ORDERS:
SETTLEMENT AGREEMENT & ORDER
This final Settlement Agreement (“Agreement”) is entered into on the dates herein subscribed
to, by and between the South Carolina Department of Health and Environmental Control (the
“Department”) and Amisub of South Carolina d/b/a Piedmont Medical Center (“Piedmont”).
PREAMBLE
As preamble to this Agreement, the parties agree as follows:
1.On April 8, 2003, a representative of the Department visited Piedmont Medical Center, Rock
Hill, South Carolina, to conduct a complaint investigation regarding an alleged medication error.
2.During the course of this investigation, the inspector noted that the medication Lidocaine
bolus had been administered to a patient in error instead of Hespan. There was no order for
Lidocaine bolus for the patient. The administration of medication in the absence of a physician’s
order is a violation of Section 404.3.A of 24A S.C. Code Ann. Reg. 61-16.
3.The inspector further note that Hospital records did not indicate the patient’s physician was
immediately notified of the error at the time it occurred. The failure to inform a physician of a
medication error is a violation of 404.3.E of 24A S.C. Code Ann. Reg. 61-16.
4.After careful review, the Department sent a letter to Charles Miller, CEO Piedmont Medical
Center, on May 30, 2003, advising that is was imposing a one thousand five hundred dollar
($1,500.00) monetary penalty in accordance with 24A S.C. Code Ann. Reg. 61-16, Standards for
Licensing Hospitals and Institutional General Infirmaries. In that letter the Department also informed
Mr. Miller of his right to appeal the Department’s decision within 30 days pursuant to S.C. Code
Ann. Section 44-7-320(B)(2002) and the Rules of Procedure for the Administrative Law Judge
Division.
5.Piedmont denies liability for any errors and submitted a timely request for a contested case
hearing by letter dated June 30, 2003.
6.Prior to proceeding to a hearing on the merits, the parties met and Piedmont provided the
following information regarding the circumstances of the medication error that contributed to the
patient’s death and formed the basis for the Department’s citations and monetary penalty.
a.) The patient at issue was admitted to Piedmont on October 30, 2002, for an aorta bi-femoral bypass graft. Several days later, on November 3, 2002, the patient underwent an
exploratory laparotomy.
b.) The anesthesiologist assigned to the laparotomy was not employed by the Hospital, but
was a member of an anesthesiology group that provides services to the Hospital. Prior to the
laparotomy, the anesthesiologist walked to the operating room pharmacy to retrieve two IV
bags of medication called Hespan. When she reached the pharmacy, she picked up a bag of
medication and confirmed it was Hespan. She picked up a second bag, but did not verify that
it was Hespan. The anesthesiologist then walked to the operating room and placed both bags
on the anesthesia table.
c.) A Certified Registered Nurse Anesthetist (“CRNA”) employed by the anesthesiologist’s
practice assisted the anesthesiologist. The anesthesiologist ordered the CRNA to administer
Hespan to the patient. The CRNA picked up one of the IV bags the anesthesiologist had
placed on the anesthesia table and administered it to the patient without first confirming that
it was Hespan. Shortly afterwards, the patient’s condition deteriorated. While still in the
operating room, the anesthesiologist examined the IV and saw that the medication being
administered was not Hespan, but Lidocaine. Without informing anyone else of the error, the
anesthesiologist removed the bag of Lidocaine from the IV pole and put it aside. Soon
afterwards, the patient died.
d.) The anesthesiologist, without informing anyone of the medication error, removed the bag
of Lidocaine from the operating room. She then met with the admitting physician and
informed him of the mistake. The admitting physician informed the patient’s family of the
patient’s death, but not of the medication error. Neither the admitting physician nor the
anesthesiologist recorded the error in the patient’s chart. No one else knew of the error.
7.Piedmont denies liability for these errors.
8.Piedmont first learned of the medication error on March 13, 2003 - over four months after
the event occurred. In accordance with Departmental regulations, the Hospital reported this matter
to the Department on March 20, 2003.
9.In view of Piedmont’s timely reporting of this event and of Piedmont’s action to ensure that
a similar situation does not recur, the Department and Piedmont were able to reach the following
settlement in this matter.
TERMS AND CONDITIONS
10.The Department and Piedmont wish to resolve this matter and to compromise and settle the
disputes and allegations that have been pled or that could have been pled in the above-captioned case.
11.In view of the foregoing, the mutual promises and covenants set forth herein, and for such
other good and valuable consideration as set forth herein, the receipt and sufficiency of which is
hereby acknowledged, the Department and Piedmont agree as follows:
a.) The Licensee has taken and will continue to take action to ensure that this type of
circumstance does not recur.
b.) The Licensee will withdraw its request for a contested case hearing pending before the
Administrative Law Judge Division.
c.) In consideration of the remedial action taken by the facility, the Department agrees to
accept $1,000 in settlement of the $1500.00 total monetary penalty assessed against Piedmont
Medical Center, for violations of 61-16.
12.Piedmont agrees to submit payment of a $1,000 settlement amount by check or money order
made payable to the S.C. Department of Health and Environmental Control prior to or at the time
of the signing of this Agreement. Payment may be mailed to the following address:
Attention: Earl Bleakley
Division of Health Licensing
S.C. Department of Health and Environmental Control
2600 Bull Street
Columbia, SC 29201
13.It is understood by the Licensee that S.C. Code Ann. Section 44-7-320(D)(2002) provides
that “[f]ailure to pay a penalty within thirty days is grounds for suspension, revocation, or denial of
a renewal of a license. No license may be issued, reissued, or renewed until all penalties finally
assessed against a person or facility has been paid.” It is further understood that the failure to pay
the settlement amount may also result in suspension, revocation, or denial of a license and that no
license may be issued, reissued, or renewed until a settlement amount has been paid.
14.The Department in no way waives its authority to enforce, by imposing penalties or otherwise,
any statutory and regulatory requirements for the licensure of Piedmont Medical Center.
15.It is further agreed that, pursuant to S.C. Code Ann. Section 44-7-320(2002), future
violations or repeat violations of the regulations, or applicable licensing statutes, may result in the
imposition of penalties or the revocation of the license to operate Piedmont Medical Center, and the
facility administrator has been informed of these potential actions.
16.Piedmont agrees to withdraw its request for a contested case hearing in Docket No. 03-ALJ-07-0279-CC that is currently pending in the South Carolina Administrative Law Judge Division.
17.This Agreement does not constitute an admission of liability by Piedmont or a withdrawal of
the citations by the Department, but is entered into by the parties solely for purposes of
compromising, settling, and resolving this disputed matter without incurring the time and expense that
would be involved in proceeding further with this legal action.
18.This Agreement constitutes the entire agreement between the parties with respect to the
resolution and settlement of the matters discussed herein and supercedes all prior or contemporaneous
agreements, promises, or understandings between the parties. The parties are not relying upon any
representations, promises, understandings, or agreements except as expressly set forth within this
Agreement.
19.The undersigned individuals signing this Agreement on behalf of the parties represent and
warrant that they are duly authorized to execute this Agreement and lawfully bind their principals.
20.In the event of the invalidity of any term or provision of this Agreement, all terms and
provision shall be considered severable and the balance of this Agreement shall remain in effect. |