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800 S WASHINGTON AVENUE

SAGINAW, MI 48601

PATIENT RIGHTS

Tag No.: A0115

Based on medical record review and interview the facility failed to inform one of one patients [patient #1] of the surgical procedures to be performed.

Findings include:

In the complaint allegation, Patient #1 states that an additional surgical procedure was not approved by the patient and no consent was obtained to perform the procedure. Refer to findings at A-0131.

PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION

Tag No.: A0123

Based on record review, interview and policy review, the facility failed to provide written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion for the resolution for 4 of 4 grievances reviewed (Patient ' s # 1, #30, #31, #32 ). Findings include:

During review of patient grievances on 06/12/2012 with staff C the following was revealed and confirmed;

Patient #1 submitted a grievance with the hospital on 04/09/2012. The hospital's patient liaison sent a "follow up" letter to the patient on 04/30/2012. The letter lacked the information in regards to the hospital's decision, lacked the name and number of a hospital contact person, lacked steps taken on behalf of the patient to resolve the grievance, lacked to inform the patient of the results and a date of completion for the grievance.

A grievance was filed on behalf of patient #30 on 05/14/2012. A "follow up" letter dated 05/17/2012 was sent to the complainant/patient representative by the patient liaison. According to staff C she was unable to locate any further letters that had been sent to the complainant in regards to to the hospital's decision, the name and number of a hospital contact person, steps taken on behalf of the patient to resolve the grievance, to inform the patient of the results and a date of completion for the grievance. According to staff C, the grievance was closed by the patient liaison on 05/21/2012.

A grievance was filed on behalf of patient #31 on 03/16/2012. A"follow up" letter was sent to the complainant/patient representative on 03/22/2012. According to staff C, the grievance was closed by the patient liaison on 03/26/2012. Staff C was unable to locate any further letters that had been sent to the complainant in regards to the hospital's decision, name and number of a hospital contact person,steps taken on behalf of the patient to resolve the grievance, inform the patient of the results and a date of completion for the grievance.

A grievance was filed on behalf of patient #32 on 03/12/2012. A letter sent to the patient that lacked the information in regards to the name and number of a hospital contact person, lacked to inform the patient of the results and a date of completion for the grievance. According to staff C, the grievance was closed by the patient liaison on 03/16/2012. Staff C was unable to locate any further letters that had been sent to the complainant.

Review of the St. Mary's of Michigan policy on 06/12/2012, titled Patient complaint-Grievance Process policy number 108840-00-66 dated 03/21/12 reads on page 3 section titled Grievance Investigation, Resolution, and Documentation: 1. "The organization must get initial information to the patient representative within seven days and whenever possible a final letter written within 30 days." The policy goes on to read in 4. "No later than 30 days after the grievance is documented, the Patient Liaison will notify the patient , in writing that the case has been investigated and any pertinent information. Documentation provided to the patient will include the name of the hospital contact person, steps taken on their behalf to investigate the grievance, the results of the grievance process, and the date of the completion. The letter will also include information to request further review of the issue and how to obtain information to file a grievance with the State of Michigan, Joint Commission."

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on medical record review and interview the facility failed to inform one of one patients [patient #1] that the procedure would include an additional surgical site (to harvest bone) resulting in treatment without patient understanding of the procedure, understanding options and agreeing to the proposed care. Findings include:

Patient #1 underwent surgery for a cervical fusion of vertebra C6 and C7 on 4/9/12. The surgical consent that Patient #1 signed identifies the procedure as "anterior cervical fusion C6-7" and states that the physician explained the risks of the procedure "as discussed with patient at office appointment and dictated in operative notes."

In the complaint allegation, Patient #1 states that the surgery to harvest the bone was not a procedure approved by the patient.

During medical record review for Patient #1 on 6/12/12 at approximately 1400, it was revealed that during the initial segment of the procedure a bone graft needed for the fusion was surgically harvested from the patient's right iliac crest and the incision site was subsequently closed. When the harvested bone was determined to be unsuitable for the fusion, a section of banked bone was used to complete the fusion.

The medical record notes that post operatively, the patient is recorded as complaining of right hip pain and subsequent ambulation was affected by the patient favoring the right hip. The operative notes did not indicate that a discussion took place with Patient #1 regarding harvesting bone from the patient as part of the procedure. This was confirmed with staff N at approximately 1700 on 6/12/2012.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0175

Based on policy review, medical record review and interview the facility failed to monitor restrained patients in 1 out of 3 (#17) records reviewed, resulting in the potential for physical harm to the patient. Findings include:

On 6/12/2012 at approximately 1130 during the review of policy #106370-1-38 the following was revealed:
"20. Ongoing assessment, monitoring and interventions, as well as the plan of care, relative to the use of restraints will be reflected on the Restraint Flow Sheet-Acute Medical/Surgical Restraints and shall begin at the time restraints are initiated and should include the assessment, interventions, evaluation and need for re-intervention, as follows:
~Restraint Status
~Patient behavior
~Skin, Circulation assessment and assessment focused on detecting any injury associated with the application of restraint
~Position
~Nutritional/PO fluids offered
~Elimination
~Range of Motion and skin care
~Restraints released
~Continued restraints
~Caregiver initials ...
...21. The REASSESSMENT IS REQUIRED EVERY 2 HOURS OR MORE OFTEN BASED UPON PATIENT NEED."

On 6/12/2012 at approximately 1100 during review of patient #17's medical record it was revealed that restraints were ordered on 6/9/2012 at 1131 (at which time the patient was placed in restraints). Monitoring of the patient on the Acute Medical/Surgical Restraints Plan of Care/Flow Sheet was not documented until 6/9/2012 at 2200. No previous documentation of monitoring could be produced.

On 6/12/2012 at approximately 1100 this finding was confirmed with staff K who stated "She was on the other unit at the time the restraints were ordered, she came here with restraints on, which is when we started to document restraint monitoring. They must have forgot to document monitoring, when I received report on that patient they told me that the patient was put in restraints at about 1130 on 6/9/2012."

MEDICAL RECORD SERVICES

Tag No.: A0450

On 6/12/2012 during medical record review it revealed that patients #29 did not have evidence of a "General Consent for Services/Payment/ and Healthcare Operations" signed by either the patient or the patient's representative. The finding was confirmed with staff A at 1530 on 6/12/2012.


29314

Based on medical record review and interview the facility failed to maintain a complete medical record by completing a general consent for 8 out of 16 patients (#1, #16, #18, #20, #25, #26, #28, #29) reviewed. Findings include:
On 6/12/2012 during medical record review it revealed that patient #1 did not have evidence of a "General Consent for Services/Payment/ and Healthcare Operations" signed by either the patient or the patient's representative. The finding was confirmed with staff A at approximately 1000 on 6/12/2012.
On 6/12/2012 during medical record review it revealed that patient #16 did not have evidence of a "General Consent for Services/Payment/ and Healthcare Operations" signed by either the patient or the patient's representative. The finding was confirmed with staff A at approximately 1010 on 6/12/2012.
On 6/12/2012 during medical record review it revealed that patient #18 did not have evidence of a "General Consent for Services/Payment/ and Healthcare Operations" signed by either the patient or the patient's representative. The finding was confirmed with staff A at approximately 1015 on 6/12/2012.
On 6/12/2012 during medical record review it revealed that patient #20 did not have evidence of a "General Consent for Services/Payment/ and Healthcare Operations" signed by either the patient or the patient's representative. The finding was confirmed with staff A at approximately 1130 on 6/12/2012.
On 6/12/2012 during medical record review it revealed that patient #25 did not have evidence of a "General Consent for Services/Payment/ and Healthcare Operations" signed by either the patient or the patient's representative. The finding was confirmed with staff A at approximately 1140 on 6/12/2012.
On 6/12/2012 during medical record review it revealed that patient #26 did not have evidence of a "General Consent for Services/Payment/ and Healthcare Operations" signed by either the patient or the patient's representative. The finding was confirmed with staff A at approximately 1245 on 6/12/2012.
On 6/12/2012 during medical record review it revealed that patient #28 did not have evidence of a "General Consent for Services/Payment/ and Healthcare Operations" signed by either the patient or the patient's representative. The finding was confirmed with staff A at approximately 1245 on 6/12/2012.
On 6/12/2012 at approximately 1000 during an interview with staff A it was stated that "Every patient should have this form (General Consent for Services/Payment/ and Healthcare Operations) completed on admission."

SURGICAL SERVICES

Tag No.: A0940

Based on policy review, interview and record review, it was determined that the hospital failed to execute a consent process that adequately described proposed surgical procedure(s) for 8 out of 24 patients reviewed (#1, #5, #8, #10, #25, #26, #27, #28) and failed to properly inform 13 of 27 patients reviewed (#5, #6, #8, #9, #10, #16, #18, #23, #24, #25, #26, #28, #29) regarding their anesthesia to be used during a procedure or surgery. The findings for Patient #1 are as follows:

Patient #1 underwent surgery for a cervical fusion of vertebra C6 and C7 on 4/9/12. The surgical consent that Patient #1 signed identifies the procedure as "anterior cervical fusion C6-7". In the complaint allegation, Patient #1 states that the surgery to harvest the bone was not a procedure approved by the patient and no consent was obtained to perform the procedure... Refer to A-0955.

INFORMED CONSENT

Tag No.: A0955

Based on policy review, medical record review and interview the facility failed to properly inform patients of the procedure or surgery to be performed and possible risks for 8 out of 24 patients reviewed (#1, #5, #8, #10, #25, #26, #27, #28), and failed to properly inform 13 of 27 patients reviewed (#5, #6, #8, #9, #10, #16, #18, #23, #24, #25, #26, #28, #29) regarding their anesthesia to be used during a procedure or surgery. These failures create the potential to have a patient agree to a procedure/treatment without enough information to make an informed decision. Findings include:

Patient #1 underwent surgery for a cervical fusion of vertebra C6 and C7 on 4/9/12. The surgical consent that Patient #1 signed identifies the procedure as "anterior cervical fusion C6-7" and states that the physician explained the risks of the procedure "as discussed with patient at office appointment and dictated in operative notes."

In the complaint allegation, Patient #1 states that the surgery to harvest the bone was not a procedure approved by the patient and no consent was obtained to perform the procedure.

During medical record review for Patient #1 on 6/12/12 at approximately 1400, it was revealed that during the initial segment of the procedure a bone graft needed for the fusion was surgically harvested from the patient's right iliac crest and the incision site was subsequently closed. When the harvested bone was determined to be unsuitable for the fusion, a section of banked bone was used to complete the fusion.

The medical record notes that post operatively, the patient is recorded as complaining of right hip pain and subsequent ambulation was affected by the patient favoring the right hip. The operative notes did not indicate that a discussion took place with Patient #1 regarding harvesting bone from the patient as part of the procedure. This was confirmed with staff N at approximately 1700 on 6/12/2012.

On 6/12/2012 at approximately 1130 during review of the medical record for patient #16 it was revealed that the consent for Anesthesia/Moderate Sedation was left blank for the Dr/CRNA section and the type(s) of anesthesia to be provided. This finding was confirmed with staff K at approximately 1130 on 6/12/2012.

On 6/12/2012 at approximately 1145 during review of the medical record for patient #18 it was revealed that the consent for Anesthesia/Moderate Sedation was left blank for the Dr/CRNA section and the type(s) of anesthesia to be provided. This finding was confirmed with staff K at approximately 1145 on 6/12/2012.

On 6/12/2012 at approximately 1415 during review of the medical record for patient #25 it was revealed that the surgical consent did not include consent for the graft that was performed on the patient. The consent for Anesthesia/Moderate Sedation was left blank for the type(s) of anesthesia to be provided. This finding was confirmed with staff N at approximately 1700 on 6/12/2012.

On 6/12/2012 at approximately 1430 during review of the medical record for patient #26 it was revealed that the surgical consent did not include consent for the graft that was performed on the patient. The consent for Anesthesia/Moderate Sedation was left blank for the type(s) of anesthesia to be provided. This finding was confirmed with staff N at approximately 1700 on 6/12/2012.

On 6/12/2012 at approximately 1445 during review of the medical record for patient #27 it was revealed that the surgical consent did not include the risks explained to the patient by the physician. This finding was confirmed with staff N at approximately 1700 on 6/12/2012.

On 6/12/2012 at approximately 1500 during review of the medical record for patient #28 it was revealed that the surgical consent did not include consent for the graft that was performed on the patient. The consent for Anesthesia/Moderate Sedation was left blank for the Dr/CRNA section and the type(s) of anesthesia to be provided. This finding was confirmed with staff N at approximately 1700 on 6/12/2012.




09885

On 6/12/2012 at approximately 1115 during review of the medical record for patient #23 it was revealed that the consent for Anesthesia/Moderate Sedation was left blank for the type(s) of anesthesia to be provided. The consent did not include a date or time. This finding was confirmed with staff A at approximately 1115 on 6/12/2012.

On 6/12/2012 at approximately 1115 during review of the medical record for patient #24 it was revealed that the consent for Anesthesia/Moderate Sedation was left blank for the Dr/CRNA and type(s) of anesthesia to be provided. This finding was confirmed with staff A at approximately 1115 on 6/12/2012.



28273

On 6/12/2012 at approximately 1130 during review of the medical record for patient's #5, #8 and #10 it was revealed that the surgical consents lacked documentation in the section titled "My physician has explained to me the risks, including but not limited to ___________."

During an interview with staff A on 06/12/2012 at 1430, they confirmed the lack of documentation. Staff A stated that "the section is supposed to contain the risks of the surgical procedure that were explained to the patient."

During review of the Anesthesia consents for patients #5, #6, #8, #9, #10 & #29 on 06/12/2012, it was revealed that anesthesia consents for patients #5, #6 & #8 lacked documentation identifying the type of anesthesia to be used for the patient's procedure.

The anesthesia consents for patients #9 & #10 lacked documentation of who explained the risks of anesthesia to the patient and what type of anesthesia was to be used for the patient's procedure.

The anesthesia consent for patient #29 lacked documentation of who explained the risk risks of anesthesia to the patient.

During an interview with staff A on 06/12/2012 at 1530, they confirmed the lack of documentation on the anesthesia consents and stated that "they are supposed to contain the name of the DR/CRNA that explained the risk of the anesthesia being used and mark the type of anesthesia being given to the patient."