The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

DALLAS MEDICAL CENTER 7 MEDICAL PARKWAY DALLAS, TX 75234 May 23, 2013
VIOLATION: GOVERNING BODY Tag No: A0043
Based on interview and record review it was determined the Governing Body failed to have an effective Governing Body.

See Tags A0144, A0169, A0179, A0952, A0955.

- 9 of 10 clinical records revealed the facility failed to properly complete the informed consents dated 5/2/2013, 4/10/2013, 4/5/2013 and 4/8/2013 (patient had 2 catheterization procedures), 3/22/2013, 1/24/2013, 12/29/2012, 11/16/2012, 10/18/2012, 10/4/2012 (#2- #10). See Tag A0955

-Clinical record review revealed for 1 of 10 (#8), there was no History and Physical (H&P) prior to the cardiac procedure performed on 4/5/2013. See Tag A0952

-Clinical record review revealed for 1 of 10 (#1), patient #1 was in restraints on 10/4/2012, 10/5/2012, and 10/6/2012. Review of the clinical record revealed physician orders on an as needed basis. See Tag A0169

-Clinical record review revealed for 1 of 10 (#1), patient #1 was placed in restraints on 10/4/12 due to behavior and the facility failed to assess the patient within 1 hour of the initiation of restraints. On 10/6/12, the clinical record revealed a behavioral restraint order. See Tag A0179

In an interview on the morning of 5/23/13, it was confirmed with the CNO and the House Supervisor that the nursing documentation revealed was Behavioral Restraints. The House Supervisor confirmed there were no one hour face to face evaluations performed or nursing assessments performed as per facility policies and procedures.

It was also confirmed the morning of 5/23/13 with the CNO and the House Supervisor that patient #8 did not have an emergent procedure and the physician failed to complete the H&P prior to surgery. The CNO confirmed that the Cardiac Check list was a tool to ensure the documentation was in the chart prior to surgery and the case was performed without the H&P.

The CNO and the House Supervisor also confirmed that the facility failed to properly complete the informed consents for 9 of 10 clinical records reviewed.

Review of Facility policies and procedures entitled "Patient Rights and Responsibilities" stated "Dallas Medical Center has adopted the attached Patient's Bill of Rights and Responsibilities statement. This has been adopted as an integral part of the healing process with the expectation that observance on the part of employees, medical staff and patient will contribute to more effective patient care and greater satisfaction for all concerned. " The Patient Bill of Rights stated " Safety: The patient has the right to receive care in a safe setting, free from all forms of abuse or harassment. " " Restraints for Acute Medical and Surgical Care: A patient has the right to be free from physical restraints and drugs that are used as a restraint that are not medically necessary, or used as a means coercion, discipline, convenience, or retaliation by the staff. "

Review of Facility policies and procedures entitled "Restraints" stated "Policy: Restraints may be used as the least restrictive effective measure based on the current assessment of the patient in the immediate care environment, after other measures have been unsuccessful or determined to be inappropriate (clinical justification); A time limited physician order is required in addition to adequate clinical justification (sic) Documentation in the medical record must include other measures attempted and rationale for continued use of restraints." "C. Patient Rights: Patients have the right to be free from restraints." "D. Assessment: 1. History of behavior ... 3. Current behavior; 4. Physical and cognitive status; 5. Current risk factors associated with observed behavior ... 7. Patient/family concepts /feelings about restraints; 8. Least restrictive method chosen; 9. Alternatives tried/ failed in the past (ineffective methods)." "E. Documentation: 1. Patient assessment prior to the implementation of restraints."

"V. Section Two: Behavioral Use of Restraints:" stated "A. Authorization and ordering of restraints." "3. The physician, or other licensed independent practitioner authorized to order restraints, must see and evaluate the patient within one hour of the initiation of restraints ... 6. "PRN or "standing" restraints orders are unacceptable and will not be employed to authorize their use ... 7. Written orders for restraints are limited to: 4 hours for adults ...10. Contents of a restraint order will include: the type of restraint, device ...the maximum length of time restraint or seclusion may be utilized." "Documentation: 3. Each episode of restraint/seclusion use documentation includes: a. Circumstances leading to use with evidence of danger to self or others ... e. Written order for use ... i. Each face to face reassessment of the patient; j. 15 minute assessments of the patient's status."

"VI. Section Three: Non-Behavioral Use of Restraints:" stated "B. Documentation: 1. Entries will be made at regular intervals according to the individual's assessed needs but not to exceed 2 hours between intervals..."

Review of Facility Bylaws: Medical Staff Rules and Regulations stated, "II. Medical Records: 3. d. A completed H&P must be done prior to any surgical procedure or the procedure will be cancelled."

Review of Facility policy and procedure entitled "Informed Consents" stated, " III. Responsibility: It is the responsibility of the physician to inform the patient or patient representative designative by law about the alternatives to, risks, benefits and potential complications of, the treatments, and services under consideration and to complete the diagnosis, procedure and risk and benefits portion of the "Disclosure and Consent." It is the responsibility of the nurse to verify that the consents are properly completed according by the physician and are properly signed by the patient or patient representative designated by law..."
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on clinical record review, policy and procedure reviews, and interviews with staff, it was determined the facility failed to protect the rights for patient #1.

-Clinical record review revealed for 1 of 10 (#1) patients that the facility failed to provide care in a safe setting. See Tag A0144.

-Clinical record review revealed for 1 of 10 (#1), patient #1 was in restraints on 10/4/2012, 10/5/2012, and 10/6/2012. Review of the clinical record revealed physician orders on an as needed basis. See Tag A0169

-Clinical record review revealed for 1 of 10 (#1), patient #1 was placed in restraints on 10/4/12 due to behavior and the facility failed to assess the patient within 1 hour of the initiation of restraints. On 10/6/12, the clinical record revealed a behavioral restraint order. See Tag A0179.

In an interview on the morning of 5/23/13, it was confirmed with the CNO and the House Supervisor that the nursing documentation revealed was Behavioral Restraints. The House Supervisor confirmed there were no one hour face to face evaluations performed or nursing assessments performed as per facility policies and procedures.

In an interview on the morning of 5/23/2013, it was confirmed with the House Supervisor the facility was currently using the Restraint ICU Flowsheet to assess patients in restraints. It was also confirmed that the Restraint ICU Flowsheet was currently used on the Med/Surg unit.

It was also confirmed the morning of 5/23/13with the CNO and the House Supervisor that the physician orders were PRN "as needed" orders.

Review of Facility policies and procedures entitled "Patient Rights and Responsibilities" stated "Dallas Medical Center has adopted the attached Patient's Bill of Rights and Responsibilities statement. This has been adopted as an integral part of the healing process with the expectation that observance on the part of employees, medical staff and patient will contribute to more effective patient care and greater satisfaction for all concerned. " The Patient Bill of Rights stated " Safety: The patient has the right to receive care in a safe setting, free from all forms of abuse or harassment. " " Restraints for Acute Medical and Surgical Care: A patient has the right to be free from physical restraints and drugs that are used as a restraint that are not medically necessary, or used as a means coercion, discipline, convenience, or retaliation by the staff. "

Review of Facility policies and procedures entitled "Restraints" stated "Policy: Restraints may be used as the least restrictive effective measure based on the current assessment of the patient in the immediate care environment, after other measures have been unsuccessful or determined to be inappropriate (clinical justification); A time limited physician order is required in addition to adequate clinical justification (sic) Documentation in the medical record must include other measures attempted and rationale for continued use of restraints." "C. Patient Rights: Patients have the right to be free from restraints." "D. Assessment: 1. History of behavior ... 3. Current behavior; 4. Physical and cognitive status; 5. Current risk factors associated with observed behavior ... 7. Patient/family concepts /feelings about restraints; 8. Least restrictive method chosen; 9. Alternatives tried/ failed in the past (ineffective methods)." "E. Documentation: 1. Patient assessment prior to the implementation of restraints."

"V. Section Two: Behavioral Use of Restraints:" stated "A. Authorization and ordering of restraints." "3. The physician, or other licensed independent practitioner authorized to order restraints, must see and evaluate the patient within one hour of the initiation of restraints ... 6. "PRN or "standing" restraints orders are unacceptable and will not be employed to authorize their use ... 7. Written orders for restraints are limited to: 4 hours for adults ...10. Contents of a restraint order will include: the type of restraint, device ...the maximum length of time restraint or seclusion may be utilized." "Documentation: 3. Each episode of restraint/seclusion use documentation includes: a. Circumstances leading to use with evidence of danger to self or others ... e. Written order for use ... i. Each face to face reassessment of the patient; j. 15 minute assessments of the patient's status."

"VI. Section Three: Non-Behavioral Use of Restraints:" stated "B. Documentation: 1. Entries will be made at regular intervals according to the individual's assessed needs but not to exceed 2 hours between intervals..."
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on clinical record review, policy and procedure reviews, and interviews with staff, it was determined the facility failed to provide care in a safe setting for patient #1. Patient #1 was in restraints on 10/4/12, 10/5/12, and 10/6/12 without assessments completed and physician orders as per facility policies and procedures.

Findings included:

Clinical record review for patient #1 revealed the patient had a cardiac catheterization procedure on 10/4/12. The record revealed the following:

A physician's order dated 10/4/12 at 4:49pm revealed "Restraints as needed; Ativan 1-2mg IV Q4 (every 4 hours)...Agitation ..."

On 10/4/12 at 5:00pm in the "Initial Restraint Evaluation" the nurse noted "Prevent injury to self, Medical necessity." The nurse also noted the behavior observed "Combative, Restless, Agitated-quiet." The restraints used "Soft limb restraints and LL (left leg)."

A physician's "Restraint Orders" dated 10/4/12 at 5:00pm to 10/5/12 at 8:00am stated "Type of Restraint: Limb; Reason for restraints: Pulling at Tubes."

Nurses notes dated 10/4/12 at 5:15pm stated "Unable to keep this patient calm even with Ativan 2 mg. Lt groin sheath intact no bleeding and no hematoma. VSS (Vital Signs Stable)." At 5:45pm the nurse noted "Pt received from the Cath Lab, on restraint, and very agitated, unable to keep pt in bed and left leg straight..."

On 10/4/12 at 6:00pm the nurse noted "Wrist restraint d/c (discontinued) and LT leg restraint remain to keep pt leg in straight postion (sic). VSS no c/o (complaints of) pain, still fighting and getting up."

On 10/4/12 at 7:20pm the left femoral sheath was discontinued. At 8:30pm the nurse noted "2 mg of Ativan given IVP for "Pt attempting to get out of bed continuously." On 10/5/12 at 2:00am, the nurse noted "pt restless attempting to get out of bed Ativan given."

On 10/5/12 at 10:00am the nurse noted in the restraint flowsheet that patient #1 was placed in vest and wrist restraints for "Pt attempting to climb oob (out of bed) unassisted and pulling at tubes."

A physician "Restraint Orders" dated 10/5/12 at 10:00am to 10/6/12 to 7:59am stated "Type of Restraint: Limb, Vest; Reason for Restraint: Pulling at tubes, other: blank."

Nurses notes dated 10/5/12 at 3:49pm stated "pt continues to be confused and occasionally combative kicking and attempting to swing punches at RN whenever unrestrained."

At 4:25pm, the nurse noted "pt very agitated and unable to redirect. Lorazepam 1mg adm IV as ordered..."

On 10/6/12 at 12:30am, the nurse noted "Patient more alert and cooperative, Dinner provided, had 50%, Restraint release for trial. Bed alarm on."

On 10/6/12 at 4:05pm, the nurse noted "pt attempting to climb out of bed. Interpretors (sic) at bedside. Stating pt is saying he needs to go some where (sic) at 6:00am. Pt placed in Posey vest, Pt previously put in wrist restraints, Pt dc'd IV to FA."

At 7:27pm the nurse called the physician for restraint order.

On 10/6/12 at 7:30pm, the nurse noted "pt transferred from ICU, pt alert but confused, tried to pull IV's, foley catheter and tried to get out of bed. Order for restraints in place. Sitter at bedside." At 10:00pm, the nurse noted "trial with releasing restraints, unable to as he tries to pull foley, IV, won't keep O2 on."

A physician "Restraint Orders" dated 10/6/12 at 7:30pm to 10/7/12 at 7:30pm stated "Type of Restraints: Limb, Vest, other: Mittens; Reasons for Restraint: Non- Behavioral: Pulling at Tubes, other: pt attempting to climb out of bed; Behavioral: Danger to Self, Danger to Others."

At 5:00am, the nurse noted "trial of restraints being off, wanting to get out of bed, sitter at bedside."

A physician "Restraint Orders" signed by the physician on 10/7/12 stated "Reason for Restraint: Pulling at Tubes" was found in the clinical record for patient #1. There was no type of restraints, start or end date and time on the restraint order.

In an interview on the morning of 5/23/13, it was confirmed with the CNO and the House Supervisor that the nursing documentation revealed was Behavioral Restraints. The House Supervisor confirmed there were no one hour face to face evaluations performed or nursing assessments performed as per facility policies and procedures.

In an interview on the morning of 5/23/2013, it was confirmed with the House Supervisor the facility was currently using the Restraint ICU Flowsheet to assess patients in restraints. It was also confirmed that the Restraint ICU Flowsheet was currently used on the Med/Surg unit.

Review of Facility policies and procedures entitled "Patient Rights and Responsibilities" stated "Dallas Medical Center has adopted the attached Patient's Bill of Rights and Responsibilities statement. This has been adopted as an integral part of the healing process with the expectation that observance on the part of employees, medical staff and patient will contribute to more effective patient care and greater satisfaction for all concerned. " The Patient Bill of Rights stated " Safety: The patient has the right to receive care in a safe setting, free from all forms of abuse or harassment. " " Restraints for Acute Medical and Surgical Care: A patient has the right to be free from physical restraints and drugs that are used as a restraint that are not medically necessary, or used as a means coercion, discipline, convenience, or retaliation by the staff. "

Review of Facility policies and procedures entitled "Restraints" stated "Policy: Restraints may be used as the least restrictive effective measure based on the current assessment of the patient in the immediate care environment, after other measures have been unsuccessful or determined to be inappropriate (clinical justification); A time limited physician order is required in addition to adequate clinical justification (sic) Documentation in the medical record must include other measures attempted and rationale for continued use of restraints." "C. Patient Rights: Patients have the right to be free from restraints." "D. Assessment: 1. History of behavior ... 3. Current behavior; 4. Physical and cognitive status; 5. Current risk factors associated with observed behavior ... 7. Patient/family concepts /feelings about restraints; 8. Least restrictive method chosen; 9. Alternatives tried/ failed in the past (ineffective methods)." "E. Documentation: 1. Patient assessment prior to the implementation of restraints."

"V. Section Two: Behavioral Use of Restraints:" stated "A. Authorization and ordering of restraints." "3. The physician, or other licensed independent practitioner authorized to order restraints, must see and evaluate the patient within one hour of the initiation of restraints ... 6. "PRN or "standing" restraints orders are unacceptable and will not be employed to authorize their use ... 7. Written orders for restraints are limited to: 4 hours for adults ...10. Contents of a restraint order will include: the type of restraint, device ...the maximum length of time restraint or seclusion may be utilized." "Documentation: 3. Each episode of restraint/seclusion use documentation includes: a. Circumstances leading to use with evidence of danger to self or others ... e. Written order for use ... i. Each face to face reassessment of the patient; j. 15 minute assessments of the patient's status."

"VI. Section Three: Non-Behavioral Use of Restraints:" stated "B. Documentation: 1. Entries will be made at regular intervals according to the individual's assessed needs but not to exceed 2 hours between intervals..."
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0169
Based on clinical record review, policy and procedure reviews, and interviews with staff, the facility failed to follow facility policies and procedures, Physician orders for restraints were written on a PRN "as needed" basis for patient #1.

Findings included:

Record review of clinical record revealed physician's order dated 10/4/12 at 4:49pm revealed "Restraints as needed; Ativan 1-2mg IV Q4 (every 4 hours)...Agitation ..."

Record review of clinical record physician "Restraint Orders" signed by the physician on 10/7/12 stated "Reason for Restraint: Pulling at Tubes" was found in the clinical record for patient #1. There was no type of restraints, start or end date and time on the restraint order.

In an interview on the morning of 5/23/13, it was confirmed with the CNO and the House Supervisor that the physician orders were PRN "standing" orders.

Review of Facility policies and procedures entitled "Patient Rights and Responsibilities" stated "Dallas Medical Center has adopted the attached Patient's Bill of Rights and Responsibilities statement. This has been adopted as an integral part of the healing process with the expectation that observance on the part of employees, medical staff and patient will contribute to more effective patient care and greater satisfaction for all concerned." The Patient Bill of Rights stated "Safety: The patient has the right to receive care in a safe setting, free from all forms of abuse or harassment." "Restraints for Acute Medical and Surgical Care: A patient has the right to be free from physical restraints and drugs that are used as a restraint that are not medically necessary, or used as a means coercion, discipline, convenience, or retaliation by the staff. "

Review of Facility policies and procedures entitled "Restraints" stated "Policy: Restraints may be used as the least restrictive effective measure based on the current assessment of the patient in the immediate care environment, after other measures have been unsuccessful or determined to be inappropriate (clinical justification); A time limited physician order is required in addition to adequate clinical justification (sic) Documentation in the medical record must include other measures attempted and rationale for continued use of restraints." "C. Patient Rights: Patients have the right to be free from restraints." "D. Assessment: 1. History of behavior ... 3. Current behavior; 4. Physical and cognitive status; 5. Current risk factors associated with observed behavior ... 7. Patient/family concepts/feelings about restraints; 8. Least restrictive method chosen; 9. Alternatives tried/ failed in the past (ineffective methods)." "E. Documentation: 1. Patient assessment prior to the implementation of restraints."

"V. Section Two: Behavioral Use of Restraints:" stated "A. Authorization and ordering of restraints." "3. The physician, or other licensed independent practitioner authorized to order restraints, must see and evaluate the patient within one hour of the initiation of restraints ... 6. "PRN or "standing" restraints orders are unacceptable and will not be employed to authorize their use ... 7. Written orders for restraints are limited to: 4 hours for adults ...10. Contents of a restraint order will include: the type of restraint, device ...the maximum length of time restraint or seclusion may be utilized." "Documentation: 3. Each episode of restraint/seclusion use documentation includes: a. Circumstances leading to use with evidence of danger to self or others ... e. Written order for use ... i. Each face to face reassessment of the patient; j. 15 minute assessments of the patient's status."

"VI. Section Three: Non-Behavioral Use of Restraints:" stated "B. Documentation: 1. Entries will be made at regular intervals according to the individual's assessed needs but not to exceed 2 hours between intervals..."
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0179
Based on clinical record review, policy and procedure reviews, and interviews with staff, the facility failed to perform the one hour face to face evaluation after the initiation of restraints for behavioral reasons.

Findings included:

Record review of clinical record on 10/4/12 at 5:00pm in the "Initial Restraint Evaluation" the nurse noted "Prevent injury to self, Medical necessity." The nurse also noted the behavior observed "Combative, Restless, Agitated-quiet." The restraints used "Soft limb restraints and LL (left leg)."

A physician's "Restraint Orders" dated 10/4/12 at 5:00pm to 10/5/12 at 8:00am stated "Type of Restraint: Limb; Reason for restraints: Pulling at Tubes."

Nurses notes dated 10/4/12 at 5:15pm stated "Unable to keep this patient calm even with Ativan 2 mg. Lt groin sheath intact no bleeding and no hematoma. VSS (Vital Signs Stable)." At 5:45pm the nurse noted "Pt received from the Cath Lab, on restraint, and very agitated, unable to keep pt in bed and left leg straight..."

On 10/4/12 at 6:00pm the nurse noted "Wrist restraint d/c (discontinued) and LT leg restraint remain to keep pt leg in straight postion (sic). VSS no c/o (complaints of) pain, still fighting and getting up."

On 10/4/12 at 7:20pm the left femoral sheath was discontinued. At 8:30pm the nurse noted "2 mg of Ativan given IVP for "Pt attempting to get out of bed continuously." On 10/5/12 at 2:00am, the nurse noted "pt restless attempting to get out of bed Ativan given."

On 10/5/12 at 10:00am the nurse noted in the restraint flowsheet that patient #1 was placed in vest and wrist restraints for "Pt attempting to climb oob (out of bed) unassisted and pulling at tubes."

A physician "Restraint Orders" dated 10/5/12 at 10:00am to 10/6/12 to 7:59am stated "Type of Restraint: Limb, Vest; Reason for Restraint: Pulling at tubes, other: blank."

Nurses notes dated 10/5/12 at 3:49pm stated "pt continues to be confused and occasionally combative kicking and attempting to swing punches at RN whenever unrestrained."

At 4:25pm, the nurse noted "pt very agitated and unable to redirect. Lorazepam 1mg adm IV as ordered..."

On 10/6/12 at 12:30am, the nurse noted "Patient more alert and cooperative, Dinner provided, had 50%, Restraint release for trial. Bed alarm on."

On 10/6/12 at 4:05pm, the nurse noted "pt attempting to climb out of bed. Interpretors (sic) at bedside. Stating pt is saying he needs to go some where (sic) at 6:00am. Pt placed in Posey vest, Pt previously put in wrist restraints, Pt dc'd IV to FA."

At 7:27pm the nurse called the physician for restraint order.

On 10/6/12 at 7:30pm, the nurse noted "pt transferred from ICU, pt alert but confused, tried to pull IV's, foley catheter and tried to get out of bed. Order for restraints in place. Sitter at bedside." At 10:00pm, the nurse noted "trial with releasing restraints, unable to as he tries to pull foley, IV, won't keep O2 on."

A physician "Restraint Orders" dated 10/6/12 at 7:30pm to 10/7/12 at 7:30pm stated "Type of Restraints: Limb, Vest, other: Mittens; Reasons for Restraint: Non- Behavioral: Pulling at Tubes, other: pt attempting to climb out of bed; Behavioral: Danger to Self, Danger to Others."

At 5:00am, the nurse noted "trial of restraints being off, wanting to get out of bed, sitter at bedside."

A physician "Restraint Orders" signed by the physician on 10/7/12 stated "Reason for Restraint: Pulling at Tubes" was found in the clinical record for patient #1. There was no type of restraints, start or end date and time on the restraint order.

In an interview on the morning of 5/23/13, it was confirmed with the CNO and the House Supervisor that the nursing documentation revealed was Behavioral Restraints. The House Supervisor confirmed there were no one hour face to face evaluations performed or nursing assessments performed as per facility policies and procedures.

In an interview on the morning of 5/23/2013, it was confirmed with the House Supervisor the facility was currently using the Restraint ICU Flowsheet to assess patients in restraints. It was also confirmed that the Restraint ICU Flowsheet was currently used on the Med/Surg unit.

Review of Facility policies and procedures entitled "Patient Rights and Responsibilities" stated "Dallas Medical Center has adopted the attached Patient's Bill of Rights and Responsibilities statement. This has been adopted as an integral part of the healing process with the expectation that observance on the part of employees, medical staff and patient will contribute to more effective patient care and greater satisfaction for all concerned. " The Patient Bill of Rights stated " Safety: The patient has the right to receive care in a safe setting, free from all forms of abuse or harassment. " " Restraints for Acute Medical and Surgical Care: A patient has the right to be free from physical restraints and drugs that are used as a restraint that are not medically necessary, or used as a means coercion, discipline, convenience, or retaliation by the staff. "

Review of Facility policies and procedures entitled "Restraints" stated "Policy: Restraints may be used as the least restrictive effective measure based on the current assessment of the patient in the immediate care environment, after other measures have been unsuccessful or determined to be inappropriate (clinical justification); A time limited physician order is required in addition to adequate clinical justification (sic) Documentation in the medical record must include other measures attempted and rationale for continued use of restraints." "C. Patient Rights: Patients have the right to be free from restraints." "D. Assessment: 1. History of behavior ... 3. Current behavior; 4. Physical and cognitive status; 5. Current risk factors associated with observed behavior ... 7. Patient/family concepts /feelings about restraints; 8. Least restrictive method chosen; 9. Alternatives tried/ failed in the past (ineffective methods)." "E. Documentation: 1. Patient assessment prior to the implementation of restraints."

"V. Section Two: Behavioral Use of Restraints:" stated "A. Authorization and ordering of restraints." "3. The physician, or other licensed independent practitioner authorized to order restraints, must see and evaluate the patient within one hour of the initiation of restraints ... 6. 7. Written orders for restraints are limited to: 4 hours for adults ...10. Contents of a restraint order will include: the type of restraint, device ...the maximum length of time restraint or seclusion may be utilized." "Documentation: 3. Each episode of restraint/seclusion use documentation includes: a. Circumstances leading to use with evidence of danger to self or others ... e. Written order for use ... i. Each face to face reassessment of the patient; j. 15 minute assessments of the patient's status."
VIOLATION: MEDICAL STAFF RESPONSIBILITIES Tag No: A0358
Based on clinical record review, policy and procedure reviews, and interviews with staff, the facility failed to complete a History & Physical (H&P) prior to the surgical procedure for patient #8.

Findings included:

During a clinical record review for patient #8 revealed the following:

-Cardiac Cath Check List revealed the nurse checked off the H&P was not in the chart.

-A consent form dated 4/5/2013 for a "Right and/or left heart catherterization (sic), possible percutaneous transluminal coronary angioplasty, possible stent placement, possible coronary artery bypass graft, possible intraortic balloon pump insertion."

-An operative report dated 4/5/2013 revealed the procedures performed "Left heart catheterization; Selective coronary angiogram; Left ventriculogram; Moderate sedation; PTCA and stent placement of right coronary artery."

In an interview on the morning of 5/23/13, it was confirmed with the CNO and the House Supervisor that patient #8 did not have an emergent procedure and the physician failed to complete the H&P prior to surgery. The CNO confirmed that the Cardiac Check list was a tool to ensure the documentation was in the chart prior to surgery and the case was performed without the H&P.

Review of Facility Bylaws: Medical Staff Rules and Regulations stated, "II. Medical Records: 3. d. A completed H&P must be done prior to any surgical procedure or the procedure will be cancelled."
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on clinical record review, policy and procedure reviews, and interviews with staff, it was determined the facility failed to evaluate the care for patient #1 while in restraints.

Findings included:

Clinical record review for patient #1 revealed the patient was a Spanish speaker who had a cardiac catheterization procedure on 10/4/12. The record revealed the following:

A physician's order dated 10/4/12 at 4:49pm revealed "Restraints as needed; Ativan 1-2mg IV Q4 (every 4 hours)...Agitation ..."

On 10/4/12 at 5:00pm in the "Initial Restraint Evaluation" the nurse noted "Prevent injury to self, Medical necessity." The nurse also noted the behavior observed "Combative, Restless, Agitated-quiet." The restraints used "Soft limb restraints and LL (left leg)."

A physician's "Restraint Orders" dated 10/4/12 at 5:00pm to 10/5/12 at 8:00am stated "Type of Restraint: Limb; Reason for restraints: Pulling at Tubes."

Nurses notes dated 10/4/12 at 5:15pm stated "Unable to keep this patient calm even with Ativan 2 mg. Lt groin sheath intact no bleeding and no hematoma. VSS (Vital Signs Stable)." At 5:45pm the nurse noted "Pt received from the Cath Lab, on restraint, and very agitated, unable to keep pt in bed and left leg straight..."

On 10/4/12 at 6:00pm the nurse noted "Wrist restraint d/c (discontinued) and LT leg restraint remain to keep pt leg in straight postion (sic). VSS no c/o (complaints of) pain, still fighting and getting up."

On 10/4/12 at 7:20pm the left femoral sheath was discontinued. At 8:30pm the nurse noted "2 mg of Ativan given IVP for "Pt attempting to get out of bed continuously." On 10/5/12 at 2:00am, the nurse noted "pt restless attempting to get out of bed Ativan given."

On 10/5/12 at 10:00am the nurse noted in the restraint flowsheet that patient #1 was placed in vest and wrist restraints for "Pt attempting to climb oob (out of bed) unassisted and pulling at tubes."

A physician "Restraint Orders" dated 10/5/12 at 10:00am to 10/6/12 to 7:59am stated "Type of Restraint: Limb, Vest; Reason for Restraint: Pulling at tubes, other: blank."

Nurses notes dated 10/5/12 at 3:49pm stated "pt continues to be confused and occasionally combative kicking and attempting to swing punches at RN whenever unrestrained."

At 4:25pm, the nurse noted "pt very agitated and unable to redirect. Lorazepam 1mg adm IV as ordered..."

On 10/6/12 at 12:30am, the nurse noted "Patient more alert and cooperative, Dinner provided, had 50%, Restraint release for trial. Bed alarm on."

On 10/6/12 at 4:05pm, the nurse noted "pt attempting to climb out of bed. Interpretors (sic) at bedside. Stating pt is saying he needs to go some where (sic) at 6:00am. Pt placed in Posey vest, Pt previously put in wrist restraints, Pt dc'd IV to FA."

At 7:27pm the nurse called the physician for restraint order.

On 10/6/12 at 7:30pm, the nurse noted "pt transferred from ICU, pt alert but confused, tried to pull IV's, foley catheter and tried to get out of bed. Order for restraints in place. Sitter at bedside." At 10:00pm, the nurse noted "trial with releasing restraints, unable to as he tries to pull foley, IV, won't keep O2 on."

A physician "Restraint Orders" dated 10/6/12 at 7:30pm to 10/7/12 at 7:30pm stated "Type of Restraints: Limb, Vest, other: Mittens; Reasons for Restraint: Non- Behavioral: Pulling at Tubes, other: pt attempting to climb out of bed; Behavioral: Danger to Self, Danger to Others."

At 5:00am, the nurse noted "trial of restraints being off, wanting to get out of bed, sitter at bedside."

A physician "Restraint Orders" signed by the physician on 10/7/12 stated "Reason for Restraint: Pulling at Tubes" was found in the clinical record for patient #1. There was no type of restraints, start or end date and time on the restraint order.

In an interview on the morning of 5/23/13, it was confirmed with the CNO and the House Supervisor that the nursing documentation revealed was Behavioral Restraints. The House Supervisor confirmed there were no one hour face to face evaluations performed or nursing assessments performed as per facility restraint policies and procedures.

In an interview on the morning of 5/23/2013, it was confirmed with the House Supervisor the facility was currently using the Restraint ICU Flowsheet to assess patients in restraints. It was also confirmed that the Restraint ICU Flowsheet was currently used on the Med/Surg unit.

Review of Facility policies and procedures entitled "Patient Rights and Responsibilities" stated "Dallas Medical Center has adopted the attached Patient's Bill of Rights and Responsibilities statement. This has been adopted as an integral part of the healing process with the expectation that observance on the part of employees, medical staff and patient will contribute to more effective patient care and greater satisfaction for all concerned. " The Patient Bill of Rights stated " Safety: The patient has the right to receive care in a safe setting, free from all forms of abuse or harassment. " " Restraints for Acute Medical and Surgical Care: A patient has the right to be free from physical restraints and drugs that are used as a restraint that are not medically necessary, or used as a means coercion, discipline, convenience, or retaliation by the staff. "

Review of Facility policies and procedures entitled "Restraints" stated "Policy: Restraints may be used as the least restrictive effective measure based on the current assessment of the patient in the immediate care environment, after other measures have been unsuccessful or determined to be inappropriate (clinical justification); A time limited physician order is required in addition to adequate clinical justification (sic) Documentation in the medical record must include other measures attempted and rationale for continued use of restraints." "C. Patient Rights: Patients have the right to be free from restraints." "D. Assessment: 1. History of behavior ... 3. Current behavior; 4. Physical and cognitive status; 5. Current risk factors associated with observed behavior ... 7. Patient/family concepts /feelings about restraints; 8. Least restrictive method chosen; 9. Alternatives tried/ failed in the past (ineffective methods)." "E. Documentation: 1. Patient assessment prior to the implementation of restraints."

"V. Section Two: Behavioral Use of Restraints:" stated "A. Authorization and ordering of restraints." "3. The physician, or other licensed independent practitioner authorized to order restraints, must see and evaluate the patient within one hour of the initiation of restraints ... 6. "PRN or "standing" restraints orders are unacceptable and will not be employed to authorize their use ... 7. Written orders for restraints are limited to: 4 hours for adults ...10. Contents of a restraint order will include: the type of restraint, device ...the maximum length of time restraint or seclusion may be utilized." "Documentation: 3. Each episode of restraint/seclusion use documentation includes: a. Circumstances leading to use with evidence of danger to self or others ... e. Written order for use ... i. Each face to face reassessment of the patient; j. 15 minute assessments of the patient's status."

"VI. Section Three: Non-Behavioral Use of Restraints:" stated "B. Documentation: 1. Entries will be made at regular intervals according to the individual's assessed needs but not to exceed 2 hours between intervals..."
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0450
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on clinical record review, policy and procedure reviews, and interviews with staff, the facility failed to ensure all clinical record entries were legible, completed, dated, timed, and authenticated.

Findings included:

During a clinical record review of 4 of 10 charts (#1, #3, #8, #9) revealed the physician failed to sign, date, and time the orders:

For example:

Review of the clinical record for patient #9 revealed a verbal order dated 4/10/2013 at 8:50am stated, "Hydralazine 20mg IV x1 now." A verbal order dated 4/10/2013 at 11:20am that stated, "Clonidine 0.1mg PO x1 now; Repeat 0.1mg in ? hour & call MD results."

In the clinical record for patient #8 revealed a verbal order dated 4/7/2013 at 11:00am that stated, "Stop IVF now; Start IV NS at 100cc/hr at 2100; NPO after light breakfast." A verbal order dated 4/9/2013 at 1:50pm stated, " D/C (discontinue) IV fluid; okay to transfer pt tele."

Review of the clinical record for patient #3 revealed an admitted [DATE] and a verbal order that stated, "Demerol 50mg IV Q4 PRN (as needed) for pain." There was no date, time the nurse received the order.

In the clinical record for patient #1 revealed a verbal order dated 10/4/2012 at 4:49pm "Restraints as needed; Ativan 1-2 mg IV, Q4 (very 4 hours)... Agitation..." A verbal physician order stated " Okay to transfer pt with sitter to telemetry." There was also no date, time the nurse received the order.

In an interview on the morning of 5/23/13, it was confirmed with the CNO and the House Supervisor that the facility failed to sign, date, and time all entries in the medical records. It was also confirmed that the facility failed to follow policies and procedures.

Review of Facility policy and procedures entitled "Medical Record Documentation" stated "IV. Procedure: Do the Following: 3. Sign, date, and time all entries using either am/pm or military time."
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on clinical record review, policy and procedure reviews, and interviews with staff, the facility failed to maintain a log incidents related to infections and communicable diseases.

Findings included:

In an interview the morning of 5/23/2013 with the Infection Control Preventionist, it was confirmed that she was unable to locate the log from 2012. She stated she started in the position in November 2012. She confirmed she could only show data from January 2013 to current. She stated each department had its own infection control data from 2012 in Handwashing (for example) but that they reported 100% compliance. She stated she believed the data to be inaccurate as her data reported the facility was not in 100% compliance.

Review of Facility policy and procedure entitled "Infection Prevention & Control Plan" stated "The Infection Prevention and Control Plan outlines the processes applicable to all infections or potential sources of infection that hospital staff, practitioners, and administrators might encounter, including a sudden influx of potentially infectious patients."
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on clinical record review, policy and procedure reviews, and interviews with staff, the facility failed to ensure surgical records were completed as per facility policies and procedures. Documentation revealed the following:

-Clinical record review revealed for 1 of 10 (#8), there was no History and Physical (H&P) prior to the cardiac procedure performed on 4/5/2013. See Tag A0952

-9 of 10 clinical records revealed the facility failed to properly complete the informed consents dated 5/2/2013, 4/10/2013, 4/5/2013 and 4/8/2013 (patient had 2 catheterization procedures), 3/22/2013, 1/24/2013, 12/29/2012, 11/16/2012, 10/18/2012, 10/4/2012 (#2- #10).

In an interview on the morning of 5/23/13, it was confirmed with the CNO and the House Supervisor that patient #8 did not have an emergent procedure and the physician failed to complete the H&P prior to surgery. The CNO confirmed that the Cardiac Check list was a tool to ensure the documentation was in the chart prior to surgery and the case was performed without the H&P.

It was also confirmed the morning of 5/23/13 with the CNO and the House Supervisor that the facility failed to properly complete the informed consents for 9 of 10 clinical records reviewed.

Review of Facility Bylaws: Medical Staff Rules and Regulations stated, "II. Medical Records: 3. d. A completed H&P must be done prior to any surgical procedure or the procedure will be cancelled."

Review of Facility policy and procedure entitled "Informed Consents" stated, " III. Responsibility: It is the responsibility of the physician to inform the patient or patient representative designative by law about the alternatives to, risks, benefits and potential complications of, the treatments, and services under consideration and to complete the diagnosis, procedure and risk and benefits portion of the "Disclosure and Consent." It is the responsibility of the nurse to verify that the consents are properly completed according by the physician and are properly signed by the patient or patient representative designated by law..."
VIOLATION: HISTORY AND PHYSICAL Tag No: A0952
Based on clinical record review, policy and procedure reviews, and interviews with staff, the facility failed to complete a History & Physical (H&P) prior to the surgical procedure for patient #8.

Findings included:

During a clinical record review for patient #8 revealed the following:

Cardiac Cath Check List revealed the nurse checked off the H&P was not in the chart.

A consent form dated 4/5/2013 for a "Right and/or left heart catherterization (sic), possible percutaneous transluminal coronary angioplasty, possible stent placement, possible coronary artery bypass graft, possible intraortic balloon pump insertion."

An operative report dated 4/5/2013 revealed the procedures performed " Left heart catheterization; Selective coronary angiogram; Left ventriculogram; Moderate sedation; PTCA and stent placement of right coronary artery."

In an interview on the morning of 5/23/13, it was confirmed with the CNO and the House Supervisor that patient #8 did not have an emergent procedure and the physician failed to complete the H&P prior to surgery. The CNO confirmed that the Cardiac Check list was a tool to ensure the documentation was in the chart prior to surgery and the case was performed without the H&P.

Review of Facility Bylaws: Medical Staff Rules and Regulations stated, "II. Medical Records: 3. d. A completed H&P must be done prior to any surgical procedure or the procedure will be cancelled."
VIOLATION: INFORMED CONSENT Tag No: A0955
Based on clinical record review, policy and procedure reviews, and interviews with staff, the facility failed to properly complete the informed consents for 9 of 10 clinical records reviewed.

Findings included:

During a clinical record review of 9 of 10 cardiac catheterization records (#2-#10) revealed the following:

Review of 1 of 10 (#10) clinical records revealed an informed consent dated 5/2/2013 the physician failed to sign, date, and time the consent form.

Review of the clinical record for patient #8 revealed the patient signed the consent form on 3/7/2013 at 10:00pm and the physician signed the consent on 4/8/2013 (no time).

Review of the clinical record for patient #7 revealed the patient signed the consent form on 3/23/2013 at 8:30am and the physician signed the consent on 3/22/2013 at 12:00pm. The Operative Report revealed patient #7 had the procedure on 3/22/2013. The patient dated the informed consent for the day after the surgical procedure.

In the section of the consent form which stated "Just as there may be risks and hazards in continuing my present condition without treatment, there are also risks and hazards related to the performance of the surgical, medical, and/or diagnostic procedures planned for me. I realize that common to surgical, medical, and/or diagnostic procedures is the potential for infection blood clots in veins, and lungs, hemorrhage (excessive bleeding), allergic reactions, and even death. I also realize that the following risks and hazards may occur in connection with this particular procedure:"

Review of 6 of 10 clinical records revealed the risk section was left blank on the informed consents dated 5/2/2013, 4/5/2013 and 4/8/2013 (patient had 2 procedures), 3/22/2013, 12/29/2012, 10/18/2012, and 10/4/2012, and (#2, #3, #5, #7, #8, and #10) the risk section was left blank.

Review of 3 of 10 clinical records revealed the informed consents dated 4/10/2013, 1/24/2013, and 11/16/2012 (#4, #6, and #9) had medical abbreviations in the risk section. For example: CVA and MI.

Review of 5 of 10 clinical records revealed the informed consents dated 4/5/2013 and 4/8/2013, 3/22/2013, 11/16/2012, 10/18/2012, and 10/4/2012 (#2, #3, #4, #7, and #8) the nurse failed to date and time the consent form.

In an interview on the morning of 5/23/13, it was confirmed with the CNO and the House Supervisor that the facility failed to properly complete the informed consents. It was also confirmed that the physician signs the consent forms prior to surgery. The CNO confirmed that the informed consents are "patient friendly" and should not have abbreviations.

Review of Facility policy and procedure entitled "Informed Consents" stated, "III. Responsibility: It is the responsibility of the physician to inform the patient or patient representative designative by law about the alternatives to, risks, benefits and potential complications of, the treatments, and services under consideration and to complete the diagnosis, procedure and risk and benefits portion of the "Disclosure and Consent." It is the responsibility of the nurse to verify that the consents are properly completed according by the physician and are properly signed by the patient or patient representative designated by law..."