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Based on interview and record review, the facility failed to ensure a mechanism was in place to evaluate the quality of each contracted service. The facility failed to ensure contracted laboratory services were provided in a safe manner. The facility failed to ensure this information regarding all of the contracted services, including nurse registries, was presented to the Governing Body. In addition, this resulted in the Governing Body being unaware of the quality of care being provided or not provided by some contracted services.

Findings:

During an interview with the Laboratory Manager (LM) and the Director Clinical Laboratory (DCL), on February 3, 2015, at 1:30 p.m., the LM stated the facility had contracted with two outside laboratories. The LM stated the facility had a contract with an organization that provided blood for transfusions, and another company that did specialized testing (including test required by the employee health department). The LM stated the facility laboratory monitored the contracted services and tracked how quickly results were available. During this interview, the LM stated the laboratory quality assurance information was presented in the Clinical Laboratory Quality Assurance (QA) Council, but was not shared with the hospital-wide QA department.

The "Clinical Laboratory- Quality Assurance Monitor Report," was reviewed. The report indicated in March 2014, the "draw to verify time" for rubella, rubeola, mumps and varicella zoster, (used by the employee health department as part of the pre-employment testing) had increased by 9.1 hours to 38.2 hours. The LM stated, at one time, the employee health department was concerned about the length of time it was taking for their tests. The contracted laboratory indicated samples were being sent to an out of state laboratory for processing.

On February 2, 2015, at 11:30 a.m., while touring the facility's Trauma Intensive Care Unit, Registered Nurse (RN) 5 was interviewed. RN 5 stated he was a travel nurse (a nurse provided by contract with an outside agency on a temporary basis), who had a six month contract with the facility.

On February 4, 2015, at 3 p.m., during an interview with the Director of Clinical Quality Improvement, (DCQI) and the Chief Nursing Officer (CNO), the DCQI stated the facility began evaluating clinical contracts as a result of the last survey. The CNO reviewed the list of contracted services evaluated and referred to the Governing Body, but was unable to find evidence the contracted agencies providing laboratory services were evaluated or presented to the Governing Body.

On February 5, 2015, a list of facility contracted services was reviewed. The list contained 35 pages of agency names. The first page of the list, contained 32 agencies that were contracted to provide a service with the facility. Included in this list were agencies that provide nurses on a temporary basis (traveler nurses).

On February 5, 2015, the Governing Body Meeting Minutes for October 2014, were reviewed. A document titled "Clinical Agreements," dated October 2014 was reviewed. The document contained a list of 17 contracting agencies, the type of agreement, the effective and termination dates, comment section, and the name of the person responsible for "Performance Expectation Retrieval." The list did not include either of the two agencies providing laboratory services. The list did not contain the names of any agency providing temporary (travel) nurses to the facility.

There was no evidence that any other contracted service, including the two laboratory services and the traveler agency, were evaluated for quality of care and this information was presented to the GB.

Based on observation, interview and record review, the facility failed to ensure patient's rights were protected by:

1. Failing to ensure the "Transfusion Information and Consent," form was completed prior to Patient 23 receiving blood on October 21, 2014. This failure had the potential for Patient 23 (or his family members) not having the information needed to make an informed decision about the risks and benefits of blood transfusions (refer to A0131);

2. Failing to ensure the restraint orders for one sampled patient (Patient 31), were dated and timed when signed by the physician (refer to A0173); and

3. Failing to ensure computer generated orders matched the facility policy and procedure for the physician required assessment for two sampled patients (Patients 6 and 8.)(refer to A0173)

The cumulative effect of these systemic problems resulted in failure of the facility to ensure patients were receiving quality care in a safe and effective manner.

Based on interview and record review, the facility failed to ensure the "Transfusion Information and Consent," form was completed prior to Patient 23 receiving blood on October 21, 2014. This failure had the potential for Patient 23 (or his family members) not having the information needed to make an informed decision about the risks and benefits of blood transfusions.

Findings:

The record for Patient 23 was reviewed on February 4, 2015. Patient 23 was admitted to the facility on October 17, 2014, for treatment of multiple trauma due to a motor vehicle accident. According to the "Emergency Reports," Patient 23 was admitted to the intensive care unit with a closed head injury, intracranial bleeding, respiratory failure, kidney laceration, and rib and pelvic fractures. Patient 23 was intubated (tube placed in throat) and mechanically ventilated (artificial respirations) due to his decreased level of consciousness.

A review of scanned "Transfusion Records," indicated Patient 23, was transfused with two units of blood on October 21, 2014.

On February 4, 2015, the patient's electronic record was reviewed with the Accreditation and Regulatory Compliance Officer (ARCO). The record contained one "Transfusion Information and Consent," form. The form was signed and dated by Patient 23's family member on October 26, 2014, (five days after Patient 23 received blood). By signing the form, Patient 23's family member certified they had received the information, "A Patient's Guide to Blood Transfusion." The document indicated, "Our nation's blood supply is very safe and high in quality. Nothing in life is risk free, however, the risks associated with blood transfusions are very small."

In addition, there was no physician signature in the area for physician verification of informed consent, on Patient 23's "Transfusion Information and Consent," form. By signing, the physician was verifying the patient or family member received "A Patient's Guide to Blood Transfusion," concerning the advantages, disadvantages, risks and benefits of autologous (self) blood and of directed and non-directed homologous blood from volunteers.

During an interview with the ARCO, on February 4, 2015, at 10 a.m., the ARCO stated there was no evidence of a blood transfusion consent in Patient 23's record, but every consent for surgery also had a section about blood transfusions.

During a tour of the Intensive Care Unit (ICU) on February 4, 2015, at 2 p.m., Registered Nurse (RN) 4, stated the surgical consent form did not replace the requirement to obtain a consent for a blood transfusions. RN 4 stated a blood transfusion consent was now required to obtain blood from the blood bank.

The facility's policy and procedure titled "Informed Consent," with a last revised date of September 17, 2014, was reviewed. The policy indicated it's purpose was to safeguard patient's rights of self-determination through disclosure of the nature of the treatment, the risk, possible complications, expected benefits or effects of the treatment, and any alternatives to the treatment with their risks and benefits. According to the policy, an "Informed Consent," was required for those procedures that were more complex or involve material risks that were not commonly understood. The policy indicated, "The physician is responsible for obtaining the informed consent and for documenting this discussion on the record..."

A review of the facility's blood transfusion competency form titled, "Administration of Blood and Blood Products 2015," was conducted. The competency document was completed annually by nursing staff. According to the document, the nurse will verbalize knowledge of the requirement for physician to obtain informed consent and documentation prior to the transfusion (unless emergent).

Based on interview and record review, the facility failed to:

1. Ensure the restraint orders for one sampled patient (Patient 31), were dated and timed when signed by the physician; and

2. Ensure computer generated orders matched the facility policy and procedure for the physician required assessment for two sampled patients, (Patients 6 and 8.)


Findings:

1. On February 2, 2015, the record for Patient 31 was reviewed. Patient 31 was admitted to the facility on January 27, 2015. The physician order for non-violent restraints was initiated on January 27, 2015, at 9:45 p.m. The indication for the restraints wa due to the inability of Patient 31 to comprehend or follow direction to refrain from activities that can injure self; observed trying to climb out of bed when instructed not to do so; and cognitive impairment, observed attempting to disconnect or remove therapeutic devices.

The facility form titled, "Physician Order Non-Violent Restraint," for Patient 31 was reviewed. The form indicated, "Signature below indicates that I have performed a face-to-face (re)assessment of the patient and the patient requires restraint." Just below the statement was an area for physician signature, date, and time.

The following orders were not dated and/or timed at the time they were signed by the physician:

a. January 28, 2015, noted by the nurse at 8 a.m., and signed by the physician with no date and time;
b. February 1, 2015, signed by physician and included date but no time; and
c. February 2, 2015, signed by physician and included date but no time.

2. On February 5, 2015, the record for Patient 6 was reviewed. Patient 6 had an order for non-violent restraints initiated on January 31, 2015, at 7 a.m. The indication for the restraints was due to Patient 6's inability to comprehend or follow directions to refrain from activities that can injure self; cognitively impaired. Will not ask for assistance. Disconnects and or removes therapeutic devices.

Patient 6's record indicated an initial written order dated January 31, 2014, at 7 a.m., documented on a form titled, "Physician Order Non-Violent Restraint." The form indicated, "My signature below indicates that I have performed a face-to face (re)assessment of the patient and the patient requires restraint."

Further review of Patient 6's record indicated the computer generated orders following the original written order, did not have a physician statement indicating a face to face assessment was completed by the ordering physician for February 2, 2015.

b. On February 5, 2015, the record was reviewed for Patient 8. Patient 8 had an order for non-violent restraints initiated on January 28, 2015, at 6:04 a.m. The indication for the restraints was due to Patient 8's inability to comprehend or follow directions to refrain from activities that can injure self; cognitively impaired. Will not ask for assistance. Disconnects and or removes therapeutic devices.

Patient 8's record indicated an initial written order dated January 28, 2015, at 6:04 a.m. documented on a form titled, "Physician Order Non-Violent Restraint." The form indicated, "My signature below indicates that I have performed a face-to face (re)assessment of the patient and the patient requires restraint."

Further review of Patient 8's record indicated the following computer generated orders did not have any indication a face to face evaluation was completed by the ordering physician:

- January 10, 2015, 10:28 a.m.
- January 11, 2015, 11:39 a.m.
- January 13, 2015, 8:50 a.m.
- January 30, 2015, 10:15 a.m.
- February 1, 2015, 1:52 p.m.
- February 2, 2015, 2:38 p.m.
- February 3, 2015, 2:11 p.m.

The computer generated orders indicated for renewal, "Continuous, if the patient continues to meet the requirements for restraint, please reorder."

An interview was conducted with the Accreditation and Regulatory Compliance Officer (ARCO), regarding the computer generated orders for both Patients 6 and 8, on February 5, 2015, at 11 a.m. The ARCO stated the computer generated policy did not match the written policy. The ARCO stated the indication or written statement, that physician's completed a face to face assessment was not implemented on the computer generated orders for renewal of the restraints orders.

The policy and procedure titled, "Restraint and Seclusion," dated August 30, 2012, was reviewed. the policy indicated, "Restraint orders must be renewed on a daily basis... A face-to-face physical exam by the physician at least every 24 hours determines the clinical justification for the continued use of restraints. Restraint orders must be dated and timed when signed by the physician..."

Based on interview and record review, the facility failed to ensure an adverse patient event was reported as defined in their policy, for one sampled patient (Patient 1). Patient 1 had a blood transfusion reaction due to receiving the wrong blood type, developed acute renal failure, and required renal dialysis while hospitalized and upon discharge. As a result of the failure of facility staff to report the event, the facility was unaware of the incident until November 17, 2014, when they received notification from a regulatory agency.

Findings:

A blood transfusion is the transfer of blood or blood products from one person (donor) into another person's bloodstream (recipient). This is usually done as a life saving maneuver to replace blood cells or blood products lost through severe bleeding, during surgery when blood loss occurs or to increase the blood count in an anemic patient.

There are four blood types: A, B, AB, or O (ABO group). Every person has one of these four blood types.

In addition, each person's blood is either: Rh-positive, or Rh-negative. Type O negative blood - is safe for just about everyone. People with type O blood are referred to as universal donors; and type O blood is used for emergencies in which there is no time to test a person's blood type. Before undergoing transfusions, a patient undergoes a type and crossmatch (determination of ABO group and Rh type and screening for unexpected antibodies).

Adverse effects of blood transfusions can be divided into two categories, acute (onset less than 24 hours) and delayed. Acute transfusion reactions included hemolytic reactions. Hemolytic reactions occur if the blood type given does not match the patient's blood type. The body attacks the new red blood cells, which then produce substances that harm the kidneys. Symptoms of a hemolytic reaction include chills, fever, nausea, pain in the chest or back, and dark urine. The doctor will stop the transfusion at the first sign of this reaction.

Patient 1's record was reviewed on February 2, 2015. Patient 1 presented to the facility Emergency Department (ED) on October 17, 2014, at 11:55 p.m., with a complaint of intermittent nose bleed, 6 days in duration. Patient 1's initial set of vital signs were temperature 36.8 degrees Celsius, blood pressure 96/61 and heart rate of 109 beats per minute.

According to the Blood Bank (BB) report, Patient 1's BB specimen was drawn on October 18, 2014, at 1:40 a.m. Patient 1 was identified as A Positive.

A review of the facility's blood transfusion records dated, October 18, 2014, revealed Patient 1 received two units of A Positive blood while in the emergency room. Patient 1 received two more units of A positive blood between 2:50 p.m. and 8 p.m., on October 19, 2014.

Documentation of the physician's progress notes indicated on October 19, 2014, at 9:30 a.m., "Yesterday hemoglobin 10 today 7...must suspect some lab error."

Documentation of the physician's progress notes indicated on October 19, 2014, at 9:06 p.m., indicated"...There is a possibility of reaction to blood transfusion that the patient got at the time of admission."

Another physician progress note dated October 20, 2014, at 2 p.m. indicated, "transfusion incompatibility."

The "Discharge Summary," dated November 21, 2014, indicated Patient 1 at the time of the patient's discharge "she was still requiring hemodialysis (removing excess fluid and waste from the blood stream using an artificial kidney machine)."

Patient 1's electronic record contained a pathology report dated, October 18, 2014, at 1:40 a.m., that had the following updated information: "On or about 11/17/14 we learned from the (Outside Agency) that this patient experienced a transfusion reaction. Following a very delayed but extensive investigation we concur - this patient suffered an acute hemolytic transfusion reaction to receiving Group A blood due to mislabeling of recipient blood tubes from the Emergency Department. Further, during the unit's administration, the signs and symptoms of a transfusion reaction were noted but the transfusion reaction protocol was not initiated. Further details are beyond the scope of this report."

During an interview with the Director of Clinical Laboratory (DCL), on February 3, 2015, at 1:30 p.m., the DCL stated after testing the blood specimens they still had in their possession, they determined the first tube drawn in the ED was labeled with Patient 1's name, but the sample was not Patient 1's blood. The DCL stated Patient 1 was not A positive.

An interview was conducted with the Director of Clinical Quality Improvement (DCQI) on February 4, 2015, at 10:30 a.m. The DCQI stated her office was not notified of Patient 1's adverse reaction and subsequent multiple treatments until an outside licensing agency had called the facility. The facility was notified by the outside agency (by way of a phone conversation) of a possible transfusion reaction (wrong blood transfused) on November 17, 2014.

During her stay at the facility, Patient 1 received 93 units of blood product, 74 units of fresh frozen plasma, one unit of cryo (blood plasma product), two units of platelets (blood component for clotting), and 16 units of packed red blood cells, multiple intermittent dialysis treatments and multiple plasmaphoresis treatments (seperation of the body's whole blood components then reinfusion) after being given the wrong type blood at the facility.

The policy and procedure titled,"Sentinel Event Response and Reporting," with a last revised date of January 28, 2013, was reviewed. The policy indicated, "The purpose of the policy is to:

A. Seek to improve patient care by reviewing and responding to Sentinel Events as set forth by the Joint Commission (TJC) Sentinel Event policy and procedures;

B. Support the improvement of patient safety and quality improvement initiatives by complying with the state mandated reporting requirements...

Adverse Event- an untoward incident, therapeutic misadventure, iatrogenic injury or other unexpected event with the potential for harm but may meet the definition of a Sentinel Event and is directly associated with the care or services provided within the Hospital..."

The policy indicated: "All Hospital staff are required to report events which reach the level of a Sentinel Event pursuant to the Hospital Event reporting policy..."

The facility's "Performance Improvement Plan 2013-2014," was reviewed. The Plan indicated in the section titled "Assessment...Intensive analysis of sentinel events is performed following the facility's Sentinel Event Policy which is summarized below: Analysis is performed when:...There is a confirmed transfusion reaction...."

Based on interview and record review, the facility failed to provide organized nursing services by:

1. Failing to ensure nursing staff followed the policy and procedure for Blood Bank specimen collection, when Registered Nurse 1 (RN 1) performed Patient 1's blood collection on October 18, 2014. RN 1 failed to correctly label a specimen sent to the laboratory for type and cross match (a method used to match blood types for transfusion). Patient 1's label was placed on a blood vial containing another patient's blood. As a result, Patient 1 received multiple blood transfusions based on the incorrectly labeled blood. (refer to 0392, A0409).

2. Failing to to ensure the facility policy and procedure titled "Blood Transfusions," was followed, when nursing staff failed to identify vital signs indicative of a blood transfusion reaction and failed to notify the physician and the Blood Bank of a possible transfusion reaction. This failed practice led to the delay in recognizing Patient 1's blood incompatability as a source of her acute kidney failure. In addition, this failed practice led to the patient receiving an additional eleven units of the wrong type of blood.
(refer to A0395, A0409).

3. Failing to ensure an adverse patient event was reported as defined in their policy, for one sampled patient (Patient 1). Patient 1 had a blood transfusion reaction due to receiving the wrong blood type, developed acute renal failure, and required renal dialysis while hospitalized and upon discharge (refer to A0410).

The cumulative effect of these systemic problems resulted in failure of the facility to provide nursing services to patients in a safe and effective manner.

Based on observation, interview, and record review, the facility failed to ensure the facility policy and procedure for Blood Bank specimen collection was followed when Registered Nurse 1 (RN 1) performed Patient 1's blood collection on October 18, 2014. RN 1 failed to correctly label a specimen sent to the laboratory for type and cross match (a method used to match blood types for transfusion). Patient 1's label was placed on a blood vial containing another patient's blood. As a result, Patient 1 received multiple blood transfusions based on the incorrectly labeled blood.

This failed practice led to Patient 1's acute kidney failure (requiring dialysis), and had the potential to result permanent kidney failure and death.

Findings:

There are four blood types: A, B, AB, or O (ABO group). Every person has one of these four blood types.

In addition, each person's blood is either: Rh-positive, or Rh-negative. Type O blood - is safe for just about everyone. People with type O blood are referred to as universal donors; and type O blood is used for emergencies in which there is no time to test a person's blood type. Before undergoing transfusions, a patient undergoes a type and crossmatch (determination of ABO group and Rh type and screening for unexpected antibodies

Patient 1 was admitted to the facility on October 18, 2014, with the following diagnoses: persistent epistaxis (nose bleed), anemia, (low red blood cell count, hemoglobin), and elevated troponin (cardiac enzyme-an elevated number is used as indicator of cardiac muscle damage). Patient 1's hemoglobin (oxygenated blood count) upon admission was 6.6 grams/ 100 milliliter (normal is between 12 -15 for females) with a hematocrit (volume of blood) of 17.9 percentage of red blood cells in the plasma (normal results for females is 37 to 48%).

According to the Blood Bank (BB) report, Patient 1's BB specimen was drawn on October 18, 2014, at 1:40 a.m. Patient 1 was identified as A Positive.

A review was conducted of the facility policy titled, "Blood Collection Specimen Collection and Handling," dated with revision on May 16, 2011. The policy indicated,"Inadequate or incorrect identification of the recipient is the most common cause of serious complications of transfusion. The importance of proper patient identification cannot be overemphasized. The patient must be positively identified upon collection of a blood bank specimen, and again prior to the administration of donor unit(s). The policy further indicated:...

The phlebotomist (or nurse) completes the Blood Bank "Specimen Tube" label with information obtained from the patient's hospital ID (Identification) armband:

1. Patient's first and last names
2. Reference and if available medical record number
3. Date of birth
4. Doctor's name
5. Room number or location
6. Date and time specimen is drawn and identification of the person drawing the specimen..."

The policy further indicated,"specimen tube" label is affixed to the blood bank collected specimen before leaving the patient's bedside..."

RN 1 failed to label Patient 1's blood according to facility policy and procedure, when the nurse failed to correctly label the cross match sample.

An interview was conducted with the Director of the Emergency Department (DED) on February 3, 2015, at 4 p.m. The DED stated one of his nurses had mislabeled a blood sample obtained from another patient and sent that sample to be typed and cross-matched (determines type of blood Patient 1 was to receive) to the facility laboratory. The mislabeled blood sample was labeled as Patient 1's blood sample. The DED stated the nurse (who drew Patient 1's blood) pre-labeled and pre-initialed the vials (before drawing blood)The DED stated the Emergency room nurse did not label blood according to facility policy which was to label immediately after collection and before leaving the patient's bedside. The DED acknowledged the nurse did not follow facility blood collection policy and procedure.

An interview was conducted with a Laboratory and Field Services Examiner II, Biologics (LFSE) from a state agency, on November 20, 2014, 2 p.m. The LFSE stated he had participated in the investigation of Patient 1's complaint and determined the result was "Wrong blood in tube (WBIT)". The LFSE stated the original sample (cross match), dated October 18, 2014, from Patient 1, was tested again. It was determined the sampled blood did not match Patient 1's blood. The LFSE stated the sampled crossmatched blood could have been from another emergency room patient's blood.

Patient 1's electronic record contained a pathology report dated, October 18, 2014, at 1:40 a.m., that had the following addendum as updated information: "On or about 11/17/14 we learned from the (Outside Agency) that this patient experienced a transfusion reaction. Following a very delayed but extensive investigation we concur - this patient suffered an acute hemolytic transfusion reaction to receiving Group A blood due to mislabeling of recipient blood tubes from the Emergency Department. Further, during the unit's administration, the signs and symptoms of a transfusion reaction were noted but the transfusion reaction protocol was not initiated. Further details are beyond the scope of this report."

Based on interview and record review, the facility failed to ensure the facility policy and procedure titled "Blood Transfusions," was followed, when nursing staff failed to identify vital signs indicative of a blood transfusion reaction and failed to notify the physician and the Blood Bank of a possible transfusion reaction. This failed practice led to the delay in recognizing Patient 1's blood incompatability as a source of her acute kidney failure. In addition, this failed practice led to the patient receiving an additional eleven units of the wrong type of blood.

Findings:

A blood transfusion is the transfer of blood or blood products from one person (donor) into another person's bloodstream (recipient). This is usually done as a life saving maneuver to replace blood cells or blood products lost through severe bleeding, during surgery when blood loss occurs or to increase the blood count in an anemic patient.

There are four blood types: A, B, AB, or O (ABO group). Every person has one of these four blood types.

In addition, each person's blood is either: Rh-positive, or Rh-negative. Type O negative blood - is safe for just about everyone. People with type O blood are referred to as universal donors; and type O blood is used for emergencies in which there is no time to test a person's blood type. Before undergoing transfusions, a patient undergoes a type and crossmatch (determination of ABO group and Rh type and screening for unexpected antibodies).

Adverse effects of blood transfusions, can be divided into two categories, acute (onset less than 24 hours) and delayed. Acute transfusion reactions included hemolytic reactions. Hemolytic reactions occur if the blood type given does not match the patient's blood type. The body attacks the new red blood cells, which then produce substances that harm the kidneys. Symptoms of a hemolytic reaction include chills, fever, nausea, pain in the chest or back, and dark urine. The doctor will stop the transfusion at the first sign of this reaction.

Patient 1's record was reviewed on February 2, 2015. Patient 1 presented to the facility Emergency Department (ED) on October 17, 2014, at 11:55 p.m., with a complaint of intermittent nose bleed, 6 days in duration. Patient 1's initial set of vital signs were temperature 36.8 ° Celsius (98.2° Farenheit) blood pressure 96/61 and heart rate of 109 beats per minute.

According to the Blood Bank (BB) report, Patient 1's BB specimen was drawn on October 18, 2014, at 1:40 a.m. Patient 1 was identified as A Positive (A Pos). Patient 1 received two units of A Pos packed red blood cells, on October 18, 2014, while still a patient in the emergency room. The "Transfusion Record," for Patient 1's first unit of packed red blood cells indicated the unit was given on October 18, 2014, at 4:20 a.m. Documentation on the form indicated pre-transfusion vital signs were taken at 4:09 a.m., and indicated the following:

Pulse: 95;
Temperature: 36.6 ° C; and
Blood Pressure: 136/75.

Fifteen minutes later, Patient 1's vital signs were documented as:
Pulse 123;
Temperature 36.6 ° C; and
Blood Pressure 99/39 (a drop from 136/75).

Post transfusion vital signs indicated:
Pulse 111;
Temperature 38.1 ° Celsius (a 1.5 ° increase in Celsius temperature and a 2.7 ° degree increase in Farenheit temperature).

Patient 1 received a second unit of blood on October 18, 2014, at 6:15 a.m.

ED documentation indicated an initial assessment for Patient 1 was completed on October 17, 2014, at 11:53 p.m. The next entry was dated October 18, 2014, at 11:31 a.m., when the patient was admitted to the floor. There was no documentation, in the patient's electronic record indicating how the patient tolerated either of the transfusions while in the ED.

During an interview with the Director of Emergency Department (DED) on February 4, 2014, at 4 p.m., the DED stated the ED was on downtime (electronic documentation could not be entered) and staff were using paper documents to chart.

The facility policy and procedure titled, "Blood Transfusions," revision dated, September 22, 2014, indicated: "Adverse or Transfusion Reaction: 1.Signs and symptoms of an adverse reaction are the most common in the first 15 minutes and include:

a. Elevated temperature greater than 1 degree Celsius or 1.8 degree Fahrenheit above baseline.

b. Hypertension (low blood pressure-normal being 120/80)

c. Pain in flank, chest or infusion site

d. Chills, shakes, nausea, vomiting, dyspnea or flushing.

e. If uticaria (rash) is the only reaction, the blood may be restated after antihistamines are given, contact physician for orders."

During an interview with the Chief Medical Physician (CMP) of the Blood Bank, on February 3, 2015, at 2 p.m., the CMP stated there documented were signs and symptoms of transfusion reaction in Patient 1's record. The CP stated if the physician had been notified about the patient's low blood pressure and increased temperature after the first transfusion, the lab could have identified the patient's ABO incompatability, earlier.

The "Blood Transfusion Competency Validation 2014," form for ED nursing personnel was reviewed on February 4, 2015. The form, a post test included the following question: "The most frequent signs and symptoms of a suspected blood transfusion reaction are?" The documented answer was "Fever and Chills."

Based on interview and record review, the facility failed to ensure blood transfusions were administered in accordance with policies and procedures, when facility staff failed to do the following for one sampled patient (Patient 1):

A. Nursing staff failed to draw and label Patient 1's blood for type and crossmatch according to facility policy and procedure.

B. Nursing staff failed to identify signs and symptoms of a blood transfusion reaction and follow the facility policy and procedure for transfusion reactions.


These failures caused temporary disability (multiple dialysis and plasma phoresis treatments) and had the potential to cause permanent disability, including kidney failure (requiring permanent dialysis), and up to and including death.

While hospitalized at the facility, Patient 1 received a total of 93 units of blood product, 74 units of fresh frozen plasma, one unit of cryo (blood plasma product), two units of platelets (blood component for clotting), and 16 units of packed red blood cells (in addition to four units that were ordered on admission), multiple intermittent dialysis treatments and multiple plasmaphoresis treatments (seperation of the body's whole blood components then reinfusion) after being given the wrong type blood at the facility. This failed practice caused temporary disability (multiple dialysis and plasmaphoresis treatments) and had the potential for permanent disability, kidney failure (requiring permanent dialysis), and up to and including death.

Findings:

A blood transfusion is the transfer of blood or blood products from one person (donor) into another person's bloodstream (recipient). This is usually done as a life saving maneuver to replace blood cells or blood products lost through severe bleeding, during surgery when blood loss occurs or to increase the blood count in an anemic patient.

There are four blood types: A, B, AB, or O (ABO group). Every person has one of these four blood types.

In addition, each person's blood is either: Rh-positive, or Rh-negative. Type O blood - is safe for just about everyone. People with type O blood are referred to as universal donors; and type O blood is used for emergencies in which there is no time to test a person's blood type. Before undergoing transfusions, a patient undergoes a type and crossmatch (determination of ABO group and Rh type and screening for unexpected antibodies.

Adverse effects of blood transfusions, can be dived into two categories, acute (onset less than 24 hours) and delayed. Acute transfusion reactions included hemolytic reactions. Hemolytic reactions occur if the blood type given does not match the patient's blood type. The body attacks the new red blood cells, which then produce substances that harm the kidneys. Symptoms of a hemolytic reaction include chills, fever, nausea, pain in the chest or back, and dark urine. The doctor will stop the transfusion at the first sign of this reaction.

Patient 1 was admitted to the facility on October 18, 2014, with the following diagnosis: persistent epistaxis (nose bleed), anemia, (low red blood cell count, hemoglobin).

Patient 1 had a physician order dated, October 18, 2014, at 2:22 a.m., for type and cross match (determines type of blood to transfuse) for two units of packed red blood cells to be transfused in the Emergency Department.

According to the Blood Bank Report, Patient 1's blood specimen was drawn on October 18, 2014, at 1:40 a.m. Patient 1 was identified as A positive.

RN 1 failed to label Patient 1's blood according to facility policy and procedure, when the nurse failed to correctly label the cross match sample.

An interview was conducted with the Director of the Emergency Department (DED) on February 3, 2015, at 3 p.m. The DED stated one of his nurses had mislabeled a blood sample obtained from another patient and sent that sample to be typed and cross-matched (determines type of blood Patient 1 was to receive) to the facility laboratory. The mislabeled blood sample was labeled as Patient 1's blood sample. The DED stated the nurse's practice (who drew patient 1's blood) pre-labeled and pre-initialed the vials (before drawing blood)The DED stated the Emergency room nurse did not label blood according to policy which was to label immediately after collection and before leaving the patients bedside. The DED acknowledged the nurse did not follow facility blood collection policy and procedure.

A review was conducted of the facility policy titled, "Blood Collection Specimen Collection and Handling," dated with revision on May 16, 2011. The policy indicated,"Inadequate or incorrect identification of the recipient is the most common cause of serious complications of transfusion. The importance of proper patient identification cannot be overemphasized. The patient must be positively identified upon collection of a blood bank specimen, and again prior to the administration of donor unit(s). The policy further indicated:...

The phlebotomist (or nurse) completes the Blood Bank "Specimen Tube" label with information obtained from the patient's hospital ID (Identification) armband:

1. Patient's first and last names
2. Reference and if available medical record number
3. Date of birth
4. Doctor's name
5. Room number or location
6. Date and time specimen is drawn and identification of the person drawing the specimen..."

The policy further indicated, "specimen tube" label is affixed to the blood bank collected specimen before leaving the patient's bedside..."

Record review of Patient 1's vital signs documented on October 18, 2014, on the facility form titled "Transfusion Record," indicated the following: "A positive blood-transfusion started at 4:20 a.m., transfusion stopped at 6 a.m. Volume infused- all. Reaction- no. Vital signs documented:

Pulse: 95;
Temperature: 36.6 ° C; and
Blood Pressure: 136/75.

Fifteen minutes later, Patient 1's vital signs were documented as:
Pulse 123;
Temperature 36.6 ° C; and
Blood Pressure 99/39 (a drop from 136/75).

Post transfusion vital signs indicated:
Pulse 111;
Temperature 38.1 ° Celsius (a 1.5 ° increase in Celsius temperature and a 2.7 ° degree increase in Farenheit temperature).

Record review of the facility policy and procedure titled," Blood Transfusions," revision dated, September 22, 2014, indicated: "Adverse or Transfusion Reaction: 1.Signs and symptoms of an adverse reaction are the most common in the first 15 minutes and include:

a. Elevated temperature greater than 1 degree Celsius or 1.8 degree Fahrenheit above baseline.

b. Hypertension (low blood pressure-normal being 120/80)

c. Pain in flank, chest or infusion site

d. Chills, shakes, nausea, vomiting, dyspnea or flushing.

e. If uticaria (rash) is the only reaction, the blood may be restated after antihistamines are given, contact physician for orders."

Record review of the emergency room nurses notes regarding the first blood transfusion did not include any further documented assessment of Patient 1's status pre transfusion, transfusion, and post transfusion.

Documentation of the physician's progress notes indicated on October 19, 2014, at 9:30 a.m., "Yesterday hemoglobin 10 today 7...must suspect some lab error."

Documentation of the physician's progress notes indicated on October 19, 2014, at 9:06 p.m.,"...There is a possibility of reaction to blood transfusion that the patient got at the time of admission."

Another physician progress note dated October 20, 2014, at 2 p.m. indicated, "transfusion incompatibility."

Review of the record did not indicate there was documented communication between the physicians and Laboratory Services in determining or ruling out a "blood incompatibility" or "suspected lab error" had occurred between October 18, and October 20, 2014. Patient 1 had already received 4 units of the wrong type of blood.

Record review of the facility policy and procedure titled,"Blood Transfusions," revised September 22, 2014, indicated, "...Notify physician immediately and and obtain orders. Notify Blood Bank of the reaction. Laboratory personnel have been instructed to bring the blood bag with any remaining blood to the lab after drawing blood for a transfusion reaction workup..."

An interview was conducted with a Laboratory and Field Services Examiner II, Biologics (LFSE), from a state agency, on December 3, 2014, at 8 a.m. The LFSE stated he had participated in the investigation of Patient 1's complaint and determined the result as wrong blood in tube (WBIT). The LFSE stated the original cross match sample, dated October 18, 2014, of Patient 1 was still located in the facility laboratory. The LFSE stated the sample of blood was tested again and it was determined the sampled original crossmatched blood did not match the intended recipient's blood (Patient 1's blood). The LFSE stated the sampled crossmatched blood could have been from another emergency room patient's blood.

An interview was conducted with the Director of Clinical Quality Improvement on February 4, 2014, at 10:30 a.m. regarding the first transfusion. The DCQI stated the nurse who transfused the first unit of blood should have stopped the blood based on the blood pressure of 99/39 (hypotension).The DCQI stated the post transfusion temperature went up more than one degree from 36.6 to 38.1 a 1.5 degree change. The DCQI stated the change in vital signs should have been reported to the physician and the facility laboratory immediately.

Record review indicated on October 21, 2014, Patient 1 was transferred from ICU to the telemetry unit with the diagnosis of thrombotic thrombocytopenia purpura (a rare disorder of the blood-coagulation system, causing extensive microscopic clots to form in the small blood vessels throughout the body) and renal failure. Hemoglobin at 4.7 grams/milliner. Patient 1 developed respiratory distress, hyperkalemia (high potassium levels) and progressive renal failure (dialysis treatment initiated). Patient 1 was transferred to ICU (Intensive Care Unit). Patient 1 received her first plasma exchange for the presumed diagnosis of TTP.

Further record review indicated, after the first plasma exchange on October 21, 2014, Patient 1's blood was re-tested again for blood type and match. The record indicated Patient 1 had A positive blood after the second re-test of her blood.

An interview was conducted with the Chief Medical Director (CMD) of the facility's Blood Bank, on February 3, 2015 at 1:45 p.m. The CMD stated, the second crossmatch and typing of blood drawn had the unfortunate timing of being completed after the patient received multiple transfusions of A positive blood and plasmaphoresis treatment. Therefore, when the patient's blood was tested the true blood type was not determined because she had received so much of the wrong blood type, she was basically converting to an A positive blood type.

Record review indicated, Patient 1 received a total of 12 units of A positive packed red blood cells (PRBCs) of the incorrect blood type, from October 18, to October 25, 2014.

Eight units of PRBCs of A positive blood were transfused after three physicians documented in Patient 1's record statements regarding blood transfusion reaction or incompatibility. During this time period between October 18 and October 24, there was no documented communication in the physician's progress notes indicating communication to the facility's blood bank regarding Patient 1's blood transfusion reaction.

The documentation by a Hematologist on October 25, 2014, untimed, indicated, "...Acute transfusion reaction evidenced by the onset of severe abnormalities immediately following blood transfusion (from October 18 to October 19, 2014). Furthermore, clinical deterioration with worsening hemolysis... with LDH (lactic dehydrogenase-an enzyme found in large amounts in the heart, liver, muscles, and kidneys) after receiving 2 more units of type A PRBCs yesterday... Patient has initial response to plasmapheresis with declining LDH... Blood band (blood typed under microscope) identified...Anti A antibody today and switched to type O blood transfusion only for this patient as she has a rare type A blood which could not be identified until Anti A antibody was detected today (not detected during provision type and cross (testing type of blood and available matches) since it had not been formed until multiple transfusion exposure." The hematologist documented,"Type O blood transfusion only per blood bank." This was the facility's first documentation involving the Blood Bank seven days after one physician had written possible blood transfusion on October 19, 2014.

Patient 1's electronic record contained a pathology report dated, October 18, 2014, at 1:40 a.m., that had the following updated information: "On or about 11/17/14 we learned from the (Outside Agency) that this patient experienced a transfusion reaction. Following a very delayed but extensive investigation we concur - this patient suffered an acute hemolytic transfusion reaction to receiving Group A blood due to mislabeling of recipient blood tubes from the Emergency Department. Further, during the unit's administration, the signs and symptoms of a transfusion reaction were noted but the transfusion reaction protocol was not initiated. Further details are beyond the scope of this report."

The CMD was re-interviewed on February 4, 2015, at 10:50 a.m. The CMD stated there were multiple potential opportunities to pick up (the error) wrong blood (type) was transfused. The CMD stated with nursing- the temperature of a one degree increase and the drop in blood pressure was the first indicator. The second indicator- would have been based on the signs and symptoms of a transfusion reaction with the physicians (assessment) and with the assistance of the transfusion service (communication to Blood Bank). The CMD stated, "(Use of) the facility's Blood Bank may have assisted with the earlier pathway to stop the (wrong) blood transfusions and to begin the investigation to pin down the diagnosis sooner."

The facility nursing staff failed to identify signs and symptoms of a blood transfusion reaction and to follow the facility policy and procedure for transfusion reactions. This failed practice caused temporary disability ( multiple dialysis and plasmaphoresis treatments) and had the potential to cause permanent disability including kidney failure (requiring permanent dialysis), and up to and including death.

Based on interview and record review, the facility failed to ensure an adverse patient event was reported as defined in their policy, for one sampled patient (Patient 1). Patient 1 had a blood transfusion reaction due to receiving the wrong blood type, developed acute renal failure, and required renal dialysis while hospitalized and upon discharge.

As a result of the failure of facility staff to report the event, the facility was unaware of the incident until November 17, 2014, when they received notification from a regulatory agency.

Findings:

A blood transfusion is the transfer of blood or blood products from one person (donor) into another person's bloodstream (recipient). This is usually done as a life saving maneuver to replace blood cells or blood products lost through severe bleeding, during surgery when blood loss occurs or to increase the blood count in an anemic patient.

There are four blood types: A, B, AB, or O (ABO group). Every person has one of these four blood types.

In addition, each person's blood is either: Rh-positive, or Rh-negative. Type O blood - is safe for just about everyone. People with type O blood are referred to as universal donors; and type O blood is used for emergencies in which there is no time to test a person's blood type. Before undergoing transfusions, a patient undergoes a type and crossmatch (determination of ABO group and Rh type and screening for unexpected antibodies.

Adverse effects of blood transfusions, can be divided into two categories, acute (onset less than 24 hours) and delayed. Acute transfusion reactions included hemolytic reactions. Hemolytic reactions occur if the blood type given does not match the patient's blood type. The body attacks the new red blood cells, which then produce substances that harm the kidneys. Symptoms of a hemolytic reaction include chills, fever, nausea, pain in the chest or back, and dark urine. The doctor will stop the transfusion at the first sign of this reaction.

Patient 1's record was reviewed on February 2, 2015. Patient 1 presented to the facility Emergency Department (ED) on October 17, 2014, at 11:55 p.m., with a complaint of intermittent nose bleed, six days in duration. Patient 1's initial set of vital signs were temperature 36.8 degrees Celsius, blood pressure 96/61 and heart rate of 109 beats per minute.

According to the Blood Bank (BB) report, Patient 1's BB specimen was drawn on October 18, 2014, at 1:40 a.m. Patient 1 was identified as A Positive.

A review of the facility's blood tranfusion records dated, October 18, 2014, revealed Patient 1 received two units of A Positive blood while in the emergency room. Patient 1 received two more units of A positive blood between 2:50 p.m. and 8 p.m., on October 19, 2014.

Documentation of the physcian's progress notes indicated on October 19, 2014, at 9:30 a.m., "Yesterday hemoglobin 10 today 7...must suspect some lab error."

Documentation of the physcian's progress notes indicated on October 19, 2014, at 9:06 p.m., "...There is a possibility of reaction to blood transfusion that the patient got at the time of admission."

Another physcian progress note dated October 20, 2014, at 2 p.m. indicated, "transfusion incompatibility."

The "Discharge Summary," dated November 21, 2014, for Patient 1 at the time of the patient's discharge indicated, "she was still requiring hemodialysis (removing excess fluid and waste from the blood stream using an artificial kidney machine)."

Patient 1's electronic record contained a pathology report dated October 18, 2014, at 1:40 a.m., had the following updated information: "On or about 11/17/14, we learned from the(Outside Agency) that this patient experienced a transfusion reaction. Following a very delayed but extensive investigation we concur - this patient suffered an acute hemolytic transfusion reaction to receiving Group A blood due to mislabelling of recipient blood tubes from the Emergency Department. Further, during the unit's administration, the signs and symptoms of a transfusion reaction were noted but the transfusion reaction protocol was not initiated. Further details are beyond the scope of this report."

During an interview with the Director of Clinical Laboratory (DCL), on February 3, 2015, at 1:30 p.m., the DCL stated, after testing the blood specimens for Patient 1 they still had in their possession, they determined the first tube drawn in the ED was labeled with Patient 1's name, but the sample was not Patient 1's blood. The DCL stated Patient 1 was not A positive.

An interview was conducted with the Director of Clinical Quality Improvement (DCQI) on February 4, 2015, at 10:30 a.m. The DCQI stated her office was not notified of Patient 1's adverse reaction and subsequent multiple treatments until an outside licensing agency had called the facility. The facility was notified by the outside agency (by way of a phone conversation) of a possible transfusion reaction (wrong blood transfused) on November 17, 2014. The Department of Public Health was notified December 5, 2014., 42 days after a physcian had documented in a progress note that Patient 1 had a possible transfusion reaction.

During her stay at the facility, Patient 1 received a total of 93 units of blood products. Seventy four units of fresh frozen plasma, one unit of cryo (blood plasma product), two units of platelets (blood component for clotting), and 12 units of packed red blood cells (in addition to the first four units ordered on admission), multiple intermittent dialysis treatments and multiple plasmaphoresis treatments (seperation of the body's whole blood components then reinfusion) due to being given the wrong type blood at the facility.

The policy and procedure titled, "Sentinel Event Response and Reporting," with a last revised date of January 28, 2013, was reviewed. The policy indicated, "The purpose of the policy is to:

A. Seek to improve patient care by reviewing and responding to Sentinel Events as set forth by the Joint Commission (TJC) Sentinel Event policy and procedures;

B. Support the improvement of patient safety and quality improvement initiatives by complying with the state mandated reoprting requirements...

Adverse Event- an untoward incident, therapeutic misadventure, iatrogenic injury or other unexpected event with the potential for harm but may meet the definition of a Sentinel Event and is directly associated with the care or services provided within the Hospital..."

The policy indicated: "All Hospital staff are required to report events which reach the level of a Sentinel Event pursuant to the Hospital Event reporting policy..."

The facility's "Performance Improvement Plan 2013-2014," was reviewed. The Plan indicated in the section titled "Assessment...Intensive analysis of sentinel events is performed following the facility's Sentinel Event Policy which is summarized below: Analysis is performed when:...There is a confirmed transfusion reaction...."

Based on observation, interview, and record review, the facility failed to ensure the operating room's malignant hyperthermia (MH) cart (rare life-threatening condition usually triggered by exposure to drugs used for general anesthesia), was updated. The facility incorrectly labeled the location of the medication mannitol (used along with dantrolene to lesson the side effects of malignant hyperthermia-MH).

This failure had the potential to delay the response to a medical emergency, malignant hyperthermia.

Findings:

According to the Malignant Hyperthermia Association of the United States (MHAUS), malignant hyperthermia was a potentially fatal disease passed down through families. The signs of MH include muscle rigidity, rapid heart rate, high body temperature, muscle breakdown and increased acid content. Immediate treatment with the drug dantrolene (along with the drug mannitol) usually reverses the signs of MH.

A tour of the operating room was conducted on February 3, 2015, at 10 a.m. A red cart situated in the south hallway of the east end of the building was observed with a black microscope cover over the top of the malignant hyperhernia cart. The microscope cover was removed and the top counter of the cart was observed to have a label which indicated, "Mannitol located in warmer."

An interview was conducted with the Director of Surgical Services (DSS), regarding the covered cart and the mannitol label on February 3, 2015, at 10:35 a.m. The DSS stated, "The cart should have never been covered with the microscope cover." The DSS took the surveyor to the operating room warmer to look for the drug mannitol as per the cart label. Upon inspection, no mannitol was in the warmer.

An interview was conducted with a Nurse Anesthesiologist (NA) on February 3, 2015, at 10:40 a.m. The NA did not know the location of the mannitol as per the MH cart label.

Further observation was conducted of the malignant hyperthermia cart on February 3, 2014, at 10 :50 a.m. with the DSS and the NA present. The cart was opened by the DSS and was found to contain the drug dantrolene. The drug dantrolene, as per the manufacturer's insert, was supplied as 70 milliliter vials containing 20 milligrams of dantrolene and 3,000 milligrams of mannitol. Each vial was to be instilled with 60 milliliters of sterile water for intravenous administration during a MH crisis.

An interview was conducted with the Director of Pharmacy (DP) on February 3, 2015, at 10:45 a.m. The DP stated in (the year) 2013 dantrolene was changed and the medication now included mannitol in combination form. The DP stated the staff members should be re-educated related to the change in the combination of the drug. The sticker (stating the mannitol was in the warmer) should not have been on the cart.

A review of the facility policy, "Malignant Hyperthermia," revised, October 3, 2013, indicated,"It is the policy to keep readily accessible supplies and medications needed to lower a patient's body temperature immediately during a malignant hyperthermia episode, while assisting providers in the management of metabolic and respiratory imbalances." A review of the policy further indicated, the policy was not updated to reflect the now combined drug dantrolene (combined with mannitol) since October 3, 2013.

The facility's failure to update the labeling of the MH cart and to update their policy and re-education of the now combined drug dantrolene, had the potential to delay the response to a medical emergency, malignant hyperthermia.

Based on observation, interview, and record review, the facility failed to ensure all crash carts were inspected at least monthly, and all outdated medications were removed. As a result, two crash carts were found to have expired medications available for patient use.

Findings:

1. On February 3, 2015, the crash cart in the Out-patient GI Lab was inspected. The sticker on top of the crash cart indicated it expired on April 1, 2015. The content list inside the medication drawer, and visible from the outside, indicated there was "Premade Magnesium Bags," with an expiration date of January 1, 2015.

On February 3, 2015, at 9:15 a.m., the contents of the crash cart was inspected with the Gastro-Intestinal Laboratory (GI Lab) Manager. The crash cart contained two bags of the premade magnesium with an expiration date of January 1, 2015.

In a concurrent interview with the GI Manager, he stated nursing inspected the crash cart daily for integrity of the cart, to ensure locks were on, and to ensure resuscitation equipment was present and functioning properly. The manager stated it was the Pharmacy responsibility to ensure the medications were removed and replenished when they became outdated.

On February 3, 2015, at 10:40 a.m., the Director of Pharmacy (DP) was interviewed. The DP stated it was a dual responsibility between nursing and pharmacy to ensure all outdated medications were removed before they expired. The DP stated the Pharmacy was ultimately responsible for completing Nursing Station Inspections (NSIs), on a monthly basis, which would include monitoring and removing medications from the crash carts that were ready to expire.

A request was made to provide documentation of the last four months of NSIs for the Out-Patient GI Lab. The most recent NSI for the Out-Patient GI Lab, was September 11, 2014. There was no evidence the medication storage areas in the Out-Patient GI Lab, including the crash cart, was inspected for the months of October, November, December 2014, and January 2015.




18918

On February 2, 2015, at 10:45 a.m., one of four crash carts in the Emergency Department (ED) was inspected. A sticker on top of the crash cart indicated one medication (Atropine 1 milligram/10 milliliters - used to increase the heart rate) expired on January 31, 2015. The content list indicated the cart contained four doses of Atropine.

The medication drawer was opened with the ED Director, on February 2, 2015, at 10:45 a.m., and the date on the four doses of Atropine was checked. There was one dose of Atropine with an expiration date of January 31, 2015. The date was circled with a black marker. The ED Director stated the cart had been used earlier this morning and then re-locked. The ED Director stated when the staff performed their crash cart inspection, they should be looking to verify the cart was available, the locks were intact and the equipment was available. The ED Director stated the check off form did not indicate the medications should be checked, but that was part of the practice.

A review of the "Crash Cart and Defibrillator Monitoring Log," for February 2014, was reviewed. According to documentation on the log, the crash cart was checked and verified by nursing staff on February 1, 2015, by both the morning and evening shifts, and on February 2, 2015, by the morning shift.

On February 3, 2015, at 10:40 a.m., the Director of Pharmacy (DP) was interviewed. The DP stated it was a dual responsibility between nursing and pharmacy to ensure all outdated medications were removed before they expired. The DP stated the Pharmacy was ultimately responsible for completing Nursing Station Inspections (NSIs), on a monthly basis, that would include monitoring and removing medications from the crash carts that were ready to expire.

The DP stated the ED cart was a "Fixed Cart", (meaning it was refilled and checked in its ED location), as a result of its frequent use. The DP stated the ED crash cart could have been refilled with stock that was located in the ED's Pyxis (automated drug dispensing cabinet), but the expired medication should have been pulled.

The policy and procedure titled, "Medication Area Inspection," dated May 22, 2014, was reviewed. the policy indicated, "At least once a month, the Director of Pharmacy (or designee), will conduct inspections of all nursing care units or other areas of the hospital where medications are dispensed, administered, or stored... Inspections should focus on storage conditions, removal of outdated and other unusable medications... The inspector facilitates replacement of all outdated or deteriorated items with fresh stock..."

Based on interview and record review, the facility failed to ensure laboratory services department had a process to notify patients, who may have received infectious blood and blood components, regarding counseling and referral for subsequent testing for infected patients, and a listing of programs or places where the patient could obtain further testing and counseling.

This failure had the potential to affect patients' informed decision about further testing and counseling, and limit resources for further assistance.

Findings:

An interview was conducted with the Administrative Director of Clinical Laboratory Services (ADCL) on February 3, 2015, at 3:30 p.m. The ADCL stated, "There was not a letter utilized by the facility which included counseling and referral services for patients who may become infected from infectious blood or blood products." The ADCL stated, "There was not a current facility policy regarding the Clinical Laboratory needing a policy on patient referral, testing and counseling, for infected patients."

Record review concurrently conducted on February 3, 2014, with the ADCL indicated there was no letter currently in the Clinical Laboratory utilized for patient counseling and referral services for patients who may have been infected with infected blood.