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NEW YORK STATE DEPARTMENT OF HEALTH
TO: Guthrie Birkhead, M.D.
Director, AIDS histitute
Assistant Director, Office of Health Systems Management\
FROM: Sherry Chorost - S.C.
Director, Chronic Care Section
Barbara Warren, PNP - B.W.
Assistant Director, Bureau of HIV Ambulatory Care
SUBJECT: Incarnation Children's Center (ICC) -- FINAL
DATE: February 27, 2004
As a result of allegations that came to our attention, we conducted an unannounced site visit on February 24, along with an OHSM staff person (John Daniel Berry) from the complaint investigation unit at MARO, to determine if they could be substantiated. A medical record review instrument (attached) was developed to capture key information about the children in residence.
When we arrived at the facility at about 10:30 A.M., we met with key staff, including: Carolyn Castro, Director; Peter Karow, Ph.D, Administrator; Catherine Painter, M.D., Medical Director; Kristen Baumann, Ph.D., Psychologist, Program Director; and Melissa Malone, P.N.P., Director of Nursing Services.
During the meeting, we questioned ICC staff about the overall care provided to children at ICC, including their medical conditions, how HIV medications were managed and by whom, monitoring of their HIV status, adherence issues, involvement of ICC children in clinical trials, use of nasogastric tubes/gastrostomy tubes and foster care status. In response to our questions, we were given the following information:
reason for admission to ICC: Five have advanced/fragile conditions
making home care difficult; five have psychosocial stressors complicating
their HIV care; five have a combination of psychosocial and adherence issues; two have adherence/mental health/psychosocial issues; two have psychosocial/mental heath issues, and I has adherence only issues.
0Eight children are in foster care, of whom only one has psychosocial/adherence issues as the reason for admission;
0the number of diagnoses per child ranged from 3 to 17, with an average of about eight per child;
* none of the children have nasogastric feeding tubes; seven children have G-tubes, of which five were placed prior to the children entering ICC;
019 of the children have a pediatric HIV specialist who remains involved in their care and in the management of HIV medications (Dr. Painter is the pediatric HIV specialist for the 20th child);
9none of the children are on clinical trials;
917 children are on HIV medications, all of which are FDA approved (Two children are not on ARV because of adherence issues/refusal to take the medications; one has a stable viral load and is not on medication), and
* the HIV status and overall condition of 14 of the children have improved since the children were admitted to ICC and the other six are stable.
In order to verify the information shared with us by ICC staff, we randomly selected a total of I I records of the 20 children in residence. In reviewing the records, it was very evident that these children have very complex medical issues. Of the records reviewed, all of the children had at least six or more significant diagnoses for which they were receiving treatment or services. The reviewers were impressed with the overall care being provided to the children. There were comprehensive care plans in place for each child that addressed the child's medical, psychosocial, mental health, developmental and educational needs. The medical notes on the children, written by Dr. Painter or the nurse practitioner, were extensive. There were also extensive progress notes written by the psychologist, various therapists and nurses.
This review strongly verified what ICC staff had told us during the meeting in their description of the children in care. Our findings of the I I charts included the following:
All of the children are receiving appropriate (excellent) care.
Four of the I I were under the care and custody of the Administration for Children's Services.
The children had a significant number of complex medical conditions to manage. The average number of significant diagnoses among the children was 7.6, with a range from 5 to 17.
Ten of the I I children were currently on HIV medications. All HIV medications were prescribed consistent with the federal and state guidelines for using antiretroviral medications in children with HIV infection. One child was not on ARV due to extremely poor compliance/refusal to take medications. The child, who also has psychosocial and mental health issues, is receiving psychiatric therapy to address his mental heath and related issues, as well as the issue related to treatment adherence.
Ten of the I I children have a pediatric HIV specialist who remains involved with the HIV-related care of the child and co-manages adjustments of the child's HIV medications with Dr. Painter; Dr. Painter is the HIV specialist for the I 11h child;
Routine immunologic and virologic monitoring of HIV status is done according to state and federal standards for such. For ten o~ the children, this is done by the child's pediatric HIV specialist with copies of test results in the ICC records. Dr. Painter does this monitoring for the I I th child.
None of the children were on clinical trials.
None of the I I children had any evidence that the child was having/had serious, life-threatening side effects (such as Stevens-Johnson syndrome) from the HIV medications they were on. We were told that no child at ICC has ever had anything like Stevens-Johnson syndrome.
Five of the I I children have gastrostomy tubes, and the use of the G-tubes is appropriate. The reasons for use of the G-tubes include: severe failure to thrive; neurological impairments resulting in the inability to swallow correctly; recurrent and aspiration pneumonia; and various malabsorption syndromes.
Of the I I children, seven have improved since being at ICC and the other four have stabilized.
In between the meeting and record review we toured the facility. Many of the children were at school or out of the facility for medical appointments. A reception area in the front of the building registers each visitor and contacts the appropriate ICC staff to come to the visitor. No unapproved access to the facility or children is allowed. The reception desk has monitoring equipment which provides a constant view of all entrances to ICC as well as the fenced in play area behind the facility. The facility was very clean. The first floor contains new therapy and counseling rooms. Since many of the children go to school if medically able to do so, therapy sessions occur after school and on Saturday. The psychologist provides mental heath services and behavioral interventions onsite. A part-time (25%) pediatric psychiatrist from Columbia Presbyterian Medical Center provides consultation to the psychologist and direct care to any child with identified needs.
When the facility was approved as an RHCF, several physical plant waivers were granted acknowledging the limitations of the building, which was a former convent. The children's rooms are small but colorful and decorated to reflect the developmental age of the child in specific rooms. These have recently been repainted, including having age appropriate scenes of animals, activities, etc. as accents.
The fourth floor is a solarium that has been remodeled to reflect the needs of the aging children in residence at ICC. Staff was decorating the solarium for a resident's 16'h birthday party to be held that night.
In summary, Department staff found no indication that any of the allegations were true. The children are receiving exemplary care by dedicated and competent staff.
cc: Gloria Maki
Chart Review Date: 2/24/04
Reviewer: SC F-1
1) Child's Initials: 5) Foster Care: Yes M No
3) Date Adm to ICC: 6) Diagnoses: 1)
4) Reason for Adm: 2)
7) Most Recent: Date: 6)
8) Feeding Tube: Yes El No El If yes, 'reason:
9) G Tube: Yes No If yes, I reason:
10) Routine Monitoring:
1) CD4 Yes No El How often: months
Most recent: No. - % Date:
NA Why NA:
2) Viral load Yes 13 No E] How often: months
Most recent: Date:
3) Resistance testing Yes El No E3 NA El
Resistance present: Yes No
If yes, Date: If yes, which drugs:
11) Disease (FHV) status since at ICC: Improved 0
12) Overall condition/general activities since at ICC: Improved
Comments: Progressing E3
13) On a clinical trial: Yes No
If yes, 'trial name/number:
14) Adherence to HV Treatment:
Good/No issues M
Poor; Non-adherent M
* For pgst meds, completeVt and last columns* Child's Initials
15) HIV Medications:
C = Current; P = Past Route: PO Oral FT Feeding Tube GT = G Tube SC = Injection
NIRTI, NtIRTI: CIP Dose Frequency Route Date Began Date Stopped
Zidovudine (ZDV, AZT, Retrovir)
Didanosine (DDI,Videx, Videx EC)
Zalcitabine (DDC, Hivid)
Stavudine (D4T, Zerit, Zerit XR)
Lamivudone (3TC, Epivir)
Abacavir (ABC, Ziagen)
Emtricitabine (FTC, Emtriva)
Tenofovir (TDF, Viread)
Trizivir (ZDV, 3TC, ABC)
Nevirapine (NVP, Viramune)
Delavirdine (DILV, Rescriptor)
Efavirenz (EFV, Sustiva)
Indinavir (IDV, Crixivan)
C = Current; P = Past Route: PO = Oral FT = Feeding Tube GT = G Tube SC = Injection
NNRTI: C/P Dose Frequency Route Date Began Date Stopped
Ritonavir (RTV, Norvir)
Nelfinavir (NFV, Viracept)
Amprenavir (APV, Agenerase)
Lopinavir/ Ritonavir (LPVr, Kaletra)
Atazanavir (ATV, Reyataz)
Enfuvirtide (T20, Fuzeon)
Comments: Side Effects: