HospitalInspections.org

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Based on record review and staff interviews during the Federal Allegation Survey it was determined that the facility failed to comply with New York State Title 10 NYCRR 69-1.3 (I) (3) and (I) (4) as well as Article 28 405.21 Prenatal HIV Expedited Maternal and Newborn HIV testing in accordance with Public Health Law Article 27-7.

Findings:

See 482.54 - TAG 1076
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Based on review of medical records, hospital policies/procedures and staff interviews during the Federal Allegation Survey, it was determined that the Governing Body did not maintain its responsibilities for the oversight and operation of all services provided by the hospital as evidenced by the findings noted under the Condition of Participation for Outpatient Services. Specifically, the facility failed to identify the HIV status of an infant, therefore, the infant did not receive timely treatment and appropriate care.

Findings:

See 482.54 - TAG 1076
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Based on review of the Ambulatory Care Performance Improvement (PI) Committee Meeting Minutes and the Pediatric PI Meeting Minutes from 2011 and 2012 during the Federal Allegation Survey, it was determined that the facility failed to show evidence of measuring, analyzing and tracking indicators in the Specialty Pediatric Clinics and as a result the clinics did not report information to the hospital-wide Quality Assurance Performance Improvement (QAPI) Program.

Findings:

See 482.54 - TAG 1076
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1. Based on document review and staff interviews during the Federal Allegation Survey it was determined that thirteen (13) of sixteen (16) records were incomplete and did not contain the reports of diagnostic screening or HIV testing results for infants exposed to intrauterine HIV.

Findings:

Review of the medical record for Patient #5 revealed the infant was born to an HIV positive mother and was delivered at another facility on 04/12/11. The patient presented to the Pediatric Infectious Disease Clinic on 05/17/11 and was instructed to return in three (3) weeks. The infant returned to the Clinic on 06/21/11 and had further HIV diagnostic testing performed. On 09/06/11, another specimen was obtained and sent for HIV testing. The patient returned to the clinic on 11/01/11 and the physician noted the patient's blood results were negative. The medical record revealed no evidence of the reports to confirm the HIV diagnostic test results obtained 06/21/11 and 09/06/11.

Similar findings were identified in the medical records for Patients #3, #8, #6, #11, #13, #15, #17, # 23, #25, #28, #29 and #30.

An interview with the designated HIV Case Manager-Social Worker in the morning of Wednesday, 09/12/11 revealed that she is responsible for receiving the blood specimens for all newborns in both the Inpatient and Outpatient Clinics. She stated that she does not keep any type of log. She completes the New York State DOH duplicate form and attaches the white copy to the specimen then sends the blood sample to the Wadsworth. She keeps the pink form in an ongoing open folder in her office but there is no formal log book or tracking system. She stated there are not that many tests done at this hospital and she generally remembers what's outstanding. The folder is accessible to the Nurse Manager if for some reason she is not available. She does not currently scan or attach the forms to the patient's medical record.
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2. Based on document review and staff interviews during the Federal Allegation Survey it was determined the facility failed to have a process in place to ensure the medical records were completed in a timely fashion.


Findings:

See 482.54 TAG 1077

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1. Based on medical record review and staff interviews, the facility failed to meet the Condition of Outpatient Services. The facility failed to meet acceptable standards of care, to have complete medical records, to have qualified staff and failed to have a system for tracking laboratory results. Specifically, the facility failed to identify the HIV status of an infant, therefore, the infant did not receive timely treatment and appropriate care resulting in the death of the infant (Patient #1).

Findings:

Review of the newborn's medical record (Patient #1) revealed the infant presented to the Emergency Room on 08/04/11 at 10:00 AM after delivery at home and was admitted to the NICU with a diagnosis of Newborn Sepsis, Anemia and Perinatal HIV Exposure. The patient was started on intravenous antibiotics for an elevated WBC and AZT prophylaxis. On 08/24/11 a repeated HIV PCR was obtained because the newborn HIV screen was reactive. The infant was discharged on 08/26/11 with appropriate discharge instructions and follow-up in the Ambulatory Care Center.

Review of the "New York State Maternal Pediatric HIV Prevention Testing History and Assessment Care Program" Form documented the mother was known positive. As a result a HIV diagnostic test was drawn on the infant on 8-4-11 which was negative. A second HIV diagnostic test was then drawn on 8-24-11.

The infant was then followed in the Well Baby Clinic on 09/02/11 at 3:21 PM. The Well Baby Pediatrician (Staff #7) documented the infant had a history of Sepsis and was on AZT for HIV exposure. There was no documentation related to the HIV testing on 08/04/11 or pending laboratory results from 08/24/11.

Review of the Pediatric ID Clinic Physician's (Staff #13) note dated 09/13/11 at 5:32 PM documented that the patient was a 5-week-old female exposed to HIV completing AZT. The note documented the physician attempted to obtain a HIV PCR unsuccessfully and that the child would return to the ID clinic in one (1) month. There is no documented evidence that the physician was aware of the positive testing results dated 09/01/11.

Review of the Well Baby pediatrician's progress notes dated 09/23/11 revealed no documentation that the pediatrician reviewed the positive PCR of 09/01/11, despite documenting the infant had intrauterine exposure to HIV. The pediatrician's progress note documents the infant was seen on follow-up and had been in the ID clinic ten (10) days earlier. The physician noted that they were unable to obtain a blood specimen at that time but would try again at the next visit on 10/18/11. The physician also documented she was aware that the prophylaxis AZT was stopped. There is no documentation related to the infant's current status or indication the pediatrician reviewed the positive PCR of 09/01/11 and no documentation of communication between the two (2) clinics.

On 10/18/11 the record then documented a missed appointment with no indication that the staff implemented the patient call policy for a infant with known HIV exposure, a positive HIV screen and positive PCR on 09/01/11.

The next progress notes documented on 10/21/11 revealed the infant was again seen in the Well Baby Clinic for follow-up but had missed the 10/18/11 ID clinic visit. The nurse documented that "Albany (Wadsworth Laboratory) was called regarding the newborn report hard copy." There is still no documentation related to the HIV testing on 08/04/11 or from 08/24/11 contained in the medical record.

The infant is then seen in the Pediatric ID Clinic on 11/15/11 and the note documented the patient was seen on follow-up for HIV exposure. The notes document a plan to continue the current management, follow-up on laboratory studies: CBC and HIV PCR done today. The patient should return to the clinic in one (1) month. But there is still no documented acknowledgement indicating the infant had a positive HIV diagnostic test from 09/01/11 and no evidence that the infant was started on appropriate treatment.

Continued outpatient visits documented on 11/22/11, 01/10/12 and on 02/14/12 revealed the infant presented for Well Baby visits and the assessments documented intrauterine HIV exposure. The Well Baby pediatrician's notes documented "Hard Copy of HIV - PCR -please scan" with again no mention of the available positive reported results from 09/01/11 and 11/18/11. There is again no documentation of communication with the ID pediatrician and no documented evidence that the infant was started on appropriate treatment.

Review of the next Pediatric ID Clinic note dated 03/06/12 at 2:45 PM revealed the infant was HIV-RNA-positive. The note documented a 7-month-old baby exposed to HIV intrauterine with multiple signs of active HIV infection and parotid enlargement. The plan then documented the diagnosis of advance symptomatic HIV infection was discussed with the mother and included laboratory studies for HIV viral load, T-cell subsets, CBC with differential. The infant was started on oral Bactrim and instructed to return to the clinic in one (1) month.

Review of the HIV case manager progress note dated 03/07/12 at 10:49 AM revealed that the patient was a 7-month-old child exposed to HIV and PCR positive. The social worker then documented that the mother was given the report about the patient's status and that the patient required additional blood studies for viral load and CD4.

The last clinic note dated 03/13/12 at 11:52 AM revealed that the infant presented to the clinic in respiratory distress, was gasping, tachypneic, pale with sub-costal retraction and had a oxygen saturation level of 88%. The infant was evaluated by the physician and transferred to the Emergency Room for further care.

The infant then presented to the Emergency Room on 03/13/12 at 3:22 PM in respiratory distress after being seen at the clinic. The Emergency Room physician documented that the infant was a 7-month-old HIV positive child with a history of anemia, who had been started on oral Bactrim. The physician documented that the child was tachypneic with bilateral wheeze, coarse breath sound and retraction. The patient was started on multiple intravenous antibiotics and was to be transferred to another facility for continued care in a Pediatric Intensive Care Unit. The physician diagnosed Anemia, HIV, Pneumonia and a UTI.

Review of the infectious disease consult dated 03/14/12 from the receiving facility revealed the infant was transferred from another hospital in acute respiratory distress and required intubation. The physician documented the infant had congenital HIV with Pneumonia and Anemia with Thrombocytopenia. The physician documented that PCP must be ruled out in this positive HIV baby and continued the patient on aggressive intravenous antibiotics.
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The HIV Case Manager (Staff #14) provided copies of the Diagnostic HIV Pediatric Laboratory Requisitions dated 08/04/11 (at birth), 08/24/11 (at eighteen {18}days of age) and 11/15/11 (at twenty-nine {29}days of age) for this infant, however theses forms incorrectly documented the infant's age.

Review of the scanned data entered into the medical records revealed that the first New York State Department of Health testing results dated 08/15/11 documented: Reactive-antibody to HIV 1 is present was scanned into the record on 10/21/11.

The next test result dated 09/01/11 documented HIV-1 Positive HIV-1 RNA detected was scanned to the medical record on 03/06/12 and the third diagnostic test dated 11/18/11 also documented HIV-1 Positive HIV-1 RNA detected and was scanned into the record on 12/06/11. This information was confirmed by phone as accurate with Assistant Director of Performance Improvement (Staff #1) on 09/20/12 at 12:30 PM.

An interview in the morning on 09/11/12 with the Well Baby Pediatrician revealed that the infant was being followed in the Well Baby Clinic, as well as the Pediatric ID clinic. The physician stated that all infants born to HIV positive mothers go to the Pediatric ID Clinic and the Pediatric Infectious Disease Specialist does all the repeated testing. She stated that she was not aware of the infant's test results until 03/06/12, when it was documented by the ID specialist and did not obtain the test results herself.

An interview with the Pediatric Infectious Disease Specialist in the afternoon on 09/11/12 revealed that he did not see the first test results form 09/01/11 and there was no indication to see the infant before the next month as the infant was on AZT prophylaxis. He stated generally the first test is done in house and the second obtained by one (1) month of age. He does not treat if negative and would not start treatment until the diagnosis was confirmed. He stated that he would start treatment as soon as the blood tests were known and would follow the CDC guidelines. He could not comment of the delay in obtaining or reviewing the HIV testing results.

These findings were confirmed by interviews on 09/11/12 and 09/12/12 with the Medical Director, Administrator, Chairmen of Pediatrics, Pediatrician and the Pediatric Infectious Disease Specialist .


2. Based on medical record review and staff interview during the Federal Allegation Survey it was determined that the facility failed to show evidence of measuring, analyzing and tracking indicators in the Specialty Pediatric Clinics and as a result the clinics did not report information to the hospital-wide Quality Assurance Performance Improvement (QAPI) Program as required.

Findings:

Review of the Ambulatory Care PI Committee Meeting Minutes and the Pediatric PI Meeting Minutes from 2011 and 2012, revealed that there was no data for Specialty Pediatric Clinics.

Interviews conducted on 09/11/12 and 09/12/12 with the Administrator of Ambulatory Care Services (Staff #4) and the Chairwoman of Pediatric Care (Staff #20) respectively, confirmed these findings.


3. Based on medical record review and staff interview during the Federal Allegation Survey it was determined that the facility failed to develop definitive policies and procedures for patients who miss appointments with conditions that are considered urgent by the medical staff.

Findings:

Review of the medical record for Patient #1 revealed that the patient failed to keep an appointment for HIV PCR blood testing needed to determine diagnosis and treatment.

The electronic system then produced a letter which was sent to the patient, but there was no documented evidence that the staff implemented the "Follow-up of Broken Appointments" Policy and called the patient.

Review of the facility's policy entitled "Follow-up of Broken Appointments" dated November 2011 revealed the policy does not include guidelines on when a patient would be considered "urgent" and require an immediate phone contact. There is no guide to determine urgency and no instructions on who makes the determination. There are also no instructions on follow -up for patients who do not respond to the non-urgent missed appointment letter.

An interview with the Administrator of Ambulatory Care Center (Staff #4) on 09/11/12 at 11:30 AM revealed that it is the attending physician's responsibility to determine the urgency of the patient according the specific specialty but there is no written policy that includes these criteria.


4. Based on medical record review and staff interview during the Federal Allegation Survey it was determined that the facility failed to ensure the medical staff, nursing staff and social service staff appropriately ordered and completed the mandatory New York State Diagnostic HIV Pediatric Laboratory Requisition as required by NYS Public Health Law - Section 2781 and the facility's Bylaws (Patients #1, #5, #6, #11, #13, #17, #19, #21, #23, #25, #26, #28 and #29).

Findings:

Review of twenty-nine (29) out of twenty-nine (29) "New York State Diagnostic HIV Pediatric Laboratory Requisitions" Forms for thirteen (13) patients requesting PCR testing were signed by the HIV Case Manager (Staff #14) instead of the Pediatric Infectious Disease Physician, who did not sign the requisition forms.

During an interview in the afternoon on 09/11/12 the Assistant Director of Nursing for Maternal Child Services (Staff #5) stated for newborns in the nursery and NICU, the physician draws the blood with the nurse's assistance, the specimen is placed in the refrigerator and the nurse calls the HIV case manager who picks up the blood to send it out for testing. The case manager completes the NYS requisition form and takes care of mailing of the specimen.

An interview with the HIV Case Manager (Staff #14) during the afternoon of 09/12/12 revealed she completes the form for all infants including the section entitled "Certification by Person Authorized to Order the HIV Test" and that it was not the physician's signature.

Review of the facility's current Bylaws revealed that orders for treatment may be written by the physician, house staff and associated health care professionals which does not include the HIV case manager-social worker.


5. Based on document review and staff interviews during the Federal Allegation Survey it was determined there was no documented evidence of communication between the Well Baby Clinic and the Pediatric Infectious Disease Specialty Clinic regarding the plan of care for a HIV positive infant, resulting in a delay in treatment.

Findings:

Review of the medical record for Patient #1 (Index Case) revealed the infant was discharged from the NICU and was to follow up at the Ambulatory Care Center for HIV tests pending from 08/24/11. The infant was treated at the Well Baby Clinic and Pediatric ID Clinic from 09/02/11 until 03/13/12. The progress notes documented that the infant was being followed with no evidence that the Well Baby pediatrician was informed when the HIV testing became positive. There is no documentation that the ID pediatric specialist communicated the change in the infant status from exposed to positive and no documented change to the plan of care or treatment by either physician.

Review of the medical record for Patient #6 revealed the infant was delivered extramural on 08/02/11 to a HIV positive mother. The Newborn Screening Test result obtained on 08/04/11 was Reactive for HIV virus. The patient was discharged on 08/04/11 and instructed to follow up in the outpatient Ambulatory Care Center and Pediatric Infectious Disease Clinic. The patient was seen in the Pediatric Well Baby Clinic on 08/16/11 and again on 11/28/11, the physician noted that HIV diagnostic testing obtained was preliminary positive. The patient was instructed to go to the pediatric infectious disease physician on 12/06/11, but there was no documented communication to the pediatric infectious disease physician.

An interview during the afternoon on 09/11/12 with the Medical Director of Ambulatory Services revealed that there are no interdisciplinary conferences between the clinics. The Director stated that the physicians generally communicate in a ad hoc forum on a case by case basis.

Additional interviews on 09/11/12 and 09/12/12 with the Administrator, Chairmen of Pediatrics, Pediatrician and the Pediatric Infectious Disease Specialist revealed there is no formal mechanism in place to communicate changes in a patient's condition or treatment plan.
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6. Based on document review and staff interviews during the Federal Allegation Survey it was determined in ten (10) of sixteen (16) medical records reviewed the physician failed to, or was delayed in, signing and dating the HIV test results indicating awareness of the infants' HIV status needed to determine an appropriate treatment plan.

Findings:

Review of the medical record for Patient #19 revealed the infant was born on 01/04/11 to a HIV positive mother. The diagnostic HIV Test result obtained on 01/04/11 was Reactive for the HIV virus. The patient was discharged with follow-up in the Outpatient Ambulatory Care Center. Further diagnostic HIV specimens were obtained at the facility on 01/18/11, 03/08/11 and 06/21/11. There was no documented evidence the physician in the Pediatric Infectious Disease Clinic obtained, signed or dated the HIV test results.

Similar findings were found in the medical records for Patients #1, #6, #17, #21 and #26.

Review of the medical record for Patient #9, revealed a nine (9) month delay in reviewing the HIV diagnostic tests results, date of collection was 09/06/11 and date of review was 06/19/12. A one (1) month delay was evident for HIV test results obtained on 03/02/11 and a two (2) month delay with test results obtained on 04/05/11.

Similar findings were found in the medical records for Patients #1, #5, #17, #21, #23 and #29.

An interview with the Administrator of Ambulatory Services on Tuesday, 09/11/12 at 10:30AM revealed there is an expectation that the physician who orders a specific test will review, date and sign the results when they are placed in his mailbox but there is no written policy in place. There is also no written timeframe documenting when this would be done. There is also no current written policy for scanning test results from outside sources into the record.

An interview with the Medical Director of Ambulatory Services on Tuesday, 09/11/12 during the afternoon revealed that it would be the ordering physician's responsibility to review and authenticate all laboratory tests when they become available and to follow up on any missing testing.

During an interview on 09/12/12 at 1:15PM the Chair of Pediatrics stated that she would expect the responsible physician to review the "Panic Value" laboratory results immediately which are usually by telephone call and all other results within twenty-four (24) hours of availability then document that review. She stated "it would not be acceptable to not review the results, nor would it be acceptable to review the results only during a patient clinic visit once a month." She stated she would expect the physician to follow up on any missing test results in a timely manner.

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1. Based on document review during the Federal Allegation Survey it was determined that eight (8) of thirty-one (31) medical records reviewed did not contain the mandatory "New York State Maternal - Pediatric HIV Prevention and Care Program Test History and Assessment" Form as required by Public Health Law Article 27-F.

Findings:

Review of the medical record for Patient #4 revealed an HIV positive patient underwent a C-section on 04/19/11 and delivered Patient #3. There was no documented evidence of the required "New York State Maternal - Pediatric HIV Prevention and Care Program Test History and Assessment" Form contained in the medical records for the mother, Patient #4, and the infant, Patient #3.

Similar findings were evident in the medical records for Patients #13, #17, #23, #29, #30 and #31.

2. Based on record review and staff interviews during a Federal Allegation Survey it was determined the faciltiy failed to ensure the Outpatient Services were intragated with the Inpatient Services as evidience by the following citations.


Findings:

See 482.11 TAG A0020
482.12(a)(5) TAG A0049
482.21(a) and (b) TAG A0273
482.24(b) TAG A0438
482.54 TAG A1076