted informed him that the time of application of Strontium 90 he had been using was wrong, that he had to double the treatment j time to deliver the intended dose of 2,000 rads, doctor de Le6n, at that time was being told that he had been underdosing his patients, which constitutes a misadministration, just as overdosing is.
At that point, and as per 10 CFR part 35, doctor de Le6n had to inform the misadministrations to the NRC and to each patient, but he failed to comply with the regulations and thus, lost the third chance that came about to uncover the real situation, i.
e., he had not misadministered in the past, he was going to misadminister in the future, if he followed the recommendations provided by the physicist.
Thus, it was not prompt action on the NRC Inspector's part which uncovered the truth, but rather a self-identified potential violation
when in February of 1996, Ryder Hospital documented in its committee minutes the discovery of the unauthorized NRC use of Strontium 90 on its premises, discovered by Ryder then and l I
. . ... - United States, Nuclear Regulatory Page 5
February 27, 1998 l immediately stopped by Ryder.2 It was not until the exit meeting of November 17, 1997 in which Ryder officials repeatedly insisted with Mr. Bermddez that he check the de Le6n file at the NRC, that the investigation began.
Hence, here are at least three sources of.information totally unknown until now to the Hospital, two apparently neglected by the NRC, and the other hidden from the patients and from the Hospital.
As stated, it was the Hospital's action in February 1996, which prevented further misadministrations at Ryder.
Refer tot above, eventhough the Hospital had no knowledge of even a threat of misadministrations.
The NRC and doctor de Le6n did.
Furthermore, we :nust clarify that the Exit meeting conducted on December 11, 1997 did not expose or discuss the apparent violations that are now presented by the NRC, but rather M r.
Berm 6dez spoke about the misadministrations discovered during December 1997.
Our first notice of the apparent violations was in the January 30 report receiwd on February 3,1998.
Nevertheless, it was Ryder Hosr> ital identification in its Committee minutes of the until then unkno a use of Sr 90 by doctor de Le6n in its facilities after authorization had been canceled, which prompted the review of doctor de Le6n's NRC file, in December 1997 which , pointed at the misadministration scenario, either before or after April O,1995, thus making the second visit (of December 1997) j necessary.
It was during thrfs visit that the misadministrations were identified, thMf Ryder instituted together with doctor de Le6n, timely and effective notice and corrective action with respect to these.
- Compliance with the NRC Regulations in a not for profit com.munity ' hospital such as Ryder, must be based on honesty, and a mutual j respect for the law on the part of licensees and practitioners.
! ' 2 efer to page 2. last paragraph of the " Report Details". which states: . the inspector " R promptly realized the potential for a misadministration scenario," We respectfully submit that over two and a half years, from April 1995 to November 97, when a routine inspection included the minutes referred to here, is not " prompt action."
- . - . . - (.. .... United States, Nuclear Regulatory ] Page 6' . February.-27,. 1998 l , Mechanisms to ensure enforcement must be both reasonable and cost-effective.
~ he NRC has erroneously associated the In conclusion, t misadministrations which occured, with the establishment and implementations of the QMP, when in fact, it was a human error, l totally outside the oversight of our Raaidiation Safety Program, which caused the problem.
Ryder Memorial Hospital was the only one i of the three parties, which -did not have the information which, if promptly. acted upon, would have prevented the misadministrations , (overdoses) here altogether.
Ryder acted. responsibly and in a timely manner within notices served.
This conduct, in addition to the I Hospital's. excellent record at the NRC, should be sufficient to exonerate the Hospital within the Enforcement Policy and history of i the NRC.
To punish the Hospital in these circumstances would be a i l gross miscarriage of justice.
'
Sincerely and respectfully, l $ Ak M L . M. Palacios de Lozano, M.S.
Angel orrk Noya, .D.
Consultant, Medical Physicist Radiation Safety Officer AkMhind f. YGWJ aturnino Pe5a Flores l Executive Director ' l c: Mrs. Lirio C. Torres, Esq.
'
' General Legal Counsel
l
. . l
ENCLOSURE 1 SWORN STATEMENT I, Satumino Pena Flores, of legal age, married, executive director of Ryder Memorial Hospital, !nc., and a resident of Las Piedras, Puerto Rico I ! under the most solemn oath declare the following: I 1. My personal circumstances are as stated above.
I 2. I personally notified doctor Jos6 do Le6n, M.D., of my letter to the N.R.C. dated June 28,1994 immediately following the drafting of said letter.
> I 3. I did not receive a copy of any letter from doctor de Le6n to the N.R.C.
or vice versa, until recently, as a result of the NRC inspection.
4. We requested the written NRC authorization from doctor de Le6n after we discovered in February 1996, that he was applying Strontium-90 on the Hospital premises l expressing to us then that he was authorized to do so l directly by the 3R.C., but he had not produced the same.
5. Again we vigorously reminded him that he was not authorized to ' apply Strontium 90 at Ryder Memorial Hospital, Inc. This last meeting ocurred in the presence of Mrs. Margie Palacios de Lozano, and doctor Angel Torres Noya. We received correspondence from doctor de Le6n to the NRC dated April of 1995, in December 1997.
6. The above stated is true to my best knowledge and belief.
Therefore, I sign and suscribe this document in Humacao, Puerto Rico this 211bday of February,1998.
n Md4 ~ SATURNINO PENA FLORES .. Affidavit No. 19% Sworn and suscribed to before me by Saturnino Pena Flores of the above stated personal circumstances whom i know personally this 2at.hday of February,1998 in Humacao, Puerto Rico.
! ( ENRQUE Q l HM NOTARYfUBLIC s- ,or . f
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LIST OF ATTENDEES Nuclear Reculatory Commission L. Reyes. Regional Administrator. Region II D. Collins. Director. Division of Nuclear Materials Safety (DNMS) A. Boland. Director. Enforcement and Investigations Coordination Staff N. Mamish. Acting Branch Chief. DNMS J. Diaz-V61ez. Radiation Specialist H. Berm 0dez Senior Radiation Specialist Ryder Memorial Hosoital J. Feliciano. Administrator L. Torres. Legal Consultant M. Lozano. Radiation Safety Officer (Medical Consultant) A. Torres. Chief. Nuclear Medicine Others J. De Le6n. M. D., Chief. Ophthalmology
I ( '
! Enclosure 4 i , }}