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A. Based on review of medical records, documents and staff interview it was determined the Critical Access Hospital (CAH) failed to provide emergency care per acceptable standards/policy for one (1) of one (1) patients reviewed (patient #1) who presented to the Emergency Department with alcohol intoxication. This failure creates the potential for the care and condition of all patients with alcohol intoxication to be adversely impacted.

Findings include:

1. Review of the Emergency Record for patient #1 revealed the patient arrived to the Emergency Department (ED) by ambulance at 1609 and was triaged at 1612 on 9/20/12. The record revealed the patient's Chief Complaint/Reason for visit was noted as: "Passed out/found laying on steps downtown." The patient's speech was noted to be slurred due to alcohol intoxication. The patient's medical history was noted to include the following: "Psychologic Disorder, Pulmonary Disease/Chronic Obstructive Pulmonary Disease, Hepatic Disorder, Hepatitis, Hypertension, Hepatitis C, Alcoholic and Depression."

The record reflected ED Physician #1 ordered multiple laboratory tests. Review of the record revealed the Community Mental Health Provider was consulted at 1627 and arrived at the hospital at 1705. The Alcohol level was drawn at 1635. At 1740 the laboratory called the ED with a High result of 314 mg/dL (milligrams per deciliter) with 0-10 mg/dL noted as the normal reference. The lab report noted Coma may appear with an alcohol level of 300 mg/dL. The patient's urine drug screen for Benzodiazepines was reported as Positive at 1700.

2. This patient's Alcohol level was reviewed and discussed with the Executive Director of Inpatient and Emergency Services at 1610 on 12/10/12. She stated the patient's Alcohol level was very high.

3. A request was made for the CAH's approved list of Critical Laboratory Values for Immediate Notification. This was provided by the Laboratory Director at 1650 on 12/10/12. Alcohol was noted to be absent from this list. She stated the Medical Staff chose not to include a Panic/Critical level for Alcohol.

The Director provided the Laboratory Department's current approved Reference Manual for Alcohol testing. She confirmed the hospital laboratory uses the Conventional Units (mg/dL) method of testing. This Reference Manuel noted Alcohol levels of 50-100 as Toxic. Levels > (greater than) 100 were noted to cause Depression of Central Nervous System (CNS) and Fatalities were noted to be reported with levels > 400. The Laboratory Director stated levels above 300 can result in Coma and levels above 400 can result in Death. She confirmed the patient's level was called to the ED by the laboratory staff due to the Critical elevation/level per the Department's Reference Manual.

4. The ED Policy and Procedure Manuel, last reviewed 9/6/11, was provided for review. Only one policy relative to managing Alcohol testing for ED patients was located. Both the Vice President (VP) of Nursing Services and the Executive Director of Inpatient and Emergency Services confirmed this policy was not current at 1400 on 12/10/12.

5. Review of the patient's medical record revealed the patient was discharged on 9/20/12 at 2019 without further Alcohol testing or treatment. The patient's vital signs were last checked at 1736, two (2) hours and forty-five (45) minutes prior to discharge. The Clinical Impression was noted as: "Ethanol Intoxication and Chronic Alcoholism."

The record lacked a report of the consultation by the Community Mental Health Provider. There was no reference to any recommendations made as a result of the Community Mental Health Consultation or discussion of the results/recommendation with the patient.

6. This record was reviewed with the VP of Nursing at 1100 on 12/11/12. She stated when a Community Mental Health Consultation is performed the results are to become part of the ED record. She also confirmed there was no Community Mental Health Consultation in the record.

7. The "Discharge Policy," effective date 4/22/10, was provided for review. It states in part: "All patients in the ED will have discharge vital signs with the exception of patients with a length of stay less than 30 minutes."

8. This record was reviewed with the VP of Nursing at 1100 on 12/11/12. She confirmed the patient's vital signs were not reassessed prior to discharge per policy/expectations.

9. The "Mental Hygiene Policy and Procedure," revised 8/2/12, was provided for review. It notes in part: "It is the policy of Roane General Hospital (RGH) to provide medical and psychiatric screening exams, including stabilization of medical and psychiatric emergencies in accordance with West Virginia Code Chapter 27: Mentally Ill Patients...Likely to cause serious harm; "Likely to cause serious harm" means an individual is exhibiting behaviors consistent with a medically recognized mental disorder or addiction...Patients presenting to the ED who are deemed medically stable but are deemed to suffer from mental illness or addiction will be provided with a consultation from Westbrook Health Services (community mental health provider)...The physician shall document a consultation."

10. The Medical Staff Policy and Procedures (Rules and Regulations), last reviewed 2/2006, were provided for review. The following is noted under Section V General Patient Care: Suicidal Patients: "Any patient treated in the hospital as a known or suspected suicide attempt or with a known or suspected intentional chemical overdose shall be offered the opportunity for a psychiatric consult. The offer for psychiatric consult and the patient's response to this offer should be documented in the patient's medical record."

11. Review of the ED Policy and Procedure Manual, last reviewed 9/6/12, revealed no policy related to the Medical Screening Examination. The VP of Nursing stated this information is included in the hospital wide "Emergency Medical Treatment and Active Labor Act" policy. This policy, last reviewed 2009, was provided for review. This policy states in part: "Abnormal findings should be normalized via treatment and documented by serial values or explained away prior to discharge."

12. This record was reviewed and discussed with the Executive Director of Quality/Risk/Medical Affairs at 1720 on 12/10/12. She agreed this policy was not followed. The Director confirmed the record lacked evidence the abnormally high alcohol level was normalized via treatment and documented by serial values or explained away prior to discharge.

B. Based on review of medical records, documents and staff interview it was determined the CAH failed to provide emergency care per acceptable standards/policy for one (1) of one (1) patients reviewed (patient #3) who presented to the Emergency Department with law enforcement for mental hygiene evaluation due to Suicidal Ideation. This failure creates the potential for the care and condition of all patients with psychiatric illness/emergencies to be adversely impacted.

Findings include:

1. Review of the ED record for patient #3 revealed the patient presented to the ED with law enforcement for evaluation due to suicidal ideation on 9/24/12. The record reflected the patient arrived at 1753 and was triaged at 1756. Review of the nursing assessment revealed the patient had history of Depression with prior inpatient psychiatric treatment, Heart Disease, Diabetes and Lung Disease. The patient's nursing assessment revealed the patient's screening was positive for Depression, Previous Psychiatric Care, Previous Suicide Attempt with Current Organized Plan or Serious Suicide Attempt.

2 The untimed medical screening examination performed by ED physician #2 revealed a chief complaint of Depression. The physician noted "prior thoughts of suicide." He also recorded a past history of two (2) prior Suicide Attempts, Depression and Bipolar Disorder. The ED physician recorded the Clinical Impression as Major Depression.

A Community Mental Health Consultation was ordered and Westbrook staff was noted to be at bedside at 1820. The Consult report noted the presenting problem to be: Mental Hygiene Petition due to Suicidal Ideations. The Community Mental Health Provider documented the patient denied suicidal ideation and noted disposition to be to obtain a motel room for the night and then take patient to a homeless shelter.

3. The patient was discharged home at 1950 with Condition noted as Unchanged. The record lacked any documentation to reflect the physician and/or nursing staff reassessed the patient for Suicidal Ideation prior to discharge in order to determine safety for disposition.
There was no record of the results/recommendations from the Community Mental Health Provider were discussed with the patient.

4. The "Mental Hygiene Policy and Procedure," revised 8/2/12, was provided for review. It notes in part: "It is the policy of Roane General Hospital (RGH) to provide medical and psychiatric screening exams, including stabilization of medical and psychiatric emergencies in accordance with West Virginia Code Chapter 27: Mentally Ill Patients...Patients presenting to the ED who are deemed medically stable but are deemed to suffer form mental illness or addiction will be provided with a consultation from Westbrook Health Services (community mental health provider)...The physician shall document a consultation."

5. The Medical Staff Policy and Procedures (Rules and Regulations), last reviewed 2/2006, were provided for review. The following is noted under Section V General Patient Care: Suicidal Patients: "Any patient treated in the hospital as a known or suspected suicide attempt or with a known or suspected intentional chemical overdose shall be offered the opportunity for a psychiatric consult. The offer for psychiatric consult and the patient's response to this offer should be documented in the patient's medical record."

6. This record was reviewed and discussed with both the Executive Director of Inpatient Services/Emergency Services and the ED Nurse Manager at 1140 on 12/11/12. They acknowledged the ED physician and nursing staff failed to document a reassessment of the patient's suicidal ideation/safety for disposition prior to discharge. They acknowledged the record lacked documentation to reflect the Consultation by the Community Health Provider (Westbrook) and subsequent disposition plan was discussed with the patient prior to discharge.

C. Based on review of medical records, documents and staff interview it was determined the CAH failed to provide emergency care per acceptable standards/policy for one (1) of one (1) juvenile patients reviewed (patient #4) who presented to the Emergency Department with an Allergic Reaction. This failure creates the potential for the care and condition of all patients to be adversely impacted.

Findings include:

1. Review of the ED record for patient #4 revealed the patient to be a twelve (12) year old who presented to the ED at 2314 on 9/30/12 with a complaint of Lips Swelling. The Nurse noted the patient complained of lips swelling after being given Mylox and Zantac in ED earlier in evening.

2. The untimed medical screening examination by ED physician #3 noted the patient had Rash on palm of right hand and upper lip. He noted the Clinical Impression to be: "Acute Allergic Reaction." Solu-Medrol 125 mg IM (intramuscular) injection was ordered and administered at 2327.

3. The patient was discharged at 2339, twenty-five (25) minutes after arriving in the ED and seventeen (17) minutes after receiving the IM administration of medication. The record lacked documentation the patient's allergic symptoms or vital signs were reassessed after administration of the medication.

4. The "Discharge Policy," effective date 4/22/10, was provided for review. It states in part: "All patients in the ED will have discharge vital signs with the exception of patients with a length of stay less than 30 minutes whom have not received any medications..."

5. This record was reviewed and discussed with both the Executive Director of Inpatient Services/Emergency Services and ED Nurse Manager at 1300 on 12/11/12. They both confirmed the nurse failed to reassess the patient after administration of the IM medication and failed to assess vital signs prior to discharge per policy and expectations.

D. Based on review of documents and staff interview it was determined the CAH failed to ensure medical staff follow policies and procedures governing the medical care provided in the emergency department (ED). The CAH failed to review ED medical records on a regular basis for clinically pertinent issues per policy. This failure has the potential to adversely impact the care and condition of all patients who receive care in the ED.

Findings include:

1. The Medical Staff Policies and Procedures (Rules and Regulations), last reviewed 2/06, were provided for review. The following is noted under Section VIII. Emergency Medical Services, Review of Medical Records: "There will be a review of Emergency Room medical records by the Director of Emergency Services on a regular basis for clinically pertinent issues. Identification of high-risk problems, unexpected outcomes, and important clinical guidelines will be documented. The methods implemented to resolve such problems, achieve such guidelines, and anticipate the unexpected will also be documented and reported to the Medical Staff Performance Improvement Committee each month by the Director of Emergency Services or his/her designee."

2. Interview was conducted with the Executive Director of Quality/Risk/Medical Affairs at 1245 on 12/12/12. She confirmed no reports of ED record reviews have been provided to the Medical Staff Performance Improvement Committee since before June 2011.

Based on observations and testing during the survey conducted from December 11/11/12, the volume of deficiencies issued to the Hospital for non compliance with the 2000 Edition of the Life Safety Code and Physical Plant, it is determined the hospital failed to ensure the safety of patients, staff and the public. Therefore, the condition is not met. C226, K017, K018, K020, K021, K022, K023, K038, K054, K071, K143 and K147.

Based on observations, reviews of documents and interview with staff, it was determined the hospital failed to ensure the humidity levels in the Operating Room suite is maintained at an acceptable level. This has the potential to create an environment conducive to bacterial growth.

Findings include:

1. Review of the Operating Room Performance Improvement (ORPI) committee meeting minutes for the 2012 year revealed there were issues with humidity discussed during the 10/16/2012 meeting. Review of the humidity logs for Operating Rooms (OR) #1 and #2 revealed that it is expected the humidity levels are between 30% and 60%. The humidity is logged daily. During the month of July 2012, the humidity was logged as being over 60% every day. Five (5) days in July, the humidity was logged at over 70%. There were also days in August, September and October the humidity was logged at over 60%.

2. During tour of the OR on 12/10/2012 starting at 2:00 p.m., it was noted there are two (2) OR rooms for procedures. Both OR's (room #1 and room #2) had ceramic tile on all walls. Both rooms had several areas of caulking added on top of the grout around the tiles. The OR Director was present during the tour. She stated during interview the caulking had been added in an attempt to correct a problem with condensation of effervescence. She stated the problem is related to humidity levels in the OR especially during the summer months and is an ongoing problem.

Based on review of policies and interview with staff, it was determined the hospital failed to ensure there are adequate infection control policies and procedures relative to the use of the "Infusion Therapy" room. This has the potential to negatively affect the quality of care provided to patients who receive services in that area.

Findings include:

1. During a tour of the outpatient "Infusion Therapy" room at 1:15 p.m. on 12/12/2012, the Registered Nurse who works in that area stated the room is used for both infusion therapy and wound care. The area was observed to be one (1) converted patient room, with two (2) chairs for patient use. The only separation in the room was a privacy curtain. There was no treatment table available for use during a dressing change of a wound. There was no designated trash receptacle for contaminated wound dressings. Review of the policies and procedures for the "Infusion Therapy" room, last reviewed 10/10/2010, revealed the policies referred to hospital wide infection control policies. There were no specific policies written to direct staff how to safely provide both infusion therapy and wound therapy in one (1) room. The Registered Nurse concurred with the findings.

Based on review of documents and interview with staff, it was determined the hospital failed to ensure policies were reviewed with a group of professional staff which included a person who was not a member of the staff. This has the potential to negatively affect the quality of care and services provided to all patients.

Findings include:

1. Review of all policy manuals for patient care areas revealed the books are not reviewed by the professional staff as a whole, nor are they reviewed annually. Review of the Policy and Procedure Committee meeting minutes for the past one (1) year revealed the committee is reviewing selected policies during each monthly meeting. Review of the sign-in list for the committee revealed the "community" member (non-staff member) of the group did not attend any meetings during the 2012 year.

2. This information was reviewed with the Executive Director of Quality, Risk and Medical Affairs on 12/12/2012 at 11:35 a.m. She concurred with the findings.

Based on reviews of documents and interview with staff, it was determined the hospital failed to assure there is a current list of delineated privileges for all surgeons available in the Operating Room (OR). This has the potential for staff to allow physicians to perform procedures they have not been approved to by the medical staff and the governing body.

Findings include:

1. During a tour of the OR starting at 2 p.m. on 12/10/2012, the current list of delineation of privileges for all surgeons was requested for review. Upon review of the book provided, it was noted the book contained outdated information. The privileges for the general surgeon, the two (2) dentists and the podiatrist were all last updated in 2008.

2. The Executive Director of Quality, Risk and Medical Staff Affairs was interviewed on 12/10/2012 at about 4:30 p.m. She stated the current list of the delineation of privileges is available to staff on-line.

3. The Post-Anesthesia Care Unit (PACU) Registered Nurse was interviewed between 8 a.m. and 10 a.m. on 12/12/2012. She stated she works both in the OR and the PACU. She stated she has been working in the OR suite for more than six (6) months. She stated she had not been educated about the availability of the delineation of privileges either in a book form or on-line and she did not know how to check for those.

The Critical Access Hospital (CAH) failed to conduct an annual review of its total program (see C331); the CAH failed to review the utilization of services, including at least the number of patients served and the volume of services (see C332); the CAH failed to review a representative sample of both active and closed clinical records (see C333); the CAH failed to review the health care policies (see C334); and the CAH failed to determine whether the utilization of services was appropriate, the established policies were followed, and any changes are needed (see C335).

Based on review of documents and staff interview it was determined the Critical Access Hospital (CAH) failed to conduct an annual review of its total program. This failure creates the potential for the quality of care for all patients to be adversely impacted.

Findings include:

1. The policy "Annual Evaluation of the Total CAH (Critical Access Hospital) Program", last revised 9/11, was provided for review. It states in part: "Annually, the CAH program will be evaluated by senior management to determine whether the utilization of services was appropriate, the established policies were followed, and any changes are needed. The evaluation will be presented to the PI (Performance Improvement) Committee for input and recommendations."

2. This policy and the 2011 Annual Evaluation were reviewed and discussed with the Executive Director of Quality/Risk/Medical Staff Affairs at 0740 on 12/11/12. Additionally the March 2012 PI Committee Meeting Minutes were reviewed. The Executive Director confirmed the annual Evaluation of the Total CAH program was not conducted as required per policy.

Based on document review and staff interview it was determined the Critical Access Hospital (CAH) failed to review the utilization of services, including at least the number of patients served and the volume of services. This failure creates the potential for the quality of care of all patients to be adversely impacted.

Findings include:

1. The 2012 Annual Evaluation of CAH Program was provided for review. It was noted to be incomplete and lacked a review of utilization of services, including at least the number of patients served and the volume of services. The 2011 Annual Evaluation of CAH Program was provided for review. It lacked a review of utilization of services, including at least the number of patients served and the volume of services.

2. These documents were reviewed and discussed with the Executive Director of Quality/Risk/Medical Affairs at 0740 on 12/11/12. She agreed with these findings.

Based on document review and staff interview it was determined the Critical Access Hospital (CAH) failed to review a representative sample of both active and closed clinical records. This failure creates the potential for the quality of care of all patients to be adversely impacted.

Findings include:

1. The 2012 Annual Evaluation of CAH Program was provided for review. It was noted to be incomplete and lacked a review of both active and closed records. The 2011 Annual Evaluation of CAH Program was provided for review. It lacked a review of active and closed clinical records.

2. These documents were reviewed and discussed with the Executive Director of Quality/Risk/Medical Affairs at 0740 on 12/11/12. She agreed with these findings.

Based on document review and staff interview it was determined the Critical Access Hospital (CAH) failed to review the CAH's health care policies. This failure creates the potential for the quality of care of all patients to be adversely impacted.

Findings include:

1. The 2012 Annual Evaluation of CAH Program was provided for review. It was noted to be incomplete and lacked a review of the CAH's health care policies. The 2011 Annual Evaluation of CAH Program was provided for review. It lacked a review of the CAH's health care policies.

2. These documents were reviewed and discussed with the Executive Director of Quality/Risk/Medical Affairs at 0740 on 12/11/12. She agreed with these findings.

Based on document review and staff interview it was determined the Critical Access Hospital (CAH) failed to determine whether the utilization of services was appropriate, the established policies were followed, and any changes are needed. This failure creates the potential for the quality of care of all patients to be adversely impacted.

Findings include:

1. The 2012 Annual Evaluation of CAH Program was provided for review. It was noted to be incomplete. The 2011 Annual Evaluation of CAH Program was provided for review. It lacked a review of the utilization of services or any review related to health care policies. Therefore, the CAH failed to determine if the utilization of services was appropriate or if established policies were followed or any changes are needed.

2. These documents were reviewed and discussed with the Executive Director of Quality/Risk/Medical Affairs at 0740 on 12/11/12. She agreed with these findings.