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Based on review of governing body bylaws, facility documents, facility policies, medical records (MR), and interview with staff (EMP), it was determined the governing body was ineffective in carrying out their responsibilities to approve, implement and enforce standards of quality management and improvement for the hospital by failing to ensure a safe setting for patients receiving blood (A286); by failing to ensure the established policy for transfusing blood was followed by ensuring the blood was prescribed by a member of the hospital staff, obtaining pre-administration vital signs, positive identification of the recipient and the blood at the patient's bedside, and obtaining vital signs 15 minutes after the transfusion was started, and failing to ensure the administrator on call was notified of a blood transfusion error (A386); by failing to ensure the step down unit was staffed with two registered nurses on the 7:00 PM to 7:00 AM shift (A392); by failing to ensure nursing assessments were completed and documented every four hours for patients in the step down unit (A396); and by failing to ensure the blood dispensed was ordered by the physician (A405).

Findings include:

Review on January 29, 2014, of Governing Body Bylaws, "Hazleton General Hospital Governance Plan for the Provision of Patient Care and the Scope of Services", dated reviewed and revised January 2013, revealed...Mission Statement: Hazleton General Hospital is organized as a community, nonprofit corporation serving health care needs in the Greater Hazleton Area. The hospital provides emergency, diagnostic and therapeutic medical services; conducts educational programs for medical and professional staff and the public; and delivers these programs and services with compassion and appropriate standards quality. ... Goals ... To strive for excellence in patient care. ... Management of the Organization Except as otherwise provided by law, the articles of incorporation of this Corporation or by these bylaws (specifically those powers reserved to the Member or delegated to GHHA [Greater Hazleton Health Alliance] as the other Body), all powers of the corporation shall be exercised by and under the authority of the Board of Directors, and the property , business and affairs of the Corporation shall be managed under the direction of the Board. Specifically, the Board shall have the power and responsibility: ... To approve, implement, supervise and enforce standards for quality management and improvement. ..."

Cross reference:
482.21(a), (c)(2), (e)(e) Patient Safety
482.23(a) Organization of Nursing Services
482.23(b) Staffing and Delivery of Care
482.23(b)(4) Nursing Care Plan
482.23(c)(1), (c)(l)(i) and (c)(2) Administration of Drugs

Based on review of facility documents, medical records (MR) and interviews with staff (EMP), it was determined the facility failed provide a safe setting for patients receiving blood by failing to ensure the established policy for transfusing blood was followed by ensuring the blood was prescribed by a member of the hospital staff, obtaining pre-administration vital signs, positive identification of the recipient and the blood at the patient's bedside, and obtaining vital signs 15 minutes after the transfusion was started, and failing to ensure the administrator on call was notified of a blood transfusion error (A386); by failing to ensure the step down unit was staffed with two registered nurses on the 7:00 PM to 7:00 AM shift (A392); by failing to ensure nursing assessments were completed and documented every four hours for patients in the step down unit (A396); and by failing to ensure the blood dispensed was ordered by the physician (A405).

Findings include:

Review on January 29, 2014, of the facility's "Patient Safety Plan (Hospital-Wide)," dated revised January 2014, revealed "Lehigh Valley Hospital-Hazleton (LTV-H) Patient Safety Plan ... Scope ... The Lehigh Valley Hospital-Hazleton Patient Safety Plan is designed to improve patient safety, improve quality of care, and to reduce risk. The plan includes all activities of Lehigh Valley Hospital-Hazleton and all other LVH-H facilities. ... Leadership Commitment ... The Board of Trustees, the President/CEO, Chief Operating Officer, Vice President of Nursing Services/CNO, Vice President of Medical Affairs,and the President of the Medical Staff require and support a comprehensive Patient Safety Plan through the establishment of policies and procedures that encompasses legal requirements, regulatory agency standards, ethical standards and staff competence. ..."

Review on January 29, 2014 of the facility policy and procedure "Subject: Patient's Bill of Rights/Responsibilities," dated approved January 2013, revealed "Patient's Bill of Rights (Outpatients and Inpatients): ... 2. The patient has the right to respectful care given by competent personnel. ... 8. You have the right to good quality care and high professional standards that are continually maintained and reviewed. ..."

Cross reference:
482.23(a) Organization of Nursing Services
482.23(b) Staffing and Delivery of Care
482.23(b)(4) Nursing Care Plan
482.23(c)(1), (c)(l)(i) and (c)(2) Administration of Drugs

Based on review of facility policy, medical records (MR), and interview with facility staff (EMP), it was determined nursing staff failed to ensure the established policy for transfusing blood was followed by ensuring the blood was prescribed by a member of the hospital staff, obtaining pre-administration vital signs, positive identification of the recipient and the blood at the patient's bedside, and obtaining vital signs 15 minutes after the transfusion was started for one of two medical records reviewed (MR1); and failed to ensure the administrator on call was notified of a blood transfusion error for one of one medical records reviewed (MR1).

Findings include:

Review on January 29, 2014, of the nursing policy "Blood and Blood Components Transfusion," dated reviewed January 2014, revealed "Policy: Blood (Packed Red Blood Cells; Whole Blood) or blood components (Fresh Frozen Plasma; Platelets; Cryoprecipitate) Must be prescribed by a member of the Hospital Medical Staff, and orders checked for clarity and accuracy. Indicate if order states to be given or kept available. Purpose: To safely administer blood and blood components. Scope: All patients receiving blood or blood components. Procedure ... 11. Baseline Vital Signs are taken prior to the blood transfusion and recorded on the Transfusion Record. Vital Signs should be checked before blood is obtained from the lab and if the patient has a temperature above 100 [degrees] F the physician must be notified before proceeding further. 12. Positive identification of the recipient and the blood/blood component is essential. Immediately before transfusion two (2) licensed personnel shall verify in writing by signing the Transfusion Record that all information identifying the container with the intended has been matched item by item at the bedside. Those items include matching the Blood Bank identification Bracelet number and the unit number to be transfused as well as all previously obtained identification materials. ... 14. Patients receiving blood transfusions must be observed within fifteen (15) minutes of the start of the transfusion and have vital signs taken and recorded on the Transfusion Record. ... 17. Documentation: The Transfusion Record must be obtained from the computer (Intranet Explore under Patient Forms) and will contain the following: a. Vital signs taken prior to the release of the blood/blood component. b. Vital signs taken prior to the start of the transfusion, the date and the time. c. Verification of the blood/blood components with two signatures of licensed personnel (one must be an an RN). d. Vital signs 15 minutes after the start of the transfusion. e. the date and time at the end of the transfusion. f. Vital signs one (1) hour post transfusion. g. Signature of the person returning any blood/blood component not used and being returned to the laboratory."

1) Review on January 29, 2014, of the transfusion record for MR1 revealed the patient's blood type was O positive. Review of MR1 revealed a nurse's note dated January 26, 2014, at 01:03 stating the following "Blood Product Administration Note 1 unit PRBC [packed red blood cells] checked as per protocol. Pre-administration vital signs taken and recorded. Started at 0100. To be infused as per protocol: will monitor for signs and symptoms of reaction. Vital signs to be obtained in 15 minutes." There was no documentation in MR1 of the pre-administration vital signs or the vital signs that were to be obtained in 15 minutes. There was no documentation of a physician's order for this blood transfusion. Review of the transfusion record for MR1 revealed no documentation of the administration of the 1 unit of PRBC.

Review on January 29, 2014, of the transfusion record for MR2 revealed the patient's blood type was B negative. MR2 was admitted on January 25, 2014, with a diagnosis of sick sinus syndrome and renal failure. Review revealed one unit of packed cells was administered in the emergency room and was still running upon arrival to the step down unit at 2221 [10:00 PM].

Review of MR2 confirmed a physician's order for a second unit of blood. The second unit of blood was ordered on hold at 9:30 PM on January 25, 2014.

Review of MR2 revealed a transfusion record with a date of January 25, 2014. The first unit of B negative blood was started in the emergency room at 2115 [10:15 PM] and completed on the stepdown unit at 0030 [12:30 AM]. There was a second unit of B negative blood documented on the transfusion record as being started at 0044. The signatures of EMP4 and EMP5 were crossed out on the second line of the transfusion record. This was the line where staff were to document that two licensed personnel checked the blood.

Interview with EMP3 during review of MR2 confirmed the signatures of EMP4 and EMP5 were crossed out on the second line of the transfusion record of MR2 because it was at this point EMP5 realized the blood given to MR1 (who was O positive) was the unit of blood that belong to MR2 (who was B negative).

Interview with EMP4 on January 29, 2014, at 1:35PM confirmed EMP4 and EMP5 checked the unit of B negative blood that was given to MR1. EMP4 confirmed the policy required the blood to be checked at the patient's bedside. EMP4 confirmed the unit of blood was checked at the nursing desk and not at the bedside, as per established facility policy.

Interview with EMP5 on January 29, 2014, at 1:35 PM confirmed they were overwhelmed with the staffing of the Step Down Unit on January 29, 2014. EMP5 stated they requested EMP7 provide additional staff, and no additional staff was provided. EMP5 stated they went to the lab to pick up the blood for MR1. EMP5 confirmed they took MR2's Transfusion Record to the lab and double checked it with the lab technician for the correct unit of blood. EMP5 confirmed they checked the blood with the LPN at the nursing station. EMP5 confirmed the check was not performed at the patient's bedside. EMP5 confirmed they did not check the patient's identification band.
EMP5 confirmed the unit of B negative blood for MR2 was given to MR1 (who was O positive).

Continued interview with EMP5 confirmed the error was not identified until after the wrong unit of blood was infused. EMP5 confirmed they notified EMP8 and the physician. The patient was unresponsive, and a Code Blue was called.

2) Review on January 30, 2014 at 10AM of the facility policy "Administrator On Call," dated reviewed January 2013, revealed "Any matters requiring the Administrator On Call shall be processed through the nursing supervisor who will evaluate all situations before contacting the on-call person. The nursing supervisor has administrative responsibility for the hospital during off hours. Employees in each department should consult with the nursing supervisor for administrative problems. Situations beyond the supervisor's authority are referred to the administrator on call."

Review on February 4, 2014, at 10:45 AM of the facility policy "Reporting of Serious Events-Pennsylvania Medical Care Availability and Reduction of Error Act (Act 13 of 2002)" revealed "Scope ... For the purpose of this policy, events that seriously compromise quality assurance or patient safety will include: Death due to injury, suicide or unusual circumstance while a patient. ... Reporting: All events that are or may be considered meeting the criteria cited in this policy will be reported immediately to the hospital administrator/administrator of call. A report including the preliminary findings will be prepared and reported within twenty-four hours."

Review on January 29, 2014, of MR1 revealed the patient was admitted on of January 20, 2014, at 4:18 PM from the physician's office with a diagnosis of right leg ischemia / foot pain. The patient had a left arteriogram performed on January 21, 2014. The results of the arteriogram were a common femoral artery occlusion. The patient was scheduled for a left femoral-popliteal bypass on January 24, 2014. The patient was admitted to the Intensive Care Unit (ICU) post operatively on January 24, 2014 at 7:05 PM. The patient was ventilated and in normal sinus rhythm. The patient was then transferred to the Cardiac Step-Down Unit on January 25, 2014 at 21:14 PM. A unit of O positive packed red blood cells was order and administered at 6:55 PM.

Review of MR1 revealed a nurse's note dated January 26, 2014, at 01:03 stating the following "Blood Product Administration Note 1 unit PRBC [packed red blood cells] checked as per protocol. Pre-administration vital signs taken and recorded. Started at 0100. To be infused as per protocol: will monitor for signs and symptoms of reaction. Vital signs to be obtained in 15 minutes." There was no documentation the vital signs were taken prior to the blood administration. There was no documentation the pre administration vital signs were taken. There was no documentation of the patient identification verification as required by the facility policy and procedure or vital signs being taken as per policy and procedure for blood administration. There was a reassessment at 5:00 AM when a "Code Blue" was called on the patient when EMP5 went into the patient's room to discontinue the blood infusion. There was no documentation of a physician's order for this unit of packed red blood cells to be administered to the patient. A "Code Blue" was called on the patient at 5:00 AM on January 26, 2014. The 7:00 PM -7:00 AM Supervisor noted compressions were in progress on arrival to patient's room. The "Code" was called (discontinued) at 6:18 AM on January 26, 2014 and the patient pronounced by OTH2.

Interview with EMP8 on January 30, 2014 at approximately 9:40AM confirmed that a unit of blood was administered to the wrong patient (MR1) and the patient had expired. EMP8 confirmed they notified EMP2 about the incident and was told by EMP2 that they would notify the administrative officer of the day on Monday. EMP8 also confirmed EMP5 had not called for relief to the floor so EMP5 could go to the lab to obtain a unit of blood.

Interview with EMP2 on January 30, 2014 at 9:30 AM confirmed EMP8 did not report the blood administration error to the administrator on call. EMP2 stated they instructed EMP8 not to call the administrator on call and they would discuss it on Monday morning.

Interview with OTH1 on January 29, 2014, at 1:45PM confirmed B negative and O positive blood are not compatible. OTH1 confirmed the administrator on call was not notified of this error until Monday morning. OTH1 confirmed the administrator on call should have been called on the night it occurred.

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to ensure the step down unit was staffed with two registered nurses on the 7:00 PM to 7:00 AM shift.

Findings include:

Review on January 30, 2014, of the facility policy "Step -Down Unit Scope of Care," dated last revised January 15, 2014, revealed "... III General Information ... E. A staffing plan is developed based upon skill level, skill mix, competencies, patient census and patient acuity. The step-down unit will have two RN'S (registered nurse) minimally, each shift. The staffing pattern will vary each shift, each day based upon the census and acuity of patients requiring care."

Review of the nursing schedules for the step down unit for the last three months revealed the following 7:00 PM to 7:00 AM shifts were staffed with one RN and one LPN (licensed practical nurse):

November 11, 2013, with a patient census of 7,
November 12, 2013, with a patient census of 9, with second RN provided from 7:00 PM -11PM,
November 15, 2013, with a patient census of 9,
November 17, 2013, with a patient census of 8,
November 26, 2013, with a patient census of 3,
December 4, 2013, with a patient census of 5,
December 5, 2013, with a patient census of 7,
December 9, 2013, with a patient census of 11, with additional LPN provided from 11:00 PM to 7:30 AM,
December 10, 2013, with a patient census of 7,with an additional RN from 7:00 PM to 11:00 PM,
December 13, 2013, with a patient census of 6,
December 14, 2013, with a patient census of 7,
December 17, 2013, with a patient census of 8,
December 18, 2013, with a patient census of 9,
December 19, 2013, with a patient census of 6,
December 23, 2013, with a patient census of 8,
December 27, 2013, with a patient census of 8,
December 28, 2013, with a patient census of 5,
December 29, 2013, with a patient census of 7,
December 31, 2013, with a patient census of 6 with an additional LPN from 7:00 PM to 7:00 PM,
January 7, 2014, with a patient census of 9, with an additional RN from 7:00 PM to 11:00 PM,
January 10, 2014, with a patient census of 9,
January 11, 2014, with a patient census 9, with an additional RN from 11:00 PM to 7:30 AM,
January 12, 2014, with a patient census of 7,
January 15, 2014, with a patient census of 8,
January 16, 2014, with a patient census of 8, with an additional LPN from 7:00 PM to 11:00 PM,
January 20, 2014, with a patient census of 10, with additional RN from 11:00 PM to 7:30 AM,
January 24, 2014, with a patient census of 7, and
January 25, 2014, with a patient census of 9.

Interview on January 29, 2014, with EMP2 confirmed the step down unit was required to be staff with two registered nurses. EMP2 confirmed the findings noted above for the staffing schedules for the last three months. EMP2 confirmed the step down unit was not staff by two registered nurses, as required by the facility's staffing plan.

Interview with EMP4 on January 29, 2014, at 1:35 PM confirmed that on the night of January 25, 2014, the department was extremely busy with an admission, a rapid response, a full cardiac arrest, and a psychiatric patient who had pulled out several lines and was very uncooperative with staff. EMP4 stated EMP5 requested additional staff from EMP7 early in the shift, and no additional staff was provided. EMP4 stated EMP5 was completely overwhelmed. EMP4 confirmed it was not within the scope of practice of the LPN to administer blood, give intravenous push medications, or complete an entire admission assessment. EMP4 confirmed the LPN was left alone in the step down unit approximately 10-15 minutes on January 26, 2014, while EMP5 went to the laboratory to obtain a unit of blood. EMP4 further confirmed this was a common practice.

Interview with EMP3 on January 30, 2014, at 2:00 PM confirmed the the nursing staff told EMP3 the step down unit was staffed with one staff member when the other nursing staff member went to the lab for blood. EMP3 was not aware of this practice.

Based on review of facility policy, medical records (MR) and interview with facility staff (EMP), it was determined the facility failed to ensure nursing assessments were completed and documented every four hours for patients in the step down unit for eight of ten medical records reviewed (MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9).

Findings include:

Review of the facility policy "Content of Medical Record," dated reviewed January 1, 2014, revealed "Procedure: 1. A complete medical record is maintained for every individual assessed or treated. ... 10. Adequate assessments of the patient's condition, treatment, and care must be documented throughout the patient's stay."

Interview with EMP3 confirmed that it was the practice of the step down unit to assess the patients and document the assessment in the nursing notes or flow sheets every 4 hours.

Review of MR2 on January 29, 2014, revealed documentation of nursing assessments on January 26, 2014, at 01:58 and 08:00 AM.

The following medical records were reviewed on January 30, 2014:

Review of MR3 revealed documentation of nursing assessments on January 26, 2014, at 00:00 and 07:30 AM.

Review of MR4 revealed documentation of nursing assessments on January 26, 2014, at 00:00 and 08:00 AM.

Review of MR5 revealed documentation of nursing assessments on January 26, 2014, at 01:58 AM and 08:00 AM.

Review of MR6 revealed documentation of nursing assessments on January 26, 2014, at 01:38 AM and 08:28 AM.

Review of MR7 revealed documentation of nursing assessments on January 26, 2014, at
00:00 and 08:00 AM.

Review of MR8 revealed documentation of nursing assessments on January 26, 2014, at 01:45 AM and 07:06 AM.

Review of MR9 revealed documentation of nursing assessments on January 26, 2014, at at 01:51 AM and 08:00 AM.

Interview with EMP4 on January 29, 2014, at 1:35 PM confirmed nursing assessments on the step down unit were to be completed every four hours. EMP4 confirmed the 4:00 AM assessments were not charted in the patients' medical records.

Based on review of facility policy, medical records (MR), and interview with staff (EMP), it was determined the laboratory failed to ensure the blood dispensed was ordered by the physician for one of two medical records reviewed (MR2).

Findings include:

Review of the laboratory policy "Release of Blood/Blood Products," dated reviewed May 13, 2013, revealed "Principle: To provide a method of issuing blood, blood products and Rh Immunoglobulin that ensures that the blood component being issued is intended for the correct recipient. "Procedure -Stepwise: 1. The laboratory will process the order as per standard operating procedure for that product."

Review on January 29, 2014, of MR2 revealed an admission date of January 25, 2014, with a diagnosis of sick sinus syndrome and renal failure. Documentation revealed one unit of packed cells was administered to MR2 in the emergency room and was still running upon arrival of the patient to the step down unit at 2221 (10:21 PM). Further review of MR2 revealed the second unit of blood was ordered on hold by the physician at 9:30 PM on January 25, 2014.

Documentation in MR2 revealed a transfusion record dated January 25, 2014. The first unit of B negative blood was started in the emergency room at 2115 (10:15 PM) and completed on the stepdown unit at 0030 (12:30AM). There was a second unit of blood documented on the transfusion record as being started at 0044. The signatures of EMP4 and EMP5 were crossed out on the second line of the transfusion record. This was the line where staff were to document that two licensed personnel checked the blood.

Interview with EMP3 during the medical record review confirmed the signatures of EMP4 and EMP5 were crossed out because it was at this point EMP5 realized the blood given to another patient (MR1) was a unit of B negative blood for MR2. The last physician order noted in MR2 was to hold the second unit of packed cells. This physician order was documented at 9:30 PM on January 25, 2014. EMP3 confirmed there was no physician's order to administer/transfuse the second unit of blood to MR2.

Interview with EMP9 at 10:30 AM on January 29, 2014, confirmed was not the laboratory's process to check for the physician order prior to releasing blood products for transfusion. EMP9 confirmed the lab staff would see the initial order for type and cross and transfuse. EMP9 confirmed the lab personnel would not have seen an order to hold the unit of B negative blood, as that was not a part of the laboratory process. EMP9 stated it was nursing's responsibility to check for the physician's order immediately prior to the transfusion.

EMP9 confirmed the nursing staff would bring the blood slip down, along with the transfusion record of the patient who was receiving the blood, and both would sign the transfusion record to confirm the proper identification of the patient to the blood slip and the unit of blood. EMP9 confirmed the unit of B negative blood was released for MR2, as that was the blood slip and transfusion record the nursing staff brought to the laboratory.