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指導教授：周天 所長 報 告 人：碩專班二年級 9520706王曉梅

國立高雄第一科技大學科技法律研究所

案例討論課程：醫療與法律

案號： Fairfax Nursing Home, Inc. v. U.S. Dept. of Health & Human Services

300 F.3d 835

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Fairfax Nursing

Home(Petitioner)

Center for MedicareService

Illinois Department of

Public Health

法院

行政處分

行政契約

行政

處分

Department ofHealth and Human

Service

Appeal Board( 訴願維持原罰鍰 )

Appellant Division ( 再訴願決定，維持原處分 )

Court of Appeal( 上訴人敗訴，罰鍰執行 )

AdministrativeLaw Judge

作 證

作

證

Apellate Division

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事實 Fairfax is a skilled nursing facility (“SNF”), see

42 U.S.C. § 1395i-3(a); 42 C.F.R. § 488.301, participating in Medicare and Medicaid (collectively “Medicare”) as a provider

Regulation of SNFs is committed to the Center for Medicare and Medicare Services (CMS) and to state agencies with whom the Secretary of Health and Human Services has contracted. See 42 U.S.C. § 1395aa(a).

If the state survey finds violations of Medicare regulations, the state may recommend penalties to civil monetary penalty. The CMS imposed here was based on an Illinois Department of Public Health (IDPH) recommendation.

CMS imposed the penalty because of series of failures in Fairfax's care of ventilator-dependent residents

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On December 20, 1996, R10, a ventilator-dependent resident at Fairfax suffered respiratory distress and required emergency .one therapist turned off R10's ventilator because the alarm was sounding. Once R10 was stabilized, the therapists left, but neglected to turn the ventilator back on. As a result, R10 died.

Fairfax began to develop a policy (vital signs/respiratory status oxygen stats [saturation]/lung sounds/vent settings/level of consciousness/odor color and consistency of secretions & comfort level of the resident for the care of ventilator-dependent residents. Q 15 minutes X 4

That policy was completed in February 1997 and was implemented in early March of that year.

事實

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R126 was observed to have a low oxygen saturation level, an elevated pulse and temperature, and to be breathing rapidly.

R126's physician was called; he ordered a chest x-ray and gave several other instructions. However, contrary to Fairfax's policy, R126's medical chart did not reflect whether these orders were carried out. R126 died .

事實

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On March 5, 1997, R127 was found with low oxygen saturation and mottled extremities. Fairfax staff failed to make a complete assessment, took no vital signs, made no follow-up assessments and did not notify a physician.

On March 7, R127 was found cyanotic and required five minutes of ambu-bagging. during the 7 a.m. to 3 p.m. shift, three episodes of respiratory distress were noted, each of which required ambu-bagging, but only observed R127's color and oxygen saturation and took no other vital signs No physician was called.

On March 10, R127's skin was observed turning blue, but there was no record of treatment for respiratory distress and no vital signs or assessments were charted.

On March 21, R127 had another episode, this time with mottled legs, shaking and a dangerously low oxygen saturation. The physician was present; R127 was ambu-bagged and administered Valium. There was no complete assessment and no follow-up.

On March 25, R127 was found to have a severe infection and died on March 27.

事實

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On March 23, 1997, R83 was found nonresponsive with low oxygen saturation, low blood pressure, an elevated pulse rate and a low respiratory rate.

R83 was ambu-bagged, and the treating physician was called. The first noted follow-up was an hour later and 2-1/2 hours passed before R83 was monitored again.

事實

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On April 2, 1997, a state surveyor observed a Fairfax employee fail to use sterile procedures while performing

tracheostomy care on R6 and R11.

The same employee also neglected to

hyper-oxygenate the residents before or after suctioning the tracheostomy

事實

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On April 3, 1997, R68 became cyanotic, with low oxygen saturation, which required ambu-bagging and an increase in the amount of oxygen given through the ventilator.

The records for R68 failed to note R68's vital signs, and the record did not reflect whether R68 oxygen saturation level ever returned to a normal level.

On April 4, R68 was not sufficiently stable to permit a routine tracheostomy change.

事實

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A survey on April 8, 1997, IDPH surveyors determined that Fairfax's actions and omissions posed “immediate jeopardy” to the health and safety of its residents. Specifically, Fairfax had violated 42 C.F.R. § 483.25(k), which pertains in part to the special care of ventilator-dependent residents.

CMS was imposing a CMP of $3,050 per day for a 105-day period, from December 20, 1996, through April 3, 1997, during which Fairfax was not in substantial compliance with HHS regulations governing the care of ventilator-dependent residents.

CMS also assessed a penalty for a period of noncompliance running from April 4, 1997, through May 14, 1997. The total penalty for this latter period was

$2,050, and Fairfax did not challenge it.

事實

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事 實Adiministrative Law Judge(ALJ): This lack of a policy and later failures to comply with the

new policy posed severe risk to the health and well-being of the patients.

CMS make out a prima facie case for the imposition of the CMP, but assigned the ultimate burden of proof to Fairfax.

The ALJ found that “there is not only a prima facie case of noncompliance here, but the preponderance of the evidence is that Petitioner was not complying substantially” Fairfax appeal.

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Appellant Division: determining that the ALJ applied the proper

legal standard, that the ALJ's decision was supported by substantial evidence and that the amount of the CMP was reasonable

Faifax appeal

事 實

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爭點 Wether substantial evidence supports

CMS' conclusion that a state of immediate jeopardy prevailed at Fairfax from December 20, 1996, until April 4, 1997

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Argument(Plantiff) the ALJ erred following the Appellate Division's earlier

ruling in Hillman and assigning the ultimate burden of proof to Fairfax.

Hillman violates APA § 7(c), which places the burden of proof on the “proponent of a rule or order “( 規則或命令之執行者 )

It further contended that the ALJ applied the wrong legal standard, linked together unrelated incidents and that the amount of the CMP was

punitive, rather than remedial.

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判決 Ripple Circuit Judge:(1) administrative law judge's

(ALJ) use of term “potential” in discussing risks to respirator-dependent residents did not support determination that ALJ employed incorrect legal standard in determining whether civil monetary penalty was warranted

(2) determination that state of immediate jeopardy to resident health existed at facility, so as to warrant penalty, was supported by substantial evidence in the record.

下級法院之判決，成立。

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判決理由（ 1 ） See 42 C.F.R. §§ 488.408, 488.438. The upper range,

permitting CMPs of $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a resident or, under some circumstances, repeated deficiencies.

The lower range of CMPs, which begin at $50 per day and run to $3,000 per day, is reserved for “deficiencies that do not constitute immediate jeopardy, but either caused actual harm or have the potential for causing more than minimal harm.”

“Immediate jeopardy” is defined as “a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”

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判決理由（ 2 ） R126:The ALJ found that “the record presents a picture

of a lackadaisical staff, rather than a staff aggressively treating a pneumonia that was further aggravating the resident's already compromised health.” Id. at 10. The ALJ clearly was aware of the proper standard for immediate jeopardy and applied it correctly. (Admin.R. at 8 )

R127:The ALJ found that this monitoring failure “had the potential for serious injury, harm, impairment, or death to the resident and constitutes immediate jeopardy.(Admin.R. at 11. )

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判決理由（ 3 ） R83 、 R68::The ALJ found: Fairfax's failure to monitor R83

and R68, which “had the potential for serious injury, harm, impairment, or death to the resident and constitutes immediate jeopardy.”( Admin.R. at 16).

R83 makes manifestly clear that there was no misunderstanding of the applicable standard: “That R83 survived Petitioner's incompetent care and treatment does not excuse the fact that he was placed at risk of serious injury, harm, impairment, or death.” (Admin.R. at 17)

R68, the ALJ remarked in a similar vein: “Ms. Daniels testified that it was ‘pretty lucky’ that nothing serious happened to R68, because, in a matter of minutes, brain damage could be sustained from lack of oxygen. Petitioner's duty to provide appropriate respiratory care to its ventilator-dependent residents

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R6 and R11 :The ALJ addressed Fairfax's failure to ensure that received proper tracheostomy care, the ALJ concluded that “[t]his had the potential for serious injury, harm, impairment, or death to the residents and constitutes immediate jeopardy.” (Id. at 18)

判決理由（ 4 ）

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Discussion A fair reading of the ALJ's opinion also makes

clear that he focused not simply on the situation of each individual patient, but also on the entire state of readiness in the facility during the time in question .

The “bottom line” is that a respiratory patient in Fairfax during the time in question was in continuous jeopardy of serious injury or death .

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法 源 護理師法第 15 條（護理機構之服務對象）護理機構之服務對象

如左：　　一 罹患慢性病需長期護理之病人。　　二 出院後需繼續護理之病人。　　三 產後需護理之產婦及嬰幼兒。第 20 條（轉介關係契約之訂定）　　 護理機構應與鄰近醫院訂定轉介關係之契約。前 項醫院以經主管機關依法評鑑合格者為限。第一

項 契約終止、解除或內容有變更時，應另訂新約，並 於契約終止、解除或內容變更之日起十五日內，檢 具新約，向原發開業執照機關報備。

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護理師法 第 23 條（護理機構之報告義務）　　　護理機構應依法令規定或依主管機關之通知，提 出報告，並接受主管機關對其人配置、設備、收 費 、作業、衛生、安全、紀錄等之檢查及資料蒐 集。 第 23- 1 條（護理機構評鑑）　　　中央主管機關應視需要，辦理護理機構評鑑。直 轄市、縣 ( 市 ) 主管機關對轄區內護理機構業務， 應定期實施督導考核。前項評鑑標準，由中央主管 機關定之。第一項之評鑑、督導考核，必要時，得 委託相關機構或團體辦理。

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法 源 護理機構設置標準 第 6 條 : 居家護理機構及護理之家機構， 對於轉診及醫師每次診察之病歷摘 要，應 連同護理紀錄依規定妥善保存。 第 7 條 : 護理機構之負責資深護理人員，應 督導其機構所屬護理人員及其他人員 ， 善盡業務上必要之注意。

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法 源 呼吸治療師法 第 2 條 : 公立或立案之私立大學、獨立學院或符合教

育部採認規定之國外大學、獨 立學院呼吸照護 ( 治療 ) 系、所、組，並經實習期滿成績及格，領有畢業 證書者，得應呼吸治療師考試。

第 13 條 呼吸治療師之業務範圍如下： 一、呼吸治療之評估及測試。 二、機械通氣治療。 三、氣體治療。 四、呼吸功能改善治療。 五、其他經中央主管機關認可之呼吸治療業務。 呼吸治療師執行業務，應在醫師指示下行之。

第 18     條 未取得呼吸治療師資格，擅自執行呼吸治療業務者，處二年以下有期徒刑 ，得併科新臺幣三萬元以上十五萬元以下罰金，其所使用藥械沒收之。但 在中央主管機關認可之醫院實習之學生或畢業生，不在此限。 護理人員、物理治療師、醫事檢驗師或其他專門職業及技術人員等依其專門職業法律規定執行業務，涉及本法所定業務時，不視為違反前項規定。

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法 源 行政程序法 第 5 條 行政行為之內容應明確。 第 6 條 行政行為，非有正當理由，不得為差別待遇。

第 38 條 行政機關調查事實及證據，必要時得據實製作書面紀錄。

第 48 條 期間以時計算者，即時起算。 期間以日、星期、月或年計算者，其始日不計算在內。但法律規定即日起 算者，不在此限。

第 10 節 聽證程序

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法 源訴願法 第 1 條 人民對於中央或地方機關之行政處分，認為違

法或不當，致損害其權利或 利益者，得依本法提起訴願。但法律另有規定者，從其規定。

第 4 條 訴願之管轄 第 52 條 各機關辦理訴願事件，應設訴願審議委員會

，組成人員以具有法制專長者 為原則。 訴願審議委員會委員，由本機關高級職員及遴聘社會公正人士、學者、專 家擔任之；其中社會公正人士、學者、專家人數不得少於二分之一。 訴願審議委員會組織規程及審議規則，由主管院定之。

第 90 條 訴願決定書應附記，如不服決定，得於決定書送達之次日起二個月內向高 等行政法院提起行政訴訟。

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Thank for your attention!