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Based on staff interviews and review of facility documents, the hospital failed to instituted a grievance process that ensure that complaints were appropriately categorized as grievances and to maintain records that separated grievances from complaints and other patient representative customer services activities. In addition, the complaint/grievance process issues/findings were not incorporated into the hospital's Quality Assurance/Performance Improvement (QAPI) activities, as required. Finally, the hospital failed to provide information (including contact information) in the notification of findings letters to the complainants about the option to refer the grievance to the state agency for further action if the issues were not resolved.

The findings were:

1. Policy/Procedure Review:

Review on 11/29/11 of the facility policy/procedure entitled "Patient and Family Complaints and Grievances," revealed the following, in pertinent parts:
"PURPOSE
To assure that all patient concerns, complaints and grievances are handled in a timely, professional manner and in accordance with Colorado state law. To provide patient experience information for analysis and review for process improvement opportunities.
SCOPE
All hospital departments and staff members who become aware of a patient or family complaint will use this policy.
GENERAL INFORMATION
Definitions
Complaint: A complaint is considered any concern a patient or family member brings to the attention of hospital associates while patient is in the hospital as an inpatient or outpatient. A complaint is resolved promptly by any hospital staff present at the time of the complaint or who can quickly be at the patient's location (e.g., hospital leader, patient representative) to address the complaint. The complaint is considered resolved when the patient or family member is satisfied with the actions taken on his/her behalf.

Patient Grievance (as per CMS guidelines): A patient grievances is formal or informal written or verbal complaint that is made to the hospital by a patient or the patient's representative regarding the patient's care (when the complaint is not resolved at the time of the complaint by staff present), abuse or neglect, issues related to the hospital's compliance with the CMS Hospital Conditions of Participation (COPs) or a Medicare beneficiary billing complaint related to rights and limitations provided by 42 CFR 489.

1. All patient and family verbal complaints and/or written grievances will be addressed in a manner consistent with standards set forth by the Colorado Department of Public Health and Environment (CDPHE), the Centers for Medicare and Medicaid Services (CMS)...
5. The (hospital) Board of Trustees will review periodic reports related to patient complaints and grievances. Review of this data will be incorporated into the hospital's overall quality program...
PROTOCOL AND GUIDELINES
8. ...Upon completion of an investigation... the patient representative or designee sends a letter to the patient or family member containing the investigation findings and actions taken to resolve the issue for the patient.
9. If the issue is not resolved to the patient's or family member's satisfaction, the patient representative will inform the patient and family members of their right to directly contact the Colorado Department of Public Health and Environment..."

2. Review of Facility Documents:

Review on 11/29/11 of governing body meeting minutes for 2011 revealed that on 8/18/11, the board was provided with a one page report "Complaint and Grievance Report for (hospital) Board of Directors," with the heading "Nature of Concern and Number of Times Received - Report Range : 01 July 2010 - 30 June 2011." The report collapsed all grievances and complaints, lost items and a category titled "Assistance" together with a tally number assigned to each category. The report ranked the types of concerns by frequency. The top categories by frequency were: lost items, quality of care, bill, timeliness, communication, assistance, discharge, rude treatment, nurses, missed or wrong diagnosis. Those categories were highlighted in red for emphasis. An additional list of 48 other categories were also listed with frequencies ranging from 20 to 1. Some of those categories included: injury professionalism, unknown, pain control, physician, multiple, wrong medication, food, lost biopsy, transfer, wrong patient, cleanliness and numerous other categories. The report did not provide any breakdown of which of the instances in each category were complaints versus grievances. The report provided did not contain information about individual grievance or complaints.

3. Staff Interviews:

During the interview with the patient representative, the administrative assistant keeping records for complaints and grievances, and director of patient experience and process improvement on 11/28/11 at approximately 1 p.m., they confirmed that they had no way to separate out complaints from grievances in their data base, without going in to the record keeping system and opening each file and categorizing it and then creating a list. They stated that the hospital's corporate health system owner/manager was trying to develop a new system to categories complaints and grievances separately, so that numbers and types could be more easily available. They confirmed that they were presently unable to provide specific numbers, from the large pool of complaints and grievances, how many of each they had during the past year, because that data was not available in their current reporting system. They confirmed that they had no way to evaluate the accuracy of categorizing concerns as complaints versus grievances, other than by looking at each case as it was being managed. They reiterated that the new system being developed would eventually allow them to break out and accurately track complaints and grievances separately. They additionally confirmed that the complaint and grievance information was not currently incorporated into the quality assurance process. They stated that they were planning to change the process to include the complaint/grievance findings in the quality assurance process in the future.

During the interview, it was also confirmed that the patient representative does not put information about following up on grievances with the state agency (Colorado Department of Public Health and Environment), if the grievance was not resolved after the hospital investigation was completed. S/he stated that if the complainant verbalizes that s/he was not satisfied with the investigation, s/he would tell them verbally that they could contact the state agency. S/he acknowledged that the referral was not routinely documented. S/he stated that s/he would begin to include the option of referral to the state agency in the letter going forward to comply with CMS and state requirements.

4. Review of Complaints:
Review the complaint/grievance case documentation from seven complaints/grievances selected randomly from the list provided, revealed that six of the cases were grievances. In all six cases, the complaint was sent a letter completing the investigation with some findings. Each letter contained a statement that if the complainant had further questions or concerns they could contact the patient representative and his/her telephone number was provided. None of the letters contained information offering the option of further investigation by referral to the state agency if the complainant felt their concerns had not been resolved. No contact information for the state agency was provided in the letter.

Based on staff interviews and review of facility documents, the hospital failed ensure that the grievance committee, which was authorized to act for the governing body to resolve grievances, maintained a record of the meetings held, kept minutes of the actions taken at the meetings, and entered committee review/actions related to specific grievances into the files for the specific grievances to ensure a complete record of the grievance activities. In addition, the grievance committee failed to provide the governing body with periodic updates of the pattern of grievances, consult the governing body, when needed, related to individual grievances, and to report on the activities of the grievance committee, including providing meeting minutes and reports of grievance actions/trends.

The findings were:

1. Policy/Procedure Review:

Review on 11/29/11 of the facility policy/procedure entitled "Patient and Family Complaints and Grievances," revealed the following, in pertinent parts:
"...4. The (hospital) Board of Trustees is responsible for the effective operation of the Grievance Process. The Board has delegated this responsibility to the patient representative who will call an ad hoc Grievance Committee meeting as needed to resolve grievances with all or some of the following participants: patient representative, and administrator or his/her designee, appropriate directors or managers, and/or the Chief Medical Officer or the president of the medical staff or his/her designee.
5. The (hospital) Board of Trustees will review periodic reports related to patient complaints and grievances. Review of this data will be incorporated into the hospital's overall quality program..."

2. Review of Facility Documents:

Review on 11/29/11 of governing body meeting minutes for 2011 revealed that on 8/18/11, the board was provided with a one page report "Complaint and Grievance Report for (hospital) Board of Directors," with the heading "Nature of Concern and Number of Times Received - Report Range: 01 July 2010 - 30 June 2011." The report collapsed all grievances and complaints, lost items and a category titled "Assistance" together with a tally number assigned to each category. The report ranked the types of concerns by frequency. The top categories by frequency were: lost items, quality of care, bill, timeliness, communication, assistance, discharge, rude treatment, nurses, missed or wrong diagnosis. Those categories were highlighted in red for emphasis. An additional list of 48 other categories were also listed with frequencies ranging from 20 to 1. Some of those categories included: injury professionalism, unknown, pain control, physician, multiple, wrong medication, food, lost biopsy, transfer, wrong patient, cleanliness and numerous other categories. The report did not provide any breakdown of which of the instances in each category were complaints versus grievances. The report provided did not contain information about individual grievance or complaints.

The meeting minutes for the governing body contained no other reports of grievance resolution activities, discussion of individual grievances or reports of grievance committee meetings.

3. Staff Interviews:

In a prior interview with the patient representative on 11/28/11 at approximately 1 p.m., while reviewing the report to the governing body and a report of complaints and grievances for the period 6/1/11 to present, generated at the request of the surveyor, the patient representative clarified the category "Assistance." S/he stated that the category contained patient representative actions that were neither complaints or grievances, but inquiries for information or assistance. S/he gave examples of actions in the "Assistance" category that including answering an inquiry about whether the hospital did paternity testing and if a patient could park his/her RV (recreational vehicle) in the parking lot.

An interview was conducted on 11/28/11 at approximately 1:00 p.m. with the patient representative, the administrative assistant keeping records for complaints and grievances, and director of patient experience and process improvement. They confirmed that the grievance committee met periodically on an ad hoc basis at the discretion of the patient representative. S/he confirmed that no log of meetings held was maintained and no meeting minutes were generated. The three staff also confirmed that they had no way to separate out complaints from grievances in their data base, without going in to the record keeping system and opening each file and categorizing it and then creating a list. They stated that the hospital's corporate health system owner/manager was trying to develop a new system to categorize complaints and grievances separately, so that numbers and types could be more easily available. They confirmed that they were presently unable to provide specific numbers, from the large pool of complaints and grievances, how many of each they had during the past year, because that data was not available in their current reporting system. They confirmed that they had no way to evaluate the accuracy of categorizing concerns as complaints versus grievances, other than by looking at each case as it was being managed. They reiterated that the new system being developed would eventually allow them to break out and accurately track complaints and grievances separately.

Based on medical record review, staff interview and review of the hospital's policies/procedures, the facility failed to ensure that the patient or his/her representative had the right to make informed decisions regarding his or her care. Specifically, the facility's staff failed to follow the facility's policy on obtaining informed consents for treatments and procedures in 3 of 32 records reviewed. In sample patient records #13 and #14, the facility failed to ensure that informed consents obtained by telephone were confirmed and were witnessed by two people, as required. In sample patient record #32, the facility failed to complete the informed consent for a procedure, including identifying the proposed procedure/treatment, the diagnosis/condition or the date of the treatment/procedure in the spaces on the form that were indicated. In addition, the facility failed to ensure that an informed consent was obtained for a central venous line placement that was accomplished during the hospitalization.

On 11/29/11, the facility policy/procedure entitled "Witnessing Signatures" was reviewed and revealed the following, in pertinent parts:

"...PURPOSE
To inform associates of the responsibilities assumed when they act as a witness....
PROTOCOL AND GUIDELINES
Telephone Consents: Provided the document identifying the legal guardian or Durable Power of Attorney for Medical Decisions is present on the patient's medical record and in effect, telephone consent can be obtained when witnessed by two people. The name of the individual giving consent and the legal relationship to the patient, along with the notation "telephone consent" must be recorded on the consent form...."

Medical Record Review:

Review of the medical record for sample patient #13 revealed that the patient was admitted to the hospital with diagnosis of subarachnoid hemorrhage. Two "Informed Consent for Treatment/Procedure" forms used for cerebral angiograms were found to be telephone consents by the patient's out-of-state family member. The telephone consents were not witnessed by two people as required by the facility's policy/procedure.

Review of the medical record for sample patient #14 revealed that the patient was admitted to the hospital with the diagnoses of subarachnoid hemorrhage and intraventricular hemorrhage. An "Informed Consent for Anesthesia/Sedation/Analgesia" used for general anesthesia for a craniotomy for aneurysm cupping was found to be a telephone consent by the patient's family member. The telephone consent was not witnessed by two people as required by the facility's policy/procedure.


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Facility Policies/Procedures:
A facility policy titled "Informed Consent" that was last revised 8/2009 stated, in pertinent parts:
"...The purpose of this policy is to ensure that any patient receiving surgery or invasive medical procedures will be fully informed by the licensed independent practitioner* providing the care, treatment or service as to all risks, benefits, side effects and alternatives prior to giving consent and to define the obligations in obtaining and documenting informed consent by medical staff and hospital personnel...
b. It is the LIP's responsibility to obtain informed consent from the patient, and to discuss sufficient medical information to enable the patient to decide whether to accept or refuse treatment. * The LIP shall also respond to any questions by the patient and/or family to clarify any issues not fully understood and ensure that the questions are answered to the patient's and/or family's satisfaction. None of the following items should be omitted or left blank on the form. The informed consent discussion should include at least the following information,
(1) A description of the proposed procedure or treatment, including the anesthesia to be used;
(2) The indications for the proposed procedure or treatment;
(3) Material risks, benefits and likelihood of success for the patient related to the procedure or treatment and anesthesia, including the likelihood of each;
(4) Alternatives to the procedure or treatment and their risks, benefits and side effect;
(5) Probable consequences of declining recommended or alternative therapies;
(6) Who will conduct the surgical intervention and administer the anesthesia;
(7) Whether LIP's other than the operating LIP, including but not limited to residents, will be performing important tasks related to the surgery; and
(8) Whether qualified medical practitioners who are not physicians will perform important parts of the surgery or administer the anesthesia..."

Medical Record Review:

Sample patient #32 was admitted to the hospital on 11/23/2011 with necrotizing fasciitis. An "Informed Consent for Treatment/Procedure Form" was present in the chart that listed the patient name, the physician's name and risks of the proposed procedure of "bleeding and collapsed lung." However, the consent did not state the proposed procedure/treatment, nor did the form list the diagnosis/condition or the date of the treatment/procedure in the spaces on the form that were indicated. The consent was signed by the physician and the patient on 11/26/2011. Other documentation within the patient's record indicated that a central venous catheter was inserted electively on 11/26/2011. There were no additional consents in the patient's record for the central venous catheter insertion.

Based on tours/observations and staff interviews, the hospital failed to ensure that all point-of-care testing supplies/controls maintained on the nursing units had not exceeded the manufacturers' expiration dates. The failure created the potential for negative patient outcomes.

The findings were:

1. On 11/29/11 at approximately 11:00 a.m., during a tour of the nursing units, a box of gastric occult blood testing packets were found to be expired as of 9/20/11. The box contained approximately 40 testing packets. The findings were confirmed with the chief nursing officer and the nurse manager for the unit, who were part of the touring staff. The nurse manager for the unit stated that s/he had personally checked the supplies in the room within the last several days and the box of gastric occult blood testing packets was not in the storage room at that time. S/he and the chief nursing officer confirmed that the point-of-care testing supplies are brought to the unit by the staff from the materials management department. They speculated that someone from the materials management department must have delivered the expired box of testing supplies to the unit without checking the expiration date, as required. The expired supplies were immediately removed from the unit supplies.

2. On 11/29/11 at approximately 11:00 a.m., during a tour of the nursing units, two full boxes of "I-STAT" analyzer controls, each box containing 10 vials, were found in a medication refrigerator. The two boxes of controls were labeled with expiration dates of 2009. The chief nursing officer, the nurse educator and nurse manager of the unit confirmed that the boxes of controls were expired. The nurse educator stated that s/he did not understand why the controls were on the unit, since they did not do "I-STAT" analyzer control testing on the unit. The expired supplies were immediately removed from the unit supplies.

Based on medical record review, staff interviews, and facility policy/procedure, the facility failed to ensure that nursing staff developed and kept current a nursing care plan for each patient in 13 of 33 sample medical records. This failure created the potential for a negative outcome.

The findings were:

1. Medical Record Reviews:

Sample patient #7 was an adult patient admitted to the hospital on 11/25/2011 with altered mental status and respiratory distress. The patient's record indicated that the patient's goals were the same as all other inpatients, which were: Comfort, Safety, Treatment planning, Discharge planning, and Education/Knowledge.

Sample medical record #9 was admitted on 9/28/11 and discharged on 10/8/11. The patient's record revealed the new "KOIN" care plan process was not in place and instead the old Process Plan/Outcome documentation existed. However, despite that several care plans had been created, including Pain, Altered Tissue Perfusion, Decreased Cardiac Output, Fear, and Impaired Gas Exchange, the care plans had only been documented on two dates: 10/1/11 and 10/7/11 by two different nurses.

Sample patient #12 was an adult patient admitted to the hospital on 11/11/2011 with altered mental status and bacterial meningitis. The patient's record indicated that the patient's goals were the same as all other inpatients, which were: Comfort, Safety, Treatment planning, Discharge planning, and Education/Knowledge.

Sample patient #13 was an adult patient admitted to the hospital on 11/21/2011 with an intercranial bleed. The patient's record indicated that the patient's goals were the same as all other inpatients, which were: Comfort, Safety, Treatment planning, Discharge planning, and Education/Knowledge.

Sample patient #14 was an adult patient admitted to the hospital on 11/21/2011 with a subarachnoid hemorrhage. The patient's record indicated that the patient's goals were the same as all other inpatients, which were: Comfort, Safety, Treatment planning, Discharge planning, and Education/Knowledge.

Sample patient #15 was an adult patient admitted to the hospital on 11/27/2011 with respiratory failure. The patient's record indicated that the patient's goals were the same as all other inpatients, which were: Comfort, Safety, Treatment planning, Discharge planning, and Education/Knowledge.

Sample medical record #23 was admitted on 11/23/11 and reviewed on 11/30/11. The patient's record contained the facility's new "KOIN" care plan process. Therefore, although five goals were present (comfort, discharge planning, safety, education/knowledge, and treatment plan) there was no specific documentation to those goals. The patient's History and Physical revealed the patient had a past medical history of bipolar disorder, however, no care planning was present regarding this diagnosis despite that the nurses' documentation on 11/29 at 9:30 a.m., stated the patient's psychosocial symptoms were "decreased coping" and "flat affect." Additionally, on 11/29 at 8:49 p.m. the nurse documented the patient's psychosocial symptoms as "flat affect" and on 11/30/11 at 8:38 a.m., the nurse documented the patient's psychosocial symptoms as "depressed" and "flat affect."

Sample medical record #24 was admitted on 11/24/11 and reviewed on 11/30/11. The patient's record contained the facility's new "KOIN" care plan process. Therefore, although five goals were present (comfort, discharge planning, safety, education/knowledge, and treatment plan) there was no specific documentation to those goals. The patient's Speech Therapy Progress Assessment note, dated 11/29/11, and timed 4:01 p.m. stated the following, in pertinent part: "...Re eval for swallow order received. Spoke to nurse ... about order and that pt was seen 3 times on 11/28 for 2 tx [treatment] sessions and 1 MBS [Modified Barium Swallow]. MBS showed silent aspiration and that patient was... Due to silent aspiration and aspiration period that another MBS would have to be done and at this time it is not indicated for this patient..." No care planning was present regarding the patient's issue of aspiration.

Sample patient #29 was an adult patient admitted to the hospital on 11/29/2011 with abdominal pain and appendicitis. The patient's record indicated that the patient's goals were the same as all other inpatients, which were: Comfort, Safety, Treatment planning, Discharge planning, and Education/Knowledge.

Sample patient #30 was an adult patient admitted to the hospital on 11/26/2011 with a headache and vertigo. The patient's record indicated that the patient's goals were the same as all other inpatients, which were: Comfort, Safety, Treatment planning, Discharge planning, and Education/Knowledge.

Sample patient #31 was an adult patient admitted to the hospital on 11/28/2011 for a total hip replacement. The patient's record indicated that the patient's goals were the same as all other inpatients, which were: Comfort, Safety, Treatment planning, Discharge planning, and Education/Knowledge.

Sample patient #32 was an adult patient admitted to the hospital on 11/23/2011 with necrotizing fasciitis. The patient's record indicated that the patient's goals were the same as all other inpatients, which were: Comfort, Safety, Treatment planning, Discharge planning, and Education/Knowledge.

Sample patient #33 was an adult patient admitted to the hospital on 11/29/2011 with an odontoid fracture fixation. The patient's record indicated that the patient's goals were the same as all other inpatients, which were: Comfort, Safety, Treatment planning, Discharge planning, and Education/Knowledge.

2. Staff Interviews:

An interview with the charge nurse on the Medical/Surgical Patient Care Unit on 11/30/2011 at approximately 7:45 a.m. confirmed that all inpatients are assigned the same five "Plan of Care Goals," which were Comfort, Safety, Treatment Plan, Discharge Plan, and Education/Knowledge. S/he stated that the patient's care was planned through the interventions delivered. When asked if all interventions were physician ordered, s/he stated that, while most were physician ordered, portions of the interventions were not. S/he gave the example of non-pharmacological pain relief measures such as repositioning and application of ice. S/he also stated that pain assessments could be changed to a more frequent assessment than what is automatically ordered if the patient is having pain issues.

On 11/28/11 at approximately 4:00 p.m., the chief nursing officer (CNO) was asked for the policy and procedure for nursing care plans and s/he stated there was not one. On 11/16/11, the CNO provided a draft policy/procedure for the new "KOIN" nursing care plan approach that was implemented 11/1/11. S/he also provided a copy of the previous policy/procedure on nursing care planning that was still technically in effect until the draft policy/procedure was adopted. S/he confirmed that the draft policy/procedure was the care plan policy currently being used and that the medical record software had been changed throughout the hospital system to accommodate the new draft policy/procedure. The electronic medical record could no longer accommodate or generate a care plan that complied with the previous, and still technically in effect, policy/procedure entitled "Documentation - Nursing: Inpatient and Observation Patients" (IV. Care Planning).

3. Policy/Procedure Review:

Review on 11/28/11 of the hospital draft policy/procedure entitled "Plan of Care for Acute Inpatients," contained the following, in pertinent parts:

"POLICY TITLE: Plan of Care for Acute Inpatients

SCOPE: This policy applies to all Centura Health acute inpatient facilities.

PURPOSE: To define a standardized process for planning and communicating the patient plan of care within and between all disciplines involved in the care of the patient.

POLICY: It is the policy of Centura Health that all patients admitted to an acute inpatient facility will have an interdisciplinary and individualized plan of care supported by documentation within the EMR. It is the policy of Centura Health that the interdisciplinary and individualized patient plan of care is constituted of the Licensed Independent Practitioner's (LIP) orders, interventions selected specific to the patient, the notes and other documentation contained within the electronic medical records, and the healthcare professional's knowledge...

DEFINITIONS:
KOIN: The acronym used to describe the components of the plan of care.

O: Orders written by the LIP caring for the individual patient.
I: List of interventions or tasks individualized for each patient based on orders or patient needs as determined through assessment.
N: Free text comments in the Electronic Medical Record.
K: Knowledge of the healthcare professional used to:
1. Educate and collaborate with the patient and his/her support system about the plan of care.
2. Plan the care of the patient and communicate the plan of care to other members of the interdisciplinary team."

Based on medical record review, policy and procedure, and staff interview, the facility failed to ensure blood transfusions were conducted in accordance with approved policies and procedures. This failure created the potential for a negative outcome.

The findings were:

The facility's policy titled, "Blood and Blood Products," last revised 3/21/2011, stated the following, in pertinent part: "Preparation for Transfusion of Blood Products... D. Obtain pretransfusion vital signs immediately prior to administering each unit of blood product and notify LIP of any temperature elevation (greater than 37.5 degrees C) before blood is obtained from the Blood Bank... Administration of Blood Products... 2. Obtain vital signs 15 minutes after starting transfusion of each unit and then immediately posttransfusion..."

Medical record review revealed sample patient #9 did not have sufficient vitals signs during two units of packed red blood cell transfusions. Unit A began on 10/3/11 at 2149 (9:49 p.m.) and ended on 10/4/11 at 0042 (12:42 a.m.). In the electronic medical record (EMR) system's "TAR" intervention, no vital signs were present. In the EMR's vital signs interventions, vitals signs were documented at 8:40 p.m. on 10/3 and 12:36 a.m. on 10/4, however, there were no vitals signs immediately prior to transfusion, 15 minutes after start of transfusion, or immediately after the transfusion was complete. Unit B began on 10/7/11 at 1821 (6:21 p.m.) and ended on 10/7/11 at 2011 (8:11 p.m.). The EMR's TAR intervention revealed vitals signs taken at 6:13 p.m., which were immediately prior to transfusion. No other vitals signs were present in the EMR's TAR. In the EMR's vital signs interventions, vitals signs were documented at 7:40 p.m. and 8:20 p.m. Therefore, no vitals signs were documented 15 minutes after start of the transfusion.

An interview was conducted on 11/30/11 at approximately 3:55 p.m. with the Regulatory Readiness Coordinator. When asked about the documentation of vitals signs during the blood administration, s/he confirmed the findings that unit A did not have vital signs obtained prior to or 15 minutes after start of the infusion and that unit B did not have vital signs obtained 15 minutes after the start of the infusion.

Based on review of personnel files and staff interviews, the facility failed to ensure that the manager of the Medical Records department met the professional qualifications outlined in the job description for that position. The facility failed to meet the Organization and Staffing Standard under the condition of Medical Record Services:

The findings were:

During the Health Information Management (HIM) Department tour and interviews conducted on 11/28/11 at approximately 11:30 a.m. with the management team, it was determined that none of the team members had current AHIMA (American Health Information Management Association) credentials (i.e. RHIA,[Registered Health Information Administrator] or RHIT, [Registered Health Information Technician]). The Health Information Management(HIM) team consisted of the department's Director, Supervisor and Coordinator. When the management team was asked if anyone was certified in HIM, the Director stated, "No, I was actually put in this role because of the revenue management aspect as it related to patient charges and coding." The HIM Director was placed in the director role in August of 2011. The department supervisor stated, "s/he had twenty one years of experience in HIM at this facility," and the coordinator had previous on the job training. In review of the facility's job description, Director of Health Information Management Job Code: 1309, created 7/1/2010, the License/Certification requirements stated: "Current AHIMA credentials (i.e. RHIA, RHIT) required and maintained."

An interview with the facility's Chief Nursing Officer (CNO) was conducted on 11/29/2011 at approximately 1:30 p.m. S/he stated that when the HIM Manager was hired into the position, the expectation was that the HIM Manager would obtain either an RHIA or RHIT certification. S/he stated that the expectation was not formally documented with a timeframe nor an exception to the job description requirements. The CNO confirmed that the job description for the HIM Manager required either an RHIA or RHIT certification. S/he also confirmed that no other employee in the Medical Records department possessed an RHIA or RHIT certification. S/he stated that the expectation for completion of certification by the HIM Manager would be within one year if s/he could use her experience to sit for the exam, or two years if s/he needed to take coursework to take the exam. Per the CNO, currently it is unknown whether the HIM Director has sufficient experience to meet the qualifications to sit for the certification exam.

Therefore, the facility failed to comply with the job description requirements for licensure and certification of the Director of Health Information Management position.

Based on policy and procedure review and observations, the facility failed to ensure that outdated, mislabeled, or otherwise unusable drugs and biologicals were not available for patient use. Specifically, the facility failed to have a process to ensure that expired intravenous (IV) medications were inaccessible in order to prevent accidental administration to a patient and that all staff members followed the same standard of practice in discarding expired IV medications. The facility failed to enforce and monitor compliance with its pharmacy Policy and Procedure entitled "Outdated Drugs" which required outdated items to be immediately removed. This failure had the potential to create negative patient outcomes.

The findings were:

A tour of the Intensive Care Unit (ICU) was conducted on 11/29/2011 at approximately 11:15 a.m. by two surveyors and the Director of Nursing. The ICU was divided into three separate pods. Each ICU pod had separate medication storage rooms, which were secured by key card entry.

The observations were:

Expired pre-mixed IV pharmacy prepared medications were found in yellow plastic shoe box sized storage bins arranged by sequential patient room number on metal shelves. Also, expired pre-mixed IV pharmacy prepared medications were found in small bins located in a small medication refrigerator of the ICU.

Expired medication located in ICU medication room #556:
Date expired 11/26/11: Two bags of pre-mixed IV solutions of Presedex (trade name) Dexmedetomidine (generic name) mixed with 100 ml of normal saline (NS). This is a sedative with analgesic properties that controls stress, anxiety and pain.
Date expired 11/28/11: three bags of Piperacillin an antibiotic mixed with 100 ml of NS were found in the refrigerator.

Expired medication located in ICU room #564:
Date expired 11/28/2011: Dexmedetomidine mixed with 100 ml of NS

Expired medication located in ICU medication room #563:
Date expired 11/28/11: Levetiracetam (generic name) mixed with 100 ml of NS. This medication is used in combination with other medications to treat certain types of seizures in people with epilepsy.

A pharmacy Policy and Procedure entitled "Outdated Drugs," revised 8/2011, revealed the following in pertinent parts: "It is necessary to make sure that outdated drugs are removed from stock, stored in a designated area and promptly returned to their vendor so as to prevent accidental use ... Outdated drugs are not permitted on nursing units, patient care areas, exchange carts, COR (Resuscitation) carts, PYXIS (electronic medication dispense) units, or in floor stock drug cabinets ...All nursing care and patient treatment areas will be inspected on a monthly basis by a pharmacy staff member, who will look for outdated stock items. If outdated items are found, they will be immediately removed, replaced with a new item, and then placed in the returned/outdated storage area of the pharmacy."

A pharmacy Policy and Procedure entitled "Drug Storage Area Inspection" revised 8/2011, revealed the following in pertinent part: "It is the responsibility of the Pharmacy Department to ensure that all medication preparation and storage areas in the hospital are neat, clean, well lit, adequately equipped, have no expired drugs on hand and drugs are properly stored."

Pharmacy policies were identified addressing the inspection for outdated drugs on a monthly basis. A review of the Nursing policy and procedure manual revealed there was no existing nursing policy addressing the removal of outdated drugs in a timely manner from any bin with a patient room number following the discharge, transfer, or removal of a patient from the unit. Although pharmacy addressed inspection and removal of expired and unauthorized medication and placement of such in the "Return to Pharmacy Bin" for pick-up by the pharmacy, their timeline was noted to be monthly. There was no process that included nursing personnel currently in effect to ensure that expired IV medications in the refrigerator and storage shelves were removed from administration areas in a timely manner such that new admissions and/or transfer patients had the appropriately ordered medication in their bins.

Approximately 30 minutes after the nursing unit tour was completed on 11/29/2011, the director of nursing returned to the surveyor and stated, "We didn't realize this was a problem. S/he presented to the surveyors a new draft policy entitled "Process for Removing Non-Current or Expired Medication" that s/he had written. Nursing personnel were now included in the process to help ensure expired and unauthorized medication was removed from patient bins in a timely manner and placed in the Pharmacy bins for pick up.

Based on observations, staff interview, and review of the facility's policies/procedures, the facility failed to ensure that the laboratory made written provisions for the proper handling of tissue specimens. Specifically, the laboratory failed to ensure that blood drawn in the facility's Emergency Department for point-of-care testing was being handled, according to a written policy/protocol, consistently.

The findings were:

A tour of the Emergency Department was conducted with the Nurse Educator of the Emergency Department on 11/28/2011 at approximately 10:40 a.m. The department's dirty utility room contained a refrigerator used to store point-of-care (POC) testing supplies. Within the refrigerator door was a square bucket that had lab tubes with blood samples as well as capped syringes with blood samples. When asked why the blood filled tubes and syringes were contained in the refrigerator, the Nurse Educator stated that the laboratory had communicated to the Emergency Department's staff to retain the blood samples that were used for point-of-care testing. S/he stated that the tubes were expected to be kept for 24 hours. S/he stated that her understanding was that the laboratory would possibly need the blood samples in the event that results were questionable. When the samples within the refrigerator were further inspected, it was discovered and confirmed that there were samples within the refrigerator that had exceeded three days of being stored within the refrigerator.

A subsequent interview with the Nurse Educator of the Emergency Department was conducted on 11/29/2011 at approximately 9:50 a.m. S/he stated that the expectations of saving the lab tubes for point-of-care testing was contained in a laboratory policy on point-of-care testing. S/he stated that s/he would provide the surveyor with the policy. S/he stated that the tubes would be used in the event that a discrepancy existed with the point-of-care test that was performed in the Emergency Department and with the laboratory testing. S/he stated that the tubes could be kept for up to seven days.

A subsequent tour of the Emergency Department was conducted on 11/29/2011 at approximately 10:05 a.m. Upon inspection the refrigerator was empty of blood samples; however, the bucket remained with a sign that stated to not store blood samples there and to discard samples each night. There was a blood tube rack on the counter with a sign that stated to discard samples every 24 hours. The Nurse Educator stated that samples would be kept at room temperature in the rack on the counter for 24 hours. S/he stated that s/he would provide staff education and that s/he would provide the handout to the surveyor.

On 11/29/2011 at approximately 11:00 a.m., the Nurse Educator presented a memorandum that was distributed to the Emergency Department staff to further clarify the expectations of blood sample storage for point-of-care testing. The memorandum stated, in pertinent parts, " ...Recently, I have found that some blood samples in tubes and syringes have been saved in the POC refrigerator in the dirty utility room. These samples ARE NOT to be saved longer than 24 hours, and DO NOT need to be refrigerated. If you keep the blood tube used for POC testing, place it in the tube holder on the counter in the dirty utility room. DO NOT put saved samples in the refrigerator. Samples must be discarded every night. Discard all POC tubes and syringes each night in a red waste container when cleaning and doing QI in the dirty utility room ..."

The facility's policies on point-of-care laboratory testing were provided to the surveyor on 11/29/2011 at approximately 11:00 a.m. It was determined that the policies, which included the policies titled "Point of Care Laboratory Testing Policy" and "i-STAT Testing-Point of Care" did not contain instructions that specified if and for how long a blood sample for point of care laboratory testing was to be retained/stored.

An interview with the Clinical Laboratory's System Specialist that was responsible for point-of-care testing was conducted on 11/30/2011 at approximately 9:00 a.m. S/he stated that the expectation for the Emergency Department from the point-of-care laboratory staff was to save blood tubes for at least 24 hours. S/he stated that if there were discrepant results, the laboratory would prefer to be able to check the blood sample to confirm that there was a specific antibody that would account for the discrepant results rather than an equipment malfunction. S/he confirmed that there was no written policy of standard operating procedure that described the expectations for the retention and storage of these blood samples and stated that it "should be written into a policy." S/he stated that the laboratory staff should go to the Emergency Department each night to retrieve the saved samples from a tube rack on the counter and then could discard the samples once they would be no longer needed as was done with other samples in the laboratory. S/he stated that there would never be a need to retain a syringe of blood as the blood could not be tested or used for any laboratory purpose if it were stored in a syringe. S/he concluded by stating that "the expectation from here on out would be that the Emergency Department would keep the blood tubes on the counter and then every night the laboratory staff will come to the Emergency Department to pick up those samples. I would not like the bucket to be used."

An unannounced onsite recertification survey was conducted (see event ID #F2CB21) November 8 through November 15, 2011 by two (2) Life Safety Code Inspectors and included an inspection for compliance with the fire safety requirements of NFPA (National Fire Protection Association) 101, Life Safety Code, (2000 edition) and NFPA 99 Health Care Facilities (1999 Edition). The facility failed to comply with the regulations set forth. Deficiencies were cited under Life Safety Code tags K0011, K0018, K0020, K0025, K0027, K0029, K0038, K0046, K0050, K0052, K0056, K0062, K0064, K0072, K00130, K0145, K0147, K0050, K0062, K0074, and K0130.

See survey event ID #F2CB21 for full details of the cited deficiencies.

Based on staff interview and facility document review, the facility failed to ensure that the emergency services were supervised by a qualified member of the medical staff. Specifically, the facility failed to have a physician assigned to be responsible for supervision on a daily basis when the Medical Director was not present.

The findings were:

A tour of the Emergency Department was conducted with the facility's Chief Nursing Officer and the Nurse Educator of the Emergency Department on 11/28/2011 at approximately 10:40 a.m. The Nurse Educator was asked how daily medical supervision was addressed by the facility. S/he stated that when there were more than one physician present in the department that responsibility was shared and that no one physician was responsible for supervision.

A subsequent interview with the facility's Chief Nursing Officer on 11/28/2011 at approximately 2:50 p.m., revealed that s/he had a discussion with the Medical Director of the Emergency Department and found out that the department did not have a "lead doctor" or someone in charge on a daily basis since there were only two physicians present at a time. S/he stated that the Medical Director was going to address the requirement for supervision and present it to the Chief Nursing Officer.

On 11/28/2011 at approximately 3:15 p.m., the facility's Chief Nursing Officer presented to the surveyor an e-mail from the facility's Emergency Department's Medical Director that stated, in pertinent part: "...as we have rotating similar shifts at each of our facilities...the 'Charge' ED physician will be the physician on the following shifts:
First AM shift - 7:00 a.m. physician
First Afternoon shift - 3:00 p.m. physician
Night Physician - midnight...
This will give us 24 hour coverage for a charge ED physician..."