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Based on interview, record review, and document review, the facility failed to ensure an effective governing body was legally responsible for the conduct of the hospital. The governing body failed to ensure the hospital developed and maintain an effective, on-going, hospital-wide, data-driven quality assessment and performance improvement program related to medication drips that required titration. (Refer to A0263 and A0267); and failed to ensure nursing services were furnished in accordance with facility policies and procedures (A0385).

The cumulative effect of these systematic practices resulted in the failure of the facility to deliver statutory mandated care to patients.

Based on interview, record review, and document review, the facility failed to ensure 3 of 50 sampled patients were informed of their rights (Patient #4, #9, #10).

Findings include:

Policy Review / Form Review

The Patient's Bill of Rights (undated) indicated at the time of registration each patient at (facility name) will receive information in written form of rights and responsibilities to the rights to access protective services, to be free from restriction on communication between patients and family members, to expect confidentiality regarding their medical care, to personal, auditory, visual, and spatial privacy, to a secure/safe environment, to considerate and respectful care, to participate in decisions regarding care, to be free from mental, verbal, physical, sexual, psychological, emotional abuse, harassment or neglect, to formulate advance directives, and to designate a representative decision-maker/surrogate.

The Patient's Bill of Rights further indicated the patient has a right "To receive from the physician the information necessary to give informed consent for procedures or treatments.

The Condition of Admission form indicated the following:

"1. Consent to Treatment. I consent to the procedures which may be performed during this hospitalization or on an outpatient basis, including emergency treatment or services, and which may include but are not limited to laboratory procedures, x-ray examination, diagnostic procedures, medical, nursing, or surgical treatment or procedures, anesthesia, or hospital services rendered to me as ordered by my physician or other healthcare professional on the hospital's medical staff...I have been given the opportunity to read and ask questions about the information contained in this form...I further consent to the hospital conducting blood-borne infectious disease testing, including, but not limited to testing for hepatitis, Acquired Immune Deficiency Syndrome (AIDS), and Human Immunodeficiency Virus (HIV), if a physician orders such tests or if ordered by protocol. I understand that potential side effects and complications of this testing are generally minor and are comparable to the routine collection of blood specimens...I, the undersigned, as the patient or legal agent of the patient, hereby certify I have read, and fully and completely understand this Conditions of Admission and Authorization for Medical Treatment, and that I have signed this Conditions of Admission and Authorization for Medical Treatment knowingly, freely, voluntarily and agree to be bound by its terms..."

The Policy and Procedure regarding Informed Consent dated 2/1/96 and revised through June, 2009 stated as follows:

"POLICY: A. It is the right of the patient to be informed of the nature of the treatment, benefits, risks, and alternative forms of treatment...C. When is Informed Consent Needed? 1. 1a. Standard practice allows the use of a general consent contained in the condition of admission form to cover simple procedures. 1b. Examples of these simple procedures are those procedures commonly understood, and for which there are either no known significant risks, or the possible risks are so remote that disclosure would not have affected the decision of the average reasonable person (i.e., the drawing of blood for test purpose, administration of intravenous fluids, administration of routine medication, taking a routine x-ray, ECG (Electrocardiogram), application of heat modalities and Pap Smears.)..."

The facility provided a flow sheet: "Policy Description: Procedure for Admission Forms and Signatures, effective date: 03/01/2001." The flow sheet indicated if a patient was unable to sign required documents, to find out if there was family/spouse or Power of Attorney (POA) present. (If not, then the next step was to document why no signatures were obtained and have all documents witnessed confirming medical condition.) If there was a family/spouse or POA present, the flowsheet indicated that the spouse, mother, or father may sign all paperwork with their name and relationship. The flow sheet indicated if the patient was able to sign the required documents, then the facility was to obtain necessary signatures and distribute documents as appropriate.

The Patient Access Department Policy Description: Procedure for Registration Forms and Signatures (effective 09/01/08) stated as follows:

"Purpose: To ensure that applicable state and federal laws and signature requirements are followed regarding obtaining signatures on all registration forms, including the Conditions of Admission and Consent for Outpatient Services.
Policy: The Patient Access Department obtains signatures on all registration forms, from the patient or legally authorized individual, at the time of each registration, with exception of specimen-only laboratory registrations...
Consent for Outpatient Services and Conditions of Admission: The Consent for Outpatient Services (COS) is obtained for Clinical Outpatient and Recurring Outpatient Registrations. The Conditions of Admissions (COA) is obtained for all other types of Registrations (Emergency, Observation, Surgery, Inpatient, and Newborn.) A facility may choose to utilize the COA for all Registrations.
A copy of the COA, COS, or Ambulance Transport Consent form is forwarded to the SSC department within the financial folder. If any of these forms are obtained at a later time, the Clinical staff and Registration should adopt a process to ensure, at a minimum, the signature page is present within the patient folder.
Other family members signing on the patient's behalf: In rare situations where the registrar recognizes the patient's inability to sign and a family member such as a spouse, mother, father, or an adult child of a patient is available to sign on the patient's behalf and a legally authorized individual is not available, the family member representative may sign...With each registration, the registrar makes reasonable effort to obtain signatures from the patient and/or the appropriate representatives as defined within this policy...
Documentation requirements when a patient is unable to sign: A physician or a licensed clinical person should document a medical reason why the patient is unable to provide a signature, within the medical record...**If a signature is not received from a patient or telephone consent from an authorized person, no treatment should be rendered unless it is an emergency.
Circumstances below should be addressed in the following manner: B. Patient unable to sign, no legally authorized/legally empowered individual, Power of Attorney for Healthcare, Legal Guardian or family is present and phone consent received or not received. Telephone consent from a legally authorized/legally empowered person or a family member (as defined by state guidelines) must be obtained...If telephone consent is not obtained, treatment should not be rendered unless it is a life-threatening emergency as defined by a physician."

Patient #9

Patient #9 arrived at the Emergency Department 1/4/11 at 1:33 PM. It was documented by the physician that Patient #9 was non-responsive. Diagnoses included syncope, hypertension with anemia, slightly elevated troponin, acute spinal cord compression status post fusion corpectomy, stable, question pneumonia with aspiration and leukocytosis.

Patient #9 was admitted to the inpatient unit on 1/4/11 at 3:41 PM.

On 1/6/11, it was verified with a unit nurse that Patient #9 was alert.

The Condition of Admission form in Patient #9's chart was not signed by the patient. The signature line indicated that the patient was unable to sign ("Patient medically unable") and was dated 1/4/11 at 1403 (2:03 PM). There was no documented evidence the facility ensured that the patient or family member was made aware of his patient rights. There was no documented evidence the facility made any attempts to telephone the spouse or to obtain a consent for medical care for Patient #9 once the patient was alert.

Patient #10

Patient #10 arrived at the Emergency Department 1/4/11 at 12:43 AM. The History and Physical Examination indicated the patient was unresponsive and diagnoses/assessment included respiratory distress, probable pneumonia with chronic obstructive pulmonary disease exacerbation, congestive heart failure exacerbation, cardiomyopathy status post automatic implantable cardioverter-defibrillator and permanent pacemaker placement, hypertension, diabetes mellitus type 2 with retinopathy, anemia, hyperlipidemia, and chronic dementia.

Patient #10 was admitted to the inpatient unit on 1/4/11 at 2:00 AM.

The Conditions for Admission form indicated the patient was unable to sign due to respiratory distress and was dated 1/4/11 0050 (12:50 AM).

On 1/6/11, it was verified with a unit nurse Patient #10 was unresponsive, but no attempt had been made to telephone the son or the spouse to sign a consent form for medical care. The Unit Nurse stated, "We don't call the family members to get a telephone consent - the person from the Admissions Department does that."

There was no documented evidence the patient's family member or POA were made aware of the patient's rights. There was no documented evidence the facility made a reasonable attempt to telephone the patient's family member to obtain a consent for medical care for Patient #10.

The facility failed to provide a consistent, systematic procedure to ensure patients admitted to the inpatient unit from the Emergency Department signed the Conditions of Admission and were informed of their patient rights. The facility failed to ensure the Admissions Office made a reasonable attempt to contact the patient's family members to obtain a telephone consent for medical care if the patient was unable to sign.


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Patient #4

Patient #4 was admitted to the facility on 12/26/10, and was discharged on 1/6/11. During the patient's hospital stay, the general consent for treatment contained in the Conditions of Admission was never signed by the patient or a family member. There was no documentation the patient or family member had the opportunity to read and ask questions about the information contained in the Conditions of Admission.

On 1/6/11 at 11:15 AM, the Director of Patient Access indicated Patient #4 was discharged from the hospital after a 12-day stay without having signed the consent for treatment.

According to the facility's "Informed Consent" policy, dated June 2009, "It is the right of the patient to be informed of the nature of the treatment, benefits, risks, and alternative forms of treatment...The Nevada Revised Statutes do not contain a distinction between the consent needed for simple or common procedures and the detailed informed consent needed for complex procedures. Standard practice allows the use of a general consent contained in the Conditions of Admission form to cover simple procedures..."

(Cross-reference Tag A466)

Based on interview and document review, the facility failed to implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program (QAPI), that reflected the complexity of the hospital's organization and services involving all hospital departments and contracted services. The following processes were not in place:

CFR 482.21(a)(2) Tag A-0267 Tracking of Quality Indicators.

The cumulative effect of systematic practices resulted in the failure of the facility to deliver statutory mandated care to patients.

Based on interview and document review, the facility failed to measure, analyze and track quality indicators, including adverse patient events and other aspects of performance that assess processes of care for all hospital services and operations.

Findings include:

The facility's Quality Assurance Performance Improvement (QAPI) program did not collect data related to patients who were ordered medication drips which required titration (such as anticoagulation therapy). The facility did not track these quality indicators on an ongoing basis.

On 1/11/11 at 8:15 AM, the Quality Coordinator indicated the facility did not have a specific audit tool for the collection of data for patients on medication drips that required titration. The employee indicated the charge nurses on each medical-surgical unit audit the patient's medical records and record the primary Intravenous (IV) orders and not the medication drips that require titration.

Based on observation, interview, record review and document review, the facility failed to ensure nursing services were furnished in accordance with facility policy and procedures regarding the assessment and documentation of wound care (A0395); initiating and updating care plans for infections, anticoagulation therapy, wound care and nutrition (A0396); and administering medication without a physician order, administration and documentation of anticoagulation therapy and calculating dosage for medication based on weight (A0404); Obtaining documented signed orders for drugs and biologicals (A0406); and administering intravenous medication (anticoagulation therapy) in accordance with approved medical staff policies and procedures (A0409). The cumulative effect of these systemic practices resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Based on interview, record review, and document review, the facility failed to ensure wound care assessments and documentation for 1 of 50 sampled patients followed the facility's written procedures and guidelines (Patient #3).

Findings include:

The facility's "Pressure Ulcer Assessment and Intervention" policy, dated 11/5/08, included the following procedure: "Standard guidelines will be used for providing care to patients experiencing pressure ulcers. Documentation when describing pressure ulcers shall include history, location, size, color of wound bed and peri-wound area, drainage/exudate, and stage."

Patient #3

Patient #3 was admitted to the facility on 12/29/10, with diagnoses including end stage renal disease, diabetes, coumadin toxicity, deep vein thrombosis, and right and left foot ulcers. Record review revealed an order on 12/29/10 for "wound care team to evaluate and manage foot ulcers, Rt (right) and Lt (left)".

On 12/30/10, the facility's consultant Wound Care Nurse documented an assessment of the wounds, along with a treatment plan, which was then incorporated into the Kardex orders and communication for nursing interventions. This initial evaluation described the location of the wounds, but did not include information on the history, size, color, drainage, or stage of the wounds.

The next assessment by the Wound Care Nurse was conducted on 1/4/11 and indicated, "Both (wounds) are now without drainage." This evaluation included the history of the foot ulcers, but did not include the size, color, or stage of the wounds.

On 1/7/11 at 8:30 AM, the Wound Care Nurse confirmed measurements of wounds, along with the other descriptive components listed in the policy, were not always included in the initial and subsequent assessments.

Based on interview, record review, and document review, the facility failed to ensure nursing care plans were kept current and documented new diagnosed problems, needs, expected outcomes and interventions for 4 of 50 sampled patients (Patient #33, #34, #50, #7).

Findings Include:

Patient #33

Patient # 33 was a full term newborn infant delivered at the facility on 01/02/11 with diagnoses that included at-risk for developmental delay, small for gestational age, hyperbilirubinemia and jaundice. The patient's mother was reported to have a history of herpes simplex virus and was taking Acyclovir medication.

Physician Orders dated 01/02/11 at 5:15 PM included orders to obtain herpes simplex virus cultures and sensitivity from the patient's conjunctiva, nasal area, urine, rectal area and umbilical area.

A Physician Progress Note dated 01/06/11 indicated Patient #33 was reported to be irritable and developed a rash on the left upper extremity. Vesicular rashes were noted on the patient's left shoulder and left upper extremity. The physician assessment included ruling out a herpes simplex infection due to vesicular rashes and irritability. The plan of care included observing the patient for signs and symptoms of sepsis; obtaining culture and sensitivity for herpes from conjunctival swabs, nasal swabs, umbilical swabs, urine and rectal swabs and placing the patient on Acyclovir medication.

Physician orders dated 01/06/11 included placing the patient in contact isolation on the NICU (Neonatal Intensive Care Unit) for presumptive herpes simplex infection.

On 01/06/11 at 12:15 PM an interview was conducted with the staff nurse of the NICU. The staff nurse reported the patient's plan of care form was generated in the computerized Meditech system and was updated on a daily basis to address the patient's diagnosed problems, needs, expected outcomes, interventions and physician orders. The Staff Nurse acknowledged Patient #33's nursing care plan had not been up-dated to reflect the patients diagnosis of possible herpes simplex virus or to monitor the patient for signs and symptoms of sepsis.

On 01/06/11 at 12:15 PM a review of Patient #33's nursing care plan in the Meditech system revealed no documented evidence the nursing care plan had been up-dated to include the diagnosis of possible herpes simplex infection or to monitor the patient for signs and symptoms of sepsis. There was no documented evidence the nursing care plan had been up-dated to reflect patient needs, expected outcomes, prescribed interventions, actions or physician orders related to herpes simplex infection.


Patient #34

Patient #34 was a newborn infant delivered at the facility on 12/31/10 with a diagnosis that included suspected sepsis.

Physician orders dated 01/01/11 at 7:45 PM included the transfer of the patient to the NICU unit and an order to obtain blood cultures and start the patient on Gentamycin and Ampicillin antibiotics.

On 01/06/11 at 12:15 PM an interview was conducted with the Staff Nurse of the NICU, who had been assigned to care for Patient #34. The Staff Nurse reviewed the patient's care plan in the computerized Meditech system and confirmed the patient's nursing care plan had not been up-dated to reflect the patient's diagnosis of suspected sepsis.

On 01/06/11 at 12;15 PM a review of Patient #34 nursing care plan in the Meditech system revealed no documented evidence the patients nursing care plan had been up-dated to include the diagnosis of possible sepsis. There was no documented evidence the nursing care plan had been up-dated to reflect patient needs, expected outcomes, prescribed interventions, actions or physician orders related to the diagnosis of suspected sepsis.

A review of the facility's Patient Care Assessment/Reassessment and Documentation Policy, last revised 10/26/10, included the following:

"Policy:

A. The process of patient care (assessment, reassessment, planning, intervention and evaluation) provides the framework used for the documentation of care provided to patients.

B. All data is documented in various formats, according to hospital policies, procedures, and guidelines; is permanently integrated into the patients medical record and is both identifiable and retrievable.

C. Development and updating of the primary care plan is the responsibility of the Nursing Service Staff. Other departments also have input into the care planning and delivery of inter-disciplinary, collaborative care, treatment and services.

Reassessment:

1. Standard of Care:

A. An ongoing assessment and/or reassessment of problems/needs/condition, is performed by a healthcare professional as defined by his/her scope of practice for each patient throughout his/her hospital stay.

B. The patient will be reassessed based on the circumstances noted below:

1. Patient transfer and/or move between patient units/services/departments.

2. Significant change in patient's condition or diagnosis and response to care.

3. At designated time frames.

E. Based on reassessment (and in collaboration with the interdisciplinary team) the RN will modify/revise the patient's problems/needs and patient's plan of care as appropriate. Changes to the plan of care will be communicated in the medical record.

F. Interventions and patient care are documented on appropriate forms/computer screens.

Evaluation:

1. The process of evaluation of the patient care interventions and patient progress toward outcome/goal achievement is accomplished by reassessments of the patient and revision of the patient's plan of care or termination of care.

Standards of Care:

A. Each patient will have his/her needs reassessed according to the:

1. Professional's established standards of practice to determine the effectiveness of patient care interventions.

2. Progress toward goal achievement.




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Patient #50

Patient #50 was admitted on 12/29/2010 with diagnoses including coumadin toxicity, deep vein thrombosis, and severe anemia.

On 1/6/2011, in the morning, the RN (registered nurse) replaced Patient #50's Heparin 25000 units/250 ml intravenous solution. The rate was not changed and continued to flow at 11 ml/hr.

Patient #50's Physician's Order form dated 1/1/2011, documented to start a Heparin drip per protocol with no bolus.

There was no evidence the initial Heparin rate and amount for Patient #50 was documented. There were no documented changes on the Heparin rate when following the Heparin protocol.

On 1/6/2011, in the morning, by using Patient #50's lab results and following the Heparin protocol the Interim Critical Care Clinical Nurse Specialist calculated the rate in which the Heparin drip should have been infusing. The Clinical Nurse Specialist indicated the rate should not be 11 ml/hr and should have been set at 17 ml/hr. The Clinical Nurse Specialist further confirmed there was no documented evidence when the Heparin rate was changed since 1/1/2011. The Interim Critical Care Clinical Nurse Specialist indicated an anticoagulation care plan was not initiated for Patient #50. She indicated that if the care plan was initiated there would be areas in the care plan to document the changes.


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Patient #7

Patient #7 was admitted 12/14/10 with diagnoses including left foot cellulitis.

Physician orders (Oral Nutrition) dated 12/18/10 indicated "2. Dietitian recommends Ensure Plus TID (3 times daily) (with) meals. Ok for pt (patient) to have Ensure milkshakes if desired. Also recommend liberal diet. Pt underweight."

On 1/4/11, the Charge Nurse was interviewed. The Charge Nurse indicated Patient #7 did not eat very much of the facility food, that the staff encouraged the patient to eat more, but the patient only ate well and especially liked when the family brought in home-cooked food.

The Kardex printed 1/4/11 stated, "Problem: Nutritional Status. Alt (altered)/at risk." The Kardex did not include interventions and measurable outcomes to address Patient #7's altered nutritional status.

The Charge Nurse confirmed there was no documented care plan including interventions regarding the patient's nutritional status, (such as nutritional supplements, encouragement/cuing at meals, or family bringing in home-cooked meals). On 1/4/11 and 1/6/11 the Charge Nurse was not able to access the computer system and obtain a complete care plan documenting any interventions.

Based on interview, record review and document review, the facility failed to ensure intravenous Heparin anticoagulant medication was administered to 2 of 50 sampled patients according to physician's orders and the facility's Heparin drip protocol (Patient #37, #50).

Findings include:

Patient #37

Patient # 37 was admitted to the facility on 12/10/10 with diagnoses including altered mental status, congestive heart failure, atrial fibrillation, coronary artery disease and chronic kidney disease.

Physician Orders dated 12/20/10 at 8:15 PM documented the following: "Start Heparin drip IV (intravenous) (no bolus) per Heparin protocol."

Physician Orders dated 12/26/10 included the following; "Stop Heparin 10:00 AM on 12/27/10."

A review of the facility's Heparin Drip Order Protocol dated 12/21/10 at 7:00 AM included the following:

Thrombolytic Inhibitor Used Heparin Protocol.

(Dosing chart based on weight based Heparin 60 units/Kg (kilogram) 12 units per kilogram/hr infusion.)

For all indications, draw a PTT (partial thromboplastin time) 6 hours after starting Heparin infusion then adjust Heparin infusion as follows:

1. If PTT less than 30 IV bolus 4,000 units of Heparin and increase infusion rate of Heparin by 300 units an hour. Draw next PTT in 6 hours.

2. If PTT 30-39 IV bolus of 2,000 units of Heparin and increase infusion rate of Heparin by 200 units an hour. Draw next PTT in 6 hours.

3. If PTT 40-49 IV bolus of 1,000 units of Heparin and increase infusion rate of Heparin by 100 units an hour. Draw PTT in 6 hours.

4. If PTT 50-79 no rate changes. Draw PTT in 24 hours.

5. If PTT 80-99 decrease Heparin infusion rate by 100 units an hour. Draw PTT in 6 hours.

6. If PTT 100-119 hold Heparin infusion for 30 minutes. Decrease Heparin infusion rate by 200 units an hour. Draw PTT in 6 hours.

7. If PTT greater than 120 hold Heparin infusion for 1 hour. Decrease Heparin infusion rate by 300 units an hour. Draw PTT in 6 hours.

On 01/07/11 at 2:30 PM, an interview with the Clinical Specialist for Education and Medical Surgical Services and Meditech computer chart review of Patient #37 was conducted. The Clinical Specialist reported it was the responsibility of the nursing staff to accurately document the patient's Heparin infusion dosages and rate changes based on the patient's PTT lab values on the Heparin Infusion Screen in the Meditech computer system. The Clinical Specialist confirmed Patient #37 received Heparin infusion therapy from 12/20/10 to 12/27/10. The Clinical Specialist acknowledged the nursing staff documented only 1 Heparin dosage and rate of infusion on the Heparin Infusion Screen on 12/22/10. The Clinical Specialist confirmed nursing staff failed to document the patient's Heparin dosage or rate on the Heparin Infusion Screen for 12/20/10, 12/21/10, 12/23/10, 12/24/10, 12/25/10, 12/26/10 or 12/27/10.

The Clinical Specialist reported every Heparin dose and rate change must be documented by 2 nurses. The Clinical Specialist acknowledged that, according to the patient's PTT lab records on 12/21/10 at 4:35 AM, the patient's PTT was documented as 83. (60-70 seconds - normal value) The Clinical Specialist acknowledged the patient's Heparin drip according to the Heparin protocol should have been decreased 100 units per hour. The Clinical Specialist acknowledged there was no documented evidence in the patient's medical record or on the Heparin Infusion Screen in the Meditech computer system that documented the nursing staff decreased the patient's Heparin infusion rate on 12/21/10 at 4:35 AM.

The Clinical Specialist acknowledged that according the patients PTT lab records on 12/21/10 at 11:40 AM the patient's PTT was documented as 80. The Clinical Specialist acknowledged the patient's Heparin drip, according to the Heparin protocol, should have been decreased 100 units per hour and the infusion rate should have been decreased to 8ml (milliliters) per hour. The Clinical Specialist acknowledged there was no documented evidence in the patient's medical record or on the Heparin Infusion Screen in the Meditech computer system that documented the nursing staff decreased the patient's Heparin infusion to 8ml per hour on 12/21/10 at 11:40 AM.

The Clinical Specialist acknowledged it was the nursing staff's responsibility to notify the patient's physician in regards to abnormally high or low PTT lab values. The Clinical Specialist, after reviewing Patient #37's medical records in the Meditech computer system, confirmed on 12/21/10 at 5:29 PM the patient's PTT was 320. The Clinical Specialist acknowledged there was no documented evidence in the nursing notes, physician progress notes or the Meditech computer charting system that the patient's physician was notified of the abnormally high PTT level.

A review of the patient's PTT lab values included the following:

1. 12/21/10 at 4:35 AM PTT was 83. No dosage or rate change for Heparin drip documented.

2. 12/21/10 at 11:40 AM PTT was 80. No dosage or rate change for Heparin documented.

3. 12/21/10 at 5:29 PM PTT 320. No dosage or rate change for Heparin documented. No documentation that the patients physician was notified of abnormal lab value.

A review of Patient # 37's medical record revealed no documented evidence the nursing staff followed physician's orders and the facility's Heparin protocol or adjusted the patient's Heparin drip dose and rate according to the patient's PTT lab values.

The facility's Medication Administration and Documentation Policy last revised 06/19/10 included the following:

"Policy: Medications will be administered in a safe method and documented according to standard.

A. Healthcare providers administering medications are responsible for administering the right medication, the right dose, at the right time, by the right route, to the right patient for the right reason with the right documentation.

Documentation of medication administration is to include:

a. Name of Drug

b. Date/Time administered.

c. Route

d. Identification of administering individual

e. Parameters if applicable

f. Dose"



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Patient #50

Patient #50 was admitted on 12/29/2010 with diagnoses including coumadin toxicity, deep vein thrombosis, and severe anemia.

On 1/6/11, in the morning, the RN (registered nurse) replaced Patient #50's Heparin 25000 units/250 ml intravenous solution with a new bag of the same solution. The rate was not changed and continued to flow at 11 ml/hr.

Patient #50's Physician's Order form dated 1/1/11, documented to start a Heparin drip per protocol with no bolus.

There was no evidence that the initial Heparin rate and amount for Patient #50 was documented. There were no documented changes on the Heparin rate when following the Heparin protocol.

On 1/6/11, in the morning, by using Patient #50's lab results and following the Heparin protocol the Interim Critical Care Clinical Nurse Specialist calculated the rate in which the Heparin drip should have been infusing. The Interim Critical Care Clinical Nurse Specialist indicated the rate should not be 11 ml/hr and should have been set at 17 ml/hr. The Interim Critical Care Clinical Nurse Specialist confirmed there was no documented evidence when the Heparin rate was changed since 1/1/2011. The Interim Critical Care Clinical Nurse Specialist indicated an anticoagulation care plan was not initiated for Patient #50. She indicated that if the care plan was initiated there would be areas in the care plan to document the changes.

Following the DVT (deep vein thrombosis)/ PE (pulmonary embolism) Heparin Protocol, Patient #50 initial Heparin dose should have been started at 1800 units/hr (18 ml/hr). There was no documented evidence found on what amount of Heparin the patient was started on and the rate the Heparin dose was infusing.

Following the Thrombolytic Inhibitor Used Heparin Protocol form, changes on the Heparin dose and rate should have been made for Patient #50 on:

-1/2/2011
-1/3/2011
-1/5/2011
-1/6/2011

There was no documented evidence on those dates regarding what dose and rate Patient #50 was receiving or what the dose and rate was changed to.

Based on observation, interview and record review, the facility failed to obtain a physician order to administer a medication for 1 of 50 sampled patients (Patient #49).

Findings include:

Patient #49

Patient #49 was admitted on 12/21/10 with diagnoses including chest pain and rule-out pneumonia.

On 1/6/11 in the morning, Patient #49 was administered Loratadine 10 mg (milligrams) orally by the RN (registered nurse).

There was no physician order to administer Loratadine to Patient #49.

On 1/6/11 in the morning, the Interim Critical Care Clinical Nurse Specialist confirmed there was no physician order to administer Loratadine.

Patient #49's Medication Reconciliation Order form dated 12/21/10, documented that Zyrtec was reviewed and deleted by the physician. The staff Pharmacist indicated that the facility policy was to substitute Zyrtec with Loratadine. There were no physician orders to administer Zyrtec or Loratadine to Patient #49.

Based on interview, record review and document review, the facility failed to ensure intravenous Heparin anticoagulant medication, weight based intravenous medications, and intravenous maintenance drips were administered to a patient according to physician's orders and the facility's Heparin drip protocol for 6 of 50 sampled patients (Patient # 37, #50, #45, #46, #47, #48).

Findings include:

(1). Patient # 37

Patient # 37 was admitted to the facility on 12/10/10 with diagnoses including altered mental status, congestive heart failure, atrial fibrillation, coronary artery disease and chronic kidney disease.

Physician Orders dated 12/20/10 at 8:15 PM documented the following: "Start Heparin drip IV (intravenous) (no bolus) per Heparin protocol."

Physician Orders dated 12/26/10 included the following; "Stop Heparin 10:00 AM on 12/27/10."

A review of the facility's Heparin Drip Order Protocol dated 12/21/10 at 7:00 AM included the following:

Thrombolytic Inhibitor Used Heparin Protocol.

(Dosing chart based on weight based Heparin 60 units/Kg (kilogram) 12 units per kilogram/hr (hour) infusion.)

For all indications, draw a PTT (partial thromboplastin time) 6 hours after starting Heparin infusion then adjust Heparin infusion as follows:

1. If PTT less than 30 IV bolus 4,000 units of Heparin and increase infusion rate of Heparin by 300 units an hour. Draw next PTT in 6 hours.

2. If PTT 30-39 IV bolus of 2,000 units of Heparin and increase infusion rate of Heparin by 200 units an hour. Draw next PTT in 6 hours.

3. If PTT 40-49 IV bolus of 1,000 units of Heparin and increase infusion rate of Heparin by 100 units an hour. Draw PTT in 6 hours.

4. If PTT 50-79 no rate changes. Draw PTT in 24 hours.

5. If PTT 80-99 decrease Heparin infusion rate by 100 units an hour. Draw PTT in 6 hours.

6. If PTT 100-119 hold Heparin infusion for 30 minutes. Decrease Heparin infusion rate by 200 units an hour. Draw PTT in 6 hours.

7. If PTT greater than 120 hold Heparin infusion for 1 hour. Decrease Heparin infusion rate by 300 units an hour. Draw PTT in 6 hours.

On 01/07/11 at 2:30 PM an interview with the Clinical Specialist for Education and Medical Surgical Services and Meditech computer chart review of Patient #37 was conducted. The Clinical Specialist reported it was the responsibility of the nursing staff to accurately document the patient's Heparin infusion dosages and rate changes based on the patient's PTT lab values on the Heparin Infusion Screen in the Meditech computer system. The Clinical Specialist confirmed Patient #37 received Heparin infusion therapy from 12/20/10 to 12/27/10. The Clinical Specialist acknowledged the nursing staff documented only 1 Heparin dosage and rate of infusion on the Heparin Infusion Screen on 12/22/10. The Clinical Specialist confirmed nursing staff failed to document the patient's Heparin dosage or rate on the Heparin Infusion Screen for 12/20/10, 12/21/10, 12/23/10, 12/24/10, 12/25/10, 12/26/10 or 12/27/10.

The Clinical Specialist reported every Heparin dose and rate change must be documented by 2 nurses.

The Clinical Specialist acknowledged according to the patient's PTT lab records on 12/21/10 at 4:35 AM the patient's PTT was documented as 83. (60-70 seconds normal value) The Clinical Specialist acknowledged the patient's Heparin drip according to the Heparin protocol should have been decreased 100 units per hour. The Clinical Specialist acknowledged there was no documented evidence in the patient's medical record or on the Heparin Infusion Screen in the Meditech computer system that documented the nursing staff decreased the patient's Heparin infusion rate on 12/21/10 at 4:35 AM.

The Clinical Specialist acknowledged that according to the patient's PTT lab records on 12/21/10 at 11:40 AM the patient's PTT was documented as 80. The Clinical Specialist acknowledged the patient's Heparin drip according to the Heparin protocol should have been decreased 100 units per hour and the infusion rate should have been decreased to 8 ml (milliliters) per hour. The Clinical Specialist acknowledged there was no documented evidence in the patient's medical record or on the Heparin Infusion Screen in the Meditech computer system that documented the nursing staff decreased the patients Heparin infusion to 8 ml per hour on 12/21/10 at 11:40 AM.

The Clinical Specialist acknowledged it was the nursing staff's responsibility to notify the patient's physician in regard to abnormally high or low PTT lab values. The Clinical Specialist after reviewing Patient #37 medical records in the Meditech computer system, confirmed on 12/21/10 at 5:29 PM the patient's PTT was 320. The Clinical Specialist acknowledged there was no documented evidence in the nursing notes, physician progress notes or the Meditech computer charting system that the patient's physician was notified of the abnormally high PTT level.

A review of the patients PTT lab values included the following:

1. 12/21/10 at 4:35 AM PTT was 83. No dosage or rate change for Heparin drip documented.

2. 12/21/10 at 11:40 AM PTT was 80. No dosage or rate change for Heparin documented.

3. 12/21/10 at 5:29 PM PTT 320. No dosage or rate change for Heparin documented. No documentation that the patients physician was notified of abnormal lab value.

A review of Patient #37's medical record revealed no documented evidence the nursing staff followed physician's orders and the facility's Heparin protocol or adjusted the patient's Heparin drip dose and rate according to the patient's PTT lab values.

The facility's Medication Administration and Documentation Policy last revised 06/19/10 included the following:

Policy: Medications will be administered in a safe method and documented according to standard.

A. Healthcare providers administering medications are responsible for administering the right medication, the right dose, at the right time, by the right route, to the right patient for the right reason with the right documentation.

Documentation of medication administration is to include:

a. Name of Drug

b. Date/Time administered.

c. Route

d. Identification of administering individual

e. Parameters if applicable

f. Dose



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Patient #50

Patient #50 was admitted on 12/29/10 with diagnoses including coumadin toxicity, deep vein thrombosis, and severe anemia.

On 1/6/11, in the morning, the RN (registered nurse) replaced Patient #50's Heparin 25000 units/250 ml (milliliters) intravenous solution. The rate was not changed and continued to flow at 11 ml/hr (hour).

Patient #50's Physician's Order form dated 1/1/11, documented to start a Heparin drip per protocol with no bolus.

There was no evidence that the initial Heparin rate and amount for Patient #50 was documented. There were no documented changes on the Heparin rate when following the Heparin protocol.

On 1/6/11, in the morning, by using Patient #50's lab results and following the Heparin protocol the Interim Critical Care Clinical Nurse Specialist calculated the rate in which the Heparin drip should have been infusing. The Interim Critical Care Clinical Nurse Specialist indicated the rate should not be 11 ml/hr and should have been set at 17 ml/hr on 1/6/2011. The Interim Critical Care Clinical Nurse Specialist confirmed there was no documented evidence when the Heparin rate was changed since 1/1/11. The Interim Critical Care Clinical Nurse Specialist indicated an anticoagulation care plan was not initiated for Patient #50, and further indicated that if the care plan was initiated there would be areas in the care plan to document the changes.

Following the DVT (deep vein thrombosis)/ PE (pulmonary embolism) Heparin Protocol, Patient #50 initial Heparin dose should have been started at 1800 units/hr (18 ml/hr). There was no documented evidence found on what amount of Heparin the patient was started on and the rate the Heparin dose was infusing.

Following the Thrombolytic Inhibitor Used Heparin Protocol form, changes on the Heparin dose and rate should have been made for Patient #50 on:

-1/2/2011
-1/3/2011
-1/5/2011
-1/6/2011

There was no documented evidence on those dates regarding what dose and rate Patient #50 was receiving or what the dose and rate was changed to.

(2). On 1/7/11, in the morning,the Intensive Care Unit (ICU) Director indicated there was no policy regarding which patient weight was to be used when calculating weight based intravenous (IV) medications. The ICU Director indicated the initial weight should be used but could change if there was a 20% difference from the initial dry weight.

On 1/7/11, in the morning, the ICU Clinical Coordinator indicated a patient weight should be taken daily and the new weight should be used to calculate weight based intravenous medications daily.

On 1/7/11, in the morning, an ICU staff nurse indicated initial dry weight should be used to calculate weight based intravenous medications.

On 1/11/11, in the morning, the Interim Critical Care Clinical Nurse Specialist indicated the weight used for weight based intravenous medications should be the weight taken the day when the drip was started and the weight should not be adjusted.

Patient #45

Patient #45 was admitted on 1/2/11. The initial weight obtained on 1/2/11, was 64 kilograms (kg).

On 1/7/11, in the morning, Patient #45 had a intravenous dose of Dobutamine infusing at a rate of 9.6 milliliters (ml)/hour (hr). The weight used to calculate the Dobutamine dose was 64 kg.

Patient #45's weight which was electronically documented on 1/6/11, was 81.3 kg. The calculated difference from the initial weight from 1/2/11, was 21.3%.

A weight for Patient #45 was performed at the bedside on 1/7/11. The weight was 82.2 kg. The calculated difference from the initial weight from 1/2/11, was 22.2%.

Patient #45's initial weight of 64 kg was still being used to calculate the weight based intravenous medication of Dobutamine even when there was a weight difference of more than 20% on 1/6/11 and 1/7/11.

Patient #46

Patient #46 was admitted on 12/10/10. The initial weight obtained on 12/10/10, was 111.2 kg.

On 1/7/11, at 10:00 AM, the ICU staff registered nurse (RN) providing care for Patient #46 indicated the daily weight should be used to calculate weight based intravenous medications. Patient #46 had a intravenous dose of Dobutamine infusing at a rate of 6 ml/hr. The weight used to calculate the Dobutamine dose was 100.7 kg which was taken on 1/6/11. As of 1/7/11, at 10:00 AM, Patient #46's weight had not been taken for the day.

Patient #46's initial weight of 111.2 kg was not used to calculate the weight based intravenous medication of Dobutamine on 1/7/11.

With no policy regarding what patient weight should be used to calculate weight based intravenous medications, staff members had no guidance and were inconsistent when obtaining a weight to use when having to calculate the intravenous medication.

(3). Patient #47

Patient #47 entered the facility on 1/5/11 for an outpatient surgical procedure.

Patient #47's electronic documentation indicated that an intravenous drip of Plasmalyte 1000 ml was initiated in the pre-op (pre-operation unit)/holding area by the pre-op unit nurse.

There was no documented evidence physician orders were obtained to start an IV and use Plasmalyte on Patient #47.

On 1/7/11, in the afternoon, the Director of Surgery Services confirmed that orders were not obtained to start an IV drip of Plasmalyte on Patient #47.

Patient #48

Patient #48 entered the facility on 1/5/11 for an outpatient surgical procedure.

There was no documented evidence physician orders were obtained to start an IV and use Plasmalyte on Patient #48.

On 1/11/11, in the morning, the Director of Surgery Services confirmed that an IV of Plasmalyte 1000 ml was initiated in the pre-op unit on Patient #48. The Director of Surgical Services confirmed there was no order to start the IV and use Plasmalyte. Also, there were no standing orders by the surgeon and the anesthesiologist to use Plasmalyte.

Based on record review, interview, and policy review, the facility failed to ensure staff consistently obtained signed consent forms for medical treatment in adherence to the facility's policy for 3 of 50 sampled patients (Patient #4, #9, #10).

Findings include:

Patient #4

Patient #4 was admitted to the facility's Emergency Department by ambulance with chest pain on 12/26/10 Review of the patient's clinical record revealed the patient was assessed by a physician at 1:57 PM. The Physician Clinical Report indicated the patient was alert and oriented, and acted as her own historian along with EMS (emergency medical services) personnel. The report included the following note: "Patient counseled in person regarding the patient's stable condition and diagnosis."

Patient #4's clinical record also included a Conditions of Admission (COA) document which contained a general consent for treatment for common procedures. In the patient's signature section, a registration employee wrote, "12/26/10, 2:14 PM - Pt (patient) unable to sign." The signatures of two registration employees were in the Witness signature section of the COA.

On 12/27/10 and 12/28/10 Patient #4 underwent two procedures. Specific consents for these procedures were signed by the patient's daughter on those days.

Patient #4 was admitted as an inpatient on 12/28/10 and was discharged on 1/6/11. According to Collection Notes provided by the Director of Patient Access, Employee #19, registration staff attempted to obtain a COA signature from the patient four times, on 12/30/10, 1/3/11, 1/5/11, and 1/6/11. The employee confirmed on 1/6/11 at 11:15 AM Patient #4 was discharged from the hospital after a 12-day stay without signing the consent for treatment.

The facility's "Procedure for Registration Forms and Signatures" policy, dated 9/1/08, included the following procedures:

"The Patient Access Department obtains signatures on all registration forms, from the patient or legally authorized individual, at the time of each registration...Documentation requirements when a patient is unable to sign: A physician or a licensed clinical person should document a medical reason why the patient is unable to provide a signature, within the medical record...Registrars are not required to document that patient is unable to sign on the consent, other registration forms, or in the system notes. The witness signature area, when signed with a second witness signature and title, indicates a patient's inability to sign with a representative not present...(When a patient is unable to sign) Telephone consent from a legally authorized/legally empowered person or family member must be obtained. The name of the person providing consent and their relationship to the patient is documented or circled on the consent form in the area provided if phone consent is received..."

On 1/5/11 at 1:00 PM, the Director of Patient Access reported telephone consents were attempted by the registration staff only for those patients who were teenagers. The Director of Patient Access acknowledged that when staff of the Patient Access department made floor rounds, patients were sometimes resting or away from their rooms. The Director of Patient Access could not explain why the patient's daughter was not contacted to sign the COA form.

Statistics provided from the facility revealed that from 12/1/10 through 1/5/11, ninety-three signatures for COAs had not been obtained (7% of all admissions).

The Director of Patient Access confirmed data related to obtaining consents were not brought to the facility's Quality Council for periodic review.

(Cross-reference Tag A117)



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Patient #9

Patient #9 arrived at the Emergency Department 1/4/11 at 1:33 PM. It was documented by the physician that Patient #9 was non-responsive. Diagnoses included syncope, hypertension with anemia, slightly elevated troponin, acute spinal cord compression status post fusion corpectomy, stable, question pneumonia with aspiration and leukocytosis.

Patient #9 was admitted to the inpatient unit on 1/4/11 at 3:41 PM.

On 1/6/11, it was verified with a unit nurse that Patient #9 was alert.

The COA form in Patient #9's chart was not signed by the patient. The signature line indicated that the patient was unable to sign ("Patient medically unable") and was dated 1/4/11 1403 (2:03 PM). There was no documented evidence the facility made any attempts to telephone the spouse or to obtain a consent for medical care for Patient #9 once the patient was alert.

Patient #10

Patient #10 arrived at the Emergency Department 1/4/11 at 12:43 AM. The History and Physical Examination indicated the patient was unresponsive and diagnoses/assessment included respiratory distress, probable pneumonia with chronic obstructive pulmonary disease exacerbation, congestive heart failure exacerbation, cardiomyopathy status post automatic implantable cardioverter-defibrillator and permanent pacemaker placement, hypertension, diabetes mellitus type 2 with retinopathy, anemia, hyperlipidemia, and chronic dementia.

Patient #10 was admitted to the inpatient unit on 1/4/11 at 2:00 AM.

The Conditions for Admission form indicated the patient was unable to sign due to respiratory distress and was dated 1/4/11 0050 (12:50 AM).

On 1/6/11, it was verified with a unit nurse Patient #10 was unresponsive, but no attempt had been made to telephone the son or the spouse to sign a consent form for medical care. The Unit Nurse stated, "We don't call the family members to get a telephone consent - the person from the Admissions Department does that."

There was no documented evidence the facility made a reasonable attempt to telephone the patient's family member to obtain a consent for medical care for Patient #10.