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Based upon observation, medical record review, review of hospital's policies and procedures, medical staff bylaws, committee meeting minutes, employees files and interview it was determined that the Condition for Governing Body was not met.

Review of the documents provided by the facility during the conduct of the survey revealed the Governing Body was ineffective and did not ensure that all hospital services were adequately reviewed for the purpose of enhancing the quality of patient care as evidenced by the deficiencies cited under:

482.12 (a) (see findings at A-0044)
482.12 (b) (see findings at A-0057)
482.12 (e) (1) (see findings at A-0084)
482.27 (a) (see findings at A-0582)

Based on review of Governance Committee minutes and NYS-DOH Laboratory Survey reports (Wadsworth Center ), it was determined that the Governing Body did not effectively ensure that the medical staff responsible for Laboratory Services provided quality care to patients.

Findings include:

Minutes of the Local Governance Committee, dated September 6, 2011 & October 11, 2011 were reviewed on 12/14/11 at 4:00 PM. It was revealed that a meeting of the Local Governance Committee was held on September 6, 2011 at 4:00 PM and on October 11, 2011 at 2:30 PM. It was also noted that New York State Department of Health (Wadsworth Center) surveyed this facility in June 2011. There was no evidence in the Local Governance Committee minutes that the survey, the deficiencies cited, the corrective actions to address the violations or the monitoring tools were discussed in these Governing Body Committee minutes.

Wadsworth Center issued citations to the facility on June 14, 2011 & October 30, 2011. On 12/16/11 at 3:00 PM the facility provided copies of the Statement of Deficiencies for review. It was noted that violations cited during the June 2011 survey were not corrected. On October 30, 2011, Wadsworth Center identified multiple violations and 46 citations were issued.

Wadsworth Center found significant findings regarding possible patient harm. A termination letter was sent to the facility in November 2011. There was no evidence that the Governing Body convened to discuss and address this issue.

Wadsworth Center surveyed the facility on December 12, 2011 after receiving a complaint regarding untrained staff. The allegation was substantiated. In addition, Wadsworth surveyors identified issues pertaining to bio hazard risk assessment, safety, untrained staff and outdated policy and procedures. As a result, the hospital's blood bank service was downgraded. There was no evidence in the Governance Committee minutes that the Governing Body was aware of the serious issues in the facility's Laboratory Department.

Based on staff interview, review of records ( medical record, employee files, Wadsworth Center report), it was determined that the Chief Executive Officer (CEO) who was responsible for the management and affairs of the hospital did not effectively ensure that all patients had quality Laboratory Services.

Findings include:

The Wadsworth Center Statement of Deficiencies dated June 14, 2011 & October 30, 2011 were reviewed on 12/14/11 at 3:00 PM. During Wadsworth Center follow up survey on October 2011, the surveyor found that the previous citations were not corrected. In addition, 46 deficiencies were issued and in November 2011 a warning letter was sent to the facility.

The Chief Executive Officer (CEO) to the facility was interviewed on 12/16/11 at approximately 1:30 PM. The CEO reported that he was not aware how serious the violations in the Laboratory Department were until Wadsworth Center surveyors were on site on 12/12/11.

Review of employee files noted that 7 of 10 employees lacked updated performance improvement evaluations and assessment. It was noted that the facility failed to implement written competence, in-service training and monitoring for staff. For example in Employee file # 1 the evaluator noted that the staff needed hands on training in Meditech LIS. There was no documented evidence that this employee had this required training. There was no documented schedule for any competence and training in any of the employee file reviewed. The responsible manager of the hospital did not ensure that the above requirement was done.

During survey on 12/12/11 to 12/15/11, DOH- Laboratory (Wadsworth Center) substantiated the allegation of untrained staff. Specific references were made to patient in MR # 1, a neonate, who needed exchange transfusion but there was no qualified staff in the laboratory to complete these tasks. The Wadsworth surveyors also made reference to the patient in MR #2. On testing this patient's blood the technician found an antibody but did no further investigation of the blood to determine if the antibody was harmful to the patient. The specimen was not referred to a qualified lab for more sensitive testing.

Review of the employee file for Blood Bank Technologist (employee # 4) noted that the employee lacked competent assessment and monitoring specific to the job functions.

Based on record review and staff interview, it was determined that the facility failed to implement a system for evaluation of the quality of its contracted services to ensure that each contracted service is provided in a safe and effective manner.

Findings include:

During the course of review of seven (7) contracts on 12/16/11, it was identified that the facility did not have a formal mechanism to evaluate the quality of each contracted service provided.

Specifically, the facility failed to perform a documented quality evaluation for the following contracts reviewed:
Management Associates Inc
S and D Medical LLP (Radiology services)
Morrison Management Specialist Inc (Food service)
New York Hyperbaric & Wound Care Centers Inc
Mediserve Inc.
Medical Information Technology Inc. (MEDITECH)
Angelica Textile Services

Data was not collected to assess the performance all 7 contracts services. There was no evidence documented of specific criteria to be utilized by the facility to assess the performance of these contracted services in accordance with the terms (deliverables) unique to each contract.

On interview with the VP of Regulatory Affairs, at 12:30 PM on 12/16/11 it was found that the hospital did not collect any information for analysis of these contracts.

Based on review of the facility's Hospital Performance Improvement minutes and Department of Pathology and Laboratory Service Performance Improvement minutes for the months of July, August, September and October 2011, it was noted that the facility failed to assess the overall problems identified in the laboratory or take corrective action for deficiencies cited as a result of surveillance activities by Wadsworth Center in June 14, 2011 and October, 2011

Findings include:

Review of the Department of Pathology and Laboratory Service Performance minutes for July 2011 mentioned the June Wadsworth Center survey, and that the facility was cited with multiple deficiencies of which several were repeated deficiencies. However, there was no assessment of the cause and scope of the problems identified and no recommendation of proposed course of actions to be taken to correct the identified problems.

Review of the Department of Pathology and Laboratory Service Performance Improvement minutes for August 2011 noted that outdated reports were discussed and current issues are not being addressed. It was noted that department statistics and proficiency testing for 2009 and 2010 were discussed. The action plans were to continue plan for smooth implementation of MEDITECH and LIS and compliance with proficiency testing.

As a result of the Blood Bank Proficiency testing in the second quarter the blood bank failed the proficiency testing because the facility failed to identify Anti e (HR). However,
The Department of Pathology and Laboratory Service Performance Improvement plan of action did not explain mechanisms or actions necessary to correct the identified problems.

Review of the Hospital Performance Improvement minutes dated July 21, 2011 noted the Accreditation Compliance reported that the hospital is in receipt of the Department of Health Survey Report for the Laboratory Division and that corrective action must be completed by August 11, 2011. It was noted that the report is in various phases of being completed. The Performance Improvement minutes for August 18, 2011 did not mention if the corrective action for deficiencies cited by DOH Laboratory were completed by August 11, 2011 as stated in the July minutes, the minutes only addressed blood utilization review for the second quarter, 2011.

The facility did not develop a Hospital Wide Quality Improvement Program to address all of the problems identified during Wadsworth Center survey concerning patient care and services as evidenced by repeat deficiencies noted under Tag A 576

Based upon medical record, policy and procedure review, and interview, the nursing staff failed to evaluate the needs of 11 of 11 patients from a sample of 11 medicals records reviewed. (MR# 1 to 11).

Findings include:
MR#1. This male infant was born on 10/22/11 to O+ mother. The baby was admitted to the NICU and the diagnosis was ABO incompatibility and hyperbilirubinemia. At 10:00 a physician ordered double exchange transfusion to be done with fresh whole blood at 80 ml/kg x 2. A unit of RBC started at 2:38 PM and completed at 2:47 PM. There was no evidence that the nursing staff monitored the pre-transfusion or 15 minute post transfusion vital signs. Another unit of PRBC began at 2:49 PM ended at 3:02 PM. There was no evidence that the nurse monitored the baby's vital signs pre-transfusion or 15 minutes after the transfusion started. A transfusion of 140 cc of PRBC started at 3:03 PM and ended at 3:18 PM. There was no evidence that nursing staff monitored the pre-transfusion or 15 minute after transfusion vital signs. Nursing staff failed to document vital signs on the Transfusion Record forms as required.
MR # 2. This 44 year old male presented to the ED on 9/6/11 and diagnoses included Hepatic Encephalopathy, Acute Necrosis of Liver, Acute Renal Failure, Alcohol Cirrhosis Liver, Pancytopenia and Thrombocytopenia. At 9:00 PM a physician's order included to transfuse 2 units of PRBC. On 9/6/11 the first transfusion was administered but there was no documentation of when the transfusion was started, completed, the volume administered, or the post transfusion vital signs. Those portions of the Transfusion Record form were blank. According to the Transfusion Record form the patient had an adverse reaction of chills and temperature. On 9/7/11 another unit of PRBC was started at 7:10 AM, there was no evidence that the nurse monitored the post transfusion vital signs. The time the transfusion was completed, and the volume administered were not documented.

MR#3. On 12/5/11 at 14:00 a physician ordered 2 units of PRBC to be administered. A transfusion of PRBC started at 4:58 PM and ended at 7:00 PM nursing staff failed to document the volume of blood that was administered.

MR# 4. On 11/211 at 1:30 PM a physician ordered for I unit of PRBC during dialysis. Nursing staff documented that the transfusion started at 3:25 PM but there was no evidence when the transfusion ended or the volume of PRBC administered as those sections of the Transfusion Record form was blank.

MR# 5. This 79 year old male presented to the ED on 10/17/11. Diagnoses were gastrointestinal bleeding, acute respiratory insufficiency, and sepsis. A physician ordered transfuses 2 units of PRBC. A nurse documented that the transfusion started at 4:50 PM and but there was no evidence when the transfusion ended or the volume of PRBC administered as those sections of the Transfusion Record form were blank.

MR# 6. On 12/29/11 this patient was administered a unit of PRBC. The transfusion started at 2:40 PM there was no evidence of when the transfusion ended or the person that started the transfusion. Those sections of the transfusion record were blank.

Similar findings were found in the following medical records.
MR# 7
MR# 8
MR# 9
MR# 10
MR# 11

An interview with the Nursing Administrative Supervisor was conducted on 12/16/11 at 12:45 PM. It was confirmed that she met with Nurse Managers and the CNO and informed them that there is a major problem with Blood Transfusion Records. She stated that nursing staff must complete the laboratory Blood Transfusion Records.

Based upon medical record review, and interview, it was determined that the facility failed to ensure the medical records were completed for 11 of 11 sampled patients. (MR# 1 to 11).

Findings include:
Review of MR#1 revealed the Transfusion Record was incomplete. A unit of RBC started at 2:38 PM and the transfusion was completed at 2:47 PM. There was no documentation of pre-transfusion or 15 minute post transfusion vital signs. Another unit of PRBC began at 2:49 PM ended at 3:02 PM. There was no documentation of vital signs pre -transfusion or 15 minutes after the transfusion started. Another transfusion of PRBC started at 3:03 PM and ended at 3:18 PM. There was no pre-transfusion or 15 minute after transfusion vital signs. Nursing staff failed to complete documentation of vital signs on the Transfusion Record as required.
Review of MR # 2 revealed on 9/6/11 the patient first transfusion was administered but there was no documentation of when the transfusion started, completed, the volume administered or the post transfusion vital signs. Those portions of the Transfusion Record were left blank. On 9/7/11 another unit of PRBC was started at 7:10 AM, there was no documentation of post transfusion vital signs. The time the transfusion was completed and the volume administered were not documented. Those areas of the Transfusion Record were left blank

Review of MR#3 revealed the patient's transfusion of PRBC started at 4:58 PM and ended at 7:00 PM. The volume of blood administered to the patient was not documented on the Transfusion Record. That section of the record was left blank.

Review of MR# 4 revealed the patient's transfusion started at 3:25 PM. There was no documented evidence of when the transfusion ended or the volume of PRBC administered as those sections of the Transfusion Record were left blank.

Similar findings were not limited to MR# 5 to MR#11.

Based upon observation, record review (policies and procedures, medical staff bylaws, committee minutes) and interviews the Condition of Participation for Laboratory Services is not met.

Evidence includes the following:

Review of the information provided by Wadsworth Center - Clinical Laboratory Evaluation Program for the survey conducted on December 12-16, 2011 revealed:

The Director Fundamental Standard of Practice was evaluated as NOT MET based on the lack of director involvement in the day to day activities of the laboratory as evidenced by the following Standards of Practice evaluated as NOT MET:
? Quality Management System Fundamental Standard of Practice based on the continued lack of audits and management review;
? Human Resources Fundamental Standard of Practice based on lack of supervision, training, and competency assessment;
? Facility Design and Resource Management Fundamental Standard of Practice based on the breadth and scope of multiple deficiencies, many repeated, under this fundamental including but not limited to the lack of lot to lot testing, the failure to store reagents at the temperature
? Conditions required by the manufacturer, an incomplete biohazardous risk assessment
and failure to train staff on how to retrieve information from the Laboratory Information
System.
? Operating Procedures and Compliance Fundamental Standard of Practice as noted by
the lack of accurate and current standard procedure manuals (SOP) available to staff
and staff not following SOPs when available.
? Examination Procedures Fundamental Standard of Practice based on the lack of multisystems agreement and QC review.
? Quality Assessment and Improvement Fundamental Standard of Practice based on the
lack of policies and procedures for identification and handling of non-conformities.
? Blood Services Fundamental Standard of Practice based on the severity of issues cited
under this Fundamental.

The hospital continues to be identified as a laboratory requiring increased scrutiny based on the number of deficiencies, the lack of implementation of a plan of correction resulting in repeat deficiencies and observations of poor quality practices identified in the laboratory.

On interview with the Laboratory Medical Director / Director of Pathology on 12/16/11 at 11:00 AM, it was started that he is aware of the deficiencies that were outlined in theWadsworth Center - Clinical Laboratory surveys. He stated that he is aware that many of the laboratory policies are outdated. He is unable to schedule staff to complete the online competency assessment program because there is not enough manpower.