The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

EDWARD JOHN NOBLE HOSPITAL OF GOUVERNEUR 77 WEST BARNEY STREET GOUVERNEUR, NY Sept. 27, 2012
VIOLATION: GOVERNING BODY Tag No: A0043
Based on findings from document review, interview and surveillance activities conducted by the New York State Department of Health (NYS DOH) Wadsworth Laboratory, the governing body failed to assure that the hospital was compliant with all Conditions of Participation. Condition-level non-compliance was determined for the hospital's QAPI Program and Laboratory Department as noted in Tags A 263 and A576.

This resulted in an Immediate Jeopardy situation on 9-28-12, when Wadsworth Laboratory determined that the facility could not safely provide laboratory services to the patients at the hospital. Please see specific findings under Tag A 576.
VIOLATION: QAPI Tag No: A0263
Based on findings from document reviews and interviews, the hospital's Quality Assessment and Performance Improvement (QAPI) Program lacked effective processes to correct significant issues potentially affecting safe patient care. Specifically, despite the NYS DOH Wadsworth Laboratory identifying multiple deficiencies in the hospital's laboratory services during a survey on 6-14-11, and the hospital's submission of an acceptable Plan of Correction (POC) targeting completion of corrective actions by November of 2011, most of the deficiencies remained uncorrected at the time of this survey. Further, additional deficiencies in laboratory services identified by the NYS DOH Wadsworth Laboratory during surveillance activities on 8-25-12 and 9-28-12 resulted in placement of limitations on the hospital's Laboratory Department and then closure, respectively. In the meantime, the hospital's QAPI program did not focus on indicators to prevent and address these problems. See the specific findings of non-compliance in the hospital's QAPI Program, A 283 and condition-level in the Laboratory Department described in A 576.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on findings from document reviews and interviews,

-in 8 sets of minutes reviewed for 8 meetings of the hospital's distinct Pharmacy, Therapeutic and Nutrition Committee (PTNC), from June 2011 through May 2012,
-in 9 sets of minutes reviewed for 9 meetings of the hospital's distinct Internal-Family Medicine/Infection Control Meeting (IFMIC), from June 2011 through June 2012, and
-in 10 sets of minutes reviewed for 10 meetings of the hospital's distinct Quality Improvement Committee (QIC) Meeting, from June 2011 through August 2012, the hospital did not document actions aimed at performance improvement (PI) and/or measurements of the success of any PI actions taken in connection with concerns identified.

Additionally, the hospital did not prioritize its performance improvement activities on the problem-prone areas in the laboratory that were identified in a 2011 New York State Department of Health (NYS DOH) Wadsworth Laboratory survey, and did not take complete and timely actions to improve its laboratory performance.

Findings include:

-- Per reviews of the distinct committees' meeting minutes noted above, all minutes lacked documentation of actions taken for potential concerns identified. For example, despite tracking of hospital acquired infections specific to catheter associated urinary tract infections (CAUTI), medication errors, and patient falls, no follow up actions to address and improve the findings in the data were described.

During interview with the Infection Control Nurse on 9-18-12 at 3:40 pm, in regards to the issue concerning CAUTI, he/she did indicate this issue was addressed but also acknowledged the actions taken were not discussed at the QIC meetings.

-- Per review of the Pharmacy, Therapeutic and Nutrition Committee (PTNC) March 2012 meeting minutes, regarding the topic "Medication Incidents," discussion documented numerous medication errors (that is, transcription errors, omissions, wrong dose, etc.) for January and February 2012. Also in the minutes is a "Med Incident Summary Trends 2008 -2011" chart that revealed 6 omission errors (that is, 14% of all 2008 facility medication errors) increased to 28 omission errors (i.e., 49% of all 2011 facility errors). This summary also indicated that the percent of medication incidents on the medical/surgical/pediatrics unit increased from 25 errors (58% of all 2008 facility errors) to 99 errors (68% of all errors in 2011). However, the meeting minutes lacked description of the follow-up actions planned for these identified issues.

During interview with the Director of Quality Assurance/Nursing on 9-18-12 at 2:00 pm, he/she acknowledged the meeting minutes of the QIC, IFMIC and PTNC lacked descriptions of actions to be taken for the identified issues. Further, he/she acknowledged that although the Performance Review Projects for medication errors and patient falls are tracked and trended, no follow up actions to address and improve the findings in the data were described.

-- Per review of the QIC meeting minutes from June 2011 through August 2012, the minutes lacked description of specific actions to be taken (and follow up to be done) when a topic warranted action. For example, despite concerns that emergency room medical staff were not signing off on medical records (which was a documented concern in every set of meeting minutes reviewed), follow up actions to address this issue are not described.

During interview with the Registered Health Information Technician on 9-18-12 at 4:15 p.m., he/she indicated the medical record (MR) sign off issue has been addressed with multiple different actions but currently the issue remains unresolved.

During interview with the Director of Quality Assurance/Nursing on 9-18-12 at 2:00 pm, he/she acknowledged the meeting minutes of the QIC did not contain documentation of the actions taken regarding emergency room medical staff not signing off on the MR.

Additionally,
-- Per review of the NYS DOH Wadsworth Laboratory Evaluation Report (LER) of the deficient practices identified in a routine laboratory survey performed on 6-14-11, it indicated there were 14 deficiencies identified and cited, of which 2 deficiencies were repeat citations. The deficiencies included, but are not limited to, lack of the following:

*laboratory policy and procedure reviews and revisions;
*a monitor to track compliance with recording lot numbers and expiration dates of all relevant reagents, control materials and calibrators, dates of receipt/ performance verification / placed in service in Bacteriology (i.e., quality control measures);
*evaluation of staff's clinical competencies (through observation) in various areas of the laboratory and testing performed;
*a risk assessment and biosafety plan for each area of the laboratory;
*development of a policy for summarizing validations and correlations and a revised policy to include the daily recording of the room temperature of the testing and storage areas.

Also on this LER, the CEO and Director of the Laboratory Services attested by signatures dated August 6, 2011 that "this plan of correction has been/or will be implemented by the date(s) indicated." The specific dates of completion in this plan of correction range from 9-15-11 to 11-15-11 with monthly monitors thereafter.

-- Per review of the QIC meeting minutes of November 2, 2011, the minutes indicated that the Laboratory Manager/Supervisor reported that the "DOH-plans of corrections: Quality Control - completed for Bacti (bacteriology), Room Temp-completed as required." There are no other references in QIC minutes, reviewed from September 2011 through August 2012, addressing the hospital's plan of correction for the DOH laboratory survey of June 2011.

During interview with the Laboratory Manager /Supervisor on 9-18-12 at 10:15 am, she/he reviewed the total June 2011 LER, reported that the Biohazardous Risk Assessment has been completed and that all other deficiencies are currently being addressed with a targeted completion date of 10-02-12.

During interview with the Director of Quality Assurance/Nursing on 9-18-12 at 11:40 am, he/she acknowledged that there were no reports to the QIC committee, other than in the 11-02-11 minutes noted above, about the status/completion of the June 2011 NYS DOH LER plan of correction .
VIOLATION: LABORATORY SERVICES Tag No: A0576
Based on findings from document review, interview and the results of surveillance activities conducted by the NYS DOH Wadsworth Laboratory, the hospital failed to provide adequate laboratory services to meet the needs of its patients. This resulted in an immediate jeopardy situation. On 9-28-12, the Commissioner of the NYS DOH ordered complete closure of the Laboratory Department and the main campus hospital due to continued issues with the laboratory's operations. All patients were either discharged (to home or a nursing home) or transferred to an area hospital by 1:30 AM on 9-29-12. The immediate jeopardy was abated at this time. Additional findings related to laboratory services noted below.


Findings include:

-- See Tag A 283 which describes the NYS DOH Wadsworth Laboratory 2011 survey findings regarding deficiencies in the hospital's laboratory services and the hospital's failure to implement all corrective actions described in its Plan of Correction.

-- On 8-25-12 the NYS DOH Wadsworth Laboratory conducted an onsite review of the hospital's Laboratory Department in response to receipt of concerns about inadequate staffing and supplies. Several deficiencies were identified; on 8-29-12 the NYS DOH Wadsworth Laboratory placed restrictions on the laboratory tests that could be performed at the hospital and provided a written action plan for improvements to laboratory operations. (An onsite review by additional staff in the NYS DOH that same day did not identify any problems in staffing or patient care in other service areas of the hospital.)

-- On 9-7-12 the NYS DOH Wadsworth Laboratory was informed that a patient was inaccurately blood typed at this hospital on 9-5-12. (The patient received a transfusion of the wrong blood type without an adverse reaction.) The hospital voluntarily surrendered its ability to perform blood bank testing, canceled all elective surgeries with potential for blood utilization, and ceased performing obstetrical deliveries.

--On 9-28-12 the hospital's Laboratory Department failed proficiency testing that was submitted to the NYS DOH Wadsworth Laboratory.