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Based on observation and interview, the facility failed to be in compliance with all state laws when the facility failed to have the current license posted at the clinic. This failure could interfere with the residents ability to contact CDPH (California Department of Public Health), the facility's licensing agency.

Findings:

During a tour of the clinic associated with the hospital on 5/7/12 at 1:30 pm, it was noted that the license posted had expired on 10/31/09. This license contained the wrong contact information for the Chico CDPH District Office. The facility's current license was posted in the main hospital's lobby.

According to Title 22, 75024; The current license shall be conspicuously posted in a location accessible to the public.

The Patient Care Coordinator, confirmed the above findings during a concurrent observation and interview on 5/7/12 at 1:45 pm.

Based on observation, staff interview, and document review, the governing body failed to ensure that when telemedicine services are furnished to the CAH's patients through an agreement with a distant-site telemedicine entity, the agreement is written and specifies that the distant-site telemedicine entity is a contractor of services to the CAH and furnishes the contracted services in a manner that enables the CAH to comply with all applicable conditions of participation for the contracted services. This has the potential to lead to under-qualified practitioners caring for patients and putting them at risk of poor outcomes.

Findings:

On 5/7/12 at 1:15 p.m. in a room adjacent to the Emergency Room, the hospital's administrative assistant (AA) pointed out the hospital's telemedicine audiovisual communication equipment and explained that recently a new service had begun which allowed patients to receive "psychiatric" services from providers at a distant location.

On 5/8/12 at 3:50 p.m., the Patient Care Coordinator (PCC) explained that she had been assigned various tasks related to assisting the establishment of the new "tele-psychology" service, and that she was the person at the hospital with the most knowledge about this new service. She explained that currently there were two psychologists associated with the service and they lived and practiced in a California city located 150 miles south. One was a PhD level psychologist with a Licensed Clinical Social Worker (LCSW) certificate and the other was a Registered Nurse with a Marriage and Family Therapist (MFT) certificate. Their services were provided cost free to the patients through a grant with a third party organization that fostered increased telemedicine connections for distant rural locations. The hospital had not yet established a written contract with the third party organization and had no documentation to show that it was a qualified "telemedicine entity" under the new federal regulation (CFR 485.635). The hospital does have a letter from the third party organization which agrees to set up an agreement, but does not state anything about credentialing of their psychologists.

On 5/9/12, the Medial Staff Coordinator (MSC) verified that the hospital did not have credential files or any credentialing information about either the LCSW or the MFT. Neither practitioner had applied for staff membership or clinical privileges.

Based on observation, interview, and record review, the facility failed to ensure that the emergency needs of its patients was met in accordance with acceptable standards of practice evidenced by:

One of the Emergency Department (ED) nurses was unable to identify and use the Braslowe tape (gives a range of drug dosages) for Pediatric (infants and children) emergencies. (Refer to C201).

The facility policy did not require its ED nurses to have Pediatric Advanced Life Support (PALS) certifications. (Refer to C201).

The Pediatric Emergency policy and procedure including pharmacology had not been revised since 2005 to reflect current standards of practice. (Refer to C274).

The Code Blue (when a patient's heart or breathing stops) policy had not been updated to reflect the current practice of the facility. (Refer to C274).

The Emergency Treatment and Active Labor Act (EMTALA) policy had not been revised to reflect the current transfer forms that were used by the facility. (Refer to C274).

Expired emergency supplies and drugs were found on the crash cart (contained supplies and drugs to be used in case of an emergency) located on the nursing unit. (Refer to C204).

These failures put patients at risk for substandard care and poor patient safety especially in an emergency situation. The cumulative effect of these systemic problems resulted in the facility's inability to comply with the statutorily mandated Emergency Services Condition of Participation.

Based on observation, interview, and record review, the facility failed to have adequate emergency services available on a 24 hour basis when it did not ensure that all staff were adequately trained for all types of emergencies. As a result, the facility placed Pediatric patients at risk for substandard care and poor outcomes.

Findings:

During an inspection of the ED on 5/7/12 at 1:25 pm, Registered Nurse (RN) C was asked about the use of the Braslowe tape in the case of emergency situations involving Pediatric patients. RN C pointed out the Pediatric emergency bag containing supplies and equipment, but was not able to locate the Braslowe tape. The Central Supply Supervisor came in and pointed out the Braslowe tape to RN C.

RN C was then asked to demonstrate the use of the Braslowe tape in determining a medication dosage for a Pediatric patient in case of an emergency, but was unable to do so.

RN C confirmed that she was the RN assigned to the ED for that shift. RN C confirmed that Pediatric patients are treated in their ED. RN C stated that the RNs in the facility are required to have ACLS (Advanced Cardiac Life Support) certifications, but not PALS (Pediatric Advanced Life Support) certifications.

A review of the ED log disclosed that two Pediatric patients who were siblings, had both presented to the ED on 4/29/12 after being involved in a motor vehicle accident.

A job description for RNs, last revised 2/5/02, required ACLS certification, and PALS certification was recommended but not required.

During an interview on 5/8/12 at 10:25 am, the Chief Nursing Officer (CNO) confirmed that the facility does not require all RNs to be PALS certified. She stated that the ED physician would always be present.

A review of the credentialing files for the facility's four ED physicians disclosed that only one of the four had PALS certification.

During an interview on 5/8/12 at 11:15 am, ED Physician (Phys) A confirmed that he's present in the facility and available for emergencies, except when he occasionally goes to a local store.

All facility RNs were not PALS certified and were not familiar with the use of the Braslowe tape. According to the ED emergency log, more than one Pediatric patient has presented to the ED at the same time and the ED physician may be out of the facility for a few minutes. As a result, the facility has put Pediatric patients at risk for substandard care and poor outcomes.

Based on observation and interview, the facility failed to ensure that all emergency supplies and drugs in the crash cart (contained supplies and drugs to be used in case of an emergency) located on the nursing unit had not expired. The facility failed to ensure that all laboratory supplies used at the clinic had not expired. This had the potential to put patients at risk for poor clinical outcomes including infection and inaccurate laboratory test results.

Findings:

1. On 5/7/12 at 12:25 pm, an inspection of the crash cart on the nursing unit disclosed the following outdated items:

Two nasopharyngeal airways (soft flexible tube that extends from the nose to the back of the throat to assist in breathing) with expiration dates of 11/09 and 4/10;

Endotracheal tube introducer and/or stylets (tubes that are inserted from the mouth or nose to the lungs to assist in breathing) with expiration dates of 3/10, 10/11, and 2/12;

Scalpel with an expiration date of 12/11 and a type of surgical clamp with an expiration date of 11/08, and an opened;

Undated tube of lidocaine (numbing medication) jelly.

During an interview on 5/7/12 at 12:40 pm, the Chief Nursing Officer confirmed the outdated supplies and medication and stated that staff should have gone through all the supplies to make sure none had expired.


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2. During a tour of the clinic associated with the hospital on 5/7/12 at 1:30 pm, the following supplies used for drawing blood were found to be expired; One blue top blood collection tube, expired 11/2011 and 22 gauge butterfly needle package, expired 2010.

The Patient Care Coordinator, confirmed the above findings during a concurrent observation and interview on 5/7/12 at 1:40 pm.

Based on observation, interview, and facility document review, the facility failed to provide preventive maintenance and housekeeping services to ensure the facility remains clean and orderly. This failure could result in an unsafe or unpleasant environment for patient, the public, and staff.

Findings:

a. On 5/9/12 at 1:30 pm, the survey team was asked to work in the employee's break room (adjacent to kitchen), while the general meeting room was utilized for a hospital staff meeting. During this time, multiple ants were observed on all three counter surfaces, the floor, and on the ice and water machine surface.

During a concurrent observation and interview with the Administrative Assistant (AA) on 5/9/12 at 2 pm, he confirmed the ant observations. The AA pointed to a white powder near the fridge and reported that the maintenance staff had been battling the ant problem. AA confirmed that the ice and water machine in the break room is used for both staff and patients.

During a concurrent interview and record review, with the MS on 5/10/12 at 8:10 am, he verified that despite his weekly pest control efforts, the ants continue to be a problem. MS stated, that he has not called in an outside company as yet.

The facility's policy and procedures was review, "Pest Abatement Procedures," dated 3/12/09, indicated, "If the treatment is outside the scope or ability of the facility staff, or if the current treatment plan is not producing positive results, external resources will be called in as necessary."

b. During an observation of Room 5 on 5/9/12 at 3:30 pm, the following was observed:

Two - 1 inch x 1 inch square holes were noted in the tiled shower wall and there were no safety grab bars present in the shower, the closet and bathroom door surfaces were scratched, a protective barrier board between bed and radiator was pulled out the wall on both sides, and personal belongings (black boots and walking stick) were stored in the closet.

During a concurrent observation and interview with the Maintenance Supervisor (MS) on 5/10/12 at 7:50 am, the above findings in Room 5 were confirmed.

During an interview with the Infection Control Nurse (ICN) on 5/10/12 at 8:05 am, she stated that the personal belongings should have been removed from the closet, prior to housekeeping cleaning the room.

A review of the facility's "Discharge of Patient from the Hospital" policy and procedure, dated 5/04, indicated, "Make sure patient has all belongings. Check the Patient Clothing Inventory List to make sure that nothing is overlooked..."

Based on interview and document review, the facility failed to prepare and train staff on what to do in the event of an external disaster. This failure could result in staff being unprepared in the event of a disaster and potentially put patient lives in danger.

Findings:

During a concurrent interview and document review with the Administrative Assistant (AA) on 5/8/12 at 10:15 am, documentation of the facility's most recent external disaster drill was reviewed. The AA confirmed that there had been one external disaster drill in the past year, and acknowledged that he knew that two drills were required, per state regulations.

According to Title 22, 70741 (d); The disaster plan shall be rehearsed at least twice a year. There shall be a written report and evaluation of all drills. The actual evacuation of patients to safe area during the drill is optional.

Based on staff interview and document review, the hospital's governing body failed to implement, monitor or enforce the hospital's policies, procedures, rules, regulations, and bylaws so as to ensure they were administered in a manner to provide quality health care in a safe environment. This has the potential to lead to under-qualified practitioners acting in a manner contrary to established standards of care and putting patients and staff members at risk of poor outcomes.

Findings:

On 5/7/12 and 5/8/12, the medical staff bylaws and minutes from meetings occurring in 2011 and 2012 were reviewed. These minutes were from the Medical Executive Committee (MEC) meetings, the Medical Staff meetings, and Board of Trustees (Board) meetings. On 5/8/12, the hospital's web page was reviewed, from which the posted April and May 2012 "Physician Schedules" were obtained and printed. On 5/9/12 at 9:00 a.m., an updated, detailed medical staff roster was provided. From these sources, a list of 10 staff members were selected for credential review. On 5/9/12 at 10:30 a.m. with the assistance of the Medical Staff Coordinator (MSC), the selected medical staff credential files were requested and reviewed. From these sources the following documented facts were obtained:

According to the web page, the hospital employs a full time Family Nurse Practitioner (FNP). Her credential file showed that she was granted privileges on 5/18/11. The 5/17/11 MEC minutes stated, "The application for (name of applicant) FNP, and Allied Health Professional has been approved. This will be taken to the Board of Directors for final approval tomorrow. (Name of FNP) will be starting work as Provisional Staff. She will be starting work on 6/2/11."

The 5/18/11 Board minutes stated, "Approval of Application to (name of applicant), FNP, Allied Health Professional..." The Board minutes did not specify that the FNP will be on provisional status. Neither minutes specify the term of appointment nor make any arrangements for proctoring. The FNP's credential file did not have any primary verification of training. Her state Board of Registered Nursing (BRN) certificates was the only documentation in the file that she was qualified as a FNP. There were no proctor reports or anything to document that proctoring has been begun.

According to the Medical Staff Bylaws (MS Bylaws) section 5.08-3 "(a) All new Allied Health Professionals shall be subject to a one-year period of formal proctoring. (b) Proctoring requirements shall be determined by the Interdisciplinary Practice Committee/Medical Executive Committee relating to, and upon review of, the medical training and employment reference information submitted."

According to the web based "Physician Schedule" a cardiologist, Physician I (Phys. I) sees patients in the clinic on the first Friday of each month. The MEC stated that the hospital had not made a credential file for Phys. I. He had never filled out an application, requested clinical privileges, or provided the MSC with any information concerning his qualifications. Review of the MEC and Board Minutes for 2011 & 2012 showed no mention of Phys. I. The MS Bylaws clearly require all physicians practicing on the premises to have both staff membership and clinical privileges.

On 5/8/12 at 3:50 p.m., the Patient Care Coordinator (PCC) provided information about a Licensed Clinical Social Worker (LCSW) and a Marriage and Family Therapist (MFT) that have been providing "tele-psychology" services to patients in the hospital. The MSC stated that the hospital had no credential files for these two practitioners. Neither had submitted an application to be part of the hospital's Allied Healthcare Practitioner (AHP) staff or to obtain any clinical privileges. Neither had provided any information about their qualification to the MSC.

Based on interview and record review, the facility failed to ensure that all ancillary staff were reviewed and evaluated when there was no performance evaluation for the Certified Dietary Manager (CDM). This had the potential to result in patients receiving substandard care.

Findings:

A review of CDM's personnel file disclosed that she was a contracted employee and there was no performance evaluation for the past year.

During an interview on 5/9/12 at 2 pm, the Administrative Assistant (AA) was asked how contracted employees were evaluated. AA stated that if their performance was good, "we renew their contracts and if not, then we don't renew their contracts."

Based on staff interview and document review, the medical staff members (physicians) failed to, in conjunction with the Family Nurse Practitioner (FNP), periodically review the hospital's patient records, medical orders, or other medical care services provided to the patients of the hospital. This lack of oversight has the potential to lead to substandard patient care and could put patients at risk of poor outcomes.

Findings:

On 5/9/12 at 11:00 a.m., the Medical Staff Coordinator (MSC) stated that in the past, when the hospital had a Physician Assistant (PA), the medical staff members did review and sign the records of patients seen by the PA. However, since the PA has left and the hospital recruited a FNP, review of the Mid-level (PA or FNP) Practitioner's charts was no longer done. When asked why, the MSC stated that for Nurse Practitioners the state does not require it and the Medical Staff (MS) modified their bylaws to allow the FNP to practice without overview and required physician countersignatures. The MSC pointed out in the Medical Staff Bylaws on page 38 at 6.05-5 (e), "The Nursing Practice Act does not require a physician countersignature for chart documentation. Revised 3/11/11."

On 5/10/12 at 2:10 p.m., the hospital's FNP was interviewed and she verified that usually she does not review her care of patients with any physicians and her chart entries, progress notes and orders are not countersigned by a physician. An exception is for rare patients with complex medical issues, she does seek a physician's opinion.

Based on staff interview and document review, the medical staff members (physicians) failed to periodically review and sign the records of all inpatients cared for by the Family Nurse Practitioner (FNP). This lack of oversight has the potential to lead to substandard patient care and could put them at risk of poor outcomes.

Findings:

On 5/9/12 at 11:00 a.m., the Medical Staff Coordinator (MSC) stated that the medical staff members never do review and sign the records of patients cared for by the nurse practitioner. The MSC pointed out in a printed copy of the medical staff bylaws that on 3/11/11, the bylaws had been modified. Section 6.05-5 (e) had been changed by removing the prior requirement for all record entries by allied health practitioners to be "countersigned within 7 days after the entry is made." That section now reads, "The Nursing Practice Act does not require a physician countersignature for chart documentation. Revised 3/11/11."

On 5/10/12 at 2:10 p.m., the FNP verified that her medical record entries (for both inpatients and outpatients) are not reviewed and countersigned by the physicians (Refer to C 259).

Based on observation, staff interview, and document review, the facility failed to ensure that services provided met the needs of patients evidenced by:

The facility failed to ensure that medications were stored and administered in a safe manner. (Refer to C 276).

The facility failed to have a system to identify and report adverse drug reactions and medication errors. (Refer to C 277).

The facility failed to review their policies annually. (Refer to C 280).

The facility failed to ensure that patients were from restraints. (Refer to C 381).

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure the provision and the quality of services safely and effectively.

Based on observation, interview, and record review, the facility failed to ensure that all emergency policies and procedures had been updated to reflect current standards and facility practice throughout the facility. This had the potential to lead to confusion during an emergency and put all patients at risk for substandard care and poor outcomes.

Findings:

1 a. The "Code Blue (when a patient's heart or breathing stops) in area outside the ED" policy, last reviewed 6/01, read, "dial 50 to use paging system to announce code blue."

During an interview and demonstration on 5/10/12 at 9:50 am, the Infection Control Nurse stated to call a Code Blue for the nursing unit, she would press "page" and "both" button twice on the phone to announce the Code Blue overhead.

During an interview and demonstration on 5/9/12 at 4:10 pm, the Radiology Supervisor stated to call a Code Blue for a patient in the CAT scanner, she would press "feature 63 0" to page Code Blue overhead.

During an interview on 5/8/12 at 1:30 pm, the Patient Care Coordinator stated to call a Code Blue in the clinic, there is a preset number that is dialed on the clinic phone.

During an interview on 5/8/12 at 8:55 am, the Chief Nursing Officer (CNO) confirmed that this policy was last reviewed on 6/01 and was the most current policy for this subject. The CNO confirmed she had not reviewed each policy contained in the Emergency Department (ED) manual.

1 b. A policy titled, "Pediatric Emergencies" from the ED policy manual was last revised on 7/26/05. The summary of BLS (Basic Life Support) /CPR (Cardiopulmonary Resuscitation) as well as the pharmacology was from 2005. It required staff to attend to airway, breathing, circulation, and defibrillation.

The current recommendation from the American Heart Association, in 2010, was to recommend the initiation of chest compressions before ventilations. The facility's policy on Pediatric Emergencies had not been revised to reflect current standards in the community.

1 c. The Emergency Treatment and Active Labor Act (EMTALA) policy was last reviewed 8/07. It contained instructions for Registered Nurses (RNs) and physicians on how to complete transfer paperwork for those ED patients who needed to be transferred to other facilities. The instructions and copy of the transfer forms contained with the policy in the ED manual did not match the current transfer forms being used by ED staff.

During an interview on 5/8/12 at 8:55 am, the Chief Nursing Officer (CNO) confirmed that this policy was last reviewed on 8/07, however, the transfer forms had been revised. The CNO stated she did not realize that the policy had not been revised so that it was consistent with their current transfer forms.

Based on observation, staff interview, and record review, the facility failed to ensure that medications were administered in a safe and effective manner when:

1. Medications were administered in error, in the absence of or contrary to physician's orders, for four of 27 sampled patients (Patients 6, 24, 25, and 26).

2. Medications were administered in the absence of monitoring to guide therapy for two of 27 sampled patients (Patients 9 and 25) when there were no culture and sensitivity checks to ensure that antibiotics administered to treat lung infection were effective. One of 27 sampled patients (Patient 7) was administered three medications at the same time for the same indication, making it impossible to know which medication gave the intended effect or which one caused adverse action. One of 27 sampled patients (Patient 6's) pain was not assessed after administering pain medications.

3. The system for controlled substances did not ensure accuracy and accountability. The facility's policy did not ensure tight control, when the automated dispensing cabinet key was available for use without tracking or accountability. It was not possible to know if controlled substances that were signed out were actually administered, for two of 27 sampled patients (Patients 6 and Patient 25). There was no surveillance to evaluate use randomly, as attempts to remove controlled substances were attempted for patients, when these patients were not in the facility.

4. Medication orders were not written in a clear manner, consistent with standards of practice for three of 27 sampled patients (Patients 9, 17, and 25).

5. Expired medications were available for use;

6. Medication was not available to be administered, as ordered by the physician, for one of 27 sampled patients (Patient 20).

Findings:

1 a. On 5/7/12 at 2 p.m., the medical record for Patient 6 was reviewed. The record revealed that Patient 6 had several orders for pain medications to manage his cancer pain. Morphine, one of the pain medications, was evaluated. The order for morphine was written to give 4 milligrams (mgs) every 4 hours as needed for pain. Review of the "Narcotic Record Sheet" revealed that nine doses were signed out between 3/29/11 and 1/3/12. The medication administration record (MAR and Treatments) for both December 2011 and January 2012 were reviewed on 5/8/12 at 6:30 p.m.

The "MAR and Treatments" showed that on 1/1/2012 at 9:10 a.m., Patient 6 was administered eight mgs of morphine. However, there was no physician's order to give eight mgs. On the bottom of the "Narcotic Record Sheet," the amount wasted was documented and cosigned for by a second person. It showed that two mgs were wasted, which confirmed that eight mgs were administered. The information was shared with the CNO on 5/9/12 at 10:30 a.m. The CNO verified the findings and suggested that may be a telephone order was given, but not written.

The facility's policy titled, "Administration of Drugs," reviewed 8/24/10, instructed, "Patient's name bands should be checked before administration. Remember the 5 "R's"." The list of the 5 R's included "Right dose."

1 b. On 5/9/12 at 3 p.m., the controlled drug record showed that morphine (pain medication) was removed for Patient 24 who was evaluated in the emergency room for pain associated with accident related to work. The emergency care flow sheet showed that 4 mgs of morphine was administered at 1701, 6 mgs at 1710, 4 mgs at 1830, 4 mgs at 2145, and 2 mgs at 2200.

There were orders for the first three doses of morphine. But there were no physician orders for the last two doses that were administered at 2145 or 2200. Six mgs of morphine were administered without physician orders. On 5/9/12 at 4:40 p.m., the information was shared with the CNO, who acknowledged the findings.

1 c. On 5/9/12 at 1:30 p.m., the record for Patient 25 was reviewed. The record revealed that Patient 25 was admitted on 10/27/10 with a diagnosis of Pneumonia (lung infection). On admission, Patient 25 had an order for fluids to be given into the veins at a rate of 75 milliliter every hour (ml/hr). Review of the medication administration record for injectable medications revealed that the fluids were given at various rates of 75, 100, 200, 250, and 300 ml/hr. On 5/10/12, at 11:15 a.m., the Infection Control Nurse (ICN) said on interview, this was "bad nursing charting." At 4:40 p.m., the same day, the Chief Nursing Officer (CNO) was presented with the documentation, but was not able to explain the difference in rates. There was no documented evidence of physician orders to vary or change the rate of the fluids.

1 d. On 5/9/12 at 3 p.m., review of Patient 26's record revealed that Patient 26 was in the emergency room on 4/22/12 for evaluation after a fall. There was an order for morphine 3 mgs to be given by injection into the veins (IV) and may repeat x 2. The record, emergency care flow sheet, showed that Patient 26 was given 2 mgs, not 3 mgs as ordered by the physician. At 4:40 p.m., on the same day, the information was discussed with the CNO who acknowledge the findings.

2 a. On 5/8/12 at 6:30 p.m., review of Patient 9's record revealed that Patient 9 was admitted to the hospital on 5/5/2010 for pneumonia, a lung infection that causes difficulty breathing in addition to other symptoms. If not treated appropriately, Pneumonia can be fatal in elder patients. Patient 9, a 97 year old, was prescribed Azithromycin 500 mgs (an antibiotic). There was no evidence that culture and sensitivity (C & S) were performed to evaluate the appropriateness of the antibiotic prescribed for the pneumonia. A culture is usually done on a sample of body fluids or tissue to find out what kind of organism (usually bacteria) is causing the illness or infection. Sensitivity checks to see what kind of antibiotic will work best to treat the infection.

On 5/9/12 at 10 a.m., the above information was shared with the CNO who suggested that the C & S might have been completed, prior to admission. A follow up with medical record staff, MRS D and MRS E at 1:30 p.m., revealed no documentation that C & S for Patient 9 was completed.

2 b. On 5/9/12 at 1:30 p.m., the record for Patient 25 was reviewed. The record revealed that Patient 25 was admitted on 10/27/10 with a diagnosis of Pneumonia. Review of the record revealed no documented evidence that culture and sensitivity was done for Patient 25. Medical record staff was asked for evidence of C& S in the record. MRS E reported on 5/10/12 at 2 p.m., that there was no order for C & S. She stated, "Only if indicated will they send out."

2 c. On 5/8/12 at 10 a.m., review of Patient 7's record revealed that the patient had a history of migraine headaches. She came to the Emergency Room at 1700 (5 p.m.) and according to the record, she was given 2 mgs of Dilaudid (pain medication more powerful than morphine), 50 mgs of Phenergan (medication that causes sedation and is used to treat nausea and vomiting), and 60 mgs of Toradol (pain medication that is in the same group as Advil). All three medications were given at 1730 (5:30 p.m.) by injections into the muscle. Giving medication in that manner would make it difficult to evaluate the effectiveness of therapy. If the patient developed any adverse effects to the treatment, it would be impossible to know which medications caused the adverse effect.

On 5/10/12 at 2:30 p.m., Physician H during a telephone interview, did not provide any explanations for using all three medications at the same time.

2 d. On 5/7/12 at 2 p.m., the medical record for Patient 6 was reviewed. The record revealed that Patient 6 had cancer for which he had several orders for pain medications. The morphine use was evaluated. Review of the "Narcotic Record Sheet" revealed that nine morphine doses were signed out between 3/29/11 and 1/3/12. The order for morphine was written to give 4 mgs every 4 hours, as needed for pain. The medication administration record (MAR and Treatments) for both December 2011 and January 2012 were reviewed.

Of the nine doses that were removed and administered, four of the nine times the record did not include documentation for reassessment of the patient's pain and condition. Forty-four percent of the time, nurses did not evaluate the intended effect of the pain medication for Patient 6. On 5/8/12 at 10:30 a.m., the CNO reviewed the information and acknowledged the practice.

According to the facility's policy for "Administration of Drugs," reviewed 8/24/10, "All PRN (as needed) medications must have reason and results documented in the nurses notes ..."

According to the Board of Registered Nursing for Pain Management Policy, the nursing function of appropriate pain management includes, but is not limited to the following:
" ...- assessing pain and evaluating response to pain management interventions using a standard pain management scale based on patient self-report. - documenting pain assessment, intervention, and evaluation activities in a clear and concise manner. - intervening to minimize drug side effects ..."

3. There was no system to ensure controlled and accountability of controlled substance. The facility's policy did not ensure tight control of controlled substances when the key to the automated dispensing cabinet (Pyxis) was available for use without any tracking or accountability.

The facility policy for the "ER/Pharmacy" Pyxis station problem solving and emergency access, revised on 4/2008, revealed the location of the keys to the Pyxis Station. Although the policy limited access to the Pharmacy Room to a few individuals namely: the Charge RN, the Pharmacy RN, and the Pharmacy Consultant, there was no system in place to track access. Entry to the pharmacy room was not tracked and there was no procedure for accessing the key. Removal of the key was not tracked or monitored.

Controlled substance records and clinical records had inconsistency between the time doses were signed out and the time they were given. The doses that were signed out were not always administered, and sometimes there was documentation that doses were administered, even though there was no documentation that the medications were signed out, obtained.

3 a. On 5/7/12 at 2 p.m., the medical record for Patient 6 was reviewed. The record revealed that Patient 6 had cancer for which he had several orders for pain management. Morphine use was evaluated. Review of the "Narcotic Record Sheet" revealed that nine doses were signed out between 12/28/11 and 1/3/12. The order for morphine was written to give 4 mgs every 4 hours, as needed for pain. The medication administration record (MAR and Treatments) for both December 2011 and January 2012 were reviewed on 5/6/12 at 6:30 p.m.

3 b. The record for Patient 6 revealed that on 1/3/2012 a dose of morphine was signed out on the "Narcotic Record Sheet" at 1300 (1 p.m.) although Patient 6 expired on 1/2/2012 at 12:40 p.m.

3 c. On 12/31//2011 at 11 a.m. and at midnight, two doses of 4 mgs of morphine were signed out for Patient 6, however, the MAR did not have any initials to indicate that the medication was administered.

3 d. Morphine doses were documented as administered to Patient 6 on 1/1/2012 at 1320 (1:20 p.m.) and on 1/2/12 at 0001 (midnight). However, there was no documented evidence that these doses were signed out on the "Narcotic Record Sheet." Similarly, the "MAR and Treatments" had an initial on 12/28/11 indicating that a dose of morphine was administered even though there was no documentation that the medication was signed out on the "Narcotic Record Sheet."

On 5/9/12 at 10:30 a.m., the CNO reviewed the information for Patient 6 and acknowledged the practice.

3 e. To evaluate accountability and accuracy of controlled substance, the activity report of morphine and Dilaudid was requested on 5/8/12. Multiple facility staff, the CNO, RN C, LVN O, and RN Pharm tried to run the report, but were unable to print it. On 5/9/12 at 3 p.m., the record was reviewed online with RN Pharm. The report revealed attempts to remove medications for Patient 24 and Patient 26 on different dates.

On 5/9/12 at 3 p.m., the controlled drug record showed that morphine was removed for "G 911" three times on 4/24/12 and on 4/25/12. G911 was the code used for Patient 24. Review of the record showed that Patient 24 was evaluated in the Emergency Room (ER) on 4/24/12 for pain associated with accident related to work. However, Patient 24 was not in the ER on 4/25/12. On follow up, the CNO and QAC confirmed that Patient 24 was not in the ER on 4/25/12. There was no justification for accessing controlled substances for Patient 24, "G911" when he was not in the facility.

On 5/9/12 at 3 p.m., the controlled drug record showed that morphine removal was attempted for Patient 26 on 4/22/12 and 5/7/12. Patient 26 was treated in the ER on 4/22/12. However, he was not in the ER on 5/7/12, as confirmed by the CNO and MRS P on 5/10/12 at 11:20 p.m.

4 a. On 5/9/12 at 1:30 p.m., review of the record for Patient 25 revealed that on 10/27/10, Patient 25 had an order for Norco 10/325 one tablet every 4 hours, as needed for pain. Norco is a combination medication of 10 mgs of hydrocodone (opioid) and 325 mgs of acetaminophen (also known as Tylenol). The "MAR and Treatments" showed documentation for only three doses from 10/28/10 until 10/30/10 while the "Narcotic Record Sheet" had eight doses signed out. There was no accountability for the doses that were signed out. In attempt to reconcile the discrepancy, the nurse notes were reviewed. There was documentation for administering Norco twice, however, the time documented in the nurses' notes did not match the time (on the MAR) that the medication was given, or the time the medication was signed out on the narcotic record sheet.

4 b. On 5/8/12 at 6:30 p.m., review of Patient 9's closed record revealed that Patient 9 was admitted to the hospital on 5/5/2010 for pneumonia. Patient 9 was discharged from the hospital and readmitted to the skilled nursing facility (SNF) on 5/7/2010. The discharge order, written on the same day at 7:50 a.m., read, "Ok to use current (SNF) med (medication) regimen."

Review of the facility's policy for "Medication Orders," revised 10/13/98 and reviewed 8/20/2010, revealed, "The order shall include the name of the drug, the dosage, and frequency of administration, the route of administrations ..." The order to use current SNF medication regimen does not comply with the facility's policy. For clarity, to promote safe medication administration, and to reduce error, drug therapy has to be fully reviewed and clearly written of the exact medications the prescriber intended for the patient to have. According to American Society of Health System Pharmacist, (ASHP) Technical Assistance Bulletin on Hospital Drug Distribution and Control: "Physician's drug order: time limits and changes. Medication orders should be reviewed automatically when the patient goes to the ... operating room, or a different service."

4 c. 4. A review of Patient 17's record disclosed that she was admitted to the Emergency Department (ED) with abdominal pain on 12/1/11. The following medication was ordered, "GI cocktail" (a combination of liquid medication to treat indigestion).

During an interview on 5/8/12 at 8:25 am, Registered Nurse (RN) C stated that she had cared for Patient 17 and had written "GI cocktail" on the record. RN C confirmed that she had written it as a verbal order from the ED physician and should have written "V.O." next to the medication to signify that it was a verbal order.

RN C was asked what medications were contained in a "GI cocktail." RN C stated that it varied with which physician ordered it. RN C then looked at the ED charge sheet to verify the specific medications and dosages that had been given to Patient 17. She explained that the charge sheet was a form that went to the billing department so all medications used for Patient 17 could be charged appropriately.

During an interview on 5/8/12 at 8:35 am, Medical Records Staff E confirmed that the ED charge sheet was not part of the patient's permanent chart.

During an interview on 5/8/12 at 10:10 am, the CNO confirmed that RN C should have written, "V.O." for verbal order next to the medication as well as specify the exact medications contained in the "GI cocktail."

A review of the facility's policy titled, "Physician's Orders", written 9/06, required that medication orders be specific as to the drug and dosage.
5. On 5/7/12 at 1 p.m., during inspection of the emergency drug supply/crash cart accompanied with the RN C, a tube of lidocaine jell ( a local anesthetic medication that is used to numb the skin) was available in the crash cart for use. The medication had an expiration date of 4/12. At the same time, in the same crash cart, four packets of Lubricating Jelly had an expiration date of November 10, 2010. They were on the cart available for use.

On 5/7/12 at 1:30 p.m., accompanied by RN C, the crash cart in the ER was inspected. Expired packets of lubricating jelly were found in the crash cart available for use. The expiration date for these packets was November 10, 2010.

On 5/7/12 at 1 p.m., during inspection of the drug room (pharmacy) accompanied with RN C, a vial of prochlorperazine, which is an antipsychotic medication and also used for nausea and vomiting, was on the shelf with an open date of 12/27, the year (2011 or 2010) was difficult to decipher.

Review of the facility's policy titled "Outdated Material," revised 8/25/10, revealed "All multi-dose vials are to be marked with the date opened. Multi dose vial are to be discarded after 30 days ..."




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6. A review of Patient 20's record disclosed that he was admitted with shortness of breath on 6/13/10 and discharged on 6/17/10. On 6/14/10 at 8:30 pm, the physician ordered Advair (medication to help with breathing) twice per day. A review of the Medication Administration Record (MAR) disclosed that it was circled as not being given from 6/14/10 through 6/17/10. "None available" was written on the MAR on 6/14/10.

During an interview on 5/10/12 at 11:30 am, the CNO confirmed that the Advair had not been given and stated that the nurse should have called the physician to tell him that the drug was unavailable and ask for another comparable medication.

Based on staff interview and record review, the facility failed to ensure the presence of a system in place for identification and reporting of adverse drug reactions and medication errors. The facility failed to report Patient 9's adverse reaction as the patient started shaking (tremors) when the inhalation medication (DuoNeb) was administered.

Findings:

On 5/8/12 at 6:30 p.m., review of Patient 9's closed record revealed that Patient 9 was admitted to the hospital on 5/5/2010 for pneumonia, a lung infection that causes difficulty breathing in addition to other symptoms. If not treated appropriately, Pneumonia can be fatal in elder patients. Patient 9, a 97 year old, was prescribed DuoNeb for inhalation. DuoNeb is a combination of two medications given by inhalation for management of (bronchospasms) narrowing of the airways and difficulty breathing. One of the medications in DuoNeb is albuterol, which dilates the airway, but also increases pulse and blood pressure. Giving too much of this medication can lead to problems.

According to Lexicomp, a drug information source, the adverse effects of albuterol are related to the amount given: "Incidence of adverse effects is dependent upon age of patient, dose ..." and includes irregular heartbeat, chest pain and discomfort, flushing, and palpitation. In addition, albuterol can cause central nervous system stimulation such as irritability, nervousness, restlessness, and seizure. Tremor (twitching or shaking) is one of the most frequently reported (about 15 %) adverse events of albuterol.

Review of the record for Patient 9 revealed that DuoNeb was ordered on 5/6/2010 at 1:35 p.m. According to documentation on "PROB CHARTING_NURSES NOTES," on 5/6/10 at 4 p.m., "breathing tx (treatment) going 5 min (minutes) pt. (patient) starting to shake tx stopped pt. stopped shaking a few min afterward."

On 5/9/12 at 11 a.m., the Chief Nursing Officer stated on interview that there was no evidence that this incident was reported.

Review of the facility's policy titled, "Adverse Drug Reporting/Medication Errors," revised 3/2005, revealed the following under procedure: "1. When an ADR is suspected it will be documented in the Nurse's Notes including: medication administered, date observed, time, nature of reaction, actions taken to manage a reaction, medication currently taken, and when the physician was notified.
A. An ADR Form will be filled out by the nurse caring for the Patient."

Based on observation, interview, and record review, the facility failed to have an adequate system for controlling and preventing communicable diseases of patients and personnel evidenced by failure to give all staff yearly Mycobacterium Tuberculosis (TB) skin tests (done to determine if the person has TB) and yearly inservices on bloodborne pathogens. The facility failed to ensure that medications and patient care equipment/devices that were opened and used were not left for subsequent use. This had the potential to result in infections for both staff and patients and presented risk of contamination and infecting other patients, especially when it was being used for patients in the emergency room (ER).

Findings:

1 a. Personnel records for eight staff members were reviewed and no annual TB skin tests could be located in the files.

On 5/9/12 at 2 pm, TB skin tests were requested from the Assistant Administrator (AA) who stated that nursing staff would have them.

On 5/10/12 at 1:25 pm, skin tests were requested from the Chief Nursing Officer (CNO) who stated that AA should have them.

The facility's policy titled, "Infection Control Policy Statement", dated 3/10/09, was reviewed. Its purpose included, "to be in compliance with mandates regarding infection control as outlined in Title 22 California Code of Regulations, approved guidelines offered by the Centers for Disease Control and Prevention (CDC)."

In the CDC's 2005, "Guidelines for preventing the transmission of Mycobacterium Tuberculosis in health care settings," the CDC recommended that all Health Care Workers (HCW) be screened at the time of hire, using a two-step process, and that all HCWs be screened annually for presence of TB.

1 b. On 5/10/12 at 8:55 am, evidence of annual inservice on bloodborne pathogens was requested from the Director of Staff Development (DSD), who stated she had not given any infection control inservices this year. DSD located the 2011 inservice notebook which contained an inservice for bloodborne pathogens, dated 11/13/11, with a blank sign-in sheet (form for staff to sign when they attended the inservice).

During an interview on 5/10/12 at 9:50 am, the Infection Control Nurse confirmed that she had not given any inservices on bloodborne pathogens.

During an interview on 5/9/12 at 3:35 pm, the CNO confirmed that inservices on bloodborne pathogens should be done yearly by staff. During a subsequent interview on 5/10/12 at 12 pm, the CNO who had reviewed the inservice notebook, stated that she could not find a sign-in sheet for the bloodborne pathogens inservice.


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2. On 5/7/12 at 1:30 p.m., accompanied by Registered Nurse (RN) C, the crash cart in the ER was inspected. On top of the crash cart was a bin that contained (Kendall) electrodes through which electric shocks are delivered to restart the heart in case of emergencies. The bag containing multiple foam electrodes was torn open and available for use. The CSS stated on interview at that time that, according to facility practice, these electrodes might be left for use after it has been opened. On the back of the package, the first line directed not to use the product if the bag was "opened or damaged."

On the ER crash cart, an Ambu Blue Sensor bag was opened and left for subsequent use. Leaving supplies for use on subsequent patients will put patients and staff at risk for exposure to infectious substances and infections.

3. On 5/7/12 at 1 p.m., during inspection of the emergency drug supply/crash cart, accompanied by RN C, a tube of lidocaine jelly (a local anesthetic medication that is used to numb the skin) was available in the crash cart for use. The tube was used as it was not sealed and had about half the amount left in it.

Based on observation, staff interview, and document review, the hospital failed to ensure the in-patient dietary services were in accordance with recognized dietary practices when the food and dietetic services was not organized, directed, and staffed in such a manner to ensure sanitary food services and that the nutritional needs of patients were met.

The facility failed to record dishwasher temperatures to ensure sanitary dishes and utensils;

The facility failed to ensure that out dated/expired foods were not available for use; and

The facility failed to ensure complete nutritional assessments and screening for three patients (Patients 11, 13 and 14).

These failures placed patients at risk of developing food borne illness and poor nutritional outcomes.

Findings:

1. During a concurrent observation and interview of the dietary services department (kitchen) on 5/7/12 at 12:45 pm with the Certified Dietary Manager (CDM), the following items were observed:

a. A posted document, titled, "Dishwasher Temperature Log, May, 2012", with multiple blank spaces.

Mustard Powder, four pound container, opened 7/20/10.

Ground Cumin Seeds, 1 pound container, opened 10/11/10.

Poultry Season, 1 pound container, opened 7/12/10.

Marjoram Leaves, 1 pound container, opened 8/1/10.

Ground Oregano, 1 pound container, opened 2/8/10.

Ground Thyme, 1 pound container, opened 8/22/09.

Pumpkin Spice, 1 pound container, opened 1/23/10.

Hickory Cooking Smoke Sauce 3.5 ounce bottle, opened 10/30/10.

Paprika container with multiple dates.

Cream of Tarter, with no opened date indicated.

b. During an interview with the CDM, she reported that the Dishwasher Temperature Log is supposed to be completed twice a day by the staff. She acknowledged that the log was incomplete, and stated that it was an indication of a lack of documentation of the dishwashers temperatures.

The CDM stated that it is her usual process to rotate all of the spices out and not have anything on hand that is over a year old. The CDM acknowledged the above findings and confirmed that multiple spices should have been discarded as they had been opened for over a year.

A review of the facility's dietary manual, "Temperature Log," reviewed 7/27/11, indicated, "To ascertain that the temperatures in the dishwasher, refrigerators and freezers are in compliance with state regulations a log shall be maintained daily... The log shall be monitored daily by the Dietary Supervisor..."

A review of the facility's dietary manual, "Recommended Maximum Storage Periods for Goods in Dry Storage," reviewed 7/27/11, indicated that seasonings such as paprika may be stored for up to one year if unopened. There were no guidelines provided for the length of time, that items may be stored if opened.

2. During a chart review on 5/8/12, it was determined that the Nutritional Risk Screening Form, had not been accurately completed for three sampled residents (Patients 11, 13, and 14). (Refer to C 302).

Based on staff interview and document review, the facility failed to review their policies annually. There was no documented evidence that pharmaceutical services polices were reviewed in 2011 and the facility's Acute Care policy and procedures manual did not contain the most current Nursing Nutritional Screening Form (NNRF) and associated policy. A discrepancy between the NNRF and the policy, regarding dietician notification was identified. These failures could result in inadequate care being provided to patients.

Findings:

1. During the survey, facility policies with non-current review and approval dates were presented. Some of the policies were approved in 2008. On 5/9/12 at 3:15 p.m., the Registered Nurse (RN) Pharm, stated that he was new and was not sure of the process and the CNO stated that the pharmacist reviewed the pharmacy policies every year.

On 5/10/12 at 11 a.m., the pharmacist stated on telephone interview that he reviewed pharmacy related policies annually and suggested to check with the CNO to verify because "she will have it."

Review of the facility policy, titled, "Pharmacy Policy and Procedure," reviewed and revised on 4/08, indicated that the pharmacist would visit the hospital weekly, and that the pharmacist shall be responsible for annual review of pharmacy policy and procedures. Evidence of the annual review for 2010 was presented. But there was no documented evidence that pharmacy policies were reviewed in 2011.


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2. During a facility's document review the following was noted:

The Dietary Manual was reviewed on 7/27/11 and contained a Nursing Nutritional Risk Screening Form (undated) and policy regarding this form (undated). According to the instructions in the policy regarding the NNRF, patients who are found to be of Priority 1 or 2, do not need immediate assessment by the dietitian. If these patients are still admitted after 3 days, nursing will notify the consulting dietitian. The printed information on the NNRF instructed, "Patients identified as Priority 1 or 2 need a referral to the dietician if they are in the hospital greater than 6 days."

During an interview and concurrent document review of the above information with the Certified Dietary Manager (CDM) on 5/9/12 at 8:30 am, she confirmed that the NNRF and it's policy in the Dietary Manual was the most current version and the version that the nursing staff was currently using. She acknowledged the notification discrepancy, but had no explanation for it.

During a review of the Nutrition section of the Acute Care policy and procedures manual, two older versions of the NNRF policy (dated 5/02 and 6/09) and NNRF (dated 4/05 and 6/07) were found. The newest version of the NNRF policy and NNRF that were in the dietary manual was not found in the Acute Care policy and procedure manual.

During a concurrent interview and record review with the Chief Nursing Officer (CNO) on 5/9/12 at 10:20 am, she confirmed the above findings. She had no explanation for why the Acute manual had not been updated and acknowledged the dietician notification discrepancy.

Based on interview and record review, the facility staff failed to accurately complete the Nursing Nutritional Risk Screening Forms for 3 of 5 patients (Patients 11, 13 and 14). This failure could have resulted in patients not being provided adequate nutritional care and poor nutritional outcomes.

Findings:

On 5/8/12, Patients 11, 13, and 14's medical records were reviewed.

Patient 11 was admitted on 11/23/11 with a diagnosis of congestive heart failure (CHF, a condition normally associated with the accumulation of extra fluid in the body) and a history of partial gastrectomy (stomach removal) resulting in limited gastric volume. Patient 11's Nursing Nutritional Risk Form (NNRF) indicated, "No Risks identified by nursing."

Patient 13 was admitted on 2/3/11 with diagnoses that included heart disease and GERD (gastroesophageal reflux disease). Patient 13's NNRF, indicated only demographic information and had not been completed by the nursing staff.

Patient 14 was admitted on 12/17/10 with diagnoses that included mental status change and dehydration. A discharge summary, dated 12/19/10 indicated, "Patient 14's intake has been marginal for a long period of time and he is clinically malnourished because of his inability to take sufficient food. More acutely the problem has been intake of fluids and he was dehydrated at the time of his admission." No NNRF could be located within Patient 14's medical record.

During a concurrent interview and record review, with the Chief Nursing Officer (CNO) on 5/9/12 at 10:20 am, she confirmed that the NNRFs were inaccurate and incomplete for Patients 11, 13, and 14. The CNO confirmed that Patient 11's diagnosis of CHF should have been triggered on the NNRF. The CNO acknowledged that Patient 13's NNRF should not have been blank and the fact that she was on a therapeutic diet should have been triggered on the NNRF. The CNO confirmed that no NNRF was present in Patient 14's chart, but due to his medical history, she would have expected a NNRF to have been completed. It was noted that the NNRF did not match the policy regarding it and that the information contained in the Acute Care policy and procedure manual was not the most current. (Refer to C 280).

A review of the facility's dietary manual, "Nutritional Risk Screening Form," reviewed 7/27/11, indicated, "All acute patients will have a nutritional risk screening form completed upon admission to Surprise Valley Hospital. The admitting nurse will completely and accurately complete the screening form within 8 hours of admit."

Based on interview, record, and facility document review, the facility failed to ensure an effective, ongoing, hospital-wide quality assessment and performance improvement program was developed, implemented, and maintained to improve patient care evidenced by:

1. The facility failed to develop appropriate objective quality indicators that included all areas of the hospital. (Refer to C 336)

2. The facility failed to revise their policies to reflect current standard of care and facility practice. (Refer to C 334)

3. The facility outlined a plan of action to address problems identified with their physician credentialing, but failed to follow through with that plan of action. (Refer to C 340 & C 341).

4. The facility failed to ensure that pharmaceutical services conducted active surveillance regarding the use of narcotics and other high risk areas including medication errors. (Refer to C 338).

These failures put patients at risk for substandard care and poor patient safety. The cumulative effect of these systemic problems resulted in the facility's inability to comply with the statutorily mandated Condition of Participation: Periodic Evaluation and Quality Assurance Review.


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3. The facility had in early 2011 an "Annual CAH Credentialing and Quality Assessment Report" identifying multiple quality improvement actions to be entertained but failed to follow through with any action to make corrections. (Refer to C 340 & C 341)

Based on interview and record review, the facility failed to ensure that all policies were reviewed and revised on an annual basis. This resulted in outdated policies that no longer reflect the current standard of care or current facility practice.

Findings:

The Pediatric Emergency policy and procedure including pharmacology had not been revised since 2005. (Refer to C274).
The Code Blue policy had not been updated to reflect the current practice of the facility. (Refer to C274).
The Emergency Treatment and Active Labor Act (EMTALA) policy had not been revised to reflect the current transfer forms that were used by the facility. (Refer to C274).

During an interview on 5/8/12 at 8:55 am, the Chief Nursing Officer (CNO) confirmed that she had not reviewed each policy contained in the Emergency Department (ED) manual. In a subsequent interview, the CNO stated that she has not reviewed each policy in the ED, Nursing, or Pharmacy manuals.

During an interview on 5/10/12 at 9:50 am, the Infection Control Nurse stated that she had not reviewed all the policies in the infection control manual.

During an interview on 5/9/12 at 10 am, the Medical Records Supervisor (MRS) stated that the facility has a hospital consultant (HC) who reviews their policies each year.

During an interview on 5/9/12 at 12 pm, the HC stated that MRS gathers specific policies that need to be revised and she reviews those specific policies. HC stated that she does not review each facility policy because it is the responsibility of the supervisor of each department to make sure all their policies are current.

Based on staff interview and policy review, the facility failed to evaluate if its established policies were followed when the pharmacist did not come to the facility every week, as outlined in policies. The facility failed to ensure that access to controlled substances was limited to registered nurses, as outlined in policies, when non registered nurses were allowed access to the medication room and the automated drug dispensing cabinets.

Findings:

On 5/9/12 at 4 p.m., the pharmacist (pharm) stated on telephone interview that he comes to the facility once every month. On 5/7/12 at 12:30 p.m., the Chief Nursing Officer (CNO) said during interview that the pharmacist comes to the facility once every month. That practice was not consistent with the facility's policy. The policy titled, "Pharmacy Policy and Procedure," reviewed and revised on 4/08, indicated that the pharmacist would visit the hospital weekly.

The facility policy for "ER/Pharmacy" addressing Pyxis Station Access, revised on 4/2008, revealed that registered nurses, physicians, and physician assistants have access to controlled and uncontrolled medications, and that "Licensed Vocational Nurses may only witness." The policy included that the "Director of Nursing and designated pharmacy Registered Nurse may refill ... run reports ..." During the survey, it was noted on several occasions that facility staff other than the DON and pharmacy designated nurses ( RN C and LVN O), were allowed access the Pyxis station and had the capability to run reports.

Based on interview and facility document review, the facility failed to develop objective quality indicators that included all services provided to patients, as well as failure to appropriately monitor and evaluate action plans and collected data. This resulted in an inability to effectively evaluate all services provided to patients and put patients at risk for poor outcomes.

Findings:

1 a. During an interview on 5/9/12 at 9:20 am, the Medical Records Supervisor (MRS) stated she was in charge of the medical records department, risk management, quality improvement, credentialing of physicians, and OSHPD (Office of Statewide Health Planning Department) reports. MRS stated she had received no formal training related to Quality Assurance and Performance Improvement prior to assuming the job.

MRS stated that each department comes up with its own QA plan, monitors and evaluates it, and once it's at 100% "for a while," will then drop it. She then in turn, reviews the reports and files them, then they are taken to the Medical Staff committee meeting. MRS was unable to think of any time that any members of the Medical Staff committee made any suggestions on how to accomplish any of the indicators or projects. Trending information that could show improvement in an area was requested but not produced.

A document titled, "Performance Improvement/Risk Management Program," last revised 6/14/06, included a section for the annual evaluation of performance improvement program. It read as follows, "Annually the Medical Staff Committee of the Whole will evaluate the effectiveness of the PI/RM Plan and review it accordingly as to: comprehensive, assessment of clinical performance, improvement in patient care, ongoing activity."

1 b. During an interview on 5/9/12 at 8:15 am, the Lab Tech (LT G)provided a form with 15 questions that had been used as the lab's quality improvement program. All questions had to be answered with either a yes or no. All questions had been answered with a yes since 2009.

During an interview on 5/9/12 at 8:30 am, the Lab Director (LD) confirmed that they had kept using the same form without changing it because no new problems had been identified. LD then stated that there had been a problem after he became the manager in 6/11 where there was an instance in which lab results were reported on the wrong patient. LD stated he took care of the problem himself and it did not go to the Quality Assurance (QA) department. LD admitted that he should have been more diligent about reporting the problem to the QA department.

A document titled, "Performance Improvement/Risk Management Program," last revised 6/14/06, read, "problems/incidents are reported on Quality Review Reports (QRR) and submitted to the Performance Improvement/Risk Management Coordinator."

During an interview on 5/9/12 at 10 am, the MRS stated she had not heard of any lab results being reported on the wrong patient and she would have expected something like that to be brought to the QA department.

1 c. The facility's infection control manual was evaluated and an extensive "Environmental Survey" of the facility had been done on 7/27/11. The following areas were noted to have not been met: corridors/floor clean, handwashing supplies available/alcohol-based hand rub, sharps container available and not overfilled, and clean linen transported covered. "Will instruct housekeeping" was written next to "clean linen transported covered." No comments were written next to the other areas that had not been met.

During an interview on 5/10/12 at 9:50 am, the Infection Control Nurse (ICN) stated she had discussed the linen issue with housekeeping. She stated she had made some subsequent observations regarding the linens but has not documented anything. The ICN stated she had no specific schedule to recheck those areas where she found problems and had no documented corrective plan, monitoring, or subsequent evaluation. The ICN confirmed she had not reported any of these areas to the QA department.

1 d. During an interview on 5/9/12 at 10 am, the MRS confirmed that the only quality indicator for the Radiology Department was to check for expired drugs. She acknowledged that this indicator was more pharmacy related than radiology related.

During an interview on 5/9/12 at 4:10 pm, the Radiology Supervisor (RS) stated that they have been working on one quality indicator for the past few years. She said they watch the outdates on the emergency drug box in the CAT scanner to make sure none of the drugs had expired. RS reviewed the quality data for the radiology department and confirmed that the last problem that they had with outdated drugs had been 3/09.

1 e. During an interview on 5/10/12 at 11:30 am, the Chief Nursing Officer stated they had goals for the nursing department for 2012, but no data had been collected thus far for 2012.

Based on staff interview and document review, the facility failed to ensure that medication therapy was evaluated. There was no evidence that controlled substances were randomly checked to ensure accuracy and no assurance that controlled substances such as morphine for Patient 6 and Norco for Patient 25, were administered. There was no monitoring for appropriate drug therapy when patients treated for pneumonia did not have culture and sensitivity to ensure effectiveness of the antibiotics selected.

Findings:

On 5/9/12 at 4 p.m., the pharmacist (pharm) stated on telephone interview that when he comes to the facility once a month, he checks inpatient records for drug usage. He stated that he evaluates appropriateness of antibiotics by ensuring that there is culture and sensitivity in the record. When asked about Patients 25 and Patient 9, he did not recall reviewing these records. He said that that there was no tracking of any of the issues identified during record review, and added that his findings were communicated to physicians directly.

When asked about controlled substances, he said that he insures inventory accuracy. He said that he did not conduct random reviews on use, to match what was signed out and what was administered because the facility did not suspect problems.

Based on staff interview and document review, the hospital failed to ensure that the quality and appropriateness of the diagnoses and treatments furnished by the Family Nurse Practitioner (FNP) were evaluated by a physician member of the medical staff. This lack of oversight has the potential to lead to substandard patient care and could put patients at risk of poor outcomes.

Findings:

On 5/9/12 at 2:00 p.m., the MSC stated that the hospital does not have a system in place for the review of the care provided by the FNP. The MSC reiterated (it had been disclosed earlier) that in March 2011, the medical staff bylaws were changed to allow Allied Health Practitioners' (AHP ) patient care records to be complete without being countersigned. The MSC verified that since the new FNP had been employed in June 2011, there has been no recorded medical review of the care provided by the FNP. Subsequent review of the minutes from the Medical Executive Committee and the Board meetings, since June 2011, verified that no physician reviews of the FNP had been conducted.

On 5/10/12 at 2:10 p.m. the hospital's FNP was interviewed and she stated that to her knowledge, she was not required to have the care she provided reviewed.

Based on staff interview and document review, the hospital failed to ensure that the quality and appropriateness of the diagnosis and treatment furnished in the facility by medical staff members and/or other practitioners was evaluated by the Quality Improvement Organization (QIO) selected by the hospital. This had the potential to lead to under-qualified practitioners furnishing poor quality care and/or inappropriate diagnoses and treatments thus putting the patients at risk of poor outcomes.

Findings:

On 5/7/12 at 12:30 p.m., the Quality Assurance/Improvement Plan with related minutes and reports were requested. On 5/9/12 at 11:00 a.m. the Quality Assurance Coordinator (QAC) provided the following available correspondence with the QIO:

A letter, dated 1/4/11, from Physician H (Phys. H, Chief of the Medical Staff) requested that the QIO "perform the 2011 Critical Access Hospital quality and credentialing reviews."

A letter, dated 2/25/11, from the QIO ("RE: Annual CAH Credentialing and Quality Assessment Review) contained a six page report of the requested reviews that were completed on 1/26/11. In that report, observations of deficiencies and related recommendations were made concerning the following six topics:

"Credentialing/Privileging" - 7 observations & 5 recommendations
"Peer Review" - 3 observations & 3 recommendations
"Allied Health Practitioners" - 7 observations & 5 recommendations
"EMTALA (emergency transfer regulations) - 11 observations & 9 recommendations
"Quality Assessment" - 5 observations & 3 recommendations
"Quality Improvement and Infection Control Program" - 5 observations & 6 recommendations.

Review of an undated and unsigned two page letter consisting of responses for three of the six topics: Credentialing/Privileging, Allied Health Practitioners and Quality Assessment indicated that many of the comments to these three topics consisted of commitments to make changes, such as, "I am looking into a Peer Review System...,"... I will arrange to have this put in our QA program again"...This will be to peer review the clinic charts & Emergency Room Charts..."...I may make this a QA (Quality Assessment or Quality Assurance) indicator...", etc.

The QAC acknowledged that she had composed the letter. The documentation available to her did not contain evidence that the letter had been approved by the medical staff, the hospital administration, or the Board of Directors. Nor was there any evidence that the letter had been sent to the QIO. There had been no further correspondence with the QIO. Review of the Medical Executive Committee (MEC) and the Board minutes available to her did not document that the QIO review report had been presented to the MEC or the Board of Directors (Board, a.k.a. governing body). The QAC had no response when asked why the hospital had not yet requested a similar quality and credentialing review in 2012.

Based on staff interview and document review, for one of one Quality Improvement Organization (QIO) report, the staff failed to consider the findings and recommendations, and failed to take needed corrective action. This inaction has the potential to lead to a wide range of failed quality maintenance issues that could permit under-qualified practitioners furnishing poor quality care and/or inappropriate diagnoses and treatments thus putting patients at risk of poor outcomes.

Findings:

On 5/9/12 at 11:00 a.m. the Quality Assurance Coordinator (QAC) was interviewed and concurrently the hospital's documents related to QA were reviewed. Among the documents reviewed was the report, dated 2/25/11, titled, "CAH Credentialing and Quality Assessment Review" (Refer to Q 340). The QAC stated the report had been presented to the Medical Executive Committee (MEC). However, after review of the minutes from the CQIC, the MEC and the Board, she had no evidence to demonstrate the report had been read by a medical staff member or a representative of the hospital administration. The hospital had nothing to show that the other staff members had been apprised of the findings and/or recommendations contained in the report. The hospital presented no evidence that the QIO's recommendations had been acted upon or that any other corrective actions had taken place.

Based on staff interview and document review, the hospital failed to ensure that requirements were met for the condition of participation: Organ, Tissue and Eye Procurement evidenced by:

Failure to develop and implement written policies, procedures, or protocols that would ensure, in collaboration with the designated Organ Procurement Organization (OPO), that the family of each potential donor is informed of its option to either donate or not donate organs, tissues, or eyes. The hospital did not have a staff member designated and trained to initiate the request to the family. (Refer to C 347).

Failure to develop and implement written policies, procedures, or protocols that encouraged the hospital staff to use discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors. (Refer to C 348).

Failure to develop and implement written policies, procedures, or protocols that would assure the hospital worked cooperatively with the designated OPO, tissue bank, and eye bank in educating staff on donation issues. (Refer to C 349).

The cumulative effect of these systemic problems resulted in the facility's inability to comply with the statutorily mandated Condition of Participation: Organ, Tissue, and Eye Procurement.

Based on staff interview and document review, the hospital failed to have and implement written protocols that ensure, in collaboration with the designated Organ Procurement Organization (OPO), that the family of each potential donor is informed of its option to either donate or not donate organs, tissues, or eyes. The hospital also failed to select and train a staff member as the designated requestor to initiate the request to the family. This has the potential to cause a situation when a family did not have sufficient information to consider organ donation in a timely manner.

Findings:

On 5/9/12 at 11:20 am, the Director of Nursing (DON) was interviewed and the policy titled, "Tissue Donation Referral," was reviewed. The DON acknowledged that the policy is not written in a manner that would ensure that the families of potential organ donors were promptly and properly notified of their options. She also acknowledged that the hospital had not selected and trained a staff member to be the designated requestor.

Based on staff interview and document review, the hospital failed to have and implement written protocols that encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors. This has the potential to allow staff members to be indiscrete and insensitive with families of potential donors.

Findings:

On 5/9/12 at 11:20 am, during an interview and review of policy, the Director of Nursing (DON) acknowledged that the current policy does not encourage the staff to act with discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors.

Based on staff interview and document review, the hospital failed to have and implement written protocols that ensure the hospital works cooperatively with the designated Organ Procurement Organization (OPO) in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes takes place. This has the potential to cause failed opportunities in achieving organ donations.

Findings:

On 5/9/12 at 11:20 am, during an interview and review of policy, the Director of Nursing acknowledged that the current policy is not written to specifically achieve the proper cooperation of the hospital with the designated OPO.

Based on staff interview and record review, the facility failed to ensure that patients were free from restraints when Patient 27 was given Haldol (antipsychotic medication) by injection to prevent him from pulling on his lines or catheter when other measures (redirection by sitter) were effective.

Findings:

On 5/10/12 at 9 a.m., the record for Patient 27 was reviewed. The record revealed an order, dated 5/9/12, for Haldol (an antipsychotic medication) to be given by injection into the muscle (IM). There was no documented evidence for the rational of using Haldol.

Review of the care flow sheet showed documentation that Patient 27 was trying to pull on an intravenous (IV) line and Foley catheter (urinary drainage device), but the sitter was there and reminded him to leave them alone and not to pull on them. The sitter left at 2100, according to the flow sheet. At 2200, the nurses notes had documentation that the patient was "Restless and continues to pull at catheter and IV," and at 2325, he was "very restless. Trying to get out of bed. " At 2300, the record showed that Patient 27 was medicated with Haldol.

There was no documented evidence demonstrating the need to use Haldol, especially since the patient responded well to having a sitter redirecting him, which was a non restrictive measure and allowed freedom from restraints.

Review of the facility's policy titled, "Physical/Chemical Restraint Use," reviewed on 5/02, revealed that chemical restraints were defined by the facility as psychoactive drugs which include antipsychotic medications. The policy directed, "Psychoactive drugs will not be administered for the purpose of discipline or convenience. They will only be given with and MD order to treat a specific condition."