HospitalInspections.org

Based on interview and record review, the hospital failed to ensure that it was in compliance with applicable Federal laws and regulations related to the health and safety of patients as follows:

1. For Patient 2, identified as having an executed Durable Power of Attorney for Healthcare/Living Trust (written instructions relating to the provision of health care when the individual is incapacitated), the hospital failed to obtain a copy of this document. This failure had the potential to result in all patients that received care in the hospital to not have their wishes implemented in an medical emergency.

2. The Rural Health Clinic (RHC) did not have the contact information of the California Department of Public Health (Department) posted within the facility. This failure had the potential for the patients that received healthcare services at the RHC to not have their grievances/complaints investigated by the Department.

Findings:

1. A review of the Conditions of Admission (COA) documentation was conducted and noted that the patient had a Durable Power of Attorney for Healthcare/Living Trust. The COA also noted that the patient did not submit a copy of the Durable Power of Attorney for Healthcare/Living Trust upon admission, nor was a copy of this document requested by the hospital personnel.

A review of the physician orders, dated March 17, 2013, showed a Do Not Resuscitate order (DNR - no actions to be accomplished in the event the patient's heart stops beating or the patient stops breathing allowing for natural death) and a Do Not Intubate (DNI- no artificial airway with mechanical ventilation to be accomplished) order.

On March 19, 2013 at 11:15 AM, an interview and record review was conducted with Registered Nurse (RN) 1 and RN 2. They were unable to locate a Durable Power of Attorney for Healthcare/Living Trust document within the patient's medical record. RN 1 and RN 2 stated that the hospital personnel should have requested and obtained the Durable Power of Attorney for Healthcare/Living Trust. They also stated that in addition to the physicians order for DNR/DNI, a completed and signed Physician Order for Life-Sustaining Treatment (POLST - a document that informs emergency care providers what kinds of treatments the individual would like in a medical emergency) form should have been completed by the physician and patient. The staff were unable to locate the completed POLST document within the medical record.

A review of a blank POLST document was obtained. The POLST form included the following:

a. Cardiopulmonary resuscitation (CPR)

b. Do Not Attempt Resuscitation/DNR (allow for natural death)

c. Medical interventions, such as comfort measures, intubation (artificial airway) with mechanical ventilation, feeding tubes (artificially administered nutrition)

On March 19, 2013 at 12 PM, an interview was conducted with Patient 2. Patient 2 was alert, oriented and was able to make her needs known. She stated that her Advance Directive (AD) was "at home". Patient 2 stated that the hospital personnel did not request for a copy of the AD, nor did she complete and sign a POLST document. Patient 2 stated that she did not want to be kept alive by any extra measures in the event that her heart stopped beating or if she stopped breathing.

A review of the hospital's policy & procedure titled, Advance Directive, undated, was conducted. The purpose statement noted that an Advance Health Care Directive was a written instruction in the event that an individual loses the capacity to make health care decisions. The policy statement included that a social worker was a member of the health care team responsible for upholding the Advance Directive. The social worker can, when requested, attempt to obtain a copy of any advance directive that the patient may have made.

2. On March 20, 2013 at 3 PM, an onsite visit at the Rural Health Clinic with RN 4 and the Chief Nursing Officer (CNO) was made. A review of the posted Patient Rights Information was observed.

The posted information noted that the patients had a right to file a grievance/complaint with the Department, however the contact information of the Department was not included. RN 4 confirmed the finding. The CNO stated that the Department's contact information should have been posted.

Based on observation, interview and record review the facility failed to provide drugs and biologicals commonly used in life-saving procedures throughout the entire facility as evidenced by the facility providing a policy and procedure (P&P) for responding to a Malignant Hyperthermia (MH-a life threatening syndrome characterized by muscle rigidity, an increase in body temperature, heart rate and respiratory rate that can be triggered by the use of a general anesthetic or muscle relaxing drugs) code that pertained only to the Anesthesia, Surgery and the Post Anesthesia Care Unit (PACU). This failure increased the risk of harm to a universe of seven (7) patients who may experience MH in other areas of the hospital not specifically covered by the P&P by delaying the treatment response time to the MH condition.

Findings:

During a tour of the surgery department on March 20, 2013 at approximately 3:45 PM with the Director of Pharmacy (DOP), the MH code cart and the facility P&P for responding to a MH code within the facility revealed that the P&P pertained specifically to the surgical staff and not to the other areas within the hospital such as the Intensive Care Unit (ICU) and the Emergency Department (ED) where other possible MH trigger drugs, such as muscle relaxants, could be administered.

When asked how the ED or ICU responds to a MH code, the Surgery Director stated that in the event of a MH code, surgery staff would bring the MH cart to ED or ICU and assist with the MH code. After 3:30 PM, the Shift Supervisor, who covers the facility's after-hours activities would obtain the MH code cart from surgery and transport it to ED or ICU.

A review of the facility's scope of services, hours of operation for Surgical Services noted service hours to be Monday - Friday 6:30 AM to 3:30 PM and "ON-CALL" between the hours of 3:30 PM to 6:30 AM surgery staff is not on site.

A review of the facility's P&P titled, "Malignant Hyperthermia" on March 20, 2013 at 3:45 PM with a revision date of 8/11 (August, 2011) recorded within the "Department" section that this P&P pertained to the following departments: "Anesthesia, PACU (Post Anesthesia Care Unit), Surgery".

Under the "SPECIAL CONSIDERATIONS" section, it is recorded that:

"Physician order required: yes
Procedure may be performed by: RN (Registered Nurse) - MEDs; LVN (Licensed Vocational Nurse) - May help with ice; OR TECH (Operating Room Technician)
Special education required to perform procedure: YES
Understanding of syndrome and review of policy and procedure.
Participation in drill on Malignant Hyperthermia"

During an interview March 20, 2013 at approximately 3:45 PM with the Director of Pharmacy (DOP) PM, the Surgery Director confirmed the finding.

Based on observation, interview and review of the facility's standards, the facility's surgical services were not performed in a safe manner. The facility failed to maintain the temperature and humidity within the Operating Rooms (ORs) within the acceptable parameters set by the facility. This resulted in an increased risk of fire due to the possible low humidity and an increased risk of bacteria and mold growth within the OR due to the possible high humidity.

Findings:

During the tour of the OR led by the Surgery Nurse Manager on March 19, 2013 at 9:15 AM, it was observed that the relative humidity in unoccupied OR # 1 was not maintained within the facility's acceptable parameters. The relative humidity registered at 26%. Each operating room and sterile supply room had separate temperature controls.

A review of temperature and humidity tracking logs was conducted to ensure that the acceptable temperature and humidity levels were maintained within acceptable parameters for the three ORs.

During a review of the temperature and tracking logs for ORs 1, 2 and 3 and that of the sterile supply room, it was verified that the appropriate temperature and humidity levels were not maintained according to the facility's acceptable ranges of temperatures which were between 68 and 74 degrees Fahrenheit (F) and humidity between 30 and 60%.

The climate log documentation for the three ORs and the sterile supply room reflected that the lowest temperature recorded was 66 degrees F and lowest relative humidity readings recorded was 21%, on the days that the facility was using those areas.

The Surgery Nurse Manager during an interview on March 19, 2013, after the OR tour, stated that she was aware that the temperature, humidity and airflow within the operating rooms must be maintained within the acceptable standards to inhibit bacterial growth and prevent infection, and to promote patient comfort. She was aware that excessive humidity in the operating room was conducive to bacterial growth and compromises the integrity of wrapped sterile instruments and supplies and that low humidity increased the risk of a fire within the OR. She stated her understanding that humidity and temperature were two factors that may contribute in the spread of infectious diseases amongst patients as well as a fire within the operating rooms.

Based on observation, interview, medical record and document review, the facility failed to ensure that the Pharmacy Services department reviewed the physician orders for 1 of 31 sampled patients (Patient 2) oxygen therapy for its appropriateness. This failure had the potential to jeopardize the health and safety of any patient cared for in the hospital.

Findings:
A review of Patient 2's medical record was conducted. Patient 2 was admitted to the hospital on March 16, 2013, with diagnoses that included altered level of consciousness.

A review of the Physician Order (PO), dated March 17, 2013, showed an order for oximetry (SpO2- pulse oximetry is a non-invasive method allowing the monitoring of bloods ability to carry oxygen throughout the body) to keep saturation greater than (>) 92 percent (% - normal range is from 96 to 100%). The order did not have a protocol for the oxygen flow rate or the equipment (nasal cannula, mask) required to meet the patient's needs.

On March 19, 2013 at 12 PM, Patient 2 was observed with oxygen (O2) at 1 liter per minute via nasal cannula.

On March 21, 2013, at 11:15 AM, an interview was conducted with Registered Nurse (RN) 2. She stated that the Respiratory Care Practitioners (RCP) were able to administer and adjust the patients' oxygen according to the oximetry physician order.

On March 21, 2013, an interview was conducted with RCP 1. He reviewed Patient 2's PO for oximetry. He stated that the RCPs were allowed to initiate and adjust the patient's O2 flow rate to achieve the desired saturation level (>92%). When asked if the RCPs obtained a PO once the oxygen flow rate and equipment (nasal cannula, mask etc.) required was determined to achieve the SpO2 >92 %, RCP 1 stated, "no."

RCP 1 submitted a policy and procedure titled, "Oxygen Therapy for Adults," dated December 2009. A review of the purpose statement noted, to assure the safe and appropriate administration of oxygen to adult and pediatric patients in the hospital setting. Oxygen will be administered by a licensed RCP, nurse, or physician via nasal cannula, nasal mask ..., to improve patient's blood oxygen level ... The policy statement section noted that the physician order may be written to achieve a specific SPO2, such as O2 to keep SpO2 greater than 92%. When O2 is ordered in this way, it is up to the RCP to adjust liter flow and/or delivery device to maintain desired SpO2 level.

On March 22, 2013 at 11:40 AM, an interview was conducted with Pharmacist 1. When asked what the Pharmacy Services process was to identify patients that received O2 administration, Pharmacist 1 stated that the pharmacy services department were informed during the 11 AM daily meeting. She stated that that the physician order (PO) for oxygen therapy did not come to the pharmacy for review, because the RCPs initiate and monitor the oxygen therapy that the patients receive. Pharmacist 1 acknowledged that O2 is a medication and stated that the PO for oxygen administration should go through the pharmacy for review.

Based on observation, interview and record review, the facility failed to meet the Condition of Participation for Provision of Services by failing to:

1. Follow its policy and procedure for performing the daily checklist procedure for the emergency department (ED). This failure had the potential to result in non-functioning equipment and lack of emergency supplies during an emergency. (Refer to C274)

2. Ensure that pharmacy services were administered according to accepted professional principles. (Refer to C276)

3. Ensure that the preventable infections contamination processes were identified and that hospital acquired infections were investigated by the Infection Control Practitioner (ICP). (Refer to C278)

4. Provide an effective dietetic service department as the Dietary Director and the food service supervisor were unaware of time/temperature monitoring for potentially hazardous foods to ensure that safe foods were provided to the patients. (Refer to C279)

5. Ensure the nutrition screening and assessments were completed timely. (Refer to C279)

6. Ensure the nutritional needs of all patients were met as evidenced by lack of a defined nutrition assessment process that was communicated with the multidisciplinary health team. (Refer to C279)

7. Ensure that the hospital's diet manual was customized to be hospital specific which could result in miscommunication from multidisciplinary team members to the patient and had the potential for misinterpretations by staff of a physician's diet order. (Refer to C279)

8. Ensure that the dietary department Quality Assurance (QA) was included in the overall evaluation of the hospital's quality assurance evaluation. (Refer to C279)

9. Ensure that 2 of 31 sampled patients had timely reassessment of their pain level after being given pain medication. This failure had the potential to contribute to the patients not having relief of their pain. (Refer to C296)

10. Ensure that nursing care plans were developed for 4 of 31 sampled patients. (Refer to C298)

The cumulative effect of these systemic practices resulted in the failure of the hospital to ensure compliance with the Condition of Participation for Provision of Services.

Based on interview and record review the facility failed to follow its policy and procedure regarding performing daily checklist procedures for 2 of 2 Emergency Department (ED) crash carts (emergency supply carts). This failure had the potential to result in non-functioning equipment and lack of emergency supplies during an emergency thereby increasing the risk of harm to the patients seeking treatment within the facility's ED.
Findings:

During the initial tour of the ED on March 18, 2013 at 4:00 PM, a review of the ED crash cart checklist was conducted. The checklist had the following items to be checked and verified:

1. Defibrillator (a device to deliver an electric shock to the heart to treat a lethal heart rhythm) Unit - A. Clean, no spills, clear of objects on top, casing intact.


2. Paddles - A. Clean, not pitted, release from housing easily (when in use)


3. Cables/Connectors - A. Inspect for cracks, broken wire or damage, connections engage securely


4. Supplies - A. Defib (defibrillator) pads in sealed packages within expiration date B. Monitoring electrodes C. Fastpatch Adult-Peds (pediatric-child) D. Spare ECG (electrocardiogram-a test to view the electrical activity of the heart) paper E. Gel or other conductive medium present and stored properly


5. Power Supply (battery powered units) - A. Verify fully charged battery in place B. Plugged into live outlet to maintain battery charge


6. Indicators/ECG Display - A. Power up - displays start up screen B. Battery charging; low battery light off


7. ECG Recorder - A. Adequate ECG paper, recorder prints with correct date and time


8. Charge/Display Cycle for Paddle or Adhesive Pad Defibrillation - A. Disconnect AC plug/test on battery power and reconnect to line power B. Charge to manufacturer's Recommended test energy level C. Charge indicators working, discharge per manufacturer's instructions D. Reconnect line power


9. Crash Cart - A. Medication drawers locked and secure, back board (a board placed under a patient's back, when on a mattress, to create a surface to give effective chest compressions) present


10. Intubation tray (a tray with supplies to place a tube in the mouth and down the throat into the lungs to deliver oxygen from a breathing machine or ventilator)


11. Lock Numbers - (Place asterisk on date/line when lock changed. Record number change below) A. Med (medication) drawer Left B. Med drawer Right C. Equipment"


A check mark was placed in the space under the date checked and by the specific item that was checked by the nurse.


The following dates had missing check marks to indicate that the items were checked for the crash cart in room 1:


March 2, 2013 - had a check mark for item number 9A
March 4, 2013 - had check mark for item numbers 1A and 3A
March 6, 2013 - had no items checked
March 9 and 10, 2013 - had no items checked
March 14, 2013 - had no items checked


The crash cart in room 7 had the following dates that were not checked:

March 3, 2013
March 7, 2013
March 9, 2013
March 15, 2013

In an interview on March 18, 2013 at 4:05 PM with Registered Nurse (RN) 7, RN 7 stated that the crash carts were checked twice a day for each shift. RN 7 acknowledged that there were days where there were items that were not checked per facility policy and procedure.

A review of a facility policy and procedure titled "Daily Checklist Procedure ER" with a revision date of May 2005, showed the following:

"Purpose: To insure the Emergency Department medical equipment is functioning properly.

Policy: The equipment checklist should be performed at least once a day by the ER staff.

4. Crash Cart: Locate and observe the plastic locks on both sides of the medication drawers of the crash cart. Record the last 3 digits of the lock number on the checklist. If a lock has been removed notify Pharmacy."

Based on observation, 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:

The facility failed to submit three (3) products:

1. LAT (Lidocaine, Adrenaline, Tetracaine), used topically for lacerations in the Emergency Department (ED)

2. ABR (Lidocaine, Sodium Bicarbonate, Vodka 80 proof) for Upper Gastrointestinal Endoscopy with procedural sedation

3. Shugarcaine (BSS, Lidocaine 4% MPF, Epinephrine 1:1000) for intra-operative floppy iris syndrome (IFIS - a possible complication during the surgery to extract a cataract of the eye) to the medical staff committees (Pharmacy & Therapeutics and Medical Executive) for approval and determination prior to their addition to the Formulary (the facility's drug list) for administration to 7 of 31 sampled patients (Patients 6, 7, 8, 23, 24, 25 and 26) within the facility. These failures had the potential to jeopardize the health and safety of any patient cared for in the hospital.

Findings:

1a. Patient 6 was seen in the ED on March 14, 2013 at 4:34 AM for laceration/puncture to the head due to 'rolling out of bed'. The anesthetic used was LAT, followed by Lidocaine with epinephrine. The wound required five (5) sutures.

b. Patient 7 was seen in the ED on March 16, 2013 at 6:05 PM for laceration/puncture to the forehead The anesthetic used was LAT, followed by Lidocaine with epinephrine. The wound required closure of three layers with 5-6 sutures.

c. Patient 8 was seen in the ED on March 1, 2013 at 9:35 PM for laceration/puncture of the scalp. The anesthetic used unknown, but the documentation in the Automated Dispensing Cabinet indicated that a transaction occurred for LAT. The wound required two (2) staples.

2a. Patient 23 was seen in Surgery on January 10, 2013 at 8:24 AM for pre-operative diagnosis of: Outlet Obstruction - Upper Gastrointestinal Endoscopy (Esophagogastroduodenoscopy or EGD - the visualization on the upper gastrointestinal tract structure and/or pathology via the use of a camera). The Primary procedure was documented as EGD Procedural Sedation in Operating Room (OR) 1 and the compounded product dispensed by pharmacy was documented as 'Lidocaine/Alcohol Spray' oral. The actual formulation in the pharmacy's compounding log is ABR (Lidocaine Hydrochloride Monohydrate as the base, Sodium Bicarbonate, Vodka 80 proof) for Upper Gastrointestinal Endoscopy with procedural sedation.

b. Patient 24 was seen in Surgery on January 17, 2013 at 10:25 AM for pre-operative diagnosis of: Upper Gastrointestinal for pre-gastric (stomach) bypass. The Primary procedure was documented as EGD Procedural Sedation in OR 1 and the compounded product dispensed by pharmacy documented as 'Lidocaine/Alcohol Spray oral'. The actual formulation in the pharmacy's compounding log is ABR (Lidocaine Hydrochloride Monohydrate as the base, Sodium Bicarbonate, Vodka 80 proof) for Upper Gastrointestinal Endoscopy with procedural sedation.

3. During an observation on March 21, 2013 the Director of Pharmacy (DOP) compounded Shugarcaine for a surgical procedure that was scheduled to be conducted. A sample of the Shugarcaine was taken to the facility's laboratory via a Litmus test to demonstrate that the pH was 6.9. The pH was within an acceptable ph range of 6.8-7.0.

a. Patient 25 was seen in Surgery on January 9, 2013 at 8:09 AM for a pre-operative diagnosis of: cataract of the right eye. Procedure note included: Phacoemulsification (the destruction of a cataract with the use of ultrasonic waves) of cataract right eye with an Intra-Ocular Lens (IOL) implantation. The Primary procedure was Cataract Extraction with IOL (Right). Patient 25 was administered, 'Shugarcaine' (BSS, Lidocaine 4% MPF, Epinephrine 1:1000) via the intraocular route on January 9, 2013 at 8:28 AM.

b. Patient 26 was seen in Surgery on January 9, 2013 at 11:05 AM for pre-operative diagnosis of: left eye cataract, Floppy Iris Syndrome. Procedure note included: Shugarcaine Cataract extraction w/(with) intraocular lens implant left eye. The Primary procedure was: Cataract Extract with Intraocular Lens (Left). Patient 26 was administered 'Shugarcaine' (BSS, Lidocaine 4% MPF, Epinephrine 1:1000) 3 milliliters via the intraocular route on January 9, 2013 at 11:19 AM.

During an interview on March 21, 2013 at approximately 9:10 AM with the Director of Pharmacy (DOP) she confirmed that the three (3) compounded products LAT (Lidocaine, Adrenaline, Tetracaine), ABR (Lidocaine, Sodium Bicarbonate, Vodka 80 proof) and Shugarcaine (BSS, Lidocaine 4% MPF, Epinephrine 1:1000) were not sent to the medical staff committees (Pharmacy & Therapeutics and Medical Executive) for approval and determination prior to addition to the Formulary. Upon further interview, the DOP reported that a pharmacist, who was no longer with the facility, formulated the products and most of the literature were not available for review. The DOP stated that any product added to the formulary had to be approved by the medical staff committees.

During an interview on March 21, 2013 at 9:35 AM with the medical staff assistant and medical staff coordinator, they confirmed that the three (3) compounded products LAT (Lidocaine, Adrenaline, Tetracaine), ABR (Lidocaine, Sodium Bicarbonate, Vodka 80 proof) and Shugarcaine (BSS, Lidocaine 4% MPF, Epinephrine 1:1000) were not sent to the medical staff committees (Pharmacy & Therapeutics and Medical Executive) for approval and determination prior to their addition to the Formulary.

Based on interview and document review, the hospital failed to ensure that 1 of 31 sampled patients (Patient 31) nosocomial infection (hospital acquired) identified after the patients discharge was investigated by the Infection Control Practitioner (ICP) to determine the origin. The hospital also failed to ensure that potential cross contamination processes were identified when clean linen was stored on the floor in the clean room. These failures had the potential to result in an infection outbreak in the hospital, which placed all patients, staff and visitors at risk for infection.

Findings:

1. On March 21, 2013 at 9:25 AM, a review of the hospital's infection control program was conducted with RN 2, the Infection Control Practitioner.

A review of the Infection Committee (IC) Report for 2012 was conducted and showed the following:

a. According to the data collected by RN 2, on May 22, 2012, Patient 31 had an indwelling catheter (tube inserted in the bladder to drain urine) placed in the emergency department (ED). The urinalysis (U/A- urine test) conducted in the ED was negative.

b. Patient 31 was admitted to the Intensive Care Unit. The indwelling catheter was discontinued on May 24, 2012. The patient was discharged home on May 25, 2012.

c. On May 30, 2012, the patient presented to her primary medical doctor with complaints of dysuria (painful urination). A U/A conducted and the results were positive for Escherichia coli (bacteria) and Staphylococcus Aureus (bacteria).

d. The patient had a symptomatic urinary tract infection (UTI) diagnosed after discharge from the hospital.

On March 21, 2013 at 10 AM, an interview was conducted with RN 2. RN 2 stated that she collected the patient's data and identified the catheter associated urinary tract infection (CAUTI) as a nosocomial infection. She stated that she reported the collected data to the infection committee (IC). When asked if she investigated Patient 31's CAUTI to determine the origin of the infection, RN 2 stated "no." RN 2 stated that all hospital personnel were in-serviced regarding infection control principles annually and as needed, but was unable to provided documented evidence to show that this event was investigated.

A review of the policy and procedure titled, Post Discharge Surveillance for Nosocomial Infections, dated September 2012, was conducted. The policy statement noted that the hospital had the responsibility to monitor hospital-associated infections that manifested after the patient was discharged from the hospital. The procedure section noted that at approximately the 25th of each month, each physician will receive a listing of all his/her hospital and out-patient surgery patients for the previous month. The physician may note any infection that occurred. The listing should be returned to the infection control practitioner (ICP) who uses the information for process improvement purposes only. The ICP uses the information to research the possible infections and determine their possible origin and if they are hospital acquired.

2. On March 20, 2013 at 3 PM, during the onsite visit at the Rural Health Clinic (RHC) with RN 3. There two bags of clean linen stored on the floor in the clean room. RN 3 confirmed the finding and stated that she would have to find a place to store clean linen.

On March 21, 2013 at 9:45 AM, an interview was conducted with the infection control practitioner regarding the RHC observation. She stated that she was unaware that the RHC staff stored clean linen on the floor in the clean room.

Based on observation, interview and record review, the hospital failed to ensure safe food handling and sanitation within the food service operation as evidenced by:

1) Potentially hazardous foods (foods capable of supporting microbial growth) were not cooled down safely. The dietary policy and procedure manual lacked guidance to staff on direction to identify potentially hazardous foods (PHFs) that needed to be cooled down, and time/temperature parameters on how to cool down safely,

2) A dietary staff member handled clean foodservice equipment after scraping dirty dishes, without washing hands,

3) The ice making portion of the ice-machine had a black substance inside of its tubing,

4) At a food preparation sink, a hose was hooked up to a cold water pipe without a backflow device which had the potential for cross-contamination,

5) Frozen food items were not dated to ensure the hospital's system for FIFO (first in, first out). The dietary policy and procedure manual lacked guidance to dietary staff on shelf-life of frozen foods,

6) A nursing referral to the Registered Dietitian (RD) for a nutrition consult was not conducted for 1 of 31 sampled patients (Patient 3). In addition, Patient 3 lacked a comprehensive nutrition assessment due to a diagnosis of a new onset of diabetes in accordance with hospital's policy and procedure,

7) The hospital's diet manual was not customized to be hospital-specific in order to be used as a guide on preparing therapeutic diet orders prescribed for patients. A non-customized diet manual which did not reflect how the hospital prepared and implemented physician's diet orders had the potential for miscommunication from multidisciplinary team members to the patient and had the potential for misinterpretations by staff of a physician's diet order,

8) The hospital's policy and procedure lacked clear guidance in regard to the hospital's expectation and criteria as to when an RD should complete a comprehensive nutrition assessment for patients. Further, the RD would use an assessment methodology based on a patients ideal body weight, versus actual weight, to determine the patient's estimated daily calorie and protein needs without establishing with the physician that a planned weight loss was a goal for the patient, as the physician was responsible for the care of the patient, and

9) The hospital's Quality Assurance and Performance Improvement (QAPI) program failed to ensure that the dietary department was included in the overall hospital-wide QAPI program within the past year.

Findings:

1. On March 18, 2013 at 4:00 PM, inside the walk-in refrigerator in the kitchen were containers of cooked beans, and of cooked rice which were in separate 6" deep pans, both with a sticker date of "3/18." Cook 1 stated that the beans and rice had been prepared by the cook that morning on March 18, 2013. Cook 2 stated that the rice and beans had been done cooking at about 11:00 AM that morning and were kept hot on the steam table for lunch. Cook 2 stated that the rice and beans were from the original full size pan that finished cooking at 11:00 AM, and were not needed on the steam table for lunch. The unused portion of the cooked rice and beans were placed in the containers that were located in the walk-in refrigerator. Cook 1 and Cook 2 stated that the rice and beans were not monitored for time/temperature cool-down. Cook 1 stated, "We only cool down meats."

A review of the hospital's "Cooling Record" for the month of March 2013 indicated that the cooks used the cooling record a total of 9 times for turkeys, pork roast and roast beef. Nine out of the 9 cooling records that were used were not done correctly to ensure safe cooling of the PHFs. The directions that were located on the Cooling Record indicated, "140 F to 40 F ___, 140 F to 70 F___, 70 F to 40 F." The directions on the log were too vague to guide dietary staff on proper cooling down procedures to ensure safe food handling.

The Food Service Supervisor was directed to look in the dietary policy and procedure (P & P) manual but stated that she was unable to find a P & P to use as guidance on direction for cooling of PHFs to ensure safe food handling. Cook 1, Cook 2, and the Food Service Supervisor were unaware that they were not cooling down PHFs safely, and had not recognized a problem once brought to their attention. They were also unaware that rice and beans were considered a potentially hazardous food that would need to be cooled down safely if they were to be used later.

Safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) has been consistently identified as one of the leading contributing factors to foodborne illness. (FDA Food Code 2009: Annex 3-Public Health Reasons/Administrative Guidelines-3-501.14 Cooling).

The Food Code provision for cooling provides for cooling from 135°F to 41°F within 6 hours, with cooling from 135°F to 70°F in 2 hours. If the PHF food had not reached 70 degrees F in 2 hours, then the PHF could be re-heated to 165 degrees F one time and the cooling process started over. The dietary staff were not ensuring that the PHF foods reached 70 degrees F in 2 hours after the initial cooling began, nor did they ensure that the PHF food reached 41 degrees F within a total of 6 hours.

On March 20, 2013 at 9:30 AM, the Director of Dietary stated that she had been the hospital's contracted consultant RD for many years to address the clinical nutrition needs of patients, and had recently been in the position of Director of Dietary as of three months ago. The Director of Dietary stated that she was not familiar with the "details" of time/temperature monitoring for PHF and thus had not identified that PHFs were not being cooled down to ensure food safety.

According to the hospital's job description that was provided for the Director of Dietary, "The Dietitian manages and directs all aspects of the dietary services including the operation of the kitchen and nutrition centers in all areas of the hospital to provide nutritious, well-prepared food for both patients and staff..., Surveys food preparation and distribution for safe practices, ensuring variety, adequate seasoning, eye appeal, proper temperature, and appropriate portion sizes."

The hospital provided a document entitled, Preparation And Serving Sanitation Infection Control Policy (last revised 9-2010) that provided incorrect cool down direction that would not have ensured food safety. According to the policy, "7... Use the cooling chart to ensure the food is cooled down to the correct temperature of 41 degrees or below. 4 to 6 hours is our goal, maximum time allowed is 8 hours."

2. On March 19, 2013 at 9:23 AM, dietary employee 3 (DE 3) had gloves on when she was scraping off leftover food from patient dishes. DE 3 then removed her gloves, opened the low-temperature dish machine and pushed the dish cart that held the clean dishes through to the clean side, without washing her hands.

Next DE 3, pushed a food delivery cart that was located in front of the dish machine over to the tray line area, without washing her hands.

Then DE 3 went to the handwashing sink to wash her hands before going back to the clean side of the dish machine. DE 3 acknowledged that she had not washed her hands after removing her soiled gloves prior to handling clean foodservice equipment. DE 3 stated, "We usually have two people washing dishes. The other person starts at 9:30 AM".

The hospital's policy and procedure entitled, Cleaning and Washing of Dishes and other utensils- Manual Ware-washing; effective date: 10/8/2012 indicated, "Handle clean utensils, dishes, pots and pans carefully avoiding contamination."

The hospital provided a document (undated) entitled, California Retail Food Code Article 4 Handwashing that indicated, "Handwashing procedure...After handling soiled equipment or utensils."

3. On March 19, 2013 at 9:05 AM, the panel to the ice-making apparatus portion of the ice-machine, located in the kitchen, was removed exposing the internal tubing. Inside the tubing was a black substance that was approximately three inches in length. The Director of Maintenance confirmed the finding and stated, "The tubing should have been replaced."

Although the hospital was able to demonstrate the ice-machine was on a regular preventative maintenance schedule for cleaning and sanitizing, the Director of Maintenance acknowledged that the tubing with the black substance was "missed."

According to the ice-machine's manufacturer guidelines it was important to ensure that tubes and rubber connectors were free of soil accumulation as algae and bacteria could develop in the ice-machine.

The hospital's policy entitled, Ice Machine Cleaning Dietary Department Infection Control Policy (last reviewed 2/2009) indicated, "The maintenance department, monthly, cleans the ice machine internally."

4. On March 19, 2013 at 9:15 AM, a hose with a spray nozzle was hooked up to plumbing located underneath a food preparation sink. The Director of Maintenance acknowledged that a backflow device was not in place at the point of use at the food preparation sink.

According to standards of practice in the foodservice industry, a backflow prevention device to preclude backflow should be installed at each point of use at the food establishment. (FDA Food Code, 2009)

5. On March 18, 2013 at 4:11 PM, inside the walk-in freezer were unopened, and undated variety of raw meats that included beef, ham, and beef roasts. Cook 1 verified that the unopened, raw meat had not contained individual dates on their packaging. Cook 1 was asked how long the meats had been there, and he stated, "We use first in and first out." Cook 1 acknowledged that without a dating system on the meat there would be no method to ensure which one should have been used first.

At that time, the food service supervisor asked, "Should we date the packages when they are taken out of the box? "The surveyor asked what the shelf life of the frozen, unopened meat was, and the food service supervisor stated," We don't have a shelf life policy, but I wouldn't keep them more than 9 months if frozen."

The dietary policy and procedure manual had not contained a policy to guide dietary staff on shelf-life for frozen food to ensure safety and quality of the food. In addition, once frozen foods were taken out of their shipping boxes, they were not individually dated to ensure an effective first in, first out system.

The hospital's policy and procedure entitled, Food Labeling (reviewed 2/2009) indicated, "Policy: All foods will be labeled with the date, contents and if the food is cooked or needs to be cooked."

6. On March 19, 2013 at 2:20 PM, Patient 3's medical record was reviewed. Patient 3 was admitted to the hospital on 3/14/13. On 3/14/13 a nurse completed an admission assessment for Patient 3. According to the nutrition screen on the nursing admission assessment, the patient had reported more than three days of "NPO[nothing by mouth]/Clear Liquid," and had "Nausea/Vomiting" more than three days prior to admission. That resulted in a score of 5 and was referred for "Dietary Consult," per hospital policy when the nutrition screen score was 3 or greater. The nursing admission nutrition screen portion indicated, "Dietitian Contacted Extension 3284; Yes."

According to a review of Patient 3's medical record, the hospital's registered dietitian (RD) had not addressed, "the Dietary Consult" referral. Registered Nurse (RN) 4 and RN 15 both stated that they would look under dietary progress notes in the electronic medical record (EMR) to locate the RD's note. RN 4 and RN 15 verified that the dietary progress notes were blank since Patient 3's date of admission.

During the course of Patient 3's stay, Patient 3 was newly diagnosed with diabetes. On March 16, 2013, Patient 3 was ordered a 2,000 calorie diabetic diet.

According to the "Multidisciplinary Patient Care Conference" note for Patient 3, dated March 18, 2013, the RD was present at the care conference. The RD documented, "2000 calorie diabetic- 95% of breakfast." There was no further documentation by the RD in the medical record. The RD had not assessed Patient 3's nutritional needs in order to determine if the therapeutic diet ordered met the patient's individualized nutrition needs.

On March 18, 2013, Patient 3's diet order was changed to 2200 kcal ADA [American diabetic diet]. According to RN 4, Patient 3's diet order was changed because he told nursing that he was hungry.

On March 20, 2013 at 9:20 AM, the RD stated that she had not received a message from nursing on her voice mail that there was a nursing referral for a dietary consult for Patient 3. The RD confirmed that she was unaware that Patient 3 had a dietary consult per nursing referral on 3/14/13.

During the same interview, the RD stated that she should have completed a comprehensive nutrition assessment for Patient 3 due to a diagnosis of diabetes in accordance with hospital policy and procedure. The RD acknowledged that she had not assessed Patient 3's nutritional needs.

At that time, the RD was asked to assess Patient 3's estimated nutritional needs to determine if the therapeutic diet ordered had met Patient 3's needs. The RD then stated, "I assessed Patient 3 as needing 2,000 calories a day. So, yes the original diet did meet the patient's needs." When the RD was asked how she came to that assessment, she stated, "I used his ideal body weight of 178 pounds (80.9 kg [kilograms]). I multiplied his ideal body weight in kilograms x 25." When asked if that method would promote weight loss, she acknowledged that it would. When asked if she coordinated with the physician to determine if weight loss was a physician driven goal for Patient 3, since the physician was the direct care provider for the patient, she stated, "No." If the RD used the same method of calculation for determining assessed nutrition needs based on the patient's actual body weight at admission, 215 pounds, the estimated calorie need would have been 2,443 calories daily.

On March 20, 2013 at 11:05 AM, during an interview with a medical staff member it was agreed that the overall goal for the patient which would include an assessment for planned weight loss should be known by all multidisciplinary health team members, as "the goal should be the same."

According to the hospital's policy and procedure entitled, Evaluation And Assessment Of Patient's Nutritional Needs (last reviewed 9/2010)," A. Identification of patients requiring nutritional intervention 1. Below average score on admission nutritional assessment form ..., 3. Recent weight loss of 10% or more of usual body weight, 4. Diagnosis of cancer, diabetes, malnutrition, obesity, gastrointestinal disorder, cardiovascular diseases, etc ..., B. Timeliness of nutritional intervention 1. Patients in need of nutritional intervention should be assessed within 24 hours of referral/discovery of need ..., C2. Assessments should address: ...c. Weight, ideal weight and height ..., f. Appropriateness/adequacy of diet order ..."

The hospital's system for nutrition assessments were unclear to the interdisciplinary health care team. The patient stated he was hungry when he was on a 2,000 calorie diabetic diet. The nurse spoke with the MD to get a new diet order for a 2, 200 calorie diabetic diet in response to the patient reporting being hungry. There was no physician driven goal for the patient to lose weight at that time per the medical record, and as evidenced by nursing response to the patient stating he was hungry. The goal for patient care should be the same among all multidisciplinary care team members, should be physician driven, and should be detailed on a nutrition care plan.

The hospital's policy and procedure entitled, Nutritional History, Assessment And Discharge Plan (revised 9/2010) indicated, "The consulting dietitian establishes a care plan and makes recommendations to the physician in writing and follows up to see if those recommendations can be implemented."

7.) On March 19, 2013 at 3:00 PM, Patient 14's medical record was reviewed. Patient 14 was admitted to the hospital on March 19, 2013 due to pneumonia per the Admission Assessment Report. Patient 14 was not identified for a dietary consult per the hospital's nutrition screen system criteria located on the nursing admission assessment report.

On March 19, 2013, Patient 14 was ordered a cardiac diet.

According to the diet clerk and the food service supervisor in the food and nutrition department, patient menus were developed and monitored to limit to 1,600 calories, 80 grams of protein, 35 grams of fat, and 2 grams of sodium daily for therapeutic cardiac diet orders.
According to Patient 14's Patient Profile report, Patient 14 was 71 inches, and 205 pounds at the time of admission. On March 20, 2013, the RD was asked to assess Patient 14's nutritional needs. The RD stated she determined Patient 14's nutritional needs to be 2,000 calories a day based on his ideal body weight. The RD verified that the therapeutic diet ordered was not meeting Patient 14's assessed nutritional needs.

In addition, the RD stated that the hospital's diet manual had not provided guidance to the interdisciplinary team members on what the patient menus for a "cardiac diet" provided at the hospital. The RD stated that the hospital's diet manual for "Fat-Controlled Diet (Cardiac)" indicated "This diet contains about 50 grams of fat daily." There were no other specifics available in regard to nutrients and calories that the hospital's cardiac menu provided to patients.

The RD verified that the hospital's diet manual would not have provided the interdisciplinary team information on what the hospital's parameters were for cardiac diets, and what the patient menus for a cardiac diet actually provided to patients at that hospital. The RD verified that it was just recently purchased and had not been customized to reflect the actual patient meal practices that occurred at that hospital for a variety of therapeutic diet orders.

According to the hospital's policy entitled, Physician's Diet Orders (last reviewed 1/2009), "The dietetic services shall provide food of the quality and quantity to meet the patient's needs in accordance with the physician's written orders ..., 2. Therapeutic diets shall be provided as prescribed by the attending physician and shall be planned, prepared and served with the supervision of a qualified food service supervisor with consultation from a registered dietitian."

The hospital's diet manual had not reflected how patient meals were prepared at the hospital as it conflicted with the therapeutic meal pattern that the dietary staff actually used within the food and nutrition department.

A non-customized diet manual which did not reflect how the hospital prepared and implemented physician's diet orders had the potential for miscommunication from multidisciplinary team members to the patient and had the potential for misinterpretations by staff of a physician's diet order.

8.) On March 20, 2013 at 9:20 AM, the RD was asked to assess Patient 3's estimated nutritional needs to determine if the therapeutic diet ordered had met Patient 3's needs. The RD then stated, "I assess Patient 3 as needing 2,000 calories a day. So, yes the 2,000 calorie diabetic diet did meet the patient's needs."When the RD was asked how she came to that assessment, she stated, "I used his ideal body weight of 178 pounds (80.9 kg [kilograms]). I multiplied his ideal body weight in kilograms x 25." When asked if that method would promote weight loss, she acknowledged that it would. When asked if she coordinated with the physician to determine if weight loss was a physician driven goal for Patient 3, since the physician was the direct care provider for the patient, she stated, "No." When asked if the multidisciplinary health team would know that the calories determined on an assessment was for weight loss, the RD said, "No."

On March 19, 2013 at 3:00 PM, Patient 14's medical record was reviewed. Patient 14 was an 81 year old male who was admitted to the hospital on 3/19/13 due to pneumonia per the Admission Assessment Report. Patient 14 was not identified for a dietary consult per the hospital's nutrition screen system criteria located on the nursing admission assessment report.

On March 19, 2013, Patient 14 was ordered a cardiac diet.

According to the diet clerk and the food service supervisor in the food and nutrition department, patient menus were developed and monitored to limit to 1,600 calories, 80 grams of protein, 35 grams of fat, and 2 grams of sodium daily for therapeutic cardiac diet orders.
According to Patient 14's Patient Profile report, Patient 14 was 71 inches, and 205 pounds at the time of admission. On March 20, 2013, the RD was asked to assess Patient 14's nutritional needs. The RD stated she determined Patient 14's nutritional needs to be 2,000 calories a day based on his ideal body weight. The RD verified that the therapeutic diet ordered was not meeting Patient 14's assessed nutritional needs.

The RD acknowledged that an assessment of calorie needs based on an ideal body weight would promote weight loss in the 81 year old patient admitted with pneumonia.

The RD stated that it was her usual assessment methodology to utilize ideal body weight to determine a patient's calorie and protein requirements. The RD was asked if the medical staff, the governing body, and the multidisciplinary team would have been aware that a patient was assessed in that manner when the RD verified that a therapeutic diet order met the patient's individualized nutrition needs, even though it was actually to promote weight loss, the RD responded, " No, I don't think that they would know."

On March 20, 2013 at 11:05 AM, during an interview with a medical staff member it was agreed that the overall goal for the patient which would include an assessment for planned weight loss should be known by all multidisciplinary health team members.

Registered Dietitian's are not allowed to act as independent practitioners. When the RD assessed that Patient 3's nutritional needs were met at 2,000 calories a day, the rest of the communication had not occurred to the physician with regard to "promote gradual weight loss toward the ideal body weight." That information would have enabled the physician to determine if the therapeutic diet prescribed met the physician-driven goal of the patient (weight maintenance, or gradual weight loss), or to change the therapeutic diet ordered. That information was not incorporated into the hospital's nutritional assessment system. An RD can complete a nutritional assessment and provide recommendations to the physician that a patient should lose weight, and provide an individualized calorie level that would promote such weight loss but the decision needs to be in the accordance of the physician.

According to the hospitals policy and procedure entitled, Evaluation And Assessment Of Patient's Nutritional Needs (last reviewed 9/2010)," A. Identification of patients requiring nutritional intervention 1. Below average score on admission nutritional assessment form ..., 3. Recent weight loss of 10% or more of usual body weight, 4. Diagnosis of cancer, diabetes, malnutrition, obesity, gastrointestinal disorder, cardiovascular diseases, etc ..., B. Timeliness of nutritional intervention 1. Patients in need of nutritional intervention should be assessed within 24 hours of referral/discovery of need ..., C2. Assessments should address: ...c. Weight, ideal weight and height ..., f. Appropriateness/adequacy of diet order ...".

The hospital's policy and procedure entitled, Nutritional History, Assessment And Discharge Plan (revised 9/2010) indicated, "The consulting dietitian establishes a care plan and makes recommendations to the physician in writing and follows up to see if those recommendations can be implemented."

In addition, Patient 14 had an admission diagnosis that included pneumonia. On March 19, 2013 at 3:00 PM, the RD was asked if Patient 14 would have been identified by the hospital's nutrition screening system for the RD to assess his nutritional status. The RD stated, "Well, I try to see everyone." The RD was asked what the hospital's system was in case she could not see every patient even though she would try. There was no further comment except the hospital policy and procedure was provided.

According to the hospital's policy entitled, Evaluation And Assessment Of patient's Nutritional Needs (Revised 9/2010)," A. Identification of patients requiring nutritional intervention ...4. Diagnosis of cancer, diabetes, malnutrition, obesity, gastrointestinal disorder, cardiovascular diseases, etc".

Policies and procedures are put in place to provide direction from the governing body, medical staff, and administrator to support systems and structures that the hospital expects to occur, and "etc." was not clear direction for the hospital's nutrition screening system.

9.) On March 20, 2013 at 10:30 AM, during an interview with the quality assurance staff (QA 16), she stated that there was no formal quality assurance or program improvement (QAPI) documentation for the dietary department within the past year.

The findings from the survey were shared with QA 16 which included lack of correct cool-down for pre-cooked potentially hazardous foods (PHFs) that involved high volume, high risk and problem prone method of foodservice preparation. QA 15 acknowledged that the QAPI program had not been made aware that there was a problem with cool down of PHFs in the dietary department in order to arrange systems designed to monitor quality and improvement to ensure food safety.

Further, QA 16 stated that since the hospital went to electronic medical record (EMR) charting approximately a year ago that there had not been any monitoring of the nutrition screening identification system or referrals to the RD to ensure that the newly developed system was effective and ensured compliance with the hospital's policies and procedures.

The dietary department of the hospital was not integrated into the QAPI program to ensure adequate systems were in place to identify and improve concerns with nutritional care to ensure the health and safety needs of patients were met.

Unsafe food handling for a method of food preparation that involved pre-cooking and the need to conduct time/temperature monitoring which involved high volume (occurred at least 9 times a month for the potentially hazardous foods that were identified by dietary), high risk and problem prone.

Based on interview and record review the hospital failed to ensure that 2 of 31 sampled patients (Patient's 10 and 2) had timely reassessment of the patient's pain level after being given pain medication. This failure had the potential to contribute to patients not having relief of their pain.


The facility failed to notify the physician after an unsuccessful attempt to obtain a sputum sample for 1 of 31 sampled patients (Patient 14). This failure had the potential to contribute to patients not having timely interventions and diagnoses.


The facility failed to ensure that the Rural Health Clinic (RHC) nursing staff monitored the two-way specimen window, which was housed within the public restroom, for out-patient stool samples that were brought in by patients to be tested. This failure had the potential to contribute to all out-patient samples to be tampered with, lost, or stolen.

Findings:

1. A review of Patient 10's medical record was conducted on March 19, 2013 and showed that the patient was admitted to the hospital on March 6, 2013 with a diagnosis of shortness of breath.

A review of the nursing "Admission Assessment Report" showed that the patient had chronic pain to the back and used a 1 to 10 scale to assess the pain. 1 equals mild pain and 10 is the worst pain ever experienced. The assessment for the patient's back pain when it was at its worst was a 5 (moderate pain) and the level of pain the patient indicated was a tolerable goal was a 2 (mild pain).

A review of the "Daily Focus Assessment Report" dated March 7, 2013 at 12:01 AM showed that Patient 10 was having pain in the lower left back with a pain score of 6 and it was documented that the patient was given medication for the pain at 12:27 AM.

A review of the "Daily Focus Assessment Report" dated March 7, 2013 at 3:18 AM (2 hours and 45 minutes after the pain medication was given) showed a pain reassessment with a pain level of 2.

A review of the hospital pain assessment policy showed no time frame to reassess a patient's pain following the administration of pain medication.

During an interview on March 19, 2013 at 4:20 PM, RN 4 stated that pain reassessment should be done 30 minutes to 1 hour after a patient receives a pain pill and 15 to 30 minutes after a patient receives a pain injection. RN 4 stated that the hospital policy for pain reassessment should be updated with the reassessment time frames.



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2. A review of Patient 2's medical record was conducted. Patient 2 was admitted to the hospital on March 16, 2013, with diagnoses that included altered level of consciousness.

A review of the Admission Assessment Inquiry, dated March 16, 2013, was conducted and noted that Patient 2 had chronic right knee pain and acute pain (having a sudden onset) in the left great toe that radiated (starts in one area and spreads to another area). The patient was instructed to use the numeric pain scale (0-10). The patient's acute pain intensity level was 3 on the 0-10 pain scale.

A review of the physician order (PO), dated March 16, 2013, was conducted. and noted that Oxycodone-Acetaminophen (Percocet-pain medication) 5 milligrams (mg)-325 mg acetaminophen, one tablet by mouth, every 4 to 6 hours as needed for pain.

A review of the Medication Administration Records (MAR), dated March 16, 2013 through March 19, 2013, was conducted and noted that Patient 2 received Percocet. Patient 2 was not reassessed timely using the numeric pain scale to determine the effectiveness of the pain relief intervention as follows:

a. March 17, 2013 at 4:22 AM- pain level =6 (0-10), reassessment conducted at 6:46 AM (2 hours later), response code= partial pain relief (not measured using numeric pain scale 0-10)

b. March 17, 2013 at 7:39 PM- pain level =5, reassessment conducted at 11:57 PM (approximately 4 hours later), response code= partial pain relief (not measured using numeric pain scale 0-10)

c. March 18, 2013 at 4:01 AM- pain level =10 (0-10), reassessment conducted at 4:48 AM (47 minutes later), response code= partial pain relief (not measured using numeric pain scale 0-10)

d. March 18, 2013 at 11:50 PM- pain level =5 (0-10), no reassessment conducted

e. March 19, 2013 at 5:54 AM- pain level =6 (0-10), no reassessment conducted

f. March 19, 2013 at 9:52 AM- pain level =5 (0-10), reassessment conducted at 10:58 AM (54 minutes later), response code= partial pain relief (not measured using numeric pain scale 0-10)

On March 19, 2013 at 11:50 AM, an interview was conducted with RN 6. She stated that Patient 2 had left great toe pain and right knee pain. She reviewed the electronic medication administration record (MAR) and confirmed that the patient received six doses of Percocet since her admission. RN 6 stated that the patient should have been reassessed within one hour after each dose of Percocet to determine the effectiveness of the pain relief intervention.

On March 19, 2013 at 12 PM, an interview was conducted with Patient 2. The patient was alert, oriented and able to make her needs known. Patient 2 stated that she received pain medications for her left great toe and right knee pain.

A review of the hospital's policy and procedure (P&P) titled, "Pain Assessment/Management, dated May 2011, was conducted. The policy statement noted that pain assessment will be documented on the admission nursing assessment form initially and on a regular basis on the unit patient care flow sheet or unit record thereafter. The numerical scale for pain (0-10, 0=no pain, 10= worst pain possible) assessment will be used for each individual patient. The standard section noted that pain intensity will be assessed after all pain relief interventions. The P&P did not have a specified timeframe for reassessments after pain relief interventions were administered to determine their effectiveness.

On March 19, 2013 at 3 PM, an interview was conducted with RN 4. He verified that the P&P for Pain Assessment/Management did not have a specified timeframe for patient reassessments after pain relief interventions were administered. RN 4 stated that the P&P should have a specified timeframe for reassessments. He also stated that the electronic medical record did not have a field that allowed the licensed nursing staff to measure pain relief using the numeric pain scale. He stated that the patient's pain response options were relieved or partial relief.

3. On March 20, 2013, a review of Patient 14's medical record was conducted. Patient 14 was admitted to the hospital on March 19, 2013. Per hospital personnel the patient was admitted with diagnosis that included pneumonia (bacterial lung infection).

A review of the admission physician orders (PO) dated March 19, 2013, for Patient 14 was conducted. The PO did not include an admission diagnosis.

On March 20, 2013 at 10:35 AM, an interview and record review was conducted with Registered Nurse (RN) 1. A review of the emergency services documentation, noted that a sputum induction (obtain sputum via induction with a hypertonic saline solution via hand held nebulizer when a patient cannot voluntary cough up a sample) was required. The documentation noted that procedure was attempted, but the patient was unable to produce sputum. RN 1 was unable to locate documented evidence to show that the doctor was notified that the procedure was unsuccessful. RN 1 stated that the RN should have notified the doctor for further orders.

On March 20, 2013 at 10:45 AM, an interview, record and policy review was conducted with Respiratory Care Practitioner (RCP) 2. He reviewed Patient 2's medical record and was unable to locate documentation to show that the doctor was informed that the patient was unable to produce sputum. RCP 2 stated that the RCP that conducted the procedure should have informed the doctor immediately for further orders.

A review of the hospital's policy and procedure (P&P) titled, "Sputum Induction," dated January 2009, was conducted. The purpose statement noted to obtain sputum via induction with a hypertonic saline solution via hand held nebulizer when a patient cannot voluntary cough up a sample. The procedure section noted that if a patient is unable to produce a specimen, notify the physician.

4. On March 20, 2013 at 3 PM, during the onsite visit at the Rural Health Clinic (RHC) with RN 3. There were two out-patients' stool samples observed in a two-way specimen window that was located in the public restroom. RN 3 confirmed the finding. RN 3 was asked how long the two stool samples were in the two-way specimen window, she was unable to determine that information.

She stated that the out-patients brought in their stool samples from home and placed them in the window for the staff pick-up and process. RN 3 was unable to provide documented evidence to show that the RHC nursing staff monitored the the two-way specimen window for the intake of the out-patients' stool samples. RN 3 confirmed that unattended patient stool samples left within public access for extended periods of time had the potential to be tampered with, lost or stolen.

Based on interview and record review the hospital failed to ensure that a nursing care plan was developed for 4 of 31 sampled patients (Patients 2, 10, 17 and 18). This failure had the potential for the nursing care needs of the patients to not be met.

For Patient 2, who was admitted to the hospital with chronic and acute pain, the facility failed to develop a plan of care that addressed the patient's pain management.

Findings:

1. A review of Patient 17's medical record was conducted on March 20, 2013 and showed that the patient was admitted to the hospital on January 23, 2013 with a diagnosis of vertigo (dizziness), gait (walk) instability and vomiting.

There was no nursing care plan found in the patient's medical record.

During an interview on March 20, 2013 at 4:00 PM, Registered Nurse (RN) 7 confirmed that no care plan could be found in Patient 17's medical record.

2. A review of Patient 18's medical record on March 20, 2013 showed that the patient was admitted to the hospital on February 28, 2013 with a diagnosis of fever, rule out sepsis (an infection that gets into the blood which spreads the infection throughout the body and can result in death). The patient became a swing bed status (allows the facility to use any of its inpatient beds for either acute care or skilled nursing [SNF] level of care) patient on March 1, 2013 and was discharged from the hospital on March 13, 2013.

A review of the "Wound Report" dated March 1, 2013 showed that Patient 18 had two (2) pressure ulcers (bedsores). The patient had a Stage 2 pressure ulcer (a break in the skin caused by unrelieved pressure to the site) on the Left Buttock and a Stage 2 pressure ulcer on the Right Ankle.

A review of the patient's care plan showed that there was a care plan for "potential for skin breakdown" and had interventions to prevent pressure ulcers. There was no care plan in the medical record for the actual pressure ulcers Patient 18 had.

During an interview on March 20, 2013 at 2:50 PM, RN 3 acknowledged that there was no care plan for the patient's actual pressure ulcers and stated there should have been a care plan for the pressure ulcers.

3. A review of Patient 10's medical record was conducted on March 19, 2013 and showed that the patient was admitted to the hospital on March 6, 2013 with a diagnosis of shortness of breath.

A review of the nursing "Admission Assessment Report" showed that the patient had chronic pain to the back and used a 1 to 10 scale to assess the pain. 1 equals mild pain and 10 is the worst pain ever experienced by the individual. The assessment for the patient's back pain when it was at its worst was a 5 (moderate pain) and the level of pain the patient indicated was a tolerable goal was a 2 (mild pain).

A review of the "Daily Focus Assessment Report" dated March 7, 2013 at 12:01 AM showed that Patient 10 was having pain in the lower left back with a pain score of 6.

There was no care plan developed to address Patient 10's pain.

During an interview on March 19, 2013 at 4:20 PM, RN 4 acknowledged that there was no pain management care plan in Patient 10's medical record and stated that there should have been.



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4. Patient 2 was admitted to the hospital on March 16, 2013, with diagnoses that included altered level of consciousness.

A review of the Admission Assessment Inquiry, dated March 16, 2013, was conducted and noted that Patient 2 had chronic pain in the right knee and acute (a sudden onset of), radiating starts in one area and spreads to another area) pain of the left great toe. The patient was instructed to use the numeric pain scale (0-10). The patient's acute pain intensity level was 3 on the 0-10 pain scale.

A review of the medical record did not show documented evidence that a pain management plan of care was developed on admission for Patient 2.

On March 19, 2013 at 10:45 AM, an interview and record review was conducted with RN 6. She confirmed that a pain management plan of care was not developed on admission for Patient 2. RN 6 stated that a "comfort" care plan should have been developed when the patient's chronic and acute pain were identified and assessed on admission for continuity of care.

A review of the policy and procedure (P&P) titled, Care Plan In-Patient, dated September 2012 was conducted. The policy statement noted that there shall be a plan of care developed for each patient in coordination with the total health care team. The patient care plan should be reviewed every shift, revised as needed, and is an integral part of the patient's permanent records. A care plan shall be initiated for each patient admission. The plan of care guidelines section noted, following admission assessment to the unit, the plan of care will be initiated within two (2) hours per hospital policy. Based upon assessment findings, identify the appropriate intervention in the electronic record.

Based on interview and medical record review, the hospital failed to ensure that 2 of 31 sampled patients' (Patient 2 and 14) computerized admission orders included an admission diagnosis. This failure had the potential for patient harm by the facility providing treatment based on information that may not accurately reflect the medical condition of the patient.

Findings:

1. On March 19, 2013, a review of Patient 2's medical record was conducted. Patient 2 was admitted to the hospital on March 16, 2013. Per the hospital staff, the patient was admitted with diagnoses that included altered level of consciousness.

A review of the admission physician orders (PO) dated March 16, 2013, for Patient 2 was conducted. The PO did not include an admission diagnosis.

On March 18, 2013 at 10:15 AM, an interview and record reviews were conducted with Registered Nurse (RN) 1. He reviewed the patient's medical record and confirmed that the Computerized Physician Order Entry (CPOE) did not include an admission diagnosis. He stated that the "Working Diagnosis," section should have captured the admission diagnosis. RN 1 stated that all in-patients' admission orders should have an admitting diagnosis.

2. On March 20, 2013, a review of Patient 14's medical record was conducted. Patient 14 was admitted to the hospital on March 19, 2013. Per the hospital staff, the patient was admitted with diagnoses that included pneumonia (bacterial lung infection).

A review of the admission physician orders (PO) dated March 19, 2013, for Patient 14 was conducted. The PO did not include an admission diagnosis.

On March 20, 2013 at 10:40 AM, an interview was conducted with Pharmacist 2. Pharmacist 2 stated that he was involved in the development of the CPOE. He acknowledged that the patient's admission diagnosis was not captured on the CPOE document. Pharmacist 2 stated that the "Working Diagnosis" section should have been populated with the patient's admitting diagnosis.

Based on observation and interview the facility failed to:

a). Safeguard and secure the patients' confidential information and to ensure that access of the patients' information is limited only to authorized individuals. The facility's storage of patients' confidential medical records in an unlocked filling cabinet in the receiving room/office allows for possible unauthorized access and unauthorized removal of patients' confidential information.

b). Protect confidential information. The facility had three (3) binders of patients' clinical records in an open book shelf.

These deficient findings had the potential for unauthorized access to the patients' protected healthcare information resulting in its unauthorized use or identity theft for a universe of seven patients.

Findings:

a) During the tour of the Outpatient Services, on March 21, 2013, the Registered Nurse (RN) Manager was asked about the location and security of the clinical records. The RN Manager presented the metal filing cabinet in an open nurses working area. The metal filing cabinet was observed to have no locking device and was readily accessible to unauthorized individuals such as visitors, patients' family members, vendors and other unauthorized individuals entering the facility.

b) It was observed that three (3) binders of clinical records were kept and stored in an open wooden bookcase. The bookcase was located outside of the Outpatient Services Clerk's office against the wall within the hallway. The client's clinical records (medical records) were readily accessible to unauthorized individuals such as visitors, patients' family members, vendors and other unauthorized individuals entering the facility.

A concurrent interview with the Outpatient Services Clerk concerning the patient's clinical records located in the book shelf was conducted. The Outpatient Services Clerk stated that, "They are clinical records of 'On Hold' services."

On March 21, 2013 at 11:15 AM, the RN Manager, acknowledged the findings that the unprotected healthcare information and clinical records could be removed from the filing cabinet or from the bookcase undetected, without the facility's knowledge.

Based on interview and record review, the facility failed to ensure that adequate post-anesthesia (the period of time when the patient is recovering from the effects of the administered anesthesia) assessments were completed and documented for 2 of 31 sampled patients. The failure to completely evaluate the patient's status post-anesthesia use had the potential to create the risk of a outcome for all patients undergoing anesthesia (general or local insensibility, as to pain and other sensation induced by certain interventions or drugs to permit the performance of surgery or other painful procedures).

Findings:


On March 19, 2013, during a review of the medical record of Patients 1 and 28, the pre-printed small box PACU (Post Anesthesia Care Unit) containing the "Post-Anesthesia" part of the record did not contain a record of the patients' status with regard to pain, nausea and vomiting and post-operative status.

At the bottom of Pre- Anesthetic Evaluation form, it showed a pre-printed Post Anesthesia Note, "Patient is awake" was checked and "There were no apparent anesthetic complications" was checked. There was no written evidence, such as a notation, that the anesthesia provider had reviewed those details (post-anesthesia care) when completing the post-anesthesia documentation.

The facility policy and procedure for Pre and Post Anesthesia Visits revised January 2001, received from the Surgery Nurse Manager was reviewed on March 19, 2013. According to the policy and procedure, POST-OPERATIVE: Item # 4, "The number and timing of post- operative visits will be determined by the status of the patient. It is recommended that a visit be made early in the post-operative period and after complete recovery from anesthesia, usually within 48 hours of surgery. # 5. Post-anesthetic assessment by an anesthesiologist shall be performed and entered in the medical records of all patients discharged directly from PACU.

A review of the clinical records for Patients 1 and 28, with the Surgery Nurse Manager, on March 21, 2013, confirmed that there was no evidence in the clinical record of Patient 1 or Patient 28 to show that both patients were evaluated by a Physician or an Anesthesiologist before being discharged.

On March 21, 2013 at 10:20 AM, the Surgery Nurse Manager confirmed that the Physician or anesthesiologist did not do post-operative assessment on Patients 1 and 28 before being discharge from PACU.

Based on interview and record review the hospital failed to ensure that for 1 of 31 sampled patients (Patient 17, a swing bed patient-allows the facility to use any of its inpatient beds for either acute care or skilled nursing [SNF] level of care) an order for restraints could not be interpreted as an "as needed" (PRN) order. This failure had the potential to contribute to the patient having restraints applied for staff convenience instead of treating the patient's medical symptoms.

Findings:

A review of Patient 17's medical record was conducted on March 20, 2013 and showed that the patient was admitted to the hospital on January 23, 2013 with a diagnosis of vertigo (dizziness), gait (walk) instability and vomiting.

A review of the "Doctor Orders", dated January 27, 2013, showed a physician order for the following:

"May use mittens if Pt. (Patient) is pulling lines/catheter."

In an interview with Registered Nurse (RN) 2 on March 20, 2013, RN 2 acknowledged that the physician order for restraints could be interpreted as a PRN order and that the staff could place the patient in restraints whenever they wanted to.

A review of a facility policy titled "Restraint Protocol for Swing Bed Patients" with a revision date of June 2011 showed the following:

"Written orders for treatment restraint or seclusion are limited to 24 hours."

Based on interview and record review the hospital failed to ensure that a Pharmacist had a criminal background check or had the reference checks performed to prevent the hospital from employing an individual found guilty of abusing, neglecting or mistreating the patients. This failure had the potential to contribute to patient abuse in a universe of seven (7).

Findings:

A review of Pharmacist 2's employee file on March 22, 2013 showed that the pharmacist was hired on December 5, 2007. There was no record that a criminal background check or reference check were conducted within the pharmacist's file.

In an interview on March 22, 2013 at 10:15 AM with Human Resources (HR) 1, HR 1 acknowledged that there should have been a criminal background check or reference check prior to Pharmacist 2 being hired.