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Based on observation, interview, and record review the facility failed to ensure there was monitoring and accurate temperature controls in refrigerators where vaccines, medications, and food items were stored. This failed practice placed patients at risk for receiving ineffective biologicals and medications, and at risk for food borne illness. Findings:

Radiology refrigerator - oral contrast

An observation in the Radiology Department on 12/3/12 at 10:45 am, revealed 8 bottles of "Redi-Cat oral contrast" in the refrigerator in the CT room. There was no thermometer present in the refrigerator.

During an interview on 12/4/12 at 10:10 am the Radiology Director stated he does not record the refrigerator temperature used to store oral contrast. In addition, he stated there was not a policy for monitoring the refrigerator temperature.

Specialty Services Refrigerator- Patient food/drinks

During an interview on 12/3/12 at 8:45 am LN #1 stated the refrigerator temperature was recorded every day except on the weekends and holidays.

Review of the Specialty Care Department refrigerator temperature logs from 8/1/12 - 12/3/12 revealed multiple days without a recorded temperature.

Infection Prevention office

An observation in the Infection Preventionist and Employee Health (IPEH) office on 12/6/12 at 10:35 am revealed a refrigerator with multiple vaccines and PPD.

During an interview on 12/6/12 at 10:35 am the IPEH Nurse stated she could not find any vaccine refrigerator temperature logs prior to 10/12.

Review of the refrigerator temperature logs from 10/1/12 - 12/6/12 revealed multiple dates with no temperatures recorded.

Outpatient Services -Medications and Vaccines

An observation in the Outpatient Services Department on 12/5/12 at 4:00 pm revealed a medication refrigerator and freezer with multiple medications and vaccines.

Review of the Outpatient Services temperature logs for medications and vaccines from 10/1/12 - 12/5/12 revealed multiple days without a recorded temperature.

During an interview on 12/4/12 at 3:10 pm the Outpatient Services Director stated temperatures were not recorded on weekends and holidays by staff. He stated they kept a wheel graph thermometer in the fridge and freezer 7 days a week.

During an interview on 12/5/12 at 4:00 pm Outpatient Staff #1 stated the temperature of the refrigerator and freezer was recorded on the temperature wheel every day and written on the log every day except on weekends and holidays.

Emergency Department - Medication and Vaccines

Review of the vaccine and medication temperature logs from 8/1-12/12 in the Emergency Department on 12/5/12 at 3:10 pm revealed multiple dates with only one temperature recorded for the day and several dates where the temperature was out of range.

Review of the facility policy "Immunization Vaccine Ordering/ Storage/ Handling" dated 10/09, revealed "check vaccine storage temperatures twice daily. The temperatures will be charted on a log placed near the refrigerator and freezer... If temperature is out of range..., do not use vaccine...document action taken..."

Review of the "Vaccine Temperature Log" form revealed, "The shaded zones [below 35 degrees Fahrenheit] represent unacceptable temperatures! Call the Alaska Immunization Program [phone number] to determine whether the potency of the vaccine has been affected. Use the Action Taken form to document activities affecting vaccine."

Review of the "Refrigerator A" log dated 9/12, revealed 4 dates with an out of range temperature of 34 degrees F. The "Action Form" was blank.

Review of the "Refrigerator A" log dated 11/12, revealed 3 dates (11/17/12, 11/18/12, and 11/19/12) with an out of range a temperature of 7 or 8 degrees Fahrenheit. In addition, on the 11/19/12 both the morning and evening shifts noted the temperature to be 8 degrees F.

The "Action Form" dated 11/17/12 revealed a message had been left with the public health nurse and the charge nurse and the engineering department had been notified. On 11/19/12 the "Action Form" entry revealed the charge nurse, biomedical, engineering and the public health office was notified. In addition an immunization request form was sent via fax.

During an interview on 12/5/12 at 3:10 pm LN #3 stated the refrigerator temperatures were monitored twice a day because they store both vaccines and medications. She stated "the vaccines are not supposed to be used when the temperature is out of range."

When asked what happened with the vaccines when the temperature recorded at 7-8 degrees F, she replied she wasn't sure, but that they did get a new refrigerator.

During an interview on 12/6/12 at 11:50 am, the Acute Care Manager stated she was "not sure" what happened with the vaccines in the refrigerator when the temperature went below range.

During an interview on 12/6/12 at 7:30 am, the Director of Compliance and Quality Services and the Quality and Utilization Manager stated no audits of refrigerator temperatures were reported to the Process Improvement Committee.

During an interview on 12/6/12 at 9:00 am the Medical Director stated she was not aware of any out of range temperatures with vaccines in the Emergency Department. She stated she should have been made aware.

During an interview on 12/6/12 at 10:25 am the Safety and Emergency Preparedness Officer was asked for a policy on temperature monitoring of the medication and food refrigerators throughout the facility. The policy "Immunization, Vaccine Ordering/ Storage/ Handling", dated 10/09, was provided.
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Based on employee record review and interview the facility failed to provide evidence that 3 employees and 1 contract employee had received their annual fire/safety in-service. The failure to ensure employees were trained in safety procedures placed patients at risk for injury in the event of a fire and/or emergency. Findings:

Review of employee records revealed Licensed Nurse (LN) #s 1, 4, 5, Pharmacist #2, and contracted Housekeeping Staff #1 had not attended annual fire/safety training in over a year.

During an interview on 12/5/12 at 1:40 pm, when asked about the missing training, the Safety Officer responded she would have to get evidence of the training from the fire department.

No evidence of the staff attending fire/safety training was provided to the survey team at the time of exit.

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Based on record review and interview the hospital failed to ensure credentialing was completed for 11 (#s 1, 2, 3, 4, 5, 6, 8, 9, 10, and 11) providers (physicians and midlevel practitioners) of 12 providers whose credentialing files were reviewed. Specifically, the hospital failed to ensure 11 (#s 1, 2, 3, 4, 5, 6, 8, 9, 10, and 11) were provided with the facility's medical staff bylaws. Findings:

On 12/5/12 the Credentialing Specialist, who was responsible for credentialing at Maniilaq Medical Center, provided credentialing files for review. Review of the credentialing files revealed 11 (#s 1, 2, 3, 4, 5, 6, 8, 9, 10, and 11) providers had no documentation they had received the Medical Staff Bylaws.

During an interview on 12/5/12, the Credentialing Specialist confirmed providers #s 1, 2, 3, 4, 5, 6, 8, 9, 10, and 11 had not received the Medical Staff Bylaws.

During an interview on 12/6/12 at 9:45 am the Medical Director stated the Medical Staff Bylaws should be sent out with credentialing.

Review on 12/5-7/12 of the most current Medical Staff Bylaws revealed "INDIVIDUAL STAFF MEMBERSHIP OBLIGATIONS...Abide by the Medical Staff Bylaws...Documents required...Signed agreement to abide by Maniilaq Health Center policies, Medical Staff Bylaws..."

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Based on interview, record review, and observation the facility failed to ensure provisions of services were met. Findings:

Refer to C274 for the facility's failure to ensure nursing staff policies were developed and implemented for use in the Emergency Department.

Refer to C276 for the facility's failure to ensure expired medications stored in the Inpatient and Outpatient Departments were disposed of properly.

Refer to C278 for the facility's failure to 1) ensure their infection control program (ICP) provided surveillance, tracking, and trending of active infections; 2) ensure employees were screened annually for tuberculosis (TB); 3) ensure infection control policies were reviewed annually; 4) ensure patient care equipment and areas were clean; 5) ensure disinfectants were approved by the infection control committee (ICC); 6) ensure high level disinfectants were used according to manufacturers guidelines; and 7) ensure containers containing disinfectants were labeled appropriately.

Refer to C279 for the facility's failure to 1) ensure physician ordered therapeutic (treatment of disease or condition) diets were followed for 2 patients and failed to ensure therapeutic menus were followed; 2) dry goods were stored in a manner to prevent potential contamination; 3) thawing meat was protected from the risk of chemical contamination; 4) dietary staff consistently performed hand hygiene when going from dirty to clean tasks; and 5) ensure all dietary staff had completed training competencies.

Refer to C280 for the facility's failure to review all policies and procedures on an annual basis.



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Based on interview and record review the facility failed to ensure policies were developed for nursing staff use in the Emergency Department (ED). Specifically, the facility failed to ensure a policy was developed for the triage of patients in the ED. The failure to ensure policies were developed and implemented for use in the ED placed patients at risk for receiving substandard and inconsistent services from the ED department. Findings:

During an interview on 12/3/12 at 10:00 am, Licensed Nurse (LN) #3 stated if the ED was busy, patients with a triage score of 4 or 5 (a method of determining patients treatments based on their condition with 4 and 5 being less urgent) would be offered an appointment in the facility's outpatient department.

During an interview on 12/5/12 at 9:30 am, the Director of Compliance and Quality Services and the Deputy Administrator stated all the facility's policies were on Policy Tech (a computerized system for storing policies).

Review of the list of the policies located in the Policy Tech revealed there were no policies specific to the care provided in the ED.

During an interview on 12/6/12 at 1:50 pm, when asked where they could find a policy on triaging the ED patients, LN #s 2, 4, and 6, working in the ED, responded it should be in the new policy program. After 15 minutes, LN #2 was able to find a policy from a different hospital. There was no policy about offering the ED patients an appointment in the outpatient department. During the interview LN #s 2, 4, and 6 were unable to find any facility policies pertaining to the ED.

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Based on observation, record review and interview the facility failed to ensure expired medications stored in the Inpatient and Outpatient Departments were disposed of properly. As a result, patients were at potential risk for adverse effects from out-of-date medications. Findings:

Observation in the Inpatient Department on 12/4/12 at 10:15 am revealed the Omnicell (locked medication storage cabinet) on the unit contained the following expired medications:

9 - GI cocktail (Donnatal/Maalox/Xylocaine) (for pain) expired 11/12;

9 - Kao-Ben-Lido (for pain) expired 11/12; and

3 - Sulfamethoxazole and trimethoprim cherry flavor suspension (used to treat infections) expired 11/12.

Observation in the Outpatient Department on 12/4/12 at 1:00 pm, with the Outpatient Manager, revealed the following expired medications in the medication drug room:

7 - Cefazolin (used to treat infections) 1 gm expired 9/12;

20 - Children's Ibuprofen oral suspension expired 11/30/12;

59 - Acetaminophen tablets expired 4/12:

15 - Droperidol injection (sedative/hypnotic) expired 3/12;

3 - Imitrex injection (for migraine headaches) expired 2/12;

2 - Kao-Ben-Lido expired 10/12;

2 - 5% Dextrose Intravenous solution (sugar based solution) expired 12/11;

10 - Albuterol Bromide Inhalation Solution (bronchodilator) expired 10/12;

6 - Naloxone HCL (reverses respiratory depression) expired 11/1/12;

5 - Epinephine injection (used to restore cardiac rhythm in cardiac arrest) expired 9/20/11;

21 - Hydroxyzine HCL injection (decreases anxiety) expired 8/11;

6 - Haldol (antipsychotic) expired 8/12;

2 boxes - Next Choice (emergency contraceptive) expired 10/12;

7 vials - 0.9% Sodium Chloride injection (salt based solution) expired 7/1/07; and

1 syringe - 0.9% Sodium Chloride injection expired 7/09.

During an interview on 12/4/12 at 10:15 am, Pharmacist #1 was asked who was responsible for ensuring medications were not outdated. Pharmacist #1 replied that Pharmacy was responsible for checking all medications in the facility.

Review of the facility's Pharmacy policy "Drug Quality and Drug Storage", dated 7/06, revealed "All drug supplies within the hospital...shall be inspected by a pharmacist or tech once every month. The purpose of the inspection shall be to determine that pharmaceutical...are not outdated."

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Based on record review, interview, and observation, observation, the facility failed to: 1) ensure their Infection Control Program (ICP) provided surveillance, tracking, and trending of active infections; 2) ensure employees were annually screened for tuberculosis (TB); 3) ensure infection control policies were reviewed annually; 4) ensure patient care equipment and areas were clean; 5) ensure disinfectants were approved by the Infection Control Committee (ICC); 6) ensure high level disinfectants were used according to manufacturers guidelines; and 7) ensure containers containing disinfectants were labeled appropriately. The failure to maintain an effective ICP placed patients at risk for infections and placed employees at risk for infectious diseases and injury from unlabeled chemicals. Findings:

Tuberculosis (TB) (a potentially lethal airborne disease)

Record review on 12/6/12 revealed 2 patients with active TB had been admitted to the facility in the past year.

Review of the "Infection Control Committee [ICC]" meeting minutes, dated 1/26/12 and 4/19/12, revealed the data about the TB cases were not included.

During an interview on 12/6/12 at 9:05 am, when asked about the missing data, the Medical Director (MD) stated all patients admitted to the facility with tuberculosis should have been reported to the ICC.

TB Screening

Review of employee health records on 12/5-6/12 revealed no evidence that Licensed Nurse (LN) #s 3, 5, 7 Environmental Staff #1, and the Director of Nursing had received a TB test within the past year.

Information regarding Tuberculosis (TB) infection control found on the Centers for Disease Control and Prevention website, accessed 12/14/12 at revealed,


"Tuberculosis (TB) transmission has been documented in health care settings where health care workers and patients come in contact with people who have TB disease. People who work or receive care in health care settings are at higher risk for becoming infected with TB; therefore, it is necessary to have a TB infection control plan as part of a general infection control program designed to ensure the following; prompt detection of infectious patients, airborne precautions, and treatment of people who have suspected or confirmed TB disease.

The TB infection control program should be based on a three-level hierarchy of control measures and include; Administrative controls, environmental controls and use of respiratory protective equipment.

The first and most important level of the hierarchy, administrative controls, impacts the largest number of people. It is intended primarily to reduce the risk of uninfected people who are exposed to people who have TB disease. These controls include the following activities;
... developing and instituting a written TB infection-control plan,...screening and evaluating health care workers (HCWs) who are at risk for TB disease or who might be exposed to M. Tuberculosis..."

Infection Surveillance

Record review revealed the last ICP review was dated from the year 2010.

During an interview on 12/5/12 at 2:40 pm, the Infection Preventionist and Employee Health Nurse (IPEHN) stated she had been unable to locate any of the surveillance data from 2012.

During an interview on 12/6/12 at 7:30 am, Director of Compliance and Quality Services (DCQS) and the MD disclosed the prior IPEHN had not been reporting surveillance data to the Quality Improvement committee.

During an interview on 12/6/12 at 9:30 am, the Director of Nursing stated she did not find any surveillance data for the year 2012.

Annual Policy Review

Record review of the Infection Control policies revealed no facility policies had been reviewed in 2011 and 2012.

During an interview on 12/5/12 at 3:00 pm, the IPEHN stated she was still trying to locate all the facility's IC policies.

Soiled Patient Equipment

In the radiology department on 12/4/12 at 8:35 am, a dried dark red substance and debris was observed on the patient stretcher used for computed tomography (CT) scans.

During an interview on 12/4/12 at 10:10 am, the Radiology Director Manager (RM) stated a patient was currently on the stretcher receiving a CT.

A second observation of the CT stretcher on 12/4/12 at 10:40 am revealed it was still soiled.

During an interview on 12/4/12 at 10:40 am, when asked about the debris and the dried substance still being on the stretcher before and after the most recent CT, the RM responded, "It must not have been cleaned after the patient yesterday."

Review of the facility policy "Radiology Infection Control" dated 7/2009 revealed, "Cleaning of X-ray tables [stretchers used for patients] will be done after each patient using the approved cleaner/disinfectant."

Radiology Department

An observation on 12/3/12 at 10:45 am in the radiology department revealed dust and debris on the floor and a white substance dried across the base of a pole used for hanging intravenous (IV) bags.

A follow up observation on 12/4/12 at 10:05 in the radiology department revealed the dust and debris remained on the floor and the white substance remained on the IV pole.

During an interview on 12/4/12 at 10:10 am, when asked about the soiled floors and equipment, the RM disclosed the radiology staff were responsible for cleaning and the housekeeping staff were responsible for cleaning the floors. The RM confirmed radiology department staff was to clean the equipment and housekeeping was supposed to clean the floor daily adding, "It must not have been done."

During an observation in the ultrasound treatment room on 12/4/12 at 11:15 am, a dirty fan covered in debris, was blowing on a vaginal ultrasound probe that was lying on a towel on the counter.

During an interview on 12/4/12 at 11:20 am, the RM confirmed the vaginal probe was clean and should not have a dirty fan blowing on it.

Review of the facility policy "Fans for Patient Rooms" dated 9/09, revealed "Fans are not to be utilized: In...treatment rooms".

Disinfectants

Observation in the ultrasound treatment room on 12/4/12 at 11:15 am, revealed an unlabeled container of clear liquid sitting on the counter.

During an interview on 12/4/12 at 11:15 am, when asked what the unlabeled liquids were, the RM identified it as a Matricide 28 a high-level disinfectant used to clean the vaginal ultrasound probes. When asked how he ensured exposure time and temperature was correct for proper disinfection, the RM replied he had not been monitoring the temperature of the Metricide 28. The RM also stated he had not consulted the ICC prior to switching disinfectants.

Review of the manufacturer's instructions on the Matricide container label revealed, "HIGH-LEVEL DISINFECTION: Immerse medical instruments/equipment completely in METRICIDE 28 solution for a minimum of 90 minutes at 25 °C [77 F]."


Review of the facility policy "Infection Control Plan" dated 2010, revealed, "To provide input regarding the purchase of all hospital equipment and supplies used for sterilization, decontamination, disinfection, and cleaning procedures."

Environmental Services (EVS)

On 12/5/12 at 3:35 pm, a spray bottle with a pink liquid was observed in an EVS cleaning cart. The bottle had "Dental" written on it.

During an interview on 12/5/12 at 3:35 pm, when asked what the solution was, EVS Staff #2 replied it was the "456" disinfectant used for cleaning.

On 12/5/12 at 4:00 pm, observation in an EVS closet revealed an unlabeled spray bottle containing a pink liquid.

During interview on 12/5/12 at 4:25 pm, when asked about the unlabeled bottles, the EVS Operations Manager confirmed the bottles should have been labeled.

Review of the facility policy "Hazard Communication Program" most recent review date 1/15/09, revealed, "Hazardous materials must have labels that list at least the chemical identity (name), appropriate hazard warning, and personal protective equipment (PPE) needed when using the product. If a hazardous product is transferred to a secondary container, it must be appropriately labeled."

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Based on record review, observation, and interview, the facility failed to" 1) physician ordered therapeutic (treatment of disease or condition) diets were followed for 2 patients (#s 10 and 17) 2) failed to ensure therapeutic menus were followed. In addition, the facility failed to ensure: 3) dry goods were stored in a manner to prevent potential contamination, 4) ensure thawing meat was protected from the risk of chemical contamination, 5) dietary staff consistently performed hand hygiene when going from dirty to clean tasks, and 6) ensure all dietary staff had completed training competencies. These failed practices placed patients at risk for receiving non-therapeutic diets and created a risk for food-borne illness and/or cross contamination for all patients who received food from the kitchen. Findings:

Therapeutic Diets

Patient #10

Record review on 12/4-6/12 revealed Patient #10 was admitted to the facility 12/2/12 with diagnoses that included congestive heart failure (failure of the heart to pump effectively) exacerbation and edema (swelling). The physician had ordered a low sodium (salt) diet.

Review of the facility's "Patient Meal Order Sheet", dated 12/4/12, revealed Patient #10 was to receive a "Lo Na [Low Sodium]" diet.

Observation on 12/4/12 at 11:30 am revealed Patient #10 received a lunch tray containing ravioli and marinara sauce, corn, and borsht (beet) soup for lunch.

Observation on 12/4/12 at 4:45 pm revealed Patient #10 sitting on the side of the bed eating an egg salad sandwich. The Patient stated she had requested the egg salad sandwich for dinner, when asked if she had been told about any nutritional concerns, she responded Dietary Staff (DS) #8 had told her she could have "zero salt".

Patient #17

Record review on 12/4-6/12 revealed Patient #17, was admitted to the facility 12/3/12 with diagnoses that included dehydration. Review of the physician's order revealed the 3-year old Patient was to receive an age appropriate diet.

Observation on 12/4/12 at 12:00 pm revealed Patient #17 received a tray that contained chicken strips and tator (potato) tots.

During a second observation on 12/4/12 at 4:55 pm, Patient #17 received a tray containing adult sized portions of meat loaf, roast potatoes, and mixed vegetables.

During an interview at 12/4/12 at 4:55 pm, when asked how Patient #17's appetite had been, the Caregiver replied the Patient had only eaten a little cereal. The Caregiver added that the evening meal was the same meal she had gotten on her tray.

Menus

During an interview on 12/4/12 at 8:10 am, when asked what recipes the kitchen used to cook for the patients, DS #6 replied, they "just shoot from the hip".

Review of the "Expressly for You Personal Choice Dining" menu used for ordering patient meals revealed the borsht soup, egg salad, tator tots, and ravioli were not listed as menu items.

During an interview on 12/5/12 at 9:00 am, when asked how inpatients diets and menus were monitored to ensure diet orders were being followed, Dietitian #1 replied she provided no oversight of the patient diets or the hospital menus.

During an interview on 12/5/12 at 1:00 pm, when asked about the physician ordered diets, the Dietary Manager (DM) replied she was not sure if the meals provided to Patient #10 were low sodium. When asked about the age appropriate diet for Patient #17, the DM replied chicken strips and tator tots would be considered a default menu and the dinner meal portions should have been smaller. The DM added that even though she was a dietitian, she did not provide any nutritional oversight of the hospital menus.

Review of the food and nutrition services contract revealed "Inpatient Meals...Modified diets, including National Dysphagia Diets...shall be available to patients and shall conform to the latest edition of the American Dietetic Association Manual of Clinical Dietetics (Diet Manual) and the Dietary Guidelines", and "Food selections for the most common diets (mechanical soft, soft, low fat/low calorie, pediatric, cardiac, renal, low salt, and diabetic) shall be made available to patients based on theses diets."

Hand washing

In the kitchen on 12/4/12 at 7:45 am, DS #5 was observed spraying a soiled bucket in the sink while wearing gloved hands. The DS then wiped the surrounding counter with a wet cloth. Without performing hand hygiene, the DS picked up the freshly washed ladles and spatulas from the dishwasher rack and returned them to the kitchen while wearing the now soiled gloves. After placing the soiled bucket into the dishwasher, DS #5 continued spraying the dishes in the sink. The DS then pulled the clean rack containing the freshly washed bucket out of the dishwasher and began to load dirty dishes and trays into the dishwasher. The DS then continued to spray the dirty dishes in the sink. After the dishwashing cycle was complete, while continuing to wear the same pair of contaminated gloves, DS #5 pulled the rack containing the freshly washed dishes and trays out of the dishwasher. The DS then began stacking the clean plates and bowls onto a wheeled cart.

During an interview on 12/4/12 at 8:00 am, when asked if there were any special precautions used when washing dishes, DS #5 replied the dishes just needed to air dry.

On 12/4/12 at 10:00 am, DS #6 was observed using a damp cloth to wipe the kitchen counter. Then, without performing hand hygiene, DS #6 donned a pair of gloves, picked up a bag of parsley, and used his right hand to sprinkle parsley on the marinara sauce in the steam table.

Review for the 2009 FDA (Food and Drug Administration) Food Code revealed: "FOOD EMPLOYEES shall clean their hands and exposed portions of their arms...immediately before engaging in FOOD preparation including working with exposed FOOD, clean EQUIPMENT and UTENSILS...After handling soiled EQUIPMENT or UTENSILS..."

Food Storage

Observation in the kitchen on 12/4/12 at 8:00 am revealed several large containers containing dry goods, the scoops used to measure the food were stored in the containers. Closer examination revealed the oatmeal, powdered milk, and brown sugar had scoop handles that were touching the top of the food.

Per the 2009 FDA Food Code: "...3-304.12...During pauses in food preparation or dispensing, food preparation and dispensing utensils shall be stored...with their handles above the top of the food within containers or equipment that can be closed..."

Thawing Meat

Observations in the kitchen on 12/3/12 and 12/4/12 revealed a 3-compartment sink labeled as a dish sink. The labeled "Sanitizer" sink was full of water.

During an interview on 12/3/12 at 10:40 am, the DM stated the water in the sanitizing sink contained the quat (quaternary compounds, or quat, are common sanitation solutions used in a commercial kitchen) sanitizer used to refill the smaller sanitizing buckets in the kitchen.

Observation on 12/4/12 at 9:45 am revealed 3 packages of sausage and a package of salami were sitting in a pan in the middle sink. Running water in the middle kitchen sink located directly next to the sink full of the sanitizing solution.

During an interview on 12/4/12 at 9:45 am, DS #7 confirmed they were thawing the meat to use later.

Observation on 12/4/12 at 10:35 am, DS #2 carried a plastic bucket containing sanitizing solution and emptied into the solution the sink located on the right side of the thawing meat. The DS employee then carried the bucket over to the left sink, located on the other side of the thawing meat and scooped out some of the sanitizing solution into the bucket.

During an interview on 12/5/12 at 1:00 pm, the DM confirmed the scoop handles should not be touching the food. During the interview, when asked about the hand hygiene in the kitchen, the DM responded the hand hygiene in the kitchen had not been very good.

Per the 2009 FDA Food Code: "3-306.11 Food Storage...(A) Except as specified in (B) and (C) of this section, FOOD shall be protected from contamination by storing FOOD ...Where it is not exposed to splash, dust, other contamination."

Dietary Staff Training

Review of the employee records for Dietary Staff #s 1, 2, 3, 4, 5, and the DM revealed no evidence of competency or training.

During an interview on 12/4/12 at 1:30 am, the DM confirmed there was no record of the employees training or competencies.

Review of the food and nutrition services policy "Competency of Employees Assessed and Improved Annually", dated 4/2002, revealed, "The competence of all employees will be assessed within the first 30 days of employment ...The competence of all employees will be assessed annually."

Review of the food safety Information services policy "Food Safety Training Requirements for Frontline Employees", dated 8/2009, revealed, "All employees hired for a food handling position must complete a two-step food safety orientation/training within a specific time period."

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Review of the hospital's policies and procedures 12/3-7/12 revealed not all the policies had been reviewed on an annual basis to ensure the policies and procedures were being implemented and to determine if policies and procedures needed revision. Findings:

During an interview on 12/5/12 at 9:50 am the Acute Care Manager said not all the policies were reviewed annually.

During an interview on 12/5/12 at 9:30 am the Deputy Administrator and the Director of Compliance and Quality Services were both asked about the review of the hospital's policies and procedures. They said the date in the upper right hand corner of the first page of a policy was the date the policy was reviewed.

Review of the hospital's policies and procedures 12/3-7/12 revealed not all policies had an annual review.

During the survey process the surveyors requested the hospital's policy and procedure for policy review. At the time of the survey exit the surveyors had not received a policy and procedure regarding annual review of policies.

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Based on record review and interview the facility failed to ensure services provided to the facility through agreement and contract were evaluated for their compliance with the Critical Access Hospital Conditions of Participation and standards. Without services being evaluated through agreement and contract the facility could not identify or adequately address areas of deficient practice. This created the risk of suboptimal patient care and safety. Findings:

Review on 12/3-7/12 of the facility's contract list revealed 107 contract service names listed under "Contract with". No other information was part of the list, only the contract service names.

Review on 12/6-7/12 of the facility's 2012 Performance Improvement Council (PIC) meeting minutes, provided by the Director of Compliance and Quality Services, revealed no documentation that agreements and contracts had been reviewed.

Review of the facility's "Organization Performance Improvement Plan" dated 9/12 revealed the PIC did not have oversight of the agreements and contracts.

During an interview on 12/5/12 at 9:30 am the Deputy Administrator confirmed there was no centralized review of the contracts.

During an interview on 12/6/12 at 11:15 am the Director of Compliance and Quality Services confirmed the facility did not have a formal process for contract review.

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Based on record review and interview the facility failed to ensure registered nurses that were licensed by the Alaska State Board of Nursing were practicing within their scope of practice. Specifically, the facility failed to: 1) ensure nurses were not administering moderate (conscious) sedation to a patient with an American Society of Anesthesiologist score of 3 or higher without a Certified Registered Nurse Anesthetist (CRNA), Advanced Nurse Practitioner (ANP), or Certified Licensed Independent Practitioner (LIP) immediately available, 2) ensure their training program had been approved by the appropriate licensing authority, and 3) ensured competencies were performed and/or completed annually for nurses administering moderate sedation. Findings:

American Society of Anesthesiologist (ASA) Score

According to the American Society of Anesthesiologists, the ASA physical status classification system is a system for assessing the fitness of patients before surgery. Patients are scored based on health related conditions with: 1-A normal healthy patient; 2-A patient with mild systemic disease; 3-A patient with severe systemic disease; 4-A patient with severe systemic disease that is a constant threat to life; and 5-A moribund [being in a state of dying] patient who is not expected to survive without the operation.

Record review on 12/5/12, revealed Patient #7 was admitted to the facility on 6/6/12 and 6/7/12 for procedures that required conscious sedation. Review of the "Procedure" record revealed the Patient had been identified as having an ASA score of 3.

Record review on 12/5/12 revealed Patient #8 was admitted to the facility on 9/19/12 for a procedure that required conscious sedation. Review of the "Provider Assessment", dated 9/19/12, revealed the provider had assigned the Patient an ASA score of 3.

There was no documentation a CRNA, ANP, LIP were immediately available for assistance.

During an interview on 12/6/12 at 9:00 am, when asked about the nurses giving conscious sedation, the Medical Director replied, "We [facility] should not be doing conscious sedation on patients with an ASA of 3 or higher." In addition, she stated she was not aware that patients with an ASA of 3 were having elective conscious sedation at the facility.

Review of the facility's policy "Moderate Sedation/Analgesia", dated 10/09, revealed "Patients with an ASA score of P-4 or higher require a special consultation." The policy did not specify what conditions were required if the nurse was administering conscious sedation to a patient with an ASA score of 3 or higher.

Training Program Approval

Record review revealed the Alaska State Board of Nursing licensed 11 of the 16 nurses that had completed the "Procedural or Moderate Sedation/Analgesia" training program for administering conscious sedation as registered nurses.

Review of the facility policy, "Moderate Sedation/Analgesia", dated 10/09, revealed no mention of the licensed nurses training program for conscious sedation being approved by the Alaska State Board of Nursing.

During an interview on 12/6/12 at 9:40 am, the Director of Nursing (DON) stated she was not aware of the Alaska Board of Nursing Position Statement for conscious sedation.

According to the Alaska State Board of Nursing advisory opinion, revised 10/30/09, revealed, "The training program must be reviewed prior to Board of Nursing approval. Approval is based on criteria in this policy statement. Facilities doing training must maintain competency documentation."

Current Validation of Competency

Review of the nurse competencies, provided by the facility, revealed 10 of 11 nurses administering conscious sedation had not completed competencies in the past year.

During an interview on 12/5/12 at 9:50 am, the Acute Care Manager stated the charge nurses were responsible for validating conscious sedation competency. In addition, she stated she was not sure which nurses had completed the conscious sedation competency.

During an interview on 12/6/12 at 12:00 pm, when asked about the nurse competencies, the DON replied competencies were not evaluated on an annual basis.

Review of the facility policy "Moderate Sedation/Analgesia" dated 10/09 revealed, "Sedation and Support Staff Competency...undergo annual reviews to include assessment of competency, knowledge and skills..."

Review of the Alaska Board of Nursing Advisory Opinion, dated 10/09 revealed, "...Nursing scope of practice relating to use of ASA physical classification: The Registered Nurse may NOT administer to adult patient with an ASA score of III or IV unless a CRNA, appropriately credentialed ANP or LIP... is immediately available...written policy and protocol, which are readily available are medically approved...should also be consistent with current practice...The training program must be reviewed prior to Board of Nursing approval. Approval is based on criteria in this policy statement. Facilities doing training must maintain competency documentation."

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Based on record review and interview the facility failed to ensure a procedure form for 1 patient (#7) was signed by the licensed nurse and failed to ensure a sedation consent was dated for 1 patient (#8). This failed practice placed patients at risk for having inaccurately documented medical records. Findings:

Medical record review on 12/5/12 of Patient #7 admitted on 9/19/12 for a conscious sedation procedure revealed the RN signature, date, and time on the Sedation/Analgesia Pre-procedure Form was blank.

Medical record review on 12/5/12 of Patient #8, admitted on 6/7/12 for a conscious sedation procedure, revealed the date the patient signed the surgical consent was blank.

During an interview on 12/6/12 at 9:40 am, the Director of Nursing stated all physician orders and nursing assessments need to be dated and timed.

Review of the facility policy "Admission Procedure" dated 9/09, revealed "...Documentation must be complete...,including but not limited to date, time..."

Review of the facility policy "Moderate Sedation / Analgesia" dated 10/09, revealed "Quarterly chart audits will be conducted on operative and other invasive procedures by the nursing division to monitor nursing care and documentation for quality processes."

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Based on record review and interview the facility failed to ensure the physician had dated orders and consents for 2 patients (#s 7 and 8) that had procedures done at the facility. This failed practice created a risk for incomplete medical records. Findings:

Medical record review on 12/5/12 of Patient #7, admitted on 9/19/12 for a conscious sedation procedure at 7:50 am and again at 1:36 pm revealed the date and time of verbal orders on the Sedation/Analgesia Procedure form was blank.

Medical record review on 12/5/12 of Patient #8, admitted on 9/19/12 for a conscious sedation procedure at 8:45 am revealed the date and time of verbal orders on the Sedation/Analgesia Procedure form was blank.

In addition, record review of Patient #8, admitted on 6/7/12 for a conscious sedation procedure revealed the date the physician signed the surgical consent was blank.

During an interview on 12/6/12 at 9:40 am the Director of Nursing stated all physician orders and nursing assessments need to be dated and timed.

Review of the facility policy "Admission Procedure" dated 9/09, revealed "...Documentation must be complete..., including but not limited to date, time..."

Review of the facility policy "Moderate Sedation / Analgesia" dated 10/09 revealed, "Quarterly chart audits will be conducted on operative and other invasive procedures by the nursing division to monitor nursing care and documentation for quality processes."

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Based on interview, observation, and record review the facility failed to 1) ensure policies were developed for nursing staff use in the Emergency Department (ED). Specifically, the facility failed to ensure a policy was developed for the triage of patients in the ED. The failure to ensure policies were developed and implemented for use in the ED placed patients at risk for receiving substandard and inconsistent services from the ED; and 2) ensure registered nurses, who provided conscious sedation to patients and had completed their competency, were evaluated to administer conscious sedation. In addition, the facility provided conscious sedation by registered nurses to patients with an anesthesia physical status score of III (a patient with severe systemic disease), which is out of licensed nurses' scope of practice without a Certified Registered Nurse Anesthestist, Advanced Nurse Practitioner, or Certified Licensed Independent Practitioner immediately available. These failed practices 1) placed patients who had received conscious sedation at risk for receiving medications from inadequately trained staff and 2) placed patients at risk for receiving conscious sedation when their anesthesia physical score classified them with severe systemic disease and not appropriate for conscious sedation from licensed nurses. Findings:

Refer to C274 for the facility's failure to ensure nursing staff policies were developed and implemented for use in the Emergency Department.

Refer to C295 for the facility's failure to ensure licensed nurses had their competencies performed and/or completed annually for registered nurses who were administering moderate sedation. In addition the facility failed to ensure registered nurses worked within their scope of practice when providing conscious sedation for anesthesia physical status score of III.


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Based on interview and record review the critical access hospital failed to conduct an annual review and evaluation of all hospital services. As a result, there was not documented evidence of an annual evaluation that included determining appropriateness of utilization of services, adherence to facility policies and procedures, and changes in facility practices. Without reviewing and evaluating all services, deficient practices cannot be detected, corrected, and maintained. Findings:

During an interview on 12/5/12 at 9:30 am with the Deputy Administrator and the Director of Compliance and Quality Services they were asked if the hospital had reviewed or evaluated all of its hospital services. The Deputy Administrator confirmed there had been no annual evaluation.

During the Quality Assessment and Performance Improvement interview on 12/6/12 at 7:30 am, the Director of Compliance and Quality Services was asked if the facility conducted an annual review of its total program. She stated they did not.

Review of the "Performance Improvement Council" meeting minutes for 2012 revealed no documentation that the hospital had completed an annual review and evaluation of all its hospital services.


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Based on interview and record review the critical access hospital failed to conduct an annual review and evaluation of all hospital services. This included an evaluation of the number of patients served and the volume of services provided. Without reviewing and evaluating these services, deficient practices cannot be detected, corrected, and maintained. Findings:

During an interview on 12/5/12 at 9:30 am with the Deputy Administrator and the Director of Compliance and Quality Services they were asked if the hospital had reviewed or evaluated all of its hospital services. The Deputy Administrator confirmed there had been no annual evaluation.

During the Quality Assessment and Performance Improvement interview on 12/6/12 at 7:30 am, the Director of Compliance and Quality Services was asked if the facility conducted an annual review of its total program. She stated they had not done an annual review.

Review of the "Performance Improvement Council" meeting minutes for 2012 revealed no documentation that the hospital had completed an annual review and evaluation of all of its hospital services.


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Based on interview and record review the critical access hospital failed to conduct an annual review and evaluation of all hospital services. This included an evaluation of inpatient and outpatient active and closed clinical records reviewed. Without reviewing and evaluating inpatient and outpatient active and closed records, deficient practices cannot be detected, corrected, and maintained. Findings:

During an interview on 12/5/12 at 9:30 am with the Deputy Administrator and the Director Compliance and Quality Services they were asked if the hospital had reviewed or evaluated all of its hospital services. The Deputy Administrator confirmed there had been no annual evaluation.

During the Quality Assessment and Performance Improvement interview on 12/6/12 at 7:30 am, the Director of Compliance and Quality Services was asked if the facility conducted an annual review of its total program. She stated they had not done an annual review.

Review of the "Performance Improvement Council" meeting minutes for 2012 revealed no documentation that the hospital had completed an annual review and evaluation of all of its hospital services.
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Based on interview and record review the facility failed to ensure that the health care policies were evaluated, reviewed and/or revised as part of the annual program evaluation. Without reviewing and evaluating health care policies, deficient practices cannot be detected, corrected, and maintained. Findings:

During an interview on 12/5/12 at 9:30 am with the Deputy Administrator and the Director of Compliance and Quality Services they were asked if the hospital had reviewed or evaluated all of its hospital services. The Deputy Administrator confirmed there had been no annual evaluation. In addition when asked about the review of the hospital's policies and procedures, they said the date in the upper right hand corner of the first page of a policy was the date the policy was reviewed.

During an interview on 12/5/12 at 9:50 am the Acute Care Manager said not all the policies were reviewed annually.

Review of the hospital's policies and procedures 12/3-7/12 revealed not all policies had an annual review.

During the survey process the surveyors requested the hospital's policy and procedure for policy review. At the time of the survey exit the surveyors had not received a policy and procedure regarding annual review of policies.

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Based on interview and record review the facility failed to ensure that the health care policies were evaluated, reviewed and/or revised as part of the annual program evaluation. Without reviewing and evaluating health care policies, deficient practices cannot be detected, corrected, and maintained. Findings:

During an interview on 12/5/12 at 9:30 am with the Deputy Administrator and the Director of Compliance and Quality Services they were asked if the hospital had reviewed or evaluated all of its hospital services. The Deputy Administrator confirmed there had been no annual evaluation. In addition when asked about the review of the hospital's policies and procedures, they said the date in the upper right hand corner of the first page of a policy was the date the policy was reviewed.

During an interview on 12/5/12 at 9:50 am the Acute Care Manager said not all the policies were reviewed annually.

Review of the hospital's policies and procedures 12/3-7/12 revealed not all policies had an annual review.

During the survey process the surveyors requested the hospital's policy and procedure for policy review. At the time of the survey exit the surveyors had not received a policy and procedure regarding annual review of policies.

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Based on record review and interview the facility failed to ensure a facility-wide quality improvement program was in place that consistently identified, implemented, monitored, and evaluated facility and patient care practices to correct quality deficiencies they had identified or should have identified. Without sufficiently identifying or adequately addressing and communicating about areas of deficient practice, systematic correction could not be achieved and maintained throughout the facility. This deficient practice increased the risk of suboptimal patient care and safety. Findings:

Review on 12/6-7/12 of the facility's 2012 Performance Improvement Council (PIC) Meeting Minutes, provided by the Director of Compliance and Quality Services, revealed the following:

· No documentation of actions plans, follow-up and evaluation of identified hospital infections;
· No documentation and discussion of facility-acquired infections and medication therapy;
· No documentation of any Infection Control surveillance being reported and monitored by PIC;
· No documentation of proper remedial actions taken that included all of the identified deficient practices;
· No documentation that contract services are evaluated;
· No documentation the PIC conducts an annual review of its total program;
· No documentation of performance improvement projects in every department;
· No documentation of Dietary Services being involved in PIC and no oversight of the department;
· No PIC oversight, knowledge, or involvement in the Emergency Department's policies being developed and implemented for use in the triage process;
· No documentation of assessing effectiveness of performance improvement project;
· No documentation that PIC oversees policies and procedures being reviewed at least annually; and
· No documentation of nursing competencies reviewed for completeness.

During an interview with the Director of Compliance and Quality Services and the Quality and Utilization Review Manager on 12/6/12 at 7:30 am they stated the Directors of the hospital departments set the monthly monitoring parameters for the managers. The PIC is not involved with selecting what the departments monitored and reported to quality.

Review of the Performance Improvement Council Meeting Minutes on 12/6-7/12, provided by the Director of Compliance and Quality Services, revealed meeting minutes from 10/25/12 and 11/6/12. The 10/25/12 minutes revealed the minutes for 3/22/12 were presented for approval.

Review of the facility's "Organization Performance Improvement Plan" dated 9/12 revealed the PIC meets monthly. The plan also revealed the PIC was responsible for "Setting priorities for performance improvement activities; Ascertaining that relevant data is being monitored; Ensuring that actions are taken to address findings of processes being monitored; Assessing effectiveness of actions to ensure that opportunities for improvements are realized and documented; and Educating staff."


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Based on interview and record review the facility failed to evaluate patient care services. Without evaluating patient care services patients were at risk for receiving substandard services. Findings:

During an interview on 12/5/12 at 9:30 am with the Deputy Administrator and the Director of Compliance and Quality Services they were asked if the hospital had reviewed or evaluated all of its hospital services. The Deputy Administrator confirmed there had been no annual evaluation.

Review of the Performance Improvement Council meeting minutes for 2012 revealed no documentation that the facility had completed any evaluation of its patient care services.


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Based on interview and record review the facility failed to provide surveillance, tracking, and trending of active infections. This failure placed patients at risk for receiving suboptimal care and placed the facility at risk for not being able to identify or adequately address infections in their facility. Findings:

During an interview on 12/5/12 at 2:40 pm, the Infection Preventionist and Employee Health Nurse (IPEHN) Manager stated she had just started working at the facility 2 weeks ago. During the interview, the IPEHN stated she had been unable to locate any of the surveillance data from 2012.

During an interview on 12/6/12 at 7:30 am, Director of Compliance and Quality Services confirmed the prior IPEHN had not been reporting surveillance data to the performance improvement council.

During an interview on 12/6/12 at 9:30 am, the Director of Nursing stated she did not find any surveillance data that the former IPEHN had collected or reported for the year 2012.

Review on 12/6-7/12 of the facility's 2012 Performance Improvement Council meeting minutes, provided by the Director of Compliance and Quality Services, revealed no documentation of surveillance, tracking, and trending of active infections. Review of the "Performance Improvement Reporting Schedule FY 2012" revealed no reporting of surveillance or infections on the schedule.

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Based on record review and interview the facility failed to address deficiencies through the quality improvement program. Specifically, the Performance Improvement Council (PIC) failed to correct any deficiencies in the Infection Control Program which the council should have identified as deficient practice. Findings:

Review on 12/6-7/12 of the facility's 2012 PIC meeting minutes revealed there was no documentation of infection control reporting to the PIC in 1) surveillance; and 2) actions plans, follow-up and evaluation of identified hospital infections.

During an interview on 12/6/12 at 9:05 am, the Medical Director said infection control surveillance should have been reported.

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Based on record review the facility failed to document the outcome of remedial actions. Without documentation the facility cannot be assured the remedial actions taken were completed and the facility cannot monitor the status of any actions needing to be completed. Findings:

Review on 12/6-7/12 of the facility's 2012 Performance Improvement Council meeting minutes, provided by the Director of Compliance and Quality Services, revealed no documented outcomes of remedial actions taken to correct deficiencies.

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Based on interview and policy review the facility failed to have policies and procedures in place regarding inpatient and outpatient visitation rights, which included any restrictions or limitations, and how the hospital staff would be trained to appropriately deal with the visitation rights of the patient. This deficient practice created the potential for unnecessarily restricting visitation by staff not knowing what restrictions or limitations are clinically necessary. Findings:

Review of the policies and procedures on 12/3-7/12 revealed no policy or procedure that addressed patient visitation rights which included any restrictions or limitations, and how the staff would be trained.

During an interview on 12/7/12 at 10:40 am the Director of Compliance and Quality Services confirmed no staff education had been done.

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Based on interview and policy review the facility failed to have written policies and procedures in place regarding inpatient and outpatient visitation rights that included: 1) informing each patient of his/her visitation rights, including any clinical restrictions; and 2) informing each patient of their right, subject to their consent, to have whomever they wish visit. Without these policies, patients and their visitors lacked information regarding any clinical restrictions that would contraindicate visits. Findings:

Review of the facility's policy "Visitors" dated 5/2005 and reviewed 12/6-7/12, provided by the Director of Compliance and Quality Services, revealed no policy and procedure which addressed patient visitation rights that included: 1) informing each patient of his/her visitation rights, including any clinical restrictions; and 2) informing each patient of their right, subject to their consent, to have whomever they wish visit.



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Based on interview and policy review the facility failed to have policies and procedures in place regarding visitation rights, which included any restriction or limitation in place and the reason for the restrictions. By not implementing these policies there is the potential for patients having unequal and inconsistent visiting rights. Findings:

Review of the facility's policy "Visitors" dated 5/2005 and reviewed 12/6-7/12, provided by the Director of Compliance and Quality Services, revealed no policy and procedure which addressed any restriction or limitation and the reason for the restrictions; specifically, addressing unequal and inconsistent visiting rights.


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