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.

HOLZER MEDICAL CENTER JACKSON 500 BURLINGTON ROAD JACKSON, OH 45640 Jan. 20, 2011
VIOLATION: EMERGENCY SERVICES Tag No: C0880
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, clinical record review and policy review, the facility failed to ensure a system was in place to notify all appropriate facility staff of laboratory equipment that was non-functioning. The facility also failed to have policies in place that address a back-up system to obtain the necessary resources for emergent patient care, including a policy for diversion of patients to other facilities. Lack of appropriate and timely communication and planning resulted in a patient's death and placed all current and future patients at risk.

Upon arrival of Patient #5 to this facility's emergency room on [DATE], who was actively bleeding from a suspected varicosity, the facility's emergency room physician and nursing staff were unaware that fresh frozen plasma was not available due to a freezer breakdown in the laboratory. Patient #5 was not given the medical services necessary to treat his/her emergent need resulting in Patient #5 requiring transfer to another acute care facility where he/she died .

After the incident involving Patient #5, the facility failed to take corrective action to ensure that a system was in place to communicate problems that have the potential to impact patient care and failed to develop policies that addressed the process for communication of any issues that have the potential to impact patient care including mechanical breakdowns. The facility also did not implement policies/procedures and staff training to address prompt identification, notification, and repair of mechanical failures that directly impact patient care, did not implement a related back-up system that includes a patient diversion policy.

These findings resulted in an immediate jeopardy for Patient #5 as well as all current and future patients who may have an emergent need for blood products.

A total of 15 clinical records were reviewed.

Findings:

According to facility documentation, it was noted that on 12/01/10, the facility's plasma freezer did not have an alarm system and therefore no fresh frozen plasma was stored there. This information was not disseminated to the rest of the organization, including its physicians, and others who might need to know. On 12/25/10, Patient #5 was brought to the facility's emergency room via emergency medical services for a chief complaint of active bleeding from a suspected varicosity. The physician ordered two units of fresh frozen plasma to be transfused to address the bleeding. The facility did not have fresh frozen plasma on campus and the physician was notified he/she would not be able to receive the fresh frozen plasma from another acute care facility located in Gallipolis, approximately 32 miles away, for two hours. Patient #5 was transferred to an acute care facility located in Columbus in serious condition with a diagnosis of coagulopathy with acute hemorrhagic anemia. Patient #5 died at that hospital shortly after arrival there.

After the incident involving Patient #5, there was no evidence that the facility took immediate action to develop a system to communicate adverse events that have the potential to affect patient care, especially in emergent situations. The facility also did not implement policies/procedures and staff training to address prompt identification, notification, and repair of mechanical failures that directly impact patient care, did not implement a related back-up system that includes a patient diversion policy.


Please refer to 42 CFR 485.618(c)(1), Tag C 205 - Blood and Blood Products for more detailed information.
VIOLATION: BLOOD AND BLOOD PRODUCTS Tag No: C0890
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, clinical record review and policy review, the facility failed to make blood products available to Patient #5 in time to effectively treat his/her emergent condition. According to facility documentation, it was noted that on 12/01/10, the facility's plasma freezer did not have an alarm system and therefore no fresh frozen plasma was stored there. This information was not disseminated to the rest of the organization, including its physicians, and others who might need to know. On 12/25/10, Patient #5 was brought to the facility's emergency room via emergency medical services (EMS) from a nursing home for a chief complaint of active bleeding from a suspected varicosity. The record revealed an emergency room /rescue squad communications report that listed the patients date of birth, chief complaint was listed as bleeding and the patients weight as 450 lbs. The physician ordered two units of fresh frozen plasma to be transfused to address the bleeding. The facility did not have fresh frozen plasma on campus and the physician was notified he/she would not be able to receive the fresh frozen plasma from another acute care facility located in Gallipolis, approximately 32 miles away, for two hours. Patient #5 was transferred to an acute care facility located in Columbus in serious condition with a diagnosis of coagulopathy with acute hemorrhagic anemia. Patient #5 died at that hospital shortly after arrival there.

After the incident involving Patient #5, there was no evidence that the facility took immediate action to develop a system to communicate adverse events that have the potential to affect patient care, especially in emergent situations. The facility also did not implement policies/procedures and staff training to address prompt identification, notification, and repair of mechanical failures that directly impact patient care, did not implement a related back-up system that includes a patient diversion policy.

Findings:

Review of the clinical record for Patient #5, on 01/20/11, revealed an emergency medical services (EMS) document that stated the EMS left for the facility at 11:11 A.M., from the nursing home in which the patient resided, had a "2 mm diameter hole in (left) abdomen (with) squirting dark red/blood," and the estimated blood loss was 200 cc prior to EMS arrival. Further review of the document stated that en route Patient #5 had an estimated blood loss of 700 to 800 cc's and complained of dizziness, thirst and nausea. EMS noted Patient #5 arrived to the emergency room at 11:26 A.M.

Further review of the clinical record revealed the [AGE]-year-old patient was brought to the emergency room on [DATE] at 11:45 A.M. with a chief complaint of active bleeding from suspected varicosity. Patient #5's vital signs were listed as a temperature of 98.2 degrees Fahrenheit, pulse 135 beats per minute, respirations of 22 breaths per minute and no blood pressure was recorded. Patient #5's weight was recorded at 11:45 A.M. at 508 pounds. Patient #5 had diagnosis including, but not limited to, morbid obesity, hypertension, congestive heart failure, diabetes, peripheral vascular disease, and chronic obstructive pulmonary disease. the patient was also listed as taking 7.5 milligrams of Coumadin (a blood thinner) once a day.

The clinical record review revealed the nurse examined Patient #5 on 12/25/10 at 11:45 A.M. and stated, "Noted small pin hole size opening around varicosity that is noted to be squirting blood. Fresh new (large) pressure (dressing) and hand held pressure applied to attempt to control bleeding." The physician note revealed that Patient #5 was examined on 12/25/10 at 11:48 A.M. and stated, "Have reviewed and agree with RN note."

A physician's note dated 12/25/10 at 12:23 P.M. stated "There is a small area consistent with spontaneous bleeding into the skin over the affected site. Multiple areas of intradermal ecchymosis noted over the affected site. This area is (left lower quadrant) has active bleeding from area that has local varicosity."

The clinical record review revealed on 12/25/10 at 12:38 P.M. Patient #5's blood pressure was 100/60 millimeters mercury. The clinical record review did not list pulse or respiration. A note dated 12/25/10 at 12:46 P.M. stated Patient #5's INR (International Normalized Ratio-an indicator of the blood's clotability) was 7.26. (A normal value is between 0.8 and 1.2)

Further review of the clinical record revealed a signed physician order, dated on 12/25/10 at 1:24 P.M., to transfuse fresh frozen plasma. (The U.S. National Library of Medicine and National Institutes of Health website describes fresh frozen plasma "as the fluid portion of one unit of human blood that has been centrifuged, separated, and frozen solid at -18? C (or colder) within 6 hours of collection" and "for anticoagulated patients who are actively bleeding ... can be used to achieve immediate hemostasis." (URL: http://www.ncbi.nlm.nih.gov/books/NBK /))

A nursing note dated 12/25/10 at 1:28 P.M. revealed that Physician C spoke with the lab and stated "does not currently have (fresh frozen plasma) available for this (patient)." The note stated it could be obtained from another facility. The note stated Physician C held the order for fresh frozen plasma and would speak to a different facility regarding transferring Patient #5 without fresh frozen plasma. On 01/19/11 at 10:50 A.M. in an interview, the Laboratory Manager stated he/she didn't inform the medical staff that they would not have access to fresh frozen plasma on site.

A physician's note dated 12/25/10 at 1:52 P.M. revealed Patient #5 was transferred in serious condition. The clinical record review revealed Patient #5's vital signs on 12/25/10 at 2:00 P.M. were documented as pulse 132 beats per minute, respirations 22 breaths per minute, and blood pressure 99/48 millimeters mercury. The clinical record review did not indicate at any time when or if the bleeding had stopped or how much blood Patient #5 lost while in the emergency room . On 01/19/11 at 10:07 A.M. in an interview, emergency room Nurse Manager confirmed the clinical record did not state when or if Patient #5's bleeding had stopped, or how much blood loss Patient #5 had sustained.

On 01/19/11 at 8:30 A.M. in an interview, Physician C stated Patient #5 had died at the receiving hospital. He/she stated Patient #5, "Clearly bled a lot" and his/her blood was too thin.
On 01/19/11 at 1:42 P.M. in an interview, Physician C stated the bleeding had stopped, that he/she had seen a clot that he/she did not want to disturb, especially without access to blood products, referencing the fresh frozen plasma. He/she said he/she initially had the impression he/she had fresh frozen plasma on site, but then was told there wasn't any on site and it would take two hours to get it on site. He/she was not aware there wasn't any fresh frozen plasma on site. He/she said it was the "first time I had to transfer someone for blood products."

On 01/19/11 at 11:25 A.M. in an interview, the Chief of Staff stated he/she was unaware the freezer was broke and there wasn't any fresh frozen plasma available on site.

On 01/20/11 at 10:13 A.M. in an interview, Vice President of Patient Care Services and the President confirmed the facility lacked a policy to ensure those who need to know are informed when laboratory equipment is broken and what impact that could have on the patient population.

A review of the facility's Laboratory Policy number 1.016, dated 11/17/2000 (lines for "reviewed by" left blank) stated if blood or blood components were not available they would be brought by "courier service" from a facility approximately 28 to 32 miles away.

A review of a preventative maintenance document entitled "Blood Storage Refrigerator/Jewett Plasma Freezer" was completed on 01/19/11. The document stated on 12/01/10: "No alarm system yet so no plasma being stored here yet." The document stated on 01/10/11 that the plasma freezer alarm was installed.
VIOLATION: ORGANIZATIONAL STRUCTURE Tag No: C0960
Based on clinical record review, interview and the facility's performance improvement plan, the facility's board of directors failed to ensure the facility's policies are administered to ensure quality health care is provided in a safe environment. A total of 15 clinical records were reviewed.

Findings:

Review of the clinical record for Patient #5 and interview of facility staff revealed the facility failed to take prompt corrective action to ensure a system was in place to identify and communicate problems that have the potential to impact patient care and failed to develop policies/procedures and staff training that address prompt notification and communication of any issues that have the potential to impact patient care including mechanical breakdowns, a back-up system, and diversion of patients. The facility also did not implement policies/procedures and staff training to address prompt identification, notification, and repair of mechanical failures that directly impact patient care, did not implement a related back-up system that includes a patient diversion policy.


These findings resulted in an immediate jeopardy for Patient #5 and any future patients with an emergent need for blood products.

Please refer to 42 CFR 485.627(a); C 241, Governing Body or Responsible Individual for more detailed information.
VIOLATION: GOVERNING BODY OR RESPONSIBLE INDIVIDUAL Tag No: C0962
Based on clinical record review, interview and the facility's performance improvement plan, the facility's board of directors failed to ensure facility policies are administered to ensure quality health care is provided in a safe environment. This affected patient 5 and patients 4, 6, 13, 14 and 15.

Findings:

Review of clinical records and staff interviews revealed that the facility Board of Directors failed to take corrective action after a patient (Patient #5) was admitted to the emergency room with active bleeding, at which time it was discovered that the laboratory did not report nor had a system to communicate to staff mechanical failures or absence of blood products that have the potential to impact patient care. The facility also did not implement policies/procedures and staff training to address prompt identification, notification, and repair of mechanical failures that directly impact patient care, did not implement a related back-up system that includes a patient diversion policy.

A review of the facility's undated Performance Improvement Plan stated the Board of Directors is responsible for the quality of patient care. Upon request for documentation of the performance improvement plan, the facility was unable to provide documentation that the incident which involved patient #5 was reviewed.

On 01/21/11 at 2:45 P.M. in an interview, the President confirmed the Board of Directors is responsible for the quality of patient care.

On 01/19/11 at 11:25 A.M. in an interview, the Chief of Staff stated he/she was unaware the freezer was broke and there wasn't any fresh frozen plasma available on site.

On 01/20/11 at 10:13 A.M. in an interview, Vice President of Patient Care Services and the President confirmed the facility lacked a policy to ensure those who need to know are informed when laboratory equipment is broken and what impact that could have on the patient population. The Vice President of Patient Care Services in interview at 3:50 P.M. revealed they did not have a diversion policy and stated "even if they did patients would come to their hospital anyway."

These findings resulted in an immediate jeopardy for Patient #5 and any future patients with an emergent need for blood products.

Please refer to 42 CFR 485.618(c)(1), C 205 - Blood and Blood Products for more detailed information.

Please refer to 42 CFR 485.635 (d), C 294 - Nursing services for more detailed information specifically for failure to meet the nursing needs for Patient 4, 6, 13, 14, and 15.
VIOLATION: NURSING SERVICES Tag No: C1046
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, staff interview, review of the medical record and review of policy and procedures it was determined that the facility failed to ensure they had a policy in place to direct staff and ensure that patient's were adequately assessed and monitored in accordance with the patients needs. This was found in 5 out of fifteen medical records reviewed and involved Patient's 4, 6, 13, 14, and 15. The hospital census is 24.

Findings include:

The medical record review for Patient 4 was completed on 01/20/11. The record review revealed a [AGE] year old patient (MDS) dated [DATE] with a chief complaint of suicidal thoughts. The medical record lacked evidence of the steps the nursing staff took to ensure the safety of the patient while the patient was in the emergency room .
The medical record review did not reveal if the nurse assessed the patient for thoughts of suicide or whether the patient had a plan and/or method to complete a suicide attempt. The medical record review did not indicate whether the facility removed from the patient any personal property that could contain a method to carry out a suicide attempt. The record review did not indicate what steps the facility took to protect the patient from self-harm. The medical record review revealed a physician's note dated 1/17/11 at 4:46 P.M. that stated a mental health counselor had assessed the patient and did not feel the patient was suicidal, but was depressed. The record revealed a nursing note dated 1/17/11 at 6:50 P.M. that stated the patient was discharged to home to follow up with a mental health professional.

On 1/19/11 at 10:07 A.M. in an interview, the emergency room Nurse Manager confirmed the medical record lacked evidence of whether the staff assessed the patient to determine whether the patient had anything on his/her person that could be used to make a suicide attempt while in the department. The emergency room Nurse Manager confirmed the medical record lacked evidence of the steps the nursing staff took to ensure the safety of the patient while in the emergency room .

The medical record for Patient 6 was reviewed on 01/19/11. Patient 6 presented to the Emergency Department (ED) via the local emergency squad on 01/12/11 at 12:13 A.M. with the complaint of suicidal thoughts. The patient was placed in ED bed #6. There was no documented evidence to support that the nurse who assessed Patient 6 interviewed the patient in regards to suicidal thoughts or specific suicide plan. There was no documented evidence that suicide precautions were put in place to protect the patient from harm. There was no documentation that any safety checks were conducted or that 1:1 observation was utilized to protect the patient from harm. There is documentation from the ED physician that states Patient 6 had a history of previous suicide attempts which included an overdose. The nursing assessment documented at 2:13 A.M. stated the patient had received information related to their pain, however, the medical record lacked evidence the patient had complained of pain. Patient 6 was transferred to a local psychiatric hospital at 2:13 A.M. for further evaluation and treatment.

The medical record for Patient 13 was reviewed on 01/19/11. Patient 13 (MDS) dated [DATE] at 5:24 A.M. with a complaint of ingestion of heroin balloons and was placed in ED room 3. The nurse's triage documentation stated that the patient admitted to thoughts of suicide and had a previous history of depression. There was no documentation that the nurse reassessed Patient 13 to ensure the patient was safe or documentation that revealed the patient remained on 1:1 observation after 6:20 A.M. The patient was evaluated by a counselor from a local psychiatric facility and determined to be stable for discharge home. The record revealed Patient 13 was discharged at 11:10 A.M.

The medical record for Patient 14 was reviewed on 1/19/11. Patient 14 (MDS) dated [DATE] at 11:48 A.M. with a complaint of anger management and anxiety. The patient was placed in ED room 6. The patient was brought by police for a psychiatric evaluation and admitted to thoughts of harming his twin brother and depression. The triage nurse documented that the patient is an assault risk. The nursing assessment that was documented at 6:40 A.M. stated the patient had received information related to their pain, however, the record lacked evidence the patient had complained of pain on admission. There was no documented evidence the patient had been reassessed for safety. Patient 14 was transferred to a veteran's hospital for further treatment at 6:49 A.M.

The medical record for patient 15 was reviewed on 01/19/11. Patient 15 (MDS) dated [DATE] at 3:12 P.M. for a psychiatric evaluation. The triage nursing documentation stated the patient admitted to suicidal thoughts and admits to having thoughts of harming others. There was no documentation to indicate what room Patient 15 was placed in or if suicidal precautions were followed. The medical record revealed Patient 15 was evaluated by a counselor from a local psychiatric facility and discharged at 9:44 P.M. There was no documentation to support that Patient 15 was reassessed for safety during the remainder of the ED visit.

A tour of the ED was conducted on 01/19/11 at 8:15 A.M. During this tour, ED room 6 was observed and identified by the ED nurse manager. The ED nurse manager revealed they try to place all psychiatric patients in this room and remove all harmful objects from the room. The manager stated the patients are placed on 1:1 observation, meaning that a staff member sits with the patient at all times. There was no documentation found in the medical records of Patient 4, 6, 13, 14, and 15 to show 1:1 observation was utilized.

A copy of the policy "Suicidal Precautions" was provided to this surveyor for review. The precautions included: place the patient in room 6 or 7, remove all unnecessary equipment from the room, lock all cabinets, place the patient in a yellow paper gown, remove all of the patient's personal belongings and place at the desk, direct observation of patient by emergency room personnel or security, if patient leaves room staff must accompany them. There was no documented evidence these precautions were put in place for Patient's 4, 6, 13, 14 and 15.

An interview was conducted with the ED nurse manager on 01/20/11 at 10:52 A.M. A request was made for an emergency department policy specific to reassessment of patients. The ED nurse manager stated there was no such policy. The ED nurse manager stated "we are reassessing the patients". There was no evidence to support the patients were being reassessed by the nursing staff and no facility policy in place to guide the staff on the frequency and need for reassessment.