HospitalInspections.org

Based on observation and interview, the hospital failed to ensure that supplies related to the administration of drugs and biologicals and intravenous (IV) fluids containing potassium, calcium, sodium chloride (salt) and glucose (sugar) were stored in compliance with the regulations. The hospital failed to ensure that a supply room, with a door to a hallway in the hospital, was kept locked. The supply room contained needles, syringes, intravenous (IV) fluids. This failure had the potential to contribute to anyone walking in the hallway, to enter the room, and take the supplies.

Findings:

A brief tour of the hospital was conducted on 4/30/12 at 1:20 PM, accompanied by the Nurse Manager (NM) of the hospital.

A door to a room labeled "ER (Emergency Room) Supply Room" was observed in a general use hallway. The door was unlocked and the survey team was able to walk right into the room. The room contained the following supplies:

Various sized needles,
Various sized syringes,
Various sized IV catheters,
Trays used to treat cuts, insert chest tubes, and minor operation trays,
IV fluids, plain sodium chloride and lactated ringers solution that contained potassium, calcium, sodium chloride, and glucose.

The NM stated "that door should be locked." She confirmed that the room contained supplies, therefore the room should be locked so that anyone walking in the hallway could not get into the room and take the supplies.

Based on interview and record review, the Governing Body failed to ensure that organizational structure requirements were met as evidenced by:

1. Pharmacy services that were not administered according to accepted professional principles by failing to ensure the following:

A. That the pharmacist reviewed patient medication orders and medication administration records to ensure that only licensed staff administered medications to patients, that only licensed staff flushed intravenous catheters and discontinue intravenous catheters and that only licensed staff took verbal orders from the physician. The hospital allowed a medical assistant (MA) to administer medications to patients, including oral (po) medications, injectable medications, and intravenous (IV) medications. The hospital also allowed the MA to independently adjust IV narcotic drips, flush IV catheters, and discontinue IV catheters. The hospital allowed the MA to take verbal orders from the physician and to confirm the verbal orders in the medical record.

B. That the pharmacist reviewed all patient medication orders and medication administration records to ensure that there are no drug incompatibilities or contraindications to administering the drugs to patients. The hospital failed to ensure that the pharmacist in charge of pharmaceutical services had acute care experience and competencies and failed to ensure that only pharmacy compounds or admixes all sterile medications except in emergencies.

C. That the controlled medication sign out sheets were accurate by not including the dosage of medications given to the patient and the amount wasted.

These failures had the potential to jeopardize the health and safety of any patient cared for in the hospital. (Refer to C-0276)

2. The facility failed to measure, analyze and track the patient care services provided by the Food and Nutrition Department to address the monitoring of the the nutrition assessments of inpatients and the safe food handling of the department. The failure to measure, analyze and track the quality plan of the Department put patients at risk of not meeting nutritional goals and increase the risk of food borne illness.

The hospital failed to ensure that they measured, analyzed and tracked the patient care services provided by contracted services such as Pharmacy Services to address unlicensed staff giving medications. The hospital failed to ensure that the pharmacy services were provided by a pharmacist with acute care experience and competencies, and failed to ensure that the patient medication orders were reviewed for drug interactions and contraindications. These failures had the potential to contribute to adverse reactions to medications and patients receiving substandard care.

The hospital failed to ensure that unlicensed staff documentation was analyzed and tracked to ensure that the unlicensed staff did not perform patient assessments. (Refer to C-0337, C-0276)

3. The Governing Body failed to ensure that only a licensed nurse administered medications in accordance with hospital policy and Federal and State laws. The hospital allowed a medical assistant (MA) to administer medications to patients, including oral (po) medications, injectable medications and intravenous (IV) medications. The hospital also allowed the MA to independently, adjust IV narcotic drips, flush IV catheters, and discontinue IV catheters. The hospital allowed the MA to take verbal orders from the physician and to confirm the verbal orders in the medical record. The hospital also failed to have a policy that limits the administration of any medication to licensed nursing staff. (Refer to C 297)

4. The Governing Body failed to ensure that the operation of the policies were administered so as to provide quality health care in a safe environment as evidenced by: 1) no quality program for the Food and Nutrition Service, 2) no nutrition assessment or nutrition care of inpatients, 3) no coverage for the Registered Dietician (RD) services when the full time RD was unavailable or on vacation. (Refer to C 278, C 279, C 330, and C 337)


5. The Governing Body failed to ensure that written policies were developed consistent with State law. The hospital failed to ensure that staffing policies reflected the requirements in the California Code of Regulations, Title 22, for nurse staffing in an acute care hospital. (Refer to C 271)

6. The Governing Body failed to assume full responsibility for determining, implementing, and monitoring polices regarding the hospital's total operation by failing to ensure that the hospital's polices were reviewed and updated. The hospital's general policies had not been reviewed and updated since 3/08. The hospital's policies for Rehabilitative Services (physical therapy) had not been reviewed and updated since 1/01. (Refer to C 241)

The cumulative effect of these systemic problems contributed to the hospital's inability to ensure the provision of high quality healthcare in a safe environment.

Based on interview and record review the Governing Body failed to assume full responsibility for determining, implementing, and monitoring polices regarding the hospital's total operation by failing to ensure that the hospital's polices were reviewed and updated. The hospital's general policies had not been reviewed and updated since 3/08. The hospital's policies for Rehabilitative Services (physical therapy) had not been reviewed and updated since 1/01. This failure had the potential to contribute to patient harm due to staff operating under outdated policies and procedures.


Findings:


A review of the hospital's policies and procedures was conducted on 5/2/12. The following policy book groupings were reviewed:

Nursing Administration, dated 3/28/08
Infection Control Manual, dated 3/28/08
Pharmacy Policies, dated 3/28/08
Dietary Policies, dated 3/28/08
Quality Improvement Polices, dated 3/28/08
Rehabilitative Services, dated 1/8/01
Emergency Room (ER) Procedure Manual (contains all of the ER's policies and procedures), dated 3/28/08
Acute Procedural Manual (contains all of acute nursing's policies and procedures), 3/28/08


An interview was conducted with the Director of Nursing (DON) on 5/2/12 at 4 PM. She stated that the hospital had not reviewed the policies in several years. The DON stated that she had started to review some of the policies; however, the review and revision had not been sent through the required hospital committees. She stated that she was aware of the requirement by state regulation of policy review every three years. She acknowledged that policy review and revision was an important part of the overall operation of the hospital to provide safe patient care.

Based on interview and record review the hospital failed to ensure that all of their medical staff (6 of 10 credential files reviewed) had re-appraisals (evaluations). For 2 of 2 telemedicine physicians' credential files reviewed, there was no verification of their licensure. These failures had the potential to contribute to substandard and unsafe care of the hospital patients.

Findings:

1. During a record review of 10 physician credential files on 5/4/12, it was noted that 6 physicians did not have a re-appraisal in their files.

In an interview on 5/4/12 at 10:45 AM with the Medical Record Manager (MRM), the MRM stated that she was behind with the physician credential files. She acknowledged that there should be re-appraisals in the physician credential files so that the hospital can track their (the physicians) performance.

2. During a record review of 2 telemedicine physicians' credential files on 5/4/12, it was noted that there was no verification that the physicians were licensed in the State of California.

In an interview on 5/4/12 at 10:45 AM with the MRM, the MRM acknowledged that the telemedicine physician files did not have a verification of their licensure and acknowledged that the licenses should have been verified with the California Medical Board.

Based on observation, interview, and record review the hospital failed to have a well-organized pharmacy service, dietary service, and nursing service, to meet the needs of patients in a universe of 4 patients as evidenced by the following:

1. The hospital failed to ensure that the pharmacist reviewed all patient medication orders and medication administration records to ensure that there are no drug incompatibilities or contraindications to administering the drugs to patients. The hospital failed to ensure that the pharmacist in charge of pharmaceutical services had acute care experience and competencies and failed to ensure that only pharmacy compounds or admixes all sterile medications except in emergencies. (Refer to C 276)

2. The hospital failed to provide nursing care for patients in accordance with the specialized qualifications and competencies of the staff by allowing an unlicensed staff person (a medical assistant, an unlicensed person, who usually works in a clinic or physician's office) perform patient assessments, by not evaluating the nursing staff competencies and by not ensuring that all nursing staff had an annual evaluation. (Refer to C 295)

3. The hospital failed to ensure that only a licensed nurse administered medications in accordance with hospital policy and Federal and State law. The hospital allowed a medical assistant (MA) to administer medications to patients, including oral (po) medications, injectable medications, intravenous (IV) medications. The hospital also allowed the MA to independently adjust IV narcotic drips, flush IV catheters, and discontinue IV catheters. The hospital allowed the MA to take verbal orders from the physician and to confirm the verbal orders in the medical record. The hospital also failed to have a policy that limits the administration of any medication to only licensed nursing staff.(Refer to C 297)

4. The hospital failed to ensure that written policies were developed that were consistent with State law. The hospital failed to ensure that staffing policies reflected the requirements in the California Code of Regulations, Title 22, for nurse staffing in an acute care hospital. This failure had the potential for any patient admitted to the hospital to suffer a negative outcome due to a lack of nurses to provide patient assessment and care. (Refer to C 271)

5. The hospital failed to ensure the dietary services met the need of all patients as evidenced by:

a) The lack of Inpatients receiving nutritional assessments for 6 of 6 ( Patients 15, 9, 14, 2, 6 and 13) closed medical records reviewed for nutritional evaluations. (Reference C-279)

b) There was no plan for registered dietitian coverage when the fulltime RD was not available. (Reference C-279)

c) The lack of quality assurance program for the food and nutrition program that reflect the scope and nature of the services. (Reference C- 279, C- 330, C- 337)


d) The lack of an infection control program, including the review of policies and procedures and implementation of CAH wide programs including the food and nutrition department. (Reference C-278)


e) The lack of maintaining the ice machine used by patients. The ice machine was not cleaned and sanitized in accordance with manufacturer's directions. There was the potential of food borne illness for all patients. (Reference C-278)


f) The lack of menus following recommended dietary intake allowances such as Recommended Dietary Allowances (RDA) or the dietary reference Intake of the Food and Nutrition Board of the National Research Council. (Reference C-279)



The cumulative effect of these systemic problems contributed to the hospital's inability to provide quality care in a safe environment.

Based on interview and record review, the hospital failed to ensure that written policies were developed that were consistent with State law. The hospital failed to ensure that staffing policies reflected the requirements in the California Code of Regulations, Title 22, for nurse staffing in an acute care hospital. This failure had the potential for any patient admitted to the hospital to suffer a negative outcome due to a the amount of nurses provided by the hospital to conduct patent assessment and care.

Findings:

A review of the California Code of Regulations, Title 22, revealed the following:

70217 (a)(8), "There shall be no fewer than two licensed nurses physically present in the emergency department when a patient is present."

70217 (14)(k), "Each patient care unit shall have a registered nurse assigned, present and responsible for the patient care in the unit on each shift."

70217 (14)(d)(2), (The hospital shall retain documentation of) "The record of the actual registered nurse, licensed vocational nurse and licensed psychiatric technician assignments by licensure category for a minimum of one year."

70217 (14)(b), "The hospital shall implement a patient classification system...for determining nursing care needs..."


The regulations stated that a rural hospital may apply for program flexibility, regarding these requirements.

Observation of the hospital, on 4/30/12 at 2 PM, revealed that there were 4 acute care beds and a room with 2 emergency room (ER) beds, in an area separate from the acute care beds.

A review of the hospital's nurse staffing revealed that on each shift, there was one Registered Nurse (RN) on duty. On the day shift there was one Licensed Vocational Nurse (LVN) or a Medical Assistant (MA) scheduled for the day shift. There was one RN scheduled for the night shift.

A review of the on call schedule revealed that there was usually an RN and an LVN on call.

A review of the hospital policy titled "Department Staffing & Scheduling", dated 3/08, revealed that there was no mention of the amount and type of nursing required when a patient was present in the acute care unit or in the ER.

An interview was conducted with the Nurse Manager (NM) of the hospital on 5/1/12 at 2:30 PM. She stated that when there was a patient in the ER, the RN would be required to stay in the ER with the patient. The NM stated that if there was an acute care patient present in the acute care area, either the LVN or the MA would be assigned the patient. She stated that at times the hospital can have up to 4 patients; however, most times there was only one or two patients at a time. The NM stated that the RN can call in another LVN or RN if she determined it was necessary. The NM stated that there was always an RN on duty in case a patient came into the ER. She stated that the nurse on duty did not call in another nurse when a patient was present, unless the on duty nurse determined that she needed help. The NM stated that the hospital had guidance for the RN to help direct them when another nurse could be called in. The NM confirmed that in the ED 2 licensed nursing staff were not present in the unit when a patient was in the unit. She stated that in the acute care unit, the hospital did not always have an RN present in the unit. She confirmed that an unlicensed person, the MA, was left in charge of patient care when the RN was in the ER.


An interview was conducted with the Director of Nursing (DON) on 5/1/12 at 3:30 PM. She was asked if the hospital documented and kept records of patient care assignments in the acute care unit. She stated that they did not. The DON was asked if the hospital had a patient classification system. She stated that they did not have such a system.

A follow up interview was conducted with the hospital Administrator and the DON on 5/4/12 at 11 AM. The DON confirmed that the hospital policy did not define the numbers and type of nursing staff required if a patient was in the hospital. The Administrator stated that they thought they had a program flexibility for their nurse staffing; however, they were not able to find the documentation allowing this program flexibility. The Administer acknowledged that even if they did have a program flexibility, it was most likely not active at this time.

Based on interview and record review the hospital failed to ensure that pharmacy services were administered according to accepted professional principles by failing to ensure the following:

1. That the pharmacist reviewed patient medication orders and medication administration records to ensure that only licensed staff administered medications to patients, that only licensed staff flushed intravenous catheters and discontinue intravenous catheters and that only licensed staff took verbal orders from the physician. The hospital allowed a medical assistant (MA) to administer medications to patients, including oral (po) medications, injectable medications, intravenous (IV) medications. The hospital also allowed the MA to independently adjust IV narcotic drips, flush IV catheters, and discontinue IV catheters. The hospital allowed the MA to take verbal orders from the physician and to confirm the verbal orders in the medical record.

(A medical assistant is an unlicensed person, who usually works in a clinic or physician's office. According to the Medical Board of California, a medical assistant was not allowed to administer medications unless the medication has been verified by a physician, podiatrist or another appropriate licensed person {such as an advanced practice nurse}. The Medical Board limits the medical assistant from giving "scheduled" medications {such as narcotics} only if the physician or physician extender was "on the premises" and does not permit the medical assistant to "place the needle or start and disconnect the infusion tube of an IV. "The Medical Board further identified the IV procedure as "invasive" {a procedure that causes a break in the skin} and specifically prohibits the MA from performing such procedures.)

2. That the pharmacist reviewed all patient medication orders and medication administration records to ensure that there were no drug incompatibilities or contraindications to administering the drugs to patients. The hospital failed to ensure that the pharmacist in charge of pharmaceutical services had acute care experience and competencies and the hospital failed to ensure that only pharmacy compounds or admixes all sterile medications except in emergencies.

3. That the controlled medication sign out sheets were accurate by not including documentation of the dosage of medication given and the amount wasted.

These failures had the potential to jeopardize the health and safety of any patient cared for in the hospital.

Findings:

A review of the hospital policy titled "Medication Handling and Administration", dated 5/11, revealed that a "licensed person obtains" narcotic medications; however, there was no statement clarifying who could administer any medication.

A review of the hospital policy titled "Administration of Narcotics", dated 3/08, revealed that access to the narcotic cabinet would be limited to licensed nursing staff and stated that the licensed nurse who signed out the medication was to administer the medication.

A review of the hospital policy titled "Verbal Orders", dated 3/08, revealed that verbal orders would be received from the physician by a Registered Nurse (RN) or a Licensed Vocational Nurse (LVN).

A review of the hospital policy titled "Noting Physician's Order", dated 5/11, revealed that the nurse was to do the check of the chart and ensure the accuracy of the transcription of the physician's orders for medications.

A review of the hospital policy titled "Saline Lock", dated 5/11, revealed that only IV certified RNs and LVNs could perform the procedure for providing the IV access and flushing the IV access. (A Saline Lock is IV an access device that permits intermittent access for the administration of medications. The Lock must be periodically flushed to keep the device ready for use.)

A review of California Code of Regulations Title 22 for acute hospitals revealed that regulation 70263 (g) "No drugs shall be administered except by licensed personnel authorized to administer drugs."

1 a. A review of the medical record for Patient 6 was conducted on 5/2/12. The review revealed that the patient was admitted to the hospital on 10/26/11 with diagnoses that included pneumonia (infection in the lungs) and heart failure (failure of the heart to pump efficiently). During the admission, the physician and the family decided to give the patient only comfort care and the patient expired on 11/2/11.

A review of the medication administration record (MAR) revealed that on 10/29/11 the MA administered Morphine Sulfate (MS) (narcotic) 2 milligrams (mg) by IV push at 8:50 PM and at 10:35 PM. The MA documented that she gave MS 2 mg IV push seven times on 10/30/11, and on 11/1/11 she gave MS 2 mg IV push twice. Further review of the MAR revealed that the MA gave the patient IV antibiotics and respiratory treatments with medications during the patient's hospitalization.

A review of the nursing notes, dated 10/28/11 at 1:03 PM, revealed that the MA gave the patient an IV mixture with potassium (Potassium IV can be dangerous to the patient and can cause irregular heart beats and patient death.).

Further review of the nursing notes, dated 10/31/11 at 11:10 AM, revealed that the MA documented that a "morphine drip 2 mg/hr (hour) (was) started." The MA documented an increase in the morphine drip at 12:55 PM, 1:20 PM, and at 4:10 PM.

A review of the physician's orders, dated 11/1/11 at 11:10 AM, revealed that the MA wrote a verbal order from the physician regarding the use of the IV.

b. A review of the medical record for Patient 7 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 3/15/12 with diagnoses that included pneumothorax (collapsed lung), decreased oxygen, and pain.

A review of the MAR revealed that the MA documented that she gave the patient IV antibiotics, IV morphine, IV fluids, and respiratory treatments with medications during the patient's hospitalization.

A review of the nursing notes revealed that on 3/16/12 at 5:15 PM, "IV was saline locked."

c. A review of the medical record for Patient 9 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 4/4/12 with diagnoses that included vomiting and dehydration.

A review of the physician's orders, dated 4/4/12 at 1:05 PM revealed that the MA "noted" (confirmed) the physicians orders for admission which included admission medications.

A review of the MAR revealed that the MA gave IV push Zofran (used for nausea), several po (oral) medications, and started an IV infusion.

The nursing notes, dated 4/8/12 at 8:55 AM, were reviewed. The MA documented that she went into the patient's room to administer the patient's lidoderm patch (topical pain relief patch) and fentanyl patch (fentanyl, a strong narcotic medication used for severe pain). She documented that the patient stated that she did not need the patch because she (the patient) re-used her patches. The MA documented that the patient opened a bedside drawer and showed her 3 patches that the patient had saved. (Information from the pharmaceutical company that produced the Fentanyl and Lidoderm patches revealed that even a used patch contains a large amount of medication that could cause inaccurate dosing of the medication, so saving and re-using the patches was not recommended by the manufacturer.) There was no documented evidence that the MA contacted the physician or provided any other intervention for the patient saving her patches.

Further review of the nurse's notes, dated 4/8/12 at 1:25 PM, revealed that the MA documented "IV catheter was removed."



d. A review of the medical record for Patient 10 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 3/12/12 with diagnoses that included pneumonia.

A review of the MAR revealed that the MA documented that she gave IV antibiotics, and several po medications.

A review of the nursing notes, dated 3/16/12 at 10 AM, revealed that the MA "went in to pts (patient's) room to flush her IV before administration of her (IV antibiotic). During the flush, fluid came out the side of the dressing. I determined that the site was not viable. I removed the IV and the catheter was intact. I was unable to establish another IV."

A review of the physician's orders, dated 3/18/12 at 3:03 PM, revealed that the MA noted the physician's order to discharge the patient.

e. A review of the medical record for Patient 12 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 2/14/12 with diagnoses that included pneumonia.

A review of the MAR revealed that the MA documented that she administered medications including IV Benadryl (antihistamine) and IV Ativan (anti anxiety and a controlled medication) and respiratory treatments with medications.

A review of the nursing notes, dated 2/16/12 at 8 AM, revealed that "IV was restarted in (right) hand." On 2/18/12 at 1 PM, the MA documented "IV removed."

f. A review of the medical record for Patient 13 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 2/20/12 with diagnoses that included colon cancer.

A review of the MAR revealed that the MA documented that she gave IV Lasix (a diuretic), IV Zofran, and that the MA cosigned for waste of IV narcotics.

A review of the nurse's notes, dated 2/23/12 at 1:10 PM, revealed that the MA documented that she gave oral morphine.

g. A review of the medical record for Patient 14 was conducted on 5/1/12. The review revealed that the patient was admitted on 12/23/11 with diagnoses that included pneumonia and high blood sugar.

A review of the nurse's notes revealed that on 12/28/11 at 1 PM, "IV removed."

The hospital was asked for a job description for the MA. The hospital in response to the survey team's request provided the job description for a nurse's aide.

An interview was conducted with the MA on 5/1/12 at 1:35 PM. She stated that she was told by the hospital that she could give medications, including IV medications and perform the other duties, such as taking verbal orders and signing off physician's orders. She stated that she was often on the acute unit, alone with patients. The MA stated that an RN was always present in the hospital; however, if there was a patient in the emergency room, she would be left in the acute unit, alone with the patient.

An interview was conducted with the Nurse Manager (NM) of the hospital on 5/1/12 at 2:30 PM. She confirmed the findings in the patients' medical records regarding the MA giving medications, including IV controlled medications. She also confirmed the medical record findings that the MA started IVs, flushed IV saline locks, and discontinued IVs. The NM confirmed the medical record findings that the MA took verbal orders from the physician and noted physician orders. She stated that she questioned the practice of the MA with the Director of Nursing (DON), but was assured, by the DON, that the MA could perform the procedures.

An interview was conducted with the DON on 5/1/12 at 3:30 PM. She confirmed that the MA was independently giving medications, taking verbal orders, and noting physician orders. She stated that the RN was responsible for the patient, but that she had looked it up on the internet, and found that an MA could give "one medication to one patient at one time." She stated that she was not sure if this was for the hospitalized patient or a patient in the clinic or a doctor's office with direct supervision of a physician or physician extender. She confirmed the hospital's policies regarding medication administration, taking verbal orders, and noting physician orders and stated that these procedures are only in the scope of a licensed nurse.

In an interview on 5/3/12 at 12:05 PM with Pharmacist 1, he stated that he did not review the patient records for administration of medications or the physician orders and did not know an unlicensed staff member was administering medications and taking verbal physician orders.

2. A review on 5/3/12 of a facility contract titled "Pharmaceutical Services Agreement", dated 6/3/2008, showed the following:

"ACUTE CARE FACILITY
Direct oversight by Consultant shall include the following:
1) Inventory entire stock of medications and return underutilized or outdated stock.
2) In conjunction with your physicians, develop usage parameters for medications. With this information we will develop par levels for efficient ordering.
3) In conjunction with your physicians, develop emergency medication needs. With this information institute an emergency medication box system. Each box would contain the needed medications for a cardiac or respiratory emergency. After each use each would be exchanged. Each box is sealed with a plastic lock with the expiration dates listed in plain view. This will enable your facility to cut stocks and maintain inventories at a lower level.
4) Investigate the opportunity for your facility to dispense medications to patients seen in your emergency department and bill accordingly.
5) Develop policy and procedures as required.
6) Drug utilization reviews where applicable.
7) Develop quality assurance programs where applicable.
8) Attend committee meetings when applicable.
9) Supply professional consultation by phone when needed.
10) In-service employees as required.

In an interview on 5/3/12 at 12:05 PM with Pharmacist 1, he stated that he did not have acute care experience or competencies and that he did not review the patient records for administration of medications or the physician orders. He stated that he did not review a patient's drug regimen to ensure that there were no drug incompatibilities or drug interaction problems. He stated that he had no responsibility for adverse drug reactions, he reviewed them in medical staff meetings but did not know where the report went after the meeting. Pharmacist 1 stated that he did not mix routine medications for the hospital.

In an interview on 5/2/12 at 10:30 AM with the Nurse Manager, she stated that the nurses, "Mix intravenous antibiotics and other intravenous critical care drips at the time they are needed. We do not mix them ahead of time." The Nurse Manager further stated that, "Sometimes we mix potassium chloride in the intravenous bottles if the physician orders it. We use the 100 cc (cubic centimeter) bags of potassium chloride and add it to the 1000 cc intravenous bottle."

Review of a hospital policy titled "IV Admixtures" with a revision date of 5/11 revealed the following:

"POLICY
It is the policy of...(name of hospital).. that all medications added to IV (intravenous) solutions will be performed by an RN (Registered Nurse) on a physician's order.

PROCEDURE
2. All drugs added to IV solutions are done by an RN."

3. On 5/2/12 at 10 AM a review of the Emergency Room (ER) medications records was conducted.

The controlled drug sign out sheets were reviewed. The sheets included the medications Fentanyl (narcotic pain medication) 100 micrograms, dated 10/11/11, Versed (a medication used for sedation) 2 milligrams, dated 10/11/11 and Ativan (an anti anxiety medication) 2 milligrams.

The sheets included many sign outs by Registered Nurse 1 (RN 1). On many of the sign outs, there was no dosage for the medication listed. There was no indication if the full dose of the medication was given or if the RN wasted any of the medication (It was common to use only a partial dose of these medications and if a partial dose was used a second signature was required for the wasted medication).

The NM stated that these sheets were not filled out properly. She stated that the nurse should document the dosage used and if the full dose was not used, the nurse must have a co-signature for the unused medication.

An interview was conducted with RN 1 on 5/3/12 at 8:30 AM. She confirmed that she had not documented completely on the controlled drug sign out sheets. She stated that some of the doses given were not full doses and that she should have had another licensed staff sign the form because some of the medications were not given to the patient and were not used.

Based on observation, staff interview, and document review, the hospital failed to ensure that:

1. The designated infection control officer had an active infection control program as evidenced by: Lack of infection control program including the review of policies and procedures and implementation of CAH wide program including the food and nutrition department, Lack of maintaining the ice machine used by patients when this machine was not cleaned and sanitized in accordance with manufacturer's directions. These failures had the potential to result in food borne illness for all patients.


2. The Physical Therapy Manager (PTM) had a test for Tuberculosis (TB) annually as required by the hospital. This failure had the potential to contribute to hospital patients and employees being exposed to TB and cause the spread of TB to anyone within the Physical Therapy area.


Findings:

1 a. On 5/1/12 a 10:15 AM, the Director of Nursing was interviewed. She stated that her role included infection control responsibilities which she had started in December of 2011. She stated that she had not reviewed the Food and Nutrition Department policies or procedures regarding infection control. She stated that she was not familiar with the standard of practice for the food service department as outlined in the FDA (Food and Drug Administration) Food Code 2009 or other food borne illness prevention standards.

b. On 5/1/12 starting at 9:30 AM, the one bin ice machine was observed. The Director of Facilities stated that this was the only ice machine for the hospital and it was emptied one time per month by the Environmental Service (EVS) department and the bin was cleaned. He stated that there was no written policy or preventative maintenance program for the ice machine except that he changed the filter two times per year.

On 5/1/12 at 9:45 AM, the EVS (Environmental Services) Manager stated the ice machine bin was cleaned quarterly. The ice machine cleaning record was reviewed on 5/1/12 at 9:45 AM. It showed the last time the ice machine bin was cleaned was in August of 2011. She stated that this task must have "fallen through the cracks" as she had not assigned other EVS staff to clean and sanitize the machine while she was not in the hospital.

The Director of Facilities stated 5/1/12 at 9:30 AM, that he did not clean or sanitize the ice making parts of the ice machine and that the machine made ice with no maintenance problems. He stated he had been employed for the last two years and that there was no cleaning or sanitizing of the ice making parts since he was at the hospital.

The policy titled "024" stated the interior of the ice machine [bin] was to be sanitized with a 50/50 concentration of bleach and water 3 times per year.

Review of the manufacture's directions for interior cleaning and sanitizing stated that the machine was to use only manufacturer approved ice machine cleaner and sanitizer. The directions stated to clean and sanitize the ice machine every six months. The cleaning and sanitizing procedure for the ice making components, apart from the bin was to be cleaned and sanitized by running the cleaning and sanitizing products through the tubing and ice machine. The Director of Facilities confirmed on 5/1/12 at 10:00 AM, that he had not followed any of the manufacturer's cleaning or sanitizing directions.

The DON was informed on 5/1/12 at 10:15 AM, about the findings for the ice machine which provided hospital patient's ice that included the bin ice machine had not been cleaned or sanitized following the manufacturer's directions for the past two years. She acknowledged the potential for patient at risk of food borne illness when provided ice from an unsanitized source.





22233


2. A review of the employee file for the PTM was conducted on 5/3/12. The review revealed that the PTM was hired by the hospital on 8/1/08.

A review of the PTM tests for TB revealed that the last TB test was done on 10/21/10.

An interview was conducted with the Nurse Manager of the hospital on 5/3/12 at 5:20 PM. She stated that all employees should have a TB test done annually to ensure the safety of the patients. She confirmed that the PTM did not have a TB test since 10/21/10.

Based on staff interview and record review the hospital failed to ensure that the nutrition needs of inpatients were met in accordance with recognized dietary practices and the orders of the practitioner as evidenced by: 1) Lack of Inpatients receiving nutritional assessments for 6 of 6 sampled patients (Patients 15, 9, 14, 2, 6 and 13) closed medical records reviewed for nutritional evaluations, 2) No plan for registered dietitian (RD) coverage when the full time RD was not available, 3) Lack of quality assurance program
for the food and nutrition program, 4) Lack of nutrition analysis of menus.

Findings:

1. Starting on 5/1/12 at 1:00 PM, 6 closed medical records were reviewed for nutrition assessments.

a. Patient 9 was admitted on 4/4/12 and discharged on 4/8/12. Patient 9 was admitted for nausea and vomiting, abdominal pain and dehydration.

Elevated labs on 4/4/12 stated glucose 132 gm/dl, (Normal 85- 110 gm/dl).

Physician admission notes dated 4/4/12 indicated that the patient stated that she had a history for the past four months of nausea and vomiting in the morning.

The Nutrition Risk Screening form dated 4/4/12 indicated that the patient was a low nutritional risk.

Patient 9 with nutrition related admission diagnoses did not receive a referral to the registered dietitian for a nutrition assessment.

There was no nutritional assessment of the patient.

b. Patient 14, was admitted 12/23/11 with diagnoses of pneumonia and Diabetes Mellitus (high blood sugar) Type 2. The patient was discharged 12/28/11.

The Physician stated on the admission history and physical note, dated 12/23/11, "Admitting for treatment of pneumonia and attempt to control his diabetes. "

There was no nutritional screen on admission, there was no RD assessment of the patient's nutritional status.

c. Patient 15 was admitted on 4/22/12 with hyponatremia (low serum sodium) and fever. The patient was discharged on 4/23/12. The Nutritional Risk Screening form stated patient was a high nutritional risk with indicators of cancer and weakness.

There was no nutritional assessment done for the patient.

d. Patient 2 was admitted on 3/31/12 with cough and fever. The Nutritional Risk Screening Form dated 4/1/12, stated that the patient was a high nutritional risk with indicators of pneumonia and low sodium and elevated glucose levels.

Labs stated Albumin (measure of visceral protein levels) 3.2, (normal 3.5 mg/dl to 5.0 mg/dl), sodium 133 L (135 to 145) dated 3/31/12, and albumin 2.6, dated 4/2/12.

There was no nutritional assessment for the patient. There was no height or weight entered on the nursing admission form.

e. Patient 6 was admitted on 10/26/11 with diagnoses of pneumonia and dehydration.

Labs dated 10/27/11 stated albumin 2.7 ( normal 3.5 mg/dl to 5.0 mg/dl) and 10/28/11 albumin 1.7 mg/dl ( normal 3.5 to 5.0 mg/dl).

There was no Nutritional Screen Form completed for the patient.

During an interview on 5/2/12 at 9:30 AM, the Nurse Manager stated the hospital did not put all of the admission forms in a packet to ensure the nurse completed the forms.

There was no nutritional assessment of patient.

f. Patient 13 had diagnoses of colon cancer and liver metastasis (spread of the cancer).

Albumin was 2.9 (normal 3.5 mg/dl to 5.0 mg/dl) dated 5/20/12.

The nutritional Risk Screening form, dated 2/20/12, stated patient was at high nutritional risk with indicators of weight change, cancer, and weakness checked off on the form.

An interview was conducted with the RD on 5/2/12 starting at 9:30 AM she stated that she was employed full time and worked 2 day per week in the skilled nursing unit, 2 days a week at home on call and at the outpatient clinic. She stated that her primary assignments were in the skilled nursing unit. The RD stated that she was involved in the training of the Dietary Manager, review of policies and procedures, and menus. She stated that the Nutritional Screening forms were put on her desk. She stated that she did not do any nutritional assessment of the inpatients on the acute hospital unit. She stated that she did not receive the Nutritional Screening Forms or information regarding a patient admitted with identified nutritional risk when she was not in the hospital and working at home or at the clinic.

A review of the policy titled General Responsibilities # 2101 dated 12/07 "Registered Dietitian's Responsibilities stated "1. Within 24 hours of admission of the patient, the RD documents the nutritional risk of the patient on the interdisciplinary Initial Assessment Form... 2. All acute patients whose length of stay is greater that two days, 48 hours are screened by the RD and nutritional level is assigned."

2. On 5/2/12 at 2:00 PM, the Chief Executive Officer stated that there was no coverage when the RD was unavailable or on vacation.

3. On 5/2/12 at 9:30 AM, the RD was interviewed regarding the quality assurance and performance improvement plan for the Food and Nutrition Department. She stated that she was not involved in any quality approval for the department. She stated that there was no quality assessment or performance plan for the Department.

A review of the policy titled Performance Improvement Plan for Nutritional Services #6001 stated "Nutrition Services Department participates in a hospital wide performance improvement program designed to monitor, evaluate and improve the quality, appropriateness and outcomes of clinical services .... " .

There was no policy or quality plan provided that included the food services department.

4. On 5/2/12 starting at 9:30 AM, the RD was asked for the nutrient analysis of the menus. The RD showed a nutrition breakdown for the spring Week 2012. The breakdown showed regular diet, 2 gram sodium, low fat/low cholesterol diet/ 80 gram protein. And no concentrated sweets/ consistent carbohydrate diet for many of the required nutrients but not all of the nutrients specified in the RDA or DRI (Dietary Reference Intake) pattern.

The Recommended Dietary Allowances (RDAs) are quantities of nutrients in the diet that are required to maintain good health in people. RDAs are established by the Food and Nutrition Board of the National Academy of Sciences, and may be revised every few years. A separate RDA value exists for each nutrient. The RDA values refer to the amount of nutrient expected to maintain good health in people.

The nutrition analysis did not provide a nutrition analysis of the small and large portion sizes to ensure they met the required nutrients for all ages served by the hospital.

The RD confirmed that the hospital did not have a system to ensure all of the nutrients specified on the RDA or DRI were compared to the menus. The RD confirmed there was no system to ensure the menus were analyzed and met the requirements for all of the diets and portion sizes served.

Based on interview and record review, the hospital failed to ensure that policies for the Emergency Room (ER) were reviewed at least annually. The hospital failed to ensure that the ED polices had been reviewed and updated since 3/28/08. This failure had the potential to contribute to patient harm due to outdated policies and procedures and had the potential to contribute to patients not receiving safe care in the ER, for any patient who required emergency services.

Findings:

A review of the policy book for the ER was conducted on 5/3/12. The review revealed that the policies had not been updated or reviewed since 3/28/08.

An interview was conducted with the Nurse Manager of the hospital on 5/3/12 at 2 PM. She stated that the Director of Nursing had started to review some of the policies; however, none of the policies had been through a complete review, update, and approval of the Governing Body since March of 2008. The Nurse Manager acknowledged that this was a yearly requirement.

Based on interview and record review, the hospital failed to follow their policy for " Performance Appraisals " for the manager of the Rehabilitation Services. This failure resulted in the direct service of Physical Therapy (PT) to be managed by a person who had not been formally evaluated by the hospital since 2008. This failure had the potential to negatively effect the PT care of any patient who required PT.

Findings:

A review of the employee file for the PT Manager (PTM) was conducted on 5/3/12. The review revealed that the PTM was hired by the hospital on 8/1/08. There was a 90 day performance review conducted by the hospital on 11/1/08. There were no further performance evaluations conducted for the PTM.

A review of the hospital policy titled " Performance Appraisals " , dated 3/28/08, revealed that a performance appraisal should be completed on each employee on an annual basis, based on the employee ' s anniversary date.

An interview was conducted with the PTM on 5/3/12 at 4:45 PM. She confirmed that she did not have a performance appraisal conducted since her 90 day evaluation.

An interview was conducted with the Director of Nursing on 5/3/12 at 5:30 PM. She stated that an employee performance appraisal should be conducted for all employees on an annual basis. She confirmed that the PTM had not had an annual evaluation.

Based on interview and record review the hospital failed to record the maintenance of their X-ray equipment to better know if the equipment was maintained according to manufacturer's specifications. This failure had the potential to contribute to patients or staff being exposed to radiation hazards.

Findings:

During an observation tour of the radiology department on 5/2/12 with the Radiology Manager (RM), the RM was asked for the maintenance logs for the radiology equipment.

The RM supplied a handwritten log book for the CT (computerized tomography machine) that showed the CT machine had regular maintenance. The RM failed to provide any maintenance logs for the X-ray equipment or the ultrasound equipment.

In an interview on 5/2/12 at 4:00 PM with the RM, he stated that he did not have records of the X-ray or ultrasound equipment maintenance. He further stated that the service person does not leave him any type of record and acknowledged that there would be no way of knowing if the maintenance to the radiology equipment was done according to manufacturer's specifications.

Based on interview and record review the hospital failed to provide nursing care for 7 of 20 sampled patients (Patients 2, 6, 7, 9, 10, 12 and 13) in accordance with the specialized qualifications and competencies of the staff by allowing an unlicensed staff person (a medical assistant, an unlicensed person, who usually works in a clinic or physician's office) perform patient assessments, by not evaluating the nursing staff competencies and by not ensuring that all nursing staff had an annual evaluation. These failures had the potential to jeopardize the health and safety of any patient cared for in the hospital.

Findings:

1. A review on 5/1/12 of the nurses notes for Patient 2 dated 4/3/12 showed that a medical assistant (MA) completed and signed the 7:00 AM to 7:00 PM patient assessment as the assessing nurse. There was an RN (registered nurse) signature under the MA signature.

In an interview on 5/1/12 at 3:45 PM with the DON (Director of Nursing), she acknowledged that an unlicensed staff person completed the assessment and stated that the RN is supposed to verify the MA's assessment. She further acknowledged that a MA should not be doing assessments as she is not a licensed nurse.

A review of a hospital policy and procedure titled "Nursing Assessment" with a review date of 6/06 showed the following:

"It is the policy of ....Hospital that a admission assessment will be done on all patients within four (4) hours of admission. This assessment is the responsibility of the Charge Nurse.

Purpose
To ensure that all the needs of the patients are addressed in a timely manner. To ensure changes of condition are quickly addressed."

A review of a hospital policy and procedure titled "Nurse License Policy" with a review date of 6/06 showed the following:

"All nursing employees functioning in the capacity of licensed nurse will possess a current, valid California license from the California Board of Registered Nursing or California Board of Vocational Nurse and Psychiatric Technician Examiners."

2. A review of eight nursing employee files on 5/2/12 showed that 7 of 8 of the files did not have a record of an evaluation of the nursing staff's competency to perform duties in their area of assignment, including the DON's (Director of Nursing) file.

In an interview with the DON on 5/2/12 at 3:55 PM, she acknowledged that there has not been a system to ensure that the nursing staff had a full competency assessment upon hire and annually.

A review of a hospital policy and procedure titled "Introductory Period", undated, showed the following:

"It is the policy of ...(hospital district name) that all new employees and all present employees transferred or promoted to a new job are to be carefully monitored and evaluated for an initial introductory period. After satisfactory completion of the introductory period, those employees will be evaluated as provided for in the Performance Appraisal policy."

3. A review of eight nursing employee files on 5/2/12 showed that 8 of 8 of the files did not have a record of an annual performance evaluation of the nursing staff in their area of assignment, including the DON's (Director of Nursing) file.

In an interview with the DON on 5/2/12 at 3:55 PM, she acknowledged that there has not been a system to ensure that the nursing staff had an annual performance evaluation.

A review of a hospital policy titled "Performance Appraisals", undated, showed the following:

"It is the policy of ...(hospital district name) that the job performance of each employee should be evaluated periodically by the employee's supervisor. All evaluations will be on the prescribed forms and signed by the Department Manager/Supervisor, Administrator, H.R. Manager, and Employee. The Human Resources Department will maintain the evaluations in the employee's personnel file."






22233



4 a). A review of the medical record for Patient 6 was conducted on 5/2/12. The review revealed that the patient was admitted to the hospital on 10/26/11 with diagnoses that included pneumonia and heart failure.

On 10/29/11, 10/30/11 and 11/1/11, the MA signed the patient shift assessment as the "Assessing Nurse" for the AM shift.

b). A review of the medical record for Patient 7 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 3/15/12 with diagnoses that included pneumothorax (collapsed lung), decreased oxygen, and pain.

On 3/15/12 and 3/16/12, the MA signed the patient shift assessment as the "Assessing Nurse" for the AM shift.


c). A review of the medical record for Patient 9 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 4/4/12 with diagnoses that included vomiting and dehydration.

On 4/8/12, the MA signed the patient shift assessment as the "Assessing Nurse" for the AM shift.


d). A review of the medical record for Patient 10 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 3/12/12 with diagnoses that included pneumonia.

On 3/15/12, 3/16/12, and 3/17/12, the MA signed the patient shift assessment as the "Assessing Nurse" for the AM shift.


e). A review of the medical record for Patient 12 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 2/14/12 with diagnoses that included pneumonia.

On 2/17/12 and 2/18/12, the MA signed the patient shift assessment as the "Assessing Nurse" for the AM shift.


f). A review of the medical record for Patient 13 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 2/20/12 with diagnoses that included colon cancer.


On 2/23/12 and 2/29/12, the MA signed the patient shift assessment as the "Assessing Nurse" for the AM shift.


The hospital was asked for a job description for the MA. In responce to the survey team's request, the hospital provided the description for a nurse's aide.

The hospital was asked for competencies for the MA performing nursing assessments. The hospital failed to provide the requested competencies for the MA.

According to the California Medical Board, "Medical assistants are unlicensed, and may only perform basic administrative, clerical and technical supportive services as permitted by law. An unlicensed person may not diagnose or treat or perform any task that is invasive or requires assessment."

"The classification of medical assistant is defined under the provisions of the Medical Practice Act (Business and Professions Code sections 2069-2071) as a person who may be unlicensed who performs basic administrative, clerical, and technical supportive services under the supervision of a licensed physician or podiatrist."

"Under the law, 'technical supportive services' are simple, routine medical tasks and procedures that may be safely performed by a medical assistant who has limited training and who functions under the supervision of a licensed physician or podiatrist. "Supervision" was defined to require the licensed physician or podiatrist to be physically present in the treatment facility during the performance of those procedures."

An interview was conducted with the MA on 5/1/12 at 1:35 PM. She stated that she did perform nursing assessments on her patients. She stated that she was not aware if she had competencies to perform the assessment. She stated that she was usually assigned to the acute care unit to care for patients. The MA stated that the Registered Nurse (RN) was present in the hospital; however, the RN would be stationed in the emergency room (ER) if a patient was present. She stated that there was not always a physician present for direct supervision of her assessments of patients. She stated that she would assume care of the patient when the nurse was not in the acute unit.


An interview was conducted with the Nurse Manager (NM) of the hospital on 5/1/12 at 2:30 PM. The NM confirmed the medical record findings of the MA performing nursing assessments. She stated that the MA was assigned patient care in the acute care unit when the RN was stationed in the ER with patients. The NM stated that the RN's primary responsibility to patient care was the patient in the ER. She stated that the RN would go into the acute care unit, when she could leave the patient in the ER and assess the patient; however, the patient was assigned to the MA. She stated that she questioned the practice of the MA with the Director of Nursing (DON), but was assured, by the DON, that the MA could perform the procedures.

An interview was conducted with the DON on 5/1/12 at 3:30 PM. She confirmed that the MA did not have competencies to perform nursing assessment and confirmed that in California only an RN could perform nursing assessments, based on scope of practice. She also confirmed that the MA was assigned independent patient care in the acute patient care unit.

Based on interview and record review, the hospital failed to ensure that a Registered Nurse evaluated the patient's response to pain treatment, according to the hospital's policy, for 1 of 20 sampled patients (Patient 7). This failure had the potential for the patient to have inadequate treatment of his pain.

Findings:

A review of the medical record for Patient 7 was conducted on 5/1/12. The patient was admitted to the hospital on 3/15/12 with diagnoses that included pneumothorax (collapsed lung), low oxygen, and pain.

A review of the Medication Administration Record (MAR) was conducted. The review revealed that the patient received Morphine Sulfate (MS) (narcotic pain medication) several times. On the MAR was an area titled "Response". The following was documented:

3/15/12 at 7:45 PM, MS 4 milligrams (mg) SQ (subcutaneous - under the skin) was given, the response was documented at 8:45 PM - one hour later.

3/16/12 at 10 PM, MS 4 mg SQ was give, the response was documented 3/17/12 at 12:30 AM - 2 hours and 30 minutes later.

3/17/12 at 5:30 AM, MS 4 mg SQ was given, the response was documented at 5 AM - 1 hour and 30 minutes later.

3/17/12 at 5:55 PM, MS 4 mg SQ was given, there was no time documented on the response.

3/18/12 at 6:05 AM, MS 4 mg SQ was given, there was no response documented.

A review of the hospital's policy titled "Pain Assessment", dated 3/28/08, revealed that pain should be reassessed within 30 minutes of implementation of a pain control mechanism. The policy stated that the hospital " respects and supports the patient's right to appropriate assessment and management of pain..."

An interview was conducted with the Nurse Manager of the hospital on 5/3/12 at 2 PM. She confirmed the documentation of the patient's pain and stated that the nurse should reassess the patient's pain levels as directed by hospital policy to help ensure the patient's pain relief.

Based on interview and record review, the hospital failed to ensure that only a licensed nurse administered medications in accordance with hospital policy and Federal and State law. The hospital allowed a medical assistant (MA) to administer medications to patients, including oral (po) medications, injectable medications, intravenous (IV) medications. The hospital also allowed the MA to independently adjust IV narcotic drips, flush IV catheters, and discontinue IV catheters. The hospital allowed the MA to take verbal orders from the physician and to confirm the verbal orders in the medical record.

(A medical assistant, an unlicensed person, who usually works in a clinic or physician's office. According to the Medical Board of California, a medical assistant was not allowed to administer medications unless the medication has been verified by a physician, podiatrist or another appropriate licensed person {such as an advanced practice nurse}. The Medical Board limits the medical assistant from giving "scheduled" medications {such as narcotics} to patients only if the physician or physician extender was "on the premises" and does not permit the medical assistant to "place the needle or start and disconnect the infusion tube of an IV." The Medical Board further identified the IV procedure as "invasive" {a procedure that causes a break in the skin} and specifically prohibits the MA from performing such procedures.)

The hospital also failed to have a policy that limits the administration of any medication to licensed nursing staff.

This failure resulted in 7 of 20 sampled patients (Patients 6, 7, 9, 10, 12, 13, and 14) having an MA perform the nursing function of medication administration, without the training necessary to complete the function safely. This failure had the potential for serious patient harm, for any patient admitted to the hospital, from medical errors committed by an unlicensed person, without the training and knowledge of a licensed nurse.

Findings:

A review of the hospital policy titled "Medication Handling and Administration", dated 5/11, revealed that a "licensed person obtains" narcotic medications; however, there was no statement clarifying who could administer any medication.

A review of the hospital policy titled "Administration of Narcotics", dated 3/08, revealed that access to the narcotics cabinet will be limited to licensed nursing staff and stated that the licensed nurse who signed out the medication was to administer the medication.

A review of the hospital policy titled "Verbal Orders", dated 3/08, revealed that verbal orders would be received from the physician by a Registered Nurse (RN) or a Licensed Vocational Nurse (LVN).

A review of the hospital policy titled "Noting Physician's Order", dated 5/11, revealed that the nurse was to do the check of the chart and ensure the accuracy of the transcription of the physician's orders for medications.

A review of the hospital policy titled "Saline Lock", dated 5/11, revealed that only IV certified RNs and LVNs could perform the procedure for providing the IV access and flushing the IV access. (A Saline Lock, a IV access devise that permits intermittent access for the administration of medications. The Lock must be periodically flushed to keep the devise ready for use.)

A review of California Code of Regulations Title 22 for acute hospitals revealed that regulation 70263 (g) "No drugs shall be administered except by licensed personnel authorized to administer drugs."

Medical Record Review:

1. A review of the medical record for Patient 6 was conducted on 5/2/12. The review revealed that the patient was admitted to the hospital on 10/26/11 with diagnoses that included pneumonia and heart failure. During the admission, the physician and the family decided to give the patient only comfort care and the patient expired on 11/2/11.

A review of the medication administration record (MAR) revealed that on 10/29/11 the MA administered Morphine Sulfate (MS) (narcotic) 2 milligrams (MG) by IV push at 8:50 PM and at 10:35 PM. The MA documented that on seven occasions, she gave MS 2 mg IV push on 10/30/11, and on 11/1/11 that she gave MS 2 mg IV push twice. Further review of the MAR revealed that the MA gave the patient IV antibiotics and respiratory treatments with medications during the patient's hospitalization.

A review of the nursing notes, dated 10/28/11 at 1:03 PM, revealed that the MA gave the patient an IV mixture with potassium. (Potassium IV can be dangerous to the patient and can cause irregular heart beats and patient death.)

Further review of the nursing notes, dated 10/31/11 at 11:10 AM, revealed that the MA documented that a "morphine drip 2 mg/hr (hour) (was) started." The MA documented an increase in the morphine drip at 12:55 PM, 1:20 PM, and at 4:10 PM.

A review of the physician's orders, dated 11/1/11 at 11:10 AM, revealed that the MA wrote a verbal order from the physician regarding the use of the IV.

2. A review of the medical record for Patient 7 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 3/15/12 with diagnoses that included pneumothorax (collapsed lung), decreased oxygen, and pain.

A review of the MAR revealed that the MA documented that she gave the patient IV antibiotics, IV morphine, IV fluids, and respiratory treatments with medications during the patient's hospitalization.

A review of the nursing notes revealed that on 3/16/12 at 5:15 PM, "IV was saline locked."

3. A review of the medical record for Patient 9 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 4/4/12 with diagnoses that included vomiting and dehydration.

A review of the MAR revealed that the MA gave IV push Zofran (used for nausea), several po (oral) medications, and started an IV infusion.

A review of the nursing notes, dated 4/8/12 at 8:55 AM. The MA documented that she went into the patient's room to administer the patient's lidoderm patch (topical pain relief patch) and fentanyl patch (fentanyl, a strong narcotic medication used for severe pain). She documented that the patient stated that she did not need the patch because she (the patient) re-used her patches. The MA documented that the patient opened a bedside drawer and showed her 3 patches that the patient had saved. (Information from the pharmaceutical company that produced the Fentanyl and Lidoderm patches revealed that even a used patch contains a large amount of medication that could cause inaccurate dosing of the medication, so saving and re-using the patches was not recommended by the manufacture.) There was no documented evidence that the MA contacted the physician or provided any other intervention for the patient saving her patches.

Further review of the nurse's notes, dated 4/8/12 at 1:25 PM, revealed that the MA documented "IV catheter was removed."

A review of the physician's orders, dated 4/4/12 at 1:05 PM revealed that the MA " noted " (confirmed) the physicians orders for admission which included admission medications.

4. A review of the medical record for Patient 10 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 3/12/12 with diagnoses that included pneumonia.

A review of the MAR revealed that the MA documented that she gave IV antibiotics, and several po medications.

A review of the nursing notes, dated 3/16/12 at 10 AM, revealed that the MA "went in to pts (patient's) room to flush her IV before administration of her (IV antibiotic). During the flush, fluid came out the side of the dressing. I determined that the site was not viable. I removed the IV and the catheter was intact. I was unable to establish another IV."

A review of the physician's orders, dated 3/8/12 at 3:03 PM, revealed that the MA noted the physician's order to discharge the patient.

5. A review of the medical record for Patient 12 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 2/14/12 with diagnoses that included pneumonia.

A review of the MAR revealed that the MA documented that she administered medications including IV Benadryl (antihistamine) and IV Ativan (anti anxiety and a controlled medication) and respiratory treatments with medications.

A review of the nursing notes, dated 2/16/12 at 8 AM, revealed that "IV was restarted in (right) hand." On 2/18/12 at 1 PM, the MA documented "IV removed."

6. A review of the medical record for Patient 13 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 2/20/12 with diagnoses that included colon cancer.

A review of the MAR revealed that the MA documented that she gave IV Lasix (a diuretic), IV Zofran, and that the MA cosigned for unused IV narcotics.

A review of the nurse's notes, dated 2/23/12 at 1:10 PM, revealed that the MA documented that she gave oral morphine.

7. A review of the medical record for Patient 14 was conducted on 5/1/12. The review revealed that the patient was admitted on 12/23/11 with diagnoses that included pneumonia and high blood sugar.

A review of the nurse's notes revealed that on 12/28/11 at 1 PM, "IV removed."

The hospital was asked for a job description for the MA. In response to the survey team's request, the hospital provided the description for a nurse's aide.

An interview was conducted with the MA on 5/1/12 at 1:35 PM. She stated that she was told by the hospital that she could give medications, including IV medications and perform the other duties, such as taking verbal orders and signing off physician's orders. She stated that she was often on the acute unit, alone with patients. The MA stated that an RN was always present in the hospital; however, if there was a patient in the emergency room, she would be left in the acute unit, alone with the patient.

An interview was conducted with the Nurse Manager (NM) of the hospital on 5/1/12 at 2:30 PM. She confirmed the findings in the patients' medical records regarding the MA giving medications, including IV controlled medications. She also confirmed the medical record findings that the MA started IVs, flushed IV saline locks, and discontinued IVs. The NM confirmed the medical record findings that the MA took verbal orders from the physician and noted physician orders. She stated that she questioned the practice of the MA with the Director of Nursing (DON), but was assured, by the DON, that the MA could perform the procedures.

An interview was conducted with the DON on 5/1/12 at 3:30 PM. She confirmed that the MA was, independently, giving medications, taking verbal orders, and noting physician orders. She stated that the RN was responsible for the patient, but that she had looked it up on the internet, and found that an MA could give "one medication to one patient at one time." She stated that she was not sure if this was for the hospitalized patient or a patient in the clinic or a doctor's office with direct supervision of a physician or physician extender. She confirmed the hospital's policies regarding medication administration, taking verbal orders, and noting physician orders and stated that these procedures are only in the scope of a licensed nurse.

Based on interview and record review, the hospital failed to ensure that a nursing care plan was developed and kept current for 3 of 20 sampled patients (Patients 7, 8 and 10). This failure had the potential to contribute to the patients' needs not being identified by nursing and lead to a negative outcome for the patients.

Findings:

1. A review of the medical record for Patient 7 was conducted on 5/1/12. The patient was admitted to the hospital on 3/15/12 with diagnoses that included pneumothorax (collapsed lung), low oxygen, and pain.

A review of the Medication Administration Record (MAR) for the patient's hospitalization revealed that he had been receiving narcotic pain medications, both intravenously and orally each day of his hospitalization from 3/15/12 to 3/19/12.

A review of the care plans for the patient revealed that there was one care plan developed. The care plan was for ineffective breathing. There was no care plan developed for treatment of the patient's pain.

An interview was conducted with the Nurse Manager of the hospital on 5/3/12 at 2 PM. She reviewed the record and stated that the nursing staff did not develop a plan of care for pain. She stated, "that was one of his main problems" and that the nursing staff should have developed a plan for treatment of the patient's pain.

2. A review of the medical record for Patient 8 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 12/23/11 with diagnoses that included pneumonia. The patient was discharged on 12/28/11.

A review of the care plans for the patient revealed a plan titled, Discharge Care Pan, dated 12/22/11. The care plan had a goal that the patient would have discharge planning starting on the day of admission and would receive verbal and written instructions prior to discharge. The plan contained no interventions or listing of how the goals would be accomplished. There was no conclusion to the care plan to indicate that the goals had been completed.

An interview was conducted with the Nurse Manager of the hospital on 5/3/12 at 2 PM. She confirmed that the care plan was not completed. She stated that the nurse should have completed the plan and indicated that the goals had been met or not met prior to the patient's discharge.

3. A review of the medical record for Patient 10 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 3/12/12 with diagnoses that included pneumonia. The patient was discharged on 3/18/12.

A review of the care plans for the patient revealed a plan for "Ineffective Breathing" related to the patient's diagnosis of pneumonia. The care plan was developed on 3/12/12 and discontinued on 3/15/12. There were no further care plans in the medical record.

A review of the nursing notes revealed the following problems that were identified by nursing after the care plan was discontinued:

3/16/12 at 3:30 AM, the patient still required oxygen therapy,

3/16/12 at 6:40 PM, the patient had not had a bowel movement since her admission,

3/17/12 at 11:45 AM, the patient had an intravenous antibiotic infiltration (medication into her tissue instead of the vein - can cause tissue death). The physician was notified; however there was no plan of care for continuing monitoring of the site,

3/17/12 at 4 PM, the patient still had decreased oxygen levels when her oxygen was taken off.

An interview was conducted with the Nurse Manager (NM) of the hospital on 5/3/12 at 2 PM. She confirmed the findings regarding the plan of care for the patient and the patient's continuing problems. The NM stated that the nursing staff should not have discontinued the plan of care before the patient's problem had been resolved. She stated that there should have been care plans developed for all of the patient's problems that were identified.

Based on staff interview and document review the hospital failed to maintain an effective ongoing hospital wide data driven quality assessment program.

1. The hospital failed to ensure that they measured, analyzed and tracked the patient care services provided by the Food and Nutrition Department to address the monitoring of the the nutrition assessments of inpatients and the safe food handling of the department. The failure to measure, analyze and track the quality plan of the Department put patients at risk of not meeting nutritional goals and for food borne illness.(Reference C-337, C-279)




25179

2. The hospital failed to ensure that they measured, analyzed and tracked the patient care services provided by contracted services such as Pharmacy Services. The lack of oversight contributed to unlicensed staff giving medications, the pharmacy services were provided by a pharmacist without acute care experience and competencies, the patient medication orders were not reviewed for drug interactions and contraindications and unlicensed staff documentation was not analyzed and tracked to ensure that the unlicensed staff did not perform patient assessments. (Refer to C-0337, C-0276, C-0295)

The cumulative effect of these systemic problems contributed to the hospitals failure to meet compliance with a hospital wide quality assurance performance improvement program.

Based on staff interview and document review, the hospital failed to ensure that they measured, analyzed and tracked the patient care services provided by the Food and Nutrition Department to address the monitoring of the the nutrition assessments of inpatients and the safe food handling of the department. The failure to measure, analyze and track the quality plan of the Department put patients at risk of not meeting nutritional goals and for food borne illness.

The hospital failed to ensure that they measured, analyzed and tracked the patient care services provided by contracted services such as Pharmacy Services to address unlicensed staff giving medications. The hospital failed to ensure that the pharmacy services were provided by a pharmacist with acute care experience and competencies, and failed to ensure that the patient medication orders were reviewed for drug interactions and contraindications. These failures had the potential to contribute to adverse reactions to medications and patients receiving substandard care.

The hospital failed to ensure that unlicensed staff documentation was analyzed and tracked to ensure that the unlicensed staff did not perform patient assessments.

Findings:

1. On 5/2/12 at 9:30 a.m., the RD was interviewed regarding the quality assurance and performance improvement plan for the Food and Nutrition Department. She stated that she was not involved in any quality approval for the department. She stated that there was no quality assessment or performance plan for the Department.

Review of the policy titled Performance Improvement Plan for Nutritional Services #6001 stated "Nutrition Services Department participates in a hospital wide performance improvement program designed to monitor, evaluate and improve the quality, appropriateness and outcomes of clinical services .... " .

There was no policy or quality plan provided that included the food services department.




25179

2. A review on 5/1/12 of the nurses notes for Patient 2 dated 4/3/12 showed that a medical assistant (MA) completed and signed the 7:00 AM to 7:00 PM patient assessment as the assessing nurse. There was an RN (registered nurse) signature under the MA signature.

In an interview on 5/1/12 at 3:45 PM with the DON (Director of Nursing), she acknowledged that an unlicensed staff person completed the assessment and stated that the RN is supposed to verify the MA's assessment. She further acknowledged that a MA should not be doing assessments as she is not a licensed nurse.

A review of a hospital policy and procedure titled "Nursing Assessment" with a review date of 6/06 showed the following:

"It is the policy of ....Hospital that an admission assessment will be done on all patients within four (4) hours of admission. This assessment is the responsibility of the Charge Nurse.

Purpose
To ensure that all the needs of the patients are addressed in a timely manner. To ensure changes of condition are quickly addressed."

A review of a hospital policy and procedure titled "Nurse License Policy" with a review date of 6/06 showed the following:

"All nursing employees functioning in the capacity of licensed nurse will possess a current, valid California license from the California Board of Registered Nursing or California Board of Vocational Nurse and Psychiatric Technician Examiners."

3a. A review of the medical record for Patient 6 was conducted on 5/2/12. The review revealed that the patient was admitted to the hospital on 10/26/11 with diagnoses that included pneumonia and heart failure. During the admission, the physician and the family decided to give the patient only comfort care and the patient expired on 11/2/11.

A review of the medication administration record (MAR) revealed that on 10/29/11 the MA administered Morphine Sulfate (MS) (narcotic) 2 milligrams (MG) by IV push at 8:50 PM and at 10:35 PM. The MA documented that she gave MS 2 mg IV push on seven occasions on 10/30/11, and on 11/1/11 that she gave MS 2 mg IV push twice. Further review of the MAR revealed that the MA gave the patient IV antibiotics and respiratory treatments with medications during the patient's hospitalization.

A review of the nursing notes, dated 10/28/11 at 1:03 PM, revealed that the MA gave the patient an IV mixture with potassium (Potassium IV can be dangerous to the patient and can cause irregular heart beats and patient death).

Further review of the nursing notes, dated 10/31/11 at 11:10 AM, revealed that the MA documented that a "morphine drip 2 mg/hr (hour) (was) started." The MA documented an increase in the morphine drip at 12:55 PM, 1:20 PM, and at 4:10 PM.

A review of the physician's orders, dated 11/1/11 at 11:10 AM, revealed that the MA wrote a verbal order from the physician regarding the use of the IV.

b. A review of the medical record for Patient 7 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 3/15/12 with diagnoses that included pneumothorax (collapsed lung), decreased oxygen, and pain.

A review of the MAR revealed that the MA documented that she gave the patient IV antibiotics, IV morphine, IV fluids, and respiratory treatments with medications during the patient's hospitalization.

A review of the nursing notes revealed that on 3/16/12 at 5:15 PM, "IV was saline locked."

c. A review of the medical record for Patient 9 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 4/4/12 with diagnoses that included vomiting and dehydration.

A review of the MAR revealed that the MA gave IV push Zofran (used for nausea), several po (oral) medications, and started an IV infusion.

A review of the nursing notes, dated 4/8/12 at 8:55 AM, was conducted. The MA documented that she went into the patient's room to administer the patient's lidoderm patch (topical pain relief patch) and fentanyl patch (fentanyl, a strong narcotic medication used for severe pain). She documented that the patient stated that she did not need the patch because she (the patient) re-used her patches. The MA documented that the patient opened a bedside drawer and showed her 3 patches that the patient had saved. (Information from the pharmaceutical company that produced the Fentanyl and Lidoderm patches revealed that even a used patch contains a large amount of medication that could cause inaccurate dosing of the medication, so saving and re-using the patches was not recommended by the manufacturer.) There was no documented evidence that the MA contacted the physician or provided any other intervention for the patient saving her patches.

Further review of the nurse's notes, dated 4/8/12 at 1:25 PM, revealed that the MA documented "IV catheter was removed."

A review of the physician's orders, dated 4/4/12 at 1:05 PM revealed that the MA "noted" (confirmed) the physicians orders for admission which included admission medications.

d. A review of the medical record for Patient 10 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 3/12/12 with diagnoses that included pneumonia.

A review of the MAR revealed that the MA documented that she gave IV antibiotics, and several po mediations.

A review of the nursing notes, dated 3/16/12 at 10 AM, revealed that the MA "went in to pts (patient's) room to flush her IV before administration of her (IV antibiotic). During the flush, fluid came out the side of the dressing. I determined that the site was not viable. I removed the IV and the catheter was intact. I was unable to establish another IV."

A review of the physician's orders, dated 3/8/12 at 3:03 PM, revealed that the MA noted the physician's order to discharge the patient.

e. A review of the medical record for Patient 12 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 2/14/12 with diagnoses that included pneumonia.

A review of the MAR revealed that the MA documented that she administered medications including IV Benadryl (antihistamine) and IV Ativan (anti anxiety and a controlled medication) and respiratory treatments with medications.

A review of the nursing notes, dated 2/16/12 at 8 AM, revealed that "IV was restarted in (right) hand." On 2/18/12 at 1 PM, the MA documented "IV removed."

f. A review of the medical record for Patient 13 was conducted on 5/1/12. The review revealed that the patient was admitted to the hospital on 2/20/12 with diagnoses that included colon cancer.

A review of the MAR revealed that the MA documented that she gave IV Lasix (a diuretic), IV Zofran, and that the MA cosigned for waste of IV narcotics.

A review of the nurse's notes, dated 2/23/12 at 1:10 PM, revealed that the MA documented that she gave oral morphine.

g. A review of the medical record for Patient 14 was conducted on 5/1/12. The review revealed that the patient was admitted on 12/23/11 with diagnoses that included pneumonia and high blood sugar.

A review of the nurse's notes revealed that on 12/28/11 at 1 PM, "IV removed."

The hospital was asked for a job description for the MA. In response to the survey team's request the hospital provided the description for a nurse's aide.

An interview was conducted with the MA on 5/1/12 at 1:35 PM. She stated that she was told by the hospital that she could give medications, including IV medications and perform the other duties, such as taking verbal orders and signing off physician's orders. She stated that she was often on the acute unit, alone with patients. The MA stated that an RN was always present in the hospital; however, if there was a patient in the emergency room, she would be left in the acute unit, alone with the patient.

An interview was conducted with the Nurse Manager (NM) of the hospital on 5/1/12 at 2:30 PM. She confirmed the findings in the patient ' s medical records regarding the MA giving medications, including IV controlled medications. She also confirmed the medical record findings that the MA started IVs, flushed IV saline locks, and discontinued IVs. The NM confirmed the medical record findings that the MA took verbal orders from the physician and noted physician orders. She stated that she questioned the practice of the MA with the Director of Nursing (DON), but was assured, by the DON, that the MA could perform the procedures.

An interview was conducted with the DON on 5/1/12 at 3:30 PM. She confirmed that the MA was, independently, giving medications, taking verbal orders, and noting physician orders. She stated that the RN was responsible for the patient, but that she had looked it up on the internet, and found that an MA could give "one medication to one patient at one time." She stated that she was not sure if this was for the hospitalized patient or a patient in the clinic or a doctor's office with direct supervision of a physician or physician extender. She confirmed the hospital's policies regarding medication administration, taking verbal orders, and noting physician orders and stated that these procedures are only in the scope of a licensed nurse.

In an interview on 5/3/12 at 12:05 PM with Pharmacist 1, he stated that he did not review the patient records for administration of medications or the physician orders and did not know an unlicensed staff member was administering medications and taking verbal physician orders

4. A review on 5/3/12 of a facility contract titled "Pharmaceutical Services Agreement" and dated 6/3/2008 showed the following:

"ACUTE CARE FACILITY
Direct oversight by Consultant shall include the following:
1) Inventory entire stock of medications and return underutilized or outdated stock.
2) In conjunction with your physicians, develop usage parameters for medications. With this information we will develop par levels for efficient ordering.
3) In conjunction with your physicians, develop emergency medication needs. With this information institute an emergency medication box system. Each box would contain the needed medications for a cardiac or respiratory emergency. After each use each would be exchanged. Each box is sealed with a plastic lock with the expiration dates listed in plain view. This will enable your facility to cut stocks and maintain inventories at a lower level.
4) Investigate the opportunity for your facility to dispense medications to patients seen in your emergency department and bill accordingly.
5) Develop policy and procedures as required.
6) Drug utilization reviews where applicable.
7) Develop quality assurance programs where applicable.
8) Attend committee meetings when applicable.
9) Supply professional consultation by phone when needed.
10) In-service employees as required.

In an interview on 5/3/12 at 12:05 PM with Pharmacist 1, he stated that he did not have acute care experience or competencies and that he did not review the patient records for administration of medications or the physician orders. He stated that he did not review a patient's drug regimen to ensure there were no drug incompatibilities or drug interaction problems. He stated that he had no responsibility for adverse drug reactions, he reviewed them in medical staff meetings but did not know where the report went after the meeting.