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Based on review of a policy and procedure, inspection of available pharmacy medication supplies, and interview of the Director of Pharmacy, the hospital failed to update the policy entitled ANTIDOTE AND EMERGENCY DRUGS, LIST OF with respect to discontinued drugs and failed to have certain drugs available in the hospital that the organized medical staff through the hospital approved policy had mandated should be available in the hospital. The hospital was missing six out of 31 listed drugs on this policy.

Findings:

1. A review of the policy and procedure entitled ANTIDOTE AND EMERGENCY DRUGS, LIST OF (New: 3/87, Reviewed 10/13) indicated it documented the purpose of the policy was: "To maintain an adequate stock of medications to meet the needs of the patients in an emergency situation. Under "Procedure" it provided a list, in table form, of 31 medications to be available in the hospital. This observation was verified by interview of the Director of Pharmacy at that time.

On 3/13/14 at 9:50 a.m. during an interview of the Director of Pharmacy and concurrent inspection of the pharmacy inventory with the Director of Pharmacy with respect to comparison with this list of drugs (as to their availability in the pharmacy) the following drugs were not available in the pharmacy:

a. Aminocaproic acid: used to treat excessive postoperative bleeding and other bleeding disorders

b. Bretylium: used to treat irregular heart rhythms but as of 2011 is no longer available in the US

c. Deferoxamine: used to treat acute iron overdose

d. Ipecac: used to induce vomiting in certain cases of oral poisoning

e. Leucovorin: used to treat certain anemias and as a rescue agent for high dose methotrexate (an anticancer drug) therapy

f. Metaraminol: used to treat low blood pressure or shock

During an interview of the Director of Pharmacy at that time, he stated he did not know why there was no aminocaproic acid in the pharmacy. He stated that Ipecac was a withdrawn drug. When the surveyor pointed out the most recent review of this policy took place 10/13, the Director of Pharmacy stated the failure to remove Ipecac from the list "was an oversight." He stated that he felt metaraminol was a "legacy item" by which he meant it was an old drug that is no longer used but is still available.

Based on the clinical record review, staff interview and facility document review the hospital failed to obtain a physician order to end "observation services" and admit the patient to the Medical Surgical Services for 1 of 2 "observation" patients (Patient 351). This failure allowed formal orders that are valuable for clarifying the physician's direction for patient care not to be written in the patient's chart.

Findings:

During a clinical record review on 3/11/14 at 11:15 a.m., Patient 351's admitting diagnosis was a possible cerebral vascular event (transient ischemic attack [TIA] is when blood flow to a part of the brain stops for a brief period of time.) The following sequence of events occurred:

3/8/14 at 11:02 a.m. - Presented to the Emergency Department;
3/8/14 at 2:51 p.m. - Discharged to home;
3/8/14 at 9:30 p.m. - Presented for the second time to the Emergency Department;
3/8/14 at 11:22 p.m. - The physician wrote an order for the patient to "Place in Observation";
3/9/14 at 1:05 a.m. - Transferred to the Medical Surgical Unit for "observation";
3/11/14 at 12 p.m. - Late entry order to admit patient to Medical Surgical Unit.

During an interview on 3/11/14 at 11:15 a.m., Administrative Staff EE in reviewing the patients physician's orders (in the computerized "order audit trail") stated, "I'm not seeing [that] (the order to admit Patient 351 to the Medical Surgical unit) in the computer. Yes, there should be an order."
During a record review on 3/11/14 at 3 p.m., Patient 351's physician order indicated that on 3/11/14 at 12 p.m., "Late entry order for 3/10/14 at 10:00: Please admit patient as inpatient for continued evaluation and treatment of CVA [stroke]."

Based on kitchen observations and dietary staff interview the hospital failed to ensure that the plumbing in dietetic services was installed in a manner to ensure food safety as evidenced by the lack of an air gap in the food production sink.

Findings:

During general kitchen observations on 3/10/14 beginning at 2:35pm, it was noted that the food production sink below the window was directly plumbed into the waste water system without the benefit of an air gap. In a concurrent interview with Dietary Staff (DS) N she stated that the sink was used for food production activities. In a follow up observation on 3/10/14 beginning at 4:45 pm, it was noted that the overflow hose from the coffee maker drained directly into the floor drain, there was no air gap. It would be the standard of practice to ensure the presence of an air gap between the water supply inlet and the flood level rim of the plumbing fixture, or non-food equipment which shall be at least twice the diameter of the water supply inlet and may not be less than 1 inch (Food Code, 2013).

Based on food storage observations, dietary staff interview and dietary document review the hospital failed to ensure the development of a mass disaster menu that 1) would be able to be implemented in the event of loss of cooking utilities and 2) that specifically designated the number of people that would be fed during the disaster.

Findings:

On 3/11/14 beginning at 3 pm, the hospitals dietary disaster food supply and plan was reviewed. It was noted that in addition to canned items the hospital planned to utilize ready to eat meals. In a concurrent interview with the Nutrition Services Manager (NSM) she was asked to describe the number of individuals that the hospital had planned for. She stated that they included the licensed bed count of 25 as well as 1 direct staff care member per patient. She also stated that the first day of the disaster would utilize perishable items. It was also noted that while some of the perishable items such as sliced ham or deli turkey would be pre-cooked, other items such as the beef or chicken would require cooking. The NSM also acknowledged that while the refrigerator/freezer was on emergency power, without gas the menu would not be able to be implemented. The surveyor asked whether or not there was a feeding plan for support staff. She replied she was unsure.

In a follow up interview on 3/12/14 beginning at 9:30 am, the NSM stated she had clarified that on a typical day shift there were approximately 90 staff members present which included direct care staff such as nurses and physicians but also management team members and clerical support staff. It was also noted that a component of the disaster plan was to prepare for a nuclear disaster. The plan guided staff that they would be prepared to stay indoors for 1-2 weeks and during that timeframe, depending on the deliveries, there would be no deliveries. The NSM stated that while the area did have an inactive nuclear power plan, she was unsure the level of risk, nor was it likely that she would be able to sustain a feeding plan for the extended timeframe. She also acknowledged that the plan may require additional review for feasibility.

Based on document review and staff interview, the critical access hospital failed to have the minutes of their hospital and the general acute care hospital's Board of Trustee Meetings distinct and separate. This had the potential for the information discussed during the board meeting to be misunderstood and applied to the wrong hospital.

Findings:

During the critical access hospital's document review on 3/12/14 at 2:50 p.m., titled "St. Joseph Health System - Humboldt County Board of Trustees Meeting" dated 1/23/13 included discussion regarding the business activities and provision of medical services of the general acute care hospital and the critical access hospital. No obvious consistent distinction existed between the minutes of the meeting related to the individual hospitals.

Based on food production observations, dietary staff interview and dietary document review, the hospital failed to ensure the development of comprehensive systems to ensure the nutritional needs of inpatients was met as evidenced by:

*1. Lack of a comprehensive diet manual that reflected all the diets offered by the hospital (Cross Reference C279);
*2. Inability to ensure nutritional needs of patients were met as a result of development of menus that did not consistently meet the Dietary Reference Index for nutrients and delivery of meals that were not consistent with physician ordered diets (Cross Reference C279).
*3. Lack of a comprehensive screening process to accurately identify patients at nutritional risk (Cross Reference C294).
*4. Development of infant formula preparation procedures that did not fully support aseptic techniques (Cross Reference C279).
*5. Development of a disaster preparedness menu that included foods that would require cooking prior to service (Cross Reference C230).
*6. Ensure development of performance improvement plan that a) demonstrated opportunities for improvement of dietetic services and b) included comprehensive action plans for issues identified in relationship to clinical nutrition care (Cross Reference C279).
*7. Installation of plumbing supply lines that did not prevent potential backflow of waste water into food production sinks (Cross Reference C279).


The cumulative effect of these systemic problems resulted in the inability of the hospitals' food and nutrition services to direct and staff in a manner to ensure that the nutrition needs of the patients were met in accordance with practitioners' orders and current standards of practice as referenced by the American Dietetic Association, the Academy of Nutrition and Dietetics, the Dietary Reference Index and the Office of Dietary Supplements, National Institutes of Health.

Based on inspection of one out of one Rapid Sequence Intubation Kits (contained medications used to facilitate placement of an air tube in a patient's airway) stored in the Emergency Department (ED) Medication Room Refrigerator, inspection of one of two Adult Crash Carts (contains equipment and medication used to manage a medical emergency) in the ED, inspection of one out of one Pediatric Crash Cart located in the ED, staff interview, and document review:

1. The hospital failed to develop written policies and procedures for the use and restocking RSI Kit as required by state regulation.

2. The hospital failed to post the medication/chemical contents of the Adult Crash Cart and the Pediatric Crash Cart outside of the carts as required by state regulation.

Findings:

1. California Code of Regulations, Title 22, Section 70263(f)(1) stipulates that a hospital will develop written policies and procedures that establish the contents and procedures for use of emergency medications supplies.

On 3/13/13 at 10:26 a.m. an inspection of the single RSI Kit stored in the ED refrigerator indicated the external content list documented the kit was to contain:

a. Three vials of pancuronium.

b. Four vials of rocuronium

c. Three vials of succinylcholine

d. Four vials of vecuronium

e. Four vials of sterile water for injection (used to reconstitute the vecuronium).

Pancuronium, rocuronium, succinylcholine and vecuronium all are used to paralyze a patient temporarily and relax their muscles to facilitate the placement of an air tube in his/her airway when he/she cannot breathe on his/her own.

A review of the policy and procedure entitled ANTIDOTE AND EMERGENCY DRUGS, LIST OF (New 3/87, Reviewed 10/13) it did not provide procedures for use and procedures for restocking this supply and this observation was verified by interview of the Director of Pharmacy at that time. The Director of Pharmacy stated he would look to see if there was a policy that provided procedures for use of this supply. He stated there was not policy describing how to restock this supply. By the end of the survey staff had not supplied any procedures describing the use of the supply or procedures for restocking the supply.

2. California Code of Regulations, Title 22, Section 70263(f)(2) stipulates that a content list will be posted outside of an emergency medication supply.

a. On 3/10/14 at 2:48 p.m. an inspection of the ED Adult Crash Cart stored in the trauma room indicated that it contained an advanced cardiac life support (ACLS) medication tray (contains the emergency medications indicated for the treatment of medical emergencies) in the fourth drawer of this cart. Inspection of the Intubation Tray (contained equipment and medication used to place an air tube in a patient's airway when that patient could not breath on his/her own) indicated it contained one bottle of 0.5% Neosynephrine Nasal Spray (used to decongest nasal passages), two 5 ml tubes of lidocaine jelly 2% (used in airway placement), one bottle of benzocaine 20% spray (a local anesthetic sprayed into the throat to help placement of an airway), and two swabsticks of compound tincture of benzoin 10% (rubbed on the skin to help tape stick to the skin). Neither the contents of the ACLS medication tray or the medication/chemicals in the intubation tray appeared on any content list posted outside the cart contrary to state regulation. This observation was verified at that time by interview of the Director of Pharmacy.

b. On 3/10/14 at 3:58 p.m. and inspection of the Pediatric Crash Cart stored in the ED Trauma Room indicated it contained an ACLS medication tray in the first drawer of this cart. The bottom drawer contained an intubation tray that contained one bottle of 1% Neosynephrine Nasal Spray and benzocaine spray, lidocaine jelly, and compound tincture of benzoin swabsticks like the intubation tray the surveyor inspected in the Adult Crash Cart. The ingredients of the ACLS tray and of the intubation tray were not posted outside of the cart on any type of content list contrary to state regulation. This observation was verified at that time by interview of the Director of Pharmacy.

Based on inspection of one out of two Adult Crash Carts and one out of one Pediatric Crash Carts (contain equipment and medications used to manage medical emergencies) located in the Emergency Department (ED), one out of one Rapid Sequence Intubation (RSI) Kits stored in the ED refrigerator (contains medication used to facilitate placement of an air tube in the airway of a patient unable to breathe for him/herself, one out of one Malignant Hyperthermia (MH: a rare but potentially lethal side effect of certain medications used in the practice of anesthesiology) Cart located in the Post Anesthesia Care Unit (PACU) in the Surgery Department, inspection of the PACU and Surgery Department refrigerators, inspection of one out of one warmers located in the surgery Department, staff interview, review of policies and procedures and clinical record review of three closed records of patients who had a fentanyl patch place on them in the last 30 days:

1. The hospital failed to implement its policy that directed the pharmacist to ensure fentanyl patches were only dispensed to opiate tolerant patients as documented in the product labeling for one out of the three patients (Patient 153) (see finding 1).

2. The hospital failed to ensure procedures were developed to ensure that the Pharmacy Department communicated shortages to the organized medical staff and to the nursing staff of 10 mg (milligram) vials of dopamine at a concentration of 40 mg/ml (milliliter) used to stock one of one Pediatric crash carts in the Emergency Department (ED) Trauma Room and the lack of pancuronium in one of one of the Rapid Sequence Intubation (RSI) Kits stored in the ED refrigerator so that these staff members representing their separate disciplines could be aware that the shortages had resulted in changes in these emergency drug supplies and so that these staff members could have input on how the hospital should deal with the shortage as recommended in a guideline regarding medication shortages published by the American Society of Health System Pharmacists (ASHP). The Director of Pharmacy stated the hospital should follow this ASHP guideline. The pharmacy had replaced the dopamine with 5 ml vials at a concentration of 80 mg/ml. There was no pancuronium in the RSI Kit. As a result, physician staff did not have the opportunity to provide input on the potential need to acquire these supplies by alternate means and neither the nursing nor the physician staff would be aware of the shortage until the cart/kit was opened to treat a medically emergent situation which could result in an adverse outcome for a patient during the treatment of a medical emergency. Dopamine is used to treat shock. Pancuronium is used to paralyze a patient to facilitate the placement of an air tube in a patient's airway when the patient is have severe difficulty in breathing or cannot breath on their own (see finding 2).

3. The hospital failed to implement the policy and procedure entitled STERILE PREPARATIONS: GENERAL (New: 6/05, Reviewed 2013) by failing to ensure that the IV room met the United States Pharmacopeial Convention (USP: establishes standards for medications enforceable by the Food and Drug Administration) Chapter 797 (<797>) standards (sets standards for manufacturing sterile compounded products [CSPs] such as IV [intravenous] solutions) the policy documented the hospital would follow when (see finding 3):

a. No provision was made to measure the pressure differential between the IV room and the pharmacy to ensure possible contaminants did not enter the IV room.

b. No provision was made to measure the airflow across the line in the IV room demarcating the buffer area (a clean area where the laminar air flow hood [LAFH] is located) and the ante area (a less clean area than the buffer area where staff gown up and wash their hands prior to entering the buffer area). A LAFH is a hood that contains a HEPA (high efficiency particulate air) filter that creates an ISO 5 (3520 non-viable particles per cubic meter) clean environment in which pharmacy staff can compound sterile IV solutions.

c. The hospital failed to ensure the air flow went from the buffer area toward the ante area: it went from the ante area toward the buffer area (the cleaner area) with the potential to introduce more particles into the buffer area than allowed per USP <797> standards. Furthermore the return vent was located in the ceiling rather than low on the wall as recommended by USP <797>.

d. The documented air changes per hour (ACPH) in the IV room did not meet USP <797> standard of 30 ACPH. It had been measured at 28.58 ACPH by the environmental staff.

e. No provision was made to do volumetric testing of viable particles in the IV room (testing of a standard volume of air of between 400 to 1000 liters in the LAFH and the IV room air to see how many colony forming units [CFUs] of bacteria, if any, grew out on an agar plate contained in the measuring device following the test. This would be followed by corrective action should the CFU count exceed levels established in USP <797>).

f. The hospital failed to test one out of four compounding staff (Pharmacist K) annually for the gloved finger-tip contamination test as stipulated by the policy entitled STERILE PREPARATIONS: COMPETENCIES FOR PHARMACY PERSONNEL (Orig 6/05, Reviewed 10/13) and mandated by USP <797>.

g. The hospital failed to ensure the beyond use dates (BUDs: date beyond which a sterile IV solution is not to be started on a patient) established by the policy for solutions compounded by nursing staff on the patient care units when the pharmacy was closed, in fact met USP <797> guidelines.

4. The hospital failed to clearly establish, in the policy entitled ANTIDOTE AND EMERGENCY DRUGS, LIST OF (which contained hospital approved emergency medication content lists for Adult Crash Carts, the Pediatric Crash Carts, the Radiology Department Emergency Kit and the Neonatal Crash Cart) or in any other policy:

a. The strength of Neosynephrine Nasal Spray to be placed in the sealed Intubation Trays found in the ED Adult Crash Cart (0.5%) and the ED Pediatric Crash Cart (1%) which otherwise were uniform in content. Crash carts contain medications and equipment used to manage medical emergencies (see finding 4).

b. The volume of solution and the amount of lidocaine (used to treat dangerous abnormal heart rhythms) available from manufacturers in premixed bags to be placed in the Adult Crash Carts in the hospital: it is available as 2 gm (gram) in 250 ml (milliliters), 2 gm in 500 ml, and 1 gm in 250 ml premixed bags (see finding 5).

c. The volume for furosemide (used to increase urine flow) stored in the Malignant Hyperthermia Cart. The content list documented this kit was to contain four vials of furosemide which is available in 2 ml, 4 ml, and 10 ml vials all at a concentration of 10 mg (milligrams)/ml. Malignant Hyperthermia (MH) is a rare but potentially lethal side effect of certain medications used in the practice of anesthesiology (see finding 6).

5. The hospital failed to update the Adult Crash Cart List contained in the policy and procedure entitled ANTIDOTE AND EMERGENCY DRUGS, LIST OF (New 3/87, Reviewed 10/13) so it matched the current list posted outside the ED Adult Crash Cart: the policy documented the cart contained two 250 ml vials of dobutamine. The external content list documented the cart contained a pre-mixed bag of dobutamine. The list specified the amount of dobutamine in a premixed bag (500mg) but not the volume. Premixed 500 mg bags of dobutamine are available in 250 ml and 500 ml premixed bags from drug manufacturers. Dobutamine is used to stimulate acutely failing hearts (see finding 7).

6. The hospital failed to ensure the organized medical staff approved the contents the MH Cart and failed to ensure that medications that the hospital approved MH policy entitled MALIGNANT HYPERTHERMIA ( New: 8/96, Reviewed 11/13) documented staff were to use in the treatment of this medical emergency were included on the content list posted outside the cart (regular insulin, refrigerated IV bags of NS, or procainamide). In addition procainamide was not included in the medications stocked in the cart and regular insulin was not available to staff either in the MH Cart itself or in the PACU or Surgery Department refrigerators. Insulin is used with 50% dextrose in water to lower the high blood potassium levels that can occur during an MH crisis. Refrigerated NS is used to cool the patient. Procainamide, can be used to treat abnormal heart rhythms that can occur during an MH crisis (see finding 8).

7. The hospital failed to store one 3000 ml irrigation bag of normal saline (NS: 0.9% saline), four 1000 ml IV bags of NS, three 1000 ml plastic pour bottles of sterile water for irrigation, and twelve 1000 ml plastic pour bottles of NS for irrigation in one out of one warmers located in the Surgery Department Sterile Core according to hospital policy which stipulated they were to be stored per manufacturers' recommendations. Per the manufacturer these solutions can be stored at warmed temperatures for up to two to four weeks as long as the temperature does not exceed 104 degrees F but the compartment these solutions were stored in registered 107 degrees F on the temperature display on the warming cabinet (see finding 9).

8. The hospital failed to ensure the organized medical staff approved the contents the Rapid Sequence Intubation Kit stored in the ED refrigerator located in the ED Medication Room (see finding 10).

9. The hospital failed to secure six bottles of irrigation solution in the ED. They were located in a hallway and had not been secured in a locked area as stipulated in the policy and procedure entitled MEDICATION ADMINISTRATION (First revised 8/96, Revised 1/13:) (see finding 11).

Findings:

1. The fentanyl transdermal system also called a fentanyl patch contains fentanyl, a potent synthetic opiate medication used to treat pain. This medication has a boxed warning (also called a "black box" warning) which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling (also called the package insert) for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for the fentanyl patch documents that it has an associated risk of fatal overdose due to respiratory depression. It documents that the fentanyl patch is indicated for the management of persistent moderate to severe chronic pain that requires continuous around-the-clock opioid (narcotic pain relievers derived from or having the pain relieving action of opium) administration for an extended period of time and that cannot be managed by other pain medications such as non-steroidal anti-inflammatory medications which include ibuprofen (Motrin), combinations of acetaminophen and opiates such as Vicodin and Percocet, or pure opiates such as morphine. It documents that use of this patch to treat patients who are not opioid-tolerant is contraindicated because serious or life-threatening respiratory depression can occur. It documents that it should only be used in patients who are opioid-tolerant. The product labeling defines opioid tolerant patients as those patients who have taken at least 60 milligrams (mg) of oral morphine, 30 mg of oral oxycodone, or 8 mg of oral hydromorphone (opiate medications used to treat pain) daily for a week or longer or an equianalgesic dose of another opiate medication.

On 7/15/2005 the Food and Drug Administration (FDA: has oversight of medications used in the United States) published a warning letter entitled SAFETY WARNINGS REGARDING USE OF FENTANYL TRANSDERMAL (SKIN) PATCHES. The FDA documented that: "The directions for using the fentanyl skin patch must be followed exactly to prevent death or other serious side effects from overdosing with fentanyl. These directions are provided in the product label and patient package insert."

On 3/13/14 a review of the policy and procedure entitled BLACK BOX WARNING (New 6/10, no revision date) indicated it documented the purpose of the policy was to provide for the safe use of medications with a black box warning. It documented that the pharmacist was to review such medications to "ensure that appropriate criteria are met for the drug to be dispensed." Under that language, the policy further documented that "For Fentanyl patches, the pharmacist will document as an intervention that the criteria for prescribing is met with respect for dose, dosing escalation, diagnosis and opiate tolerance ...In the event that Fentanyl patches are ordered outside of the approved criteria, the pharmacist will contact the ordering physician to resolve the discrepancy."

On 3/13/14 a review of the policy and procedure entitled MEDICATION PRODUCT SAFETY (New: 1/89, Revised 10/13) indicated that the purpose of the policy was: "To identify ...medications designated as high-alert or high-risk in order to reduce the risk of causing harm to any patient." Fentanyl patches appeared on an appended list of "High-Alert/High-Risk Medications (Updated 10/2013)." Under the entry for the fentanyl patch it documented to "Follow the black box warning."

These two policies were verified at that time with the Director of Pharmacy.

On 3/13/13 a review of Patient 153's clinical record indicated that the patient was admitted to the hospital from the Emergency Department on 1/24/14 at midnight. On 1/26/14 at 4:27 p.m. a physician ordered that a 12 mcg (microgram)/hr fentanyl patch be placed on Patient 153 and staff placed the patch on Patient 153 on that date at 5:11 p.m.

A review of Patient 153's electronic medication administration record (eMAR: an electronically formatted document used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) indicated that Patient 153 received the following opioid medications in the three 24 hour periods (going from 5:12 p.m. on a prior day to 5:11 the next day as 5:11 p.m. was the time that staff placed the patch on Patient 153) prior to placement of the fentanyl patch:

Patient 153 received 170 mg of oral morphine solution between 5:12 p.m. on 1/25/14 through 5:11 p.m. on 1/26/14 as well as 4 mg of IV (intravenous) morphine between 5:12 p.m. on 1/25/14 through 5:11 p.m. on 1/26/14. This was equivalent to 194 mg of oral morphine (using the conversion of 60 mg of oral morphine being equivalent to 10 mg of IV morphine as documented on the fentanyl patch product labeling) during this 24 hour period.

Patient 153 received 50 mg of oral morphine solution between 5:12 p.m. on 1/24/14 through 5:11 p.m. on 1/25/14 as well as 6 mg of IV morphine between 5:12 p.m. on 1/24/14 through 5:11 p.m. on 1/25/14 which was equivalent to 86 mg of oral morphine during this 24 hour period.

Patient 153 received 30 mg of oral morphine solution between 5:12 p.m. on 1/23/14 through 5:11 p.m. on 1/24/14 as well as 12 mg of IV morphine between 5:12 p.m. on 1/23/14 through 5:11 p.m. on 1/24/14 which was equivalent to 102 mg of oral morphine during this 24 hour period.

A review of the Home Medication Reconciliation record indicated that nursing staff documented that Patient 153 had been taking 15 mg oral morphine tablets at home twice daily. Thus Patient 153 had only been taking 60 mg of morphine or more in the three 24 hour periods (days) prior to the placement of the fentanyl patch not a full seven days as mandated by the black box warning.

On 3/13/14 at 2:16 p.m. during an interview of the Director of Pharmacy he stated he had dispensed the patch and he did not interview Patient 153 as to how much morphine the patient actually took at home. He stated the pharmacy profile system had a "Query" that forced the pharmacist to answer the question as to whether a patient had been taking 60 mg of oral morphine (or its equivalent) for the 7 day period prior to the placement of a fentanyl patch. He pointed out the comment he documented in the Query: "Hx (history) of 15 mg BID (twice daily) morphine, 12 mcg patch, comfort care." He stated he should have answered the question as "no". He stated after reviewing the clinical record during the survey process, he felt at that time that Patient 153 did not meet the black box criteria for dispensing the fentanyl patch.

2. The American Society of Health System Pharmacists (ASHP) is a nationally recognized organization that sets standards of practice for hospital pharmacies. This organization has published ASHP GUIDELINES ON MANAGING DRUG PRODUCT SHORTAGES IN HOSPITALS AND HEALTH SYSTEMS in which it describes a "Phased Approach to Planning for Drug Shortages". This approach includes identifying the shortage, analyzing the impact the shortage will have on the hospital, and establishing a final plan. It documents that "Information about the drug product shortage, alternative therapies, temporary therapeutic guidelines, and implementation plans should be communicated to clinical staff ...Communication of this information is essential for ensuring patient safety and preventing medication errors ..." and "Clear communication with all affected clinicians about the status of a shortage is vital."

On 3/10/14 at 3:58 p.m. an inspection of the Pediatric Crash Cart stored in the ED Trauma Room indicated that the internal content list in the sealed medication tray containing the advanced life support medications (used to resuscitate [revive from apparent death or unconsciousness] patients undergoing a medical emergency) documented it contained dopamine 10 ml vials of dopamine at a concentration of 40 mg/ml. Inspection of the cart indicated it contained 5 ml vials of dopamine at a concentration of 80 mg/ml and this observation was verified by interview of the Director of Pharmacy.

On 3/10/14 at 5:18 p.m. during an interview of the Director of Pharmacy he stated that he had obtained the 5 ml dopamine vials as the 10 ml vials were not available due to a shortage of that product. He stated he had not communicated with the organized medical or nursing staff regarding this shortage. He stated that he felt he should follow the ASHP guidelines regarding drug shortages by communicating with the medical and nursing staff about shortages and working with them to come up with replacements.

On 3/13/13 at 10:26 a.m. an inspection of the single RSI Kit stored in the ED refrigerator indicated the external content list documented the kit was to contain 3 vials of pancuronium. Inspection of the contents of the RSI Kit indicated that it did not contain any vials of pancuronium. During an interview of the Director of Pharmacy at that time, he stated there was a national shortage of pancuronium. He stated he had not informed the ED physicians there was a national shortage of pancuronium and that therefore none would be stocked in the RSI Kit. He stated again that he should follow the published ASHP guidelines regarding communication with staff about drug shortages.

3. The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines ...USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopea/National Formulary (USP 35/NF 30). The USP revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death to patients that could result from microbial contamination and excessive bacterial toxins among other things." If a hospital puts all the environmental controls as well as all the personnel training, certification, and compounding practices into place as described in USP 797, the hospital can assign beyond use dates (BUDs: date beyond which an IV product cannot be started) to compounded IV products as described in USP 797.

On 3/11/14 a review of the policy and procedure entitled STERILE PREPARATIONS: GENERAL (New: 6/05, Reviewed: 10/13) indicated it documented: "The Director of Pharmacy ensures the sterility and integrity of sterile preparations compounded and used within the facility." Under "Standards for Sterile Preparation" it documented: "The pharmacy prepares, labels, transports, and stores sterile preparations in accordance with USP 797 and other recognized authoritative references and pharmacy policies and procedures."

USP <797> documents under "Low-Risk Level CSPs" that "The compounding involves only transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into any on sterile container or package (e.g. bag, vial) of sterile product or administration container/device to prepare the CSP ... the storage periods cannot exceed the following time periods: before administration, the CSPs are properly stored and are exposed for not more than ...14 days at a cold temperature." It documented under "Medium-Risk Level CSPs", "The compounding process includes complex aseptic manipulations other than the single-volume transfer ... the storage periods cannot exceed the following time periods: before administration, the CSPs are properly stored and are exposed for not more than ...9 days at a cold temperature."

USP <797> documents under "Facility Design and Environmental Controls" that "The buffer area shall maintain at least ISO Class 7 conditions ...The room shall be segregated from surrounding, unclassified spaces to reduce the risk of contaminants being blown, dragged, or otherwise introduced into the filtered unidirectional airflow environment, and this segregation shall be continuously monitored. For rooms providing a physical separation through the use of walls, doors, and pass-throughs, a minimum differential positive pressure of 0.02- to 0.05-inch water column is required." This means that the buffer area will be maintained at least 0.02 inches of water column of positive pressure relative to the ante area (if a wall separates the buffer area from the ante area otherwise air flow is measured as describe below) and the ante area will be maintained at least 0.02 inches of positive pressure with respect to the main pharmacy. The positive pressure prevents dust from the less clean areas from entering the cleaner areas. An ISO Class 7 area bathed in HEPA filtered air should not contain more than 352,000 non-viable particles greater than 0.5 micrometers in one cubic meter of air.

USP <797> documents under "Pressure Differential Monitoring" that "A pressure gauge or velocity meter shall be installed to monitor the pressure differential or airflow between the buffer area and the ante-area and between the ante-area and the general environment outside the compounding area. The results shall be reviewed and documented on a log at least every work shift (minimum frequency shall be at least daily) or be a continuous recording device. The pressure between the ISO Class 7 and the general pharmacy area shall not be less than 5 Pa (0.02 inch water column). In facilities where low- and medium-risk CSPs [compounded sterile products] are prepared, differential airflow shall maintain a minimum velocity of 0.2 meters per second (40 feet per minute) between buffer area and ante-area." Pa is an abbreviation for Pascals and is a unit of measurement of pressure: 5 Pa is equivalent to 0.02 inches column of water. Air velocity is measured across the buffer/ante area boundary when no wall/door separates these areas otherwise the pressure differential across a wall is measured using a gauge.

USP <797> documents under "Facility Design and Environmental Controls" that "HEPA-filtered supply air shall be introduced at the ceiling, and returns should be mounted low on the wall creating a general top-down dilution of area air with HEPA-filtered make-up air. Ceiling returns are not recommended.

USP <797> documents under "Environmental Viable Airborne Particle Testing Program" that "Evaluation of airborne microorganisms using volumetric collection methods in the controlled air environments ...shall be performed ...A sufficient volume of air (400 to 1000 liters) shall be tested ...any cfu [colony forming unit] that exceeds it respective action level ...should prompt re-evaluation of personnel work practices, cleaning procedures, operational procedures, and air filtration efficiency within the aseptic compounding location."

USP <797> documents under "Facility Design and Environmental Controls" that "Room air exchanges are typically expressed as ACPHs. Adequate HEPA-filtered airflow supplied to the buffer area and ante-area is required to maintain cleanliness classification during operational activity through the number of ACPHs ...An ISO Class 7 buffer area and ante-area supplied with HEPA-filtered air shall receive an ACPH of not less than 30." HEPA is an abbreviation of "high efficiency particle air." ACPH means air changes per hour.

USP <797> documents under "Competency Evaluation of Garbing and Aseptic Work Practice" - "Gloved Fingertip Sampling" a method to evaluate whether a worker has contaminated his/her gloves after donning them. It documents this evaluation should occur annually.

USP <797> documents under "Immediate-Use CSPs" that "The immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a CSP ...Administration begins not later than 1 hour following the start of the preparation of the CSP ...compounding in worse that an ISO 5 conditions [3520 non-viable particles per cubic meter: found in laminar air flow hoods with HEPA filters] increases the likelihood of microbial contamination, and administration durations of microbially contaminated CSPs exceeding a few hours increase the potential for clinically significant microbial colonization and thus for patient harm, especially in critically ill or immunocompromised patients."

The hospital made IV solutions. On 3/11/14 at 9:45 a.m. an inspection of the Medical/Surgical Nursing Unit Medication Room refrigerator indicated it contained one IV bag of normal saline ( NS: 0.9% sodium chloride used to administer a second drug) 50 ml containing gentamicin 100 mg (an antibiotic). It was labeled as due at 3/10/14 at 3 p.m. and due to expire at 3 p.m. on 3/11/14. It had been made for Patient 154.

On 3/11/14 at 10:06 a.m. during an interview of the Director of Pharmacy and a concomitant review of an IV compounding log that contained four IVs including the IV bag for Patient 154 the surveyor noted it also listed penicillin G 5 million units (an antibiotic) in a 50 ml IV bag of NS, gentamicin 480 mg in a 100 ml IV bag of NS, and vancomycin in a 250 ml IV bag of NS. The Director of Pharmacy stated that all these IVs were good for 7 days under refrigeration and it was hospital policy to store IVs under refrigeration on the units. He stated the pharmacy could go for days without compounding an IV and then have days where one made a dozen IVs. These would be a low-risk IVs based on USP 797 standards and could be assigned up to a 15 day BUD if stored under refrigeration if pharmacy staff followed all the USP guidelines for environmental control and establishment of staff competencies. However, the hospital did not do this as documented below.

On 3/11/14 at 10:51 a.m. an inspection of the IV room indicated the room was about 9 feet wide by 12 feet long. It was accessed via a door in the main pharmacy. In the room to the left of the door was a sink, a countertop and a wall mounted cabinet that ran about 5 feet into the room. Opposite this countertop was a wire shelving system placed against the far wall. On the right was a countertop that ran about 5 feet into the room. Next to this countertop in the far end of the room was a LAFH that contained a HEPA filter in which staff compounded IV solutions. A tag on the hood indicated that a contracted service had certified the hood as meeting USP specifications on 12/19/13. A red line crossed the floor at the far end of the cabinets. There was an air vent in the ceiling just inside the door and a second air vent in the ceiling next to the far wall between the wire wall shelving system and the LAFH. There was no pressure gauge in the wall outside the room that measured the pressure differential between the pharmacy and the IV room (to be 0.02 inches of water per USP <797>).

On 3/11/14 at 10:51 a.m. during the inspection of the IV room and an interview of the Director of Pharmacy, he stated that pharmacy staff did not measure the flow of air from the buffer area to the ante area. A review of reports from the contracted certification service provided no indication that they measured the airflow from the buffer to the ante area.

On 3/11/14 at 10:51 a.m. during the inspection of the IV Room the Director of Pharmacy placed a tissue next to the air grill located in the IV room ceiling just behind the doorway. It was pushed away from the grill which indicated the air entered the room at that point. He gowned up in protective clothing and crossed into the buffer area and placed a tissue against the far grill located in the ceiling next to the far wall between the wire wall shelving system and the LAFH: the tissue clung to the grill indicating this was an air intake. This indicated the airflow moved from the door and ante area to the buffer area (less clean to more clean area) when USP <797> indicates the flow should be from the buffer toward the ante area. On 3/12/14 at 10:09 a.m. during an interview of Contractor l, an employee of an HVAC (heating, ventilation, and air-conditioning) company, he verified that the air flow went from the air vent in front of the IV room door to the rear air vent in the ceiling next to the far wall in the buffer area. He stated there was a HEPA filter in the air duct system that supplied air to the IV room.

On 3/11/14 at 2:35 p.m. review of documentation provided by Staff J indicated that the IV room had 28.58 ACPHs and this was verified by interview of Staff J at that time. Hence the IV room did not have the 30 ACPHs required by USP <797>.

On 3/11/14 at 10:51 a.m. during the inspection of the IV room and an interview of the Director of Pharmacy, he stated that the contracted service that certified the LAFH and the IV room did not do viable particle testing. He stated pharmacy staff did plate testing by exposing agar plates to the air for about ½ hour in the IV room and the pharmacy did swab testing of surfaces in the IV room but not volumetric air testing.

A review of the policy and procedure entitled STERILE PREPARATIONS: COMPETENCIES FOR PHARMACY PERSONNEL (Orig: 6/05, Reviewed: 10/13) indicated that pharmacy personnel were to undergo an annual fingertip glove test. On 3/11/14 at 2:48 p.m. a review of staff competency testing contained in the "Education Competency Manual" provided by the Director of Pharmacy, indicated three out of four staff had undergone a fingertip glove test in the past year. The record indicated that Pharmacist K, identified by the Director of Pharmacy as one of the staff who compounded IV solutions, had not had a fingertip test in over a year. This observation was verified by interview of the Director of Pharmacy at that time.

On 3/11/14 at 1:36 p.m. a review of the policy and procedure entitled STERILE PREPARATIONS: BEYOND USE DATES (Orig 6/05, Reviewed 2013) indicated it documented that: "Compounded sterile preparations mixed in the patient care areas have a maximum beyond use date of 24 hours from the time of preparation." This was not in compliance with USP <797> requirements which document the BUD should have been 1 hour.

4. On 3/10/14 at 2:48 p.m. an inspection of the ED Adult Crash Cart indicated it contained an intubation tray (contained equipment and medications used to place a tube in the airway of a patient who could not effectively breathe on his/her own). Inspection of this tray indicated it contained one bottle of Neosynephrine 0.5% nasal spray (used to open congested nasal passages) and this observation was verified by interview of the Director of Pharmacy at that time. On 3/10/14 at 3:58 p.m. an inspection of the ED Pediatric Crash Cart stored in the Trauma Room indicated staff had placed a sealed intubation tray in the bottom drawer. Inspection of the contents of that tray indicated staff had placed a bottle of Neosynephrine 1%

Based on observation, staff interviews, and document review, the facility failed to ensure: 1. One licensed nurse (Licensed Staff FF), who declined the influenza vaccine, was properly wearing a mask while providing care to a patient in the Critical Care Unit; 2. The Surgical Services Manager (Administrative Staff KK) conducted infection control surveillance audits of OR (Operating Room) staff; 3. The Surgical Services Manager conducted infection control related inservices to OR staff; and 4. OR staff were knowledgeable in Surgical Services policies and procedures, including infection control. These findings had the potential to cause cross-contamination of pathogens and subsequent patient infections which could further compromise the patients' health or cause death.

Findings:

1. During an observation and concurrent interview on 3/10/14 at 9:37 a.m., Licensed Staff FF was providing care to a patient in the Critical Care Unit (Bed 4). She was wearing a mask that was only covering her mouth. Administrative Staff EE stated Licensed Staff FF was wearing a mask because she declined to receive an influenza vaccination, adding that such staff must wear a mask when within six feet of a patient.

During an interview on 3/10/14 at 9:45 a.m., Licensed Staff FF was asked why she was wearing a mask. She stated: "I don't take the flu shot." When asked if she normally wears a mask only covering her mouth, Licensed Staff FF stated, "No," adding that she wears it covering both her nose and mouth when she is with a patient. When told she was observed
providing care to a patient with the mask covering only her mouth, Licensed Staff FF stated, "Oh." She indicated that her glasses fog up when the mask covers her nose.

During an interview on 3/13/14 at 8:09 a.m., Administrative Staff CC was asked about her expectation for staff who decline the influenza vaccine. She stated she expects such staff to wear a mask, covering both their nose and mouth, when within six feet of a patient and/or providing patient care.

Review of the minutes from the November 25, 2013 meeting of the Infection Prevention committee indicated: "The Influenza Plan was reviewed. [Administrative Staff CC] asked the Nurse Managers to remind staff that if a declination was signed, masks must be worn by those staff when caring for patients. PPE [Personal Protective Equipment] must be worn correctly, completely on or completely off; not under the chin or hanging off the ear.

Review of the policy titled, "Influenza Vaccination & Patient Safety," revised 2/2014, indicated: "All healthcare providers who choose not to be vaccinated are encouraged to wear a surgical mask while in the building or in patient care areas during the 'influenza season.'" This language is contrary to the expectations of Administrative Staff CC. The policy did not indicate the proper way to wear a face mask.

Review of the policy titled, "Personal Protective Equipment (PPE)," revised 2/2014, did not indicate the proper way to wear a face mask.

Review of Appendix B, titled "2013-2014 Influenza Plan, part of the 2014 Infection Prevention Program Plan, indicated under Administrative Controls: "All HCP [Health Care Providers] and hospital staff who decline the influenza vaccine are expected to wear a surgical mask when within six feet of a patient."

2. During an interview and concurrent document review on 3/13/14 at 9:37 a.m., Administrative Staff KK was asked if, during the past 12 months, she had documentation verifying she had conducted infection control surveillance audits of OR staff, specifically in regards to aseptic/sterile technique. She stated she had not. Administrative Staff KK was asked to provide copies of all OR audits she had conducted in the past 12 months. The provided audits consisted of:

A. Three (3) "OR Audit" forms, two conducted in December 2013 and one undated. The items audited included: the Time-Out process; surgical site marking; patient verification; sponge, needle, and instrument counts; and fire safety measures. There were no items specific to infection control. During an interview on 3/13/14 at 9:37 a.m., Administrative Staff KK acknowledged this tool did not monitor for infection control. During the same interview, Administrative Staff KK was asked to identify the individual auditors. Of the audit forms which identified the auditor, none of the audits were conducted by Administrative Staff KK.

B. Ninety-eight (98) "Surgery Observation Checklist Total Joint Cases" audits conducted from March 2013 through February 2014. The items audited included: proper attire; closure of the OR door; number of people in the OR, length of time instrument pack was opened; length of time for skin preparation; length of time skin prep disinfectant was allowed to be in contact with the patient's skin; number of entries/exits from OR; and if there was any break in sterile technique. During an interview on 3/13/14 at 9:37 a.m., Administrative Staff KK stated total joint cases were being monitored in response to a past cluster of joint infections following surgery. She stated no such monitoring was conducted for other surgical cases. Of the audit forms which identified the auditor, none of the audits were conducted by Administrative Staff KK.

C. Fifty-five (55) "Time Out Performance Improvement Project" audits conducted from March 2013 through February 2014. The items audited included: patient history and physical is updated prior to induction; all activity is stopped during the time out; music is off during the time out; surgeon is shown the consent; verification of correct site/side/procedure; prep allowed to dry greater than 3 minutes; and verification of sterilization indicators. Of the audit forms which identified the auditor, none of the audits were conducted by Administrative Staff KK.

D. Sixty-one (61) "PACU [Post Anesthesia Care Unit; i.e. recovery room] Performance Improvement Project" audits conducted from March 2013 through February 2014. The items audited included taking the patients' temperature and documentation of the temperatures. Of the audit forms which fully identified the auditor, two of the audits were conducted by Administrative Staff KK.

During an interview and concurrent document review on 3/13/14 at 9:37 a.m., Administrative Staff KK stated the audit tools were "designed to address areas, not people." When asked about the lack of specific auditors' names or names of those being observed on some of the audit forms, Administrative Staff KK acknowledged that without names it was not possible to track the performance of individual staff members.

During an interview on 3/13/14 at 1:52 p.m., Licensed Staff HH was asked if Administrative Staff KK had ever observed her while working in the OR. She stated, "She's in and out and observes, but as far as standing there and watching, no."

During an interview and concurrent document review on 3/14/14 at 7:52 a.m., Administrative Staff CC was asked if she made infection control "rounds" in the Surgical Services department. She stated she conducted an audit in November 2013. Review of the audit tool indicated some of the areas assessed related to infection control were: sharps containers, linens, storage, trash, ice machines, refrigerators, bathrooms, general cleanliness, furniture, gurneys, curtains, sinks, supplies, and floors. Administrative Staff CC stated she had not observed staff's aseptic/sterile technique in the OR.

3. During an interview and concurrent document review on 3/13/14 at 9:20 a.m., Administrative Staff KK was asked if she had conducted infection control related inservices for OR staff during the past 12 months. She stated, "No." Administrative Staff KK was asked to provide copies of all OR inservices that had been conducted during the past 12 months. The provided inservice records included:
A. Annual Radiation Safety Training (1/6/14)
B. Pathology Specimen Inservice (1/6/14)
C. Malignant Hyperthermia (11/2013)
D. Intralipid Inservice (9/27/13)
E. Review of the policies titled "Medication Administration on the Operative Field," and "Surgical Counts-Sponges, Sharps, & Instruments" (9/23/13)
F. Hand Table Inservice (6/28/13)
G. Stryker Eye Gurney (4/23/13)
H. VasoPres Sequential Compression Device (2/15/13)

During an interview on 3/13/14 at 1:50 p.m., Licensed Staff GG was asked if he could recall if Administrative Staff KK had conducted any infection control inservices during the past year. He stated, "None come to mind right off the top of my head right now."

During an interview on 3/13/14 at 1:52 p.m., Licensed Staff HH was asked if she could recall if Administrative Staff KK had conducted any infection control inservices during the past year. She stated, "Not right off the top of my head."

Review of three OR staff members' training records specific to infection control indicated:
* Unlicensed Staff QQ took the "Annual All-Staff Infection Prevention Training Module" (via the HealthStream computer-based training program) on 6/26/13;
* Licensed Staff OO had no infection control inservices from 7/2/12 to 3/13/14;
* Licensed Staff HH took the "Annual All-Staff Infection Prevention Training Module" on 6/26/13;

4. During an interview on 3/13/14 at 10:30 a.m., Administrative Staff KK was asked how she knows that OR staff are aware of the Surgical Services and infection control policies and procedures. She stated, "I don't know."

During an interview on 3/13/14 at 5:15 p.m., Administrative Staff BB was informed of the above-mentioned findings. She stated she was "remiss" in the over-site of Administrative Staff KK and the Surgical Services Department.

During an interview on 3/14/14 at 7:52 a.m., Administrative Staff CC was informed of the above-mentioned findings. When asked if she was aware of the lack of infection control auditing and inservices in the Surgical Services department, she stated, "No." She stated it was her expectation that monitoring of the OR staffs' aseptic/sterile technique would have been done and that infection control inservices specific to the OR would have been conducted. Administrative Staff CC acknowledged that infection control training in the OR needs to be "above and beyond" the infection control training provided annually to all hospital staff via the HealthStream computer-based training program.

During an interview on 3/14/14 at 1:14 p.m., Administrative Staff AA was informed of the above-mentioned findings. When asked if this was acceptable he stated: "No. That's not acceptable. That's something we need to get on right away."

Based on dietetic services observations, medical record review, dietary and administrative staff interview, and dietary and administrative document review the hospital failed to ensure the implementation of effective systems to ensure the nutritional needs of inpatients were met as evidenced by 1) lack of formula preparation procedures that supported aseptic techniques; 2) lack of a comprehensive diet manual that fully reflected the hospitals physician ordered diets; 3) inability of Food and Nutrition services to follow physician ordered diets for patients with gluten allergies and carbohydrate consistent diets; 4) development of a menu that did not meet the nutritional needs of inpatients; and 5) ensure that performance improvement activities demonstrated opportunities for improvement and demonstrated the development of an action plan for areas identified as requiring improvement.

Findings:

*1. During general observations and concurrent interview, on 3/11/14, beginning at 9 am, with Licensed Staff O, she was asked to describe the process of preparing infant breast milk/and or formula. She stated that the counter top next to the breast milk storage area, which was approximately 2 feet long, would be used for this function, and primarily served as the staging area for using stored breast milk. She stated on occasion, physician orders required the addition of a modifier to the breast milk or formula. She stated the sink within the area would be used for handwashing purposes. It was noted that besides the countertop refrigerator there was a breast milk warmer, two white plastic containers of disinfectant wipes, as well as a pump bottle containing hand sanitizer. Licensed Staff O stated the wipes were utilized to clean patient equipment and all counter surfaces. Concurrent review of the manufacturers' use label for the wipes revealed the product was not intended to be used for food contact surfaces, unless the disinfectant was wiped off with clear potable water (is water which is fit for consumption by humans and other animals. It is also called drinking water) after use. Licensed Staff O confirmed that the surface was not wiped with water after being disinfected.

During a concurrent interview, with Administrative Staff DD. he was asked to describe how chemical products were chosen. He stated all products would be reviewed by the infection control committee prior to standardized use.

During interview on 3/12/14 beginning at 9 am, with the Nutrition Services Manager (NSM), she stated she had not reviewed the operational process for breast milk/formula preparation.

Hospital policies titled, "Infant Feeding Standards", dated 10/13 and "Breast Pumping: Manual/Electric", dated 10/13, was limited to elements such as breastfeeding standards, infant assessment and pumping procedures. The policies did not include procedures for ensuring breast milk preparation was conducted based on a defined standard of practice. The standard of practice would be to ensure that the design and function of the area promotes a workflow that supports aseptic techniques (Infant Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities, dated April 1, 2011.)

Hospital policy titled, "Cleaning Products Approved", dated 2/14, revealed " 4. All cleaners that are used for food preparation surfaces are designated "food safe cleaners." Hospital minutes titled "Medical Staff Quality Assurance Committee, Infection Prevention" dated 5/20/13 revealed while the hospital had reviewed and approved the product for use, the product did not meet the criteria set forth in hospital policy.

*2. On 3/11/14 beginning at 9 am, the hospitals diet manual, the document intended to provide guidelines for physician ordered diets, was reviewed. The purpose of a diet manual is to provide comprehensive guidance for all hospital staff for the effective implementation of hospital diets (Academy of Nutrition and Dietetics, 2012). Under the carbohydrate modified diet section there was a general description of a carbohydrate controlled diet. Additionally, the hospitals list of physician orders included three types of consistent carbohydrate diets with associated calorie levels. The guidance for physicians was to order the diet utilizing the consistent carbohydrate terminology; however there was no mention of the three different types of carbohydrate diets that were offered at the hospital which were depicted as a carbohydrate control of 1500-1700 calories; 1700-2000 calories and 2000-2400 calories.

During an interview on 3/11/14 beginning at 8:30 am, with Dietary Staff P, she was asked to describe how these diets were implemented. She stated that she had a grid that she utilized for each of the calorie levels and would calculate the amount of carbohydrate patients would get based on the calorie range of the physicians order. It was noted, the physicians order for gestational diabetic diets were described as Gestational Diabetic Diet Step I, II and III respectively; however the diet manual did not define the parameters of these diets. There were no indications, rationale, description, nutritional adequacy, or how to order a gestational diabetic diet.

In an interview on 3/11/14 beginning at 2 p.m., with the Nutrition Services Director, she stated the hospital recently purchased the diet manual and acknowledged that the manual did not fully reflect the hospital's physician ordered diets.

Review of the diet manual revealed there was no mention of the hospital's "Pediatric Diets for 6 months to 18 years". There was no mention of the low residue/fiber diet, bariatric phased diets or the high protein/high calorie diets, despite the ability for physicians to order the diets. Review, on 3/12/11 at 2 p.m., of all diet orders revealed there were a total of 41 potential diet orders that could be written. The diet manual did not reflect the scope of the diets that physicians were able to order.

*3a. During observation of meal distribution on 3/10/14 beginning at 5 p.m., it was noted that there were 2 patients with physician ordered gluten free diets. A gluten free diet eliminates foods and products that eliminate the gluten protein which is found in wheat, barley and rye (Mayo Clinic Foundation, 2012). Patients with gluten sensitivity typically experience symptoms such as nausea, diarrhea or non-gastrointestinal symptoms such as joint pain, and numbness in the legs, arms or fingers. Symptoms typically appear hours or days after gluten has been ingested (National Foundation of Celiac Awareness, 2014). Both of the patients received the breaded fish for their evening meal.

Review, on 3/11/14 at 8:30 am, of the food label of the fish revealed one of the ingredients was wheat. In a concurrent interview, the NSD acknowledged that this product would not be appropriate for a gluten free diet. She stated there was no developed menu for patients with gluten allergies.

*b. During observation of meal distribution of 3/10/14 beginning at 5 p.m., there were two patients with physician ordered carbohydrate controlled diets with calorie parameters of 1500-1700 calories/day. One of the patients had a meal tray that consisted of 49 grams of carbohydrate while the other meal tray consisted of 66 grams of carbohydrate (CHO).

During an interview on 3/11/14 beginning at 9:30 am, with Dietary Staff P she was asked to describe how this diet would be implemented. She stated that she used a guide that depicted 1200, 1500, 1800, 2000, 2200 and 2500 calorie diets. Concurrent review of the undated document titled, "HS Snack CHO [carbohydrate] content" revealed each calorie level had designated levels of carbohydrate ranging from 45 to 99 grams/meal. She also stated that for the range of 1500-1700 calorie diets she would utilize 65 grams CHO/meal. When the surveyor asked how she would handle patient meal tickets that either had more or less than the designated amount of carbohydrate she stated if the patient chose more or less than the designated level she would add or subtract food items containing carbohydrate. She stated for all carbohydrate controlled diets she would add an evening snack. While the hospital had a system to implement the physician ordered diet, the system was not consistently followed. It was noted the carbohydrate level for the various levels was not included in the hospital's diet manual. During an interview on 3/11/14 at 2:45 p.m., with the NSM she acknowledged that the consistent carbohydrate diet material in the diet manual did not reflect the hospital's current operational processes.

*4. The Dietary Reference Index (DRI), published by the National Academy of Sciences, Institute of Medicine (NAC/IOM), is intended as a reference guide to health professionals in the daily planning of nutritional needs of groups and individuals. The DRI is comprised of macronutrients such as calories, protein, fat, carbohydrates, cholesterol and fiber as well as greater than 30 micronutrients (vitamins and minerals-NAC/IOM, 2005).

On 3/11/14 beginning at 11am, the hospital's menu, accompanying nutritional analysi,s and daily hospital census was reviewed. The majority of the hospital's inpatients were above 50 years of age. While the hospital developed an analysis of some of the hospital's standardized diets the analysis did not meet the nutritional needs of the demographics of the population based on the inpatient census. As an example review of the analysis for the non-select regular diet revealed the menu did not meet DRI for fiber, magnesium, Vitamins D and E. The menu did not consistently meet the daily requirement for folate, meeting the DRI for only 2 of 7 days. The unit of measure for the Vitamin A content was calculated in international units which was an average of 2000 IU (international units) per day. There was no conversion of this value which current units of measure described as micrograms/deciliter. Conversion from international units to retinol activity equivalents noted that the menu did not meet the nutritional standards for Vitamin A (Office of Dietary Supplements, National Institutes of Health, 2012).

During an interview on 3/12/14 beginning at 3 p.m., with the Nutrition Services Manager (NSM), she confirmed the majority of their patients were older than 50 years of age. She stated in order to meet the nutritional needs of the population she would compare the adequacy of the diet to the needs of males 51-70 years of age. The comparison was not completed. The NSM confirmed the menu analysis was limited to the regular, consistent carbohydrate, heart healthy diet, dysphagia 1, and renal diet as well as the analysis of listing of foods that may be served to pediatric patients. Concurrent review of the hospital's diets, printed from the electronic medical record system on 3/12/14, revealed there was a 2 gram sodium diet, multiple stages of bariatric diets, various levels of carbohydrate controlled and gestational diabetic diets, and multiple levels of pediatric diets.

*5. On 3/12/14 beginning at 3 p.m., the departments' performance improvement plan was evaluated with the Nutrition Services Manager. Review of the foodservice departments' plan revealed all activities monitored reached near 100% compliance rates. The elements monitored included tray safety, tray accuracy in relationship to the physician ordered diet, dish machine temperatures, kitchen cleanliness, and refrigerator/freezer checks in patient care areas. The hospital was monitoring dietary recommendation follow up for patients at nutritional risk. For calendar year 2013, this element was below the hospital's performance benchmark of 100%. The results of the performance monitoring revealed for the four quarters the results were 43%, 73%, 74%, and 73% respectively. While the hospital completed an individual analysis of the lack of compliance for each of the months, there was no consistent development of an action plan to mitigate (make less severe) and/or solve the identified problems. As an example for January 2013 the hospital's compliance rate for dietary recommendation was 55%. The analysis revealed of the 11 recommendations that were suggested five of the recommendations were not reviewed by the physician. For these five elements the patient was discharged before the physician reviewed the recommended dietary intervention. The hospital indicated that there were no improvements necessary. Follow up data collection dated March 2013, revealed a decline to a 21% compliance rate. The plan to mitigate was a discussion between the dietitian and the manager to discuss possible causes of the fall-outs, with the action plan to continue monitoring. While monitoring is an integral component of the effective development of a performance plan, the standard of practice would be to develop an action plan as issues were identified.

During an interview on 3/12/14 beginning at 3:30 p.m., with the Administrative Staff RR, she stated it was the responsibility of each department to develop their own performance improvement indicators and action plans to be submitted to the committee. She stated she was aware that plan for Food and Nutrition services required some additional work.

Based on staff interviews, medical record review and document review, the facility failed to ensure:

1. Nursing services consistently completed admission nutrition risk screening as evidenced by lack of screening of greater than 60 percent of inpatients on 2 days during the survey.

2. A contracted licensed nurse (Licensed Staff PP) was oriented to the hospital and had her competencies verified within 14 days of her assignment per facility policy; and

3. The Surgical Services Manager's (Administrative Staff KK) skills, duties, and responsibilities, as outlined in her job description, were evaluated. These deficiencies had the potential to create an unsafe environment for patients, further compromise their health status, and cause death.

Findings:

*1a. On 3/11/14 beginning at 1:45 pm, Patient 200 ' s medical record was reviewed. A history and physical dated 2/25/14, the day of admission revealed that the patient became progressively ill during the previous 3 days and had poor dietary intake. The physical noted admission diagnosis of sepsis. Review of nursing admission assessment dated 2/25/14 revealed that there was no documentation of the patients ' compromised nutritional status prior to admission. In a concurrent interview and document review with Administrative Staff C she stated that in February the hospital converted to a different nursing screening in the electronic medical record. Concurrent review of the nursing screening process revealed that the nutritional screen should have consisted of an evaluation of weight loss, appetite prior to admission, difficulties eating or inability to swallow, evaluation of acute or chronic diseases as well as patient height and weight. Upon completion of these elements the patient would be given a nutritional risk score that would be electronically transmitted to the dietary department for evaluation.

Review of hospitals ' diet list that consisted of the nutritional risk information revealed that Patient 200 did not receive a nutrition risk score at the time of admission.

In an interview on 3/11/14 at 2:30 pm, with the Clinical Nutrition Manager and Administrative Staff C they stated that if the nutrition score was blank it would indicate that the admission risk assessment was not completed. She also stated that nursing staff were trained on the format change of the nursing nutrition risk assessment. The surveyor concurrently requested in-service training materials related to the topic. A second request for training materials was requested on 3/12/14 at 1:30 pm. As of 3/12/14 at 5 pm, at the time of the survey exit, the hospital had not presented the requested materials. During an interview on 3/12/14 beginning at 9 am, the Nutrition Services Director acknowledged that patients were not fully screened for nutritional risk at the time of admission.

Review of the diet list dated 3/10/14 revealed that 13 of 21 or 62% of the inpatients were not screened for nutritional risk at the time of admission. Hospital diet list dated 3/11/14 revealed that 69% of hospital inpatients were not screened for nutritional risk at the time of admission. It was also noted that the hospital had not developed a policy or procedure related to the updated operational process of patient screening related to nutrition risk of inpatients.

*1b. On 3/12/14 beginning at 9:30 am, Patient 201 ' s medical record was reviewed. A history and physical dated 3/3/14, the date of admission revealed that the patient was admitted through the emergency room with generalized weakness, stating that he could no longer care for himself. The physical also noted that the patient had been vomiting for several days, had significant failure to thrive with a significant decline in functional status.

Review of hospital diet list dated 3/10/14 which was printed on 3/10/14 at 2:22 pm, revealed that the patient was classified as a patient at moderate nutritional risk, despite the admission diagnosis of significant failure to thrive and functional decline. It was also noted that the RD consult was completed on 3/7/14, four days after admission. In an interview on 3/11/14 beginning at 2 pm, with the RD she stated that the current standard of practice was to see all patients within 48 hours of admission for initial evaluation.










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2. During an interview on 3/14/14 at 9:15 a.m., Administrative Staff RR stated the most recent "competencies" (performance evaluation) for Licensed Staff PP was conducted on 10/26/12.

During an interview and concurrent document review on 3/14/14 at 9:55 a.m., Administrative Staff LL was asked to describe the orientation process for contracted staff. She stated if the contracted employee is new to the facility or has had a break in service greater than 12 months, they must go through the full orientation process within 14 days of their assignment. If a contracted employee has had a break in service less than 12 months, they are able to go through the facility's abbreviated orientation process which they must complete within 14 days of their assignment. Administrative Staff LL stated the full or new employee orientation consists of hospital orientation, clinical orientation, and specific department orientation and includes computer-based training, in-person speakers, videos, and PowerPoint presentations. The abbreviated orientation consists of computer-based training only. Clinical orientation is at the discretion of the department manager. Regarding performance evaluations of contracted employees, Administrative Staff LL stated they must have a performance/ competency evaluation within 14 days of their assignment. When asked why Licensed Staff PP's (a "traveler" or contracted employee) personnel file did not contain documentation of completion of an orientation program or performance evaluation within 14 days of her current assignment, Administrative Staff LL stated: "That was in violation of the policy. [Licensed Staff PP] should have gone through the basic (abbreviated) orientation process" since her break in service was less than 12 months.

During an interview on 3/14/14 at 10:25 a.m., Administrative Staff MM was asked about the lack of orientation and competency evaluation for Licensed Staff PP during her most recent assignment. Administrative Staff MM stated Licensed Staff PP has worked in her department on and off since 2005 and, prior to this latest assignment, Licensed Staff PP had a break in service of approximately three months. Administrative Staff MM stated she was unaware that Licensed Staff PP needed to again go through the orientation process or have her performance evaluated again.

During an interview on 3/14/14 at 10:50 a.m., Management Staff NN was asked who was responsible for processing and monitoring completion of the paperwork for temporary contracted employees. She stated she was. Management Staff NN was then asked to describe the process regarding the completion and monitoring of required paperwork for contracted employees. She stated she "sets up" all the employee's information into the computer and checks weekly to see if the employee has completed all the necessary paperwork, as well as the orientation process, and has been given a performance evaluation within 30 days of their assignment by the department manager. When asked if the orientation and evaluation needed to be completed within 14 or 30 days, Management Staff NN stated: "As far as I know it's 30 days. I've been doing this for two years and have never seen the policy."

During a telephone conference call on 3/14/14 at 11:12 a.m., Administrative Staff LL stated reactivation of a contracted employee would be processed through the Human Resources department, not through the Staffing office (Management Staff NN). She added, "There's obviously a communication gap between the staffing office and HR [Human Resources]." If the reactivation of a contracted employee is not communicated to the Staffing office, they would not know that that employee needed to be tracked and monitored for the required processes and documentation.

Review of the policy titled, "Orientation," revised 6/2013, indicated: "If a former employee or temporary (agency) employee is rehired within 12 months of termination or if an employee returns from an extended Leave of Absence, they must complete a Basic Orientation Packet and sign a HIPAA (patient privacy) agreement. Attendance at New Employee Orientation is not required. Clinical Orientation will be completed at the discretion of the hiring manager."

Review of the policy titled, "Plan for the Management of Human Resources," revised 5/20/13, indicated under the section "Orientation and Competency Validation of Temporary Clinical and Non-Clinical Personnel:" "Temporary agency staff will have a completed performance review within the first 14 days of their assignment and after one year of continuous work as a temporary staff member...Responsibility for verification of the above documents [compliance with minimum requirements of the position; completion of basic hospital orientation, completion of orientation to the work area; and completion of a performance review] is as follows: Temporary clinical personnel: Staffing Coordinator."

3. During an interview and concurrent document review on 3/13/14 at 5:15 p.m., Administrative Staff BB verified she was Administrative Staff KK's immediate supervisor and thus, responsible for her annual evaluation. Administrative Staff BB was asked to describe the evaluation process for department managers. She stated nursing managers are evaluated by her in the following areas: Healthiest Communities, Support of Organizational Mission and Values, Sacred Encounters, Perfect Care, Stewardship, and Personal Development. Administrative Staff BB added that managers are also evaluated by physician and peer reviews. She stated she evaluates managers based on data [i.e. management of the department's budget and of staff FTEs (Full Time Equivalent) positions], peer and physician reviews, and direct observation. When asked if her observations are based on the skills, duties, and responsibilities outlined in the manager's job description, Administrative Staff BB stated: "No," and indicated they are based solely on the above-mentioned criteria. When asked if this was a problem, Administrative Staff BB was silent, offering no response. When asked if she was aware that Administrative Staff KK had not conducted any audits of OR staff's compliance/performance related to aseptic/sterile technique, or any infection control related inservices over the past 12 months, Administrative Staff BB stated she was not aware of this and was "remiss" in the oversite of Administrative Staff KK and the Surgical Services department.

Review of the "Nurse Manager--Surgical Services/Sterile Processing [name of facility]" job description, indicated: Under "Function:" "Under the general direction of the VP Chief Nursing Officer, the Nurse Manager of Surgical Services/Sterile Processing coordinates available resources to efficiently and effectively provide professional patient care and services to a quality consistent with nursing and [name of facility] standards and at a cost compatible with the fiscal and other resources of [name of facility]. Assumes 24 hour responsibility for the management and direction of patient care and services in the assigned areas and delegates authority, as appropriate..." The performance standard "Competence" indicated the manager "demonstrates competency in age specific skills for patients [infants through geriatric patients]. The Measurement Criteria under this standard included, "direct observation: peers, physicians;" "department standards;" and "competency standards." The performance standard "Quality Improvement" indicated the manager "Participates in performance improvement activities by monitoring activities, identifying trends, and reporting to staff for outcome improvements in practices. Maintains appropriate quality control programs...Develops and implements policies and procedures that guide and support the provision of services." The Measurement Criteria under this standard included, "Direct observation, peer evaluation," "QI [Quality Improvement] reports," Standards developed," and "Problem intervention." Other standards included: "Leadership" and "Interpersonal Relations." The job description failed to mention compliance with current or facility infection control practices/guidelines, adherence to current professional standards [the facility indicated it follows the professional standards of the Association of peri-Operative Registered Nurses (AORN) and the Centers for Disease Control (CDC)], or monitoring of staff compliance with these policies/guidelines/standards.

Review of the "Director-Nursing Services-[name of facility]" job description, indicated under "Function:" "Under the general direction of the VP/Chief Nursing Officer, the Director of Nursing Services coordinates available resources to efficiently and effectively provide professional patient care and services to a quality consistent with nursing and [name of facility/organization] standards and at a cost compatible with the fiscal and other resources of [name of facility/organization]. Assumes 24 hour responsibility for the management and direction of patient care and may oversee RNs working in non-nursing areas..." The performance standard "Competence" included three sub-categories: "Age Specific Needs," "Fiscal Management/Resource Utilization," and "Human Resource Management." The category "Human Resource Management" indicated the Director of Nursing Services: "...Assures that performance appraisals, coaching, counseling, feedback, and discipline are conducted in concert with policies, values, and standards. Effectively recruits, hires, orients, trains, and evaluates staff to assure competency and meeting of patient, departmental and organizational needs..." The "Measurement Criteria" for this standard included "Direct observation." The performance standard "Quality Assurance" indicated: "Monitors activities, identifies trends, and takes actions which assess and improve departments' performance. Maintains appropriate quality control programs...Assures safe environment for customers and others; identifies and takes effective action when necessary to assure safety standards are met. Develops and implements policies and procedures that guide and support the provision of services." The "Measurement Criteria" for this standard included "Direct observation."

Based on observation of three nurses passing medications to four patients on two separate day shifts (3/12/14 and 3/13/14), the hospital failed to ensure that two out of four patients (Patient 151 and 152) received one medication each as ordered by their physicians. Patient 151 received pantoprazole (used to decrease stomach acid) while eating his breakfast when the physician ordered it to be given prior to the meal and Patient 152 did not receive a dose of metformin (used to treat high blood sugar levels seen in diabetic patients) with her meal as ordered by the physician; she received it prior to the meal. Neither medication error was significant. Two medication errors were made out of a total of 17 opportunities for error.

Findings:

1. On 3/11/14 at 8:27 a.m. Nurse G administered one pantoprazole 40 mg (milligram) tablet to Patient 151. Patient 151 was laying at about a 60 degree angle in his bed and was eating his breakfast during the medication pass. On 3/11/14 at 9:14 a.m. a review of Patient 151's clinical record indicated that on 3/8/14 at 2:31 p.m. a physician had ordered that Patient 151 receive the 40 mg of pantoprazole before breakfast.

2. On 3/11/14 Nurse H administered medications to Patient 152 between 8:42 a.m. through 8:47 a.m. Metformin was not among the medications that Nurse H administered to Patient 152. On 3/11/14 at 9:22 a.m. a review of Patient 152' s clinical record indicated that on 3/8/14 at 11:45 p.m. a physician ordered that Patient 152 receive 1000 mg of metformin twice daily with meals. A review of the electronic medication administration record (eMAR: an electronically formatted document used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) indicated that on 3/11/14 Patient 152 received the morning dose of metformin at 6:57 a.m. During an interview of Nurse H at that time she stated that Patient 152 received her breakfast tray right after her last medication was given to her at 8:47 a.m. (1.75 hours after receiving the metformin).

Based on clinical record review, staff interview and hospital documentation the critical access hospital failed to properly document an executed informed patient consent (is a process for getting permission before conducting a healthcare intervention) and the patient's acknowledgement of her Medicare rights. This failure had the potential for patients to not be aware of her rights or aware of the medical treatments administered when she was unable to make an informed decision regarding their health care.

Findings:

During a clinical record review on 3/14/14 at 9 a.m., Patient 352 was admitted to the critical access hospital on 12/31/13 and discharged on 1/8/14. The patient's acknowledgement for her Medicare rights within the document titled, "An Important Message From Medicare About Your Rights" had written in on the signature line, "ALOC/Intubated" (Altered Level of Consciousness is characteristic of nervous system dysfunction and warrants thorough examination to rule out all possible causes and ('intubated' is insertion of a tube into a hollow organ or body passage). Two staff initialed as witnesses to the patient's level of consciousness on admission 12/31/13.

In addition, the "Condition of Admission" under the headings-
1. Personal Belongings/ Valuables;
2. Physicians are Independent Contractors;
3. Acknowledgements that the patient is in receipt of the "Notice of Privacy Practice, Important Patient Information, Patient's Rights and Responsibilities, and Patient Safety Statement; and
4. Financially Responsible Party INCLUSIVELY USED "ALOC" IN LIEU OF THE PATIENT'S SIGNATURE.

During an interview on 3/14/14 at 11:30 a.m., Administrative Staff II stated the hospital's process for a patient with an altered level of consciousness would be for two staff to Initial on the line where the patient would normally sign. In addition, when the patient is coherent the staff would have the patient sign their name to complete the documentation. Staff did not have Patient 352 sign the documents once she became coherent.

In the hospital's computerized system training module, Meditech 5.64 "Standard Work" indicated, "...If the patient is altered at the time of service make sure to document on the consent and two people must witness the consent. If the patient is admitted within our facility the Admissions counselor provides feedback to the supervisor that a consent needs to be obtained when the patient is able. The supervisor follows up with the patient. The document continues, "Medicare message... If the patient is altered follow the same instructions as with the consent."

Based on document reviews of contracted services for independent contractors and volunteers' files the hospital failed to perform
criminal background investigations for three of three individuals who have contact with patients while providing services. This failure has the potential of exposing patients to individuals with a criminal history.

Findings:


During document reviews on 3/13/14 and 3/14/14 of contracts for an independent contractor (Audiologist) and volunteer files, these documents did not contain criminal background checks.


Further document review of the "volunteer list" indicated that their duties included: Information Desk, Floor Duty, Radiology Department Support, Gift Shop, Surgery Liaison and Emergency. Administrative Staff BB corroborated that volunteers do interact with patients.

During an interview on 3/14/14 at 2 p.m., Administrative Staff JJ stated hospital's management does recognize a concern regarding the current background information obtained for these individuals and corroborated the need to make changes.

The facility was unable to provid policies and procedures relevant to background checks for contractors and volunteers.