HospitalInspections.org

Based on observation, interview and record review, the hospital failed to ensure the GB was responsible for the conduct of the hospital as evidenced by:

1. The quality of services provided by the medical staff was not ensured through timely and pertinent performance evaluation. Cross Reference A- 0050.

2. The quality of contracted services was not been ensured through quality review of contracted pharmacy services. Cross Reference A- 0084.


3. The hospital failed to protect and promote the rights of each patient. Cross Reference A- 0155.

4. The hospital failed to ensure a sanitary environment and an active program to prevent the spread of infections in accordance with the hospital's P&P and nationally recognized infection control practices and guidelines. Cross Reference A- 0747.

5. The hospital failed to ensure surgical services were provided organized and staffed to ensure the health and safety of patients. Cross Reference A- 0940.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe environment to the patients.

Based on interview and record review, hospital failed to ensure medical staff provider performance criteria reflected the privileges and duties of some medical staff, the performance evaluations were completed and reviewed timely each six months, one patient's grievance with an allegation regarding the medical staff was referred to the medical staff for review. These failures created the risk of unidentified poor performance in medical staff members.

Findings:

The hospital's P&P titled Attending Staff Policy Guidelines & Procedures, effective 1/4/09, read in part, "Only indicators relative to an individual physician's performance will be used for the physician profile.", "The data will be reviewed on an ongoing basis so that physician performance trends can be addressed in an ongoing manner and more frequently than the two year reappointment cycle." and "Physician profiles shall be generated every six months for departmental review and action."

1a. During a review of a sample of nine physicians (MDs F, M, O, P, Q, R, S, T and W) and three allied health providers' (CRNA 1, NP 1 and PA 1) credential files on 3/5/14, the files did not contain evidence of ongoing provider performance evaluation (OPPE) data gathered since December, 2012. For some providers (MD P and CRNA 1), there was no data documented in the file since June, 2012.

The physicians and allied health providers' OPPEs was reviewed on 3/5/14. For some providers, the performance parameters did not reflect their duties and privileges with the result of little or no performance data was reviewed.

Each file contained an OPPE summary form on which professional activities were listed in a column, followed by a column listing the number of times the activity occurred, a column to indicate the number of times an error was detected in the activity performed, followed by a column in which the percentage of errors was resulted in a box indicating satisfactory or unsatisfactory performance.

However, since the performance activities measured for some of the providers did not match their actual duties, the number of times those activities were performed were zero; hence, the percentage of errors was zero. This resulted in the provider's performance being depicted as satisfactory when there was little or no performance activity reviewed.

Review of CRNA 1's credential file on 3/5/14, showed the CRNA was granted privileges only for pre-operative and post-operative assessments. However, the OPPE parameter list consisted of measures such as administration of conscious sedation and medication prescribing that was not relevant to her privileges and duties. Although the form indicated CRNA 1 performed services for 1079 patients for the OPPE period and the measured performance activities were all performed "0" times.

Review of MD T's credential file, a department chief not involved in direct patient care showed the OPPE contained performance activities such as medication prescribing, but not his actual duties. There was only one activity on the list MD T had ever performed and the rest were performed "0" times.

For other medical staff members reviewed, there was a variation in the number of parameters that reflected actual services performed, with some providers' parameters resulting in more performance data than others.

During a review of the credential file of CRNA 1 on 3/5/14, the file contained OPPE data, but the data did not include the results of random medical record reviews. The OPPE summary form indicated that CRNA 1 saw 1079 patients; however, "0" medical records were reviewed.

In interviews with medical staff leaders, MDs W, X and Y on 3/7/14 at 0830 and 1145 hours, the MDs reviewed the OPPEs of MD T and CRNA 1. The MDs concurred the OPPE parameters did not reflect the providers' actual duties. The MDs stated the OPPE needed to be signed off within about six months; however, there was a delay in obtaining and reviewing the OPPE results.

b. During a review of the physicians and allied health providers' OPPEs on 3/5/14, for some providers, the performance parameters did not reflect their duties and privileges; hence, little or no performance data was reviewed.

Each file contained an OPPE summary form on which professional activities were listed in a column, a column listing the number of times the activity occurred, a column to indicate the number of times an error was detected in the activity performed, followed by a column in which the percent of errors was resulted in a green colored box that indicated satisfactory or a red colored box that indicated unsatisfactory performance.

However, since the performance activities measured for some providers did not match their actual duties, the number of times those activities were performed were zero; hence, the percent of errors was zero. This resulted in the provider's performance being depicted as satisfactory when there was little or no performance activity reviewed.

CRNA 1's credential file was reviewed on 3/5/14. The CRNA was granted privileges only for pre-operative and post-operative assessments. However, her OPPE parameter list consisted of measures such as administration of conscious sedation and medication prescribing that were not relevant to her privileges and duties.

Although the form indicated the CRNA performed services for 1079 patients for the OPPE period, her measured performance activities were all performed "0" times.

Similarly, for MD T, a department chief not involved in direct patient care, the OPPE contained performance activities such as medication prescribing, but not his actual duties. There was only one activity on the list that he had ever performed and the rest were performed "0" times.

For other medical staff members reviewed, there was variation in the number of parameters that reflected actual services performed, with some providers' parameters resulting in more performance data than others.

c. During a review of the credential file of CRNA 1 on 3/5/14, the file contained OPPE data, but the data did include the results of random medical record reviews. The OPPE summary form indicated CRNA 1 saw 1079 patients, but "0" medical records were reviewed.

In interviews with medical staff leaders, MDs W, X and Y on 3/7/14 at 0830 and 1145 hours, they reviewed the OPPE of MD T and CRNA 1. The MDs concurred the OPPE parameters did not reflect the providers' duties. They stated the OPPE was to be signed off within about six months, but that there was a delay in obtaining and reviewing the OPPE results.

2. The hospital's P&P titled Visitor/Patient Complaints and Grievances, effective 7/10/12, read in part, "Grievances, excluding HIPAA Privacy Complaints, shall be acknowledged within seven (7) business days of the stamped receipt date." and "The final written response should include the following: 1. Name of the hospital contact person. 2. Steps taken on behalf of the patient to investigate the grievance. 3. Results of the grievance process and or investigation. 4. Corrective actions, if indicated. 5. Date the investigation was completed.

The grievance of Patient 78 dated 9/12/13 was received on 9/19/13. The grievance contained an allegation of neglect by medical care providers. The complaint read in part, "I need immediate back treatment."

A summary of the patient's medical visits showed Patient 78 had a history of colon cancer and had been seen more than 10 times in the hospital's outpatient settings since 2/12/12. There was no indication the grievance was referred to the medical staff for review of the care provided to Patient 78.

In an interview with medical staff leaders, MDs W, X and Y on 3/5/14 at 1520 hours, they stated the medical staff should have received the grievance for review, but they had not received the grievance for review.

Based on interview and review of the hospital's list of drugs which were currently compounded by the contracted pharmacy, the hospital failed to obtain quality assurance data (which includes end product testing data and sterility testing data) for all of the 27 different drugs compounded by the contracted pharmacy. This failure created the risk of substandard services being provided in the hospital.

Findings:

Interview with the Director of Pharmacy and the Pharmacy Service Supervisor II on 3/3/14 at 1100 hours, showed the facility had a contract for obtaining compounded drugs from a compounding pharmacy provider.

On 3/6/14 at 1430 hours, the Pharmacy Service Supervisor II stated the contracted pharmacy provider made 27 different types of IV medications for this facility. These 27 different drugs included: Fentanyl Citrate syringes and bags (a controlled narcotic), Hydromorphone syringes (a controlled narcotic), Midazolam syringes and bags (a controlled narcotic), Morphine syringes and bags (a controlled narcotic), Oxytocin bags (induction of labor) and various other drugs in both bag and syringe forms.

Interview with the Pharmacy Service Supervisor II on 3/6/14 at 1435 hours and later with the DOP showed the hospital performed random quality assurance testing on the products which it compounded for patient use in order to ensure sterility and safety.

The Pharmacy Service Supervisor II and the Director of Pharmacy were asked if they had in their possession any quality assurance data on the products prepared for them by the contracted pharmacy.

The staff was also asked if they were in possession of any quality assurance data which was evaluated and sent to the P&T Committee (P&T Committee is responsible for all drugs used and stored within the facility) for review. The P&T Committee is responsible for the use, distribution and safety of all drugs which are administered within the facility.

The Pharmacy Service Supervisor II and the Director of Pharmacy were able to provide only generalized quality assurance data for what may have been part of the facility's TPN products. No other quality assurance data was available for the 26 other drugs which were compounded for the facility by the contracted pharmacy.

The P&T Committee did not have a system in place to ensure the compounded drugs, which were obtained from the contracted pharmacy, met the safety expectations of the P&T Committee. The hospital was unable to provide any evidence that any of the quality assurance data for the 26 different drugs had gone to the Quality Assurance Department or that this data was forwarded to the GB for analysis and evaluation.

Based on observation, record review, and interview, the hospital failed to protect and promote the rights of each patient as evidenced by:

1. The hospital failed to ensure the patients were informed their rights as a patient. Cross Reference A-0117.

2. The hospital failed to ensure the patients were made aware of the process for filing a grievance regarding their care issues. Cross Reference A-0118.

3. The hospital failed to investigate patient grievances. Cross Reference A-0119.

4. The hospital failed to ensure the patients or their representatives had evidence of the right to consent to basic procedures and care during his or her hospital stay. Cross Reference A-0131.

5. The hospital failed to ensure the patients had the right to formulate the advance directives. Cross Reference A-0132.

6. The hospital failed to ensure the patient's right to care in a safe setting when surgical services were not carried out in settings that were designed and maintained to minimize the risks of infection and surgical complications. Cross References A-0144, A-0749 and A-0951.

7. The hospital failed to ensure the patients had the right to confidentiality of their health information when there was no confidentiality clause written into the agreements with outside contracted services handling confidential patient information. Cross Reference A-0147.

8. The hospital failed to identify the rationale for the use of multiple restraints. Cross Reference A-0165.

9. The hospital failed to implement the hospital's P&P for restraints when nursing staff failed to assess the patients for the use of behavioral restraints every 15 minutes. Cross Reference A-0167.

10. The hospital failed to ensure the physician's order of restraints for management of violent behavior was renewed within four hours as required by the hospital's P&P. Cross Reference A-0171.

11. The hospital failed to ensure the physician's order of soft wrist restraints was renewed at least every 24 hours as per hospital's P&P. Cross Reference A-0173.


The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe environment to the patients.

Based on interview and record review, the hospital failed to show documentation two of 82 sampled patients were informed their rights as a patient (Patients 11 and 50). This posed the potential for the patients and/or the patients' representative not being allowed to exercise the patient's rights.

Findings:

Review of the hospital's P&P titled Consent for Care dated 9/11/12, showed medical treatment shall not be permitted unless the adult patient or a person legally authorized to act on his or her behalf, has given permission and signed the appropriate consent form at the point of service. Authorized consent forms included the Emergency Medical Treatment Conditions of Admission. The original copy of the completed consent form shall be placed in the appropriate section of the patient's health/medical record.

1. Review of Patient 50's medical record was initiated on 3/5/14. Patient 50 was admitted to the hospital on 2/6/14.

Review of the Conditions of Admission/Clinic Visit showed the section to show the patient or responsible person's signature, relationship to patient was not signed and was left blank. Review of the reverse side of the Conditions of Admission/Clinic Visit listed the patient's rights.

During an interview and medical record review with the Clinical Nursing Director I, Risk Management Manager, and RN AF on 3/5/14 at 0845 hours, they confirmed the finding.

2. Review of Patient 11's medical record was initiated on 3/3/14. Patient 11 was admitted to the hospital on 2/28/14.

Review of the Emergency Medical Treatment Conditions of Admission dated 2/28/14 at 0328 hours, showed the section to show the patient or responsible person's signature, relationship to patient was not signed and left blank. Review of the reverse side of the Conditions of Admission/Clinic Visit listed the patient's rights.

During an interview and medical record review with RN H, the Nurse Manager of Burn Unit and the Clinical Nursing Director-ICU on 3/3/14 at 1325 hours, RN H stated Patient 11's family member visited the patient on Sunday. Staff was asked if Patient 11 and/or the patient's family member were informed of their rights. The Director stated the patient's rights were listed on the reverse side of the Emergency Medical Treatment Conditions of Admission; however, she confirmed the section for the patient or responsible person to sign confirmation of these rights was blank.

Based on interview and record review, the hospital failed to ensure one of 82 sampled patients (Patient 78) and one unsampled patient were made aware of the process for filing a grievance regarding their care issues, creating the risk of failed grievance processes and unmet healthcare needs to the patients receiving services in the hospital.

Findings:

The hospital's P&P titled Patient/Visitor Complaints and Grievances, effective 7/10/12, read in part, "LAC+USC will make every attempt to resolve each complaint, verbal or written, at the point at which it is first expressed. If staff is unable to resolve a verbal complaint to the patient/visitor's satisfaction within the same business day, the complaint becomes a grievance and shall be documented on a 'Patient/Visitor Complaint Report' form..)." and "Patients and visitors shall be advised of the method by which they may express complaints/grievances."

1. On 3/3/14 at 1344 hours, during a clinic patient interview, the patient stated the attitude of the staff in some areas made him feel he should stop coming to the hospital for healthcare needs. The patient stated he did not know where and to whom he should address his concerns.

2. On 3/5/14 at 0943 hours, Patient 78 was interviewed regarding her care. The patient stated she came to the Neurology clinic many times for appointments. The patient stated she was often not seen at the appointed time and there was sometimes confusion about when the appointment was scheduled. In addition, sometimes the staff could not find notes regarding her care needs. The patient stated that she had tried to voice her concerns many times, when these events occurred, but was told that there was nothing to be done.

Based on interview and record review, the hospital failed to investigate one of three patients' grievances (Patient 78) reviewed, creating the risk of persistent poor practices and unmet patient healthcare needs to that patient.

Findings:

The hospital's P&P titled Visitor/Patient Complaints and Grievances, effective 7/10/12, read in part, "Grievances, excluding HIPAA Privacy Complaints, shall be acknowledged within seven (7) business days of the stamped receipt date." and "The final written response should include the following: 1. Name of the hospital contact person. 2. Steps taken on behalf of the patient to investigate the grievance. 3. Results of the grievance process and or investigation. 4. Corrective actions, if indicated. 5. Date the investigation was completed."

Documentation was requested for three randomly selected patient grievances on 3/3/14. Patient 78's grievance dated 9/12/13, was received by the hospital on 9/19/13. The grievance contained allegations regarding a delay in treatment of pain, difficulty obtaining a medical report and neglect by medical care providers. The complaint read in part, "I need immediate back treatment."

A summary of the patient's medical visits was reviewed. Patient 78 had a history of colon cancer and had been seen more than 10 times in the hospital's outpatient settings since 2/12/12. The response to the grievance, a letter dated 10/5/13, read in part, "Every complaint is investigated ..." However, no investigation of the complaint was documented.

According to the response letter, an appointment was made for Patient 78 on 11/19/13, two months from the date the complaint was received. There was no documentation to show the patient was contacted to determine whether an appointment two months later would meet his needs. There was no indication the grievance was referred to the medical staff for review of the care that was provided to Patient 78. A review of the patient's visits subsequent to the 9/12/13, visit showed Patient 78 visited the ED for back pain prior to the appointment scheduled on 11/19/13.

In an interview with medical staff leaders, MDs W, X and Y on 3/5/14 at 1520 hours, they stated the medical staff should have received Patient 78's grievance for review; however, they had not received the grievance. The MDs concurred the response letter showed effort was made to facilitate care for the patient, but not to investigate the allegations.

Based on interview and record review, the hospital failed to ensure the patients or their representatives had evidence of the right to consent to basic procedures and care during their hospital stay for three of 82 sampled patients (Patients 60, 61 and 74). This failure had the potential to result in the hospital treating patients without documentation of the patient/responsible party's consent (to avoid claims for battery) and result in the lack of documentation of financial responsibility for payment of services rendered.

Findings:

The hospital's P&P #205 titled Consent for Care, effective 9/11/12, was reviewed on 3/7/14. The policy section read in part, "Medical treatment shall not be permitted unless the adult patient, or a person legally authorized to act on his or her behalf, has given permission and signed the appropriate consent form at the point of service....In most cases, a child's parent(s) or legal guardian provides consent for medical treatment of a minor."

Also reviewed on 3/7/14, was the hospital's P&P #703 titled Admission to LAC+USC Medical Center Facilities, effective 10/16/08. The procedure section read in part, "All patients seen in the Medical Center facilities shall: Sign a general consent for treatment. At each inpatient admission..."

1. The medical record for Patient 60 was reviewed on 3/5/14. The patient was an infant born in the hospital. The infant had a four day stay after birth due to hyperbilirubinemia (a condition requiring light therapy); however, the infant's mother was discharged 2 days earlier.

No signed Conditions of Admission (COA) form was found in the medical record for Patient 60 as verified during interview with the Interim HIM Director. The Director stated the hospital's practice was not to have the mother sign a separate form for their infant(s) and she thought that infants were covered by the COA the mother signed.

However, there was no "Maternity Patients" clause included in the COA form HS62A (2-13), which would state the mother/legal representative's signed form will cover any baby born during hospitalization.

2. Record 61 was reviewed on 3/6/14. The COA was signed by someone other than the patient (determined by comparing the patient's legible signature on another consent form). The relationship of this person to the patient and the printed name were not documented. This finding was confirmed by Interim HIM Director.


29558


3. The hospital policy title Patient Rights, effective 9/23/08, read in part, "The Network's patients have rights to: ...Receive information about their health status, course of treatment, and prospects for recovery in terms they can understand." and "Make decisions regarding medical care and receive as much information concerning any proposed treatment or procedure, as they may need in order to give informed consent or to refuse a course of treatment."

The hospital P&P titled Consents/Witnessing Signatures, effective date 12/13, showed legal authorization must be obtained from the patient or the patient's authorized representatives prior to performing treatment, specialty procedures or an operation. The consent is a legal document and should be dated signed and witnessed. The Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures (form #231) consisted of an explanation to the patient of the nature of the treatment, the risk, complications and alternative treatments, The Physician of the Record shall be responsible for obtaining informed consent on all patients undergoing an operation, invasive procedure or interventional X-rays. Both the professional and "lay" description of the procedure are required.

Review of Patient 74's medical record was initiated on 3/7/14. The patient went to hospital for a surgical procedure on 2/19/14, as an outpatient.

Review of the Informed Consent for Anesthesia and Anesthesia-Related Services signed by Patient 74 on 2/19/14 at 0934 hours, showed "anesthesia service(s) explained to patient or guardian and question were answered." A box was checked for general anesthesia.

However, review of the Procedure-Hand Services Note dated 2/19/14 at 1440 hours, showed a regional block, not general anesthesia was used for the surgical procedure performed on Patient 74 on 2/19/14.

Based on interview and record review, the hospital failed to ensure two of 82 sampled patients (Patients 11 and 76) had the right to formulate the advance directives. This posed the potential for the patients and/or the patient's family members not being allowed to make medical care decisions.

Findings:

Review of the hospital's P&P titled Advance Directives, revised 3/5/14, showed adults who present for hospital admission shall be informed in writing that one method by which they may exercise their right to make health care decision is through the use of an advance health care directive. They shall also be asked whether or not they have executed a written advance directive, if so, to make a copy available for the medical record.

1. Review of Patient 11's medical record was initiated on 3/3/14. Patient 11 was admitted to the hospital on 2/28/14.

Review of the Emergency Medical Treatment Conditions of Admission showed the section of Advance Directive was left blank.

During an interview and medical record review with RN H, the Nurse Manager of Burn Unit and the Clinical Nursing Director of ICU on 3/3/14 at 1325 hours, they confirmed the finding.


22553


2. Patient 76 was interviewed on 3/4/14 at 0920 hours. The patient stated he was not given information about an advanced directive.

Review of Patient 76's medical record showed the Conditions of Admission/Clinic Visit documentation for an Advance Directive had the area to check yes/no/unknown for the patient were left blank.

Based on observation, interview and record review, the hospital failed to ensure the patient's right to care in a safe setting when surgical services were not carried out in settings that were designed and maintained to minimize the risks of infection and surgical complications, creating the increased risk to the safety of patients having surgery in a non-surgical area.

Findings:

The hospital's policy titled Patients Rights, effective 9/23/08, read in part, "The Network's patients have rights to:... Receive care in a safe setting, free from mental, physical, sexual or verbal abuse and neglect, exploitation or harassment."

During a review of surgical areas in the hospital on 3/6/14, it was noted that surgery was regularly conducted in a treatment room on the sixth floor of the inpatient area of the hospital, the 6G unit.

Observations, interviews and record reviews showed surgical and infection control policies and standards were not implemented in that area, creating the risk to the safety of the patients treated in the 6G unit. Cross Reference A- 0749 #1 and A- 0951 #1.

Based on record review and interview, the hospital failed to ensure the patients had the right to confidentiality of their health information when there was no confidentiality clause written into two of six agreements with outside contracted services handling confidential patient information. This posed the potential for the patients' medical information being disclosed.


Findings:

The contracts for an off-site storage company and the hospital's document destruction service were reviewed on 3/6/14. There was no clause stating the confidentiality of the patient's clinical information would be maintained.

On 3/7/14 at 0930 hours, the Interim HIM Director confirmed this omission. The Director also stated that a Business Associate Agreement (which included the confidentiality requirement) was not signed after being routed on 9/23/13, to the department overseeing these contracts.

Based on observation, interview and record review, the hospital failed to identify the rationale for the use of multiple restraints for two of the six patients (Patients 48 and 49) reviewed for the use of restraints. This had the potential for unnecessary use of restraints for those patients.

Findings:

Review of the hospital's P&P titled Restraints/Seclusion dated 10/8/13, showed the goal of the hospital is to move towards a restraint free environment:

* Restraints are applied only after less restrictive measures have been considered/implemented.

* Utilizing the least restrictive form of restraint when restraint is necessary.

* Facilitation the discontinuation of restraint at the earliest possible time.

1. Review of the hospital's P&P titled Fall Prevention dated 3/12, showed if possible, consider having patients at risk for fall relocated to an area that allows closer nursing observation.

Medical record review for Patient 49 was initiated on 3/4/14. Patient 49 was admitted to the hospital on 3/28/14, with a diagnosis of intracerebral hemorrhage (when a blood vessel bursts in to the brain tissue; stroke-like symptoms usually appear including confusion, weakness, and paralysis, particularly on one side of the body).

On 3/4/14 at 0815 hours, observation of Patient 49 showed the patient lying quietly in the bed with his eyes closed. Four point restraints to all the patient's extremities (legs and arms) were attached to the bed and a cloth vest was secured his upper body to the bed. In addition, the patient had a cervical collar, an indwelling urinary catheter and an intravenous line in place to his right arm used for infusion of medication. The patient's room was the last room down the hallway away from the nursing station. CNA 1 was Patient 49's sitter (companion) in the room and was at his bedside. CNA 1 stated the patient was non-English speaking.

According to Medical-Surgical Nursing, Concepts & Clinical Practice, USA, Mosby, 2012, a Posey cloth vest is a type of medical restraint used to prevent patients from injuring themselves by falling or climbing out of the bed or chair. The vest is placed on the patient and straps extending from each corner are tied individually to each side of the bed.

Review of a physician's order dated 3/4/14, showed an order the patient was to have a 1 to 1 sitter for close patient supervision to assist with feeding.

Review of a physician's order dated 3/4/14 at 0800 hours, showed a restraint order to apply soft restraints to all extremities and a vest restraint. The physician documented the behavior necessitating restraints was due to the patient attempting to pull out lines, tubes and other treatments; he is unable to follow directions and attempts to ambulate independently but he was unable to. Verbal de-escalation, contracting, limit setting, divisional activities and close and continuous monitoring were the alternative methods attempted prior to the restraints application.

Review of the Single Assessment Neurology Progress Note dated 3/5/14, documented Patient 49 was on restraints, had a right lower facial droop, and moved his left side spontaneously; however, there were no spontaneous movements observed on right upper extremity (arm) and right lower extremity (leg). In addition, the documentation showed Patient 49 received Seroquel (an antipsychotic medication) 25 mg as needed for agitation.

Review of a Single Assessment for Restraints Observation dated 3/4/14, showed documentation the patient remained in restraints due to repeated attempts to remove medical equipment therapy. The patient failed to follow instructions. The alternative measures attempted, but were ineffective, were listed as: close monitoring, contracting, and the patient does not understand the criteria. There was no documentation to show how the alternative measures were the least restrictive methods used by the hospital.

During an interview with RN AC on 3/4/14 at 0900 hours, she stated the patient remained in the vest restraint because the patient was trying to climb out of bed and was pulling at his medical devices and tubing.

During an interview with RN AC on 3/4/14 at 0915 hours, RN AC was asked to explain the reason for the use of four point restraints, vest restraint and a sitter, if the patient was unable to move the right side of his body. The RN stated she was unable to state how the vest or the restraint to both legs would prevent the patient from pulling at tubes with his hands, the RN stated nursing staff did not identify the rationale the restraints used for the patient. RN AC stated restraints were discouraged as an intervention for patients at risk for falling.

2. Medical record review for Patient 48 was initiated on 3/4/14. Patient 48 was admitted to the hospital on 2/6/14, with a diagnosis of sepsis (infection).

On 3/4/14 at 1450 hours, Patient 48 was observed lying quietly in bed with his eyes closed. Patient 48 had bilateral wrist restraints attached to the bed, a cloth vest securing his upper body against the bed, and a hand mitten (a restraint designed to restrict hand movement) applied to his right hand. A nasogastric tube (tube inserted into the nares to the stomach) for liquid feedings, an intravenous access, and an indwelling urinary catheter were in place. In addition, a sitter was in the room at the bedside.

Review of a Single Assessment Progress Note, Hematology, dated 2/28/14, showed documentation Patient 48 was non-verbal, did not follows commands, and continued to attempt to pull out the nasogastric tube. Documentation showed the day prior the patient's nasogastric tube was in his left bronchus (passage of airway in the respiratory tract that conducts air into the lungs); the nasogastric tube was replaced on 2/28/14, and was verified as in correct position.

Review of a physician's order dated 3/4/14 at 0800 hours, showed an order for "soft" wrist restraints bilaterally and a vest restraint. The physician documented the behavior necessitating restraints was due to the patient's attempts to pull out lines, tubes and other treatments, and he was unable to follow directions. Verbal de-escalation, contracting, limit setting, divisional activities and close and continuous monitoring were the alternative methods attempted prior to the restraints application.

Review of a Single Assessment for Restraints Observation dated 3/5/14, showed documentation the patient was resting quietly in bed through the night. The patient did not verbalize, but opened his eyes. The sitter was at bedside due to the patient attempting to pull out lines. The patient was wearing a vest restraint and had a mitten restraint on his right upper extremity in addition to a soft restraint on left upper extremity. The patient's left hand was slightly swollen.

During an interview with RN AB on 3/4/14 at 1430 hours, RN AB was asked to explain the reason for the use of bilateral wrist restraints, a mitten to the right hand, a vest cloth restraint and, in addition, a sitter at bedside. The RN stated the reason for the restraint was to avoid Patient 48 pulling out the nasogastric tube. RN AB stated she was unable to state how the vest cloth restraint would prevent the patient from pulling at the nasogastric tube. RN AB confirmed the nursing staff did not identify the rationale for the use of restraints.

Based on observation, interview and record review, the hospital failed to implement the hospital's P&P for restraints when nursing staff failed to assess one of six patients (Patient 52) reviewed for the use of behavioral restraints every 15 minutes. This could lead to injury and unnecessary use of restraints for that patient.

Findings:

Review of the hospital's P&P titled Restraints/Seclusion dated 10/8/13, showed documentation of the use of restrains and/or seclusion shall be consistent with the clinical protocol.

Review of the hospital's Nursing Clinical Protocol titled Restraints/Seclusion: Violent or Self-Destructive Behavior (Behavioral), revised 10/13, showed a behavioral health reason is defined as an unanticipated severely aggressive or self-destructive behavior that places the patient or others in imminent danger. Further review showed to monitor/perform the following upon initiation of restraints or seclusion, every 15 minutes thereafter, and more frequently based on the patient's conditions:

* Level of conscientious,

* Signs of injury associated with the application of restraints or seclusion (such as skin integrity),

* Skin color and

* Respiratory distress.

Review of Patient 52's medical record was initiated on 3/5/14. The patient was admitted to the hospital on 3/5/14.

Review of the Restraint Order for Patient 52 showed a physician's order dated 3/5/14 at 1240 hours, to apply hard restraints to all four extremities for aggressive/violent behaviors which could result in actual/potential injury to others.

Review of the H&P dated 3/5/14 at 1451 hours, showed Patient 52 threw objects and was not directable when the patient came to the unit. The patient "was placed in four point hard restraints for threatening staff and violent behavior."

During an interview and medical record review with RN M on 3/5/14 at 1515 hours, the RN stated four point hard restraints were applied to Patient 52 at 1240 hours. The patient was assessed every two hours at the site of the restraints, for neurological function, vascular function, hydration, diet, comfort, and pressure. The RN administered Haldol (an anti-psychotic), Ativan (an anti-anxiety) and Benadryl (an anti-histamine causing drowsiness) at 1350 hours. The RN assessed the patient at 1350 hours when the RN administered medications to the patient.

On 3/5/14 at 1530 hours, Patient 52 was observed sleeping in the bed. The RN stated the patient had four point hard restraints.

During an interview and medical record review with RN N on 3/6/14 at 1315 hours, the RN stated Patient 52's four points hard restraints for non-behavioral reasons. The RN stated Patient 52 was assessed every two hours while the patient was restrained. Review of the medical record did not show the patient was assessed every 15 minutes as per hospital's P&P for behavioral restraints.

During an interview with MD A on 3/6/14 at 1345 hours, MD A stated Patient 52 was threw objects and was put in four point hard restraints. The MD stated the four point hard restraint was used for behavioral and medical reasons. The MD stated she expected nursing to assess or monitor the patient for safety at least every hour.

Based on interview and record review, the hospital failed to ensure the physician's order of restraints for management of violent behavior was renewed within four hours as required by the hospital's P&P for one of six patients (Patient 52) reviewed for restraint use. This could lead to unnecessary restraint use for that patient.

Findings:

Review of the hospital's Nursing Clinical Protocol titled Restraints/Seclusion: Violent or Self-Destructive Behavior (Behavioral), revised 10/13, showed a behavioral health reason is defined as an unanticipated severely aggressive or self-destructive behavior that places the patient or others in imminent danger. Further review showed to ensure the preprinted "Restraint Order" is completed and specifies with time limitation of four hours for ages 18 or older. The physician's order may be renewed according to the time limited for a maximum of 24 consecutive hours. The physician would be notified for need to renew the order for an expired order if the behavior necessitating restraints persists.

Review of Patient 52's medical record was initiated on 3/5/14. The patient was admitted to the hospital on 3/5/14.

Review of the Restraint Order showed a physician's order for Patient 52 dated 3/5/14 at 1240 hours, to apply hard restraints to all four extremities for aggressive/violent behaviors which could result in actual/potential injury to others. The duration of restraints was not to exceed 24 hours for non-behavioral reasons. The form failed to show the time limitation for the use of four point hard restraints for behavioral reasons.

Review of the H&P dated 3/5/14 at 1451 hours, showed Patient 52 threw objects, and was not redirectable when the patient came to the unit. The patient "was placed in four point hard restraints for threatening staff and violent behavior."

An interview and medical record review was conducted with the Assistant Nursing Director-Women's Services and Med-Surg, Risk Management Manager, Nurse Manager 6D, and RN N on 3/6/14 at 1315 hours. The staff was asked to show Patient 52's physician's order for four point hard restraints was renewed in four hours. They stated Patient 52 had four point hard restraints for non-behavior reasons; the Restraint Order showed the restraints was not exceed 24 hours. The four point hard restraint was not used for behavior reason.

However, during an interview with MD A on 3/6/14 at 1345 hours, MD A stated Patient 52 threw objects and was put on four point hard restraint for violent behavior. The MD stated the four point hard restraint was used for behavior reason and medical reasons.

Based on interview and record review, the hospital failed to ensure the physician's order of soft wrist restraints was renewed at least every 24 hours as per hospital's P&P for one of six patients (Patient 11) reviewed for the use of restraints. This resulted in the potential for the unnecessary use of restraints for that patient.

Findings:

Review of the hospital's Nursing Clinical Protocol titled Restraints: Non-Violent or Non-Self-Destructive Behavior (Non-Behavioral) revised 10/13, showed to ensure the preprinted "Restraint Order" is completed and specifies time limitation (not to exceed 24 hours) and type of restraint; notify the physician of the need for a new order for an expired order if the condition necessitating restraints persists.

Review of Patient 11's medical record was initiated on 3/3/14. Patient 11 was admitted to the hospital on 2/28/14.

Review of the preprinted Restraint Order showed a physician's order dated 2/28/14 at 0515 hours, for soft wrist restraints to all of Patient 11's four extremities, not to exceed 24 hours.

Further review of the medical record failed to show the physician's order for soft wrist restraints was renewed for Patient 11 within 24 hours.

Review of the preprinted Restraint Orders showed a physician's order dated 3/1/14 at 0838 hours, for restraints to the patient's four extremities not to exceed 24 hours. The form failed to specify the type of restraints to use for Patient 11.

Review of the Restraints Assessment showed Patient 11 required soft restraints for both upper extremities on 3/1/14 at 0400, 0600, 0800 and 1000 hours.

An interview and medical record review was conducted with RN H and the Clinical Nursing Director of ICU on 3/3/14 at 1325 hours. The Director stated the physician's order for restraints should be renewed in 24 hours. The RN and the Director confirmed the above findings.

Based on interview and record review, the QAPI program failed to ensure the provision of safe services to the patients as evidenced by:
1. Surgical services were provided to patients in a physical area in which controls to regulate the quality of services were not implemented.

2. The QAPI program did not ensure the prompt implementation of a measure to reduce delays in scheduling outpatient MRI and CT scans. The scheduling delays were subject to incomplete analysis.

3. The safety of lead lined radiation protection garments was not subject to review.

These failures created the risk of substandard patient care to the patients receiving services in the hospital.

Findings:

1. During a review of surgical services provided to patients in the hospital, surgical procedures were observed being performed on a routine basis in a sixth floor treatment room, 6G. During subsequent observations, interviews and record reviews, controls to ensure a sanitary surgical environment and processes to ensure patient safety were not implemented in the 6 G area. Cross Reference A-0951, example #1.

During an interview on with the nurse assigned to the 6G unit on 3/6/14 at 1440 hours, she stated a log of the surgeries was reported to the quality assurance department, but that just the number of cases performed in the 6G unit was reported.

During a review of the quality assurance meeting minutes for 2013, there was no quality data or discussion seen regarding the surgical services being provided in the 6G unit.

2. During an interview with the Lead Rad Tech and the Admin Diagnostic Services on 3/4/14 at 1015 hours, the Admin Diagnostic Services stated there was a 30 week wait time for patients needing outpatient MRIs. The Lead Rad Tech stated there was a 16 week wait time for patients needing outpatient CT scans. The Admin Diagnostic Services stated the outpatient CT scan wait time applied to both adult and pediatric patients, and that the wait time had been stable.

During interviews with the MRI Nurse Manager and the Lead Rad Tech, they stated there were complaints from patients regarding the wait time for an MRI. The Nurse Manager stated there was no specific policy for scheduling MRIs and there was no discussion of acquiring more MRI units. The Nurse Manager stated there was a limited study regarding the appropriateness of lumbar spine MRI requests; however, no studies were done by quality assurance regarding the wait time for outpatient MRIs or MRI utilization.

During a review of the Department of Radiation Safety Quality Improvement Committee Reports from April through December, 2013, there was documentation of inpatient and emergency department order to scan times being tracked, but no documentation to show the wait times for outpatient MRI and CT scans were presented or discussed.

During an interview with Quality Improvement Department representatives on 3/6/14 at 1030 hours, they stated they were aware of the long wait times for outpatient MRIs, that the wait time was increasing, and there were complaints about the wait times from patients. The staff stated they hoped to establish alternate routes of access for such tests in the community.

The staff stated there was a mechanism for consultation, the e-consult, that was implemented in different departments in the hospital. The staff stated they hoped the e-consult would help to improve access to care; however, the e-consult was not yet implemented in the radiology department. The staff stated there was no projection of how much the e-consult system was expected to improve the wait time for outpatient Radiologic services.

3. The Radiation Protection Devices Inventory and Inspection Log, divided by department, was reviewed on 3/4/14. The log showed in most departments, there were some garments that did not have an inspection recorded, and instead had the comment "missing" listed in the remarks section. The log for the Surgery Department showed 355 radiation safety garments were "missing" from the department and had not been inspected in 2013. Cross Reference A-0537.

During an interview on 3/5/14 at 0900 hours, the Rad Safety Officer stated he was not sure why there were so many radiation safety garments listed as "missing" on the log. The Safety Officer stated a lot of people bring in their own aprons because they did not trust the aprons in the hospital. The Safety Officer stated the hospital had a responsibility to check the garments; however, more than one person was needed to chase them down.

The Safety Officer confirmed the lead lined radiation safety garments used on patients should be functional; however, there was no policy to check the garments. The Safety Officer stated he had mentioned the problem of radiation safety garments being missing and not available for annual screening to hospital administration at the clinical council. The Safety Officer stated he was told the administration would work on the problem but he had not heard of a solution.

During a review of quality improvement department documents from 2013, no discussion of radiation safety garment issues was seen.

Based on record review and interview, the hospital failed to ensure the HIM department's QAPI efforts were communicated to and evaluated by the hospital's oversight committee(s) and GB. This failure created the risk of substandard patient care in the hospital.

Findings:

The Health Information Committee minutes dated from February, 2013 through January, 2014, were reviewed on 3/7/14. The HIM department's performance monitoring activities relating to timely completion of records was reported to the committee.

During an interview with Interim HIM Director on 3/7/14 at 1130 hours, she stated all the additional monitoring and quality assessment done relating to various activities performed by both employees and the contracted services were no reported to the Health Information Committee, whose minutes were reviewed by the Medical Executive Committee and the governing body. The Director confirmed the HIM department used contracted services to perform coding, almost 100% of the medical transcription, management of the department, and the privacy officer.

Based on interview and record review, the medical staff failed to ensure:

1. Provider performance criteria reflected the privileges and duties of the medical staff, and the performance evaluations were completed and reviewed timely each six months for nine of 10 physicians (MDs F, M, O, P, Q, R, S, T and W) and three allied health providers' (CRNA 1, NP 1 and PA 1) credential files reviewed.

2. One of three patient grievance's reviewed that contained an allegation regarding the medical staff was referred to the medical staff for review (Patient 78).

These failures created the risk of unidentified poor performance in medical staff members.

Findings:

The hospital's P&P titled Attending Staff Policy Guidelines & Procedures, effective 1/4/09, read in part, "Only indicators relative to an individual physician's performance will be used for the physician profile.", "The data will be reviewed on an ongoing basis so that physician performance trends can be addressed in an ongoing manner and more frequently than the two year reappointment cycle." and "Physician profiles shall be generated every six months for departmental review and action."

1a. During a review of a sample of 10 physicians and three allied health providers' credential files on 3/5/14, only one of the files contained evidence of OPPE data gathered since December, 2012. For some providers (MD P and CRNA 1), there was no data documented in the file since June, 2012.

b. The physicians and allied health providers' OPPEs was reviewed on 3/5/14. For some providers, the performance parameters did not reflect their duties and privileges with the result of little or no performance data was reviewed.

Each file contained an OPPE summary form on which professional activities were listed in a column, followed by a column listing the number of times the activity occurred, a column to indicate the number of times an error was detected in the activity performed, followed by a column in which the percentage of errors was resulted in a box indicating satisfactory or unsatisfactory performance.

However, since the performance activities measured for some of the providers did not match their actual duties, the number of times those activities were performed was zero; hence, the percentage of errors was zero. This resulted in the provider's performance being depicted as satisfactory when there was little or no performance activity reviewed.

Review of CRNA 1's credential file on 3/5/14, showed the CRNA was granted privileges only for pre-operative and post-operative assessments. However, the OPPE parameter list consisted of measures such as administration of conscious sedation and medication prescribing that were not relevant to her privileges and duties. Although the form indicated CRNA 1 performed services for 1079 patients for the OPPE period, the measured performance activities were all performed "0" times.

Review of MD T's credential file, a department chief not involved in direct patient care showed the OPPE contained performance activities such as medication prescribing, but not his actual duties. There was only one activity on the list MD T ever performed and the rest were performed "0" times.

For other medical staff members reviewed, there was a variation in the number of parameters that reflected actual services performed, with some providers' parameters resulting in more performance data than others.

c. During a review of the credential file of CRNA 1 on 3/5/14, the file contained OPPE data, but the data did not include the results of random medical record reviews. The OPPE summary form indicated that CRNA 1 saw 1079 patients; however, "0" medical records were reviewed.

In interviews with medical staff leaders, MDs W, X and Y on 3/7/14 at 0830 and 1145 hours, the MDs reviewed the OPPEs of MD T and CRNA 1. The MDs concurred the OPPE parameters did not reflect the providers' actual duties. The MDs stated the OPPE needed to be signed off within about six months; however, there was a delay in obtaining and reviewing the OPPE results.

2. The hospital's P&P titled Visitor/Patient Complaints and Grievances, effective 7/10/12, read in part, "Grievances, excluding HIPAA Privacy Complaints, shall be acknowledged within seven (7) business days of the stamped receipt date." and "The final written response should include the following: 1. Name of the hospital contact person. 2. Steps taken on behalf of the patient to investigate the grievance. 3. Results of the grievance process and or investigation. 4. Corrective actions, if indicated. 5. Date the investigation was completed.

Patient 78's grievance dated 9/12/13 was received by the hospital on 9/19/13. The grievance contained an allegation of neglect by medical care providers. The complaint read in part, "I need immediate back treatment."

A summary of the patient's medical visits was reviewed. Patient 78 had a history of colon cancer and was seen more than 10 times in the hospital's outpatient settings since 2/12/12. There was no indication to show the grievance was referred to the medical staff for review of the care provided to Patient 78.

In an interview with medical staff leaders, MD W, X and Y on 3/5/14 at 1520 hours, they stated the medical staff should receive the grievance for review; however, they had not received the grievance for review.

Based on observation, interview and record review, the medical staff failed to ensure the rule and regulation guidelines for supervision of residents were implemented as evidenced by:

1. The attending physician's supervision in the 6G unit surgical area failed to ensure the hospital's policies regarding patient safety were implemented.

2. The attending physician failed to ensure completion of one or more portions of the medical records for three of 82 sampled patients (Patients 7, 35 and 74).

These failures created the increased risk of poor health outcomes to the patients receiving services in the 6G unit.

Findings:

The Network Rules and Regulations of the MEC dated 5/10/05, page 9, read in part, "All employees, attending staff, house staff and volunteers shall at all times put the patients' health and well-being first and shall provide considerate and respectful patient care. All administrative operations shall be conducted in an ethical manner consistent with the mission, vision, values, strategic plan, goals and Network policies. All physicians are responsible for preparing complete documentation of their treatment of patients as set forth in this Attending Staff Rules and Regulations." and "An attending must ensure an operative or procedure note is written or dictated with 24 hours of the procedure and shall document in all situations for which direct attending supervision is required."


The Rules and Regulations Guidelines for Supervision of Residents dated 10/3/12, read in part, "An attending or supervisory resident shall see and evaluate each patient prior to any operative procedure or delivery and shall document this evaluation in the medical record."

1. During a review of surgical services provided in the hospital during the survey dates, it was noted surgeries were performed on a routine basis in a sixth floor treatment room, 6G.

The policy statement for Medical Direction showed the responsibility for directing medical care on the unit is that of the assigned or on call attending physician. The specific responsibilities of the admitting physician for patients seen or treated as outpatients or inpatients included completing a H&P examination on all patients and documenting the findings in the patient's chart, assisting in monitoring compliance with quality assurance/improvement activities on the unit, and performing surgeries.

During an interview with MD AB, a surgical department chair on 3/7/14 at 1130 hours, he stated he was aware surgeries were being performed in the 6G unit. MD AB stated he expected the surgeries were done under sterile conditions; however, he stated he was not aware if there was infection control monitoring of the room.

MD AB stated there was no expectation that anesthetic blocks placed for surgeries in the room would be followed up. The MD stated no special training was expected for the nurses who worked in the area.

During observations, interviews and record reviews, it was determined that controls to ensure a sanitary surgical environment and processes to ensure patient safety were not implemented in the 6G area.

a. Infection control standards for surgical environment were not implemented and maintained for surgical instrument processing, room cleaning, temperature and humidity controls and the delineation of sterile and non-sterile areas. Cross Reference A-0749.

b. The nurse providing services in the roles of circulating nurse, recovery nurse and scrub nurse received no training or competencies for those roles. Cross Reference A-0397, example #1.

c. Surgical policies regarding site marking and time-out, and preparation of a surgical log were not being implemented for surgeries in 6G. Cross Reference A-0951, example #1.

d. There was no follow-up by the anesthesia department as per hospital policy for the anesthetic blocks placed for patients in the 6G unit. Cross Reference A-1005.

In an interview with MD AD, a second year resident on 3/7/14 at 1020 hours, he stated only sometimes were attending physicians present for the surgical procedures in the 6G unit.

2a. Review of the medical record for Patient 7 showed the H&P examination was incomplete as information was omitted from the evaluation documentation. Cross Reference A-449.

b. Review of the medical record for Patient 74 did not show a H&P examination was completed prior to a surgical procedure. Cross Reference A-0959.

c. Review of the medical record for Patient 35 did not show a post-procedure handoff and evaluation by the physician and the procedure note lacking some details, such as the name of the supervising physician and no separate documentation found by the directly supervising attending physician. Cross Reference A- 0449.

During an interview with MD O on 3/4/14 at 0930 hours, she stated residents in the IR area did no independent procedures and had direct supervision.

Based on interview and record review, the hospital failed to ensure the medical record contained a H&P examination reviewed within 24 hours of an admission by an attending physician (licensed physician who is part of the hospital's medical staff) as per medical staff's rules and regulations for one of 82 sampled patients (Patient 5), creating the risk of a substandard health outcome to that patient.

Findings:

The Rules and Regulations dated 5/10/05, read in part on page 20, "An Attending Physician must review each admission within 24 hours of admission." The rules stipulated the attending physician review could be documented via co-signature on the resident physician's H&P document or via a separate progress note within 24 hours of admission.

The medical record for Patient 5 was reviewed on 3/3/14. The patient was admitted on 2/18/14 at 1124 hours. The initial H&P examination dated 2/18/14 at 1319 hours was signed by a PGY1 (physician in the first year of training). There was no co-signature found from an attending physician. In addition, there was no note by the attending physician seen in the medical record on 2/18/14 or 2/19/14.

During an interview with RN AG on 3/3/14 at 1450 hours, he confirmed there was no co-signature on the H&P document by an attending physician.

On 3/5/14, notes by the attending physician for Patient 5 dated 2/18/14 or 2/19/14, were requested; however, none was provided as of the survey exit date of 3/7/14 at 1715 hours.

Based on interview and record review, the hospital failed to ensure the policy for RN staffing in the IR area was implemented, creating the risk of substandard health outcomes to the patients receiving services in the hospital.

Findings:

The Interventional Radiology Staffing Plan revised 1/24/13, read in part, "There will be 1 RN per IR procedure room. There are 3 IR procedure rooms designated for Vascular, Angiogram and Neurovascular procedures. The Pre-procedure/Recovery Area accommodates up to 6 patients. The staffing for the recovery area is based on the number of patients and the nurse to patient ratio is 1:3 for pre-and post-procedure patients. One RN is designated as a float RN to assist either in the procedure room, CT or the recovery area. Nursing Attendant provides support for answering calls, and activities of daily living."

During an observation in the IR pre-operative and PACU area on 3/4/14 at 0920 hours, Patient 35 was observed in bed 6, with the nurse providing a pre-procedure assessment.

In an interview with Rad Tech 1 on 3/4/14 at 0920 hours, he stated the CT patients were housed in the Interventional Radiology PACU area.

The medical record for Patient 35 was reviewed on 3/5/14. The patient came to the IR area on 3/4/14, for a CT guided lung biopsy.

Review of the Nursing Day Surgery Record showed Patient 35 came to the recovery area at 1200 hours. The patient's pain of was reported as 7/10 (zero being no pain and 10 being the worst pain) at 1200 and at 1215 hours. However, there was no order for pain medication from the physician until 1220 hours. Pain medication was not administered to the patient until 1230 hours.

During an interview with RN AH, the nurse who cared for Patient 35 after her procedure, on 3/5/14 at 1100 hours, the RN stated she was the only RN in the area as two nurses were called away to assist with pediatric MRIs. RN AH stated two nurses handled outpatients, inpatients (except ICU patients) and answered the phone. RN AH stated she had monitored two complex patients and one less complex patient while also doing pre-operative assessments for procedures. RN AH stated she sometimes was not aware that a patient was coming to the area until they arrived. RN AH stated when there were too many patients, she could call a manager who would try to find an RN to assist.

In an interview with the Clinical Nursing Director for ICU on 3/5/14 at 1110 hours, she stated the RN was to monitor two to four patients in the IR PACU area. The Nursing Director stated the MRIs were not always scheduled ahead. The Nursing Director concurred a couple of nurses had had to leave the PACU to assist with MRIs on that day.

Based on observation, interview and record review, the hospital failed to ensure nursing services were provided for six of 82 sampled patients (Patients 10, 23, 47, 50, 53 and 70) as evidenced by:

1. The RN failed to closely monitor Patient 23 after the administration of Duramorth (narcotic analgesic).

2. There was a delay in the staging of Patient 47's pressure ulcer by the wound care nurse and the nurses as required by the hospital's P&P.

3. The RN failed to evaluate Patient 70 for safety prior to the CNA removing the patient's restraints, resulting in the patient traumatically removing his urinary drainage catheter.

4. The RN failed to reassess Patient 10, a pediatric patient for a decreased heart rate.

5. There was no documented evidence to show the left buttock pressure ulcer was measured when Patient 50 transferred to the medical unit on 3/4/14 at 1608 hours. There was no documented evidence to show the patient's right and left buttocks pressure ulcers were measured and described on 3/5/15 at 0823 hours. In addition, Patient 50's pressure ulcer sites and heels were not offloaded to relieve pressure of the wound sites to promote wound healing and prevent from further pressure ulcer development.

6. The RN failed to conduct and document the initial nursing assessment, failed to ensure the laboratory tests were obtained as ordered and failed to ensure the wound assessment was completely assessed for Patient 53.

These failures created the increased risk of poor health outcomes to the patients receiving services in the hospital.

Findings:

1. During a tour of the Post-partum unit on 3/4/14 at 1050 hours, Patient 23's medical record was reviewed with the patient's primary nurse, RN A and the Nurse Manger of the LDR unit. RN A stated Patient 23 delivered her infant by C (cesarean)-section (surgical delivery of the infant via an incision into the abdomen and uterus) at 2141 hours on 3/3/14 .

When RN A was asked about the medication Patient 23 received for pain relief following the surgery, the RN stated the physician ordered Percocet (a strong oral opiate narcotic) and IV push Morphine for breakthrough pain (strong opiate narcotic). When asked if epidural Duramorph was used for pain relief post C-section at this hospital, the RN stated, no it was not. (Duramorph is a preservative free form of morphine injected into the epidural space [the space around the dura mater of the spinal cord] for pain management following the delivery of the infant).

Review of Patient 23's anesthesia record completed by the anesthesiologist for the C-section with the Nurse Manager of LDR showed the patient received 5 mg Duramorph on 3/3/14 at 2200 hours, via the epidural catheter. When asked, the Nurse Manager was unable to locate the orders by the anesthesiologist or the obstetrician for increased monitoring of the patient after the administration of Duramorph.

RN A stated she was unaware Patient 23 received Duramorph after her C-section. RN A stated Patient 23 so far received two Percocets for pain at 0114 hours, and one tablet of Percocet at 0830 hours, following the C-section.

When asked, RN A stated she had not received training regarding the care of patients who received Duramorph. When asked RN A stated she "thought respiratory depression" was a side effect of the medication; however, the RN stated she was unsure of the length of the effects of the medication. The RN stated she assessed Patient 23 every four hours, the patient was not monitored any more frequently than any C-section. Monitoring included measurement of the patient's vital signs, including respirations and a measurement of oxygen saturation (oxygen saturation is a measure of how much oxygen the blood is carrying as a percentage of the maximum it could carry).

RN G was interviewed on 3/5/14 at 0925 hours. The RN stated she was assigned to care for Patient 23 that day. The RN confirmed the patient was monitored no more frequently than every four fours.

The Pharmacy Services Supervisor was interviewed on 3/6/14 at 1340 hours. The Duramorph manufacturer's package insert was reviewed and showed the following:

*Parenteral (IM or IV) administration of narcotics in patient receiving epidural morphine (Duramorph) may result in overdose.

* The most serious adverse reaction encountered during administration of Duramorph is respiratory depression and/or respiratory arrest (decreased breathing rate/cessation of breathing) and could require intervention.

* Duramorph should be administered only in settings where adequate patient monitoring is possible. Resuscitative equipment and a specific antagonist (Narcan) should be immediately available for the management of respiratory depression as well as complications. Patient monitoring should be continued for at least 24 hours since delayed respiratory depression may occur.


26756


2. In February, 2007, the NPUAP (The National Pressure Ulcer Advisory Panel) defined a pressure ulcer as a localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction.

In 2007, the NPUAP defined:

A Stage I pressure ulcer: intact skin with non-blanchable redness of a localized area usually over a bony prominence.
A Stage II pressure ulcer: a partial thickness skin loss presenting as a shallow open ulcer with a red pink wound bed, without slough (dead tissue).
Unstageable pressure ulcer: a full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed. Until enough slough and/or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined.

Review of the hospital's P&P titled Pressure Ulcer Prevention and Management undated, showed to consult the WOCN)or designee whenever a patient:

* Develops a hospital acquired pressure ulcer.
* Is admitted with pressure ulcer (s).
* Needs specialized pressure ulcer evaluation.
* Note: If the WOCN or designee is not available, two unit nurses will verify stage of pressure ulcer.

The WOCN or designee will prioritize consults as follows: hospital acquired pressure ulcers (III, IV, Unstageable and suspected deep tissue injury) will be seen first and then all other hospital acquired stages.

Medical record review for Patient 47 was initiated on 3/4/14, and showed the patient was admitted to the hospital on 12/21/13.

Observation of Patient 47 on 3/4/14 at 1040 hours, showed the patient was lying in bed. The patient was alert and able to make her needs known. Patient 47 stated she was able to use the side rails to assist her with repositioning of her body.

Review of Patient 47's Single Assessment form dated 12/22/13, showed documentation the patient was identified with a skin risk of 17, indicating a mild risk. There were no identified skin breakdown issues documented on the initial nursing assessment.

Review of Patient 47's Wound, Ostomy Continence Consult dated 2/13/14, showed the WOCN saw the patient. She was awake and alert, had surgery for a left below the knee amputation on 2/10/14, and required maximum assistance with repositioning.

Review of Patient 47's physician's orders dated 2/19/14, showed an order for a referral to the wound care consult for a sacral pressure ulcer.

Review of an Order Management Form dated 2/20/14 to 2/21/14, showed an order was sent electronically on 2/19/14 at 1415 hours, for wound consult for Patient 47 due to skin excoriation (skin-pinking).

Review of a the Single Assessment Wound, Ostomy, Continence Consult Note dated 2/24/14, (five days after the physician's order) showed currently Patient 47 had a large area of denuded skin on either side of natal folds (intergluteal cleft), measuring 7 cm (length) x 6 cm (width) in size. The left side the wound bed was red and moist with irregular edges. On the left side there was a necrotic (dead tissue) area, measuring 5 cm x 1 cm in size, surrounded by adherent slough (a layer of dead tissue) and dermal tissue. There was no documentation to show the WOCN staged Patient 47's pressure ulcer at this time.

Review of Patient 47's Single Assessment Wound, Ostomy, Continence Consult Note dated 2/25/14, showed the patient had multiple denuded areas with measurements unchanged from the previous day. The area was surrounded by 5 cm x 2 cm of slough and dermal tissue. There was no documentation to show the WOCN staged Patient 47's pressure ulcer at this time.

Review of Patient 47's Single Assessment Wound, Ostomy, Continence Consult Note dated 2/28/14, showed Patient 47 area of denuded skin to the right of the intergluteal cleft measuring was unchanged in size; however, the left side the wound bed was red, moist and was assessed as an "Unstageable area," measuring 5 cm x 3 cm, with 30% black-tan necrotic tissue and the rest was adherent yellow slough.

An interview was conducted on 3/4/14 at 1400 hours with WOCN 1 who evaluated the patient on 2/24/14. The WOCN stated they were normally consulted for any skin issues and would be contacted for any changes in the wound and changes in staging of the wound. When the WOCN was asked why there was a delay in the Patient 47's evaluation by the wound care nurse after the request for consult was made on 2/19/14, the WOCN stated she received the physician's order for wound care consult on 2/19/14, due to Patient 47 skin excoriation, which was not a priority.

WOCN 1 stated she remembered the wound as a black eschar on the buttocks of the Patient 47. When asked, WOCN 1 confirmed Patient 47's pressure ulcers were not staged as per hospital P&P when the patient was seen on 2/19, 2/24, and 2/25/14.

The RN Manager of the Med-Surgical Unit joined the interview on 3/4/14 at 1415 hours, and reviewed Patient 47's wound care documentation, . The RN confirmed there was no other assessment of Patient 47's wound by nursing regarding the staging of the pressure ulcer.

3. Review of the hospital's P&P Nursing Attendant Sitter Assignment duties and responsibilities undated, showed:

* Make sure patient does not climb out of bed and hurt themselves.
* Make sure patient does not reach for out and try to pull out invasive lines such as IV line, etc.

Medical record review for Patient 70 was initiated on 3/4/14, and showed the patient was admitted to the hospital on 3/1/14.

On 3/4/14 at 0800 hours, Patient 70 was observed lying down in bed, alert. The patient was non-English speaking and unable to make her needs known. The patient had bilateral wrist restraints attached to the bed. A sitter (companion), CNA 1 was at the bedside. Patient 70 had an indwelling urinary drainage catheter attached to a urinary bag attached to the bed and an IV line inserted to his right arm.

During an interview with CNA 1 on 3/4/14 at 0805 hours, she stated Patient 70 was confused and attempted to pull out the medical devices and tubing whenever she released the wrist restraints every two hours for range of motion.

Review of Patient 70's initial assessment for the restraints dated 3/1/14, showed the patient failed to follow directions that could result in a potential to compromise his safety. Patient 70 attempted to pull out lines, tubes or other treatment devices and exhibited aggressive violent behaviors. Close monitoring, verbal de-escalation, limited setting, and medication administration were considered.

Review of a physician's order dated 3/1/14, showed an order to place soft restraints bilaterally to Patient 70's wrists. Verbal de-escalation and close continuous monitoring were attempted prior to the application of restraints.

Review of a physician's order dated 3/3/14 at 0730 hours, showed an order to discontinue Patient 70's indwelling urinary catheter.

Review of a Single Assessment dated 3/3/14 at 0826 hours, showed the RN documented Patient 70 pulled out his indwelling urinary catheter prior to the discontinuing the catheter. The RN documented the sitter took the patient to the bathroom and when placing the patient back to bed, he pulled out his indwelling urinary catheter at approximately 0745 hours, causing moderate bleeding. Urology (branch of medicine that focus on genitourinary system) consultation was requested.

Review of a Single Assessment of a Urology Consult Note dated 3/3/14, showed Patient 70 had a traumatic indwelling urinary catheter removal by the patient with the balloon inflated. The urinary catheter was reinserted. The plan was to continue restraints to prevent removal of the catheter and leave the urinary catheter in for seven to 10 days.

During an interview with RN AD on 3/4/14 at 0830 hours, she stated the sitter who took the patient to the bathroom did not communicate with the assigned RN prior to removing the patient's restraints.


29558


4. Review of hospital's Clinical Protocol titled Physiologic Monitoring/Hygiene/Comfort-Newborn/Pediatric revised 3/05, showed to assess all body systems and pain every four hours and more often as the patient's condition indicates and report significant changes, abnormal assessment findings and abnormal vital signs from baseline or age specific parameters. Documentation in the protocol showed a normal heart rate for an infant (30 days to one year) is between 100 to 160 beats per minute.

Review of Patient 10's medical record was initiated on 3/3/14 at 1440 hours, and showed the patient was admitted to the hospital on 3/3/14 at 0500 hours. The patient was nine months old.

According to the hospital's Clinical Protocol, Patient 10's normal heart rate would be between 100 to 160 beats per minute.

Review of Patient 10's Vital Signs form dated 3/3/14, showed Patient 10's heart rate was documented as 158 at 0550 hours, 113 at 0950 hours, and 54 at 1130 hours.

There was no documented evidence to show the RN reassessed Patient 10 for the decreased heart rate or notified the physician of the patient's heart rate of 54.

An interview and medical record review was conducted with RN L on 3/3/14 at 1440 hours. The RN stated Patient 10's vital signs were assessed every four hours. The RN was asked if the patient was reassessed by an RN when the patient's heart rate was documented as 54 at 1130 hours, or if the physician was notified of the patient's decreased heart rate. The RN stated the RN was not made aware that Patient 10's heart rate had decreased to 54 at 1130 hours.

5. Review of the hospital's P&P titled Pressure Ulcer Prevention & Management Program dated 1/14, showed the pressure ulcer prevention and management program includes assessment, reassessment, communication, implementation of the Pressure Ulcer Prevention and Management Protocol and implementation of an interdisciplinary plan of care including prescribed wound treatments, bed therapy, nutritional support and an individualized plan of care.

Review of Patient 50's medical record was initiated on 3/5/14, and showed the patient was admitted to the hospital on 2/6/14. The patient was transferred to the medical unit on 3/4/14 at 1608 hours.

a. Review of the hospital's Nursing Clinical Protocol titled Pressure Prevention and Management dated 4/12, showed to assess the skin a minimum of every eight hours (wards); assess tissue involvement and describe wound or pressure (and two nurses stage the wound if wound care team is not available) upon identification and dressing changes for location, size, undermining, color, appearance including evidence of healing, drainage, odor, pain, and signs and symptoms of infection.

Review of the All Assessment By Discipline-Single Patient form showed Patient 50's baseline assessments upon transfer to the medical unit as follows:

* On 3/4/14 at 1608 hours, Patient 50 had the right and left buttocks pressure ulcers. The right buttock pressure ulcer was red, pink with full thickness skin loss, measuring 1.2 cm in size. The left buttock pressure ulcer was documented as red, pink with full thickness skin loss.

* On 3/5/14 at 0823 hours, documentation showed the patient had "sacral wound to the sacral area."

There was no documented evidence to show the left buttock pressure ulcer was measured when Patient 50 transferred to the medical unit on 3/4/14 at 1608 hours. In addition, there was no documented evidence to show the patient's right and left buttocks pressure ulcers were measured and described on 3/5/15 at 0823 hours.

During an interview and medical record review with RN J, the Nurse Manager of 6A, Clinical Nursing Director I and the Risk Management Manager on 3/5/14 at 0915 hours, RN J confirmed the above findings.

b. Review of the Nursing Clinical Protocol titled Pressure Ulcer Prevention and Management dated 4/12, showed to implement a turning/repositioning schedule every two hours using a turning schedule as a guide unless contraindicated and avoid turning onto a wound.

Review of the All Assessment by Discipline-Single Patient form showed Patient 50 was positioned in a supine (lying on the back) position on 3/4/14 at 1816 hours and on 3/5/14 at 0000 and 0600 hours. The patient was positioned on the right side on 3/5/14 at 0800 hours.

During an observation on 3/5/14 at 0838 hours, Patient 50 was positioned on the back, leaning toward the left side. A folded thin blanket was placed under the patient's right hip and right flank. The patient's back, buttocks, and sacral coccyx areas were in contact with the mattress. RN I confirmed Patient 50's position did not offload pressure from the patient's wound sites.

During an interview and medical record review with RN J on 3/5/14 at 0915 hours, the RN verified Patient 50 was positioned supine during the above observation. The RN confirmed pressure was not offloaded from the patient's pressure ulcer sites.

During an interview with CNA 1 on 3/5/14 at 1140 hours, the CNA stated CNA turned Patient 50 every two hours and the patient's position would be rotated to the left side, the back and to the right side. The CNA did not verbalize the need to keep pressure off the patient's wound sites by not turning on to the back.

c. Review of the Nursing Clinical Protocol titled Pressure Ulcer Prevention and Management dated 4/12, showed to to use Braden Scale to assess skin risk upon admission, daily and when there is a change in condition (the most commonly used pressure ulcer assessment tool in the United States is the Braden Scale. It consists of 6 subscales based on the primary etiologic factors of pressure ulcer development. The lower the score, the higher the patient's risk for developing a pressure ulcer).

Further review showed the Braden Scale Score Based Interventions for Pressure Ulcer Prevention included the following:

* When the Braden Score is 15 and 16, the patient is at risk for developing pressure ulcers. The interventions include to reposition or encourage the patient to reposition at least every two hours, and offload heels.

* When the Braden Score is 13, and 14, the patient is at moderate risk for developing pressure ulcer.

Review of Patient 50's All Assessments by Discipline-Single Patient form showed documentation dated 3/5/14 at 0800 hours, Patient 50's heels were offloaded. At 0823 hours, the patient's Braden Score was 15.

During an observation on 3/5/14 at 0838 hours, Patient 50 was lying in bed. The patient's heels were not offloaded and were in contact with the mattress.

During an interview with CNA 1 on 3/5/14 at 1140 hours, the CNA was asked to state interventions to protect Patient 50's heels from developing pressure ulcers. The CNA was unable to state clear interventions.

6. Review of Patient 53's medical record was initiated on 3/5/14. The patient was admitted to the hospital on 1/17/14 at 0309 hours.

a. Review of the hospital's P&P titled Documentation-Inpatient dated 1/14, showed an admission assessment shall be completed by the RN on all admitted patients with a length of stay greater than 24 hours. The RN is responsible for documenting the care provided to patients in accordance to the nursing process. The RN documents the assessment findings on initial admission. The LVN (Licensed Vocational Nurse) contributes to the initial and to the ongoing assessment/reassessment of patients through data collection.

Review of the Single Assessment showed an entry dated 1/17/14 at 1330 hours, the "INITIAL" assessment was signed and edited by a LVN.

An interview and medical record review was conducted with RN M, the Risk Management Manager and the Assistant Nursing Director of Women's Services and Med-Surg on 3/5/14 at 1400 hours. When asked to provide Patient 53's initial nursing assessment, RN M provided the above documentation signed by the LVN.

During a follow-up interview on 3/7/13 at 0920 hours, with the Assistant Nursing Director of Women's Services and Med-Surg, the Director confirmed Patient 53's nursing initial assessment was signed and documented by the LVN, not the RN. The Assistant Nursing Director stated a LVN would collect the data; however, the LVN would not assess the patient, an RN would conduct an initial assessment when the patient was admitted. The Assistant Nursing Director stated she would investigate further to see if an RN validated the LVN's documentation.

At the time of the exit of the survey team on 3/7/14 at 1715 hours, no further documentation was provided.

b. Review of Patient 53's blood tests results collected on 3/4/14 at 0830 hours, showed the following:

* The potassium level was 5.3 (normal range is 3.5 to 5.1).
* The creatine level was 1.87 (normal range is 0.5 to 1.0).
* The WBC (white blood count) level was 12.9 (normal range is 3.7 to 10.3; an elevated WBC may indicate an infection).
* The Hemoglobin level (the blood level to check for the patient's anemia) was 7.7 (normal range is 11.8 to 14.7).

Review of Patient 53's physician's order dated 3/4/14 at 1215 hours, showed to obtain a CBC with diff (Complete Blood Count, a blood test to check for infection or anemia), a BMP (Basic Metabolic Panel, a blood test to check for potassium level or kidney function), Mg (magnesium, an electrolyte), Phos (phosphorus, an electrolyte) and Calcium (an electrolyte).

An interview and medical record review was conducted with RN M on 3/5/14 at 1400 hours. When asked, the RN stated the above laboratory tests were not obtained as ordered.

c. Review of Patient 53's Single Assessment showed the following:

* On 3/2/14 at 0800 hours, Patient 53 had a dressing to the left upper buttock and lower buttock.

* On 3/3/14 at 0800 hours, the patient had a left buttock wound.

* On 3/3/14 at 2000 hours, the patient's left buttock skin was open; the patient had an Unstageable pressure ulcer. The color of pressure ulcer was red/pink.

* On 3/4/14 at 0800 hours, the patient had a left buttock wound.

There was no documented evidence to show the left buttock wound was assessed for size and color as per hospital P&P on the above dates.

During an interview and medical record review with RN M on 3/5/14 at 1400 hours, the RN confirmed the findings.

Based on observation, interview and record review, the hospital failed to ensure the plan of care developed for eight of 82 sampled patients (Patients 10, 47, 48, 49, 50, 52, 53 and 70) met patient specific needs. A lack of comprehensive care plan development may result in interventions not developed which could further compromise the patients' medical status.

Findings:

1. Medical record review for Patient 47 was initiated on 3/4/14. Patient 47 was admitted to the hospital on 12/21/13.

Review of the Single Assessment dated 12/22/13, documented Patient 47 was identified at "mild risk" for skin breakdown. No identified skin breakdown issues were documented on the initial nursing assessment.

Review of Patient 47's Single Assessment Wound, Ostomy, Continence Consult Note dated 2/28/14, showed Patient 47 had a large area of denuded skin on either side of natal folds (intergluteal cleft), measuring 7 cm x 6 cm in size. On the left side there was a necrotic area, measuring 5 cm x 1 cm in size, surrounded by adherent slough and dermal tissue. However, on the left side the wound bed was red, moist and was assessed as an "Unstageable area" (full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed. Until enough slough and/or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined), measuring 5 cm x 3 cm, with 30% black-tan necrotic tissue and the rest was adherent yellow slough.

On 3/5/14, review of the Interdisciplinary Patient Care Plan for Patient 47 showed a care plan was developed to address the actual/potential for impaired skin integrity related to open wound. The desired outcome was for wound healing improvement, skin integrity maintained and for the patient to verbalize/demonstrate understanding of the management of the skin problem. Interventions included to assess and document the skin's condition, reposition, wound/skin care, pressure reduction/relief devices, and instruct patient/care giver on importance of nutrition, mobility, implement clinical protocol for pressure ulcer prevention, wound management, and intravenous therapy.

There was no documentation in Patient 47's care plan to show specific interventions were developed to address the identified pressure ulcers on the buttocks and intergluteal cleft prior to or after the discovery of the breakdown.

During an interview on 3/4/14 at 1400 hours with WOCN 1, she stated Patient 47 developed the buttock pressure ulcers due to friction and shear associated with diarrhea. The WOCN confirmed nursing staff should have updated the care plan when the pressure ulcers were identified.

The above findings were confirmed at the time of medical record review during interviews with the WOCN 1 and with the RN Manager of Medical Surgical Unit.

2. Medical record review for Patient 70 was initiated on 3/4/14. Patient 70 was admitted to the hospital on 3/1/14.

Review of the Single Assessment dated 3/1/14, documented an initial assessment for the use of restraints for Patient 70. The patient was assessed as failing to follow directions that could result in a potential for a compromise in his safety. Patient 70 was attempted to pull out lines, tubes or other treatment devices and exhibited aggressive violent behaviors. Close monitoring, verbal de-escalation, limit setting and medication administration were considered.

Review of a physician's order dated 3/1/14, showed a restraint order to place soft restraints bilaterally to Patient 70's wrists. Verbal de-escalation and close continuous monitoring were attempted prior to the application of restraints.

Review of Patient 70's Interdisciplinary Patient Care Plan reviewed on 3/5/14, showed the care plan was developed to address the safety/restraints for potential of serious or life-threatening injury related to the patient's lack of understanding. The desired outcome was for the patient not to sustain an injury during the hospital stay. Interventions included to implement the following protocols: restraints non-behavioral for agitated and/or confused patients.

No documentation was found in Patient 70's care plan to show specific interventions were developed for the use of restraints. The care plan did not specify the type of restraint applied, individualized nursing interventions and goals developed for restraint discontinuation.

During an interview with RN 1 Manager of the Medical-Surgical Unit on 3/4/14 at 0820 hours, she stated restraints interventions and assessments were developed by the patient's nurse and were documented on the Single Assessment electronic forms; however, the patient's care plans were done on the paper records. Patient 70's care plan did not reflect specific interventions to meet the patient's care needs.

3. Medical record review for Patient 49 was initiated on 3/4/14. Patient 49 was admitted to the hospital on 3/28/14, with a diagnosis of intracerebral hemorrhage (when a blood vessel bursts into brain tissue, stroke-like symptoms usually appear including confusion, weakness, and paralysis, particularly on one side of the body).

On 3/4/14 at 0815 hours, observation of Patient 49 showed the patient lying quietly in the bed with his eyes closed. Four point restraints to all the patient's extremities (legs and arms) were attached to the bed and a cloth vest was secured his upper body to the bed. In addition, the patient had a cervical collar, an indwelling urinary catheter and an IV line in place to his right arm used for infusion of medications. The patient's room was the last room down the hallway away from the nursing station. CNA 1 was Patient 49's sitter (companion) in the room and was at his bedside. CNA 1 stated the patient was non-English speaking.

Review of a physician's order dated 3/4/14 at 0800 hours, showed a restraint order to apply soft restraints to all extremities and a vest restraint. The physician documented the behavior necessitating restraints was due to the patient attempting to pull out lines, tubes and other treatments and he was unable to follow directions and attempted to ambulate independently but was unable to. Verbal de-escalation, contracting, limit setting, divisional activities and close and continuous monitoring were the alternative methods attempted prior to the application of restraints.

On 3/5/14, review of Patient 49's Interdisciplinary Patient Care Plan showed the care plan was developed to address the safety/restraints for potential of serious or life-threatening injury related to the patient's lack of understanding. The desired outcome was for the patient not to sustain injury during the hospital stay. The interventions developed included to implement the restraints and non-behavioral protocol.

No documentation was found in the care plan to show specific interventions were developed for the use of restraints for Patient 49. The care plan did not specify the type of restraints applied to the patient with individualized nursing interventions and goals for restraint discontinuation.

4. Medical record review for Patient 48 was initiated on 3/4/14. Patient 48 was admitted to the hospital on 2/6/14.

On 3/4/14 at 1450 hours, Patient 48 was observed lying quietly in bed with his eyes closed. Patient 48 had bilateral wrist restraints attached to the bed, a cloth vest securing his upper body to the bed and a hand mitten (a restraint designed to restrict hand movement) applied to his right hand. A nasogastric tube (tube inserted into the nares to the stomach) for liquid feeding, an IV line and an indwelling urinary catheter were in place. In addition, a sitter was in the room at the bedside.

During an interview with RN Y on 3/4/14 at 1430 hours, RN Y state Patient 48's restraints were in place to keep the patient from removing the nasogastric tube.

On 3/5/14, review of Patient 48's Interdisciplinary Patient Care Plan showed a care plan was developed to address the safety/restraints for potential of serious or life-threatening injury related to the patient's lack of understanding. The desired outcome was for the patient not to sustain injury during the hospital stay. Interventions developed included implementation of the non-behavioral restraint protocol.

No documentation was found to show Patient 48's care plan was developed with specific interventions for the use of restraints. The care plan did not specify the type of restraints applied to the patient with individualized nursing interventions and goals for restraint discontinuation.


29558


5. Review of Patient 10's medical record was initiated on 3/3/14 at 1440 hours. Patient 10, a pediatric patient was admitted to the hospital on 3/3/14 at 0500 hours.

Review of Patient 10's Vital Signs form dated 3/3/14, showed Patient 10's heart rate was 158 beats per minute at 0550 hours, 113 at 0950 hours, and 54 at 1130 hours.

Review of the Interdisciplinary Patient Care plan failed to show a care plan was developed to address Patient 10's low heart rate.

During interview and medical record review with RN L on 3/3/14 at 1440 hours, the RN confirmed the finding.

6. Review of Patient 52's medical record was initiated on 3/5/14. The patient was admitted to the hospital on 3/5/14.

Review of Patient 52's medical record showed a physician's Restraint Order dated 3/5/14 at 1240 hours was to apply hard restraints to all four of the patient's extremities for aggressive/violent behaviors which could result in actual/potential injury to others.

Review of the H&P examination dated 3/5/14 at 1451 hours, showed Patient 52 threw objects and was not redirectable when the patient came to the unit. The patient "was placed in four point hard restraints for threatening staff and violent behavior."

Review of Patient 52's Interdisciplinary Patient Care Plan showed a care plan was developed on 3/5 (no year documented) and reviewed on 3/6/14, to address the non-behavioral restraint. No care plan was developed to address the use of four point hard restraint for the patient's violent behavior.

During an interview and medical record review with RN N on 3/6/14 at 1315 hours, the RN confirmed the finding.

7. Review of Patient 50's medical record was initiated on 3/5/14. Patient 50 was admitted to the hospital on 2/6/14. The patient was transferred to the medical floor on 3/4/14 at 1608 hours.

a. Documentation showed the patient had the left and right buttocks pressure ulcers. Cross Reference A-0395, example #5.

Review of Patient 50's Interdisciplinary Patient Care Plan showed a care plan was initiated on 2/6/14 and reviewed on 3/5/14, to address actual/potential impaired skin integrity related to decreased mobility and disease process. Interventions included assessing and documenting the skin condition, reposition, wound/skin care, and implementing generic patient teaching protocol.

The care plan failed to address Patient 50's Stage III pressure ulcer (full thickness tissue loss. Subcutaneous fat may be visible but bone, tendon or muscles are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunneling) and did not specify how often to turn and reposition the patient and avoid the pressure on the buttocks pressure ulcers. In addition, the care plan did not specify interventions to offload the pressure on the bilateral heels to promote wound healing and prevent further pressure ulcer development.

During an interview and medical record review with RN J and Nurse Manager 6A on 3/5/14 at 0915 hours, they confirmed the findings.

b. Review of the All Assessments by Discipline-Single Patient form showed Patient 50 had edema (swelling) to all extremities.

Review of the Interdisciplinary Patient Care Plan failed to show a care plan was developed to address Patient 50's edema.

During an interview and medical record review with RN J on 3/5/14 at 0915 hours, the RN confirmed the finding.

8. Review of Patient 53's medical record was initiated on 3/5/14. The patient was admitted to the hospital on 1/17/14 at 0309 hours. The patient had a left buttock wound. Cross Reference A 0395, example #6.

Review of Patient 53's Interdisciplinary Patient Care Plan showed a care plan was developed on 1/17/14 and revised on 3/4/14, to address actual impaired skin integrity; however, the care plan did not specify to offload pressure from the left buttock wound.

During an interview and medical record review with RN M on 3/5/14 at 1400 hours, the RN verified the finding.

Based on observation, interview and record review, the hospital failed to ensure nursing staff received the training, education, experience and competence to care for patients to whom they were assigned as evidenced by:

1. The RN assigned to care for patients undergoing surgical procedures and regional anesthesia in the 6G unit worked independently providing patient care for pre-operative, intra-operative and recovery patients in the unit. The RN did not have the training for activities associated with assisting in anesthetic or surgical procedures.

2. The RNs in the obstetrical area did not have the training or competency to care for patients who received an epidural injection of a narcotic by the anesthesiologist for pain management post-operatively.

These failures to provide the necessary education and competency for the care of the patients to whom they were assigned had the potential for poor outcomes to the patients receiving services in the hospital.

Findings:

1. The AORN Definition of a Circulating Nurse showed the circulating nurse's duties in the OR are performed outside the sterile field. The circulating nurse is responsible for managing all nursing care within the OR, observing the surgical team from a broad perspective and assisting the team to create and maintain a safe, comfortable environment for the patient's surgery.

The Department of Anesthesiology Guidelines for Performance for Peripheral Nerve Blocks (undated) read in part, "Responsibilities of PACU nurses or ambulatory unit nurses: All nurses with the ambulatory surgery unit and PACU will be in-serviced prior to participating the in the care of patients receiving peripheral nerve catheters...Assure that no nerve block is performed without the continuous presence of an attending anesthesiologist ....May assist/monitor anesthesiologist during performance of the block....Attach cardiac monitor, pulse oximeter, BP and supplemental oxygen by green mask....Help position the patient for the nerve block....Record vital signs during and after procedure...Open supplies as requested by the anesthesiologist."

On 3/5/14 at 1520 hours, RN F was observed functioning as the circulating RN in the 6G unit. The RN also monitored the patients' vital signs during this time. During the observation RN F stepped out the room to get supplies from another area.

On 3/5 and 3/6/14, RN F was interviewed. RN F stated the 6G Unit provided minor orthopedic procedures for inpatients and outpatients. RN F stated the surgeries performed included carpal tunnel release (a surgery to treat carpal tunnel syndrome, pain and weakness in the hand caused by pressure on a nerve in the wrist) and skin grafts (a patch of skin that is removed by surgery from one area of the body and transplanted, or attached, to another area.).

RN F was the only nurse assigned to 6G. RN F stated she worked independently providing patient care for pre-operative, intra-operative and recovery patients in the unit. RN F monitored patients who received regional anesthesia without a licensed anesthesia provider onsite during and post procedures.

RN F stated the procedures were done on a patient need basis and were not scheduled. The RN stated some patients' procedures required a nerve block by anesthesia providers. The anesthesia providers placed the nerve block and left the patient after completing the injection and when they were satisfied with the block. RN F stated the anesthesia providers did not reassess the patients after the procedures or prior to discharge.

RN F stated she cleaned the dirty instruments and packaged small instruments for sterilization. RN F sent all surgical instruments and trays to central processing for sterilization.

RN F stated she did not have formal training or experience in surgical services. RN F also stated she did not have formal training for OR, perianethesia unit (pre op and PACU) or instrument care. RN F stated that she received preceptorship for her role when she started in 2008. RN F stated that among her duties were preparing the patient for anesthetic blocks. RN F stated only patients with ASA classification I or II were operated on in the 6G unit. The RN stated she assigned ASA classifications to the patients.

RN F stated she logged patients' procedures on a piece of paper. RN F stated she used the Moderate Sedation documentation form to record the patient's vital signs and the procedure because it allowed documentation of frequent vital signs.

Review of RN F's personnel file on 3/7/14, showed RN F's job description and competencies were for a medical-surgical staff nurse position. RN F's job duties included nursing assessment, planning, implementation, evaluation and administrative/ancillary for nursing service. The most recent evaluation was documented on 5/2/13, with a supervisor's signature. RN F had a Basic Life Support certificate for CPR. The job description document did not show a set of specific competencies related to the care that was provided for the patients in 6G. There was no special training documented for activities associated with assisting in anesthetic or surgical procedures. There was no training, for example, in proper patient positioning or surgical instrument decontamination.

The Assistant Nursing Director Med-Surg was interviewed on 3/6/14 at 1450 hours. The Nursing Director she had responsibility for the 6G unit. The Nursing Director stated the nursing competency utilized for RN F was that of a medical-surgical staff nurse providing basic inpatient care with some training in providing a sterile field as would be required for placing a central line at the bedside.

During the interview the Assistant Nursing Director Med-Surg she stated she also did not have training nor experience in surgical services.
Medical record review on 3/7/14, for four patients who received services in 6G (Patients 32, 79, 80 and 81) also received peripheral nerve blocks. RN F assessed, monitored and discharged these patients from 6G. Documentation showed RN F assisted during the procedures and processed the instruments and supplies.



25720


2. During a tour of the Post-partum unit on 3/4/14 at 1050 hours, Patient 23's medical record was reviewed with the patient's primary nurse, RN A and the Nurse Manger of the LDR unit. RN A stated Patient 23 delivered her infant by C-section at 2141 hours on 3/3/14.

When RN A was asked the medication Patient 23 received for pain relief following the surgery, the RN stated the physician ordered Percocet and IV push Morphine for breakthrough pain. When asked if Duramorph was used for pain relief post C-section at this hospital, the RN stated, no it was not. (Duramorph is a preservative free form of morphine injected into the epidural space [the space around the dura mater of the spinal cord] for pain management following the delivery of the infant).

Review of Patient 23's anesthesia record completed by the anesthesiologist for the C-section with the Nurse Manager of LDR showed the patient received 5 mg Duramorph on 3/3/14 at 2200 hours via the epidural catheter. When asked, the Nurse Manager was unable to locate orders by the anesthesiologist or the obstetrician for increased monitoring of the patient after the administration of Duramorph.

RN A stated she was unaware Patient 23 received Duramorph after her C-section. RN A stated Patient 23 so far received two Percocets for pain at 0114 hours and one tablet of Percocet at 0830 hours, following the C-section.

When asked, RN A stated she had not received training regarding the care of patients who received Duramorph. When asked RN A stated she "thought respiratory depression" was a side effect of the Duramorph; however, the RN stated she was unsure of the length of the effects of the medication. The RN stated she assessed Patient 23 every four hours, the patient was not monitored any more frequently than any C-section. Monitoring included measurement of the patient's vital signs, including respirations and a measurement of oxygen saturation.

The Assistant Director of Nursing for Women's Services was interviewed on 3/5/14 at 0915 hours. The Assistant Director stated the hospital did not have a P&P or a physician's protocol for the use of Duramorph for post-partum patients. When asked, the Assistant Director stated the hospital did not provide education to nursing regarding the care of patients receiving Duramorph for pain following a C-section.

RN G was interviewed on 3/5/14 at 0925 hours. The RN stated she was assigned to care for Patient 23 that day. The RN confirmed the patient was monitored no more frequently than every four fours. When asked the treatment if the patient's respiratory rate decreased significantly. The RN stated the patient did not have orders for Narcan (a narcotic antidote). She would have to call the physician for orders to administer the medication.

The Pharmacy Services Supervisor was interviewed on 3/6/14 at 1340 hours. The Duramorph manufacturer's package insert was reviewed and showed the following:

*Parenteral (IM or IV) administration of narcotics in patient receiving epidural morphine (Duramorph) may result in overdose.

* The most serious adverse reaction encountered during administration of Duramorph is respiratory depression and/or respiratory arrest (decreased breathing rate/cessation of breathing) and could require intervention.

* Duramorph should be administered only in settings where adequate patient monitoring is possible. Resuscitative equipment and a specific antagonist (Narcan) should be immediately available for the management of respiratory depression as well as complications. Patient monitoring should be continued for at least 24 hours since delayed respiratory depression may occur.

Based on interview and record review, the hospital failed to ensure medications were prepared and administered to three of 82 sampled patients (Patients 28, 30 and 68) as ordered by the physician as evidenced by:

1. Patient 68 did not receive the first dose of one medication within two hours of the time the medication was ordered as outlined in the hospital's P&P.

2. The MAR for Patient 30 did not match the physician's order for an IV antibiotic, resulting in the potential for a medication administration error.


3. A pain medication was not administered to Patient 28 in accordance with the physician's order.

These failures created the risk of poor health outcomes to those patients.

Findings:

1. Review of the hospital's P&P entitled: "Medication Administration System" dated 12/13, showed on page 3: "Timely Dispensing Of Medication (Medication turnaround time) Medication turnaround time is defined as the time at which an order is prescribed to the time when the medication is administered to the patient, or available for administration, as defined in the standards below: Routine Order: The turnaround time for the first dose of a routine order is 120 minutes and is defined from when the medication order is written to when it is available for administration ...."

Review of the medical record for Patient 68 on 3/5/14 at 0920 hours revealed patient's physician wrote an order on 3/4/14 at 0900 hours, for the patient to have: "Amphojel (an antacid medication) 60 milliliters three times a day with meals."

Nursing documentation in Patient 68's record showed the order was received by nursing at 1100 hours on 3/4/14. The next meal was served at 1130 hours on 3/4/14; however, the Amphojel was not administered to the patient at this time by nursing.

The first dose of Amphojel was not administered to the patient until 1730 hours on 3/4/14 (eight and ½ hours after the medication was ordered by the patient's physician). The medication was available in the hospital's ADC for immediate administration.

During an interview with RN P on 3/5/14 at 0920 hours, RN P verified the patient's medication nurse on 3/4/14, did not document in the patient's record why the patient's Amphojel was not administered with the lunch meal, as ordered by the patient's physician on 3/4/14.


32097


2. On 3/4/14, review of the hospital's P&P titled Medication Adminstration Record (MAR) dated 03/08, indicated under responsibility: "The night shift RN will
review the new MAR against the Nursing Kardex ....Compare with the physician's order and make corrections on the MAR as necessary, if there is any discrepancy .....Report any discrepancies on the MAR discrepancy report ....Fax to the pharmacy by 0600 ...
RN reviews the MAR against Kardex at the beginning of each shift. If a medication discrepancy is found on the MAR at any time throughout the day, the RN notifies Pharmacy immediately and faxes the MAR Discrepancy Report."

On 3/4/14, review of the hospital's P&P titled Medication Administration System dated 12/13, indicated under administration: "The licensed nurse shall:... Ensure the MAR/medication ticket matches the Kardex and the physician's orders."

Review of Patient 30's medical record was conducted on 3/4/14, beginning at 1320 hours. Patient 30 was admitted to the hospital on 2/26/14, for drainage and biopsy. An order for ceftriaxone (antibiotic) 2 gm IV every 12 hours was initially written on admission. The ceftriaxone order was later changed to 2 gm IV daily on 3/2/14 at 1950 hours.

Reconciliation of Patient 30's MAR with the physician's order showed the ceftriaxone 2 gm daily physician's order was different from ceftriaxone 2 gm every 12 hours on the MAR on 3/3/14 and 3/4/14. The frequency on 3/3/14's MAR was crossed out and changed to daily; however, the frequency on 3/4/14's MAR was not changed.

RN 1 reviewed Patient 30's medical record and acknowledged the discrepancy. RN 1 indicated she expected the medication order on the MAR to correspond to the physician's medication order. The RN stated expected nursing to notify the pharmacy when there was any discrepancy between the MAR and the physician's order.

During an interview with Pharmacy Services Supervisor II on 3/6/14 at 0900 hours, she also acknowledged the discrepancy.



25281


3. Review of the hospital's P&P titled Medication Administration System indicated "The nurse administering the medications is responsible for the accuracy of administration and documentation. The licensed nurse shall comply with the five (5) rights ...Right medication."

Review of the hospital's P&P titled Automatic Stop Orders indicated "Narcotics Analgesic: Twenty-four (24) hours unless the physician specifies the duration."

Review of Patient 28's medical record showed on the Admission order and Medication Reconciliation form dated 2/9/14, the physician documented to continue home medications, Norco 5/325 mg (narcotic) by mouth every 6 hours as needed for a pain level between seven and 10 (on a scale of 0 to 10 with 0 being no pain and 10 being worst pain imaginable) and Tramadol 50 mg (a synthetic narcotic) by mouth every 6 hours as needed for a pain level between three and six.

There was also a physician's order on Patient 28's MAR for acetaminophen 650 mg by mouth every 4 hours as needed for mild pain between 1 and 3 or a temperature above 100.1 degrees (F and to call the doctor.

Review of Patient 28's MAR indicated Norco, as a narcotic analgesic would be stopped on 2/10/14, if not renewed by the physician.

Review of Patient 28's MAR for the days following 2/10/14, showed the Norco order was dropped off the MAR and there was no pain medication order to complement the patient's pain level between seven and 10.

Documentation on the back of the MAR showed on 2/24/14, Ultram 50 mg was administered to Patient 28 for pain level of nine out of 10.

Review of the Patient 28's medical record did not show the physician changed the Ultram medication order to administer for a pain level other than between three and six

During an interview on 3/7/14 at 1000 hours, MD Z3 indicated, by not having an active pain medication order for a pain level between seven and 10 there would be a possible delay in treatment. The MD expected pain medication orders to address all pain levels from one to 10.

During an interview on 3/7/14 at 1100 hours, MD Z1 stated the physicians made round daily and were readily available. The MD stated he would question the administering nurse for not contacting the physician for the patient's severe pain for which there was no medication order.

During an interview on 3/7/14 at 1130 hours, MD Y indicated even though the narcotic order might have dropped off due to the short stop order policy, it was a workable policy and house staff physicians were available 24 hours a day. MD Y confirmed the nurse should have contacted the physician.

During an interview on 3/7/14 at 1150 hours, RN A5 stated she would not have given Ultram to the patient and would instead call the physician.

Based on observation, record review and interview, the hospital failed to ensure there was adequate personnel to promptly complete the medical records. This failure had the potential to result in delays of pertinent information being available for the patients' continuing care.

Findings:

A tour of the HIM Department was made on 3/4/14, beginning at 1345 hours, escorted by the Interim HIM Director. The following backlogs were noted:

1. The "Deficiency Unit" which processes inpatient and outpatient surgery records was working on discharges of 2/21/14 (a 10-day backlog). The Interim HIM Director stated the goal was to be working on records no older than five days after a patient's discharge.

2. While in the Release of Information Unit, the Assistant MR Director reported that there were 4000 requests pending completion, which represented about a six-week backlog. The unit provided copies of medical records upon request by various outsiders, such as to other physicians, attorneys, for disability claims, etc.

3. In the Scanning Unit, tables and file cabinet shelves full of stacks of papers were observed. The Interim HIM Director stated these were outpatient encounter forms (financial papers) waiting scanning. The backlog dated back to July 2013.

Based on further interview with Interim HIM Director on 3/6/14, beginning at 0900 hours, she reported the inpatient and emergency room records pending coding of diagnoses/procedures was currently on 2/1/14, discharges; but the backlog was usually about 2 weeks.

Review of the organization chart of the HIM department during the interview showed there were vacant positions for both of the two Medical Records Directors (File Room Operations and Technical Services+Compliance). The HIM Director position was held by an interim contract person for almost four years. Additionally, there were vacancies of nine supervisor and 30 staff positions.

In addition, each month the department was "down" about 2.5 full-time equivalent positions due to staff being out sick, on paid time off, or leave of absences.

Based on interview and record review, the hospital failed to ensure the medical records were completed and accurate for 10 of 82 sampled patients (Patients 7, 11, 12, 13, 35, 72, 73, 74, 75 and 76). This could lead to lack of knowledge in providing care to the patients.

Findings:

1. The Network Rules and Regulations, effective 5/10/05, read in part on page 21, "Records shall include identifying data, complaints, pertinent present and past history and the results of the physical examination."

Review of the medical record for Patient 7 on 3/3/14, showed Thyroid Evaluation was undated, but apparently was from a 2/26/14 visit during which the patient had a nuclear medicine treatment for a thyroid nodule. The Thyroid Evaluation consisted of a pre-printed sheet on which information was to be filled in to indicate the patient's signs and symptoms of a thyroid disorder.

However, the "Doctor's Physical" portion of the form was left blank except for a drawing of the thyroid. There was no documentation of the physician's examination of the patient's eyes, voice, hair or skin. The spaces for documentation of the characteristics, such as size, location, mobility of the thyroid nodule depicted in the drawing were left blank.

In an interview with MD U on 3/3/14 at 13:45 hours, the MD reviewed the Patient 7's Thyroid Evaluation. The MD stated he did not know why it was not completed.

In an interview with the nuclear medicine supervisor on 3/3/14 at 1350 hours, she concurred there was no date on the Thyroid Evaluation.

2. The Healthcare Network Rules and Regulations dated 5/10/05, read in part on page 21, "Every time an invasive procedure or operation is performed, a note must be made in the patient's chart immediately that documents: a) the patient's pre-procedure and post-procedure diagnosis. b) a description of the informed consent that was obtained. c) the details of the procedure that was performed. d) findings, specimens, prosthetics/implants. e) any complications. f) fluids administered, blood lost. g) participants in the procedure. h) the patient's condition at the conclusion of the procedure. i) type of Anesthesia. j) dictation Confirmation number for operative cases. The full details of the procedure may be dictated for transcription in addition to the immediate post-procedure notation.

The hospital's policy titled Health/Medical Record: Documentation, effective 11/12/13, read in part, "In accordance with statutory requirements for credentialed professionals, all entries documenting the patient care shall be signed by the individual with the category designation rendering care. To facilitate consistency and continuity in patient care, patient-specific information is provided to support timely, accurate, secure, and confidential recording as outlined in the Attending Staff Manual and regulatory standards."

The medical record for Patient 35 was reviewed on 3/5/14. A procedure note was dictated on 3/4/14 at 1529 hours, regarding a 3/4/14 lung biopsy that ended at 1200 hours. A handwritten procedure note was not found. Required information omitted from the dictated procedure note included the persons present in the room for the procedure.

The procedure note listed medications given to Patient 35, including lidocaine (a local pain reliever), morphine 4 mg (a narcotic pain reliever), and Zofran 4 mg (an anti-nausea medication). A section at the end of the note listed complications including pulmonary (lung) hemorrhage and hemoptysis (spitting out blood), after which the procedure was stopped, and "mild pain."

Review of the Nursing Day Surgery Record showed upon arrival in the PACU at 1200 hours, the patient complained of pain at a level 7 out of 10 (severe pain) which increased to 10/10 (severe pain) at 1300 hours. There was no handoff documented (transfer of information about the patient's condition from the surgical team to the PACU nurse). There was no progress note indicating the physician reassessed the patient post-operatively.

In an interview with MD N who participated in Patient 35's procedure on 3/5/14 at 0930 hours, he stated a radiology technician and the attending physician were in the procedure room. There was no nurse or anesthesiologist in the procedure. After the procedure, when the patient was in the PACU, he handed off the patient to the nurses and went to prepare the biopsy specimen for pathology, but was paged by the nurse and returned to the PACU where he reassessed the patient.

MD N stated he did not document the reassessment of Patient 35. MD N stated the morphine and Zofran documented on the procedure note were actually given in the PACU while the mild pain documented under "complications" represented the patient's mild discomfort as assessed during the procedure, not the pain noted in the PACU.

3. The hospital's P&P titled Patient Rights, effective 9/23/08, read in part, "The Network's patients have rights to: ...Receive information about their health status, course of treatment, and prospects for recovery in terms they can understand." and "Make decisions regarding medical care and receive as much information concerning any proposed treatment or procedure, as they may need in order to give informed consent or to refuse a course of treatment."

The hospital's P&P titled Consents/Witnessing Signatures, effective date 12/13, showed legal authorization must be obtained from the patient or the patient's authorized representatives prior to performing treatment, specialty procedures or an operation. The consent is a legal document and should be dated signed and witnessed. The Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures (form #231) consisted of an explanation to the patient of the nature of the treatment, the risk, complications and alternative treatments, The Physician of the Record shall be responsible for obtaining informed consent on all patients undergoing an operation, invasive procedure or interventional X-rays. Both the professional and "lay" description of the procedure are required.

a. Patient 12's medical record review was conducted on 3/6/14. Patient 12 had cystoscopy (a procedure in which a tube with a small camera is introduced into the bladder) on 3/3/14. The Authorization for Informed Consent to Surgery or Special Diagnostic Therapeutic Procedures was reviewed. The documentation on page 4 of 5 showed a space on the pre-printed form for documentation of Interpreter Services, for Interpreter used: yes/no, and second section, Blood Transfusion, the choice of Blood Transfusion Form Required: yes/no. Neither section was checked to indicate yes or no. On page 5 of 5, the documentation for Interpreter used yes/no was not completed.


b. Patient 76's medical record review was conducted on 3/6/14. Patient 76 had two surgical services on 3/4/14. The patient signed two consents, one consenting to the surgery of "Ankle open reduction and internal fixation of ankle fracture." On the consent for Authorization for Informed Consent to Surgery or Special Diagnostic Therapeutic Procedures, the documentation on page 5 of 5 for Interpreter used yes/no was not completed.

The second consent for the surgery "debridement and irrigation with possible incision/drainage of wound" also showed on page 5 of 5, for Interpreter used: yes/no was not completed.


c. On 3/4/14 at 1410 hours, Patient 13 was interviewed for pre-operative procedure. Patient 13 stated he was evaluated by an anesthesiologist in the Pre-operative area and was told spinal anesthesia was an option for his surgery. The patient accepted the option of spinal anesthesia and initialed the consent.

Review of the documentation for Informed Consent for Anesthesia and Anesthesia-related Services showed the date the consent was signed was 3/3/14 at 1620 hours (the previous day). The documentation showed the patient's initials on Spinal or Epidural Analgesia Anesthesia.

Further interview with MD D revealed the MD evaluated the patient on 3/4/14, and spinal anesthesia was discussed. The patient understood and agreed to have the spinal anesthesia for his surgery. MD D had the patient initial the section of Spinal or Epidural Analgesia Anesthesia but was not aware the addition and change of the consent should include documentation of the date and time.


29558


4. Review of the hospital's P&P Policy & Procedure titled Rules and Regulations Guidelines for Supervision of Residents, approved 10/3/12, showed attending physicians must ensure there is documentation of the supervision in the resident's daily progress note or the attending physician shall record his or her own note.

Review of Patient 11's medical record was initiated on 3/3/14. The patient was admitted to the hospital on 2/28/14.

Review of the H&P dated 2/28/13 at 1301 hours, showed the document was signed by MD B.

Further review failed to show daily progress notes from the physician for 3/1 and 3/2/14.

An interview and medical record review was conducted with RN H, the Nurse Manager of Burn Unit and the Clinical Nursing Director of ICU on 3/3/14 at 1325 hours. When asked, RN H and the Nurse Manager were unable to find the physician's daily progress notes for 3/1 and 3/2/14.

5. Review of the hospital's P&P titled Health/Medical Record: Documentation dated 11/12/13, showed to assure that all pertinent information gathered and care delivered are documented in the patient's health/medical record. Operative or other invasive procedures and/or anesthesia shall be documented on the health/medical record immediately after surgery and verbal dictation the electronic dictation system shall occur within 24 hours of the procedure.

Review of Patient 72's medical record was initiated on 3/7/14. The patient was admitted to the hospital on 2/25/14.

The Progress-Hand Services Notes dated 2/26/14 at 0947 hours, showed a plan for a revision amputation of the middle finger in the treatment room today. The plan was discussed with Patient 72 and the patient had consented. The consent was in the patient's medical record.

a. There was no informed consent signed by Patient 72 for a procedure performed on 2/26/14. Cross Reference A-0955.

b. There was no operative report documented by the physician for the procedure performed on 2/26/14. Cross Reference A-0959.

c. Review of the Moderate/Deep Sedation Flow Sheet dated 2/26/14, showed the planned surgery was a "L (left) MF (middle finger) amputation." The procedure was started at 1608 hours and was ended at 1637 hours.

However, the Universal Protocol Procedures Performed Outside of the Operating Room form showed a time out was performed for a procedure of " L (left) MF (middle finger) failed replant amputation" on 2/26/14 at 1608 hours.

6. Review of Patient 73's medical record was initiated on 3/7/14. The patient went to the hospital for a procedure on 2/20/14, as an outpatient.

a. Review of the Report of Operation dated 2/20/14, showed a right carpal tunnel release was performed on Patient 73. Further review showed the patient was brought to the "operating suite." The patient's right upper extremity was sterilely prepped and draped in a usual fashion. Anesthesia was "local with block consisting of 0.25% marcaine (a local anesthetic) and 1% plain lidocaine (a local anesthetic)."

Review the Moderate/Deep Sedation Flow Sheet showed the procedure was started at 0955 hours and ended at 1020 hours. A section of procedure of the Moderate/Deep Sedation Flow Sheet showed Patient 73 had local anesthesia. However, the form failed to show what medication, what dose and what route were administered to the patient.

b. Review of the Moderate/Deep Sedation Flowsheet dated 2/20/14, showed a section of Discharge Home Checklist was left blank. There was no documented evidence to show a discharge instruction was provided to Patient 73.

During an interview and medical record review with RN O on 3/7/14 at 1005 hours, the RN confirmed the above findings.

7. Review of Patient 74's medical record was initiated on 3/7/14. The patient went to hospital for a procedure on 2/19/14, as an outpatient.

Review of the Surgical Coordinator Notes dated 2/18/14 at 1122 hours, showed Patient 74 had an appointment in the orthopedic treatment room on 2/19 (no year documented) for a procedure.

a. Review of the Informed Consent for Anesthesia and Anesthesia-Related Services signed by Patient 74 on 2/19/14 at 0934 hours, showed "anesthesia service(s) explained to patient or guardian and question were answered." A box to indicate general anesthesia was checked.

However, review of the Procedure-Hand Services Note dated 2/19/14 at 1440 hours, showed the procedure was performed on Patient 74 with the operative site anesthetized with regional block by anesthesia.

b. Further review of Patient 74's medical record failed to show the following documents:

* The physician's order for a procedure performed on 2/19/14,
* The patient's history and physical,
* If any medications was administered to the patient during procedure,
* pre-anesthesia assessment and post anesthesia assessment,
* Documentation to show the patient was assessed and monitored during procedure,
* The physician's order to discharge the patient,
* A discharge instruction and when the patient was discharged.

An interview and medical record review was conducted with RN O on 3/7/14 at 1005 hours. RN O was asked for the above missing documents. The RN stated the RN was unable to locate the above documentation. However, the RN stated she would look for the above missing documentation.

On 3/7/14 at 1715 hours, at the exit of the survey, no further documentation was provided.

8. Review of the procedure list for the 6G unit for February, 2014, showed Patient 75 went to the 6G unit on 2/26/14 for a procedure.

Review of Patient 75's medical record was initiated on 3/7/14. The following documents were unable to be located:

* The physician's order for a procedure performed on Patient 75 on 2/26/14,
* An informed consent for the procedure performed on 2/26/14,
* Time out for the procedure,
* Nursing documentation to show the patient was assessed before procedure, during procedure, and after the procedure and
* Operative report.

An interview and medical record review was conducted with RN O and RN AB on 3/7/14 at 1005 hours. The RNs informed of the above missing documents. RN O was unable to locate the above missing documents. RN O stated the RN would look for the above missing documents.

On 3/7/14 at 1715 hours, at the exit of the survey, no further documentation was provided.

Based on record review and interview, the hospital failed to ensure all entries in the medical records were complete (with patient identifier), dated, timed and authenticated in six of seven records reviewed (Patients 56, 57, 59, 60, 61 and 62). This could lead to incorrect information in these patients' medical records.

Findings:

The Attending Staff Rules and Regulations, last approved 10/14/03, were reviewed on 3/5/14. Section 2.8.B showed: "...Every entry in the chart must be properly authenticated which includes: 1) the date and time. 2) the physician's signature..."

The hospital's P&P #414 titled Legal Health/Medical Record, effective 11/12/13, was reviewed 3/5/14. Section III showed: "...All documentation and entries in the medical record, both paper and electronic, must be identified with the patient's full name and a unique LAC+USC Medical Center facility's healthcare medical record number. All double-sided or multi-page forms must also have both identifiers on each page, as a subsequent page becomes a single document once photocopied, faxed or imaged..."

The following records were reviewed on 3/5 and 3/6/14, with the findings confirmed concurrently by the HIM Coding Manager, QI Manager and/or Interim HIM Director:

1. The medical records for Patients 60 and 62 contained a handwritten H&P report that did not show the time the report was documented.

2. The medical records for Patients 59 and 62 contained double-sided forms (Peri-operative Patient Care Plan and ED Assessment, respectively) that did not contain any patient identification on the back sides of the forms, which were viewed in the electronic record as single document.

3. The medical record for Patient 57 contained the form, "The Active Labor and Delivery Physician's Orders." The form was not signed on page 1, and the missing signature was not flagged for completion after discharge.

4. In the medical record for Patient 61, the "Plans to Limit Treatment Adults" form was not dated or timed by the physician. This form documents the family conference and gives instructions to other caregivers for the type of care to be given to the terminally-ill patient.

5. Signatures were not timed on the patient discharge instructions form (Patients 57, 59, 60), and on the Conditions of Admission form (Patient 59).

6. Both the transcribed Death Summary and the Discharge Note that the physician entered into the electronic record did not contain a final diagnosis (Patient 61). The transcribed Operative Record did not document the name of the procedure in the header information (Patient 56).

7. The transcribed operative record was not signed and the missing signature was not flagged for completion by the physician after discharge (Patient 56).

Based on record review and interview, the hospital failed to ensure medical records were completed within 14 days following a patient's discharge as required by the medical staff bylaws, rules and regulations. This failure had the potential to result in the lack of pertinent information being available for the patients' continuing care after discharge.

Findings:

The hospital's Attending Staff Rules and Regulations, last approved 10/14/03, were reviewed on 3/5/14. Section 11.1.D. showed: "All hospital and patient charts should be completed and signed by the time of discharge. They must be completed and signed within 14 days after discharge..."

On 3/7/14 at 1345, the Interim HIM Director presented a report and explained the count of delinquent medical records (those still incomplete more than 14 days following discharge). The total number of records was 2183. There were 1506 unsigned electronic reports.

Additional information about the delinquent discharge summaries was requested. On 3/7/14 at 1600 hours, the Interim HIM Director presented and explained that the count revealed there were 1502 discharge summaries still awaiting completion by the physicians for patients who were discharged more than 61 days ago.

Based on observation, interview and record review, the hospital failed to ensure accurate records were kept of controlled substances and a system was developed for the tracking of these controlled drugs while they were stored on the Pediatric unit. In addition, the hospital failed to accurately account for and track movement of the controlled CSPs compounded in the Pharmacy IV Room from preparation to their disposition. These failures could lead to diversion of CSs not being detected timely.

Findings:

1. Inspection of the hospital's Pediatric unit Medication Room on 3/5/14 at 1500 hours, revealed a locked medication cabinet. Inside the cabinet was with a clip board with a single sheet of paper on top of it.

During an interview with RN Q on 3/5/14 at 1505 hours, the RN stated this locked medication cabinet was used by the nursing staff on the unit to store controlled drugs for patients who were going to be discharged from the unit. RN Q also indicated during the interview that the sheet of paper on the clipboard was the hospital's log for the controlled drugs stored inside this cabinet.

Review of the cabinet log on 3/5/14 at 1500 hours, showed one bottle (120 ml) of Tylenol with Codeine elixir, 12 mg per 5 ml should be present inside the locked storage cabinet; however, no bottle could be found. Review of the log also indicated the Tylenol with Codeine elixir bottle was present inside the medication cabinet on 2/28/14 at 0725 hours; however, according to the discharge summary Patient 69 was discharged from the hospital on 2/27/14 at 1630 hours.

During an interview with RN Q on 3/5/14 at 1515 hours, the RN indicated the controlled drug (Tylenol Elixir with Codeine) was sent home with the patient; however, there was no documentation in Patient 69's medical record to show the patient had indeed taken this medication home.

Review of Patient 69's "Instructions for the Medical Discharge of the Patient" on 3/7/14 at 1130 hours, revealed the Tylenol Elixir with Codeine was not documented on the patient's home instruction sheet.


25281


2. During an inspection of the hospital's CS Room on 3/7/14 at 1145 hours, two pharmacy compounded 200-ml IV bags containing Dilaudid 4 mg (narcotic pain medication) and Ropivacaine 400 mg (an anesthetic agent) were observed stored in the lockable cabinet drawer along with other unusable CS medications.

During a concurrent interview, PH 8 stated the IV bags were made in the Pharmacy IV Room and were kept in the CS Room until they were dispensed to the nursing units for patients or until they were expired after two days. The expired bags were then placed in the lockable cabinet drawer in the CS Room.

PH 8 indicated Dilaudid vials used to compound the bags were taken out of the C-II Safe located within the CS Room (an ADC utilized by the Pharmacy to store and keep track of the movement of all CS medications). PH 8 indicated the bags made from Dilaudid and Ropivacaine were recorded in the narcotic IV logs; however, there no log was kept to account for the bags used by the patients and the expired bags that were placed inside the lockable cabinet drawer.

During a concurrent interview, PH 8 indicated the key to the lockable cabinet drawer used to store expired CS medications was kept inside the CS Room accessible to all pharmacists with access to CS Room.

Review of the hospital's P&P titled Handling of Expired, Deteriorated, Discontinued, Recalled, or Otherwise Unwanted Drugs. Disposal of Materials Used in the Preparation of Dosage Forms and Drug Administration showed it was the only policy provided by the hospital related to CS disposition. The P&P did not delineate the procedure with respect to the accountability of controlled CSPs before they were pickup up by the outside vendor.

Based on observation, interview and record review, the hospital failed to ensure all drugs and biologicals were controlled and distributed by pharmacy services as evidenced by:

1. The storage and use of extra emergency drug supplies on the 6-D and Pediatric unit were not approved by the hospital's P&T Committee and/or the hospital's Code Committee.
2. The pharmacy did not have oversight of the use of the narcotic medication, Duramorph administered to patients by anesthesiologists following a C-section. This resulted in the potential for decreased respirations in patients due to the administration of additional narcotics ordered by the surgeon post-operatively. The pharmacist reviewing for the appropriateness of the ordered narcotics was unaware the patient received Duramorph.

3. Laboratory testing agents were not stored separately from the medications in the medication refrigerator in Jail ED.

4. Contrast agents used in the Cath Lab (Catheterization Laboratory) were not stored in a warmer in accordance with the manufacturer's recommendation.

5. Access of retired pharmacists to controlled substances stored in the pharmacy C-II Safe was not terminated.

6. First Aid medication boxes were locked by nurses at the psychiatric hospital campus instead of pharmacists as per P&P. Outdated medications were found in the First Aid Medication supply boxes.

These failures had the potential to cause patient harm from preventable medication errors.

Findings:

1. Review of the hospital's P&P titled Emergency Medications dated 3/1/13, showed: "The contents and the use of all emergency medication boxes must be approved by the Pharmacy and Therapeutics Committee."

a. During inspection of the hospital's 6-D unit Medication Room on 3/5/14 at 1400 hours, a second set of Emergency Drugs for the unit's Emergency Drug Crash Cart (for a Code Blue emergency), was observed stored in the hospital's Medication Room. The drugs were labeled as box 1 and box 2. Code Blues emergencies are conducted when a patient may not be breathing or may not have a pulse and the patient needs to be revived through the administration of medications and/or other means.

Interview with the hospital's DOP on 3/5/14 at 1405 hours, revealed these two boxes were not approved by the hospital's P&T Committee or the hospital's Code Committee for storage and use on the unit.

During the discussion with the hospital's DOP, he indicated the hospital's Code Committee, in conjunction with the hospital's Pharmacy and Therapeutics Committee would have been responsible for approving the storage and use of these Emergency Drugs on 6-D. The DOP was asked by the surveyor if he could review the hospital's P&T minutes and the Code Committee minutes to determine if either of these Committees approved the storage and use of these two Emergency Drug supplies on 6-D.

The DOP indicated on 3/7/14 at 1345 hours, he was unable to find in the both Committees minutes that storage of box 1 and box 2 was approved for storage and use in the hospital's 6-D Medication Room.

b. Inspection of the hospital's Pediatric unit Medication Room on 3/5/14 at 1445 hours, revealed an Emergency Drug supply which the hospital referred to as their "Extravasation Kit." This Extravasation Kit contained emergency drugs and supplies (such as Hydrocortisone, Sodium Bicarbonate, Sodium Thiosulfate, etc.), which would be used in the event a patient receiving Chemotherapy medications started to develop problems or complications resulting from the administration of Chemotherapy drugs.

During an interview with the hospital's DOP on 3/5/14 at 1450 hours, the DOP was asked to review the hospital's P&T minutes to determine if this Committee approved the storage and use of the Extravasation Kit on the Pediatric unit. The DOP confirmed the hospital's Pharmacy and Therapeutics Committee was responsible for approving the storage and use of this Extravasation Kit on the Pediatric unit.

On 3/7/14 at 1345 hours, the DOP stated he was unable to find in the P&T minutes where the storage and use of the Extravasation Kit was approved in the Pediatric unit Medication Room.


25720


2. During a tour of the Post-partum unit on 3/4/14 at 1050 hours, Patient 23's medical record was reviewed with the patient's primary nurse, RN A, and the Nurse Manger of the LDR unit. RN A stated Patient 23 delivered her infant by C-section at 2141 hours on 3/3/14.

When RN A was asked the medication Patient 23 received for pain relief following the surgery, the RN stated the physician ordered Percocet and IV push Morphine for breakthrough pain. When asked if Duramorph was used for pain relief post C-section at this hospital, the RN stated, no it was not. Duramorph is a preservative free form of morphine injected into the epidural space [the space around the dura mater of the spinal cord] by an anesthesiologist for pain management following the delivery of the infant.

Patient 23's anesthesia record for the C-section completed by the anesthesiologist was reviewed with the Nurse Manager of LDR. Documentation showed the patient received 5 mg of Duramorph on 3/3/14 at 2200 hours, via the epidural catheter. When asked, the Nurse Manager was unable to locate orders by the anesthesiologist or the obstetrician for increased monitoring of the patient after the administration of Duramorph.

RN A stated she was unaware Patient 23 received Duramorph after her C-section. RN A stated Patient 23 received two Percocet for pain at 0114 hours, and one tablet of Percocet at 0830 hours, during the 12 hours following the C-section.

The RN stated she was unsure of the length of the effects of the Duramorph. The RN stated she assessed Patient 23 every four hours, the patient was not monitored any more frequently than any C-section. Monitoring included measurement of the patient's vital signs, including respirations and a measurement of oxygen saturation.

The Assistant Director of Nursing for Women's Services was interviewed on 3/5/14 at 0915 hours. The Assistant Director stated the hospital did not have a P&P or a physician's protocol for the use of Duramorph for post-partum patients.

RN G was interviewed on 3/5/14 at 0925 hours. The RN stated she was assigned to care for Patient 23 that day. The RN confirmed the patient was monitored no more frequently than every four fours. When asked the treatment if the patient's respiratory rate decreased significantly. The RN stated the patient did not have orders for Narcan and she would have to call the physician for orders to administer the medication.

The Pharmacy Services Supervisor was interviewed on 3/6/14 at 1340 hours. The Duramorph manufacturer's package insert was reviewed and showed the following:

*Parenteral (IM or IV) administration of narcotics in patient receiving epidural morphine (Duramorph) may result in overdose.

* The most serious adverse reaction encountered during administration of Duramorph is respiratory depression and/or respiratory arrest (decreased breathing rate/cessation of breathing) and could require intervention.

* Duramorph should be administered only in settings where adequate patient monitoring is possible. Resuscitative equipment and a specific antagonist (Narcan) should be immediately available for the management of respiratory depression as well as complications. Patient monitoring should be continued for at least 24 hours since delayed respiratory depression may occur.

The Pharmacy Services Supervisor provided Pharmacy records showing 33 doses of Duramorph were dispensed from the ADC in LDR from 2/5-3/5/14. The Supervisor stated they knew epidural Duramorph was used by anesthesiologists for pain management following C-sections. The Supervisor stated the pharmacy refilled the ADC with the medication; however, the Supervisor stated the pharmacy was not involved in the use of Duramorph.

The Supervisor stated in her previous employment there were protocols for the use of Duramorph, such as physician's standing orders for the use of additional narcotics for break-through pain relief, the availability of Narcan to treat decreased respirations, and frequent monitoring of the patient for the first 12-24 hours.

The Supervisor stated when reviewing for the appropriateness of the pain medications ordered for C-section patients post-operatively, the pharmacist did not have information to show the patient received Duramorph. The medication was removed from the ADC in the LDR OR by the anesthesiologist and administered to the patient in the OR. Since the anesthesiologist did not write a medication order indicating Duramorph was administered, the pharmacy did not know the patient received the medication until the ADC was refilled the day following the surgery. The Supervisor confirmed the pharmacy was not overseeing medications dispensed by anesthesia.


25281


3. The hospital's P&P titled Drug Storage indicated "External use drugs shall be segregated from drugs for internal use. Test agents, germicides, disinfectants, and other household substances shall be stored separately from drugs."

During a tour of the the Jail ED on 3/4/14 at 1042, observation of the medication refrigerator showed two boxes of iSTAT TriControls 3 quality control solutions along with the medications.

During a concurrent interview, RN A1 indicated the boxes contained quality control solutions used to calibrate the portable laboratory device called iSTAT. The RN stated the control solutions should not be stored in the medication refrigerator; there was a separate refrigerator in different location to store these boxes.

During a concurrent interview, the PIC confirmed the control solutions should not be stored in the medication refrigerator.

4. During a tour of the Cath Lab (catheterization laboratory where various heart procedures are performed) on 3/5/14 at 1100, a contrast media warmer was observed maintained at 35 degrees C with various sizes of Visipaque contrast media injectable solutions.

The Visipaque vials were not labeled with a date to indicate when the vials were placed in the warmer.

During a concurrent interview, the PIC indicated she was not able to tell when the vials were placed inside the warmer.

During a concurrent interview, RN A2 and RN A3 indicated it would be difficult to know when the vials were placed in the warmer without marking the vials with the date they were placed.

During an interview on 3/6/14 at 0900 hours, the PIC indicated the contrast agents placed in the warmer would be good for 30 days. The PIC stated the hospital did not have a P&P for the use of warmer to warm the contrast agents. The PIC agreed that the date placed should be on the vials.

According to the Lexi-Comp, a nationally recognized pharmacy reference, Visipaque "Vials, glass and polymer bottles (not flexible containers) may be stored for up to 1 month at 37°C (98.6°F) in contrast agent warmer."

5. The hospital's P&P titled Controlled Substances indicated "Access to the Pyxis cabinets (ADC) or double locked cabinets is limited to authorized personnel, or authorized personnel under the direct supervision of licensed personnel. Licensed personnel include nurses, pharmacists, and physicians ..."

The hospital's P&P titled Automated Medication Dispensing Machines (ADM) did not define procedures for removing or deactivating pharmacy personnel no longer employed as a result of retirement.

During an inspection of the CS Room on 3/7/14 at 1145, a C-II Safe was observed (a Pyxis Cabinet- an ADC, utilized by the pharmacy to store and keep track of the movement of all CS medications. It also provides secure access to CS medications by only the authorized personnel).

The list of authorized personnel with access to the C-II Safe was requested and was reviewed with PH 8. PH 8 indicated the list contained the name of pharmacist that was retired and no longer worked at the Pharmacy. PH 8 also indicated only the pharmacists have access to the C-II Safe.

During a concurrent interview, the PIC indicated there were 11 pharmacists on the list that were no longer working at the Pharmacy. The PIC indicated their access should have been removed. The PIC indicated she was not aware they were still active and did not know how to deactivate them.


32097


6. Review of the hospital's P&P titled Supplies and Equipment dated 2/12, indicated under First Aid/Non-Arrest Medication Box: "Maintenance of the First-Aid /Non-Arrest Medication box and Automatic external defibrillator is the responsibility of the nurse manager /designee on each unit ...Boxes unlocked for use or that contain expired items must be resealed by pharmacy."

Review of the hospital's P&P titled Emergency Medications dated 01/01/11, indicated under procedure: "All emergency medication boxes are inspected and sealed by a designated pharmacist."

A tour of the medication storage areas at the psychiatric hospital campus was conducted with Pharmacy Supervisor I, Clinical Nursing Director II and the Assistant Nursing Director of Administration on 3/5/14, beginning approximately 0945 hours.

An interview was conducted with Charge RN 2 on 3/5/14 at 1045 hours, regarding the process for the First Aid medication supply box on Ward A . Charge RN 2 indicated the pharmacy delivered First Aid box replacement medications to nursing. Nursing updated the expiration dates on the box label and then locked and sealed the First Aid Medication supply box with a yellow numbered tag. Pharmacy supervisor I acknowledged the above process.

Based on observation, interview and record review, the hospital failed to ensure the Epidural Cart in the LDR unit was locked to prevent unauthorized access, creating the risk of drug diversion not being detected timely.

Findings:

The hospital's P&P titled Medication Security indicated "All drugs, except those in the crash carts, will be stored in lockable containers or areas."

During a tour of the LDR Unit on 3/4/14 at 1445 hours, an Epidural Cart that contained medications was observed in the hallway of the unit. The Epidural Cart was unlocked and medications inside were assessable.

During a concurrent interview with the Assistant Nursing Director Women's Services and Med-Surg and RN A 7, both staff acknowledged the cart should be locked.

Based on observation, interview and record review, the hospital failed to ensure failed to ensure outdated drugs and biologicals were not available for patient use. This failure had the potential for patients to receive outdated drugs in an emergency situation.

Findings:

The hospital's P&P titled Handling of Expired, Deteriorated, Discontinued, Recalled, or Otherwise Unwanted Drugs; Disposal of Materials Used in the Preparation of Dosage Forms and Drug Administration indicated "All areas are required to remove drugs from the inventory that are: discontinued from patient use, overstocked, have been recalled by the manufacturer, expired, deteriorated, or deleted from formulary, RCRA agents (opened and unopened) are returned to the pharmacy ..."

1. During a tour of CCU on 3/4/14 at 1500 hours, a medication refrigerator was inspected. There was one 2.5-ml latanoprost (medication for glaucoma) 0.005% eye drop bottle for a patient that was dispensed by the pharmacy on 2/1/14, according to the label on the bottle.

During a concurrent interview, RN A 4 stated the patient was discharged on 2/27/14. The RN acknowledged the medication should not have been in the medication refrigerator.


32097


2. Review of the hospital's P&P titled Supplies and Equipment dated 2/12, indicated under First Aid/Non-Arrest Medication Box: "Maintenance of the First-Aid /Non-Arrest Medication box and Automatic external defibrillator is the responsibility of the nurse manager /designee on each unit ...Checked by an RN or LVN responsible for the maintenance at the beginning of each shift. She/he ensure the box remains locked (locked number verified on check Log), emergency drug box expiration date recorded on outside of box are not expired."

Review of the hospital's P&P titled Emergency Medications dated 01/01/11, indicated under procedure: "All emergency medication boxes are inspected and sealed by a designated pharmacist."

A tour of the Ward B medication storage areas at the psychiatric hospital campus was conducted on 3/5/14, beginning approximately 1120 hours, with Pharmacy Supervisor I, Clinical Nursing Director II and Assistant Nursing Director, Administration.

During inspection of the medication storage areas in Ward B, drugs with outdated expiration dates were noted recorded outside of the First Aid Medication supply box. Inspection of the contents of the First Aid medication supply box showed glucagon 1 mg (a drug that raises the blood sugar level) emergency kit had expired on 9/13, and a sterile water 10 ml bottle had expired on 5/12.

RN R, Pharmacy Supervisor I, Clinical Nursing Director II and Assistant Nursing Director/Administration witnessed and acknowledged the expired dates.


20059


3. On 3/6/14, during inspection of the Rehabilitation Service area, three plastic ultrasound gel bottles were observed in the general storage area. The bottles had a expiration date of 10/09, inscribed on each bottle.

Interview with the Physical Therapist 1 showed the bottles were used for ultrasound applications. Each bottle was refilled from a larger container of the ultrasound gel. The larger container of ultra sound gel was on the shelf with the three bottles of ultrasound gel. There was no expiration date on the larger container of ultrasound gel.

Based on observation, interview and record review, the hospital failed to implement proper safety precautions for patients received care and staff provided radiation care, resulting in a potentially hazardous radiation exposure to patients and staff.

Findings:

1. On 3/4/14 at 1050 hours, the hospital's surgical services area was toured with the Director of Perioperative Services and the OR Manager Team II.

In OR 16, a paper taped on the door showed a "Laser in Use." The OR Manager stated, in OR 16 a ongoing procedure utilizing a laser was in progress. The Manager stated the circulating RN posted the sign to stop people walking to the room without wearing protective devices.

During an interview with the circulating RN in the next room, the RN stated a standard sign should be posted outside of the room if a laser machine was used.

The following observation of OR 16 showed the paper sign "Laser in Use" was removed. When the Manager checked with the staff in OR 16, staff stated a second case was in progress and a laser machine was used for the procedure. The staff in the room handed out a 8 X 10 yellow sign "Laser in Use" to the Manager for posting on the door.

2. The hospital's P&P titled Monitoring of Lead Aprons and Gloves, effective 1/1/02, read in part, "A Supervising Radiologic Technologist or designee will inspect all aprons and gloves to confirm their integrity before the end of the first quarter of each year. Results of the inspection will be given to Radiology Physics."

a. On 3/4/14 at 1050 hours, an apron with the identification of OR-2-03/11 was observed in the hallway between ORs 16 and 17. According to the OR staff, the apron was for use in the ORs.

In a concurrent interview, OR Manager Team II stated the Radiology Department was responsible for inspecting the apron annually.

Review of the Radiation Protection Devices Inventory and Inspection Log did not show this apron was on the list for inspection.

b. On 3/5/14 at 1035 hours, in the IR area, MD G was observed wearing an apron with a different MD's name. The apron had multiple blood-colored spots.

During a concurrent interview with IR staff, one staff member stated all the radiological protective devices should be inspected annually and the inspection recorded in a log book. However, the staff member in charge of the log book was unavailable and the IR staff did not have access to the log book.

c. On 3/6/14 at 0805 hours, a radiation protection pad was observed in the ERCP room. The pad showed a faded hand written "3M9 radiology WCH." The staff in the unit stated this pad was used for the pregnant patients to protect the abdominal area. Staff believed this equipment should be inspected by the Radiology Department for safety.

On 3/5/14 at 0900 hours, during an interview the Radiation Safety Officer stated the hospital had not inspected radiation protective devices used for patients.

Based on interview and record review, the hospital failed to have an effective process in place to maintain lead lined radiation safety garments used by staff and patients, creating the increased risk of a radiation safety hazard.

Findings:

The hospital's P&P titled Acquisition and Tracking of Radiographic Protective Lead Aprons, effective 1/1/02, read in part, "When delivered, the department is to register each apron and perform a baseline radiation check to ensure that protective status of the apron meets regulatory requirements."

The hospital's P&P titled Monitoring of Lead Aprons and Gloves, effective 1/1/02, read in part, "A Supervising Radiologic Technologist or designee will inspect all aprons and gloves to confirm their integrity before the end of the first quarter of each year. Results of the inspection will be given to Radiology Physics."

The Radiation Protection Devices Inventory and Inspection Log, divided by department, was reviewed on 3/4/14. The log showed in most departments, there were some garments that did not have an inspection recorded. Instead the comment "missing" was listed in the remarks section.

The 27 page log for the Surgery Department for the year 2013 was reviewed. The first page of the log showed six garments were inspected and passed, one failed inspection and was removed from service. Twenty two radiation protection devices were documented as "missing."

On the second page of the log, four garments were inspected and passed, two failed inspection and were removed from service, and 23 were noted as "missing."

The log for the Surgery Department showed 355 radiation safety garments were "missing" from the department and had not been inspected in 2013. Also, on pages 13 through 20, approximately 150 lead shield garments were itemized: two with inspection dates in March, 2013, but most with no inspection date or outcome. Under remarks "Pending New Lead Device" was written.

During an interview with Rad Tech 1 on 3/4/14 at 0940 hours, he stated he performed the annual lead garment checks for the hospital. Rad Tech 1 stated he sent an email to the departments that the lead aprons were to be brought to radiology for inspection under fluoroscopy.

During a second interview at 0950 hours, Rad Tech 1 stated no one went to the surgery department to check for missing aprons; that it was difficult to keep track of whether the department brought the aprons down for inspection. Rad Tech 1 stated only the list of aprons that failed the screening was sent to the Surgery Department after the inspection, not the list of aprons that were missing.

During an interview with the Radiation Safety Officer on 3/5/14 at 0900 hours, he stated Rad Tech 1 checked most lead aprons annually; however there was no way for him to chase the aprons down. The Safety Officer stated he was not sure why there were so many radiation safety garments listed as "missing" on the log. The Safety Officer stated a lot of people bring in their own aprons because they did not trust the aprons in the hospital, and they might store the aprons in their offices.

The Safety Officer stated the hospital had a responsibility to check the garments, but more than one person was needed to chase them down. The Safety Officer confirmed lead lined radiation safety garments used on patients should be functional; however, the Safety Officer stated there was no policy to check the garments. The Safety Officer stated he the problem of missing radiation safety garments and not available for annual screening was mentioned to the hospital administration at the clinical council. The Safety Officer was told the administration would work on the problem, but he had not heard of a solution.

Based on observation, interview, and record review, the hospital failed to ensure the Director of Food and Dietetic Services, who was responsible for the day to day operation, maintained the hospital's P&Ps regarding safe practices for food handling and supervision of work, as evidenced by observations of equipment used to store food was not maintained and clean, staff was unable to state knowledge of and identify the expiration dates of perishable items. Failure to develop and monitor standardized procedures might result in patients being exposed to foodborne illness and cross contamination which might further compromise patient medical status.

Findings:

On 3/3/14 at 1100 hours, during the kitchen tour, the following was observed:

1. Review of the hospital's P&P #F013 titled Required Cleaning and Sanitation showed nonfood contact surfaces of utensils and equipment must be made of materials that are safe, corrosion resistant, non-absorbent, smooth and cleanable. The P&P defined non-food contact surfaces as exposed surfaces other than food-contact surfaces. The policy referenced The Food and Drug Administration Food Code 2009.

Two metal racks storing packaged vegetables observed in the vegetable walk-in refrigerator were dirty, with dried food debris. The metal finish was corroded on the surface of all six shelves.

During a concurrent interview, the EC 1 stated the shelves were to be cleaned on a cleaning schedule. EC 1 acknowledged the shelves were dirty and the surface's finish was corroded. EC 1 stated he did not know the requirement for surfaces to be made of a cleanable and corrosive resistant material. EC 1 stated the shelves needed to be replaced. EC 1 acknowledged the ECs were responsible for overseeing the staff cleaning.

2. One package of chopped onions, one bag of spinach, four bags of shredded carrots, six bags of chopped celery and approximately 10 bags of fresh herbs were not labeled with a date received or a manufacturer's expiration date.

During a concurrent interview EC 1, he stated the produce was stored as first in and first out; however, he was not able to state how the food service staff would identify the expiration dates of these perishable vegetable items. EC 1 stated food service staff should label the produce with the required orange stickers marked with the date received.

3. Review of the hospital's P&P #B023 titled Shelf Life of Products showed the "procedures are established to ensure all food received, produced and stored in the FNS (Food and Nutrition Department) are only kept during their recommended shelf life. The FNS dates all foods according to the date received or produced unless it is a patient tray item, which is dated according to its expiration date. All foods are checked often to ensure they have not expired." The attached refrigeration storage life of food list stated "all Cheese except Hard (i.e. Cheddar, Mozz [mozzarella], and Swiss) unopened maximum storage period was listed as "Follow expiration date on package."

a. Two unopened packages of shredded cheese were marked with the manufacture pack date of 2/14/14. EC 1 stated the packages could be stored unopened for one month.

During an interview on 3/7/14 at 0830 hours, the Senior Director of Food Services stated the refrigeration list needed to be updated.

b. Approximately 25 packaged muffins were labeled produced on 2/24, with an expiration date of 2/28/14. Muffins were located in walk-in refrigerator 1 and were available to serve to patients.

During a concurrent interview EC 1 stated the muffins should be discarded but were missed. EC 1 stated it was the supervisor's responsibility to throw out the expired product.

3. Review of the hospital's P&P #F017 titled Storage of Pots, Dishes, Flatware, and Utensils showed under procedures: "Air dry all food contact surfaces, including pots, dishes, flatware, and utensils before storage, or store on a self-draining position. Do not stack or store when wet."

On 3/4/14 at 1005 hours, DW 1 was removing dishware including domes and patient trays from the dishwashing machine and stacking the items with visible water on surface. When asked, DW 1 stated the dishware should be dry before stacking. He acknowledged the items were still wet but stated there were a lot of dishes being washed.

During a concurrent interview the Patient Services Manager acknowledged the stacking of wet items was a problem. The Manager stated there were not adequate drying racks to ensure dishwashing staff to allow the dishware to air dry before stacking.

Based on observation, interview and record review, the hospital failed to ensure supplies and equipment were inspected timely and maintained to ensure safety in the LDR ORs, NICU, procedure room in a medical surgical unit and the psychiatric and post anesthesia care units. Failure to maintain patient care equipment had the potential for injury to patients.

Findings:

1. The LDR unit was toured with the Assistant Nursing Director of Women's Services and the LDR Nurse Manager on 3/4/14, beginning at 0840 hours. Two of the two ORs on the unit were inspected. The Nurse Manager stated the ORs were not in use at this time; however, they had been cleaned and were ready for surgery.

Portable de-humidifier machines were observed in each LDR OR, numbers 1 and 2. The machines were not on. When asked, the Nurse Manager opened the reservoirs at the bottom of each machine. There was standing water in each of the reservoirs.

The preventative maintenance label on each of the machines showed service was due 11/13. The Manager was unable to state the last time the machines were used to decrease humidity; however, the Manager stated there was a problem with too much humidity in the LDR ORs and the machines were used to decrease the humidity to the required levels for safety.

Review of the manufacturer's Owner's Manual for the portable de-humidifier machines used in the LDR ORs showed the following:

*To clean the grille and case use a mild detergent, do not use bleach or abrasives.

* The air intake and outlet grilles get soiled easily, so use a vacuum attachment or brush to clean.

* Every few weeks, clean the bucket.

* The air filter behind the grille should be checked and cleaned at least every 30 days.

Infection Control RN Practitioner 5 was interviewed on 3/5/14 at 0950 hours. When asked regarding the use of de-humidifiers in the LDR ORs 1 and 2, the RN stated she was aware of their use; however, she was not sure if there was a P&P for the care of the humidifiers.

The Infection Control Committee was interviewed in a meeting with the survey team on 3/6/14 at 0900 hours. The Committee consisted of nursing staff, physician's and EVS staff.

The Committee was asked about the process for selecting a new product for use in a surgical environment. Staff stated the product was reviewed in a Products and Equipment Standardization Committee. If approved and purchased, the manufacturer's recommendations were used to educate staff in the use of the product. Facilities Management checked the product for safety. A P&P for the use of the product would be developed and put into place and staff educated. The P&P would be approved by the GB.

The Committee members were asked if Infection Control staff monitored the OR temperature and humidity logs. Staff stated they monitored the logs; the Facilities staff notified Infection Control whenever the levels were out of range. "We make sure the LDR knows and they make the decision to move the case to the OR" or use the de-humidifiers to lower the humidity to a safe level. When asked, staff stated they were unaware of any C-sections done in the main OR in the past year.

The hospital's Facility Manager was interviewed on 3/6/14 at 1545 hours. The Manager confirmed the LDR OR dehumidifiers did not receive preventative maintenance as found in the owner's manual. The Manager stated Facilities staff had incorrectly described the OR dehumidifiers as "refrigerator portable" on the paperwork following their purchase. When annual preventative maintenance was due 10/13, the Facilities staff was unable to locate the machines. The work ticket was closed as "unable to locate."


21177


2. On 3/4/14 at 1402 hours, during a tour of the NICU, review of the green preventive maintenance stickers on five of the five electrical breast pumps used by the mothers of the patients indicated preventive maintenance was due in 2012.

On 3/5/14 at 1040 hours, during an interview, the hospital's Facility Manager stated the preventive maintenance should be done annually for patient equipment.


22553


3. On 3/5/14 at 1512 hours, during a tour of the 6G treatment room, a portable light in the storage room did not have a sticker to show the light was inspected by hospital for safety. In a concurrent interview with RN M, the RN stated the light was used for surgical procedures in the 6G treatment room.

On 3/7/14, the hospital provided a documentation showing when inspected, the light was missing ground pin on the plug and a missing ground wire. The engineer was unable to do the current leakage test.


26756


4. Review of the hospital's P&P titled Warming Cabinet and Fluids, revised 8/11, showed the use of the warming cabinet shall be in compliance with safety guidelines and temperature range, it shall be checked when used for the appropriate temperature settings. The temperature range must be between 90-120 degrees F.

Observation during tour on 3/3/14 at 0950 hours, of the LDR PACU showed a warming cabinet was in use. The temperature of the upper compartment of the cabinet showed it was 124 degrees F. Inside the upper compartment blankets were stored.
A sign posted on the cabinet's front door showed the "temperature not to exceed 120 F."
During a concurrent interview on 3/3/14 at 0955 hours, the Assistant Nursing Director of Women's Services confirmed the nursing staff failed to follow hospital procedures to keep the warming cabinet at the appropriate temperature.



20059


5. On 3/6/14 at 1410 hours, during a tour of the NICU three Emergency Bags were stored underneath a desk were inspected. Laboratory blood specimen tubes stored in bag 1 showed four of six purple top tubes and six of the six yellow top tubes had expiration dates of 10/13.

In bag 2, three of the six purple top tubes had an expiration date of 9/13. Six of the six yellow top tubes had an expiration date of 7/11.

On 3/6/14 at 1430 hours, during an interview with the NICU Nurse Manager she stated the Emergency Bags were used when staff transported the neonates to and from other hospitals. The Nurse Manager stated a process was not developed for maintenance and inventory checks of the supplies stored in the emergency bags.

6. During an inspection of a clean room on the psychiatric inpatient service, a phlebotomy tray with supplies to draw blood specimens was observed. 15 green top and 6 blue top vacutainer collection tubes had expiration dates of 9/13. In addition, exam gloves were loose in the tray and the roll of tape appeared soiled and dirty.

7. During a tour of the PACU on 3/4/14 at 1335 hours, a cart designated as an ECT cart was inspected. Unpackaged assorted/miscellaneous patient care equipment was loose in the drawers of the cart.

In first drawer of the cart were assorted rubber bands, paper clips, vacutainer tubes, and a box of Temp Dots (Temperature Probes) with an expiration date of 5/12. Electrodes used for the procedure were not in protective packaging. A used deodorant stick was also in the drawer.

The psychiatric charge nurse responsible for the ECT cart for psychiatry was interviewed. The Charge Nurse stated the last ECT was done in February 2014. The Charge Nurse stated a resource manual was in the fourth drawer of the ECT cart; however, when the fourth drawer of the cart was opened there was no resource manual.

The Charge Nurse verified there was no inventory list for each drawer of the ECT cart and no system was in place for routine care of the cart.

Based on observation, interview, and record review, the hospital failed to ensure a sanitary environment and an active program to prevent the spread of infections in accordance with the hospital's P&P and nationally recognized infection control practices and guidelines as evidenced by:


1. On 3/7/14 at 1310 hours, the hospital administration was notified of the IJ to the health and safety of hospital patients due to the following practices of performing surgical procedures outside of the main OR in the 6G unit room:

- The 6G unit's RN provided services as a circulating nurse, scrub tech and recovery nurse; however, the RN did not have evidence of training or proven competencies in surgical nursing.

- Staff did not routinely perform a site or side marking prior the patient's surgical procedures. The 6G room did not have cleaning between cases and at the end of the day as per the main OR and there was no specific disinfection process to clean or disinfect the room after a patient with infected wound was treated.

- Contaminated instruments were not cleaned and disinfected as per the hospital's P&P.

- The hospital's P&Ps did not address the actual services provided to patients in 6G unit.

- Acceptable OR attire was not overseen by the IC group.

- There was no documentation to show outpatients receiving surgery in 6G received post-operative care planning and coordination, and provisions for follow-up care.

On 3/7/14 at 1530 hours, the hospital submitted a written plan of action to correct the IJ. The acceptable plan of correction showed the 6G unit would be closed and locked. Signage on the door would show the room was "not in use." A memo would be sent to all department chiefs, nursing and hospital management with instructions to ensure all staff were informed. Surgeries usually performed in 6G would be scheduled in the main OR.

After confirmation of the plan of action by the survey team through observation and staff interviews, the IJ was abated at 1620 hours on 3/7/14, prior to the exit of the survey team.

Cross Reference A-0749, example #1.

2. The following failures were identified:

- The RN assisting with the surgeries, cleaning the room and the used instruments did not have surgical specific training. In addition, the Nurse Manager and Assistant Director Nursing overseeing the 6G room did not have surgical specific training.

- Staff performing cystoscopy procedures did not scrub hands prior to donning sterile gloves and wore clothing that was laundered outside the hospital.


- The padding and the cover of the foot rests used for positioning of patients for cystoscopy procedures were cracked. The table and the pads were dusty and dirty. The equipment was dusty on the surface.


- Observations in the main OR showed staff did not follow hand hygiene policies. In one OR room, bodily fluid spill was not cleaned in accordance per the hospital's P&P and nationally approved practices and guidelines.

- The endoscope reprocessing disinfectant was not validated in accordance with the manufacturer's guidelines.

- The glucometer (instrument to measure blood sugar) was not disinfected in accordance with the manufacturer's guidelines.

- No hospital P&P was provided to outline the cleaning of radiation protection garments.

- The cabinetry of central sterile supply decontamination sinks were not maintained in a manner that assured disinfection.

- Surgical instruments were not reprocessed or maintained in accordance with the hospital's P&P and manufacturer's guidelines.

- Surgical instrument marking tape was not maintained in accordance with the manufacturer's guidelines and hinged instruments in sterile peel packs were in the closed position.

- In the LDR unit, portable dehumidifiers were used in two of two LDR ORs with no P&P developed for their use, cleaning and maintenance. The hopper used to dispose of waste was located next to clean and sterile supplies in a utility room.

- LDR OR 2 was used for storage of equipment which was not cleaned following each surgical procedure.

- Sanitizing gel, gloves and masks for use by patients and visitors were not available to patients during an observation in the main ED. Patient chairs in the triage area were ripped and torn.

- In the NICU, breast milk for patients was not stored separately to minimize the chance of contamination or error. The formula preparation area did meet infection control standards for safe and sanitary powder formula preparation.

- The open enteral delivery system for patients did not follow the IC practices for one patient (Patient 22).

- Staff were observed in the kitchen without designated hair coverings.

- Staff in multiple areas of the hospital were observed not practicing hand hygiene.

Cross References A-0749 and A-0951.

The cumulative effect of these systemic practices resulted in the hospital's inability to minimize the risk of the spread of infections in the hospital.

Based on observation, record review and interview, the hospital failed to ensure the IC officers developed, implemented and evaluated a system for controlling sources of infections in accordance with the hospital's P&P and nationally recognized infection control practices and guidelines as evidenced by:

- Surgeries were performed in the 6G unit which was a treatment room on an inpatient tower unit. There was no ongoing oversight of the types of patients and activities occurring and of the EVS cleaning of the 6G unit. The 6G unit was not cleaned between patients or at the end of the day per the hospital's P&P for the cleaning of an OR room.

- The 6G unit set-up did not allow staff to scrub hands in a semi-restricted area prior to the surgery; therefore, staff could easily enter the room without decontaminating their hands.

- The RN assisting with the surgeries, cleaning the room and the used instruments did not have surgical specific training. In addition, the Nurse Manager and Assistant Director Nursing overseeing the 6G room did not have surgical specific training.

- Staff performing cystoscopy procedures did not scrub hands prior to donning sterile gloves and wore clothing that was laundered outside the hospital.


- The padding and the cover of the foot rests used for positioning of patients for cystoscopy procedures were cracked. The table and the pads were dusty and dirty. The equipment was dusty on the surface.


- Observations in the main OR showed staff did not follow hand hygiene policies. In one OR room, bodily fluid spill was not cleaned in accordance per the hospital's P&P and nationally approved practices and guidelines.

- The endoscope reprocessing disinfectant was not validated in accordance with the manufacturer's guidelines.

- The glucometer (instrument to measure blood sugar) was not disinfected in accordance with the manufacturer's guidelines.

- No hospital P&P was provided to outline the cleaning of radiation protection garments.

- The cabinetry of central sterile supply decontamination sinks were not maintained in a manner that assured disinfection.

- Surgical instruments were not reprocessed or maintained in accordance with the hospital's P&P and manufacturer's guidelines.

- Surgical instrument marking tape was not maintained in accordance with the manufacturer's guidelines and hinged instruments in sterile peel packs were in the closed position.

- In the LDR unit, portable dehumidifiers were used in two of two LDR ORs with no P&P developed for their use, cleaning and maintenance. The hopper used to dispose of waste was located next to clean and sterile supplies in a utility room.

- LDR OR 2 was used for storage of equipment which was not cleaned following each surgical procedure.

- Sanitizing gel, gloves and masks for use by patients and visitors were not available to patients during an observation in the main ED. Patient chairs in the triage area were ripped and torn.

- In the NICU, breast milk for patients was not stored separately to minimize the chance of contamination or error. The formula preparation area did meet infection control standards for safe and sanitary powder formula preparation.

- The open enteral delivery system for patients did not follow the IC practices for one patient (Patient 22).

- Staff were observed in the kitchen without designated hair coverings.

- Staff in multiple areas of the hospital were observed not practicing hand hygiene.

These failures created the increased risk of transmission of infections and further compromised acutely ill patients' clinical conditions.

Findings:

According to the hospital's Infection Control Plan, approved 2/11/14, surgical entry into tissues, cavities, or organs (invasive procedures) shall require wearing of barrier gown, gloves, surgical mask and protective eye wear or face shield.

According to the hospital's P&P titled Hand Hygiene Policy, effective date 8/13/13, "Antiseptic agent - Antiseptic agents are antimicrobial substances that are applied to the skin to reduce the number of microbial flora. Decontaminate hands - to reduce bacterial counts on hands by performing antiseptic hand rub or antiseptic handwash. Hand antisepsis - refers to either antiseptic handwash or antiseptic hand rub."

According to the AORN Perioperative Standards and Recommended Practices, Recommended Practices for Hand Hygiene in the Perioperative Setting, 2013, "A surgical hand scrub should be performed by health care personnel before donning sterile gloves for surgical or other invasive procedures. The objective of a surgical hand scrub is the reduction of transient and resident flora, which also may reduce health care-associated infections. With the addition of a health care organization-approved antiseptic soap, which acts as a surfactant, transient and some resident microorganisms can be lifted and flushed away under running water. A multiuser scrub sink should be located near the entrance to the OR."

According to the AORN Perioperative Standards and Recommended Practices, Recommended Practices for Surgical Attire, 2013, clean surgical attire, including shoes, head covering, masks, jackets, and identification badges should be worn in the semi-restricted and restricted areas of the surgical or invasive procedure setting. Clean attire minimizes the introduction of microorganisms and lint from health care personnel to clean items and the environment. Facility-approved, clean, and freshly laundered or disposable surgical attire should be donned daily in a designated dressing area before entry or reentry into the semi-restricted and restricted areas. Changing from street apparel into facility-approved, clean, and freshly laundered or disposable surgical attire in a designated area decreases the possibility of cross-contamination and assists with traffic control.

1. On 3/5/14 at 1512 hours, the 6G unit on the 6th inpatient tower was toured with the 6C unit Assistant Nurse Manager. The 6G unit was divided into three areas.

Observation of 6G Exam Room #1 (room 103) showed a patient was in the room draped with sterile drapes for an ongoing procedure. There was a suspensional surgical light, Mayo stand and surgical supplies inside the room.

An ante room was connected to Exam Rooms #1 and #2. The room contained a hand wash sink. Three bottles of enzymatic agent were next to the hand wash sink. In the same area, a wall mounted cabinet stored sterile packages of surgical instruments and new sterile peel packs.

In Exam Room #2, a mobile cart stored sterile packs of surgical supplies and instruments.

On 3/5/14 at 1512 hours, during an interview, RN F stated she decontaminated dirty instruments in the ante room sink. RN F stated she washed, soaked and dried the used instruments.

To clean Exam Room #1 after a procedure, RN F stated she disinfected the surfaces with bleach wipes and then let it air dry. RN F stated she did not perform a different cleaning or disinfection process if the room was used for a patient with identified infected wounds.

During a follow-up interview on 3/7/15 at 0945 hours, RN F stated she cleaned the instruments with a diluted enzymatic agent solution. However, RN F stated she did not monitor the temperature of the water used to dilute the enzymatic agent.

Review of the manufacturer's guidelines showed to use warm water for diluting the agent and the temperature of the warm water should not exceed 150 degrees F.

During the interview, RN F stated immediately after the surgical procedures, she cleaned the dirty instruments in the ante room. The RN stated she also packed the cleaned instruments in the ante room. The instruments that needed to be packed in trays she would take to central services. All the instruments would be sterilized in the central processing department.

The RN stated the patients who received surgical services in 6G unit were mostly from the Orthopedic Eval Treatment Area. Patients from hospital inpatient units were also treated. The services in this location were provided based on the patients' needs and RN F's availability.

During a follow-up interview with RN F and the Assistant Nurse Manager on 3/6/14 at 1330 hours, RN F stated she learned the work from a previous employee who worked in the 6G unit, including patient care and instrument cleaning and handling.

The Manager supervising RN F's work was assigned to the orthopedic patient care unit. During an interview, the Manager stated she did not have surgical services training.

When asked, RN F stated the last IC staff visited the 6G unit about two years ago.

On 3/7/14 at 1000 hours, during an interview with RN F, the RN stated the surgeon for a surgery in the 6G unit could scrub hands in Exam Room #2 at the hand wash sink and pass through the ante room to Exam Room #1 for the surgery.

Observation of the area showed to enter into Exam Room #1, the only option was to use your hands to open the door.

On 3/6/14 at 0900 hours, during an interview with the IC department staff (ICPs 1, 2, 3, 4 and 5), committee members were asked what types of patients were treated in the 6G unit. The committee members responded that the types of patients that were treated in this unit were described in the nursing unit structure standards. Cross Reference A-0951, example #1.

The committee also confirmed the IC department had approved to"signed off" on these unit policies.

The committee stated the only patients treated in the 6G unit were inpatients. These patients were brought to the treatment room so that the treatment did not have to be done at their bedside. Only minor procedures were performed in this room, including:

* I & D (Incision and Drainage: a procedure when a medical instrument enters into the skin and fluid or pus is removed from the area under the skin).

* Wound debridement (when skin and tissue are removed from the area inside and around the perimeter of the wound with a knife like instrument).

* Hardware removal, for example, external fixation pins (surgically implanted pins that are secured to a rod to stabilize a fracture).

The committee stated some procedures use supplies requiring sterilization (complete elimination of all microorganisms) or high-level disinfection (elimination of all microorganisms, except for small numbers of bacterial spores). These supplies require staff to wear surgical attire, including gloves, gown, surgical mask and head cover.

Because similar instruments, cleaning standards (i.e., sterilization or high-level disinfection) and surgical attire (i.e., gloves, gown, surgical mask and head cover) were used for surgery in the OR, the committee was asked to clarify the difference between procedures that occurred in the 6G unit and surgeries that occurred in the OR. The committee stated, "The policy and procedure should be reviewed in relation to the scope of procedures. It would be good to have policy and procedure specific to this area. We should revisit the list [of approved procedures] and clarify that the room is only used for simple procedures."

The committee stated the surgical instruments used in the 6G procedure room were dedicated to that area.

The committee stated the procedure room was cleaned with "Cavi Wipes" (a disinfectant towelette) or bleach wipes. A log of cleaning was requested; however, no document was received.

Review of the hospital's P&P titled Surgical Suite, In-Depth dated 3/15/13, showed the procedure for in-depth cleaning of all ORs, core and associated surrounding areas. The procedure included to clean all equipment, furniture, horizontal surfaces, tables, ceiling, cords, walls, door frames and hinges from ceiling to floor daily.

On 3/7/14 at 0805 hours, the 6G unit was inspected with the Assistant Nursing Director, the EVS Supervisor, EVS Staff 1, RN F and Charge RN 1. No restricted or semi-restricted areas were observed for the room.

The following was observed in the 6G Room #1 and was confirmed by staff:

* the bottom of a surgical cart had a white dusty build up.

* a gurney had a torn mattress.

* a chair had nylon and net like surface, which would make it difficult to disinfect.

On 3/7/14 at 0815 hours, EVS Staff 1 was asked how often the chair was cleansed. The EVS Staff stated, "sometimes."

On 3/7/14 at 0910 hours, the EVS General Service Manager stated the chair would be wiped daily and would be brought down for pressure wash when it soiled.

On 3/7/14 at 0815 hours, RN F was asked about cleaning procedures in the 6G unit. RN F stated she cleaned the blood pressure cuff and the monitor cables after each use. The RN stated the C-arm machine was stored in this room and was cleaned prior to the use; however, she stated she did not clean the C-arm machine daily or after each use. The RN cleaned the bottom of three surgical carts twice a week.

RN F was asked about any terminal cleaning procedure for the 6G unit. The RN stated she cleaned the gurney and vital signs machine and the EVS staff cleaned the rest of the room.

On 3/7/14 at 0815 hours, EVS Staff 1 was asked about the cleaning procedure for the room 6G. EVS Staff 1 stated EVS Staff cleaned the room daily in the morning. The EVS Staff stated she cleaned the sink and the counter, removed the trash and filled up the supplies. EVS 1 stated she cleaned the head clamp, wiped and mopped the floor. EVS 1 stated she "sometimes" cleaned the gurney, the stand, the top surface of the surgical cart, the chair and the knob of the door.

EVS 1 stated she did not clean the bottom of the surgical carts. RN F cleansed the bottom of the surgical carts. EVS 1 stated she decontaminated the mattress with a Clorox wipe whenever the physician told her to decontaminate the mattress.

During the interviews with RN F and EVS 1, neither staff verbalized to clean all equipment, horizontal surfaces, ceiling, walls, doorframes and hinges from ceiling to floor daily.

On 3/7/14 at 0840 hours, the EVS Supervisor stated the procedures for routine cleaning and OR suite cleaning were different. The staff was not specifically trained to cleanse the procedure room by using the procedure for cleaning the OR suite.

On 3/7/14 at 1000 hours, the Assistant Nursing Director stated there was no specific P&P to address the cleaning and/or disinfecting of 6G room.

On 3/7/14 at 1310 hours, the hospital administration was notified of the IJ to the health and safety of hospital patients due to the above practices of performing surgical procedures outside of the main OR in the 6G unit room.

On 3/7/14 at 1530 hours, the hospital submitted a written plan of action to correct the IJ. The acceptable plan of correction showed the 6G unit would be closed and locked. Signage on the door would show the room was "not in use." A memo would be sent to all department chiefs, nursing and hospital management with instructions to ensure all staff were informed. Surgeries usually performed in 6G would be scheduled in the main OR.

After confirmation of the plan of action by the survey team through observation and staff interviews, the IJ was abated at 1620 hours on 3/7/14, prior to the exit of the survey team.

2. According to the hospital's Health Care Network Medical-Surgical/Specialty Nursing Services Unit Structure Standards, Addendum BBBB Urology, Cystoscopy, revised 2/13, "4) hand scrubbing, at least two-five minutes of scrubbing, sterile surgical clothing or protective devices are worn to maintain asepsis in the cysto room. 5)Sterile packages or fields are opened or prepared as close as possible to the time of actual use. 6) Assemble sterile cysto tray using sterile technique (Must be prepared in Cysto Room)."

a. On 3/3/14 at 1450 hours, observation of a cystoscopy procedure (endoscopy of the urinary bladder via the urethra, the tube that carries urine from the bladder to the outside of the body, performed with a cystoscope, a device with lenses to view internal structures of the body) showed Patient 12 was in position and sterile drapes were in place ready for the procedure. MD C walked in to the room wearing a cloth cap and a pair of regular non-sterile gloves. MD C verified and examined the patient, documented on the patient's record and then approached the sterile field. The MD removed the regular gloves and donned sterile gloves and a gown.

After finishing the procedure, MD C removed the sterile gloves and put on regular gloves and started documenting on the patient's record.

During an interview, MD C stated he wore a cloth cap that he washed at home and bought in for his personal use. MD C stated he wore the regular gloves for documentation in the Cysto Room as he was not comfortable touching the pen with bare hands because the pen was used by other people.

Observation of MD C did not show any hand hygiene was done before and after removal of the gloves and after the procedure.

The Cysto Room was inspected with RN T. The following was found:

* An IV infusion stand was noticed with multiple white colored residues.

* The padding and the cover of the foot rests used for positioning of patients for cystoscopy procedures were cracked.

* The radiation equipment was dusty on the surface.

* The table and the pads were dusty and dirty.

* There was no red line to define the semi-restricted and restricted areas between the cysto room and the ante room (where the sterile packages were stored).

b. On 3/4/14 at 0940 hours, during an observation and interview with ICP 2 and the Endo RN in the Cystoscopy area, scrub sinks were noted outside of the cystoscopy rooms; however, the Avagard (surgical hand antiseptic) dispensers were empty.

ICP 2 stated staff did not perform a surgical scrub, using soap and water, before donning sterile gloves and surgical gowns because a cystoscopy was a procedure and not a surgery.

The Endo RN stated, although sterilized and high-level disinfected supplies and equipment were used, cystoscopy was not surgery. Personnel wore scrub attire that was laundered and worn from home, which was the same policy and procedure as nursing services.

The cystoscopy room contained a sink, sterilized instruments and equipment pack open for use with the drape folded onto itself, verified by the Endo RN.

3. On 3/3/14 at 1525 hours, during the tour in the GI lab PACU, one RN walked out of a patient care unit; the RN removed the gloves but there was no hand hygiene performed.

4. On 3/4/14 at 1026 hours, the cleaning of OR 17 was observed between cases. EVS #3 used one cloth towel to wipe positioning devices, the back table and liner holders and the positioning device holder. EVS #3 wiped with the motions of up and down, back and forth on all the devices and surfaces.

A laser vacuum filter attached on a laser machine was observed with black and colored stains. In a concurrent interview with RN in the room, the RN stated the laser machine was used in another OR (OR 19). The RN stated the filter should be removed and discarded after use.

5. On 3/4/14 at 1430 hours, the following was observed in OR 23:

* MD F walked into the OR wearing a disposable bouffant hat and cloth cap. The bouffant hat only covered 1/3 of the cloth cap. Sterile supplies and packages for surgery were open in the room.

During a concurrent interview, the Director of Perioperative Services stated the hospital's P&P required staff to use a disposable bouffant hat to cover a staff's personal cloth cap in the surgical services area.

* Two anesthesia providers performed a regional block anesthesia service. During the observation of an injection of spinal anesthesia, one of the anesthesia providers (MD D) removed the regular gloves and changed to sterile gloves; the other provider (MD E) donned a pair of sterile gloves and assisted the injection. There was no hand hygiene performed by either of the providers prior to donning sterile gloves.

6. On 3/4/14 at 1535 hours, the anesthesia work room was toured with MD A. The following was observed:

* There was no physical space to separate the decontamination and disinfection work areas for the cleaning and disinfection of dirty fiberscopes

* During an interview, Anesthesia Technician 1 was unable to state the proper dilution of the disinfection agent used.

* Review of the Daily Metricide OPA Plus Activity Monitoring Log showed a note on the document indicating Metricide OPA Plus solution poured from the gallon container may be used for up to 14 days maximum.

Review of the log for January and February 2014, showed the solution was changed on 1/28 and 2/25/14. There was no documented evidence to show the solution was changed in required 14 days. The documentation to show testing of the effectiveness readings was left blank from 2/14/14 to 2/21/14.

During a concurrent interview, the Anesthesia Administrator stated Anesthesia Technician 2 was responsible for the log and the change of the solution; however, Anesthesia Technician 2 was not available for interview and the Administrator stated he was not aware of the incomplete log, nor that the dirty and clean spaces were not separated.

Review of Anesthesia Technician 1's personnel file showed documentation of annual competency. The position summary indicated the employee was to perform the assigned duties following departmental and hospital infection control guidelines.

7. On 3/5/14 at 0943 hours, the IR department was toured (utilizes minimally-invasive image-guided procedures to diagnose and treat diseases in nearly every organ system). The following was observed:

* MD G wore a radiological protective apron embroidered with a name. In a concurrent interview with MD G, the MD stated MD H owned this apron. MD G and H used the apron alternatively during patient procedures. The apron was used for years.

Dark red saturated spots were noted all over the apron. According to RN AC, the staff disinfected the aprons at the end of the cases by using Cavi wipes (a disinfectant towelette) on the surface of the apron.

On 3/6/14 at 0900 hours, during an interview with the IC department staff (ICPs 1, 2, 3, 4 and 5), the committee members were told that when RN AC was questioned on the process used to clean the lead aprons used for shielding during x-ray procedures they used Cavi Wipes to clean the surface of the aprons.

When the committee members were asked about the process to routinely clean lead aprons and to clean lead aprons contaminated with visible blood, they deferred to the policy that the committee agreed to produce to the survey team. However, on 3/7/14 at 1715 hours, at the exit of the survey, no further documentation was provided.

* MD G was wearing street clothes. He scrubbed his hands and waited in the control room. 10 minutes later, MD G entered the IR procedure room, put on a sterile gown and donned sterile gloves. There was no hand hygiene performed.

* The door from control room to the procedure room remained opened during the vascular IR procedure. A sterile field was set up for sterile devices and medications for the procedure.

During a concurrent interview RN AA stated the physicians traveled between the procedure room and the control room to review the patient's radiologic images shown on the control room monitors.



29398


8. According to the CDC/HICPAC, Guidelines for Environmental Infection Control in Health-Care Facilities, Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas, 2011, "Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas: Select EPA-registered disinfectants ...and use them in accordance with the manufacturer's instructions."

According to Nova Biomedical [manufacturer of glucometer (instrument to measure blood sugar)], "Stat Strip" glucose monitoring system (device to validate glucometer measurement) guidelines, provided by the facility, no date:"

Clean the Meter: Wearing gloves, wipe the external surface of the meter thoroughly with facility approved disinfectant, e.g. Cavi Wipes.

Disinfect the Meter: Using a new wipe, thoroughly wipe the surface of the meter (top, bottom, left, and right sides) a minimum of 3 times horizontally and 3 times vertically avoiding the meter's bar code scanner and electrical connector. Ensure the meter surface stays wet for the required amount of time as per facility approved disinfectant. Remove gloves and wash your hands thoroughly with soap and water.

According to Metrex (manufacturer) of Cavi Wipes guidelines, "Cleaning: Use one CaviWipe towelette to completely pre-clean surface of gross debris. For use as a disinfectant: Use a second CaviWipe towelette to thoroughly wet the surface ...ensure the surface remains visibly wet for 3 minutes."

According to the hospital's Infection Control Plan, approved 2/11/14, "Cleaning and Disinfection of the Environment, Control of Pathogens ...Read label regarding usage of cleaning solutions, and comply with the contact time. Contact time is the time the surface must remain wet in order for the chemical to do its job."

On 3/3/14 at 1118 hours, during an observation and interview, RN AI used "Cavi Wipes" to clean a glucometer (instrument to measure blood sugar), which had two red-colored spots, approximately 2 mm circumference, near the test-strip port.

RN AI donned gloves, wiped the glucometer with a single vertical stroke, removed gloves, and performed hand hygiene with an alcohol based hand rub. RN AI said the glucometer must remain visibly wet with disinfectant for one minute; the glucometer was wet for two minutes. However, the guidelines for the Cavi Wipes used to disinfect the glucometer required the surface to remain visibly wet for three minutes. The guidelines were confirmed by Clinical Nursing Director 1.

On 3/314 at 1410 hours, during an interview, ICP 4 stated the facility changed to "Cavi Wipes 1" (one minute disinfection time) and "Cavi Wipes" (three minute disinfection time) should not have been available to staff.

9. According to Buckeye (manufacturer) "Sani-Care Quat 256" (liquid disinfectant) directions for use, provided by the facility, no date, "Thoroughly wet surface...Let solution remain on surface for a minimum of 10 minutes."

Hydrion Quat Check 1000 "Single Roll Hydrion Quat Check Test Paper provides a simple, reliable, and economical means to measure the concentration of Quaternary Sanitizers...Test kit is used for detecting exhaustion of solutions that should be replaced as well as helping to avoid using excessive amounts of sanitizing agents.

Federal, State and Local health regulations require users of Quaternary Ammonium Sanitizer Solutions to have appropriate test kits available to verify the strength of sanitizer solutions."

On 3/5/14 at 1024 hours, during an observation and interview, EVS E cleaned and disinfected a room with Buckeye (manufacturer) "Sani-Care Quat 256" liquid disinfectant). The disinfectant was dry after seven minutes, confirmed by EVS E. EVS E demonstrated how "Sani-Care Quat 256" was diluted from concentrate using the manufacturer's "Action Control System" (auto-mixing device); however, EVS E did not know when the last calibration of the auto-mixer occurred or how to validate the auto-mixed concentration of disinfectant.

10. According to the hospital's Infection Control Plan, Standard Precautions, approved 2/11/14, "all body fluid and blood spills shall be cleaned up with absorbent material then cleaned with a detergent solution followed by a disinfectant solution."

According to the hospital's Cleaning and Disinfection of the Environment[al] Control of Pathogens, no date, "if a minor area is soiled with blood or body fluids do the following: put on personal protective equipment; use absorbent material to pick-up the fluid; ...discard soiled disposable material in bio-hazardous container..."

According to the AORN Perioperative Standards and Recommended Practices, Recommended Practices for Environmental Cleaning in the Perioperative Setting, 2013, "When visible soiling by blood or other potentially infectious materials appear on OR surfaces or equipment during or after a surgical procedure, an EPA-registered detergent/disinfectant should be used to clean those areas as soon as possible.

Spills that contain blood or other potentially infectious material should be removed with an absorbent material as soon as possible, and then the area should be disinfected with an EPA-registered disinfectant to confine and contain the spill.

Environmental surfaces can serve as a means of secondary transmission by providing a reservoir for infectious organisms that can contaminate the hands of health care personnel, showing the importance of environmental cleaning and disinfection as part of an infection prevention process in reducing microbial bio-burden in the environment, thereby interrupting microorganism transmission."

On 3/4/14 at 1010 hours, during an observation and interview, staff cleaned and disinfected OR 17 after a surgery. Liquid blood, visible on the floor, was not contained and removed prior to cleaning and disinfection of the operating room; personnel walked on the liquid blood and tracked it through the room without changing their shoe covers.

Equipment tubing, soiled with liquid blood, was not cleaned or disinfected. During interview, RN AJ and RN AK stated the EVS team was responsible for cleaning this equipment.

During interview, EVS C and EVS D stated environmental services staff was responsible to clean the tubing but confirmed this was not done. When asked about policies and procedures to prevent exposure to blood and body fluids or disinfect blood and body fluids, EVS C, EVS D and EVS Supervisor A did not respond.

11. According to the hospital's Health Care Network Medical-Surgical/Specialty Nursing Services Unit Structure Standards, Addendum EEE, Gastroenterology, revised 2/13, "Direction for use of Verify Chemical Monitoring Strips for Resert Solutions ...After 90 seconds compares [sic] the indicator pad to the color references on the bottle ..."

On 3/3/14 at 1335 hours, during an observation and interview, the GI Tech demonstrated how to validate the "Custom Ultrasonics" (manufacturer) automated endoscope re-processor (AER) disinfectant minimum effective concentration (MEC) by dipping a "Verify" disinfectant MEC monitoring strip in the "Resert" (disinfectant), waiting approximately 30 seconds, and comparing the color to the strength scale on the bottle. The GI Tech said the disinfectant passed. However, the "Verify" monitoring strip guidelines indicated results were compared 90 seconds after removal from the solution; this was verified by the GI Tech.

12. According to CDC/HICPAC, Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, "Inspect equipment surfaces for breaks in integrity that would impair either cleaning or disinfection/sterilization. Discard or repair equipment that no longer functions as intended or cannot be properly cleaned, and disinfected or sterilized."

According to AORN Perioperative Standards and Recommended Practices, Recommended Practices for Environmental Cleaning in the Perioperative Setting, 2013, "Instruments should be decontaminated in an area separated from locations where clean activities are performed. Cross-contamination can result when soiled items are placed in close proximity to clean items ..."

On 3/4/14 at 1400 hours, during an observation and interview, the sink cabinetry in Central Sterile Supply was corroded; this was confirmed by RN AL. The metal appeared pitted and rusted and the paint appeared bubbled, chipped, peeled, and flaked. When asked if the sink cabinetry could assuredly be cleaned and disinfected, RN AL said "no."

Facility disinfectants (e.g., CaviWipe 1, Clorox Healthcare Bleach Germicidal Wipes, Diversey 21 Spitfire, and Medline Virex II 256) were for use on nonporous surfaces. The corrosion of the decontamination sink and paint provided a porous surface incompatible with disinfectant manufacturers' guidelines.

13. According to the hospital's Perioperative Services Unit Specific Procedures, Sterilization Process, no date, "Check / inspect instruments for...Integrity of color coding on instruments."

According to the hospital's Request for Supplies or Services dated 2/28/14, Surgery Department requests Key Surgical [Identification Tape] to color code surgery trays.

According to Key Surgical (800.541.7995), Identification Tape guidelines, showed "Wrap tape around instrument a minimum of once, but not more than twice. Tape should lay flat without gaps. Inspect tape each time the instrument is reprocessed. Replace tape when it starts to chip, flake, or lift off the instrument."

According to AO

Based on observation, interview and record review, the hospital failed to ensure surgical services were provided organized and staffed to ensure the health and safety of patients as evidenced by:

1. On 3/7/14 at 1310 hours, the hospital administration was notified of the IJ to the health and safety of hospital patients due to the following practices of performing surgical procedures outside of the main OR in the 6G unit room:

- The 6G unit's RN provided services as a circulating nurse, scrub tech, and recovery nurse; however, the RN did not have evidence of training or proven competencies in surgical nursing.

- Staff did not routinely perform a site or side marking prior the patient's surgical procedures. The 6G room did not have cleaning between cases and at the end of the day as per the main OR and there was no specific disinfection process to clean or disinfect the room after a patient with infected wound was treated.

- Contaminated instruments were not cleaned and disinfected as per the hospital's P&P.

- The hospital's P&Ps did not address the services provided to patients in 6G unit.

- Acceptable OR attire was not in use and the process was not overseen by the IC group

- There was no documentation to show outpatients receiving surgery in 6G received post-operative care planning and coordination, and provisions for follow-up care.

On 3/7/14 at 1530 hours, the hospital submitted a written plan of action to correct the IJ. The acceptable plan of correction showed the 6G unit would be closed and locked. Signage on the door would show the room was "not in use." A memo would be sent to all department chiefs, nursing and hospital management with instructions to ensure all staff were informed. Surgeries usually performed in 6G would be scheduled in the main OR.

After confirmation of the plan of action by the survey team through observation and staff interviews, the IJ was abated at 1620 hours on 3/7/14, prior to the exit of the survey team.

Cross Reference A-0951, example #1.

2. The hospital's P&P was not implemented for the time-out procedure for two patients reviewed for surgeries in the main OR during two of observations of surgical patients in the main OR (Patients 13 and 76). Cross Reference A-0951, example #2.

3. Portable dehumidifiers were used in two of two LDR ORs with no P&P developed for their use, cleaning and maintenance. Cross Reference A-0951, example #3.

The cumulative effect of these systemic practices resulted in the hospital's inability to provide safe and effective surgical services.

Based on observation, interview and record review, the hospital failed to provide a safe and effective environment and maintain high standards of care for patients receiving surgical services as evidenced by:

- Surgical services provided in the hospital's 6G unit treatment room were not provided in a safe and sanitary environment.

- The nurse providing services as a circulating nurse, scrub tech, and recovery nurse did not have evidence of training or proven competencies in surgical nursing.

- Staff did not routinely perform a site or side marking prior the patient's surgical procedures.

- The room was not cleaned as outlined in the hospital's P&P for cleaning of an OR room between cases and was not terminally cleaned by EVS services at the end of the day. There was no specific disinfection process to clean or disinfect the room after a patient with infected wound was treated. The room temperature and humidity were not monitored.

- The RN did not clean the contaminated instruments prior to sterilization per the manufacturer's instructions and could not verbalize the temperature of the warm water used to dilute the enzymatic agent.

- The hospital's P&Ps did not address the actual services provided to patients in 6G unit.

- Acceptable operating room attire was not was not followed and overseen by the IC group.

- Lack of outpatient surgery post-operative care planning and coordination, and provisions for follow-up care .

- The hospital's P&P was not implemented for the time-out procedure for two patients surgeries observed in the main OR (Patients 13 and 76).

- Portable dehumidifiers were used in two of two LDR ORs with no P&P developed for their use, cleaning and maintenance.

These failures resulted in the potential for poor health outcomes to patients receiving surgical services in the hospital.

Findings:

The American College of Surgeons and the CMS definition of surgery is a procedure performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery also is the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles.

The tissue can be cut, burned, vaporized, frozen, sutured, probed, or manipulated by closed reductions for major dislocations or fractures, or otherwise altered by mechanical, thermal, light-based, electromagnetic, or chemical means. Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system also is considered to be surgery (this does not include the administration by nursing personnel of some injections, subcutaneous, intramuscular, and intravenous, when ordered by a physician).

1. On 3/5/14 at 1520 hours, a surgical procedure was observed ongoing in the 6G unit procedure room. Inside the room was a handwashing sink. There was no scrub sink located outside of the room.

A sterile field was set up with sterile supplies and surgical instrument trays. One surgeon wore a surgical gown and sterile gloves while working on the patient. RN F left the room, passed through an ante room into another room to obtain sterile supplies on a cart and then returned to the procedure room.

On 3/5 and 3/6/14, RN F was interviewed. RN F stated the 6G unit provided minor orthopedic procedures for inpatients and outpatients. The service was based on the patient needs. The procedure schedules were provided on the surgical day.

a. The AORN Definition of a Circulating Nurse showed the circulating nurse's duties in the operating room are performed outside the sterile field. The circulating nurse is responsible for managing all nursing care within the operating room, observing the surgical team from a broad perspective, and assisting the team to create and maintain a safe, comfortable environment for the patient's surgery.

The circulating nurse ensures that all members of the surgical team perform in a united effort. One perioperative RN is dedicated to the patient during that patient's entire intraoperative experience. During surgery, most patients are anesthetized or sedated and are powerless to make decisions on their own behalf. By employing critical thinking, assessment, diagnosing, outcome identification, planning, and evaluation skills, RN circulators direct the nursing care and coordinate activities of the surgical team for the benefit of the patient, whose protective reflexes or self-care abilities are compromised by the procedure.

These critical nursing functions of the RN circulator are not delegable in the operating room. To conclude the role of the RN in the perioperative setting is vital to the provision of optimal and safe patient care. The perioperative RN is the health care practitioner with the knowledge, training, and skills to successfully perform circulating duties in the surgical setting. Using sound nursing judgment, critical thinking skills, and interpersonal communication skills, the RN circulator is able to assess and evaluate individual patient needs and to ensure positive patient outcomes. To ensure that patients receive the highest quality and standard of nursing care, it is essential that there is a perioperative registered professional nurse in the role of the circulator throughout every operative or invasive procedure.

RN F stated she was the only nurse assigned to 6G. RN F stated she worked independently providing patient care for pre-operative, intra-operative and recovery patients in the unit.

RN F stated she decontaminated and cleaned the surgical instruments and packed the instruments for sterilization. RN F stated she provided environmental cleaning of the room pre and post surgery.

RN F stated she monitored patients who received regional anesthesia without a licensed anesthesia provider onsite, during and post procedures. RN F stated she did not have formal training or experience in surgical services.

RN F stated only patients who were felt to be ASA (American Society of Anesthesiology) classification I or II had procedures performed in the 6G unit, and that she, not the anesthesia provider selected the ASA classification. RN F stated that patients with hypertension or diabetes would be classified as ASA II.

During a concurrent interview with the 6th floor Nursing Manager, the Manager stated she was aware of the current practice in the 6G unit. The Manger stated she did not have training for surgical services, but was responsible for the Unit.

Review of the Job Description for RN F on 3/6/14, showed the job duties included nursing assessment, planning, implementation, evaluation, administrative/ancillary for nursing service. The most recent evaluation was documented on 5/2/13 with a supervisor signature. RN F had a Basic Life Support certificate for CPR. The job description documentation did not show a set of specific competencies related to the care provided for the surgical patients in the 6G unit.

In an interview with the Assistant Nursing Director Med-Surg on 3/6/14 at 1450 hours, she stated the nursing competency utilized for RN F was that of a floor nurse, providing basic inpatient care, with some training in providing a sterile field as would be required for placing a central line at the bedside.

b. Review of the hospital's document 6G Medical-Surgical/Orthopedics Unit Structure Standards 2012-2014, showed the procedure room located on the 6th floor of the hospital inpatient tower is utilized to perform simple procedures that do not required procedural sedation.

The objectives for 6G unit were:

* To promote and provide diagnostic procedures to determine the etiology of the patient's presenting complaints.

* To perform nursing assessment on every patient seen in the area.

* To administer patient care utilizing the nursing process.

The Administration/Organization of Unit showed the 6G unit was referred to as the Orthopedic Procedure Room and was organized as a nursing unit within orthopedic services. Overall management of the unit is the responsibility of the Nurse Manager with supervision, direction, and support by the Clinical Nursing Director Woman's & Children's Services. Collaboration with physicians and appropriate department head takes place. The Nurse Manager is a RN with requisite clinical and managerial experience and is specially selected by Nursing Administration to assume responsibility for the effective organization and manage the Unit.

The policy statement for Medical Direction indicated the responsibility for directing medical care on the unit is that of the assigned or on call Attending Physician. The specific responsibilities of the admitting physician for patients seen or treated as outpatients or inpatients included completing a history and physical examination on all patients and documenting the findings in the patient's chart, assisting in monitoring compliance with quality assurance/improvement activities on the unit, and performing surgeries.

The Addendum A for Orthopedic Treatment Room -Procedure preparation listed 14 procedures. The listed items for the procedures for those procedures 12 of 14 procedures required surgical instrument trays and/or radiologic equipment.

c. The Addendum E infection control, showed the Nursing Manager of 6G or her designee is responsible to provide sufficient and appropriate supplies necessary for adherence to Standard Precautions. EVS is responsible for cleaning/decontamination of patient unit and all the maintenance and cleaning of floors, sinks, soap dispensers, walls, cubicles, curtains, and toilets.

On 3/6/14 at 1350 hours, during interview, RN F stated she cleaned the surfaces of countertops and table with bleach wipes between cases. RN F would not know or monitor the room temperature and humidity. The mini C-arm x ray would utilize in the room if procedure needed. According to RN F, the surgeon would use the C-arm on the procedures. The room would be cleaned at the end of the day by EVS services. There was not specific disinfection process to clean or disinfected the room after the room treated a patient with infected wound.

On 3/6/14 at 0900 hours, during interview with the IC department staff (ICPs 1, 2, 3, 4 and 5) committee members were asked what types of patients were treated in Treatment Room 6G. The committee members responded that the types of patients that are treated in this room were described in the nursing unit structure standards. The committee also confirmed the IC department "signed off" on these unit policies.

The committee stated the only patients treated in room 6G are inpatients (patients admitted to the hospital). The patients were brought to the 6G room in order so the treatment did not have to be done at their bedside. The committee stated only minor procedures were performed in this room, including:

* I & D (Incision and Drainage: a procedure when a medical instrument enters into the skin and fluid or pus is removed from the area under the skin).

* Wound debridement (when skin and tissue are removed from the area inside and around the perimeter of the wound with a knife like instrument).

* Hardware removal, for example, external fixation pins (surgically implanted pins that are secured to a rod to stabilize a fracture);

The committee stated some procedures used supplies that required sterilization (complete elimination of all microorganisms) or high-level disinfection (elimination of all microorganisms, except for small numbers of bacterial spores). These supplies required surgical attire, including gloves, gown, surgical mask and head cover.

Because similar instruments, cleaning standards (i.e., sterilization or high-level disinfection), and surgical attire (i.e., gloves, gown, surgical mask, and head cover) were used for surgeries done in the main operating room, the committee was asked to clarify the difference between procedures that occurred in the 6G unit and surgery that occurred in the Operating Room.

The committee stated "The policy and procedure should be reviewed in relation to the scope of procedures. It would be good to have a policy and procedure specific to this area. We should revisit the list [of approved procedures] and clarify that the room is only used for simple procedures."

The committee stated the surgical instruments used in the 6G procedure room were dedicated to that area. The committee stated the procedure room was cleaned with "CaviWipes" (a disinfectant towelette) or bleach wipes. A log of cleaning was requested; however, no document was received.

d. During an interview on 3/6/14, with the Nursing Manager for 6G, the Manager stated the surgeon who performed surgeries in 6G was required to wear a surgical gown and mask. The Manager stated however, there was no special attire or requirement for a person entering the room (the area where surgery was performed) during a procedure.

On 3/5/14 at 1520 hours, while a procedure was ongoing, the Nursing Manager entered the Exam Room with med/surg uniform, with no hair cover or face mask.

e. According to the CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, cleaning is the removal of foreign material (e.g., soil, and organic material) from objects and is normally accomplished using water with detergents or enzymatic products. Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes.

Cleaning is done manually in use areas without mechanical units or for fragile or difficult-to-clean instruments. The enzyme solutions used in cleaning should be used in accordance with manufacturer's instructions, which include proper dilution of the enzymatic detergent and contact with equipment for the amount of time specified on the label.

On 3/6/14 at 1350 hours, during interview, RN F stated she cleaned the contaminated instruments in 6G ante room before sending them out for sterilization. RN F cleaned the instruments with surgical scrub brushes (not enzymatic cleaner) and flushed with water.

On further interview on 3/7/14 at 0945 hours, RN F stated she used a diluted enzymatic agent solution to clean contaminated instruments; however, she was unable to state the temperature of the warm water used to dilute the enzymatic agent.

Review of the manufacturer's instruction for the enzymatic solution showed the water temperature should not be greater than 150 degrees F.

On 3/6/14 at 1350 hours, during an interview RN F stated most patients receiving procedures were outpatients. The patients had procedures in 6G with or without anesthesia services. The patients were discharged to home or returned to outpatient treatment area from the 6G unit.

The RN stated the post procedure care and post anesthesia care instructions were given to the patient or family verbally by their treating physician. RN F assessed the patient's wound prior to discharge.

Review of the following medical records for two patients with surgical procedures in 6G did not show documentation of the patients' follow-up care after surgery:

1) Patient 32's record review showed the patient came to 6G on 3/5/14, for a surgical procedure. On the pre-printed form to document the Patient Status at Time of Discharge, there were spaces to indicate the status of consciousness, ambulatory, void, taken oral fluid, dizziness, pain control, and aldrete score; however, the check boxes were not marked.

The Discharge Home list, discharge order by physician, aftercare instructions including access to emergency care, follow up appointments, activity, limitations and restrictions, were not documented. The Disposition/Time was left blank.

2) Patient 77's record review showed the patient came to 6G on 3/6/14, for a surgical procedure. The pre-printed form for Discharge Home list, included space for a discharge order by physician, aftercare instruction including access to emergency care, follow-up appointments, activity limitations and restrictions; however, the spaces for those items were left blank.

The admission time and discharge time were not documented. Patient 77 returned to the outpatient treatment area with a volunteer; the Disposition/Time was left blank.

g. The hospital's P&P titled Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery, effective date 8/13/13, indicated the P&P will apply to all surgical and non surgical invasive procedures. A time-out is required to be performed for the procedure, during the time out, the team members agree at the minimum on correct patient identity. In addition, the P&P stated the procedure site is marked by a licensed independent practitioner who is ultimately accountable for the procedure and will be present when the procedure is performed.

The hospital's P&P titled Universal Protocol-Non Operating Room dated 8/13/13, showed this P&P is for any location that is not designated as a licensed OR and for any therapeutic or diagnostic invasive intervention that penetrates the patient's skin or enters an orifice.

* The protocol step 2 indicated in preparation for the procedure the licensed provider will verify the patient, correct procedure, correct site and correct side. The licensed provider is responsible for reviewing relevant documentation, e.g. the consent.

* Step 3 showed that after review of all documentation the anatomical site will be marked by a licensed independent practitioner who is ultimately accountable for the procedure and will be present when the procedure is performed. Site marking will be done prior to any sedation or anesthesia (regional or local) site marking will take into consideration the laterality.

* The step 4 showed immediately prior to initiating the procedure, the Licensed Independent Practitioner must initiate a "Time-Out" with all members of the team performing the procedure.

On 3/6/14 at 1350 hours, RN F was interviewed. RN F stated in the 6G Unit services, the orthopedic surgical procedures were performed to patients in the 6G unit. She stated the surgeon or the staff did not perform a site or side marking prior the patient's procedures.

Review of Patient 32's medical record on 3/6/14, showed the patient had a nerve block for the left index finger pinning procedure in the 6G unit that day. There was no documented evidence to show a "Time out" for the nerve block had been performed prior to the procedure.

2. The following observations were made in the main OR on 3/4/14:

a. On 3/4/14 at 1410 hours, Patient 13 was interviewed in the Preoperative unit. Patient 13 stated he had a twin was also a patient in the hospital.

On 1430 hours, during observation in OR 23, a Time Out was conducted by the anesthesia team and the surgical team for the spinal anesthesia. The Time Out did not include the patient's first name. The Director of the Surgical Service concurred with this observation .

b. On 3/4/14 at 0930 hours, Patient 76 was observed and interviewed in the preoperative area. Patient 76 was scheduled for a surgical procedure for the right ankle. A "Yes" "MS" was initialed on the patient's right lower extremity. Patient 76 stated he came to the hospital around 0530 hours, and an MD marked his leg.

Further interview with the Preop staff revealed "MS" were the initials for a third year resident (MD V). Review of the patient's medical record showed on the 3/4/14, procedure notes, MD V was not present in the surgery.


25720


3. The LDR unit was toured with the Assistant Nursing Director of Women's Services and the LDR Nurse Manager on 3/4/14, beginning at 0840 hours. Two of the two ORs on the unit were inspected. The Nurse Manager stated the ORs were not in use at this time; however, they had been cleaned and were ready for surgery. The following was observed:

a. Portable de-humidifier machines were observed in each LDR OR, numbers 1 and 2. The machines were not on. When asked, the Nurse Manager opened the reservoirs at the bottom of each machine. Standing water was in each of the reservoirs. The preventative maintenance label on each of the machines showed service was due 11/13. The Manager was unable to state the last time the machines were used to decrease humidity. The Manager stated there was a problem with too much humidity in the LDR ORs and the machines were used to decrease the humidity to the required levels for safety.

The Nurse Manager stated she was unaware if there was a P&P for the use of de-humidifier machines. The nurses only emptied the water from the machines.

Review of the manufacturer's Owner's Manual for the portable de-humidifier machines used in the LDR ORs showed the following:

* To clean the grille and case use a mild detergent, do not use bleach or abrasives.

* The air intake and outlet grilles get soiled easily, so use a vacuum attachment or brush to clean.

* Every few weeks, clean the bucket.

* The air filter behind the grille should be checked and cleaned at least every 30 days.

Infection Control RN Practitioner 5 was interviewed on 3/5/14 at 0950 hours. The RN stated she oversaw the LDR area and made administrative and infection control rounds of the area every couple of months with the Nurse Manager and Assistant Nursing Director of Women's Services. When asked regarding the use of de-humidifiers in the LRD ORs 1 and 2, the RN stated she was aware of their use; however, she was not sure if there was a P&P for the care of the humidifier.

The IC Committee was interviewed in a meeting with the survey team on 3/6/14 at 0900 hours. The Committee consisted of nursing staff, physician's and EVS staff.

The use of dehumidifiers in the LDR ORs was discussed with the committee members. The committee members were asked how the machine would be disinfected per OR standards as the manufacturer's directions showed not to use any cleaning product but a mild detergent. The committee members confirmed the dehumidifiers should have gone through the new products process; however, this one of the staff stated "is a big place and products do not always get reviewed."

The committee members were asked if the IC staff monitored the OR temperature and humidity logs. Staff stated they did monitor the logs; the Facilities staff notified the IC staff whenever the levels were out of range. "We make sure the LDR knows and they make the decision to move the case to the OR" or use the de-humidifiers to lower the humidity to a safe level. When asked, staff stated they were unaware of any C-sections done in the main OR in the past year.

Based on interview and record review, the hospital failed to ensure the H&P examination was completed prior to a surgery for one of 15 surgical patients (Patient 74) reviewed, creating the risk of unrecognized medical conditions and a substandard health outcome for that patient.

Findings:

The hospital's P&P titled Rules and Regulations Guidelines for Supervision of Residents dated 10/3/12, read in part on page 3, "An attending or supervisory resident shall see and evaluate each patient prior to any operative procedure or delivery and shall document this evaluation in the medical record."

Review of Patient 74's medical record was initiated on 3/7/14. The patient went to hospital for a procedure on 2/19/14, as an outpatient.

Review of the Surgical Coordinator Notes dated 2/18/14 at 1122 hours, showed Patient 74 had an appointment at the orthopedic treatment room on 2/19 (no year documented) for a procedure.

However, review of the Procedure-Hand Services Note dated 2/19/14 at 1440 hours, showed a surgical procedure was performed on Patient 74. The patient's "right hand (small finger) operative site anesthetized with regional block by anesthesia."

There was no documented evidence to show the H&P was completed prior to the surgical procedure.

An interview and medical record review was conducted with RN O on 3/7/14 at 1005 hours. When asked, the RN stated she would look for the documentation.

On 3/7/14 at 1715 hours, at the exit of the survey, there was no further documentation provided.

Based on interview and record review, the hospital failed to ensure the informed consents were completed prior to surgical procedures for eight of 15 surgical patients (Patients 63, 64, 65, 66, 67, 72, 73 and 74) reviewed. This created the risk of the patients not being allowed to make decisions about their healthcare and the risk of substandard health outcomes.

Findings:

The hospital's P&P titled Consents/Witnessing Signatures, effective date 12/13, showed legal authorization must be obtained from the patient or the patient's authorized representatives prior to performing treatment, specialty procedures or an operation. The consent is a legal document and should be dated signed and witnessed.


1. Review of Patient 72's medical record was initiated on 3/7/14. The patient was admitted to the hospital on 2/25/14.

The Progress-Hand Services Notes dated 2/26/14 at 0947 hours, showed a plan for revision amputation of MF (middle finger) in the treatment room (6G) on this day. The plan had been discussed with Patient 72. The patient had consented. The consent was in the patient's medical record.

However, there was no documented evidence to show an informed consent was signed by Patient 72 for the procedure on 2/26/14.

Review of the Moderate/Deep Sedation Flow Sheet dated 2/26/14, showed the procedure was performed on 2/26/14 as planned. The procedure was started at 1608 hours and ended at 1637 hours.

Further review showed the Authorization for and Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures signed by Patient 72 on 2/28/14 at 1530 hours, showed the patient consented for finger amputation and left middle finger revision amputation with primary closure. The form was incomplete as the sections to document the use of interpreter services and document if blood transfusion was given were left blank.

2. Review of Patient 73's medical record was initiated on 3/7/14. The patient went to the hospital for a procedure on 2/20/14, as an outpatient.

Review of the Authorization for and Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures published in Spanish and English, signed by Patient 73 on 2/20/14 at 0830 hours, showed the form was not complete as the sections to document the use of interpreter services and document if blood transfusion was given were left blank.

3. Review of Patient 74's medical record was initiated on 3/7/14. The patient went to hospital for a procedure on 2/19/14, as an outpatient.

Review of the Authorization for and Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures signed by Patient 74 on 2/19/14 at 1145 hours, showed the form was not complete as the sections to document the use of interpreter services and document if blood transfusion was given were left blank.



20059


4. On 3/7/14, review of Patient 63's medical record showed a surgical procedure was performed on 2/25/14. A document found in the record titled: Authorization for And Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures showed the form was incomplete as there was no designation whether interpreter services were required and whether a blood transfusion form was required.

5. Review of Patient 64's medical record showed a surgical procedure was performed on 2/6/14. There was no documentation of an informed consent found in the medical record for the surgical procedure performed.

6. Review of Patient 65's medical record showed a surgical procedure was performed on 2/25/14. There was no documentation of an informed consent found in the medical record for the surgical procedure performed.

7. Review of Patient 66's medical record showed a surgical procedure was performed on 3/3/14. There was no documentation of an informed consent found in the medical record for the surgical procedure performed.

8. Review of Patient 67's medical record showed a surgical procedure was performed on 2/26/14. A document found in the record titled: Authorization for And Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures showed the form was incomplete as there was no designation whether interpreter services was required and whether a blood transfusion form was required.

Based on interview and record review, the hospital failed to ensure the log for patients seen for surgical procedures in the 6G unit was complete with all patients serviced and the required information. This resulted in incomplete information available regarding the patients and procedures done in the 6G unit.

Findings:

Review of a hospital document for the 6G unit showed the 6G unit had a computer system for maintaining registration and disposition of patients seen for procedures in the unit. When the computer system was down records would be utilized for logging patients in and out until the system was operational again.

On 3/6/14 at 1350 hours, RN F provided a log of the patients who received services in 6G. The log showed 14 patients for February, 2014, and four patients for March, 2014. The log included a patient identification sticker, the time in and time out in the 6G unit and the procedures performed. However, the log did not contain information regarding the personnel present, type of anesthesia used and the pre and post-op diagnoses.

RN F stated there was no structured log book for the 6G unit. RN F recorded patient information on a piece of paper. RN F also stated she maintained the Patient Fluoro Time, a log which contained information about the duration of radiation from the C-arm (radiologic equipment) used during procedures in 6G.

During review of the Patient Fluoro Time log in the 6G unit for February, 2014, the log contained information about two patients from 2/28/14, who received fluoroscopy, one for seven minutes and 11 seconds and one for four minutes and 26 seconds.

The presence of several physicians during the procedure was noted on the Patient Fluoro Time log for each patient. However, neither of the patients was listed on the handwritten surgical log for the 6G unit supplied by RN F.

Based on interview and record review, the hospital failed to ensure operative report was completed for one of 15 surgical patients (Patient 72) reviewed. This could lead to patient operative information not being available to other health professionals.

Findings:

The hospital's P&P titled Health/Medical Record: Documentation, effective 11/12/13, read in part, "Operative or other invasive procedures, and/or anesthesia shall be documented on the health/medical record immediately after the surgery and verbal dictation on the electronic dictation system shall occur within 24 hours of the procedure."

Review of Patient 72's medical record was initiated on 3/7/14. The patient was admitted to the hospital on 2/25/14.

The Progress-Hand Services Notes dated 2/26/14 at 0947 hours, showed a plan for revision amputation of MF (middle finger) in the treatment room (Room 6G) on this day.

Review of the Moderate/Deep Sedation Flow Sheet dated 2/26/14, showed a procedure was performed for Patient 72 on 2/26/14. The procedure was started at 1608 hours and ended at 1637 hours.

Further review failed to show documented evidence an operative report was completed for the procedure performed on 2/26/14.

During the interview and medical record review with RNs O and S on 3/7/13 at 1005 hours, the RNs confirmed the finding.

Based on record review and interview, the hospital failed to show documented evidence the pre-anesthesia evaluations for four of 15 patients (Patients 15, 32, 74 and 80)reviewed who received surgical services in the 6G unit included the patient's health information and physical evaluation. This created an unsafe environment for the patients receive services in the 6G unit.

Findings:

According to Practice Advisory for Preanesthesia Evaluation, the Update Report by American Society of Anesthesiologists Task Force on Preanesthesia Evaluation dated 3/12, preanesthesia consists of the consideration of information from multiple sources that may include the patient's medical records, interview, physical examination, and findings from medical tests and evaluations. A minimum a preanesthetic physical examination should include (1) an airway examination (2) a pulmonary examination to include auscultation of the lung, and (3) a cardiovascular examination.

The hospital Guidelines for Performance for Peripheral Nerve Blocks for the Department of Anesthesiology showed the guidelines was to outline the procedure for the administration of a peripheral nerve block as a single injection or with a continuous catheter in the ambulatory surgery administration and recovery/discharge unit. The policy indicated the responsibility of the anesthesiologist included discuss post-operative pain management with the patient preoperatively and to obtain consent, complete the "Anesthesia Peripheral Nerve Block Record" and sign; enter the patient into the post-op pain log record for follow-up. The required forms necessary prior of nerve block included a surgical H&P and an anesthesia H&P and consent.

1. On 3/7/14, Patient 32's medical record review was conducted. Patient 32 received a surgical service in 6 G unit. The documentation for Informed Consent for Anesthesia and Anesthesia-Related Services documented the patient consented for Nerve Block anesthesia.

Review of an Inpatient Progress Notes, dated 3/5/14, showed MD M assessed the patient for pre-anesthesia. Documentation of the physical examination of the patient showed an assessment of the patient's left hand and finger nerve, range of motion, and nerve sensation of left index finger. There was no documented evidence of a system review of the patient's heart, lung, breathing, activity, conscious level, circulation and previous anesthesia history nor potential risk according to established standard of practice (e.g. ASA classification of risk).


21177


2. On 3/7/14, medical record review showed Patient 80 had a closed reduction and percutaneous pinning of the right wrist done on 2/14/14.

Review of the Informed Consent for Anesthesia and Anesthesia-Related Services showed the patient consented for nerve block anesthesia. The anesthesiologist performed a local nerve block at 1134 hours. Review of the anesthesiologist's Regional Anesthesia note dated 2/14/14 at 1130 hours, and the H&P did not show a review of the patient's ASA classification of risk.


25720


3. The medical record for Patient 15 was reviewed on 3/7/14. The patient had a procedure performed on 2/21/14, in the 6G unit to manipulate a fractured left index finger into place and secure with the bone alignment with wires.

The patient signed consent for a Minor/Major Nerve Block prior to the procedure. The risks documented on the consent form were infection, convulsions, weakness, persistent numbness, residual pain, injury to blood vessels, buzzing in the ears and injury to blood vessels and nerves.

Review of Patient 15's medical record showed an H&P was documented by the anesthesiologist on 2/21/14 at 1030 hours. Review of the H&P did not show a review of the patient's drug and allergy history and an ASA classification of risk.




29558


4. Review of Patient 74's medical record was initiated on 3/7/14. The patient went to the hospital for a procedure on 2/19/14, as an outpatient.

Review of the Procedure-Hand Services Note dated 2/19/14 at 1440 hours, showed a procedure of right small finger dynamic external fixation was performed on Patient 74. The patient's "right hand (small finger) operative site anesthetized with regional block by anesthesia."

Further review failed to show documented evidence a pre-anesthesia evaluation was completed and documented.

An interview and medical record review was conducted with RN O on 3/7/14 at 1005 hours. When asked, the RN was unable to locate the missing document. The RN stated she would look for the above missing documentation.

On 3/7/14 at 1715 hours, at the exit of the survey, no further documentation was provided.

Based on observation, interview and record review, the hospital failed to ensure nine of 15 patients (Patients 15, 32, 63, 67, 71, 74, 79, 80 and 81) reviewed who received surgical services with regional nerve blocks in the 6G unit had an intra-operative anesthesia records documented by the anesthesiologist to show monitoring during the surgery. This failure created the risk of poor surgical outcomes to these patients.

Findings:

When the hospital's P&P for the monitoring of regional anesthesia was requested on 3/6/14, the hospital provided the document, Standard for Basic Anesthetic Monitoring, approved by the ASA House of Delegates, effective date of 7/1/11.

Standard 1 of the document showed because of the rapid changes in patient status during anesthesia, qualified anesthesia personnel shall be continuously available to monitor the patient and provide anesthesia care. The qualified should be present in the room throughout the conduct of all general anesthetics, regional anesthetics and monitored anesthesia care.

1. On 3/5/14 at 1512 hours, MD M was observed walking out from the 6G unit 1 with a portable machine. A concurrent interview with RN F revealed Patient 32 was in the room having an orthopedic procedure. MD M provided a nerve block for the patient as anesthesia for the procedure.

During review of Patient 32's medical record on 3/7/14, the documentation on Peripheral Nerve Blockage form showed an axillary nerve block was started 1416 hours and ended time 1419 hours.

On 3/6/14 at 1322 hours, during an interview, MD M stated she performed nerve block anesthesia services for the patients in the 6G unit. MD M evaluated the patients after the block and when satisfied with the nerve block effectiveness, MD M left the room.

On 3/6/14 at 0920 hours, during interview with RN F, the RN stated she monitored and documented patients' vital signs during the surgical procedures and recorded the surgical procedure. RN F stated she was the circulating nurse and the monitoring RN. However, RN F stated she also had to leave the room to perform other tasks.


25720


2. The medical record for Patient 15 was reviewed on 3/7/14. The patient had a procedure performed on 2/21/14, in the 6G unit to manipulate a fractured left index finger into place and secure with the bone alignment with wires.

The patient signed consent for a Minor/Major Nerve Block prior to the procedure. The risks documented on the consent form were infection, convulsions, weakness, persistent numbness, residual pain, injury to blood vessels, buzzing in the ears, and injury to blood vessels and nerves.

Review of the Peripheral Nerve Blockade procedure note form showed a anterior axillary nerve block was performed by the anesthesiologist at 1051 hours; however, there was no documentation to show if the nerve block was performed on the right or left side of the body.

The form contained the patient's vital signs immediately before and after the block, pain score, and the type of needle and medication used for the block. Under the area to document the "success" of the block, the anesthesiologist checked the box "a full evaluation is pending."

The surgical procedure began at 1133 hours and concluded at 1215 hours. There was no anesthesia record found in the medical record to show the patient's condition was monitored by the anesthesiologist during the procedure.


26881


3. Patient 71 came to the hospital on 2/19/14, for a procedure on his fractured right hand. The procedure note indicated that the operative site was anesthetized with a regional block per anesthesiology.

The Peripheral Nerve Blockade Procedure Note dated 2/19/14, indicated the anesthesia time began at 0856 hours, but no end time was recorded.

The anesthesia procedure note indicated the anesthetic was "well tolerated." There was no documentation to show the anesthesiologist was present during the surgical procedure.

The nursing, anesthesia and orthopedic surgeon's records did not show the anesthesiologist was present during the surgical procedure.


29558


4. Review of Patient 74's medical record was initiated on 3/7/14. The patient went to hospital for a procedure on 2/19/14, as an outpatient.

Review of the Procedure-Hand Services Note dated 2/19/14 at 1440 hours, showed a hand surgery was performed on Patient 74. The patient's "right hand (small finger) operative site anesthetized with regional block by anesthesia."

Further review failed to show documented evidence Patient 74 was assessed and monitored during the procedure.

An interview and medical record review was conducted with RN O on 3/7/14 at 1005 hours. When asked, RN O was unable to locate the missing document. The RN stated she would look for the above missing documentation.

On 3/7/14 at 1715 hours, at the exit of the survey, there no further documentation was provided.


20059


5. Review of Patient 63's medical record on 3/7/14, showed a surgical procedure was performed on 2/25/14, for a right wrist carpal tunnel release. There was no documentation found to show intra-operative monitoring by the anesthesiologist.

6. Review of Patient 67's medical record on 3/7/14, showed a surgical procedure was preformed on 2/26/14. Documentation showed the procedure was a right internal fixation and pinning of the wrist. There was no documentation found to show intra-operative monitoring by the anesthesiologist.


21177


7. Medical record review on 3/7/14, showed Patient 79 had a closed reduction with pertacuneous pinning of the right middle finger on 2/7/14 at 1140 hours in the 6G unit. The patient received a peripheral nerve blockage by an anesthesiologist at 1034 hours.

RN F monitored and assessed the patient from 1001 hours to 1228 hours. Patient 79 was discharged from the 6G unit and escorted to the Orthopedic Evaluation and Treatment Clinic by a volunteer at 1228 hours.

There was no anesthesia record found in the medical record to show the patient's condition was monitored by the anesthesiologist during the procedure.

8. Medical record review on 3/7/14, showed Patient 80 had a closed reduction and percutaneous pinning of the right wrist done on 2/14/14 in the 6G unit. The anesthesiologist performed a local nerve block at 1134 hours. RN F monitored and assessed the patient from 1134 hours to 1405 hours, when the patient was discharged from the 6G unit and escorted to the Orthopedic Evaluation and Treatment Clinic by a volunteer.

There was no anesthesia record found in the medical record to show the patient's condition was monitored by the anesthesiologist during the procedure.

9. Medical record review on 3/7/14, showed Patient 81 had the debridement and irrigation with possible incision/drainage of the wound and a wound vacuum change of the right hand done on 2/14/14, in the 6G unit.

An anesthesiologist performed a peripheral nerve block at 1419 hours on 2/14/14, for Patient 81's surgery. RN F monitored and assessed Patient 81 unit from 1519 hours to 1605 hours, when the patient was discharged from the unit escorted back to a medical surgical unit.

There was no anesthesia record found in the medical record to show the patient's condition was monitored by the anesthesiologist during the procedure.

Based on observation, interview and medical record review, the hospital failed to ensure the qualified anesthesia practitioner completed post-anesthesia evaluations for nine of 15 patients (Patients 15, 32, 63, 67, 71, 74, 79, 80 and 81) reviewed who received regional nerve blocks for surgeries in the 6G unit. This failure created the risk of the potential side effects of the anesthesia not to be recognized and poor surgical outcomes for those patients.

Findings:

Review of the Department of Anesthesiology Guidelines for performance for peripheral nerve blocks (undated) showed "In house patients are to be followed by Anesthesia daily, while home patients are to be followed by telephone by the assigned Anesthesiologist (PACU resident or peripheral nerve block nurse)."

1. On 3/5/14 at 1512 hours, MD M was observed to walk out from the 6G unit with a portable machine. In a concurrent interview with RN F the RN stated Patient 32 was in the room for a orthopaedic procedure. MD M provided a nerve block for the patient.

Review of Patient 32's medical record on 3/7/14, showed an auxiliary nerve block was started by MD M on 3/5/14 at 1416 hours. Review of the documentation on the Moderate/Deep Sedation Flow Sheet for Patient 32 showed areas to document Patient Status for: time of Discharge, pre-sedation level of consciousness, ambulatory, able to void without difficulty, able to take oral fluids, minimal or no nausea, minimal or no dizziness, pain adequately controlled, the Discharge Home Checklist, written order for discharge by physician, aftercare instruction and the disposition/time. None of the check boxes for documentation of the patient's status were checked.

On 3/6/14 at 0920 hours, during an interview, RN F stated she monitored and documented the patients' vital signs during the procedures in the 6G unit on a Moderate/Deep Sedation Flow Sheet form. RN F stated she observed the patients for recovery after the surgery for 15 minutes and then discharged the patients. RN F stated the anesthesia provider did not evaluate the patients prior to their discharge from the 6G unit.

On 3/6/14 at 1322 hours, during an interview, MD M stated she performed nerve block anesthesia services for the patients in the 6G unit. MD M stated she evaluated the patient after the block and when satisfied of the nerve block's effectiveness, she left the room. MD M stated she provided and educated the patient regarding the nerve block and gave aftercare information at the same time the patient signed the consent for nerve block. MD M stated there was no evaluation upon patient's discharge.


21177


2. The medical record for Patient 79 was reviewed on 3/7/14. The patient had a closed reduction with pertacuneous pinning of the right middle finger done on 2/7/14 at 1140 hours, in the 6G unit.

The patient received a peripheral nerve block by an anesthesiologist at 1034 hours. RN F monitored and assessed patient from 1001 hours to 1228 hours. The patient was escorted to the Orthopedic Evaluation and Treatment Clinic by a volunteer at 1228 hours. There was no post-anesthesia evaluation completed and documented by an anesthesiologist for the patient.

3. The medical record for Patient 80 was reviewed on 3/7/14. Patient 80 had a closed reduction and percutaneous pinning of the right wrist done on 2/14/14, in the 6G unit. The anesthesiologist performed a local nerve block at 1134 hours. RN F monitored and assessed the patient from 1134 hours to 1405 hours, when the patient was escorted to the Orthopedic Evaluation and Treatment Clinic by a volunteer. There was no post-anesthesia evaluation completed and documented by an anesthesiologist for the patient.

4. The medical record for Patient 81 was reviewed on 3/7/14. Patient 81 had the debridement and irrigation with possible incision/drainage of the wound and wound vacuum change of the right hand done on 2/14/14, in the 6G unit. An anesthesiologist performed the peripheral nerve block at 1419 hours on 2/14/14. RN F monitored and assessed Patient 81 from 1519 hours to 1605 hours, when the patient was escorted back to a medical surgical unit. There was no post-anesthesia evaluation completed and documented by an anesthesiologist for the patient.


25720


5. The medical record for Patient 15 was reviewed on 3/7/14. The patient had a procedure performed on 2/21/14, in the 6G unit to manipulate a fractured left index finger into place and secure with the bone alignment with wires.

Review of the Peripheral Nerve Blockade procedure note form showed a anterior axillary nerve block was performed by the anesthesiologist at 1051 hours. Under the area to document the "success" of the block, the anesthesiologist checked the box "a full evaluation is pending."

The surgical procedure concluded at 1215 hours. There was no documentation found to show follow-up of the patient's condition by the anesthesiologist after the procedure.


20059


6. Review of Patient 63's medical record on 3/7/14, showed a surgical procedure was performed on 2/25/14, in the 6G unit. Patient 63 had a right wrist carpal tunnel release. There was no documentation of a post-anesthesia assessment by the anesthesiologist.

7. Review of Patient 67's medical record on 3/7/14, showed a surgical procedure was performed on 2/26/14, in the 6G unit. Documentation showed the procedure was a right internal fixation and pinning of the wrist. There was no documentation of a post-anesthesia assessment by the anesthesiologist.


26881


8. Patient 71 came to the hospital on 2/19/14, for a procedure on his fractured right hand in the 6G unit. The procedure note indicated that the operative site was anesthetized with a regional block per anesthesiology. There was a Peripheral Nerve Blockade Procedure Note dated 2/19/14.

The patient was discharged after the procedure. However, no post-anesthesia evaluation or follow-up was seen in the record.


29558


9. Review of Patient 74's medical record was initiated on 3/7/14. The patient went to hospital for a procedure on 2/19/14 as an outpatient in the 6G unit.

Review of the Procedure-Hand Services Note dated 2/19/14 at 1440 hours, showed a hand surgery was performed on Patient 74 in the 6G unit. The patient's "right hand (small finger) operative site was anesthetized with regional block by anesthesia."

Further review failed to show documented evidence a post-anesthesia evaluation was completed and documented.

An interview and medical record review was conducted with RN O on 3/7/14 at 1005 hours. When asked, the RN was unable to locate the missing document. The RN stated she would look for the above missing documentation.

On 3/7/14 at 1715 hours, at the exit of the survey, no further documentation was provided.

Based on interview and record review, the hospital failed to ensure the patients or their representatives had evidence of the right to consent to basic procedures and care during their hospital stay for three of 82 sampled patients (Patients 60, 61 and 74). This failure had the potential to result in the hospital treating patients without documentation of the patient/responsible party's consent (to avoid claims for battery) and result in the lack of documentation of financial responsibility for payment of services rendered.

Findings:

The hospital's P&P #205 titled Consent for Care, effective 9/11/12, was reviewed on 3/7/14. The policy section read in part, "Medical treatment shall not be permitted unless the adult patient, or a person legally authorized to act on his or her behalf, has given permission and signed the appropriate consent form at the point of service....In most cases, a child's parent(s) or legal guardian provides consent for medical treatment of a minor."

Also reviewed on 3/7/14, was the hospital's P&P #703 titled Admission to LAC+USC Medical Center Facilities, effective 10/16/08. The procedure section read in part, "All patients seen in the Medical Center facilities shall: Sign a general consent for treatment. At each inpatient admission..."

1. The medical record for Patient 60 was reviewed on 3/5/14. The patient was an infant born in the hospital. The infant had a four day stay after birth due to hyperbilirubinemia (a condition requiring light therapy); however, the infant's mother was discharged 2 days earlier.

No signed Conditions of Admission (COA) form was found in the medical record for Patient 60 as verified during interview with the Interim HIM Director. The Director stated the hospital's practice was not to have the mother sign a separate form for their infant(s) and she thought that infants were covered by the COA the mother signed.

However, there was no "Maternity Patients" clause included in the COA form HS62A (2-13), which would state the mother/legal representative's signed form will cover any baby born during hospitalization.

2. Record 61 was reviewed on 3/6/14. The COA was signed by someone other than the patient (determined by comparing the patient's legible signature on another consent form). The relationship of this person to the patient and the printed name were not documented. This finding was confirmed by Interim HIM Director.


29558


3. The hospital policy title Patient Rights, effective 9/23/08, read in part, "The Network's patients have rights to: ...Receive information about their health status, course of treatment, and prospects for recovery in terms they can understand." and "Make decisions regarding medical care and receive as much information concerning any proposed treatment or procedure, as they may need in order to give informed consent or to refuse a course of treatment."

The hospital P&P titled Consents/Witnessing Signatures, effective date 12/13, showed legal authorization must be obtained from the patient or the patient's authorized representatives prior to performing treatment, specialty procedures or an operation. The consent is a legal document and should be dated signed and witnessed. The Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures (form #231) consisted of an explanation to the patient of the nature of the treatment, the risk, complications and alternative treatments, The Physician of the Record shall be responsible for obtaining informed consent on all patients undergoing an operation, invasive procedure or interventional X-rays. Both the professional and "lay" description of the procedure are required.

Review of Patient 74's medical record was initiated on 3/7/14. The patient went to hospital for a surgical procedure on 2/19/14, as an outpatient.

Review of the Informed Consent for Anesthesia and Anesthesia-Related Services signed by Patient 74 on 2/19/14 at 0934 hours, showed "anesthesia service(s) explained to patient or guardian and question were answered." A box was checked for general anesthesia.

However, review of the Procedure-Hand Services Note dated 2/19/14 at 1440 hours, showed a regional block, not general anesthesia was used for the surgical procedure performed on Patient 74 on 2/19/14.

Based on interview and record review, the hospital failed to ensure two of 82 sampled patients (Patients 11 and 76) had the right to formulate the advance directives. This posed the potential for the patients and/or the patient's family members not being allowed to make medical care decisions.

Findings:

Review of the hospital's P&P titled Advance Directives, revised 3/5/14, showed adults who present for hospital admission shall be informed in writing that one method by which they may exercise their right to make health care decision is through the use of an advance health care directive. They shall also be asked whether or not they have executed a written advance directive, if so, to make a copy available for the medical record.

1. Review of Patient 11's medical record was initiated on 3/3/14. Patient 11 was admitted to the hospital on 2/28/14.

Review of the Emergency Medical Treatment Conditions of Admission showed the section of Advance Directive was left blank.

During an interview and medical record review with RN H, the Nurse Manager of Burn Unit and the Clinical Nursing Director of ICU on 3/3/14 at 1325 hours, they confirmed the finding.


22553


2. Patient 76 was interviewed on 3/4/14 at 0920 hours. The patient stated he was not given information about an advanced directive.

Review of Patient 76's medical record showed the Conditions of Admission/Clinic Visit documentation for an Advance Directive had the area to check yes/no/unknown for the patient were left blank.

Based on observation, interview and record review, the hospital failed to ensure nursing services were provided for six of 82 sampled patients (Patients 10, 23, 47, 50, 53 and 70) as evidenced by:

1. The RN failed to closely monitor Patient 23 after the administration of Duramorth (narcotic analgesic).

2. There was a delay in the staging of Patient 47's pressure ulcer by the wound care nurse and the nurses as required by the hospital's P&P.

3. The RN failed to evaluate Patient 70 for safety prior to the CNA removing the patient's restraints, resulting in the patient traumatically removing his urinary drainage catheter.

4. The RN failed to reassess Patient 10, a pediatric patient for a decreased heart rate.

5. There was no documented evidence to show the left buttock pressure ulcer was measured when Patient 50 transferred to the medical unit on 3/4/14 at 1608 hours. There was no documented evidence to show the patient's right and left buttocks pressure ulcers were measured and described on 3/5/15 at 0823 hours. In addition, Patient 50's pressure ulcer sites and heels were not offloaded to relieve pressure of the wound sites to promote wound healing and prevent from further pressure ulcer development.

6. The RN failed to conduct and document the initial nursing assessment, failed to ensure the laboratory tests were obtained as ordered and failed to ensure the wound assessment was completely assessed for Patient 53.

These failures created the increased risk of poor health outcomes to the patients receiving services in the hospital.

Findings:

1. During a tour of the Post-partum unit on 3/4/14 at 1050 hours, Patient 23's medical record was reviewed with the patient's primary nurse, RN A and the Nurse Manger of the LDR unit. RN A stated Patient 23 delivered her infant by C (cesarean)-section (surgical delivery of the infant via an incision into the abdomen and uterus) at 2141 hours on 3/3/14 .

When RN A was asked about the medication Patient 23 received for pain relief following the surgery, the RN stated the physician ordered Percocet (a strong oral opiate narcotic) and IV push Morphine for breakthrough pain (strong opiate narcotic). When asked if epidural Duramorph was used for pain relief post C-section at this hospital, the RN stated, no it was not. (Duramorph is a preservative free form of morphine injected into the epidural space [the space around the dura mater of the spinal cord] for pain management following the delivery of the infant).

Review of Patient 23's anesthesia record completed by the anesthesiologist for the C-section with the Nurse Manager of LDR showed the patient received 5 mg Duramorph on 3/3/14 at 2200 hours, via the epidural catheter. When asked, the Nurse Manager was unable to locate the orders by the anesthesiologist or the obstetrician for increased monitoring of the patient after the administration of Duramorph.

RN A stated she was unaware Patient 23 received Duramorph after her C-section. RN A stated Patient 23 so far received two Percocets for pain at 0114 hours, and one tablet of Percocet at 0830 hours, following the C-section.

When asked, RN A stated she had not received training regarding the care of patients who received Duramorph. When asked RN A stated she "thought respiratory depression" was a side effect of the medication; however, the RN stated she was unsure of the length of the effects of the medication. The RN stated she assessed Patient 23 every four hours, the patient was not monitored any more frequently than any C-section. Monitoring included measurement of the patient's vital signs, including respirations and a measurement of oxygen saturation (oxygen saturation is a measure of how much oxygen the blood is carrying as a percentage of the maximum it could carry).

RN G was interviewed on 3/5/14 at 0925 hours. The RN stated she was assigned to care for Patient 23 that day. The RN confirmed the patient was monitored no more frequently than every four fours.

The Pharmacy Services Supervisor was interviewed on 3/6/14 at 1340 hours. The Duramorph manufacturer's package insert was reviewed and showed the following:

*Parenteral (IM or IV) administration of narcotics in patient receiving epidural morphine (Duramorph) may result in overdose.

* The most serious adverse reaction encountered during administration of Duramorph is respiratory depression and/or respiratory arrest (decreased breathing rate/cessation of breathing) and could require intervention.

* Duramorph should be administered only in settings where adequate patient monitoring is possible. Resuscitative equipment and a specific antagonist (Narcan) should be immediately available for the management of respiratory depression as well as complications. Patient monitoring should be continued for at least 24 hours since delayed respiratory depression may occur.


26756


2. In February, 2007, the NPUAP (The National Pressure Ulcer Advisory Panel) defined a pressure ulcer as a localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction.

In 2007, the NPUAP defined:

A Stage I pressure ulcer: intact skin with non-blanchable redness of a localized area usually over a bony prominence.
A Stage II pressure ulcer: a partial thickness skin loss presenting as a shallow open ulcer with a red pink wound bed, without slough (dead tissue).
Unstageable pressure ulcer: a full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed. Until enough slough and/or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined.

Review of the hospital's P&P titled Pressure Ulcer Prevention and Management undated, showed to consult the WOCN)or designee whenever a patient:

* Develops a hospital acquired pressure ulcer.
* Is admitted with pressure ulcer (s).
* Needs specialized pressure ulcer evaluation.
* Note: If the WOCN or designee is not available, two unit nurses will verify stage of pressure ulcer.

The WOCN or designee will prioritize consults as follows: hospital acquired pressure ulcers (III, IV, Unstageable and suspected deep tissue injury) will be seen first and then all other hospital acquired stages.

Medical record review for Patient 47 was initiated on 3/4/14, and showed the patient was admitted to the hospital on 12/21/13.

Observation of Patient 47 on 3/4/14 at 1040 hours, showed the patient was lying in bed. The patient was alert and able to make her needs known. Patient 47 stated she was able to use the side rails to assist her with repositioning of her body.

Review of Patient 47's Single Assessment form dated 12/22/13, showed documentation the patient was identified with a skin risk of 17, indicating a mild risk. There were no identified skin breakdown issues documented on the initial nursing assessment.

Review of Patient 47's Wound, Ostomy Continence Consult dated 2/13/14, showed the WOCN saw the patient. She was awake and alert, had surgery for a left below the knee amputation on 2/10/14, and required maximum assistance with repositioning.

Review of Patient 47's physician's orders dated 2/19/14, showed an order for a referral to the wound care consult for a sacral pressure ulcer.

Review of an Order Management Form dated 2/20/14 to 2/21/14, showed an order was sent electronically on 2/19/14 at 1415 hours, for wound consult for Patient 47 due to skin excoriation (skin-pinking).

Review of a the Single Assessment Wound, Ostomy, Continence Consult Note dated 2/24/14, (five days after the physician's order) showed currently Patient 47 had a large area of denuded skin on either side of natal folds (intergluteal cleft), measuring 7 cm (length) x 6 cm (width) in size. The left side the wound bed was red and moist with irregular edges. On the left side there was a necrotic (dead tissue) area, measuring 5 cm x 1 cm in size, surrounded by adherent slough (a layer of dead tissue) and dermal tissue. There was no documentation to show the WOCN staged Patient 47's pressure ulce

Based on observation, interview and record review, the hospital failed to ensure the plan of care developed for eight of 82 sampled patients (Patients 10, 47, 48, 49, 50, 52, 53 and 70) met patient specific needs. A lack of comprehensive care plan development may result in interventions not developed which could further compromise the patients' medical status.

Findings:

1. Medical record review for Patient 47 was initiated on 3/4/14. Patient 47 was admitted to the hospital on 12/21/13.

Review of the Single Assessment dated 12/22/13, documented Patient 47 was identified at "mild risk" for skin breakdown. No identified skin breakdown issues were documented on the initial nursing assessment.

Review of Patient 47's Single Assessment Wound, Ostomy, Continence Consult Note dated 2/28/14, showed Patient 47 had a large area of denuded skin on either side of natal folds (intergluteal cleft), measuring 7 cm x 6 cm in size. On the left side there was a necrotic area, measuring 5 cm x 1 cm in size, surrounded by adherent slough and dermal tissue. However, on the left side the wound bed was red, moist and was assessed as an "Unstageable area" (full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed. Until enough slough and/or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined), measuring 5 cm x 3 cm, with 30% black-tan necrotic tissue and the rest was adherent yellow slough.

On 3/5/14, review of the Interdisciplinary Patient Care Plan for Patient 47 showed a care plan was developed to address the actual/potential for impaired skin integrity related to open wound. The desired outcome was for wound healing improvement, skin integrity maintained and for the patient to verbalize/demonstrate understanding of the management of the skin problem. Interventions included to assess and document the skin's condition, reposition, wound/skin care, pressure reduction/relief devices, and instruct patient/care giver on importance of nutrition, mobility, implement clinical protocol for pressure ulcer prevention, wound management, and intravenous therapy.

There was no documentation in Patient 47's care plan to show specific interventions were developed to address the identified pressure ulcers on the buttocks and intergluteal cleft prior to or after the discovery of the breakdown.

During an interview on 3/4/14 at 1400 hours with WOCN 1, she stated Patient 47 developed the buttock pressure ulcers due to friction and shear associated with diarrhea. The WOCN confirmed nursing staff should have updated the care plan when the pressure ulcers were identified.

The above findings were confirmed at the time of medical record review during interviews with the WOCN 1 and with the RN Manager of Medical Surgical Unit.

2. Medical record review for Patient 70 was initiated on 3/4/14. Patient 70 was admitted to the hospital on 3/1/14.

Review of the Single Assessment dated 3/1/14, documented an initial assessment for the use of restraints for Patient 70. The patient was assessed as failing to follow directions that could result in a potential for a compromise in his safety. Patient 70 was attempted to pull out lines, tubes or other treatment devices and exhibited aggressive violent behaviors. Close monitoring, verbal de-escalation, limit setting and medication administration were considered.

Review of a physician's order dated 3/1/14, showed a restraint order to place soft restraints bilaterally to Patient 70's wrists. Verbal de-escalation and close continuous monitoring were attempted prior to the application of restraints.

Review of Patient 70's Interdisciplinary Patient Care Plan reviewed on 3/5/14, showed the care plan was developed to address the safety/restraints for potential of serious or life-threatening injury related to the patient's lack of understanding. The desired outcome was for the patient not to sustain an injury during the hospital stay. Interventions included to implement the following protocols: restraints non-behavioral for agitated and/or confused patients.

No documentation was found in Patient 70's care plan to show specific interventions were developed for the use of restraints. The care plan did not specify the type of restraint applied, individualized nursing interventions and goals developed for restraint discontinuation.

During an interview with RN 1 Manager of the Medical-Surgical Unit on 3/4/14 at 0820 hours, she stated restraints interventions and assessments were developed by the patient's nurse and were documented on the Single Assessment electronic forms; however, the patient's care plans were done on the paper records. Patient 70's care plan did not reflect specific interventions to meet the patient's care needs.

3. Medical record review for Patient 49 was initiated on 3/4/14. Patient 49 was admitted to the hospital on 3/28/14, with a diagnosis of intracerebral hemorrhage (when a blood vessel bursts into brain tissue, stroke-like symptoms usually appear including confusion, weakness, and paralysis, particularly on one side of the body).

On 3/4/14 at 0815 hours, observation of Patient 49 showed the patient lying quietly in the bed with his eyes closed. Four point restraints to all the patient's extremities (legs and arms) were attached to the bed and a cloth vest was secured his upper body to the bed. In addition, the patient had a cervical collar, an indwelling urinary catheter and an IV line in place to his right arm used for infusion of medications. The patient's room was the last room down the hallway away from the nursing station. CNA 1 was Patient 49's sitter (companion) in the room and was at his bedside. CNA 1 stated the patient was non-English speaking.

Review of a physician's order dated 3/4/14 at 0800 hours, showed a restraint order to apply soft restraints to all extremities and a vest restraint. The physician documented the behavior necessitating restraints was due to the patient attempting to pull out lines, tubes and other treatments and he was unable to follow directions and attempted to ambulate independently but was unable to. Verbal de-escalation, contracting, limit setting, divisional activities and close and continuous monitoring were the alternative methods attempted prior to the application of restraints.

On 3/5/14, review of Patient 49's Interdisciplinary Patient Care Plan showed the care plan was developed to address the safety/restraints for potential of serious or life-threatening injury related to the patient's lack of understanding. The desired outcome was for the patient not to sustain injury during the hospital stay. The interventions developed included to implement the restraints and non-behavioral protocol.

No documentation was found in the care plan to show specific interventions were developed for the use of restraints for Patient 49. The care plan did not specify the type of restraints applied to the patient with individualized nursing interventions and goals for restraint discontinuation.

4. Medical record review for Patient 48 was initiated on 3/4/14. Patient 48 was admitted to the hospital on 2/6/14.

On 3/4/14 at 1450 hours, Patient 48 was observed lying quietly in bed with his eyes closed. Patient 48 had bilateral wrist restraints attached to the bed, a cloth vest securing his upper body to the bed and a hand mitten (a restraint designed to restrict hand movement) applied to his right hand. A nasogastric tube (tube inserted into the nares to the stomach) for liquid feeding, an IV line and an indwelling urinary catheter were in place. In addition, a sitter was in the room at the bedside.

During an interview with RN Y on 3/4/14 at 1430 hours, RN Y state Patient 48's restraints were in place to keep the patient from removing the nasogastric tube.

On 3/5/14, review of Patient 48's Interdisciplinary Patient Care Plan showed a care plan was developed to address the safety/restraints for potential of serious or life-threatening injury related to the patient's lack of understanding. The desired ou

Based on observation, interview and record review, the hospital failed to ensure nursing staff received the training, education, experience and competence to care for patients to whom they were assigned as evidenced by:

1. The RN assigned to care for patients undergoing surgical procedures and regional anesthesia in the 6G unit worked independently providing patient care for pre-operative, intra-operative and recovery patients in the unit. The RN did not have the training for activities associated with assisting in anesthetic or surgical procedures.

2. The RNs in the obstetrical area did not have the training or competency to care for patients who received an epidural injection of a narcotic by the anesthesiologist for pain management post-operatively.

These failures to provide the necessary education and competency for the care of the patients to whom they were assigned had the potential for poor outcomes to the patients receiving services in the hospital.

Findings:

1. The AORN Definition of a Circulating Nurse showed the circulating nurse's duties in the OR are performed outside the sterile field. The circulating nurse is responsible for managing all nursing care within the OR, observing the surgical team from a broad perspective and assisting the team to create and maintain a safe, comfortable environment for the patient's surgery.

The Department of Anesthesiology Guidelines for Performance for Peripheral Nerve Blocks (undated) read in part, "Responsibilities of PACU nurses or ambulatory unit nurses: All nurses with the ambulatory surgery unit and PACU will be in-serviced prior to participating the in the care of patients receiving peripheral nerve catheters...Assure that no nerve block is performed without the continuous presence of an attending anesthesiologist ....May assist/monitor anesthesiologist during performance of the block....Attach cardiac monitor, pulse oximeter, BP and supplemental oxygen by green mask....Help position the patient for the nerve block....Record vital signs during and after procedure...Open supplies as requested by the anesthesiologist."

On 3/5/14 at 1520 hours, RN F was observed functioning as the circulating RN in the 6G unit. The RN also monitored the patients' vital signs during this time. During the observation RN F stepped out the room to get supplies from another area.

On 3/5 and 3/6/14, RN F was interviewed. RN F stated the 6G Unit provided minor orthopedic procedures for inpatients and outpatients. RN F stated the surgeries performed included carpal tunnel release (a surgery to treat carpal tunnel syndrome, pain and weakness in the hand caused by pressure on a nerve in the wrist) and skin grafts (a patch of skin that is removed by surgery from one area of the body and transplanted, or attached, to another area.).

RN F was the only nurse assigned to 6G. RN F stated she worked independently providing patient care for pre-operative, intra-operative and recovery patients in the unit. RN F monitored patients who received regional anesthesia without a licensed anesthesia provider onsite during and post procedures.

RN F stated the procedures were done on a patient need basis and were not scheduled. The RN stated some patients' procedures required a nerve block by anesthesia providers. The anesthesia providers placed the nerve block and left the patient after completing the injection and when they were satisfied with the block. RN F stated the anesthesia providers did not reassess the patients after the procedures or prior to discharge.

RN F stated she cleaned the dirty instruments and packaged small instruments for sterilization. RN F sent all surgical instruments and trays to central processing for sterilization.

RN F stated she did not have formal training or experience in surgical services. RN F also stated she did not have formal training for OR, perianethesia unit (pre op and PACU) or instrument care. RN F stated that she received preceptorship for her role when she started in 2008. RN F stated that among her duties were preparing the patient for anesthetic blocks. RN F stated only patients with ASA classification I or II were operated on in the 6G unit. The RN stated she assigned ASA classifications to the patients.

RN F stated she logged patients' procedures on a piece of paper. RN F stated she used the Moderate Sedation documentation form to record the patient's vital signs and the procedure because it allowed documentation of frequent vital signs.

Review of RN F's personnel file on 3/7/14, showed RN F's job description and competencies were for a medical-surgical staff nurse position. RN F's job duties included nursing assessment, planning, implementation, evaluation and administrative/ancillary for nursing service. The most recent evaluation was documented on 5/2/13, with a supervisor's signature. RN F had a Basic Life Support certificate for CPR. The job description document did not show a set of specific competencies related to the care that was provided for the patients in 6G. There was no special training documented for activities associated with assisting in anesthetic or surgical procedures. There was no training, for example, in proper patient positioning or surgical instrument decontamination.

The Assistant Nursing Director Med-Surg was interviewed on 3/6/14 at 1450 hours. The Nursing Director she had responsibility for the 6G unit. The Nursing Director stated the nursing competency utilized for RN F was that of a medical-surgical staff nurse providing basic inpatient care with some training in providing a sterile field as would be required for placing a central line at the bedside.

During the interview the Assistant Nursing Director Med-Surg she stated she also did not have training nor experience in surgical services.
Medical record review on 3/7/14, for four patients who received services in 6G (Patients 32, 79, 80 and 81) also received peripheral nerve blocks. RN F assessed, monitored and discharged these patients from 6G. Documentation showed RN F assisted during the procedures and processed the instruments and supplies.



25720


2. During a tour of the Post-partum unit on 3/4/14 at 1050 hours, Patient 23's medical record was reviewed with the patient's primary nurse, RN A and the Nurse Manger of the LDR unit. RN A stated Patient 23 delivered her infant by C-section at 2141 hours on 3/3/14.

When RN A was asked the medication Patient 23 received for pain relief following the surgery, the RN stated the physician ordered Percocet and IV push Morphine for breakthrough pain. When asked if Duramorph was used for pain relief post C-section at this hospital, the RN stated, no it was not. (Duramorph is a preservative free form of morphine injected into the epidural space [the space around the dura mater of the spinal cord] for pain management following the delivery of the infant).

Review of Patient 23's anesthesia record completed by the anesthesiologist for the C-section with the Nurse Manager of LDR showed the patient received 5 mg Duramorph on 3/3/14 at 2200 hours via the epidural catheter. When asked, the Nurse Manager was unable to locate orders by the anesthesiologist or the obstetrician for increased monitoring of the patient after the administration of Duramorph.

RN A stated she was unaware Patient 23 received Duramorph after her C-section. RN A stated Patient 23 so far received two Percocets for pain at 0114 hours and one tablet of Percocet at 0830 hours, following the C-section.

When asked, RN A stated she had not received training regarding the care of patients who received Duramorph. When asked RN A stated she "thought respiratory depression" was a side effect of the Duramorph; however, the RN stated she was unsure of the length of the effects of the medication. The RN stated she assessed Patient 23 every four hours, the patient was not monitored any more frequently than any C-section. Monitoring included measurement of the patient's vital signs, including respirations and a measurement of oxygen saturation.

The Assistant Director of Nursing for Women's Services was interviewed on 3/5/14 at 0915 hours. The Assistant Director stated the

Based on interview and record review, the hospital failed to ensure medications were prepared and administered to three of 82 sampled patients (Patients 28, 30 and 68) as ordered by the physician as evidenced by:

1. Patient 68 did not receive the first dose of one medication within two hours of the time the medication was ordered as outlined in the hospital's P&P.

2. The MAR for Patient 30 did not match the physician's order for an IV antibiotic, resulting in the potential for a medication administration error.


3. A pain medication was not administered to Patient 28 in accordance with the physician's order.

These failures created the risk of poor health outcomes to those patients.

Findings:

1. Review of the hospital's P&P entitled: "Medication Administration System" dated 12/13, showed on page 3: "Timely Dispensing Of Medication (Medication turnaround time) Medication turnaround time is defined as the time at which an order is prescribed to the time when the medication is administered to the patient, or available for administration, as defined in the standards below: Routine Order: The turnaround time for the first dose of a routine order is 120 minutes and is defined from when the medication order is written to when it is available for administration ...."

Review of the medical record for Patient 68 on 3/5/14 at 0920 hours revealed patient's physician wrote an order on 3/4/14 at 0900 hours, for the patient to have: "Amphojel (an antacid medication) 60 milliliters three times a day with meals."

Nursing documentation in Patient 68's record showed the order was received by nursing at 1100 hours on 3/4/14. The next meal was served at 1130 hours on 3/4/14; however, the Amphojel was not administered to the patient at this time by nursing.

The first dose of Amphojel was not administered to the patient until 1730 hours on 3/4/14 (eight and ½ hours after the medication was ordered by the patient's physician). The medication was available in the hospital's ADC for immediate administration.

During an interview with RN P on 3/5/14 at 0920 hours, RN P verified the patient's medication nurse on 3/4/14, did not document in the patient's record why the patient's Amphojel was not administered with the lunch meal, as ordered by the patient's physician on 3/4/14.


32097


2. On 3/4/14, review of the hospital's P&P titled Medication Adminstration Record (MAR) dated 03/08, indicated under responsibility: "The night shift RN will
review the new MAR against the Nursing Kardex ....Compare with the physician's order and make corrections on the MAR as necessary, if there is any discrepancy .....Report any discrepancies on the MAR discrepancy report ....Fax to the pharmacy by 0600 ...
RN reviews the MAR against Kardex at the beginning of each shift. If a medication discrepancy is found on the MAR at any time throughout the day, the RN notifies Pharmacy immediately and faxes the MAR Discrepancy Report."

On 3/4/14, review of the hospital's P&P titled Medication Administration System dated 12/13, indicated under administration: "The licensed nurse shall:... Ensure the MAR/medication ticket matches the Kardex and the physician's orders."

Review of Patient 30's medical record was conducted on 3/4/14, beginning at 1320 hours. Patient 30 was admitted to the hospital on 2/26/14, for drainage and biopsy. An order for ceftriaxone (antibiotic) 2 gm IV every 12 hours was initially written on admission. The ceftriaxone order was later changed to 2 gm IV daily on 3/2/14 at 1950 hours.

Reconciliation of Patient 30's MAR with the physician's order showed the ceftriaxone 2 gm daily physician's order was different from ceftriaxone 2 gm every 12 hours on the MAR on 3/3/14 and 3/4/14. The frequency on 3/3/14's MAR was crossed out and changed to daily; however, the frequency on 3/4/14's MAR was not changed.

RN 1 reviewed Patient 30's medical record and acknowledged the discrepancy. RN 1 indicated she expected the medication order on the MAR to correspond to the physician's medication order. The RN stated expected nursing to notify the pharmacy when there was any discrepancy between the MAR and the physician's order.

During an interview with Pharmacy Services Supervisor II on 3/6/14 at 0900 hours, she also acknowledged the discrepancy.



25281


3. Review of the hospital's P&P titled Medication Administration System indicated "The nurse administering the medications is responsible for the accuracy of administration and documentation. The licensed nurse shall comply with the five (5) rights ...Right medication."

Review of the hospital's P&P titled Automatic Stop Orders indicated "Narcotics Analgesic: Twenty-four (24) hours unless the physician specifies the duration."

Review of Patient 28's medical record showed on the Admission order and Medication Reconciliation form dated 2/9/14, the physician documented to continue home medications, Norco 5/325 mg (narcotic) by mouth every 6 hours as needed for a pain level between seven and 10 (on a scale of 0 to 10 with 0 being no pain and 10 being worst pain imaginable) and Tramadol 50 mg (a synthetic narcotic) by mouth every 6 hours as needed for a pain level between three and six.

There was also a physician's order on Patient 28's MAR for acetaminophen 650 mg by mouth every 4 hours as needed for mild pain between 1 and 3 or a temperature above 100.1 degrees (F and to call the doctor.

Review of Patient 28's MAR indicated Norco, as a narcotic analgesic would be stopped on 2/10/14, if not renewed by the physician.

Review of Patient 28's MAR for the days following 2/10/14, showed the Norco order was dropped off the MAR and there was no pain medication order to complement the patient's pain level between seven and 10.

Documentation on the back of the MAR showed on 2/24/14, Ultram 50 mg was administered to Patient 28 for pain level of nine out of 10.

Review of the Patient 28's medical record did not show the physician changed the Ultram medication order to administer for a pain level other than between three and six

During an interview on 3/7/14 at 1000 hours, MD Z3 indicated, by not having an active pain medication order for a pain level between seven and 10 there would be a possible delay in treatment. The MD expected pain medication orders to address all pain levels from one to 10.

During an interview on 3/7/14 at 1100 hours, MD Z1 stated the physicians made round daily and were readily available. The MD stated he would question the administering nurse for not contacting the physician for the patient's severe pain for which there was no medication order.

During an interview on 3/7/14 at 1130 hours, MD Y indicated even though the narcotic order might have dropped off due to the short stop order policy, it was a workable policy and house staff physicians were available 24 hours a day. MD Y confirmed the nurse should have contacted the physician.

During an interview on 3/7/14 at 1150 hours, RN A5 stated she would not have given Ultram to the patient and would instead call the physician.

Based on interview and record review, the hospital failed to ensure the medical records were completed and accurate for 10 of 82 sampled patients (Patients 7, 11, 12, 13, 35, 72, 73, 74, 75 and 76). This could lead to lack of knowledge in providing care to the patients.

Findings:

1. The Network Rules and Regulations, effective 5/10/05, read in part on page 21, "Records shall include identifying data, complaints, pertinent present and past history and the results of the physical examination."

Review of the medical record for Patient 7 on 3/3/14, showed Thyroid Evaluation was undated, but apparently was from a 2/26/14 visit during which the patient had a nuclear medicine treatment for a thyroid nodule. The Thyroid Evaluation consisted of a pre-printed sheet on which information was to be filled in to indicate the patient's signs and symptoms of a thyroid disorder.

However, the "Doctor's Physical" portion of the form was left blank except for a drawing of the thyroid. There was no documentation of the physician's examination of the patient's eyes, voice, hair or skin. The spaces for documentation of the characteristics, such as size, location, mobility of the thyroid nodule depicted in the drawing were left blank.

In an interview with MD U on 3/3/14 at 13:45 hours, the MD reviewed the Patient 7's Thyroid Evaluation. The MD stated he did not know why it was not completed.

In an interview with the nuclear medicine supervisor on 3/3/14 at 1350 hours, she concurred there was no date on the Thyroid Evaluation.

2. The Healthcare Network Rules and Regulations dated 5/10/05, read in part on page 21, "Every time an invasive procedure or operation is performed, a note must be made in the patient's chart immediately that documents: a) the patient's pre-procedure and post-procedure diagnosis. b) a description of the informed consent that was obtained. c) the details of the procedure that was performed. d) findings, specimens, prosthetics/implants. e) any complications. f) fluids administered, blood lost. g) participants in the procedure. h) the patient's condition at the conclusion of the procedure. i) type of Anesthesia. j) dictation Confirmation number for operative cases. The full details of the procedure may be dictated for transcription in addition to the immediate post-procedure notation.

The hospital's policy titled Health/Medical Record: Documentation, effective 11/12/13, read in part, "In accordance with statutory requirements for credentialed professionals, all entries documenting the patient care shall be signed by the individual with the category designation rendering care. To facilitate consistency and continuity in patient care, patient-specific information is provided to support timely, accurate, secure, and confidential recording as outlined in the Attending Staff Manual and regulatory standards."

The medical record for Patient 35 was reviewed on 3/5/14. A procedure note was dictated on 3/4/14 at 1529 hours, regarding a 3/4/14 lung biopsy that ended at 1200 hours. A handwritten procedure note was not found. Required information omitted from the dictated procedure note included the persons present in the room for the procedure.

The procedure note listed medications given to Patient 35, including lidocaine (a local pain reliever), morphine 4 mg (a narcotic pain reliever), and Zofran 4 mg (an anti-nausea medication). A section at the end of the note listed complications including pulmonary (lung) hemorrhage and hemoptysis (spitting out blood), after which the procedure was stopped, and "mild pain."

Review of the Nursing Day Surgery Record showed upon arrival in the PACU at 1200 hours, the patient complained of pain at a level 7 out of 10 (severe pain) which increased to 10/10 (severe pain) at 1300 hours. There was no handoff documented (transfer of information about the patient's condition from the surgical team to the PACU nurse). There was no progress note indicating the physician reassessed the patient post-operatively.

In an interview with MD N who participated in Patient 35's procedure on 3/5/14 at 0930 hours, he stated a radiology technician and the attending physician were in the procedure room. There was no nurse or anesthesiologist in the procedure. After the procedure, when the patient was in the PACU, he handed off the patient to the nurses and went to prepare the biopsy specimen for pathology, but was paged by the nurse and returned to the PACU where he reassessed the patient.

MD N stated he did not document the reassessment of Patient 35. MD N stated the morphine and Zofran documented on the procedure note were actually given in the PACU while the mild pain documented under "complications" represented the patient's mild discomfort as assessed during the procedure, not the pain noted in the PACU.

3. The hospital's P&P titled Patient Rights, effective 9/23/08, read in part, "The Network's patients have rights to: ...Receive information about their health status, course of treatment, and prospects for recovery in terms they can understand." and "Make decisions regarding medical care and receive as much information concerning any proposed treatment or procedure, as they may need in order to give informed consent or to refuse a course of treatment."

The hospital's P&P titled Consents/Witnessing Signatures, effective date 12/13, showed legal authorization must be obtained from the patient or the patient's authorized representatives prior to performing treatment, specialty procedures or an operation. The consent is a legal document and should be dated signed and witnessed. The Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures (form #231) consisted of an explanation to the patient of the nature of the treatment, the risk, complications and alternative treatments, The Physician of the Record shall be responsible for obtaining informed consent on all patients undergoing an operation, invasive procedure or interventional X-rays. Both the professional and "lay" description of the procedure are required.

a. Patient 12's medical record review was conducted on 3/6/14. Patient 12 had cystoscopy (a procedure in which a tube with a small camera is introduced into the bladder) on 3/3/14. The Authorization for Informed Consent to Surgery or Special Diagnostic Therapeutic Procedures was reviewed. The documentation on page 4 of 5 showed a space on the pre-printed form for documentation of Interpreter Services, for Interpreter used: yes/no, and second section, Blood Transfusion, the choice of Blood Transfusion Form Required: yes/no. Neither section was checked to indicate yes or no. On page 5 of 5, the documentation for Interpreter used yes/no was not completed.


b. Patient 76's medical record review was conducted on 3/6/14. Patient 76 had two surgical services on 3/4/14. The patient signed two consents, one consenting to the surgery of "Ankle open reduction and internal fixation of ankle fracture." On the consent for Authorization for Informed Consent to Surgery or Special Diagnostic Therapeutic Procedures, the documentation on page 5 of 5 for Interpreter used yes/no was not completed.

The second consent for the surgery "debridement and irrigation with possible incision/drainage of wound" also showed on page 5 of 5, for Interpreter used: yes/no was not completed.


c. On 3/4/14 at 1410 hours, Patient 13 was interviewed for pre-operative procedure. Patient 13 stated he was evaluated by an anesthesiologist in the Pre-operative area and was told spinal anesthesia was an option for his surgery. The patient accepted the option of spinal anesthesia and initialed the consent.

Review of the documentation for Informed Consent for Anesthesia and Anesthesia-related Services showed the date the consent was signed was 3/3/14 at 1620 hours (the previous day). The documentation showed the patient's initials on Spinal or Epidural Analgesia Anesthesia.

Further interview with MD D revealed the MD evaluated the patient on 3/4/14, and spinal anesthesia was discussed. The patient understood and agreed to have the spinal anesthesia for his surgery. MD D had the patient initial the section of Spinal or Epidural Anal

Based on observation, interview and record review, the hospital failed to ensure accurate records were kept of controlled substances and a system was developed for the tracking of these controlled drugs while they were stored on the Pediatric unit. In addition, the hospital failed to accurately account for and track movement of the controlled CSPs compounded in the Pharmacy IV Room from preparation to their disposition. These failures could lead to diversion of CSs not being detected timely.

Findings:

1. Inspection of the hospital's Pediatric unit Medication Room on 3/5/14 at 1500 hours, revealed a locked medication cabinet. Inside the cabinet was with a clip board with a single sheet of paper on top of it.

During an interview with RN Q on 3/5/14 at 1505 hours, the RN stated this locked medication cabinet was used by the nursing staff on the unit to store controlled drugs for patients who were going to be discharged from the unit. RN Q also indicated during the interview that the sheet of paper on the clipboard was the hospital's log for the controlled drugs stored inside this cabinet.

Review of the cabinet log on 3/5/14 at 1500 hours, showed one bottle (120 ml) of Tylenol with Codeine elixir, 12 mg per 5 ml should be present inside the locked storage cabinet; however, no bottle could be found. Review of the log also indicated the Tylenol with Codeine elixir bottle was present inside the medication cabinet on 2/28/14 at 0725 hours; however, according to the discharge summary Patient 69 was discharged from the hospital on 2/27/14 at 1630 hours.

During an interview with RN Q on 3/5/14 at 1515 hours, the RN indicated the controlled drug (Tylenol Elixir with Codeine) was sent home with the patient; however, there was no documentation in Patient 69's medical record to show the patient had indeed taken this medication home.

Review of Patient 69's "Instructions for the Medical Discharge of the Patient" on 3/7/14 at 1130 hours, revealed the Tylenol Elixir with Codeine was not documented on the patient's home instruction sheet.


25281


2. During an inspection of the hospital's CS Room on 3/7/14 at 1145 hours, two pharmacy compounded 200-ml IV bags containing Dilaudid 4 mg (narcotic pain medication) and Ropivacaine 400 mg (an anesthetic agent) were observed stored in the lockable cabinet drawer along with other unusable CS medications.

During a concurrent interview, PH 8 stated the IV bags were made in the Pharmacy IV Room and were kept in the CS Room until they were dispensed to the nursing units for patients or until they were expired after two days. The expired bags were then placed in the lockable cabinet drawer in the CS Room.

PH 8 indicated Dilaudid vials used to compound the bags were taken out of the C-II Safe located within the CS Room (an ADC utilized by the Pharmacy to store and keep track of the movement of all CS medications). PH 8 indicated the bags made from Dilaudid and Ropivacaine were recorded in the narcotic IV logs; however, there no log was kept to account for the bags used by the patients and the expired bags that were placed inside the lockable cabinet drawer.

During a concurrent interview, PH 8 indicated the key to the lockable cabinet drawer used to store expired CS medications was kept inside the CS Room accessible to all pharmacists with access to CS Room.

Review of the hospital's P&P titled Handling of Expired, Deteriorated, Discontinued, Recalled, or Otherwise Unwanted Drugs. Disposal of Materials Used in the Preparation of Dosage Forms and Drug Administration showed it was the only policy provided by the hospital related to CS disposition. The P&P did not delineate the procedure with respect to the accountability of controlled CSPs before they were pickup up by the outside vendor.

Based on observation, interview and record review, the hospital failed to ensure all drugs and biologicals were controlled and distributed by pharmacy services as evidenced by:

1. The storage and use of extra emergency drug supplies on the 6-D and Pediatric unit were not approved by the hospital's P&T Committee and/or the hospital's Code Committee.
2. The pharmacy did not have oversight of the use of the narcotic medication, Duramorph administered to patients by anesthesiologists following a C-section. This resulted in the potential for decreased respirations in patients due to the administration of additional narcotics ordered by the surgeon post-operatively. The pharmacist reviewing for the appropriateness of the ordered narcotics was unaware the patient received Duramorph.

3. Laboratory testing agents were not stored separately from the medications in the medication refrigerator in Jail ED.

4. Contrast agents used in the Cath Lab (Catheterization Laboratory) were not stored in a warmer in accordance with the manufacturer's recommendation.

5. Access of retired pharmacists to controlled substances stored in the pharmacy C-II Safe was not terminated.

6. First Aid medication boxes were locked by nurses at the psychiatric hospital campus instead of pharmacists as per P&P. Outdated medications were found in the First Aid Medication supply boxes.

These failures had the potential to cause patient harm from preventable medication errors.

Findings:

1. Review of the hospital's P&P titled Emergency Medications dated 3/1/13, showed: "The contents and the use of all emergency medication boxes must be approved by the Pharmacy and Therapeutics Committee."

a. During inspection of the hospital's 6-D unit Medication Room on 3/5/14 at 1400 hours, a second set of Emergency Drugs for the unit's Emergency Drug Crash Cart (for a Code Blue emergency), was observed stored in the hospital's Medication Room. The drugs were labeled as box 1 and box 2. Code Blues emergencies are conducted when a patient may not be breathing or may not have a pulse and the patient needs to be revived through the administration of medications and/or other means.

Interview with the hospital's DOP on 3/5/14 at 1405 hours, revealed these two boxes were not approved by the hospital's P&T Committee or the hospital's Code Committee for storage and use on the unit.

During the discussion with the hospital's DOP, he indicated the hospital's Code Committee, in conjunction with the hospital's Pharmacy and Therapeutics Committee would have been responsible for approving the storage and use of these Emergency Drugs on 6-D. The DOP was asked by the surveyor if he could review the hospital's P&T minutes and the Code Committee minutes to determine if either of these Committees approved the storage and use of these two Emergency Drug supplies on 6-D.

The DOP indicated on 3/7/14 at 1345 hours, he was unable to find in the both Committees minutes that storage of box 1 and box 2 was approved for storage and use in the hospital's 6-D Medication Room.

b. Inspection of the hospital's Pediatric unit Medication Room on 3/5/14 at 1445 hours, revealed an Emergency Drug supply which the hospital referred to as their "Extravasation Kit." This Extravasation Kit contained emergency drugs and supplies (such as Hydrocortisone, Sodium Bicarbonate, Sodium Thiosulfate, etc.), which would be used in the event a patient receiving Chemotherapy medications started to develop problems or complications resulting from the administration of Chemotherapy drugs.

During an interview with the hospital's DOP on 3/5/14 at 1450 hours, the DOP was asked to review the hospital's P&T minutes to determine if this Committee approved the storage and use of the Extravasation Kit on the Pediatric unit. The DOP confirmed the hospital's Pharmacy and Therapeutics Committee was responsible for approving the storage and use of this Extravasation Kit on the Pediatric unit.

On 3/7/14 at 1345 hours, the DOP stated he was unable to find in the P&T minutes where the storage and use of the Extravasation Kit was approved in the Pediatric unit Medication Room.


25720


2. During a tour of the Post-partum unit on 3/4/14 at 1050 hours, Patient 23's medical record was reviewed with the patient's primary nurse, RN A, and the Nurse Manger of the LDR unit. RN A stated Patient 23 delivered her infant by C-section at 2141 hours on 3/3/14.

When RN A was asked the medication Patient 23 received for pain relief following the surgery, the RN stated the physician ordered Percocet and IV push Morphine for breakthrough pain. When asked if Duramorph was used for pain relief post C-section at this hospital, the RN stated, no it was not. Duramorph is a preservative free form of morphine injected into the epidural space [the space around the dura mater of the spinal cord] by an anesthesiologist for pain management following the delivery of the infant.

Patient 23's anesthesia record for the C-section completed by the anesthesiologist was reviewed with the Nurse Manager of LDR. Documentation showed the patient received 5 mg of Duramorph on 3/3/14 at 2200 hours, via the epidural catheter. When asked, the Nurse Manager was unable to locate orders by the anesthesiologist or the obstetrician for increased monitoring of the patient after the administration of Duramorph.

RN A stated she was unaware Patient 23 received Duramorph after her C-section. RN A stated Patient 23 received two Percocet for pain at 0114 hours, and one tablet of Percocet at 0830 hours, during the 12 hours following the C-section.

The RN stated she was unsure of the length of the effects of the Duramorph. The RN stated she assessed Patient 23 every four hours, the patient was not monitored any more frequently than any C-section. Monitoring included measurement of the patient's vital signs, including respirations and a measurement of oxygen saturation.

The Assistant Director of Nursing for Women's Services was interviewed on 3/5/14 at 0915 hours. The Assistant Director stated the hospital did not have a P&P or a physician's protocol for the use of Duramorph for post-partum patients.

RN G was interviewed on 3/5/14 at 0925 hours. The RN stated she was assigned to care for Patient 23 that day. The RN confirmed the patient was monitored no more frequently than every four fours. When asked the treatment if the patient's respiratory rate decreased significantly. The RN stated the patient did not have orders for Narcan and she would have to call the physician for orders to administer the medication.

The Pharmacy Services Supervisor was interviewed on 3/6/14 at 1340 hours. The Duramorph manufacturer's package insert was reviewed and showed the following:

*Parenteral (IM or IV) administration of narcotics in patient receiving epidural morphine (Duramorph) may result in overdose.

* The most serious adverse reaction encountered during administration of Duramorph is respiratory depression and/or respiratory arrest (decreased breathing rate/cessation of breathing) and could require intervention.

* Duramorph should be administered only in settings where adequate patient monitoring is possible. Resuscitative equipment and a specific antagonist (Narcan) should be immediately available for the management of respiratory depression as well as complications. Patient monitoring should be continued for at least 24 hours since delayed respiratory depression may occur.

The Pharmacy Services Supervisor provided Pharmacy records showing 33 doses of Duramorph were dispensed from the ADC in LDR from 2/5-3/5/14. The Supervisor stated they knew epidural Duramorph was used by anesthesiologists for pain management following C-sections. The Supervisor stated the pharmacy refilled the ADC with the medication; however, the Supervisor stated the pharmacy was not involved in the use of Duramorph.

The Supervisor stated in her previous employment there were protocols for the use of Duramorph, such as physician's standing orders for the use of additional narcotics for break-through pain relief, the availability of Narcan to treat decreased respirations, and frequent monitoring of the patient for the fi

Based on observation, interview and record review, the hospital failed to ensure failed to ensure outdated drugs and biologicals were not available for patient use. This failure had the potential for patients to receive outdated drugs in an emergency situation.

Findings:

The hospital's P&P titled Handling of Expired, Deteriorated, Discontinued, Recalled, or Otherwise Unwanted Drugs; Disposal of Materials Used in the Preparation of Dosage Forms and Drug Administration indicated "All areas are required to remove drugs from the inventory that are: discontinued from patient use, overstocked, have been recalled by the manufacturer, expired, deteriorated, or deleted from formulary, RCRA agents (opened and unopened) are returned to the pharmacy ..."

1. During a tour of CCU on 3/4/14 at 1500 hours, a medication refrigerator was inspected. There was one 2.5-ml latanoprost (medication for glaucoma) 0.005% eye drop bottle for a patient that was dispensed by the pharmacy on 2/1/14, according to the label on the bottle.

During a concurrent interview, RN A 4 stated the patient was discharged on 2/27/14. The RN acknowledged the medication should not have been in the medication refrigerator.


32097


2. Review of the hospital's P&P titled Supplies and Equipment dated 2/12, indicated under First Aid/Non-Arrest Medication Box: "Maintenance of the First-Aid /Non-Arrest Medication box and Automatic external defibrillator is the responsibility of the nurse manager /designee on each unit ...Checked by an RN or LVN responsible for the maintenance at the beginning of each shift. She/he ensure the box remains locked (locked number verified on check Log), emergency drug box expiration date recorded on outside of box are not expired."

Review of the hospital's P&P titled Emergency Medications dated 01/01/11, indicated under procedure: "All emergency medication boxes are inspected and sealed by a designated pharmacist."

A tour of the Ward B medication storage areas at the psychiatric hospital campus was conducted on 3/5/14, beginning approximately 1120 hours, with Pharmacy Supervisor I, Clinical Nursing Director II and Assistant Nursing Director, Administration.

During inspection of the medication storage areas in Ward B, drugs with outdated expiration dates were noted recorded outside of the First Aid Medication supply box. Inspection of the contents of the First Aid medication supply box showed glucagon 1 mg (a drug that raises the blood sugar level) emergency kit had expired on 9/13, and a sterile water 10 ml bottle had expired on 5/12.

RN R, Pharmacy Supervisor I, Clinical Nursing Director II and Assistant Nursing Director/Administration witnessed and acknowledged the expired dates.


20059


3. On 3/6/14, during inspection of the Rehabilitation Service area, three plastic ultrasound gel bottles were observed in the general storage area. The bottles had a expiration date of 10/09, inscribed on each bottle.

Interview with the Physical Therapist 1 showed the bottles were used for ultrasound applications. Each bottle was refilled from a larger container of the ultrasound gel. The larger container of ultra sound gel was on the shelf with the three bottles of ultrasound gel. There was no expiration date on the larger container of ultrasound gel.

Based on observation, interview and record review, the hospital failed to ensure supplies and equipment were inspected timely and maintained to ensure safety in the LDR ORs, NICU, procedure room in a medical surgical unit and the psychiatric and post anesthesia care units. Failure to maintain patient care equipment had the potential for injury to patients.

Findings:

1. The LDR unit was toured with the Assistant Nursing Director of Women's Services and the LDR Nurse Manager on 3/4/14, beginning at 0840 hours. Two of the two ORs on the unit were inspected. The Nurse Manager stated the ORs were not in use at this time; however, they had been cleaned and were ready for surgery.

Portable de-humidifier machines were observed in each LDR OR, numbers 1 and 2. The machines were not on. When asked, the Nurse Manager opened the reservoirs at the bottom of each machine. There was standing water in each of the reservoirs.

The preventative maintenance label on each of the machines showed service was due 11/13. The Manager was unable to state the last time the machines were used to decrease humidity; however, the Manager stated there was a problem with too much humidity in the LDR ORs and the machines were used to decrease the humidity to the required levels for safety.

Review of the manufacturer's Owner's Manual for the portable de-humidifier machines used in the LDR ORs showed the following:

*To clean the grille and case use a mild detergent, do not use bleach or abrasives.

* The air intake and outlet grilles get soiled easily, so use a vacuum attachment or brush to clean.

* Every few weeks, clean the bucket.

* The air filter behind the grille should be checked and cleaned at least every 30 days.

Infection Control RN Practitioner 5 was interviewed on 3/5/14 at 0950 hours. When asked regarding the use of de-humidifiers in the LDR ORs 1 and 2, the RN stated she was aware of their use; however, she was not sure if there was a P&P for the care of the humidifiers.

The Infection Control Committee was interviewed in a meeting with the survey team on 3/6/14 at 0900 hours. The Committee consisted of nursing staff, physician's and EVS staff.

The Committee was asked about the process for selecting a new product for use in a surgical environment. Staff stated the product was reviewed in a Products and Equipment Standardization Committee. If approved and purchased, the manufacturer's recommendations were used to educate staff in the use of the product. Facilities Management checked the product for safety. A P&P for the use of the product would be developed and put into place and staff educated. The P&P would be approved by the GB.

The Committee members were asked if Infection Control staff monitored the OR temperature and humidity logs. Staff stated they monitored the logs; the Facilities staff notified Infection Control whenever the levels were out of range. "We make sure the LDR knows and they make the decision to move the case to the OR" or use the de-humidifiers to lower the humidity to a safe level. When asked, staff stated they were unaware of any C-sections done in the main OR in the past year.

The hospital's Facility Manager was interviewed on 3/6/14 at 1545 hours. The Manager confirmed the LDR OR dehumidifiers did not receive preventative maintenance as found in the owner's manual. The Manager stated Facilities staff had incorrectly described the OR dehumidifiers as "refrigerator portable" on the paperwork following their purchase. When annual preventative maintenance was due 10/13, the Facilities staff was unable to locate the machines. The work ticket was closed as "unable to locate."


21177


2. On 3/4/14 at 1402 hours, during a tour of the NICU, review of the green preventive maintenance stickers on five of the five electrical breast pumps used by the mothers of the patients indicated preventive maintenance was due in 2012.

On 3/5/14 at 1040 hours, during an interview, the hospital's Facility Manager stated the preventive maintenance should be done annually for patient equipment.


22553


3. On 3/5/14 at 1512 hours, during a tour of the 6G treatment room, a portable light in the storage room did not have a sticker to show the light was inspected by hospital for safety. In a concurrent interview with RN M, the RN stated the light was used for surgical procedures in the 6G treatment room.

On 3/7/14, the hospital provided a documentation showing when inspected, the light was missing ground pin on the plug and a missing ground wire. The engineer was unable to do the current leakage test.


26756


4. Review of the hospital's P&P titled Warming Cabinet and Fluids, revised 8/11, showed the use of the warming cabinet shall be in compliance with safety guidelines and temperature range, it shall be checked when used for the appropriate temperature settings. The temperature range must be between 90-120 degrees F.

Observation during tour on 3/3/14 at 0950 hours, of the LDR PACU showed a warming cabinet was in use. The temperature of the upper compartment of the cabinet showed it was 124 degrees F. Inside the upper compartment blankets were stored.
A sign posted on the cabinet's front door showed the "temperature not to exceed 120 F."
During a concurrent interview on 3/3/14 at 0955 hours, the Assistant Nursing Director of Women's Services confirmed the nursing staff failed to follow hospital procedures to keep the warming cabinet at the appropriate temperature.



20059


5. On 3/6/14 at 1410 hours, during a tour of the NICU three Emergency Bags were stored underneath a desk were inspected. Laboratory blood specimen tubes stored in bag 1 showed four of six purple top tubes and six of the six yellow top tubes had expiration dates of 10/13.

In bag 2, three of the six purple top tubes had an expiration date of 9/13. Six of the six yellow top tubes had an expiration date of 7/11.

On 3/6/14 at 1430 hours, during an interview with the NICU Nurse Manager she stated the Emergency Bags were used when staff transported the neonates to and from other hospitals. The Nurse Manager stated a process was not developed for maintenance and inventory checks of the supplies stored in the emergency bags.

6. During an inspection of a clean room on the psychiatric inpatient service, a phlebotomy tray with supplies to draw blood specimens was observed. 15 green top and 6 blue top vacutainer collection tubes had expiration dates of 9/13. In addition, exam gloves were loose in the tray and the roll of tape appeared soiled and dirty.

7. During a tour of the PACU on 3/4/14 at 1335 hours, a cart designated as an ECT cart was inspected. Unpackaged assorted/miscellaneous patient care equipment was loose in the drawers of the cart.

In first drawer of the cart were assorted rubber bands, paper clips, vacutainer tubes, and a box of Temp Dots (Temperature Probes) with an expiration date of 5/12. Electrodes used for the procedure were not in protective packaging. A used deodorant stick was also in the drawer.

The psychiatric charge nurse responsible for the ECT cart for psychiatry was interviewed. The Charge Nurse stated the last ECT was done in February 2014. The Charge Nurse stated a resource manual was in the fourth drawer of the ECT cart; however, when the fourth drawer of the cart was opened there was no resource manual.

The Charge Nurse verified there was no inventory list for each drawer of the ECT cart and no system was in place for routine care of the cart.

Based on observation, record review and interview, the hospital failed to ensure the IC officers developed, implemented and evaluated a system for controlling sources of infections in accordance with the hospital's P&P and nationally recognized infection control practices and guidelines as evidenced by:

- Surgeries were performed in the 6G unit which was a treatment room on an inpatient tower unit. There was no ongoing oversight of the types of patients and activities occurring and of the EVS cleaning of the 6G unit. The 6G unit was not cleaned between patients or at the end of the day per the hospital's P&P for the cleaning of an OR room.

- The 6G unit set-up did not allow staff to scrub hands in a semi-restricted area prior to the surgery; therefore, staff could easily enter the room without decontaminating their hands.

- The RN assisting with the surgeries, cleaning the room and the used instruments did not have surgical specific training. In addition, the Nurse Manager and Assistant Director Nursing overseeing the 6G room did not have surgical specific training.

- Staff performing cystoscopy procedures did not scrub hands prior to donning sterile gloves and wore clothing that was laundered outside the hospital.


- The padding and the cover of the foot rests used for positioning of patients for cystoscopy procedures were cracked. The table and the pads were dusty and dirty. The equipment was dusty on the surface.


- Observations in the main OR showed staff did not follow hand hygiene policies. In one OR room, bodily fluid spill was not cleaned in accordance per the hospital's P&P and nationally approved practices and guidelines.

- The endoscope reprocessing disinfectant was not validated in accordance with the manufacturer's guidelines.

- The glucometer (instrument to measure blood sugar) was not disinfected in accordance with the manufacturer's guidelines.

- No hospital P&P was provided to outline the cleaning of radiation protection garments.

- The cabinetry of central sterile supply decontamination sinks were not maintained in a manner that assured disinfection.

- Surgical instruments were not reprocessed or maintained in accordance with the hospital's P&P and manufacturer's guidelines.

- Surgical instrument marking tape was not maintained in accordance with the manufacturer's guidelines and hinged instruments in sterile peel packs were in the closed position.

- In the LDR unit, portable dehumidifiers were used in two of two LDR ORs with no P&P developed for their use, cleaning and maintenance. The hopper used to dispose of waste was located next to clean and sterile supplies in a utility room.

- LDR OR 2 was used for storage of equipment which was not cleaned following each surgical procedure.

- Sanitizing gel, gloves and masks for use by patients and visitors were not available to patients during an observation in the main ED. Patient chairs in the triage area were ripped and torn.

- In the NICU, breast milk for patients was not stored separately to minimize the chance of contamination or error. The formula preparation area did meet infection control standards for safe and sanitary powder formula preparation.

- The open enteral delivery system for patients did not follow the IC practices for one patient (Patient 22).

- Staff were observed in the kitchen without designated hair coverings.

- Staff in multiple areas of the hospital were observed not practicing hand hygiene.

These failures created the increased risk of transmission of infections and further compromised acutely ill patients' clinical conditions.

Findings:

According to the hospital's Infection Control Plan, approved 2/11/14, surgical entry into tissues, cavities, or organs (invasive procedures) shall require wearing of barrier gown, gloves, surgical mask and protective eye wear or face shield.

According to the hospital's P&P titled Hand Hygiene Policy, effective date 8/13/13, "Antiseptic agent - Antiseptic agents are antimicrobial substances that are applied to the skin to reduce the number of microbial flora. Decontaminate hands - to reduce bacterial counts on hands by performing antiseptic hand rub or antiseptic handwash. Hand antisepsis - refers to either antiseptic handwash or antiseptic hand rub."

According to the AORN Perioperative Standards and Recommended Practices, Recommended Practices for Hand Hygiene in the Perioperative Setting, 2013, "A surgical hand scrub should be performed by health care personnel before donning sterile gloves for surgical or other invasive procedures. The objective of a surgical hand scrub is the reduction of transient and resident flora, which also may reduce health care-associated infections. With the addition of a health care organization-approved antiseptic soap, which acts as a surfactant, transient and some resident microorganisms can be lifted and flushed away under running water. A multiuser scrub sink should be located near the entrance to the OR."

According to the AORN Perioperative Standards and Recommended Practices, Recommended Practices for Surgical Attire, 2013, clean surgical attire, including shoes, head covering, masks, jackets, and identification badges should be worn in the semi-restricted and restricted areas of the surgical or invasive procedure setting. Clean attire minimizes the introduction of microorganisms and lint from health care personnel to clean items and the environment. Facility-approved, clean, and freshly laundered or disposable surgical attire should be donned daily in a designated dressing area before entry or reentry into the semi-restricted and restricted areas. Changing from street apparel into facility-approved, clean, and freshly laundered or disposable surgical attire in a designated area decreases the possibility of cross-contamination and assists with traffic control.

1. On 3/5/14 at 1512 hours, the 6G unit on the 6th inpatient tower was toured with the 6C unit Assistant Nurse Manager. The 6G unit was divided into three areas.

Observation of 6G Exam Room #1 (room 103) showed a patient was in the room draped with sterile drapes for an ongoing procedure. There was a suspensional surgical light, Mayo stand and surgical supplies inside the room.

An ante room was connected to Exam Rooms #1 and #2. The room contained a hand wash sink. Three bottles of enzymatic agent were next to the hand wash sink. In the same area, a wall mounted cabinet stored sterile packages of surgical instruments and new sterile peel packs.

In Exam Room #2, a mobile cart stored sterile packs of surgical supplies and instruments.

On 3/5/14 at 1512 hours, during an interview, RN F stated she decontaminated dirty instruments in the ante room sink. RN F stated she washed, soaked and dried the used instruments.

To clean Exam Room #1 after a procedure, RN F stated she disinfected the surfaces with bleach wipes and then let it air dry. RN F stated she did not perform a different cleaning or disinfection process if the room was used for a patient with identified infected wounds.

During a follow-up interview on 3/7/15 at 0945 hours, RN F stated she cleaned the instruments with a diluted enzymatic agent solution. However, RN F stated she did not monitor the temperature of the water used to dilute the enzymatic agent.

Review of the manufacturer's guidelines showed to use warm water for diluting the agent and the temperature of the warm water should not exceed 150 degrees F.

During the interview, RN F stated immediately after the surgical procedures, she cleaned the dirty instruments in the ante room. The RN stated she also packed the cleaned instruments in the ante room. The instruments that needed to be packed in trays she would take to central services. All the instruments would be sterilized in the central processing department.

The RN stated the patients who received surgical services in 6G unit were mostly from the Orthopedic Eval Treatment Area. Patients from hospital inpatient units were also treated. The services in this location were provided based on the patients' needs and RN F's availability.

During a follow-up interview with RN F and the Assistant Nurse Manager on 3/6

Based on observation, interview and record review, the hospital failed to provide a safe and effective environment and maintain high standards of care for patients receiving surgical services as evidenced by:

- Surgical services provided in the hospital's 6G unit treatment room were not provided in a safe and sanitary environment.

- The nurse providing services as a circulating nurse, scrub tech, and recovery nurse did not have evidence of training or proven competencies in surgical nursing.

- Staff did not routinely perform a site or side marking prior the patient's surgical procedures.

- The room was not cleaned as outlined in the hospital's P&P for cleaning of an OR room between cases and was not terminally cleaned by EVS services at the end of the day. There was no specific disinfection process to clean or disinfect the room after a patient with infected wound was treated. The room temperature and humidity were not monitored.

- The RN did not clean the contaminated instruments prior to sterilization per the manufacturer's instructions and could not verbalize the temperature of the warm water used to dilute the enzymatic agent.

- The hospital's P&Ps did not address the actual services provided to patients in 6G unit.

- Acceptable operating room attire was not was not followed and overseen by the IC group.

- Lack of outpatient surgery post-operative care planning and coordination, and provisions for follow-up care .

- The hospital's P&P was not implemented for the time-out procedure for two patients surgeries observed in the main OR (Patients 13 and 76).

- Portable dehumidifiers were used in two of two LDR ORs with no P&P developed for their use, cleaning and maintenance.

These failures resulted in the potential for poor health outcomes to patients receiving surgical services in the hospital.

Findings:

The American College of Surgeons and the CMS definition of surgery is a procedure performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery also is the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles.

The tissue can be cut, burned, vaporized, frozen, sutured, probed, or manipulated by closed reductions for major dislocations or fractures, or otherwise altered by mechanical, thermal, light-based, electromagnetic, or chemical means. Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system also is considered to be surgery (this does not include the administration by nursing personnel of some injections, subcutaneous, intramuscular, and intravenous, when ordered by a physician).

1. On 3/5/14 at 1520 hours, a surgical procedure was observed ongoing in the 6G unit procedure room. Inside the room was a handwashing sink. There was no scrub sink located outside of the room.

A sterile field was set up with sterile supplies and surgical instrument trays. One surgeon wore a surgical gown and sterile gloves while working on the patient. RN F left the room, passed through an ante room into another room to obtain sterile supplies on a cart and then returned to the procedure room.

On 3/5 and 3/6/14, RN F was interviewed. RN F stated the 6G unit provided minor orthopedic procedures for inpatients and outpatients. The service was based on the patient needs. The procedure schedules were provided on the surgical day.

a. The AORN Definition of a Circulating Nurse showed the circulating nurse's duties in the operating room are performed outside the sterile field. The circulating nurse is responsible for managing all nursing care within the operating room, observing the surgical team from a broad perspective, and assisting the team to create and maintain a safe, comfortable environment for the patient's surgery.

The circulating nurse ensures that all members of the surgical team perform in a united effort. One perioperative RN is dedicated to the patient during that patient's entire intraoperative experience. During surgery, most patients are anesthetized or sedated and are powerless to make decisions on their own behalf. By employing critical thinking, assessment, diagnosing, outcome identification, planning, and evaluation skills, RN circulators direct the nursing care and coordinate activities of the surgical team for the benefit of the patient, whose protective reflexes or self-care abilities are compromised by the procedure.

These critical nursing functions of the RN circulator are not delegable in the operating room. To conclude the role of the RN in the perioperative setting is vital to the provision of optimal and safe patient care. The perioperative RN is the health care practitioner with the knowledge, training, and skills to successfully perform circulating duties in the surgical setting. Using sound nursing judgment, critical thinking skills, and interpersonal communication skills, the RN circulator is able to assess and evaluate individual patient needs and to ensure positive patient outcomes. To ensure that patients receive the highest quality and standard of nursing care, it is essential that there is a perioperative registered professional nurse in the role of the circulator throughout every operative or invasive procedure.

RN F stated she was the only nurse assigned to 6G. RN F stated she worked independently providing patient care for pre-operative, intra-operative and recovery patients in the unit.

RN F stated she decontaminated and cleaned the surgical instruments and packed the instruments for sterilization. RN F stated she provided environmental cleaning of the room pre and post surgery.

RN F stated she monitored patients who received regional anesthesia without a licensed anesthesia provider onsite, during and post procedures. RN F stated she did not have formal training or experience in surgical services.

RN F stated only patients who were felt to be ASA (American Society of Anesthesiology) classification I or II had procedures performed in the 6G unit, and that she, not the anesthesia provider selected the ASA classification. RN F stated that patients with hypertension or diabetes would be classified as ASA II.

During a concurrent interview with the 6th floor Nursing Manager, the Manager stated she was aware of the current practice in the 6G unit. The Manger stated she did not have training for surgical services, but was responsible for the Unit.

Review of the Job Description for RN F on 3/6/14, showed the job duties included nursing assessment, planning, implementation, evaluation, administrative/ancillary for nursing service. The most recent evaluation was documented on 5/2/13 with a supervisor signature. RN F had a Basic Life Support certificate for CPR. The job description documentation did not show a set of specific competencies related to the care provided for the surgical patients in the 6G unit.

In an interview with the Assistant Nursing Director Med-Surg on 3/6/14 at 1450 hours, she stated the nursing competency utilized for RN F was that of a floor nurse, providing basic inpatient care, with some training in providing a sterile field as would be required for placing a central line at the bedside.

b. Review of the hospital's document 6G Medical-Surgical/Orthopedics Unit Structure Standards 2012-2014, showed the procedure room located on the 6th floor of the hospital inpatient tower is utilized to perform simple procedures that do not required procedural sedation.

The objectives for 6G unit were:

* To promote and provide diagnostic procedures to determine the etiology of the patient's presenting complaints.

* To perform nursing assessment on every patient seen in the area.

* To administer patient care utilizing the nursing process.

The Administration/Organization of Unit showed the 6G unit was referred to as the Orthopedic Procedure Room and was organized as a nursing unit within orthopedic service

Based on interview and record review, the hospital failed to ensure the informed consents were completed prior to surgical procedures for eight of 15 surgical patients (Patients 63, 64, 65, 66, 67, 72, 73 and 74) reviewed. This created the risk of the patients not being allowed to make decisions about their healthcare and the risk of substandard health outcomes.

Findings:

The hospital's P&P titled Consents/Witnessing Signatures, effective date 12/13, showed legal authorization must be obtained from the patient or the patient's authorized representatives prior to performing treatment, specialty procedures or an operation. The consent is a legal document and should be dated signed and witnessed.


1. Review of Patient 72's medical record was initiated on 3/7/14. The patient was admitted to the hospital on 2/25/14.

The Progress-Hand Services Notes dated 2/26/14 at 0947 hours, showed a plan for revision amputation of MF (middle finger) in the treatment room (6G) on this day. The plan had been discussed with Patient 72. The patient had consented. The consent was in the patient's medical record.

However, there was no documented evidence to show an informed consent was signed by Patient 72 for the procedure on 2/26/14.

Review of the Moderate/Deep Sedation Flow Sheet dated 2/26/14, showed the procedure was performed on 2/26/14 as planned. The procedure was started at 1608 hours and ended at 1637 hours.

Further review showed the Authorization for and Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures signed by Patient 72 on 2/28/14 at 1530 hours, showed the patient consented for finger amputation and left middle finger revision amputation with primary closure. The form was incomplete as the sections to document the use of interpreter services and document if blood transfusion was given were left blank.

2. Review of Patient 73's medical record was initiated on 3/7/14. The patient went to the hospital for a procedure on 2/20/14, as an outpatient.

Review of the Authorization for and Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures published in Spanish and English, signed by Patient 73 on 2/20/14 at 0830 hours, showed the form was not complete as the sections to document the use of interpreter services and document if blood transfusion was given were left blank.

3. Review of Patient 74's medical record was initiated on 3/7/14. The patient went to hospital for a procedure on 2/19/14, as an outpatient.

Review of the Authorization for and Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures signed by Patient 74 on 2/19/14 at 1145 hours, showed the form was not complete as the sections to document the use of interpreter services and document if blood transfusion was given were left blank.



20059


4. On 3/7/14, review of Patient 63's medical record showed a surgical procedure was performed on 2/25/14. A document found in the record titled: Authorization for And Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures showed the form was incomplete as there was no designation whether interpreter services were required and whether a blood transfusion form was required.

5. Review of Patient 64's medical record showed a surgical procedure was performed on 2/6/14. There was no documentation of an informed consent found in the medical record for the surgical procedure performed.

6. Review of Patient 65's medical record showed a surgical procedure was performed on 2/25/14. There was no documentation of an informed consent found in the medical record for the surgical procedure performed.

7. Review of Patient 66's medical record showed a surgical procedure was performed on 3/3/14. There was no documentation of an informed consent found in the medical record for the surgical procedure performed.

8. Review of Patient 67's medical record showed a surgical procedure was performed on 2/26/14. A document found in the record titled: Authorization for And Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures showed the form was incomplete as there was no designation whether interpreter services was required and whether a blood transfusion form was required.

Based on record review and interview, the hospital failed to show documented evidence the pre-anesthesia evaluations for four of 15 patients (Patients 15, 32, 74 and 80)reviewed who received surgical services in the 6G unit included the patient's health information and physical evaluation. This created an unsafe environment for the patients receive services in the 6G unit.

Findings:

According to Practice Advisory for Preanesthesia Evaluation, the Update Report by American Society of Anesthesiologists Task Force on Preanesthesia Evaluation dated 3/12, preanesthesia consists of the consideration of information from multiple sources that may include the patient's medical records, interview, physical examination, and findings from medical tests and evaluations. A minimum a preanesthetic physical examination should include (1) an airway examination (2) a pulmonary examination to include auscultation of the lung, and (3) a cardiovascular examination.

The hospital Guidelines for Performance for Peripheral Nerve Blocks for the Department of Anesthesiology showed the guidelines was to outline the procedure for the administration of a peripheral nerve block as a single injection or with a continuous catheter in the ambulatory surgery administration and recovery/discharge unit. The policy indicated the responsibility of the anesthesiologist included discuss post-operative pain management with the patient preoperatively and to obtain consent, complete the "Anesthesia Peripheral Nerve Block Record" and sign; enter the patient into the post-op pain log record for follow-up. The required forms necessary prior of nerve block included a surgical H&P and an anesthesia H&P and consent.

1. On 3/7/14, Patient 32's medical record review was conducted. Patient 32 received a surgical service in 6 G unit. The documentation for Informed Consent for Anesthesia and Anesthesia-Related Services documented the patient consented for Nerve Block anesthesia.

Review of an Inpatient Progress Notes, dated 3/5/14, showed MD M assessed the patient for pre-anesthesia. Documentation of the physical examination of the patient showed an assessment of the patient's left hand and finger nerve, range of motion, and nerve sensation of left index finger. There was no documented evidence of a system review of the patient's heart, lung, breathing, activity, conscious level, circulation and previous anesthesia history nor potential risk according to established standard of practice (e.g. ASA classification of risk).


21177


2. On 3/7/14, medical record review showed Patient 80 had a closed reduction and percutaneous pinning of the right wrist done on 2/14/14.

Review of the Informed Consent for Anesthesia and Anesthesia-Related Services showed the patient consented for nerve block anesthesia. The anesthesiologist performed a local nerve block at 1134 hours. Review of the anesthesiologist's Regional Anesthesia note dated 2/14/14 at 1130 hours, and the H&P did not show a review of the patient's ASA classification of risk.


25720


3. The medical record for Patient 15 was reviewed on 3/7/14. The patient had a procedure performed on 2/21/14, in the 6G unit to manipulate a fractured left index finger into place and secure with the bone alignment with wires.

The patient signed consent for a Minor/Major Nerve Block prior to the procedure. The risks documented on the consent form were infection, convulsions, weakness, persistent numbness, residual pain, injury to blood vessels, buzzing in the ears and injury to blood vessels and nerves.

Review of Patient 15's medical record showed an H&P was documented by the anesthesiologist on 2/21/14 at 1030 hours. Review of the H&P did not show a review of the patient's drug and allergy history and an ASA classification of risk.




29558


4. Review of Patient 74's medical record was initiated on 3/7/14. The patient went to the hospital for a procedure on 2/19/14, as an outpatient.

Review of the Procedure-Hand Services Note dated 2/19/14 at 1440 hours, showed a procedure of right small finger dynamic external fixation was performed on Patient 74. The patient's "right hand (small finger) operative site anesthetized with regional block by anesthesia."

Further review failed to show documented evidence a pre-anesthesia evaluation was completed and documented.

An interview and medical record review was conducted with RN O on 3/7/14 at 1005 hours. When asked, the RN was unable to locate the missing document. The RN stated she would look for the above missing documentation.

On 3/7/14 at 1715 hours, at the exit of the survey, no further documentation was provided.

Based on observation, interview and record review, the hospital failed to ensure nine of 15 patients (Patients 15, 32, 63, 67, 71, 74, 79, 80 and 81) reviewed who received surgical services with regional nerve blocks in the 6G unit had an intra-operative anesthesia records documented by the anesthesiologist to show monitoring during the surgery. This failure created the risk of poor surgical outcomes to these patients.

Findings:

When the hospital's P&P for the monitoring of regional anesthesia was requested on 3/6/14, the hospital provided the document, Standard for Basic Anesthetic Monitoring, approved by the ASA House of Delegates, effective date of 7/1/11.

Standard 1 of the document showed because of the rapid changes in patient status during anesthesia, qualified anesthesia personnel shall be continuously available to monitor the patient and provide anesthesia care. The qualified should be present in the room throughout the conduct of all general anesthetics, regional anesthetics and monitored anesthesia care.

1. On 3/5/14 at 1512 hours, MD M was observed walking out from the 6G unit 1 with a portable machine. A concurrent interview with RN F revealed Patient 32 was in the room having an orthopedic procedure. MD M provided a nerve block for the patient as anesthesia for the procedure.

During review of Patient 32's medical record on 3/7/14, the documentation on Peripheral Nerve Blockage form showed an axillary nerve block was started 1416 hours and ended time 1419 hours.

On 3/6/14 at 1322 hours, during an interview, MD M stated she performed nerve block anesthesia services for the patients in the 6G unit. MD M evaluated the patients after the block and when satisfied with the nerve block effectiveness, MD M left the room.

On 3/6/14 at 0920 hours, during interview with RN F, the RN stated she monitored and documented patients' vital signs during the surgical procedures and recorded the surgical procedure. RN F stated she was the circulating nurse and the monitoring RN. However, RN F stated she also had to leave the room to perform other tasks.


25720


2. The medical record for Patient 15 was reviewed on 3/7/14. The patient had a procedure performed on 2/21/14, in the 6G unit to manipulate a fractured left index finger into place and secure with the bone alignment with wires.

The patient signed consent for a Minor/Major Nerve Block prior to the procedure. The risks documented on the consent form were infection, convulsions, weakness, persistent numbness, residual pain, injury to blood vessels, buzzing in the ears, and injury to blood vessels and nerves.

Review of the Peripheral Nerve Blockade procedure note form showed a anterior axillary nerve block was performed by the anesthesiologist at 1051 hours; however, there was no documentation to show if the nerve block was performed on the right or left side of the body.

The form contained the patient's vital signs immediately before and after the block, pain score, and the type of needle and medication used for the block. Under the area to document the "success" of the block, the anesthesiologist checked the box "a full evaluation is pending."

The surgical procedure began at 1133 hours and concluded at 1215 hours. There was no anesthesia record found in the medical record to show the patient's condition was monitored by the anesthesiologist during the procedure.


26881


3. Patient 71 came to the hospital on 2/19/14, for a procedure on his fractured right hand. The procedure note indicated that the operative site was anesthetized with a regional block per anesthesiology.

The Peripheral Nerve Blockade Procedure Note dated 2/19/14, indicated the anesthesia time began at 0856 hours, but no end time was recorded.

The anesthesia procedure note indicated the anesthetic was "well tolerated." There was no documentation to show the anesthesiologist was present during the surgical procedure.

The nursing, anesthesia and orthopedic surgeon's records did not show the anesthesiologist was present during the surgical procedure.


29558


4. Review of Patient 74's medical record was initiated on 3/7/14. The patient went to hospital for a procedure on 2/19/14, as an outpatient.

Review of the Procedure-Hand Services Note dated 2/19/14 at 1440 hours, showed a hand surgery was performed on Patient 74. The patient's "right hand (small finger) operative site anesthetized with regional block by anesthesia."

Further review failed to show documented evidence Patient 74 was assessed and monitored during the procedure.

An interview and medical record review was conducted with RN O on 3/7/14 at 1005 hours. When asked, RN O was unable to locate the missing document. The RN stated she would look for the above missing documentation.

On 3/7/14 at 1715 hours, at the exit of the survey, there no further documentation was provided.


20059


5. Review of Patient 63's medical record on 3/7/14, showed a surgical procedure was performed on 2/25/14, for a right wrist carpal tunnel release. There was no documentation found to show intra-operative monitoring by the anesthesiologist.

6. Review of Patient 67's medical record on 3/7/14, showed a surgical procedure was preformed on 2/26/14. Documentation showed the procedure was a right internal fixation and pinning of the wrist. There was no documentation found to show intra-operative monitoring by the anesthesiologist.


21177


7. Medical record review on 3/7/14, showed Patient 79 had a closed reduction with pertacuneous pinning of the right middle finger on 2/7/14 at 1140 hours in the 6G unit. The patient received a peripheral nerve blockage by an anesthesiologist at 1034 hours.

RN F monitored and assessed the patient from 1001 hours to 1228 hours. Patient 79 was discharged from the 6G unit and escorted to the Orthopedic Evaluation and Treatment Clinic by a volunteer at 1228 hours.

There was no anesthesia record found in the medical record to show the patient's condition was monitored by the anesthesiologist during the procedure.

8. Medical record review on 3/7/14, showed Patient 80 had a closed reduction and percutaneous pinning of the right wrist done on 2/14/14 in the 6G unit. The anesthesiologist performed a local nerve block at 1134 hours. RN F monitored and assessed the patient from 1134 hours to 1405 hours, when the patient was discharged from the 6G unit and escorted to the Orthopedic Evaluation and Treatment Clinic by a volunteer.

There was no anesthesia record found in the medical record to show the patient's condition was monitored by the anesthesiologist during the procedure.

9. Medical record review on 3/7/14, showed Patient 81 had the debridement and irrigation with possible incision/drainage of the wound and a wound vacuum change of the right hand done on 2/14/14, in the 6G unit.

An anesthesiologist performed a peripheral nerve block at 1419 hours on 2/14/14, for Patient 81's surgery. RN F monitored and assessed Patient 81 unit from 1519 hours to 1605 hours, when the patient was discharged from the unit escorted back to a medical surgical unit.

There was no anesthesia record found in the medical record to show the patient's condition was monitored by the anesthesiologist during the procedure.

Based on observation, interview and medical record review, the hospital failed to ensure the qualified anesthesia practitioner completed post-anesthesia evaluations for nine of 15 patients (Patients 15, 32, 63, 67, 71, 74, 79, 80 and 81) reviewed who received regional nerve blocks for surgeries in the 6G unit. This failure created the risk of the potential side effects of the anesthesia not to be recognized and poor surgical outcomes for those patients.

Findings:

Review of the Department of Anesthesiology Guidelines for performance for peripheral nerve blocks (undated) showed "In house patients are to be followed by Anesthesia daily, while home patients are to be followed by telephone by the assigned Anesthesiologist (PACU resident or peripheral nerve block nurse)."

1. On 3/5/14 at 1512 hours, MD M was observed to walk out from the 6G unit with a portable machine. In a concurrent interview with RN F the RN stated Patient 32 was in the room for a orthopaedic procedure. MD M provided a nerve block for the patient.

Review of Patient 32's medical record on 3/7/14, showed an auxiliary nerve block was started by MD M on 3/5/14 at 1416 hours. Review of the documentation on the Moderate/Deep Sedation Flow Sheet for Patient 32 showed areas to document Patient Status for: time of Discharge, pre-sedation level of consciousness, ambulatory, able to void without difficulty, able to take oral fluids, minimal or no nausea, minimal or no dizziness, pain adequately controlled, the Discharge Home Checklist, written order for discharge by physician, aftercare instruction and the disposition/time. None of the check boxes for documentation of the patient's status were checked.

On 3/6/14 at 0920 hours, during an interview, RN F stated she monitored and documented the patients' vital signs during the procedures in the 6G unit on a Moderate/Deep Sedation Flow Sheet form. RN F stated she observed the patients for recovery after the surgery for 15 minutes and then discharged the patients. RN F stated the anesthesia provider did not evaluate the patients prior to their discharge from the 6G unit.

On 3/6/14 at 1322 hours, during an interview, MD M stated she performed nerve block anesthesia services for the patients in the 6G unit. MD M stated she evaluated the patient after the block and when satisfied of the nerve block's effectiveness, she left the room. MD M stated she provided and educated the patient regarding the nerve block and gave aftercare information at the same time the patient signed the consent for nerve block. MD M stated there was no evaluation upon patient's discharge.


21177


2. The medical record for Patient 79 was reviewed on 3/7/14. The patient had a closed reduction with pertacuneous pinning of the right middle finger done on 2/7/14 at 1140 hours, in the 6G unit.

The patient received a peripheral nerve block by an anesthesiologist at 1034 hours. RN F monitored and assessed patient from 1001 hours to 1228 hours. The patient was escorted to the Orthopedic Evaluation and Treatment Clinic by a volunteer at 1228 hours. There was no post-anesthesia evaluation completed and documented by an anesthesiologist for the patient.

3. The medical record for Patient 80 was reviewed on 3/7/14. Patient 80 had a closed reduction and percutaneous pinning of the right wrist done on 2/14/14, in the 6G unit. The anesthesiologist performed a local nerve block at 1134 hours. RN F monitored and assessed the patient from 1134 hours to 1405 hours, when the patient was escorted to the Orthopedic Evaluation and Treatment Clinic by a volunteer. There was no post-anesthesia evaluation completed and documented by an anesthesiologist for the patient.

4. The medical record for Patient 81 was reviewed on 3/7/14. Patient 81 had the debridement and irrigation with possible incision/drainage of the wound and wound vacuum change of the right hand done on 2/14/14, in the 6G unit. An anesthesiologist performed the peripheral nerve block at 1419 hours on 2/14/14. RN F monitored and assessed Patient 81 from 1519 hours to 1605 hours, when the patient was escorted back to a medical surgical unit. There was no post-anesthesia evaluation completed and documented by an anesthesiologist for the patient.


25720


5. The medical record for Patient 15 was reviewed on 3/7/14. The patient had a procedure performed on 2/21/14, in the 6G unit to manipulate a fractured left index finger into place and secure with the bone alignment with wires.

Review of the Peripheral Nerve Blockade procedure note form showed a anterior axillary nerve block was performed by the anesthesiologist at 1051 hours. Under the area to document the "success" of the block, the anesthesiologist checked the box "a full evaluation is pending."

The surgical procedure concluded at 1215 hours. There was no documentation found to show follow-up of the patient's condition by the anesthesiologist after the procedure.


20059


6. Review of Patient 63's medical record on 3/7/14, showed a surgical procedure was performed on 2/25/14, in the 6G unit. Patient 63 had a right wrist carpal tunnel release. There was no documentation of a post-anesthesia assessment by the anesthesiologist.

7. Review of Patient 67's medical record on 3/7/14, showed a surgical procedure was performed on 2/26/14, in the 6G unit. Documentation showed the procedure was a right internal fixation and pinning of the wrist. There was no documentation of a post-anesthesia assessment by the anesthesiologist.


26881


8. Patient 71 came to the hospital on 2/19/14, for a procedure on his fractured right hand in the 6G unit. The procedure note indicated that the operative site was anesthetized with a regional block per anesthesiology. There was a Peripheral Nerve Blockade Procedure Note dated 2/19/14.

The patient was discharged after the procedure. However, no post-anesthesia evaluation or follow-up was seen in the record.


29558


9. Review of Patient 74's medical record was initiated on 3/7/14. The patient went to hospital for a procedure on 2/19/14 as an outpatient in the 6G unit.

Review of the Procedure-Hand Services Note dated 2/19/14 at 1440 hours, showed a hand surgery was performed on Patient 74 in the 6G unit. The patient's "right hand (small finger) operative site was anesthetized with regional block by anesthesia."

Further review failed to show documented evidence a post-anesthesia evaluation was completed and documented.

An interview and medical record review was conducted with RN O on 3/7/14 at 1005 hours. When asked, the RN was unable to locate the missing document. The RN stated she would look for the above missing documentation.

On 3/7/14 at 1715 hours, at the exit of the survey, no further documentation was provided.