ORDERS:
FINAL ORDER AND DECISION
STATEMENT OF THE CASE
This case comes before the Administrative Law Judge Division (“ALJD”) pursuant to S.C.
Code Ann. § 1-23-600 (Supp. 2002), S.C. Code Ann. § 44-7-110 et seq. (2002), and 25A S.C. Code
Ann. Regs. 61-97 (Supp. 2002). Petitioner Gambro Healthcare Lancaster, Inc. (“Gambro”) contests
Respondent South Carolina Department of Health and Environmental Control (“DHEC”)’s
imposition of an $11,100 civil penalty for violations of the State Certification of Need and Health
Facility Licensure Act , S.C. Code Ann. § 44-7-110 et seq. (2002). DHEC contends the penalty is
warranted based on the extent and severity of violations found at Gambro’s renal dialysis clinic in
Lancaster, South Carolina. Gambro contends that the penalty is excessive in light of existing
regulations governing renal dialysis clinics and challenges the extent of those violations cited. After
notice to both parties, a contested case hearing was conducted at the offices of the ALJD in
Columbia, South Carolina on July 15, 2003.
FINDINGS OF FACT
Having carefully considered all testimony, exhibits, and arguments presented at the hearing
of this matter, and taking into account the credibility and accuracy of the evidence, I make the
following findings of fact by a preponderance of the evidence:
1.Notice of the date, time, place, and nature of the hearing was given to all parties.
2.Renal dialysis clinics are licensed by DHEC pursuant to S.C. Code Ann. § 44-7-260(A)(8) (2002).
3.Gambro owns and operates a renal dialysis facility located in Lancaster, South
Carolina, licensed for 17 stations by DHEC. Gambro purchased this facility in 1997.
4.Patients at renal dialysis facilities must dialyze three times a week, typically for three
and a half hours to four and a half hours each day. Dialysis patients have suppressed immune
systems, and many require frequent hospitalizations.
5.At Gambro’s request, DHEC provided Gambro in-service training during 2002
regarding medical records, infection control, and water analysis.
6.In 2002, DHEC conducted an annual inspection of Gambro’s facility, which resulted
in no violations.
7.On February 6, 2003, four representatives from DHEC’s Division of Health Licensing,
one of whom was receiving on-the-job training, made an unannounced visit to Gambro to conduct
a general inspection.
8.The inspectors met with Jessie Hoffman, Gambro’s administrator, and, shortly
thereafter, with Jo Edwards, Gambro’s regional director. The inspectors also talked with additional
staff members.
9.When examining a facility, the inspectors generally look for patterns of non-compliance before citing a violation.
10.During the February 6, 2003 visit, DHEC representatives cited the facility for 44
violations of 19 different sections of 25A S.C. Code Ann. Regs. 61-97 (Supp. 2002), “Standards for
Licensing Renal Dialysis Facilities.” DHEC did not consider any of the violations “repeat violations.”
11.Section 103 of Regulation 61-97 categorizes violations as follows:
A.Class I violations are those which the Department determines present an
imminent danger to the patients of the facility or a substantial probability that
death or serious physical harm could result therefrom. A physical condition,
one or more practices, means, methods or operations in use in a facility may
constitute such a violation. . . .
B.Class II violations are those other than Class I violations, which the
Department determines have a direct or immediate relationship to the health,
safety or security of the facility’s patients. . . .
C.Class III violations are those which are not classified as serious in these
regulations or those which are against the best practices as interpreted by the
Department.
25A S.C. Code Ann. Regs. 61-97 § 103 (Supp. 2003).
12.The Department cited the following violations of Regulation 61-97 and imposed the
following penalties:
1.Section 305 (Class II, $100 penalty imposed):
a.There was no documentation of a dated standing order
approved by a physician for the registered nurse to conduct a
health assessment.
b.In 3 of 4 employee personnel records reviewed, the health and
work history questionnaire was signed by a registered nurse.
c.In 1 of 4 employee personnel records reviewed, the health and
work history questionnaire was not signed by a licensed South
Carolina nurse.
2.Section 307.B (Class III, $100 penalty imposed): In 2 of 3 patient
medical records reviewed, there was no documentation of the
exchange of medical information upon hospital admission.
3.Section 401 (Class II, $500 penalty imposed): In 3 of 5 patient
medical records reviewed, there was no documentation of patient
instructions to follow during a medical emergency inside the facility,
i.e., quarterly emergency termination training.
4.Section 402.A (Class III, $200 penalty imposed):
a.In 1 of 5 patient medical records reviewed, the short-term care
plan was not reviewed every 6 months on a stable patient.
b.In 2 of 5 patient medical records reviewed, there was no
notation of stability on the short-term care plans.
c.In 3 of 5 patient medical records reviewed, the short-term care
plans did not reflect the social and dietary needs of the patient
or the patient signature.
5.Section 402.B (Class III, $100 penalty imposed):
a.In 1 of 5 medical records reviewed, the long-term care plan
had not been updated annually.
b.In 1 of 5 medical records reviewed, the long-term care plan
was not developed within 30 days.
6.Section 402.C (Class III, $100 penalty imposed): In 2 of 5 patient
medical records reviewed, there was no documentation of a monthly
dietary progress note or quarterly social worker note.
7.Section 403.A.2 (Class II, $2,000 penalty imposed):
a.In 5 of 5 patient medical records reviewed, the physician’s
standing orders indicated “re-use” as did the short-term care
plans, when in fact the facility had discontinued re-use in May
2002.
b.In 5 of 5 patient medical records reviewed, the physician’s
orders for blood flow rates had not been followed.
c.In 2 of 5 patient medical records reviewed, the physician’s
orders for the duration of dialysis had not been followed.
8.Section 405.A.1 (Class I, $1,000 penalty imposed): The contents of
the emergency cart did not correspond with the inventory list (e.g.,
Gelco 18-gauge catheter - none available; 7.5% Na Bicarb; Digoxin;
D 50 N ampules; Lanoxin and Lidocaine).
9.Section 405.B (Class I, $100 penalty imposed): In 2 of 5 medical
records reviewed, verbal and/or telephone orders were not signed
and/or dated within 72 hours.
10.Section 405.C (Class I, $500 penalty imposed): There were expired
and outdated medications in the medication cabinet in the peritoneal
dialysis training (“PDT”) area, e.g., Procel 1/2003, Calcimv 11/2002,
Cal-Carb 12/2000.
11.Section 405.H (Class II, $2,000 penalty imposed): In 5 of 5 patient
medical records reviewed, there was no documentation of monthly
medication reviews.
12.Section 407.E (Class II, $500 penalty imposed): There were expired
and outdated supplies in various areas of the facility: PDT-
vaccutainers 1/2002, 11/2002, 12/2000; laboratory area- swabs
1/2000, Combos Lifepak 9/2001; emergency lock box- sterile sponges
3/1999, sodium chloride 7/2000.
13.Section 409.D (Class I, $100 penalty imposed): In 2 of 5 patient
medical records reviewed, there was no documentation available to
indicate that the patient had been offered the hepatitis vaccine.
14.Section 2005.N (Class III, $100 penalty imposed): A patient bathroom
in the PDT area was heavily soiled and was being used as a “Dirty
Utility Area” in the clinic. Biohazardous items were also being stored
in this room.
15.Section 2006 (Class II, $100 penalty imposed):
a.There was a 6” x 3” hole in the wall in the main warehouse
room.
b.There were damaged baseboards in the main clinic area.
c.Cabinets had chipped area and had veneer missing in several
areas in the treatment room.
16.Section 2007 (Class II, $500 penalty imposed):
a.All storage rooms in the facility were cluttered and had
accumulations of debris on the floor.
b.There was an accumulation of a liquid (spillage) around the
base of the Pepsi machine in the Patient Waiting Room.
c.The equipment technician repair room was cluttered and had
accumulations of debris on the floor. The sink in the room
was heavily soiled.
d.The janitor’s closet was heavily soiled with accumulations of
grime and debris on the deep sink, the walls, and the floor.
The dust mop was heavily soiled with dirt and grime and large
clumps of dust.
e.The medical storage room in the main warehouse area was
cluttered with supplies stored directly on the floor and had
debris on the floor.
f.The PDT area was cluttered with supplies and other items
stored directly on the floor.
g.The top surfaces of the vending machines in the patient
waiting area had heavy accumulations of dust, debris, paper,
etc.
h.The smoking area on the facility loading dock was heavily
soiled with cigarette ashes, and the grounds next to the
smoking area were strewn with many cigarette butts.
i.The metal plates for ventilation located in the floor of the
clinic were rusted and soiled.
17.Section 2103 (Class I, $1,000 penalty imposed):
a.Two unsecured oxygen cylinders were observed stored by the
emergency cart.
b.There were no “No Smoking” signs posted where oxygen was
stored in the back medication storage closet or by the
emergency cart.
18.Section 2301 (Class II, $2,000 penalty imposed):
a.There was no documentation that the Gambro Technical
Service (“GTS”) had been notified, as required by the Gambro
Water Procedure w 04.0 page 2 of 9, #19, in regard to the
Endotoxin Filter Δ Pressure = (Pre-Filter Pressure - Post Filter
Pressure Δ Pressure > 2 psi and ≤ 15. According to
documentation, the difference (Δ) in psi in 1/22/03, 1/23/03,
1/24/03, 1/25/03, 1/27/03, 1/28/03, 1/29/03, and 1/11/03 was
1 psi. There was no documentation that these readings had
been reported to GTS.
b.Documentation on the January 2003 Daily Water Quality
Monitoring log for 1/13/03 for Line 16, Most Recent DI
Exchange Date: Note: DI tanks must be changed at least every
three months indicated a date of 9/12/02. On 1/14/03, the
new date was recorded as 1/03. In addition, documentation
on 1/8/03 stated 9/12/02 as the latest date, but on 1/9/03 the
documentation stated 1/03 as the new date. Documentation
was unclear as to when the actual exchange date was and if
the exchange had occurred at least every three months.
c.Documentation was unclear on several dates that the facility’s
policy had been followed in recording data in regard to CWP
RO Unit Chemical Disinfection, Line 51, Chemical
Disinfection Initiated (time) –indicates AM or PM, Line 52
Test for Chemical Residual record results… after disinfection;
and Line 53, Check for Chemical Consumption. On 12/31/02,
there was no a.m. or p.m. noted on 51, no results on 52 and
NA on 53; on 12/2/02m there were no results on 52; on
11/18/02, lines 52 and 53 were marked with • and on
10/21/02 lines 52 and 53 were marked with •. In addition,
according to staff the readings for disinfection should be
recorded on the following a.m. shift. No results would be
available before that time.
d.According to documentation on a Sept./Oct. 2002 Daily
Water Quality Monitoring Log for 10/1/02, the facility was
operating on DI Tanks. Facility policy requires that Total
Chlorine Water Checks be conducted every 30 minutes.
Documentation on the Total Chlorine Water Checklist for
10/1/02 indicated readings at 6 a.m., 10:00 and 12:30.
e.Documentation was unclear on numerous dates of the Total
Chlorine: Water Checklist in regard to the readings of Total
Chlorine (≤0.1 mg/L) Primary Tank. There were readings of
<0.00 on 10/21/02, 10/23/02, 9/17/02, 12/26/02, 1/31/03,
2/1/03, and 1/28/03.
f.There was no documentation on numerous “DI tank in use”
lists and Total Chlorine: Water Checklists that the data had
been cosigned by a licensed staff person as required by facility
policy. DI tank – 9/9/02, 8/31/02, 9/3/02, 9/11/02; Total
Chlorine- 2/14/02, 3/28/02, 4/15/02.
g.Dialysis Machines were not checked and/or tested at such
intervals to insure proper operating and a state of good repair.
The Dialysis Machine manufacturer and the facility policy
requires an annual preventive maintenance service check every
3000 hours of machine operation, or 1 year between such
service, whichever comes first. (E.G., Machine #18, P.M.
10/5/01 and 11/12/02; Machine #16, P.M. 10/8/2001 and
11/7/2002; Machine #22, P.M. 2/20/2001 and 3/21/2002;
Machine #24, P.M. 10/17/2001 and 11/14/2002; Machine #15,
P.M. 2/20/2001 and no other P.M. documentation; Machine
#20, P.M. 7/20/2001 and 9/11/2002; Machine #13, P.M. 0004
hours on 2/19/2001 and 3085 hours on 2/27/2002.)
19.Section 2401 (Class III, $100 penalty imposed): There were many
items stored under the sinks in the facility that may be damaged or
compromised by contamination. These items included sterile supplies,
gauze pads, syringes, supplies, etc.
13.Gambro does not dispute that it violated Sections 305,
307.B, 401, 402.A, 402.B,
402.C, 402.C, 403.A.2, 405.A.1, 405.B, 405.H, 407.E, 409.D, 2006, 2007
, 2103, 2301,
and 2401
of Regulation 61-97. Gambro does, however, challenge the penalties imposed by DHEC for most
of these violations. One of the bases of Gambro’s challenge to the penalties is the method by which
DHEC inspectors reviewed its medical records.
14.In inspecting medical records at a health care facility with a licensed capacity of 17,
for purposes of determining regulatory compliance, the DHEC’s Operations Manual indicates that
inspectors should review 9 records. However, the Operations Manual further indicates that
“discretion to abbreviate or expand the client record review, based on the circumstances of the
inspection, is appropriate.” In this case, the DHEC inspector determined, based on the volume of
each medical record and the type of health care facility (renal dialysis) involved, that she would
review five medical records. Gambro contests this method, arguing that it is arbitrary and is an
insufficient basis upon which to judge the severity of the violations for purposes of determining the
appropriate penalties. Gambro does not dispute, however, the substantive violations the DHEC
inspector cited based upon her review of the five records. The method used by DHEC in this case
for inspecting medical records was sufficient to establish patterns of non-compliance for purposes of
citing substantive violations of Regulation 61-97, and it is appropriate to consider those cited
violations for the purpose of determining the appropriate penalty to be imposed.
15.Gambro disputes that it violated Sections 405.C and 2005.N of Regulation 61-97.
16.Section 405.C of Regulation 61-97 requires that “[m]edicines and drugs maintained
in the facility for daily administration shall be properly stored and safeguarded in enclosures of
sufficient size and which are not accessible to unauthorized persons.” 25A S.C. Code Ann. Regs. 61-97 (Supp. 2002). The inspector cited Gambro for violating Section 405.C based on his observation
that expired and outdated medications were in the medication cabinet located in the Peritoneal
Dialysis Training (“PDT”) area. The medication cabinet was locked at the time of the inspection; an
authorized employee of Gambro unlocked the cabinet with a key in order for the DHEC inspector
to inspect its contents. The PDT area of the facility is used to train patients who want to conduct
their dialysis treatments at home. No medications are administered in the PDT area. The facility has
expired medications which it keeps in a locked cabinet in the PDT area. These medications are used
for education and demonstration purposes only. These medications are never administered to
patients. A Registered Nurse dedicated to this training always accompanies patients into this area.
When the medications are not being used, they are kept in a locked cabinet and are inaccessible to
unauthorized persons. When the medications are being used demonstratively to educate patients, a
Registered Nurse is always present, and therefore there is minimal risk of a patient ever having direct
access to these medications. Although the practice of maintaining these medications is certainly
questionable, there is no persuasive evidence that these medications were “maintained in the facility
for daily administration” or “accessible to unauthorized persons,” and I therefore find this citation to
be without merit.
17.Section 2005.N of Regulation 61-97 requires a facility to provide patient toilet
facilities. 25A S.C. Code Ann. Regs. 61-97 § 2005.N (Supp. 2002). The citation for violating
Section 2005.N was issued based on the inspector’s observation that a “patient bathroom” in the PDT
area was heavily soiled, being used as a “Dirty Utility Area,” and being used to store biohazardous
items. The room at issue previously was used as a patient bathroom, but Gambro has designated it
as a dirty utility area by posting signs on the door and sink of the bathroom. Two other bathrooms
are out in the main lobby, and staff direct patients to those bathrooms. It is not likely that patients
could accidentally go into and use the dirty utility area. The biohazardous material is stored in a box
marked as such with a sticker. Finally, after the inspection, Hoffman obtained verification from
DHEC’s Facilities Construction Division that the facility provides a sufficient number of restrooms
without using the bathroom designated as the dirty utility area. Based on the above, I find this
citation to be without merit.
CONCLUSIONS OF LAW
Based on the above findings of fact, I conclude the following as a matter of law:
1.The ALJD has jurisdiction over DHEC Division of Health Licensing contested cases
pursuant to S.C. Code Ann. § 44-7-320(B) (2002) and § 1-23-600(B) (Supp. 2002).
2.The standard of proof in weighing the evidence and making a decision on the merits
in a contested case hearing is a preponderance of the evidence. Anonymous v. State Bd. of Med.
Exam’rs, 329 S.C. 371, 496 S.E.2d 17 (1998). In the instant case, DHEC bears the burden to prove
the regulatory violations by a preponderance of the evidence.
3.DHEC is the state agency charged with licensing and inspection of renal dialysis clinics
pursuant to S.C. Code Ann. §§ 44-7-250, -260(A)(8) (2002) and 25A S.C. Code Ann. Regs. 61-97
§ 102 (Supp. 2002).
4.The licensee is “[t]he individual, agency, group or corporation in which the ultimate
responsibility and authority for the conduct of the renal dialysis facility is vested.” 25A S.C. Code
Ann. Regs. 61-97 § 101(K) (Supp. 2002).
5.The State Certification of Need and Health Facility Licensure Act, S.C. Code Ann.
§ 44-7-260 et seq. (2002), contains requirements for licensure of health care facilities and monetary
penalties for violations of any provisions of that article or of departmental regulations. Further,
Regulation 61-97 contains penalties for violations of that regulation, including a schedule of monetary
penalty ranges to be used as a guide in determining monetary penalties imposed for violations of the
regulation. 25A S.C. Code Ann. Regs. 61-97 § 103(D) (Supp. 2002).
6.The administrator of a renal dialysis facility is responsible for the management and
administration of the facility and is charged with assuring compliance with the bylaws and
amendments of the facility. 25A S.C. Code Ann. Regs. 61-97 § 303 (Supp. 2002).
7. The Administrative Law Judge trying a contested case is the finder of fact and issues
a final written decision containing findings of fact and conclusions of law. S.C. Code Ann. §§ 1-23-350 and 1-23-600(B) (1986 & Supp. 2002); Brown v. S.C. Dep’t of Health and Envtl. Control, 348
S.C. 507, 520, 560 S.E. 2d 410, 417 (2002). Inherent and fundamental to the powers of an
Administrative Law Judge, as the trier of fact, is the authority to decide the appropriate sanction
when such is disputed. Walker v. S.C. ABC Comm’n, 305 S.C. 209, 407 S.E.2d 633 (1991). Since
the amount of the penalty imposed is within the sound discretion of the Administrative Law Judge,
there is no need to address whether DHEC must use Section 103(D) of Regulation 61-97 as a guide,
whether it did so in this case, or whether it assessed appropriate penalties.
8.Section 103(D) of Regulation 61-97 provides the DHEC Board’s official policy on
the amount of monetary penalties to be assessed for violations of that regulation. The monetary
penalty ranges listed in that section are as follows:
Number of OffenseClass IClass IIClass III
1st $200-1000$100-500$0
2nd 500-2000200-1000100-500
3rd 1000-5000500-2000200-1000
4th 50001000-5000500-2000
5th 500050001000-5000
6th and more500050005000
Id.
Section 103(D) of Regulation 61-97 states only that it “will be used as a guide.” Id.
Although the regulation itself does not contain language making it mandatory that the range of
monetary penalties set forth in Section 103(D) of the regulation be adhered to in issuing penalties,
I find no reason to reject its guidance and therefore will assess the penalties for the citations found
to be valid in this case in accordance with the policy of the DHEC Board as set forth in that section
,
with one exception. For Class III violations, first offense, Section 103(D) of the regulation provides
for no penalty. However, S.C. Code Ann. § 44-7-320 (C) (2002) mandates, in cases in which a
monetary penalty is imposed, that the penalty be no less than $100 for each violation of that article
or its regulations. Where a regulation conflicts with the statute it seeks to implement, the statute
must prevail. See, e.g., Chevron U.S.A., Inc. v. Natural Res. Def. Council, 467 U.S. 837, 844 (1984)
(“legislative regulations are given controlling weight unless they are arbitrary, capricious, or
manifestly contrary to the statute”) (emphasis added); Allen v. U.S., 173 F.3d 533, 536 (4th Cir. 1999)
(“we must overturn a regulation that clearly conflicts with the plain text of the [implementing]
statute”). Therefore, the minimum penalty imposed in this matter for each offense, including a first
offense of a Class III violation, will be $100
.
9.I find Gambro violated the following Sections of Regulation 61-97, and I assess the
corresponding penalties, in accordance with the range of penalties for first offenses set forth in
Section 103(D) of Regulation 61-97 and with the statutorily mandated minimum penalty of $100 per
violation set forth in S.C. Code Ann. § 44-7-320 (C) (2002):
Violation Penalty
305 $100
307.B 100
401 500
402.A 100
402.B 100
402.C 100
403.A.2 500
405A.1 1000
405.B 100
405.H 500
407.E 500
409.D 100
2006 100
2007 500
2103 1000
2301 500
2401 100
10.Based on the evidence presented by both parties at the hearing, I find that Gambro did
not violate Sections 405.C and 2005.N. of Regulation 61-97.
11.Pursuant to ALJD Rule 29.C, all issues raised but not addressed in this order are
deemed denied.
ORDER
Based on the foregoing findings of fact and conclusions of law,
IT IS HEREBY ORDERED that citations issued for violations of 25A S.C. Code Ann.
Regs. 61-97 §§ 405.C and 2005.N (2002) are vacated;
IT IS FURTHER ORDERED that the citations issued for violations of 25A S.C. Code Ann.
Regs. 61-97 §§ 305, 307.B, 401, 402.A, 402.B, 402.C, 403.A.2, 405.A.1, 405.B, 405.H, 407.E,
409.D, 2006, 2007, 2103, 2301, and 2401 (2002) are affirmed, and the penalties imposed for these
violations are modified as set forth above in paragraph 9 of the Conclusions of Law;
IT IS FURTHER ORDERED that Gambro remit to DHEC within 30 days of the date of
this Order payment in the amount of $5,900.
AND IT IS SO ORDERED.
______________________________
C. DUKES SCOTT
ADMINISTRATIVE LAW JUDGE
October 9, 2003
Columbia, South Carolina |
