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.

WILKES-BARRE GENERAL HOSPITAL 575 NORTH RIVER STREET WILKES-BARRE, PA 18764 Jan. 14, 2013
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility documents, medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure blood was administered safely for eight of eight medical records reviewed (MR1, MR2, MR3, MR4, MR5, MR6, MR7, and MR8).

Findings include:

Review on January 11, 2013, of the facility's "Quality Improvement Plan Wilkes-Barre General Hospital 2012," dated reviewed August 16, 2012, revealed "I. Mission: The mission of Wilkes-Barre General Hospital Quality Improvement Program is to guide all departments within the hospital to work within concert with our patients, families, and physicians to provide excellent care in a cost effective, patient centered manner. ... IV. Philosophy: The mission of the hospital is based upon a comprehensive system that allows for implementation of continuous improvement through the following: ... The recognition that all individuals are responsible for quality of care / services, patient safety, and performance improvement. ... V. Goals: The goals of the program are as follows: ... To ensure that the same level of high quality care is provided throughout the organization."

Review on January 11, 2013, of the facility document "Patient's Bill of Rights," dated effective July 2011, revealed ... Your Rights ... As our patient, you have the right to safe, respectful, and dignified care at all times. You will receive services and care that are medically suggested and within the hospital's services, its stated mission, and required law and regulation. ... Care Delivery You have the right to: ... Receive care in a safe setting free from an form of abuse, harassment, and neglect. Receive kind, respectful, safe quality care delivered by skilled staff. ... Receive efficient and quality care with high professional standards that are continually maintained and reviewed."

Review on January 11, 2013, of facility documents revealed two reports filed regarding a transfusion error. These reports confirmed the blood administered to MR1 was administered in error. The blood was a unit intended for MR2. MR1's blood type was O positive. MR2's blood type was B negative.

Review on January 11, 2013, of MR1 revealed the following nurses' notes "First unit of RBC [red blood cells] up at 2248, temperature elevated, medicated per doctors order, error found in blood initiation at 2330, blood stopped immediately, [OTH1] notified, no signs or symptoms of [DIAGNOSES REDACTED]"

Continued review of MR1 revealed the following nurses' notes for the 11-7 shift of January 8, 2013, "1:10 AM Respirations 30-40, urine bloody, skin mottled, 3:15 AM urine output less than 50 cc last two hours." 10:00AM note revealed "Awake, head side to side, blood pressure down, tardive dyskinesia." Further review of MR1 revealed the physician progress note dated January 8, 2013, "acute transfusion [DIAGNOSES REDACTED] reaction with 0 urinary output."

Interview with EMP1 on January 14, 2013, confirmed the documentation noted above in MR1.

Cross Reference
109.21 Policies (Nursing) -Principles
125.2 Blood Transfusion
VIOLATION: BLOOD TRANSFUSIONS AND IV MEDICATIONS Tag No: A0409
Based on review of facility policy, facility documents, medical records (MR), and interview with facility staff (EMP), it was determined the facility failed to ensure established policies for blood administration were followed for eight of eight transfusion medical records reviewed (MR1 MR2, MR3, MR4, MR5, MR6, MR7, MR8).

Findings include:

Review on January 11, 2013, of the facility policy "Blood and Blood Component Transfusions," dated revised November 2012, revealed "Purpose: To establish a policy and guidelines for the administration of blood and blood components when restoring blood loss from surgery, hemorrhage or disease, or to provide passive immunity. Policy: ... 5. Absolute and positive identification of the donor blood and the recipient / patient will be made and verified in writing at the time of issue and at the time of infusion. ... Verification ... 3. At the time of the infusion, two nurses (registered nurses, a registered nurse and a graduate nurse or a registered nurse and a licensed practical nurse) will compare the transfusion order with the physician order on the medical record and sign the order sheet and the transfusion slip as verification of same. The Patient and product identification will then be verified at the bedside immediately before transfusion, by two registered nurses, a registered nurse and a graduate nurse or a registered nurse and a licensed practical nurse. The Hollister bracelet system, a three way identification system, applicable when transfusing cross matched products, will be used to coordinate the transfusion candidate, blood specimen, unit cross-matched, medical record and unit tag / transfusion record and the transfusion slip. The two nurses will sign the transfusion slip of verification of product and patient identification and matching."

Review on January 11, 2013, of facility documents revealed two reports were filed regarding a transfusion error. These reports confirmed the blood administered to MR1 was administered in error. The blood was a unit intended for MR2.

Review on January 11, 2013, of MR1 revealed a written order dated January 7, 2013, at 1815 "Transfuse 2 units RBCS [red blood cells]." There were no signatures noted on this order by EMP4 and EMP5 to confirm verification by two nurses for the transfusion, as required by the facility policy.

Review on January 11, 2013, of MR2 revealed two electronic orders, one at 0704 on January 7, 2013, "Transfuse 3 units of red blood cells" and a second electronic order at 1031 on January 7, 2013, "transfuse red blood cells 2 units stat." There were no signatures on these orders confirming the verification by two nurses as required by the facility policy.

Review on January 11, 2013, of MR1 revealed the following nurses' notes "First unit of RBC [red blood cells] up at 2248, temperature elevated, medicated per doctors order, error found in blood initiation at 2330, blood stopped immediately, [OTH1] notified, no signs or symptoms of blood transfusion reaction, Protocol initiated will continue to monitor closely."

Interview on January 11, 2013 at 12:50 PM with EMP4 confirmed EMP4 and EMP5 did not take the unit of blood into the room of MR1 to perform the bedside verification as required by the facility policy. EMP4 noted the unit of blood was checked at the nurses' station.

EMP5 was not available for interview.

Interview on January 11, 2013, at 1:15 PM with EMP1 confirmed EMP5 was questioned by the facility concerning the transfusion error, and EMP5 confirmed the blood was not checked at the bedside as required by facility policy. EMP1 confirmed the facility policy for a blood transfusion was not followed for MR1 and MR2.

Review of MR3, MR4, MR5, MR6, MR7 and MR8 revealed no documentation the orders for transfusion were signed by the two nurses completing the verification check as required by the facility policy.

Interview with EMP2 on January 11, 2013, at 2:00 PM confirmed there was no documentation that two nurses had performed the verification check for physician orders in MR3, MR4, MR5, MR6, MR7 and MR8.
VIOLATION: ADEQUACY OF LABORATORY SERVICES Tag No: A0582
Based on review of facility documents, medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure blood transfusions were provided to meet the needs of the patients for of eight of eight medical records reviewed (MR1 MR2, MR3, MR4, MR5, MR6, MR7, and MR8).

Findings include:

Review of January 14, 2013, of the job description "Administrative Director Pennant Laboratory Services Wilkes-Barre General Hospital," revealed "Position Purpose - Oversee a wide variety of administrative, fiscal, and technical activities to ensure the efficient operation of the clinical laboratory and compliance with corporate policies. ... Responsible for the quality control program, quality assurance, and the point of care testing programs within the clinical laboratory. ... Plan, organize, direct, control, and evaluate the work of the clinical laboratory and coordinating it with other areas of the hospital. ..."

Review on January 14, 2013, of the facility policy and procedure "Blood and Blood Component Transfusions," dated reviewed November 2012, revealed "Purpose: To establish a policy and guidelines for the administration of blood and blood components when restoring blood loss from surgery, hemorrhage or disease, or to provide passive immunity. Policy: ... 5. Absolute and positive identification of the donor blood and the recipient / patient will be made and verified in writing at the time of issue and at the time of infusion. ... b) At the time of issue: 1. The Blood Bank personnel who issue the blood product and the nursing unit representative who receives the blood product will identify the blood and review all the information on the attached transfusion record / tag and physician order. ..."

Review on January 11, 2013, of facility documents revealed two reports filed regarding a transfusion error. These reports confirmed the blood administered to MR1 was administered in error. The blood was a unit intended for MR2. MR1's blood type was O positive. MR2's blood type was B negative.

Interview with EMP3 on January 11, 2013, at approximately 9:30 AM confirmed the Blood Bank personnel check the transfusion pickup slip for MR2. EMP3 confirmed the Blood Bank personnel did not review the physician order for MR2 at the time the blood was issued.

Interview with EMP6 on January 11, 2013, at approximately 10:50 AM confirmed the Blood Bank personnel check the transfusion pickup slip and not the physician order at the time of issue of blood products.

Interview with EMP8 on January 14, 2013, confirmed that MR2 was to have 2 units of blood stat. EMP8 further confirmed the third unit of blood, which was administered to MR1 in error, should not have been released by the laboratory staff, as there was no physician's order for this third unit of blood.

Cross Reference
109.21 Policies (Nursing) - Principle