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Based on medical record review and staff interview it was determined the facility failed to ensure that medical records were complete, accurate, and/or authenticated with date and time, for 2 of 22 emergency department patients (Patients #26 & #35) whose records were reviewed. This had the potential to result in insufficient information to identify the patient, document the course of care, and promote continuity of care. Findings include:

1. Patient #26 was a 25 year old male who presented to the ED on Sunday, 3/30/14 at 3:16 AM, with a complaint of chest pain. He was discharged from the ED on 3/30/14 at 5:07 AM.

Patient #26's record included 2 ECG reports, with date and time stamps of 3/30/14 at 3:21 AM, and 3/30/14 at 4:51 AM. Both of the reports were marked "Confirmed By", and indicated the name of the physician who had confirmed the ECG results, however the reports did not indicate the date and time they were confirmed.

During an interview on 11/06/14 at 1:00 PM, the Medical Director for the ED reviewed Patient #26's record. He stated ECG's performed in the ED were reviewed by a physician in the ED when the test was completed, and confirmed by a cardiologist at a later time. The Medical Director stated the physician indicated next to "Confirmed By" on Patient #26's ECG reports was a cardiologist. Additionally, he stated the cardiologist was not in the hospital to confirm the results at the time the ECG was completed. The Medical Director confirmed the ECG reports did not indicate the date and time the ECG was confirmed by the cardiologist.

Patient #26's medical record contained ECG reports that did not include the date and time they were confirmed by the cardiologist.



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2. Patient #35's medical record documented a 24 year old female who arrived by ambulance to the ED on 10/24/14 at 3:44 AM.

A "NURSING ASSESSMENT," dated 10/24/14 at 3:47 AM, said Patient #35 " ...states she is addicted to cutting and went too deep tonight to left forearm, pt states she has been cutting self for 12 years, pt states she does not want to be here, pt denies SI just cutting on self, pt states she did not want to come but EMS brought her in, pt states she wants to leave. pt has wrap to left forearm, pt able to move arm and fingers, pressure wrap applied by EMS in place, pt states she called EMS." A description of the wound to her forearm was not documented in the record. The nurse documented, on 10/24/14 at 4:05 AM, that Patient #35 eloped before the physician had seen her.

A physician note in Patient #35's record, dated 10/24/14 at 4:04 AM, stated the patient reported she was not suicidal and did not want to be in the hospital. The note then said Patient #35 eloped out of the ER prior to the physician's assessment. The physician documented Patient #35's diagnosis at 4:04 AM as "Self-Inflicted Laceration." Also at 4:04 AM, the physician documented " Disposition type: Incomplete Care, Disposition: Elopement, Disposition Transport: Private Vehicle, Condition: Stable." It was not documented how the physician determined Patient #1 was stable since he did not examine her.

The Director of the ED was interviewed on 11/05/14 beginning at 1:45 PM. He reviewed Patient #35's record and confirmed the physician documented the patient was stable even though the physician did not examine her.

The physician did not accurately document Patient #35's condition.

Based on review of patient medical records, policies, and staff interview, it was determined the hospital failed to ensure written consent forms for treatment and procedures were properly executed to include the signature of the patient or legal representative, the reason the patient was not able to consent, if applicable, and the date and time consent was obtained for 9 of 50 (#2, #7, #8, #9, #14, #21, #27, #28, and #37) patients whose records were reviewed. This had the potential to result in treatment being provided without the consent of the patient or legal representative. Findings include:

A hospital policy titled "Patient Consents," revised 2/2011, provided direction for staff related to Implied Consent, Admission Consent, Informed Consent, and Verification of Informed Consent.

The policy noted an Admission Consent was obtained from inpatients and outpatients at the time of admission by the Admitting Clerk. The policy stated an Admission Consent was sufficient for routine tests and procedures.

The policy noted an Informed Consent was to be obtained for more complex procedures or treatment. An Informed Consent was to be obtained in which regional or general anesthesia and moderate sedation was used. Additionally, an Informed Consent was required for use of blood and blood products, minor or major surgery, and all procedures that require a specific explanation by the physician or provider. The policy stated that an Informed Consent is to include the name of the physician or other practitioner who has primary responsibility for the patient's care, and the identity and professional status of the individuals responsible for performing the procedure or treatment.

The policy did not address Verbal Consents.

The following records include consents that were not properly executed:

1. Patient #37 was an 84 year old female admitted to the facility on 9/25/14, for services related to blockage of blood flow in her right leg. She was transferred to another facility due to her requirement for a higher level of care.

Patient #37 signed the Admission Consent, however, a Transfer Consent was signed by her son. The section of the form that indicated why the patient was unable to sign was left blank. Additionally, the section of the consent titled "Transfer Request," remained blank. The name of the accepting facility was also blank. The section of the form where the patient or authorized representative was to sign indicating they understood the medical record was to be copied and sent to the receiving facility was not completed. The witness signature and date was left blank. Page 2 of the Transfer Consent included a place to document the name of the individual at the receiving facility who accepted the transfer, and the time and date the person was contacted. However, the name of the individual and contact date was not documented. The name of the agency that would be transporting Patient #37 was to be documented on the consent, but was not. The bottom of the consent included a space for the administrator or designee who approved the transfer, with a time and date, which remained blank.

During an interview on 11/06/14 at 4:30 PM, the Manager of Labor and Delivery reviewed Patient #37's record and confirmed the consent for transfer included sections which were left incomplete. She stated the entire consent should have been filled out by the physician and nursing staff who facilitated the transfer.

Patient #37's consent form was not properly completed to indicate who consented to the procedure.

2. Patient #8 was a 22 year old female admitted to the facility on 9/02/14 for services related to pregnancy complications and delivered a premature baby girl on 9/03/14.

a. Patient #8's record included a consent titled "Consent to Medical & Surgical Treatment," that was signed and witnessed on 9/02/14 at 9:25 PM. The top of the form included sections for the date and patient number to be written in, which remained blank. The bottom of the form included a box, with the words "Patient Label," for the label to be placed, but did not have a label affixed.

b. Plans to transfer Patient #8 to a facility which could provide a higher level of care before the infant was born were made. The transfer was initiated, but was aborted when she arrived at the airport and it was determined she was laboring too quickly and she was returned to the hospital. The "Consent to Transfer" form was incomplete as follows:

- Section III: "Transfer Consent," for the patient to sign, acknowledging she received an explanation from the physician of the risks of transfer and potential risks of non transfer, was not signed by Patient #8.

- "Transfer Requirements,"
- item 2: The section that stated the receiving facility has agreed to accept transfer and to provide appropriate medical treatment, and who authorized the transfer with name, title, phone number, date and time, remained blank.
- item 3: The section that confirmed medical records of the patient were provided, and required initials, remained blank.
- item 4: The section of the consent that stated who the transport agency and that qualified personnel and equipment would be utilized, remained blank.
- The bottom of the consent included a space for the physician and the administrator or designee who approved the transfer, with a time and date, which remained blank.

c. A form titled "Consent to Anesthesia," signed by Patient #8 and witnessed on 9/03/14 at 1:19 AM, did not specify the type of anesthesia, or who would be providing anesthesia services. Additionally, the consent included the text "The nature and purpose of anesthesia, including General, Neuraxial, Regional & Moderate Sedation, possible alternate methods, the risks involved and the possibility of complications have been explained to me". The Labor and Delivery Flowsheet included an entry on 9/03/14 at 1:34 AM, that documented the CRNA was notified, and came to speak with Patient #8.

During an interview on 11/06/14 beginning at 4:45 PM, the Manager for Labor and Delivery reviewed Patient #8's record and confirmed the consents were incomplete. She stated the Consent for Anesthesia was usually signed by the patient during the admission process, especially if the patient expressed a desire for an epidural during labor. The Manager for Labor and Delivery confirmed the consent stated the procedure was explained to the patient, and stated the consents would probably need to be re-worded.

Patient #8's consent forms were not properly completed.

3. Patient #9 was a premature newborn female who was born on 9/03/14. She was transported to another facility on 9/03/14, as she required a higher level of care. Her record indicated she was intubated, she received surfactant, and umbilical lines were placed. She was then stabilized and transported. Patient #9's record did not include procedural consents for umbilical line placement, intubation, or surfactant. A Consent to Transfer was signed by Patient #9's mother, but the consent was incomplete in the following sections:

a. Section 1: "Transfer Request," the section where Patient #9's parent was to sign, date and time the consent authorizing the medical record be copied and sent to the receiving facility was left blank.

b. Section III: "Transfer Consent," there was no indication why the patient was not able to sign the consent, such as "minor child, infant, etc."

c. "Condition," Three sections of the consent included blank lines beside the identified condition of the patient to indicate if the condition was or was not stabilized, or if the patient was in labor. The lines would indicate the physician's determination of the patient condition.

d. "Transfer Requirements,"
- item 1: The receiving facility was identified to have space and qualified personnel, but the individual who acknowledged the patient transfer, their title, phone number and date and time of acknowledgement was not included.
- item 2: The section that stated the receiving facility has agreed to accept transfer and to provide appropriate medical treatment, and who authorized the transfer with name, title, phone number, date and time, remained blank.
- item 3: The section that confirmed medical records of the patient were provided, required initials, remained blank.
- item 4: The section of the consent that stated who the transport agency and that qualified personnel and equipment would be utilized, remained blank.

During an interview on 11/06/14 beginning at 4:45 PM, the L&D Manager reviewed Patient #9's record and confirmed the transfer consent form was not completed. She confirmed Patient #9's record did not include procedural consents for the intubation, umbilical line placement, and surfactant administration.

Patient #9's consent forms were not properly completed.

4. Patient #7 was a premature newborn male born on 10/24/14. His record included documentation he was intubated and received surfactant administration shortly after delivery. He was transferred to the NICU for further care. In the NICU his physician placed umbilical lines. Patient #7's record did not include consents for the intubation, surfactant administration, or umbilical line placement.

During an interview on 11/06/14 beginning at 4:45 PM, the L&D Manager reviewed Patient #7's record and confirmed Patient #7's record did not include procedural consents for the intubation, umbilical line placement, and surfactant administration.

Patient #7's consent form was not properly completed.

5. Patient #2 was a premature newborn male admitted to the hospital on 10/21/14. His admission record included documentation that he had respiratory distress, and a chest x-ray determined he had a pneumothorax (collapsed lung) on the left side.

A procedural note dictated by the neonatologist on 10/22/14, documented the father of Patient #2 was at the bedside and was informed of the need to decompress the pneumothorax.

Patient #2's record included a "Consent for Procedure," dated 10/22/14 at 8:45 PM. The procedure listed on the consent was for "Left pneumothorax needle decompression." The section for the parent to sign the form and the date and time, had "Verbal Consent" written in. There was no date or time, or indicator to include who the verbal consent was received by. According to the procedural note by the neonatologist, he spoke with Patient #2's father who was at the bedside prior to the procedure.

During an interview on 11/06/14 beginning at 4:45 PM, the L&D Manager reviewed Patient #2's record and stated the father was present before the procedure, and spoke with the physician, he could have signed the consent. Additionally, the L&D Manager stated the words "Verbal Consent" were not sufficient to indicate who offered verbal consent. She confirmed the policy did not address verbal consents.

Patient #2's consent form was not properly completed to indicate who consented to the procedure.

6. Patient #14 was a 27 year old female who was admitted to the hospital on 6/16/14 for care related to complications of pregnancy.

A form titled "Consent to Anesthesia," signed by Patient #14 and witnessed on 6/16/14 at 12:30 AM, did not specify the type of anesthesia, or who would be providing anesthesia services. Additionally, the consent included the text "The nature and purpose of anesthesia, possible alternate methods, the risks involved and the possibility of complications have been explained to me". The consent did not include what type of anesthesia was to be provided for Patient #14.

During an interview on 11/06/14 beginning at 4:45 PM, the L&D Manager reviewed Patient #14's record and confirmed the Consent to Anesthesia did not include the provider name or the proposed procedure.

Patient #14's consent form was not properly completed.

7. Patient #21 was a 74 year old female admitted to the hospital on 10/14/14 for psychiatric services. She was currently a patient during the time of the survey.

Patient #21's record included documentation her husband was listed as her DPOA, however, her record did not include an official document stating this. Her record included 8 consents which indicated telephone consent was obtained:

a. A Consent for Voluntary Admission for Behavioral Health Services, was dated 10/14/14 at 3:45 PM. The space identified as "Patient's Signature," was written "Telephone Consent [name] husband, DPOA." The consent included the signature of 2 licensed nurses.

b. A form titled "Behavioral health Services In-Patient Unit Patient Rights," was dated 10/14/14 at 3:45 PM. The space identified as "Patient's Signature," was written "Telephone Consent [name] husband, DPOA." The consent included the signature of 2 licensed nurses.

c. A form titled "Patient/Family Confidentiality Statement," was dated 10/14/14 at 3:45 PM. The space identified as "Patient's Signature," was written "Telephone Consent [name] husband, DPOA." The consent included the signature of 2 licensed nurses.

d. A form titled "Notification and/or Visitation Consent," was dated 10/14/14 but not timed. The space identified as "Patient's Signature," was written "Telephone Consent [name] husband, DPOA." The consent included the signature of 2 licensed nurses.

e. A form titled "Consent to Media Release/Photograph & Publish," was dated 10/14/14 at 3:45 PM. The space identified as "Patient's Signature," was written "Telephone Consent [name] husband, DPOA." The consent included the signature of 2 licensed nurses.

f. A form titled "Gero Psych Patient Rules & Expectations," was dated 10/14/14 at 3:45 PM. The space identified as "Patient's Signature," was written "Telephone Consent [name] husband, DPOA." The consent included the signature of 2 licensed nurses.

g. A form titled "Advance Directives," was dated 10/14/14 at 5:05 PM. The space for the patient signature was blank, and the form included a single witness signature. The form included the statement "Got consent over the phone from pts husband [name]."

h. A form titled "Consent to Medical & Surgical Treatment," was dated 10/14/14 at 5:05 PM. The space for the patient signature was blank, and the form included a single witness signature. The form included the statement "Got consent over the phone from pts husband [name]."

During an interview on 11/05/14 beginning at 8:50 AM, the Director of Quality and Risk Management reviewed Patient #21's record and confirmed the consents were not yet signed by the DPOA or the patient. She declined to comment on the policy direction for the behavioral health unit staff.

Patient #21's consent form was not properly completed to indicate who consented to the procedure.



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8. Patient #28 was a 58 year old male who was brought to the emergency department on 10/30/14, in cardiac arrest.

Patient #28's medical record included a "CONSENT TO MEDICAL AND SURGICAL TREATMENT". The line labeled "Signature of Patient, Date, Time" contained the signature of an RN. The date and time were blank. The line labeled "Legal Relationship to Patient if not signed by Patient" was blank.

Patient #28's medical record included a form titled "YOUR RIGHT AS A PATIENT TO MAKE MEDICAL TREATMENT DECISIONS". The section of the form titled "ADVANCE DIRECTIVE ACKNOWLEDGEMENT" contained check boxes to indicate the patient's status related to advance directives. One of the check boxes stated "Unable to obtain due to patient's condition". However, all of the boxes were unchecked. The line labeled "Signature of Patient, Date, Time" contained the signature of an RN. The date and time were blank.

During an interview on 11/07/14 at 9:20 AM, the ED Director reviewed Patient #28's record, including the consent forms. He confirmed the forms were signed by an RN in the ED. He stated this was not the ED's process and was unable to explain why the RN signed the forms.

Patient #28's consent forms were not properly completed to indicate he was unable to sign at the time of his ED admission.

9. Patient #27 was a 59 year old female who was brought to the emergency department on 10/13/14, with a diagnosis of altered mental status.

Patient #27's medical record included forms titled "CONSENT TO MEDICAL AND SURGICAL TREATMENT", and "YOUR RIGHT AS A PATIENT TO MAKE MEDICAL TREATMENT DECISIONS", dated 10/13/14 at 4:30 PM. On both forms the line for patient signature was completed with "pt [patient] medically unable to sign."

Patient #27's medical record also included a consent for the insertion of a peripheral catheter, dated 10/13/14 at 8:15 PM. The line titled "Patient/Representative Signature" contained a signature, however, it was unclear whose signature it was, as the lines titled "Legal Relationship to patient if representative" and "Reason patient unable to sign" were blank.

During an interview on 11/07/14 at 9:20 AM, the ED Director reviewed Patient #27's record, including the consent forms. He confirmed Patient #27 was unable to sign a consent form and it was unclear who signed the consent for the insertion of a peripheral catheter. He stated this was not the hospital's process and was unable to explain why the form did not indicate who had signed it.

Patient #27's consent form was not properly completed to indicate who consented to the procedure.

The facility failed to ensure consent forms were properly executed to ensure informed consent was obtained from the patient or representative.

Based on interview, observation, and review of policies, it was determined the hospital failed to ensure compliance with infection control policies as they related to the disposal of biohazardous trash and standard precautions, including the use of personal protective equipment by staff. This presented an infection control safety risk to patient care staff, patients, housekeeping staff, and visitors coming into contact with infectious patients or biohazardous waste that was improperly disposed of in the regular trash. Findings include:

1. A policy titled Medical and Infectious Waste, revised 1/2014, defined infectious medical waste as waste that may be contaminated by blood, body fluids, or other potentially infectious materials. Per the policy those items would be disposed of in red biohazard trash bags. Red bag trash would not be combined with regular trash. Examples given of items to be placed in the red biohazard trash bags included contaminated items, that if compressed would drip or release blood, as well as body fluids removed during surgery.

An observation of pre-operative care was made in the Outpatient Surgery unit, on 11/05/14 at 12:05 PM. A pre-operative patient had her porta-cath (a device for intravenous access in patients who require frequent or continuous administration of intravenous substances) accessed by needle for IV fluid to be administered during the procedure. The RN opened a kit to access the porta-cath and laid the kit out on the patient's lap. Once the porta-cath was accessed, the RN flushed the IV with normal saline through a syringe. She then aspirated blood through the IV, to check the placement of the needle, and some of the patient's blood entered the syringe and mixed with the saline solution. The syringe, with the blood tinged saline, was placed on the open package in the patient's lap. The RN then wrapped all the trash from the kit, including the bloody fluid filled syringe, into a ball and placed the contents into a regular trash bin.

During an interview with the Clinical Lead for Outpatient Surgery, on 11/05/14 at 1:45 PM, he confirmed the policy was to discard biohazardous waste into a red trash bag or bin. He stated a syringe which contained blood tinged fluid would not be considered biohazardous or infectious, it did not contain enough blood, and may be thrown into a regular trash bin.

During an interview on 11/05/14 at 2:45 PM, the Director of Surgical Services stated the policy was to dispose of biohazardous or infectious material in the red trash bag or bin. She confirmed the syringe was considered infectious waste and should have gone into the red biohazardous trash bag or red hard sided receptacle.

An observation was made during clean up in the OR post operatively, on 11/05/14 beginning at 1:45 PM. An anesthesia techincian disposed blood tinged yankar (hard plastic tip for suctioning) and suction tubing into a regular trash bag. He then preceded to the biohazard room, where he placed the regular trash bag in the elevator used for soiled items, and closed the door.

During an interview on 11/06/14 at 2:45 PM, the ICO confirmed the policy stated that blood tinged fluid would be considered infectious or biohazardous. The ICO stated the syringe and all suctioning materials should have been disposed of in the red trash bag or red hard sided receptacle.

Biohazardous and infectious waste was not disposed of according to the facility policy.

2. A PICC line insertion was observed in the ICU on 11/04/14 at 9:45 AM. During the observation the RN who performed the procedure did not use gloves when assisting the patient to change position in the hospital bed or when touching the patient. Towards the end of the procedure the Director of the ICU approached the door of the room and held up a sign that indicated the patient was being placed in Contact Isolation for infectious diarrhea. The sign was to gain the attention of the RN performing the procedure, as well as, the surveyors who were observing the procedure.

During an interview on 11/04/14 at 10:30 AM, the RN that was assigned to the patient stated the patient had persistant diarrhea and laboratory tests were sent to determine if the patient had an active gastrointestinal infection.

According to a hospital protocol dated 6/12/14, if a patient has diarrhea of an unknown source or is suspected to have Clostridium difficile, the patient would be placed in contact isolation and treated as if an infection was present until results are confirmed. The protocol indicated the physician must also be notified and orders should be received for laboratory testing of the patient's stool. Clostridium difficile, or C-diff, is defined as a bacterial infection which causes severe diarrhea and is highly infectious.

A policy, revised 3/14, titled Isolation Guidelines stated automatic isolation is done for a suspected case of Clostridium difficile bacteria using the "Infectious Diarrhea Protocol."

During an interview on 11/04/14 at 2:00 PM, the Director of the ICU stated the patient's laboratory test came back positive for Clostridium difficile. She stated the test had been ordered because the RN had suspected the bacterial infection. The Director confirmed the policy for isolation was to place a patient in contact isolation when infection is first suspected. The Director confirmed the patient should have been under contact isolation precautions while the laboratory test was pending results, according to facility policy and protocol.

During an interview on 11/06/14 at 4:00 PM, the ICO confirmed the protocol for Infectious Diarrhea and confirmed the patient should have been placed in isolation when an infectious process was suspected.

Staff failed to follow the facility's protocol and policy for infectious diarrhea while caring for a patient.