The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

SURPRISE VALLEY COMMUNITY HOSPITAL 741 NORTH MAIN STREET CEDARVILLE, CA 96104 June 29, 2016
VIOLATION: EMERGENCY PROCEDURES, TRAINING Tag No: C0227
Based on interview and record review, the hospital failed to ensure the safety of patients in the event of a fire:

1. Not all staff were educated on the procedures related to a fire emergency.

2. A fire door that opened into an area used for overflow emergency patients was propped open with a trash can for the entire survey.

These failures had the potential for fires to spread and patients to be endangered by a fire emgergency.

Findings:

1. On 6/27/16, the training for staff in fire procedures was reviewed. The staff training rosters did not contain names of all staff working on 6/27/16.

On 6/29/16 at 8:50 am, Administrative Staff O acknowledged he was in the process of training all the employees and had not yet trained everyone on staff including the contract staff.

2. On 6/27 at 1 pm through 6/29/16 at 5:30 pm, the conference room door connected to the Emergency Department overflow area was propped open and unable to close using the automatic closure in the event of a fire.

On 6/29/16 at 8:50 am, Administrative Staff O acknowledged the door would not close as intended in case of a fire.
VIOLATION: AGREEMENTS - LIST OF SERVICES Tag No: C0291
Based on interview and document review, the Critical Access Hospital (CAH) failed to maintain a list of all contracted services, describing the nature and scope of the services provided. This deficiency had the potential to lead to inadequate updates and monitoring of the contracted services.

Findings:

When the surveyor requested a list of the contracted services on 6/28/16, a sheet of paper was provided several hours later. This paper contained only provider or entity names of seven contracted services, including pharmacy, lab, dietary, housekeeping, business office, radiology, and administration.

During a concurrent interview and document review with the Chief Executive Officer (CEO) on 6/29/16 at approximately 12 pm, the CEO agreed that the list did not describe the nature and scope of the services provided, such as services being offered; whether the services are offered on- or off-site; whether there is any limit on the volume or frequency of the services provided; and when the service(s) are available.
VIOLATION: COMPLIANCE WITH STATE AND LOCAL LAWS Tag No: C0152
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, the hospital failed ensure to State laws were followed when:

1. The emergency drug supply was not sealed in the emergency room (ER) crash (emergency) cart and the pediatric (children's) emergency cart.

2. Two of two crash carts failed to have contents accurately listed on the exterior of the cart.

3. The hospital's drug storage policy had not been reviewed, updated, or implemented since 4/2008, over eight years ago.

4. The hospital's drug policy was not consistent with current State regulations.

5. Registered Nurse C failed to demonstrate and have evidence of competency in pediatric resuscitation (providing life saving measures).

6. One of two employee records sampled did not contain annual performance evaluations. (Registered Nurse, RN N)

7. Five of five employee files did not contain evidence of vaccination status. (RN N, Director of Nursing-DON, RN C, RN E and Laboratory Supervisor B),

8. Three of five employee files did not have evidence of current tuberculin (TB - a contagious respiratory disease) testing. (Lab Superviosr B, RN D, and DON)

Findings:

1. California Code of Regulations Title 22, Division 5, Chapter 1 Paragraph (f) reads "Supplies of drugs for use in medical emergencies only shall be immediately available at each nursing unit or service area as required. (1) Written policies and procedures establishing the contents of the supply procedures for use, restocking and sealing of the emergency drug supply shall be developed. (2) The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within. (3) The supply shall be inspected by a pharmacist at periodic intervals specified in written policies. Such inspections shall occur no less frequently than every 30 days. Records of such inspections shall be kept for at least three years."

On 6/28/16 at approximately 10 am, a hospital registered nurse, (RN D) and a Central Supply Clerk were observed in the hallway checking the emergency medication supply, (crash cart).

In the emergency room (ER) at 11:15 am, RN D confirmed that they were checking for outdated medications in the crash cart and removed them. RN D confirmed that she checks medications and pulls out the outdated medications in the hospital including the crash carts. When asked about sealing of the crash cart, RN D stated that when nurses access any of the carts, they would leave a note of what was removed from the crash cart, so it is easy for RN D to know what to replenish and then seal the cart. RN D pointed to where the crash cart seals (red plastic breakable seals) were stored. They were observed in a clear plastic bag in the first top drawer on the right of the ER door in to the hospital.

Inspection of the crash cart in the ER with RN D on 6/29/16 at 3 pm showed the seals on the outside of cart were not locked. They were put in the designated place, but were not in the locked position. The locks could be removed without breaking them. Additionally, the medication trays inside the crash carts had a clear plastic cover, that was not locked. This was true for all emergency medication supplies: The acute crash cart and the medication trays within, and the ER crash cart, the medication trays within, the pediatric Broselow bag, and the different compartments within. Broselow system is a commercial product designed for management of pediatric emergencies. The Broselow tape facilitates determination of medication dosages and equipment sizes for children, by measuring the child length against the tape. The cart is color coded that matches the colors zones on the tape to serve as quick guide to clinicians for quickly identifying the location of and for fast retrieval of appropriate (color coded, weight) supplies.

2. On 6/28/16, there was no medication content list observed on the outside of the ER cart, or in any of the medication trays inside the cart. It was pointed out later by hospital staff, that the list was in a binder that was located on a stainless steel cart in the room.

On 6/28/16, the medication content list for the ER crash cart was reviewed. The list had a few items that were lined through and the volume or the concentration was changed by hand. Also, the quantity for some of the medications was changed by nurses.

Similarly, the crash cart in the medical unit hallway, Acute Crash Cart, was inspected on 6/28/16 at 2:30 p.m. The list of the content of the cart had multiple items that were crossed off and items that were written in. There were nine items that were added, crossed off or changed. The list had "Master" written on it, but it did not have the date it was created or revised.

What was stocked in the crash carts did not match the corresponding content lists.
In the acute crash cart, Metoprolol, a blood pressure medication; epinephrine a medication used to increase blood pressure and heart rate; and Sodium chloride, an injectable solution to restore blood pressure or replenish sodium did not match the content list.

Metoprolol 1 mg/ml five 5- milliliter (ml) vials were in the cart, when the list indicated three vials.
Epinephrine 1:1000 three ampules were in the cart, when the list indicated four.
Sodium chloride flush - 10 ml or 20 ml, there were 1 vial and 4 syringes when the list indicated four.
The list included sodium chloride injection 0.9%, no volume specified, but none was in the cart.

On the ER crash cart, magnesium sulfate, an injectable medication used to treat irregular heartbeat, did not match the content list. The content list included magnesium sulfate 50% (500 mg /ml) two milliliters five vials, and magnesium sulfate 50% (500 mg /ml) 5 milliliters two vials.
In the cart was seven, two ml vials of magnesium sulfate. There were no five ml vials on the cart

The ER crash cart drug inventory list was revised on 4/29/14.

During interview on 6/28/16 at approximately 12 noon, RN D clarified that they changed the list based on what medication they have. The decision to what to be included in the crash cart should not be what the front line staff nurses think it should be or what they have on hand. Deciding what to include in the emergency crash cart should be the responsibility of medical staff, pharmacy, administration, and nursing, based on the size of the hospital, the type of patients, and consistent with national standards of practice. The emergency medications supply should not vary from month to month or be at the whim of one or two people that replenishes the carts.

3. Review of the hospital policy, titled, "Drug Storage," revised 4/2008, contained the list of medications to be included in the acute crash carts. However, the medications that were in the crash carts did not match the content list that was established by policy and last revised in 2008:

The list in the policy indicated that the cart should contain two vials of aminophylline (used to treat asthma), but the content list for the acute crash carts had a line through aminophylline.

The list in the policy indicated that the cart should contain two vials of 5000 Units heparin (used to thin blood and prevent clots), but the content list on the acute crash cart did not have any heparin listed on it.

The list in the policy indicated that the cart should contain two vials of procainamide (used to treat irregular heart beat), but the content list on the acute crash cart had a line through procainamide.

The list in the policy indicated that the cart should contain three - 20 milliliter vials of sodium chloride (used to restore blood pressure or replenish sodium), but the content list on the acute crash cart had four different entries for sodium chloride.

Similarly the content list that was on the ER crash cart was different from the content list in the policy.

The list in the policy indicated that the cart should contain two vials of aminophylline (used to treat asthma), but the content list on the ER crash cart had a line through aminophylline.

The list in the policy indicated that the cart should contain two vials of 5000 Units heparin (used to thin blood and prevent clots), but the content list on the ER crash cart did not have any heparin listed on it.

The list in the policy indicated that the cart should contain two ampules of 150 mg of amiodarone (used to treat irregular heart beat), but the content list on the ER crash cart had 2 different types of amiodarone: 150 mg in 3 ml and the premixed 150 mg in 100 ml.

The list in the policy indicated that the cart should contain three - 20 milliliter vials of sodium chloride (used to restore blood pressure or replenish sodium), but the content list on the ER crash cart had four different entries for sodium chloride.

4. Review of the hospital's policy and procedure that included the emergency drug supply information "Drug Storage" revised on 4/08, included the following under Crash Carts (ER, Acute, OR): "Crash carts are locked. The lock is replaced with documentation anytime the cart is opened. RN will check crash carts monthly for outdates if pharmacist not available. Pharmacist will allow RN to replace any drugs used from crash carts or outdates between regular monthly checks by pharmacist."

The hospital currently did not have an OR (Operation Room), and the policy was last updated in 2008. The policy was not consistent with State regulation for having a policy for establishing the contents of the supply, the procedures for use, and restocking and sealing of the emergency drug supply. The policy did not include what was required by the regulation, such as placing the content list on the outside of the crash cart, for locking and securing the medications which included both the trays inside the crash carts and the crash carts themselves. The policy did not comply with the regulations, that a pharmacist was to seal the crash cart and to check for outdates. The policy did not have a system in place for ensuring that medications and equipment are available for use in emergency situations or delineation of responsibilities. The pharmacist cannot allow someone to practice outside of their scope or do something that is inconsistent with State Regulations.

5. California Code of Regulations Title 22, Division 5, Chapter 1 Paragraph (a) read, "There shall be a written, organized in-service education program for all patient care personnel, including temporary staff as described in subsection (m). The program shall include, but shall not be limited to, orientation and the process of competency validation as described in subsection (c).

(2) All patient care personnel, including temporary staff as described in subsection (m), shall be subject to the process of competency validation for their assigned patient care unit or units. Prior to the completion of validation of the competency standards for a patient care unit, patient care assignments shall be subject to the following restrictions:

(C) Registered nurses shall not be assigned total responsibility for patient care, including the duties and responsibilities described in subsections (a) and (h)(3), until all the standards of competency for that unit have been validated."

a. On 6/28/16 at approximately 3 pm, RN C was asked to show the Broselow bag for the pediatric emergency supplies. RN C started to talk about the Broselow system and the color coding, and mentioned the Broselow tape, but could not find it. RN D was in the ER at that time and also looked for the Broselow tape and could not find it. RN C went outside of the ER and spoke to the Central Supply Clerk who came back found the Broselow.

b. RN C pulled a book that was color coded and open to a page and demonstrated that if the patient was within this specific color zone, the atropine dose would have been 0.1 mg. So RN C was asked to prepare that dose. Atropine was used in cardiac emergencies to increase the heart rate, but its use is no longer recommended in the management of asystole or pulseless electrical activity (PEA) according to the 2010 guidelines for Advanced Cardiovascular Life Support (ACLS)

RN C tried to open the ER crash cart, and made a comment that the lock was open. She pulled the disposable (unlocked lock) and attempted to open the individual drawers one by one, but they did not open. RN C asked RN D for a key to unlock the crash cart. RN C did not know the mechanism to open the drawers of the crash carts where medication and equipment to treat patients in emergency situation. The vertical closer for the bottom compartment had to be lifted and pushed back into the cart; that was the mechanism to unlock the individual drawers of the crash cart.

Later, after opening the ER crash cart, RN C looked in the medication drawer for the atropine. RN C checked every vial in the drawer, and then started checking the premade syringes where she found the atropine. RN C looked at the concentration and restated that dose would be 0.1 mg, (as it was recommended in the book.) RN C was asked to prepare the dose. RN C was reluctant to open the paper packing, but she opened the packing and got the two compartments but she was having difficulty opening and connecting them to measure the dose.

RN C was asked to prepare the dose. She looked for small syringes and needles and withdrew the one milliliter (0.1 mg) but hesitated. She stated that she would have the doctor and other resources if that was a real life code situation (life threatening emergency). So she was told to use her resources. She pulled a book and checked the dose and the rate of infusion and then she left the room. When she came back, she announced that she checked with the Director of Nursing (DON) who told her to look for a small single dose vial and that she went to the pharmacy and looked but did not find any.

About 30 minutes passed and the dose of atropine was not prepared.

c. RN C was asked about the laryngoscope which is a device equipped with a source of light and magnification used in emergency to help open the airway for the patient. There were two of them in the Broselow bag. RN C looked at them and indicated that they were batteries and pointed to the symbol of battery and charges on the top of the handle. RN C was asked to demonstrate how to connect the blade to the handle to check for the light source. The nurse was reluctant to open any of the Broselow compartments but RN C did not open the pouch to pull the laryngoscope blade and check if the light worked.

d. RN C was asked if she had any PALS (Pediatric Advanced Life Support) training. She stated that she did not. She was also asked if she received any orientation when she first started, and she confirmed that she was not given any formal orientation or training, but a co-worker told her about the organization of the ER and the labels on the drawers and the color coding of the keys.

On 6/28/16 at 3:40 pm, the DON acknowledged that although it was only her (DON's) second day at the hospital, RN C's competence in dealing with the above simulated emergency did not meet her professional expectations.

RN C's employee file record was reviewed on 6/29/16. RN C's file indicated she was a temporary nurse under contract. RN C's record did not contain a skills assessmemt checklist, a competency assessment for emergency services or the medical unit and an orientation to those units to which she was assigned. Her file also did not contain any information regarding emergency or pediatric experience or specialized training. RN C's file did not include a PALS card.

The hospital personnel were asked for pediatric policies and did not provide any for review.

A review of the Emergency Log of patients indicated that of six of the 33, or 18 percent, of patients seen in the ED in the last thirty days (5/28-6/26/16) were pediatric patients [AGE] years old or younger.





6. The California Code of Regulations, Title 22, Division 5, Chapter 1, Paragraph (a) (a) read, "Each hospital shall adopt written personnel policies concerning qualifications, responsibilities and conditions of employment for each type of personnel, which shall be available to all personnel. Such policies shall include but not be limited to:...
(3) A plan for at least an annual evaluation of employee performance."

On 6/29/16, five employee records were reviewed. One of the five was eligible for an annual performance review, RN N. RN N's file did not contain any evidence of a performance evaluation since 1/6/14.

On 6/29/16 at 10:45 am, Admininstrative (Admin) Staff B acknowledged RN N's file did not include an annual performance evaluation.

7. California Code of Regulations, Title 8, paragraph 5199, relating to 'Aerosol transmissible diseases,' (h)(5) requires employers to make available to all susceptible healthcare workers with occupational exposure all vaccine doses listed in Appendix E. Doses listed in Appendix E include seasonal influenza vaccine, [DIAGNOSES REDACTED],[DIAGNOSES REDACTED], and [DIAGNOSES REDACTED] vaccine, varicella vaccine, and tetanus-[DIAGNOSES REDACTED]-acellular pertussis (Tdap) vaccine. Employers are required to ensure that employees who decline to accept a recommended and offered vaccination sign the declination statement in Appendix C1 for each declined vaccine. This regulation applies to hospitals, skilled nursing facilities, clinics, medical offices and other outpatient medical facilities, among others. Outpatient medical facilities whose policy is not to diagnose or treat aerosol transmissible diseases are not required to comply with this standard if they meet certain other conditions ..."

All five employee files reviewed (RN N, Director of Nursing, RN C, RN E and Laboratory Supervisor B), did not contain any evidence of the above required vaccinations or declination forms.

On 6/29/16 at 10:45 am, Admin Staff B acknowledged the files did not included the required vaccination information.

8. California Code of Regulations, Title 22, Paragraph (a)(1) read, "Initial examination for [DIAGNOSES REDACTED] shall include a tuberculin skin test using the Mantoux method using a 5 Tuberculin Unit dose of PPD tuberculin stabilized with Tween-80, the result of which is read and recorded in millimeters of induration. If the result is positive, a chest film shall be obtained. A skin test need not be done on a person with a documented positive reaction to PPD but a baseline chest X-ray shall be obtained...
(3) An annual skin test for [DIAGNOSES REDACTED] shall be performed on those individuals with a previously documented negative tuberculin skin test. If an individual with a previously documented negative skin test has a subsequent positive reaction, a chest X-ray shall be obtained."

On 6/29/16 a reveiw of Lab Superviosr B, RN D, and DON's files, did not have evidence of current TB testing in their files.

The hospital policy for "Screening for [DIAGNOSES REDACTED] form Patients and Employees", dated 7/2005, read, "All employees are to be screened at the time of hire... This screening will be repeated on an annual basis for the duration of employment."

On 6/29/16 at 10:45 am, Admin Staff B acknowledged the employee files did not include the required TB testing.
VIOLATION: AGREEMENTS - CEO RESPONSIBILITIES Tag No: C0292
Based on interview, the Chief Executive Officer (CEO) of the Critical Access Hospital (CAH) failed to oversee the quality of services provided by contract services. These failures put patients at risk for injuries or adverse outcomes resulting from the delivery of unsafe services.

Findings:

1. During an interview with Quality Assurance Coordinator (QAC) on 6/29/16 at 9:30 am, the QAC stated that there was no quality assurance program for contracted services.

2. During an interview with the Chief Executive Officer (CEO) on 6/29/16 at 11:30 am, the surveyor asked the CEO about how he provided oversight to all contracted services related to patient care. The CEO replied, "I made sure the contracts get executed." When asked, "Do you do any evaluation of the contracted services?" the CEO replied, "No."

When surveyor requested a policy on contract service evaluations from multiple staff on 6/29/16, the surveyor was informed that no such policy existed.
VIOLATION: NURSING SERVICES Tag No: C0294
Based on interview and record review, the hospital failed to ensure that pain medications were monitored for efficacy (effectiveness) and/or for side effects for two of 15 sampled patients. (Patients 1 and 7) This failure had the potential for pain to go untreated and overdose or side effects to go undetected.

Findings:
1. On 6/29/16 at approximately 4 pm, the clinical record for Patient 7 was concurrently reviewed with Registered Nurse C (RN C). Patient 7 had orders for pain medications. One of the physician orders written on 6/7/16 was for MS Contin (morphine, for pain) 30 milligrams to be given two times every day. During review of documentation relating to pain assessment, RN C stated that for routine (scheduled) pain medications, the pain assessments before and after administration of pain medications are not expected. Review of the MAR showed no documentation of pain assessment associated with administration of the twice daily morphine doses.

According to the Nursing Practice Act, Section 2725, the registered nurse provides "direct and indirect patient care services to insure patients' comfort. It also states that proper management of patient's pain is a nursing function incorporated within nurse's role as a patient advocates.
The Board of Registered Nursing endorses pain management guidelines established by the World Health organization, the U.S. Department of Health and Human Services - Agency for Health Care Policy and Research, and the American Pain Society.

The nursing function of appropriate pain management includes, but is not limited to the following:
1. Assessing pain and evaluating response to pain management interventions using a standard pain management scale based on patient self-report.
2. Intervening to treat pain before the pain becomes severe.
3. Documenting pain assessment, intervention, and evaluation activities in a clear and concise manner, and
4. Intervening to minimize drug side effects.

Evaluating response to medication serves to evaluate effectiveness of therapy to ensure that the intended effect (controlling pain, or reducing it severity) is achieved. Monitoring therapy also serves for early detection and recognition of side effects or toxic effects associated with morphine, such as sedation or decrease in respiratory rate.


Review of the hospital's policy, titled, "Pain Assessment", approved on 5/2000 and updated on 06/2009, read, "For Acute/Extended Care patients- pain assessment will be documented on the Vital Sign Flowsheet, and addressed in the Nurse's notes, if applicable." There was no specific procedure on how to and when to assess pain if a patient is receiving pain medication on as needed or regular bases. The policy was not updated to reflect the new process of using the electronic medical record.


2. On 6/29/16 at approximately 9 am, concurrent review of Patient 1's record with a hospital's medical record person (MR 1) showed that Patient 1 presented to the emergency room (ER) on 6/24/16 at 2041 (8:41 pm) for pain which was related to a bone fracture. Review of the electronic and the paper record with MR 1 showed initial pain assessment for Patient 1, at 2051 (8:51 pm). The pain was rated as severe (8 out of 10), but there was no additional documentation for assessing the pain after that time. Patient 1 left the ER at 2217 (10:17 pm,) but there was no documentation to show if the pain was managed, if the intensity of the pain was lowered, or if the pain was completely resolved. From the documentation in the record it was not clear if Patient 1 who came to the ER for pain related issues, (severe pain, at level 8) was discharged with the same severe pain (level 8) or if the pain was controlled and managed before discharge.

The Pain Assessment policy further read, "A pain assessment will be completed on all ... patients within this hospital. The pain assessment will be completed when the vital signs are taken and more frequently if needed. The pain assessment will be documented within the vital signs on the ER records."
VIOLATION: AGREEMENTS Tag No: C0197
Based on interviews, the Critical Access Hospital (CAH) failed to provide evidence of internal review of the telemedicine (the remote diagnosis and treatment of patients by means of telecommunications technology) service physicians who provided telemedicine services to its patients in the clinic site of the CAH.

This failure could potentially lead to inadequate appraisal of these telemedicine service providers and monitoring of the quality of the telemedicine services.

Findings:

During an interview with the Patient Care and Telehealth (used interchangeably with telemedicine) Coordinator (PCC) on 6/28/16 at 9 am, PCC stated that the clinic site of the CAH received telemedicine services from several providers who were granted privileges at the CAH. When asked whether the clinic kept track of adverse events associated with the telehealth services, the PCC stated that the clinic did not keep track of the outcomes of telehealth services. The PCC acknowledged that the CAH did not have any documentation of the evaluation of telehealth service.

During an interview with Physician 1, who was the Medical Director of the CAH, on 6/29/16 at 8:15 am, Physician 1 stated he read the notes from those telemedicine providers. Physician 1 acknowledged that the CAH did not have a system in place to evaluate the quality of the telemedicine services.
VIOLATION: EMERGENCY SERVICES Tag No: C0200
Based on observation, staff interview, and record review, the hospital failed to ensure that policies and procedures for emergency drug supplies and emergency services were updated to reflect hospital practice or were consistent with state regulations:

1. The emergency medication supply in the carts and the crash (emergency supply) carts were not sealed. Refer to C 152 finding 1.

2. Two of two crash carts failed to have contents accurately listed on the exterior of the cart. Refer to C 152 finding 2.

3. The hospital's drug storage policy had not been reviewed , updated, or implemented since 4/2008, over eight years ago. Refer to C 152 finding 3.

4. The hospital's drug policy was not consistent with current State regulations. Refer to C 152 finding 4.

5. The hospital failed to ensure that drugs commonly used in life saving emergencies were readily available. Refer to C 203 findings 1 and 2.

6. Emergency supplies were missing from the emergency crash cart. Refer to C 204 findings 1 and 2.

7. Nursing staff did not know where the emergency drug supply for pediatric patients was located and were not knowledgeable in handling pediatric emergencies. Refer to C 152 finding 5.

9. The hospital failed to have approved policies and appropriate storage to maintain an adequate supply of blood products needed for emergencies. Refer to C 205.

These failures had the potential to delay or prevent successful treatment for patients in emergency situations and could potentially lead to unsuccessful resuscitation and patient's death.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of services was in compliance with the statutorily mandated Condition of Emergency Services.
VIOLATION: LABORATORY SERVICES Tag No: C0282
Based on interview, the laboratory (lab) failed to have written policies and procedures for the collection, preservation, transportation, receipt, and reporting of tissue specimen results The lab conducted at least 30 different tests. This failure had the potential for errors to occur and result in inaccurate test results which could lead to a decline in patient's health status.

Findings:

On 6/27/16 at 2:20 pm, during the initial tour, Laboratory Supervisor (LS) A stated the hospital had just had a CLIA (Clinical Laboratory Improvements Amendment, the Federal regulatory standards which clinical laboratories must operate) and the hospital was currently working on its plan of correction for this survey. LS A stated the hospital did not have laboratory polices available and the hospital was in the process of establishing policies consistent with the current laboratory standard of practice.

On 6/29/16 at 9 am, LS A stated there were at least 30 different tests that the lab performed and confirmed that the hospital's previous policy book was no longer available, requiring it to be re-created.
VIOLATION: ORGANIZATIONAL STRUCTURE Tag No: C0240
Based on interview and record review, the facility failed to have a governing body that assumed full legal responsibility for determining, implementing, and monitoring policies governing the hospitals total operation and for ensuring that those policies were administered so as to provide quality health care in a safe environment as evidenced by:

1. Failure to periodically appraise its medical staff and grant appropriate privileges for its health care providers for six of seven providers. Refer to C 197 and C 241 findings 1a-2.

2. Failure to ensure policies were developed, reviewed, and current with State/Federal regulations and current standards of practice. Refer to C 152 findings 1-5, C 200 findings 3, 4 and 9, C 205, C 222 findings 1, 2, and 5, C 276 findings 1, 3, and 6, C 279 findings 1-3, C 282, C 292, C 334, and C 349.

3. Failure to ensure that adequate drugs, supplies, and competent staff for the provision of emergency services to inpatient and outpatients. Refer to C 152 findings 1-5d, C 200, C 203 findings 1-2, C 204 findings 1-2, and C 205.

4. Failure to provide pharmaceutical services in a safe and effective manner, and consistent with State and Federal regulations. Refer to findings C 152 findings 1-5, C 200, C 203 findings 1-2, C 276 findings 1-10, C 277, C 297 findings 1-2, and C 337 findings 1-6.

5. Failure to provide nursing services in a safe and effective manner, and consistent with State and Federal regulations. Refer to C 294 findings 1 and 2, and C 297 findings 1-2c.

6. Failure to ensure the contract services were provided in a safe and effective manner. Refer to C 291 and C 292.

7. Failure to have an effective infection control program. Refer to C 152 findings 7 and 8, C 278, C 279 and C 338.

8. Failure to ensure the basic services, such as radiology, were available at all times. Refer to C 283.

9. Failure to conduct a credible annual evaluation to review the quality of care and services. Refer to C 330, C 333, C 334, C 337 findings 1-6, C 338, and C 340.

10. Failure to have a Quality Improvement Organization (QIO) or equivalent entity review the health care quality provided by the doctors of medicine or osteopathy at the CAH. Refer to C 340.

11. Failure to work together with the designated Organ Procurement Organization (OPO) in educating and training staff on organ donation issues. Refer to C 349.

12. Failure to ensure that patients and staff were safe and knowledgeable to respond to a fire. Refer to C 227 findings 1-2.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of services was in compliance with the statutorily mandated Condition of Organizational Structure.
VIOLATION: GOVERNING BODY Tag No: C0241
Based on interview and document review, the Critical Access Hospital (CAH) failed to ensure its governing body periodically appraised its medical staff and granted appropriate privileges for its health care providers in six of seven provider files reviewed (Physician 1, 3, 4, 5, 6, and Family Nurse Practitioner (FNP)).

This failure put patients at risk for receiving health care services from unqualified providers.

Findings:

1. During a concurrent interview and document review with Medical Staff Coordinator (MSC) on 6/28/16 at approximately 12 pm, the credentialing files of the CAH's medical staff were reviewed, and the following was confirmed with the MSC:

a. FNP was initially appointed on 9/19/14. On the form titled "Application for and delineation of clinical privilege", various privileges were checked under clinic, while the column under "privileges granted" was left blank in all the pages. The form was signed and dated by the Medical Executive Committee (MEC) and Governing Board (GB) on 9/29/14. The MSC acknowledged that the granted privileges should have been checked.

b. Physician 1, also the CAH's Medical Director (MD), was last reappointed on 7/2015. However, in Physician 1's credentialing files, the most recent form of "Application for and Delineation of Clinical Privileges" was dated 4/7/09. On this form, various privileges were requested, yet the column of "privileges granted" was left blank on all the pages. The form was signed and dated by the MEC on 4/7/09.

c. Physician 3 was initially appointed in 2000, and last reappointed in 3/2015. In Physician 3's credentialing files, the most recent "Podiatrist privilege request form" was approved on 1/17/07. When asked why there was not an updated privilege request form during the last reappointment process, the MSC replied, "Nothing [the privilege] has changed. I didn't know I need to re-do [privileges] during reappointment."

d. Physician 6 was initially appointed in 9/14, yet there was no privilege granting form in Physician 6's credentialing files. MSC acknowledged that the form should have been there.

e. In Physician 3, 5, and 6's credentialing files, no evidence of peer review was located. MSC stated that she had been asking the medical staff to perform timely peer reviews for some time.

f. In FNP and Physician 4, 5, and 6's credentialing files, no National Provider Data Bank reports were located. MSC concurred that these reports should have been available during the appointment and reappointment process.

2. During a concurrent interview and document review with the Medical Director (MD), on 6/29/16 at 8:15 am, the copies of the credentialing files for FNP, Physician 1, 3, 5 and 6 were reviewed. MD confirmed that FNP provided health care at the clinic and the skilled nursing facility (SNF) sites of the CAH. MD acknowledged that on the form titled "Application for and delineation of clinical privilege", it did not have any granted privileges for FNP checked, nor did it have any privileges of the FNP at the SNF checked.

MD also acknowledged that there were no update of the privilege granting for Physicians 1 and 3.

MD agreed that the privilege granting form should have been in Physician 6's credentialing files.

When MD asked why there were no peer reviews from medical staff for Physician 3, 5, and 6, MD stated that he had been reading the notes from those providers, but the CAH did not have formal evaluation of these physicians.

Review of the CAH's Medical Staff By-Laws Policy and Procedure Manual last approved on 7/16/14, indicated under "Article IV, 4.01-4 Processing the Application", that "The application will not be deemed complete until all necessary information has been provided and verifications have been obtained, including ... National Practitioner Data Bank information ... a final recommendation shall be formulated, and the Medical Executive Committee shall forward to the Governing Body through the Chief Executive officer, a written report and recommendations as to Staff appointment, Clinical Privileges to be granted ..."

Review of this manual also indicated under "4.03 Reappointment Process" that "The reappointment form shall be a prescribed from and shall seek at least the following: ... a renewed request for Clinical Privileges. This form shall be developed by the Medical Executive Committee and be approved by the Governing Body ...Continued membership and exercise of Clinical Privileges shall require at least the following ...Satisfactory results in Medical Staff quality improvement reviews ..."

Review of this manual also indicated under "5.08 Credentialing of Allied Health Professionals" that "The applicant and the sponsoring physician will obtain and complete an application form that has been developed by the Medical Executive Committee and approved by the Governing Body. The Medical Executive Committee shall make a recommendation to the Governing Body ... Allied Health Professionals may exercise only those Privileges specifically granted them by the Governing Body."

Review of the CAH's Governing Body Bylaws last revised 7/2015, indicated under "Article VIII. Medical Staff", that "Final action on all matters relating to Medical Staff quality assurance membership status, clinical privileges and corrective action shall be taken by the Board after considering Medical Staff in granting and defining the scope of clinical capabilities."
VIOLATION: DRUGS AND BIOLOGICALS Tag No: C0203
Based on observation, interview and record review, the hospital failed to ensure that drugs commonly used in life saving emergencies were readily available, as follows:

1. Nitroglycerin drip which is used to treat chest pain resulting from decreased blood supply to the heart (heart attack) was not available in the emergency room (ER) crash (emergency) cart.

2. Obstetrical (OB, managing preganancy) and Pediatric (children)/Neonatal (infants) trays were not available in the ER crash cart.

Findings:

1. On 6/28/16 at approximately 11 am, the nitroglycerin drip was not observed in the ER crash cart. Registered Nurse (RN) D explained that the nitroglycerin drip was removed because it was expired and it would be replaced "after lunch

On 6/28/16 at approximately 12 noon, the nitroglycerin drip was not observed in the Acute Crash Cart.

On 6/28/16 at 2:30 pm, the crash carts were checked with the Director of Nursing (DON) and the Central Supply Clerk, and it was confirmed no drips were available on the carts. Refer to C 152 finding 2.

2. On 6/28/16 at approximately 11 am, the ER Crash Cart Drug Inventory included three different sections: Crash Cart Drug Drawer, Crash Cart IV Med Drawer Tray, and Crash Cart Bottom Shelf. The bottom shelf table on the form included two items: Emergency OB (Obstetrics, management of pregnancy and childbirth) Tray and Pediatric/ Neonatal (child/newborn) Emergency Drug Tray.

The OB and the Pediatric/ Neonatal Emergency Drug trays were not present during inspection. The Central Supply Supervisor said during a concurrent interview and inspection that the OB tray was in the autoclave being sterilized. And there were no comments on where the Pediatric/ Neonatal Emergency Drug Tray could be found.

On 6/28/16 at 2:30 pm, the crash carts were checked with the DON and she acknowledged the above finding.
VIOLATION: EQUIPMENT AND SUPPLIES Tag No: C0204
Based on observation, interview and record review, the hospital failed to ensure that two of two emergency carts (also known as crash carts) drug trays were stocked with equipment necessary in performing life-saving procedures as follows:

1. The Acute Crash Cart did not contain a pediatric (child) carbon dioxide (CO2) detector. CO2 detectors measure gas concentration to help evaluate if the patient is getting enough oxygen.

2. The emergency room (ER) Crash Cart Obstetric (OB, management of pregnancy) and the Pediatric/ Neonatal (infant) Emergency Drug trays were not available during the inspection.

These failures leave patients with emergency conditions at risk of not being treated appropriately and can result in a further decline in condition, including death.

Findings:

1. On 6/28/16 at approximately 12 noon, during inspection of the Acute Crash Cart, the pediatric (child) carbon dioxide (CO2) detector was not in the crash cart.

In a concurrent interview, with Registered Nurse (RN) D and Central Supply Supervisor, they acknowledged the above findings.

2. On 6/28/16 at approximately 11 am, the ER Crash Cart was inspected. The ER Crash Cart Drug Inventory included three different sections: Crash Cart Drug Drawer, Crash Cart IV (intravenous, directly in the vein) Med Drawer Tray, and Crash Cart Bottom Shelf. The bottom shelf table included two items: Emergency OB Tray (OB is short for obstetric care: relating to pregnancy and childbirth) and Pediatric/ Neonatal Emergency Drug Tray (children and newborn).

The OB and the Pediatric/ Neonatal Emergency Drug trays were not present during inspection. In a concurrent interview, the Central Supply Supervisor said during inspection that the OB tray was in the autoclave being sterilized. No comments were made on where the Pediatric/ Neonatal Emergency Drug Tray could be found.
VIOLATION: BLOOD AND BLOOD PRODUCTS Tag No: C0205
Based on observation and interview, the hospital failed to provide the policies and appropriate storage to maintain an adequate supply of blood products needed for emergencies. This failure had the potential for patients to receive blood that had deteriorated or was provided in a manner that was inconsistent with nationally accepted standards, thus placing patients at risk for further decline in health status.

Findings:

On 6/27/16 at 2:20 pm, during the initial tour, Laboratory Supervisor (LS) A stated the hospital had just had a CLIA survey (Clinical Laboratory Improvements Amendment, the federal regulatory standards which clinical laboratories must operate) and the hospital was currently working on its plan of correction for this survey. LS A stated the hospital did not have laboratory polices available and the hospital was in the process of establishing policies consistent with the current laboratory standard of practice.

LS A demonstrated that four units of blood were stored in a freezer in the lab. The June 2016 monitoring form for the blood storage refrigerator temperature was reviewed and had blank spots for the weekends. LS A stated a new refrigerator for blood products was ordered and would be arriving soon. This new refrigerator had continuous monitoring of temperature to ensure that the blood products did not deteriorate. LS A had a policy for the new refrigerator but did not have a policy or a process to ensure that the four units of blood currently stored remained viable (safe) for use.
VIOLATION: MAINTENANCE Tag No: C0222
Based on observation and interview, the hospital failed to ensure that patient care equipment and supplies were maintained in a safe operating condition.

1. The Clinic pulmonary (lung) function testing (PFT) machine did not have an annual preventative maintenance inspection.

2. The Emergency Department (ED) blanket warmer was dusty, had a broken thermometer inside, and did not have any monitoring recorded for the temperature.

3. Expired supplies and unsecured sharps (such as needles, lancets and scapels) were available in the Clinic and in the hospital Central Supply (CS) Department.

4. Housekeeping chemicals and patient care supplies were stored under the sinks in the clinic.

5. Neutral, a disinfectant cleaner, was transferred from large containers to small containers, without labeling the containers with the product and the date of transfer.

6. The scales for weighing infants and adult patients had no current evidence of being calibrated (adjusted for accuracy to a weight standard).

7. Electrical outlets were not covered in the two rooms used to see children in the clinic.

These failures had the potential for equipment malfunction, testing inaccuracies, spread of infection, ingestion of dangerous chemicals, and injuries that could lead to patient, staff, and visitor harm.

Findings:

1. On 6/29/16 at 9 am, during a tour of the hospital clinic, the PFT machine was observed to not have a preventative maintenance sticker attached.

In a concurrent interview, the Clinic Manager, RN G, confirmed that the PFT machine did not have a sticker and that it should have had testing prior to being placed in service and annually thereafter.

A policy for the preventative maintenance program was requested but was not provided by the end of survey.

2. On 6/27/16 at 3:10 pm, the blanket warmer used for ED patients was observed to have a significant amount of dust on the shelves and contained a thermometer that was broken.

In a concurrent interview, CS Supervisor, acknowledged the dust and the broken thermometer and stated that there were no records to measure the temperature for the blanket warmer.

ECRI Institute's (a nonprofit organization which uses applied scientific research to discover which medical procedures, devices, drugs, and processes are best) 4/1/14 recommendations for maximum blanket temperatures is 130 degrees Fahrenheit to prevent burns.

A policy for the the blanket warmer and monitoring of temperatures was requested but was not provided by the end of survey.

3. On 6/29/16 at 9:30 am, a large box of outdated medical supplies was present in the room used for sterilizing medical equipment. Outdated sterile supplies were also present in another box.

In a concurrent interview, RN G stated they had gathered all the outdated supplies the night before in anticipation of the tour the next day but had not disposed of them. RN G stated there was no routine oversight of expired supplies.

4. On 6/29/16 at 9 am, the clinic rooms were toured with RN G. Five of five sinks had housekeeping chemicals and patient care items (linen and gloves), stored under the sinks.

In a concurrent interview, RN G acknowledged the above findings.

The National Institute of Health, in conjunction with the Joint Commission, and the Occupational Safety and Health Administration, recommended chemicals that can interact with each other or can react with exposure to moisture, and patient care items should not be stored under sinks due to the risk of undetected leaks.

5. On 6/29/16 at 9:55 am, the clinic room used for sterilizing medical instruments was observed to have a small bottle of fluid that had an unreadable label.

In a concurrent interview, Certified Nurse Aide (CNA) K stated the bottle contained Neutral, a disinfectant cleaner. CNA K acknowledged the label was unreadable and did not include a date for when it was filled.

A policy for the handling of hazardous substances was requested but was not provided by the end of survey.

6. During the clinic tour, an infant scale and an adult scale were observed to not have preventative maintenance or any recent calibration of the scales.

On 6/29/16 at 12 pm, RN G confirmed that the clinic did not have evidence of the above scales being calibrated.

7. During the clinic tour at 9:40 am, electrical outlets in the clinic rooms used to see pediatric (child) patients were observed to not be plugged or outfitted with tamper resistant electrical outlets.

In a concurrent interview, RN G acknowledged they have plugs available but staff forget to replace them.
VIOLATION: RADIOLOGY SERVICES Tag No: C0283
Based on interview and record review, the hospital failed to ensure that radiology (x-rays) services were available at all times to meet the needs of one of five sampled patients requiring emergency services. (Patient 9) This failure had the potential for delays in care that could result in life threatening decline in health status.

Findings:

On 6/29/16, Patient 9's record was reviewed. Patient 9 was seen in the emergency department on 6/4/16 with pelvic pain following a fall several days prior. Patient 9's record indicated he had to be transported to another hospital for an x-ray series.

On 6/29/16 at 4:25 pm, Patient 9's physician, Physician B, reported the hospital did not have a radiology technician available on 6/4/16 to an unexpected staff shortage so he had to transfer Patient 9 to another hospital for x-rays.
VIOLATION: QUALITY ASSURANCE Tag No: C0340
Based on interview and document review, the Critical Access Hospital (CAH) failed to have a Quality Improvement Organization (QIO) or equivalent entity review the health care quality provided by the doctors of medicine or osteopathy at the CAH.

This failure had the potential to not adequately evaluate the health care services by the physicians at the CAH, thus missing the opportunities to monitor and improve the health care provided by physicians.

Findings:

During an interview on 6/29/16 at 8:30 am, the Medical Director (MD) was asked whether the doctors of medicine or osteopathy at the CAH, were evaluated by a QIO or equivalent entity, regarding the diagnosis and treatment they provided, the MD replied that there was no such mechanism in the CAH.
VIOLATION: PROVISION OF SERVICES Tag No: C0270
Based on observation, interview, and record review, the hospital failed to ensure that the provision of services was done in a safe manner, as evidenced by:

1. The hospital failed to have a system for the accurate accounting of scheduled drugs, such as narcotics. Refer to C 276 finding 1.

2. Expired medications were available for use in both the hospital drug room and the clinic. Refer to C 276 finding 3 and 7.

3. Medications were not secured in the hospital Emergency Department (ED) and the clinic. Refer to finding C 152 finding 1, and C 276 finding 2.

4. The hospital did not have accurate records for the dispensing of medications for ED patients. Refer to C 276 finding 2.

5. The hospital failed to have an effective process for evaluating adverse drug reactions and medication errors. Refer to C 277.

6. The hospital failed to have a process for recalled medications. Refer to C 276 finding 6.

7. Emergency drug supply policies were not current with applicable State regulations. Refer to C 152 finding 1-3, and C 271.

8. Medication refrigerators and the drug room were not consistently monitored for temperature to ensure the stability of the stored medications. Refer to C 276 finding 10.

9. The hospital failed to have an organized infection control system. Refer to C 278 and C 152 findings 7 and 8.

10. Dietary staff failed to ensure food and kitchen supplies were handled in a sanitary manner. Refer to C 279 findings 1-3.

11. The hospital failed to ensure the Laboratory (Lab) had policies for the testing provided. Refer to C 282.

12. The hospital's list of contracted services did not included the scope and nature of the services. Refer to C 291.

13. The contract services were not evaluated to ensure compliance with all conditions of participation and standards of care. Refer to C 292.

14. Two of fifteen sampled patients' (Patients 1 and 7) pain level was not assessed following pain medication administration. Refer to 294 findings 1 and 2.

15. A physician signature was not obtained timely for two of 11 patients with verbal orders (Patients 4 and 7). Refer to C 297 findings 1-2.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of services was in compliance with the statutorily mandated Condition of Provision of Services.
VIOLATION: PATIENT CARE POLICIES Tag No: C0271
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, the hospital failed to ensure the policy for securing the emergency drug supply was current with applicable State regulations. These failures create the opportunity for drug diversion and lack of availability of needed drugs in an emergency.

Findings:

The hospital's policy and procedure that included the emergency drug supply information "Drug Storage" revised on 4/2008, was reviewed. The policy included the following under Crash Carts (ER (emergency room ), Acute, OR(Operating Room)):

"Crash carts are locked. The lock is replaced with documentation anytime the cart is opened.
RN will check crash carts monthly for outdates if pharmacist not available. Pharmacist will allow RN to replace any drugs used from crash carts or outdates between regular monthly checks by pharmacist."

Based on observation of the hospital on [DATE] and 6/29/16, and interview with hospital staff, the hospital did not have an OR (Operation Room). The policy was last updated in 2008, and it did not reflect the services the hospital provided.

The policy was not consistent with State regulation for having a policy for establishing the contents of the emergency drug supply, the procedures for its use, or restocking and sealing of the emergency drug supply in accordance with State requirements. The policy did not address other components required by State regulations such as placing the content list on the outside of the crash cart, locking and securing the medications trays inside the crash carts, and locking and securing the crash carts themselves for the supplies within. The policy did not comply with State regulations, that a pharmacist was to seal the crash cart and to check for outdates. The policy did not have a system in place for ensuring that medications and equipment were available for use in emergency situations by having the pharmacist checking the supply every 30 days. The policy included a comment that the "pharmacist will allow" RNs to replace drugs in the crash cart. The State regulation specifically stated that the pharmacist was to seal and inspect; the pharmacist cannot allow nurses to practice outside of their scope of practice or do something that is inconsistent with State regulations.

According to California Code of Regulation, Title 22, chapter 1, Paragraph (f), "Supplies of drugs for use in medical emergencies only shall be immediately available at each nursing unit or service area as required.
(1) Written policies and procedures establishing the contents of the supply procedures for use, restocking and sealing of the emergency drug supply shall be developed.

(2) The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within.

(3) The supply shall be inspected by a pharmacist at periodic intervals specified in written policies. Such inspections shall occur no less frequently than every 30 days. Records of such inspections shall be kept for at least three years."
VIOLATION: POLICIES - DRUG MANAGEMENT Tag No: C0276
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, staff interview, and record review, the hospital failed to ensure the following:

1. The presence of a system for accurately accounting for controlled substances.

2. Dispensing medications from the Emergency Department to patients was in accordance with the hospital policy to ensure tracking of medications and accurate documentation.

3. Outdated, mislabeled and unusable drugs were not available for use.

4. Medication orders were written in a clear manner, consistent with applicable regulations.

5. Pain medications were monitored for efficacy and or for side effects.

6. Recalled mediation notices were evaluated to ensure that recalled medications were sequestered (removed) and were not available for patient use.

7. Medications had not expired in the clinic.

8. Scheduled drugs (drugs with no current accepted medical use and with a high risk of abuse), controlled substances, specifically narcotics (for pain) were accounted in a manner to be able to track discrepancies in the clinic.

9. Medications were secured in the clinic.

10. Medications were consistently monitored to be stored under appropriate temperature.

Findings:

1a. On 6/29/16 at approximately 4 pm, the clinical record for Patient 7 was concurrently reviewed with Registered Nurse C (RN C). Patient 7 had orders to receive pain medications. One of the physician orders written on 6/7/16 was for MS Contin (morphine, for pain) 30 milligrams (mgs) to be given two times every day.

Review of the controlled drug record (CDR) sheets with RN C, showed that the medication was removed two times every day for administration at 0600 and 1800. The medication admiration record (MAR) showed that the medication was not administered on the following days: 6/20, 6/21, 6/22, and 6/23/16, even though the CDR indicted removal of eight tablets from the supplies. Additionally, on 6/17 and 6/18/16, the MAR showed that only the morning dose was documented as being administered. There was no documentation explaining what happened to the afternoon doses if they were administered, lost, or refused. RN C confirmed the finding, but did not find any documented evidence to explain what happened to these tablets.

From 6/7 to 6/23/16, 10 out of 32 morphine 30 mgs tablets were not accounted for. It meant that about 31% (percent), that is almost one of every three morphine tablets removed was not administered to the patient according to the record. That could also mean that patient's pain was not addressed about one third of the time. It was impossible to account for these doses in the absence of documentation.

1b. On 6/28/16 at 9:20 am, the controlled substances were evaluated for accountability with Registered Nurse (RN C). In a locked cabinet in the drug room (pharmacy), where the controlled medications were stored, there were three sealed 100 tablet bottles of Norco. Norco is a brand name for prescription drug, a pain medication that contains a combination of acetaminophen /hydrocodone. This combination contained five milligrams (mg) of hydrocodone and 325 mgs of acetaminophen (known as Tylenol). With these three bottles of Norco, there were only two sheets, not three. The information on the two sheets was duplicative and indicating accountability for only 50 tables. There were no records for the remaining 250 Norco tablets.

1c. On 6/28/16 at 9:20 am, the controlled substances were evaluated for accountability with a RN C. In a locked cabinet in the drug room (pharmacy), where the expired controlled substance medications were stored, two bottles of Norco 5/500 (5 mg of hydrocodone and 500 mg of acetaminophen) were observed; one 100 tablet bottle was sealed, and the other had 8 whole tables and 4 partials tablets. There were 3 different accountability sheets with this medication. One sheet indicted that there should be 5 tablets; the second sheet had no medication signed out, but indicated that there should be 30 tablets. The third sheet had three different entities dating back to 6-2-2014. Two entries showed that two 30 tablets were dispensed to "acute", but there was no lot number or expiration date to identify the product. There was no documenting of what should be left according to that sheet. The accountability records did not match what was in the cabinet for Norco 5/500.

1d. On 6/28/16 at 9:20 am, the controlled substances were evaluated for accountability with RN C. In a locked cabinet in the pharmacy, where the expired controlled substance medications were stored, there was a bottle that contained 40 tablets of alprazolam 1 mg each. Alprazolam is an anti-anxiety medication also known as Xanax. There was no count sheet to match this bottle, so it could not be determined if 40 tablets was the actual number that should have been there. So in the absence of documentation, it was not clear if only one bottle or multiple bottles were supposed to there.


1e. On 6/28/16 at 9:20 am, the controlled substances were evaluated for accountability with RN C. In a locked cabinet in the pharmacy, where the expired controlled substance medications were stored, there was a count sheet for diazepam 5 mg tablets which had 30 tablets on the sheet, indicating that the 30 tablets were expired 05/2015. Diazepam is an anti-anxiety medication also known as Valium; however, there were no diazepam bottles or tables in the cabinet.

The lack of accountably and the above discrepancy was confirmed with RN C who had access to the pharmacy. RN C stated that another hospital registered nurse (RN D) managed the pharmacy and the controlled substances in the absence of the pharmacist.

During interview with RN D at approximately 11 am, on 6/28/16, RN D confirmed that she handled, ordered, and repackaged controlled substances in the absence of the pharmacist. RN D when asked about the discrepancy, stated that another licensed nurse was trying to manage the pharmacy, but that nurse did not know what s/he was doing and things were "messed up", and that the hospital was trying to put things back in order.

On 6/29/16 at 10 am, during a telephone interview with the hospital contracted Pharmacist (Pharm) in the presence of the hospital director of nursing (DON), Pharm stated that controlled substances were all accounted for and that there were no concerns about missing, abuse, or diversion of controlled substance. Pharm did not say anything indicating there was a problem with controlled substance. Pharm confirmed that there were no problems, misuse, abuse or any issues related to controlled substance accountability.

Review of the hospital's policy, titled, Controlled Drug Record, revised on 8/25/10, showed no specific comments or procedures related to maintenance and accountability of the expired controlled substances such as counting or storing. The hospital's policy titled, "To establish that the narcotic count be completed as described below", revised on 4/2008, and the policy titled, "Pyxis Station", revised on 4/2008, were both reviewed. None of the policies had clear procedures for accountability of expired controlled substances.

2. On 6/28/16 at approximately 10 am, accompanied with RN C, the medication room in the acute nursing station was inspected and the system for accountability of controlled substance was evaluated. A sample of the accountability sheet for Norco 5/325 (5 mg of hydrocodone and 325 mg of acetaminophen) was evaluated. The sheet had 10 tablets signed out on the same day (6/24/16) at the same time (2130/ 9:30 pm) for Patient 1, but there was no RN signature for them. RN C was asked about the multiple entries; she said that she thought that these tablets were given to a patient in the emergency room (ER) to take home.

On 6/29/16 at approximately 9 am, a concurrent review of Patient 1's record with a hospital's medical record person (MR 1) showed no clear documentation that this mediation was given to Patient 1. The record showed that Patient 1 was in the ER on 6/24/16. The ER intake form had Norco written twice in the order section: "Norco 10/325 1 to go (was 5/325)," the second entry separated by other orders, was "Norco 5/325 #10."

Additional review of the electronic record showed an unclear comment related to Norco, written by Physician 2: "Norco here some to go and Rx." Rx means a prescription. The Emergency Department After Care Instructions had the following comment related to Norco: "Norco when needed every 4 hs." Hs is short for hours.

There were no additional notes or documentation specifying what medication and how many tablets were given to Patient 1 to go home with.
Review of the hospital's policy and procedure, titled, "Dispensing Medication from emergency room ", approved on 11/1999 and last revised on 12/2005, showed instruction to complete the logbook. There were eight items that were supposed to be logged in the logbook:
a. Date/time
b. Drug name
c. Strength
d. Amount dispensed
e. Lot #
f. NDC (an identification number) #
g. Patient name
h. Nurse initial

The emergency room log form was attached to the policy.

On 6/29/16, at approximately 1 pm, the ER log book was reviewed with RN C who stated that the log referenced in the policy was not used. RN C said that they used the narcotic record sheet (accountability) instead. The accountability sheet did not match the logbook sheets: it did not address all the elements required by policy or State laws or regulations.
There are specific requirements for dispensing dangerous drug or controlled substance to emergency room patients according to the California Business and Professions Code 4000, Chapter 9, Division 2, section 4068 as follow:
"...a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply:
...
(3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens.
(4) The hospital pharmacy retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section of the Health and Safety Code ..."

3. On 6/28/16 at approximately 8 am, inspection of the Drug Room accompanied with administration staff (Admin Staff B) the following expired medications were found.

Eight vials of injectable calcium gluconate were expired on ,d+[DATE]. Calcium gluconate is used for treating multiple conditions related to low blood calcium including irregular heart beat and black widow spider bites.
Fifty capsules of Doxycycline, 50 milligrams (mg) were expired on ,d+[DATE]. Doxycycline is an antibiotic medication that is used to treat infection.
Fifty tablets of Diflucan, 100 mg were expired on ,d+[DATE]. Diflucan is a medication used to treat fungal infections.
Twenty four suppositories of hydrocortisone 25 mg were in the medication refrigerator in the Drug Room. They were expired as of 7/2015. Hydrocortisone is an anti- inflammatory medication.
Ten acetaminophen (Tylenol) 325 mg suppositories were expired on ,d+[DATE]. Acetaminophen is a medication used to treat pain and reduce fever.
Six bottles, 100 tablets each of Zinc sulfate 220 mg tablets were expired on ,d+[DATE]. Zinc sulfate is a supplement used to improve wound healing.
One bottle containing 130 tablets of Vitamin B-12, 1000 microgram tablets, expired on ,d+[DATE].

The above expired medications were confirmed with Admin Staff B and a Registered Nurse (RN C).

On 6/28/16 at approximately 10 am, inspection of the medication room was completed with RN C. In the medication refrigerator were several medications that were kept beyond the recommended time for use.

There was a bottle of Lantus, a type of insulin used to control blood sugar, that had an open date of 5/15/16. According to the manufacturer's recommendations for storage and use of Lantus, "...Once punctured (in use), store vials refrigerated or at room temperature < (less than) 30C (<86F) and use within 28 days." RN C stated that according to the policy for medication storage, they can keep Lantus for 28 days. The expiration date for the vial of Lantus was supposed to be 6/11/16. The vial was available for use for a total of 44 days from opening, which was 18 days beyond the expiration date.

There were another bottle of Lantus that was dispensed on 4/29/16. The bottle had puncture marks in the stopper and about half of the insulin was used up. There was no open date on the bottle. RN C stated she did not know when the bottle was opened. Consequently, she could not be certain that that bottle was within the allowed time for use, 28 days, according to the hospital policy and the manufacturer's specification.

Also in the refrigerator, there was a vial of Tubersol, which is a skin test used in diagnosis of tuberculosis. According to the manufacturer's instructions, the opened product should be discarded after 30 days: "Opened vials should be discarded after 30 days." The vial did not have an open date on it; therefore, it was impossible to know if it was usable or expired (beyond the 30 days).

The hospital's policy, titled, "Drug Storage", revised on 4/2008 had no specific instructions or procedures for removing expired medications and ensuring that they are not available for use. There were no procedures for handling multi dose vials such as where and how to store them and for how long.

4. On 6/28/16 at approximately 10 am, accompanied with RN C, the medication room in the acute nursing station was inspected, and the system for accountability of controlled substance was evaluated. A sample of the accountability sheets for Norco 5/325 (5 mg of hydrocodone and 325 mg of acetaminophen) was evaluated. The sheet had 10 tablets signed out on the same day (6/24/16) at the same time (2130/ 9:30 pm) for Patient 1.

Concurrent review of Patient 1's record with medical record person (MR 1) showed that Patient 1 was in the Emergency Department (ED) on 6/24/16. The ED intake form had Norco (pain medication) written in the order section: "Norco 10/325 1 to go (was 5/325)." Additional review of the electronic record showed an unclear comment related to Norco, written by Physician 2: "Norco here some to go and Rx." Rx means a prescription. The Emergency Department After Care Instructions had the following comment related to Norco: "Norco when needed every 4 hs." Hs is short for hours.

The way the order was written, it was not clear if the order was for a 10/325 tablets or 5/325 tablets of Norco.There was no documented evidence that it was clarified. There were no instructions on how often to use the medication. There was no specific dose to be taken.

Review of the hospital's policy, titled, "Physician's Orders", written on 9/2006 and reviewed on 6/2007 read:

"Medication Orders; Must be specific as to the drug, dosage, route and frequency of administrations. Inclusion of the indication (reason) is required. (Orders are not to be implemented until complete.)"

Another policy titled, "Medication Orders" was presented by hospital staff. This policy was dated 8/20/10 and read, ".... The order shall include the name of the drug, the dosage, the frequency of administration, the route of administration if other than oral, and the date, time and signature of the prescriber ..." The language in the policy exactly duplicated the language of the State regulation in Title 22, chapter 1, section (g).

5. a. On 6/29/16 at approximately 4 pm, the record for Patient 7 was concurrently reviewed with Registered Nurse C (RN C). Patient 7 had orders for pain medications. One of the physician orders written on 6/7/16 was for MS Contin (morphine) 30 milligrams to be given two times every day. And before this order, Patient 7 was receiving morphine 30 mg every 8 hours. On 6/29/16 at approximately 4 pm, during review of documentation relating to pain assessment, RN C stated on interview that for routine (scheduled) pain medications, the pain assessments before and after administration of pain medications are not expected. Review of the MAR showed no documentation of pain assessment associated with administration of the twice daily morphine doses.

According to the Nursing Practice Act, Section 2725, the registered nurse provides"direct and indirect patient care services to insure patients' comfort. It also states that proper management of patient's pain is a nursing function incorporated within nurse's role as a patient advocates.

The Board of Registered Nursing endorses pain management guidelines established by the World Health organization, the U.S. Department of Health and Human Services - Agency for Health Care Policy and Research, and the American Pain Society.
The nursing function of appropriate pain management includes, but is not limited to the following: 1. Assessing pain and evaluating response to pain management interventions using a standard pain management scale based on patient self-report. 2. Intervening to treat pain before the pain becomes severe. 3. Documenting pain assessment, intervention, and evaluation activities in a clear and concise manner, and 4. Intervening to minimize drug side effects.

Evaluating response to medication serves to evaluate effectiveness of therapy; to ensure that the intended effect, (controlling pain, or reducing it severity) is achieved. Monitoring therapy also serves for early detection and recognition of side effects or toxic effects associated with morphine, such as sedation or decrease in respiratory rate.

Review of the hospital's policy, titled, "Pain Assessment", dated 06/2009, read, "For Acute/Extended Care patients- pain assessment will be documented on the Vital Sign Flowsheet, and addressed in the Nurse's notes, if applicable." There was no specific procedure for how and when to assess pain if patient is receiving pain medication on an as needed or regular basis. The policy was not updated to reflect the new process of using the electronic medical record.

5b. On 6/29/16 at approximately 9 am, concurrent review of Patient 1's record with a hospital's medical record person (MR 1) showed that Patient 1 was in the Emergency Department (ED) on 6/24/16 for a pain issue. Patient 1 was an adult who came to the emergency room at 2041 (8:41 pm) for pain which was related to a bone fracture. Review of the electronic and the paper record with MR 1 showed initial pain assessment for Patient 1, at 2051 (8:51 pm). The pain was rated as severe (8 out of 10) but there was no additional documentation for assessing the pain after that time. Patient 1 left the ED at 2217 (10:17 pm) and there was no documentation that the pain was assessed before the patient was discharged .

Review of the hospital's policy titled, "Pain Assessment", approved on 5/2000 and updated on 06/2009, read, "A pain assessment will be completed on all ... patients within this hospital. The pain assessment will be completed when the vital signs are taken and more frequently if needed. The pain assessment will be documented within the vital signs on the ER records."

6. On 6/29/16 at 10 am, in the presence of the Director of Nursing (DON), the hospital contracted pharmacist (Pharm) was interviewed by phone. Pharm was asked about recalled medications and the hospital process for removing them so that they are not available for patient use. Pharm stated that RN D logged the recalls in the pharmacy binder and that he checks them when he comes to the hospital.

On 6/29/16, at approximately 11 am, the recall log was reviewed with the DON. The most recent filed recalled notice in the binder was from December 30, 2015; it was the email notice for recalling allopurinol tables. Allopurinol is a medication used for gout (joint inflammation), kidney stones, and other stones. In the binder, there were older recall notices, but these notices did not have any comments to show evidence of any actions that hospital staff took.

In the absence of any comments on these notice or documented actions, it was not possible to know if the medication (Allopurinol) was available in the hospital, if the hospital had the recalled product on hand, which was identified in the recall notice by NDC # and a Lot #. It was not possible to know if the recall medication was found, sequestered, destroyed, or sent back.

No policy for handling recalled medication was presented, after requesting it. The pharmacy policy binder was provided, but there was no specific policy to address recalled products. However, if there was a procedure on how to handle recalled items in another policy, staff did not know about it, as nothing was pointed out by hospital staff.





7. On 6/29/16 at 9 am, a tour of the clinic revealed a large box (approximately 18 inches (in.) by 18 in. by 18 in.) full of expired medications on a counter in the utility room. Eight expired medications were also found in the the cupboard above the clinic nurse RN G's desk, one expired vaccine in the clinic refrigerator, four expired narcotics in the clinic narcotic storage drawer, and 19 expired medications in a cupboard in the medication room, 13 of which were patient prescriptions, and one patient prescription that was lorazapam, that should be handled as a scheduled drug (see below). Some of the patient prescription medications had very old expirations dates, dating back as far as 4/6/12, over four years ago. Hospital supplied medications had expirations dates back to 1/2013, over three years ago.

On 6/29/16 at 9:30 pm, when asked about the box of medications, RN G stated she had gathered up expired medications the night before in anticipation of the clinic tour the next day. RN G explained that Licensed Vocational Nurse (LVN) J used to discard medications but no longer performs that task. RN G acknowledged that expired medications should not be available for use.

RN G stated that patients will bring in their medications to the clinic to be discarded. RN G further stated the clinic did not have a record of oversight by the hospital pharmacist accounting for the medications.

When asked for a policy, RN G stated that there was not a policy for discarding of patient prescriptions.

On 6/29/16, the hospital policy, titled, "Handling of Clinic Stock Medications," not dated, did not reference a process for discarding patient medications and expired medication other than "Narcotics are checked for outdated medications and refilling low supply once a month by the Hospital Registered Pharmacist."

8. During the clinic tour, the narcotic drawer contained a package of 10 Dilaudid (narcotic pain medication) 2 mg injectables. The drawer also contained a form titled "Narcotic Count Sheet" which listed dates down the left hand column and had two signature columns, a column labeled "Correct Count" and a column labeled "Incorrect" and "Description". The dates were seven days apart starting on 3/7/16 , 3/14/16, and so on. The form was signed by RN G every seven days through 6/6/16 with an "OK" marked in the correct count column and no signatures were present on 6/13, 6/20 or 6/27/16. The form had no evidence of two signature accountability for narcotics, when or who the medication was dispensed and administered to, and what the count of medication actually was. The form had a notation on 5/31/16 that read "Transferred 4 doses (ampoules - vials) of Dilaudid 2 mg injectable to S.V. Hosp."

In a concurrent interview, RN G stated that she sent some Dilaudid to the hospital on the above date. RN G acknowledged that the count process for narcotics was not the the standard she had learned in nursing school.

The policy, titled, "Handling of Clinic Stock Medications," not dated, read, "Narcotics are counted once a week by the RN and the LVN. Due to the low volume of dispensing Narcotics, the policy requires counting weekly.

The U.S. Department of Justice Drug Enforcement Administration (DEA) classifies drugs that are controlled in accordance with the Controlled Substances Act into five "schedules", ranging from Schedule I substances, which have a high potential for abuse and no currently accepted medical use in treatment, to Schedule V substances, which have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. The hospital is required to accurately track the receipt and disposition of all scheduled drugs used in the hospital. Components of a record system for scheduled drugs would include:

Locked storage of scheduled drugs when not in use.

Accountability procedures to ensure control of the distribution, use, and disposition of all scheduled drugs.

A record system tracking movement of all scheduled drugs from the point of entry into the hospital to the point of departure either through administration to the patient, destruction or return to the manufacturer. The system should provide documentation on scheduled drugs in a readily retrievable manner to facilitate reconciliation of the receipt and disposition of all scheduled drugs.

Any discrepancies in count are reconciled promptly. The hospital should be capable of readily identifying loss or diversion of all controlled substances in such a manner as to minimize the time frame between the actual loss or diversion to the time of detection and determination of the extent of loss or diversion.

Ensuring that outdated, mislabeled, or otherwise unusable drugs are not used for patient care

Dilaudid is a Schedule II drug and lorazapam is a Schedule IV drug and should be handled according to the above standards.

9. During the clinic tour at 10:20 am, a supply of sample medications was found in an unlocked cupboard in the medication room which was directly across from the pediatric (child) examination room. The door was propped open with a trash can and had a sign posted "employees only". The sample medications included:

Spiriva and Stiolto (for respiratory symptoms)
Jantedueto and Tradjenta (for controlling blood sugar in diabetes)
Zetia (for lowering cholesterol level in the blood)

In a concurrent interview, Family Nurse Practitioner (FNP) 1 was asked about the sample medications. FNP 1 stated the samples were provided by drug company representatives free of charge to trial with patients. FNP 1 acknowledged the medications should be stored in a locked cabinet.

On 6/29/16, the hospital policy, titled, "Handling of Clinic Stock Medications," not dated, indicated that sample medications are stored in a locked cabinet.

10. On 6/27/16, the 6/2016 medication refrigerator and medication room temperature log for the medical unit contained blanks for 6/17 and 6/18 on the day shift, and 6/9, 6/15, 6/16, and 6/17/16 on the night shift. This record indicated that medication storage temperatures were not accounted for from 6/15 at 8 pm to 6/18/16 at 8 pm, a period of 72 hours.

On 6/9/16, the hospital policy, titled, "Drug Storage" dated 4/2008, read, "Drugs requiring special conditions for storage to insure stability shall be properly stored. For example, refrigeration and temperature shall be between 36 degrees Fahrenheit and 46 degrees Fahrenheit and room temperatures shall be between 59 and 86 degree Fahrenheit." The policy did not outline who was responsible or how often the temperature should be monitored.
VIOLATION: POLICIES - MED ERRORS & ADRS Tag No: C0277
Based on staff interview and record review, the hospital failed to ensure the presence of an effective system for identification and reporting of adverse drug reactions and medication errors. This failure placed patient's at risk of preventable drug reactions and errors that could compromise patients' health status.

Findings

On 6/29/16 at 10 am, in the presence of the Director of Nursing (DON), the hospital consultant pharmacist (Pharm) was interviewed by phone. Pharm was asked about the process in which medication errors and adverse drug reactions (ADR) are reported. Pharm stated that he had not received any reports of medication errors or ADR this year. Pharm was asked if there was any in-service training or education to help staff identify and therefore report medication related issues (med errors or ADR). Pharm stated that there has not been any in-service or training for the past 2 years.

On 6/29/16, the pharmacist reports were requested. Five Monthly Consultant Pharmacist Reports were provided from January until May 2016. The June report was not presented for review, because facility staff could not locate it. Review of these reports showed, "Adverse Drug Reactions: None received." The medication errors in the report for May 2016 indicated, "None reported." For the previous three months, February, March and April, the monthly report included the following: "Reviewed two reports with Director of Nursing during visit." The January report also recorded, "Reviewed with Director of Nursing during visit."

During an interview with Pharm, he mentioned no medication errors, and said nothing about the "two reports" that were reviewed 2/2016 to 4/2016.
The previous DON was unreachable, and the new DON started on the first day of the survey. The new DON could not speak to the discrepancy between the reports and what the pharmacist stated on interview.
Review of the facility's policy, titled, "Adverse Drug Reporting /Medication Error", revised 3/2008, showed the following under Procedure: "B. An ADR/Med Error form is to be completed by the nurse making the error. The completed form is given to the Director of Nursing for review by the Quality Assurance Committee and Pharmacy Consultant."
VIOLATION: NURSING SERVICES - DRUG ADMINISTRATION Tag No: C0297
Based on interview and record review, the hospital failed to ensure that verbal orders for two of 15 sampled patients were signed by an authorized practitioner. (Patients 4 and 7) This failure could result in miscommunication that could result in a decline in the patient's health status.

Findings:

1. On 6/28/16, Patient 4's record was reviewed. Patient 4 presented to the Emergency Department (ED) on 6/4/16 with complaints of abdominal pain. Patient 4's record contained five different verbal orders for intravenous fluid and pain medication. Patient 4's record did not have a physician's signature for these orders.

On 6/29/16 at 12:30 pm, the Director of Nurses reviewed Patient 4's record and acknowledged that the physician signature and date section of the order form was blank.

On 6/29/16, the hospital policy, titled, "Physician's Orders," dated 9/2006, read, "Verbal orders are to be written immediately and signed with the name of the prescriber and the name of the transcriber... On acute (inpatient and emergency department) charts, the physician must cosign verbal orders within 24 hours.





2a. On 6/29/16 at approximately 4 pm, the clinical record for Patient 7 was concurrently reviewed with Registered Nurse C (RN C). Patient 7 had physician orders to receive pain medications. One of the orders was for MS Contin (morphine) 30 milligrams to be given two times every day. The order was taken as a verbal order, written on 6/7/16 at an undocumented time. On 6/29/16 at approximately 4 pm, 22 days later, the order was not cosigned by the prescriber. RN C confirmed this finding.

2b. On 6/14/16 at 11 am, an order for MS Contin 30 mg was obtained by a facility nurse for Patient 7, and the order was not co-signed by the prescriber as of 6/29/16 at 4 pm, 15 days later.

2c. Additionally, on 6/21/16 at 7:25 am, an order for MS Contin 30 mg was obtained by a facility nurse for Patient 7, and the order was not co-signed by the prescriber as of 6/29/16 at 4 pm, eight days later.
Review of the hospital's policy titled, "Physician's Orders", written on 9/2006 and reviewed on 6/2007 read, "Verbal (direct or telephone) orders are to be written immediately ... On acute charts, the physician must cosign verbal orders within 24 hours."
VIOLATION: POLICIES - INFECTION CONTROL Tag No: C0278
Based on interview and record review, the hospital failed to ensure that that there was a system for identifying, reporting, investigating, and controlling infections. This failure places patients at risk of acquiring an infection that could result in a decline in health status.

Findings:

During the survey, several issues related to the control of infections and food borne illnesses were identified. Refer to C 152 findings 7 and 8, C 276 findings 3 and 10, C 279 findings 1-3, and C 338.

On 6/28/16, the physician files were reviewed and no evidence of tuberculin (TB, tuberculosis is a contagious respiratory disease) testing was present.

The hospital's Medical Staff Bylaws, dated 2014, read, "The purpose of the Infection Control Committee and Sub-Committee is to develop and monitor the Hospital's infection control program, and the Staff's treatment of infectious diseases, including review of the clinical use of antimicrobials (antibiotics to combat bacterial and other infections)...The Infection Control Sub-Committee shall meet at least every other month and report to the Medical Staff Committee..."

On 6/28/16, the Governing Body (GB) minutes were reviewed. There was no evidence of an infection control program report for the last six months.

In an interview on 6/28/16 at 2:40 pm, Physician 2 stated he was responsible for the infection control program and acknowledged there was not an organized infection control program. He further stated the person previously responsible for the infection control program left the hospital several months ago and files for the program had not yet been found.
VIOLATION: POLICIES - NUTRITION Tag No: C0279
Based on observation, interview, and record review, the hospital failed to ensure that dietary practices were consistent with hospital policies and standards of practice, as follows:

1. Food items were stored on the floor of the freezer.

2. Hair was not restrained for three of three dietary workers.

3. Dishwasher rinse temperatures were not monitored to ensure proper sanitation.

These failure had the potential for patients to incur food borne illnesses.

Findings:

1. On 6/27/16 at 1:30 pm, during a tour of the kitchen, a box of croissants and another box of bacon was observed on the floor of the freezer.

In a concurrent interview, the Dietary Supervisor (DS) acknowledged that that food order had come in and need to be placed on the shelves. DS further acknowledged that food should not be stored on the floor.

2. During the above tour, three of three kitchen workers were observed to have their bangs uncovered with their hair nets.

In a concurrent interview, DS acknowledged all hair should be covered so as to not get into the patient's food.

3. During the tour at 1:45 pm, Dietary Staff H was observed running a load of dishes through the dishwasher. The dishwasher sensor on the outside of the machine read that the rinse cycle was at 153 degrees Fahrenheit.

Dietary Staff H was asked how she knew the dishes were properly sanitized and she responded that she runs a strip through the dishwasher that shows the proper temperature occurs. Dietary Staff H ran a load with a strip and the load showed that the proper temperature of 180 degrees was obtained but the thermometer read the temperature as 153 degrees.

In a concurrent interview, DS stated the dishwasher was old and they had the thermometer repaired but it looked like it might have broken again. When asked if they had a log of the dishwasher temperature monitoring, DS responded they did not.

DS was asked for polices for the above practices and stated she did not have policies for these items.
VIOLATION: PERIODIC EVALUATION & QA REVIEW Tag No: C0330
Based on interview and record review, the hospital failed to ensure that the care was adequately evaluated to ensure the hospital's actual practice reflected their policies and procedures, as well as the law, regulation or standard of practice, as evidenced by:

1. An inadequate amount of clinical records were reviewed as part of the annual evaluation of its total program. Refer to C 333, finding 1 and 2.

2. Health care policies were not evaluated, reviewed and revised as part of the annual program evaluation. Refer to C 334.

3. Nosocomial infections (acquired in the hospital) and medication therapy were not reviewed. Refer to C 338.

4. A Quality Improvement Organization (QIO) or equivalent entity did not review the health care quality provided by the doctors of medicine or osteopathy at the CAH. Refer to C 340.

5. Data collected for the periodic review of medication storage failed to identify widespread problems with the availability of emergency drugs, retention of expired mediations, drug storage, and oversight of controlled substances. Refer to C 152 findings 1, 2, and 3, C 276 findings 1-10, and C 337 findings 1-3 and 5-6.

6. Systematic review of medication errors and adverse drug reactions was not completed. Refer to findings C 277 and C 337 finding 4.

7. Effective monitoring of the adequacy of emergency drugs, supplies including blood products and nursing competence was not done. Refer to C 152 findings 1-5, C 200 findings 1-7, C 203 findings 1-2, C 204 finding 1-2, and C 205.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of services was in compliance with the statutorily mandated Quality Review and Periodic Evaluation.
VIOLATION: ORGAN, TISSUE, EYE PROCUREMENT Tag No: C0349
Based on interview and document review, the Critical Access Hospital (CAH) failed to work together with the designated Organ Procurement Organization (OPO) in educating and training staff on donation issues.

This deficient practice had the potential to cause failed opportunities in achieving organ donations.

Findings:

During an interview on 6/29/16 at 1 pm, Registered Nurse (RN) C was asked whether she had seen any cooperation from the OPO and CAH to educate and train clinical staff about donation issues, reviewing death records to improve identification of potential donors, and maintain potential donors while necessary testing and placement of potential donated organs, tissues, and eyes took place. RN C replied, "No." RN C also stated that the CAH used to have an organ requestor, who was giving "some education" to the staff, but the organ requestor left in early 2016.

During an interview on 6/29/16 at 1:10 p.m., the newly hired Director of Nursing (DON) was asked whether she was aware of the CAH, with the OPO, provided any education on donation issues. The DON replied, "No."

When the surveyor requested for the CAH's updated policy regarding organ donation, the surveyor was provided a form titled, "[the CAH's name] Annual 2014 Organ, Eye, & Tissue Donation Strategic Plan" which was dated 6/2014.
VIOLATION: PERIODIC EVALUATION OF PATIENT RECORDS Tag No: C0333
Based on interview and document review, the Critical Access Hospital (CAH) failed to perform reviews of an adequate and representative sample of clinical records, as part of its periodic evaluation of its total program.

This failure limited the ability of the CAH to monitor its clinical performance continuously and make improvements on its quality of care accordingly.

Findings:

1. During an interview with the Quality Assurance Coordinator (QAC) on 6/28/16 at 10:30 am, the QAC stated that it had been challenging to have the medical staff perform timely peer review.

During an interview on 6/28/16 at 3 pm, the QAC was asked what percentages of the clinic charts were reviewed during the process of evaluating Family Nurse Practitioner (FNP). The QAC replied, "3-5 percent of closed charts in clinic [was reviewed]." Review of the FNP's credentialing files indicated that the last record review was performed in 03/2016. The QAC acknowledged that the amount of the clinical records reviewed did not ensure representative sample of both active and closed clinical records were reviewed, since the quantity of charts did not reach 10 percent.

During an interview with the Medical Director (MD) on 6/29/16 at 8:30 am, the MD concurred that the current practice at the CAH did not ensure an adequate sample of both active and closed clinical records were reviewed.

Review of the CAH's Medical Staff Bylaws, Policy and Procedure Manual, last revised on 7/16/14, indicated under "6.05 Allied Health Professionals", that "Assure that the supervising MD or DO periodically, but not less than every 2 weeks, reviews and signs 5% (percent) of outpatient records of patient cared for by practitioners, clinical nurse specialists or physician assistants."





2. On 6/29/16 at 10 am, in the presence of the Director of Nursing (DON), the pharmacist (Pharm) stated during a telephone interview that when he came to the hospital once a month, he checked controlled substance accountability and patient's records for drug usage. Pharm stated that he looked into the clinical records to see that controlled substance removed from the supply were accounted for by administration documention on the Medication Administration Record (MAR). Pharm was asked if he kept these charts audits and he said that he did audits for survey findings.

On 6/29/16 at approximately 11 am, both the DON and Registered Nurse C (RN C) checked the Drug Room (pharmacy) multiple binders for the chart audits. There was a binder where audits from 2012 were filed, but there were no evidence or any audits more recently than 2012.

A Quality Assurance (QA) project binder was reviewed which had no evidence of anyclinical record audits or QA projects.
VIOLATION: PERIODIC EVALUATION OF POLICIES Tag No: C0334
Based on interview and record review, the hospital failed to ensure that health care policies were evaluated, reviewed and revised as part of the annual program evaluation. This failure resulted in policies not being current with State and Federal laws and current standards of practice which could result in patients not receiving appropriate care.

Findings:

On 6/28/16, the Governing Body (GB) minutes were reviewed. The minutes did not contain evidence of an annual review or revision of policies.

a. During the survey, many policies were presented that had dates that were very old and had no evidence of review or revision for many years, such as:

Job descriptions for Registered Nurse and Laboratory Personnel were last reviewed in 1998, 18 years ago.
Tuberculosis Exposure Plan, last revised 9/2005, 11 years ago.
Controlled Drug Records, last reviewed 8/25/2010, six years ago.
Drug Storage, last reviewed 1/2009, seven years ago.
Adverse Drug Reporting /Medication Error, last revised 3/2008,eight years ago.
Physician's Orders, last revised 6/2007, nine years ago.
Medication Orders, last reviewed 8/20/10, nine years ago.
Pain Assessment, last revised 06/2009, seven years ago.
Narcotic Count, last revised 4/2008, eight years ago.
Pyxis Station, last revised on 4/2008, eight years ago.
Dispensing Medication from emergency room , last revised 12/2000.
Annual 2014 Organ, Eye, & Tissue Donation Strategic Plan" last revised 6/2014, two years ago.

b. Policies were not updated to reflect current facility practices:

The hospital's policy and procedure that included the emergency drug supply information had the following: "Drug Storage," revised on 1/2009, included the followings under Crash Carts (ER, Acute, OR). The facility currently does not have an OR (Operation Room), and the policy was last updated in 2009.

The hospital's policy titled, "To establish that the narcotic count be completed as described below," was revised on 4/08, and last reviewed on 5/12 for narcotic count verification in the emergency room referred to the Pyxis policy. The Pyxis according to the administration was no longer in use and it did not have medication stored in it.

c. Several policies were requested during survey and were not provided. Refer to C 152 finding 5d, C 205, C 222 findings 1, 2, and 5, C 279 findings 1-3, C 282, and C 292.

d. Additional review of the hospital's pharmacy policy and procedure manual showed that the most recent revision and approval for the policy and procedure manual was 2011, which was dated and singed by the Administrator, the Medical Director, the Governing Board, the Pharmacy Consultant, another outside consultant, and a Registered Nurse.

On 6/29/16 at 11:45 am, the hospital Administrator acknowledged the hospital was behind in policy development and review, and stated a consultant was hired to provide the hospital assistance with this task in the near future.
VIOLATION: QUALITY ASSURANCE Tag No: C0337
Based on staff interview and document review, the hospital failed to ensure that services affecting patient health were evaluated as evidenced by the following:

1. There was no system in place to ensure that medications and equipment for medical emergencies were readily available and that staff were knowledgeable about the procedures or the location of the supplies. Refer to C152 findings 1, 2, and 5.

2. Controlled substances were not accounted for, and there was no evidence of conducting audits to ensure accuracy and accountability. Refer to C 276 findings 1 and 8.

3. There was no evidence that oversight was exercised to ensure that medication was stored appropriately: refrigerated medication was stored under appropriate temperatures, and expired medications were not avaiable for use. Refer to C 276 findings 3, 6, 7, 9, and 10.

4. There was no system in place for identifying medication errors or adverse drug reactions (ADR) or reporting them. Refer to C 277.

5. The hospital failed to ensure that medication therapy was evaluated for efficacy (effectiveness) or for side effects. Refer C 294.

6. The clinic failed to demonstrate proper medication storage and accountability for controlled substances. Refer to C 276 findings 7, 8, and 9.

Findings:

1. The hospital did not have an effective system to ensure that emergency medication supplies were secure and readily available for treating medical emergencies as follow:
The pharmacist did not seal the emergency drug supply in accordance with State regulations; the medication supply in the carts and the crash carts were not sealed; front line staff nurses were determining what was placed in the emergency drug supply, when this was a medical staff and pharmacy responsibility; Emergency medications and supplies were not available in the crash carts for immediate use when needed such as:
Nitroglycerin drip, which is used to treat pain in the chest resulting from decreased blood supply to the heart (heart attack), was not available.
Pediatric (child) carbon dioxide (CO2) detector used in emergency was not in the emergency drug supply cart. CO2 detectors measure gas concentration to help evaluate if the patient is getting enough oxygen.
OB (Obstetrics, treatment of pregnancy and children) drug and Pediatric/ Neonatal (newborn) Emergency Drug trays were not available during inspection of the supplies.

The medications placed in the crash carts did not match the content list established by the hospital's policy. The policies and procedures last updated in 2008, did not have specific procedures consistent with State regulations; Lastly, nursing staff did not know where the emergency drug supply for pediatric patients was located and were not knowledgeable in handling pediatric emergencies.


2. The record keeping for controlled substance was not in order; the lack of accountability of controlled substance in the Drug Room (pharmacy) allowed for possible diversion or misuse. There for hundreds of tablets of controlled substance that were not accounted for.

a. From 6/7/16, until 6/23/16, ten out of thirty two morphine (for pain) 30 milligrams (mgs) tablets, removed for Patient 7, were not accounted for. It meant that about 31%, that is almost one of every three morphine tablets removed were not administered to the patient according to the record.

b. There were no accountability sheets to track the use of 250 tablets of Norco (for pain, a combination of acetaminophen /hydrocodone). This combination contained five milligrams (mg) of hydrocodone and 325 mgs of acetaminophen tablets. The count sheets for this medication accounted only for 50 out of 300 tablets, leaving 250 tablets that were unaccounted for and free for the taking.

c. The accountability sheets for Norco 5/500 (5 mg of hydrocodone and 500 mg of acetaminophen) did not match what was in the cabinet. So depending on how they were read, it could be either 65 tablets were missing already, or 75 tablets were available to be taken without accountability as there was one sealed bottle of 100 tablets and another with 8 whole tables and 4 partials tablets, but the accountability sheets were as follows: One accounted for five tablets; the second for 30 tablets, and the third sheet would possibly indicate that 140 tablets should have been there. It is also possible that the third sheet was completely unrelated to the current supply in the cabinet, as there was no Lot or NDC number to identify the medication by, and the sheet had 2014 and 2015 transactions dates on it.

d. There were 40 tablets of alprazolam (for anxiety) 1 mg each without accountability sheet to match this bottle.

e. There was a count sheet for 30 tablets of diazepam (for anxiety) 5 mg but no diazepam bottles or tablets in the cabinet.

On 6/29/16 at 10 am, in the presence of Director of Nursing (DON), the pharmacist (Pharm) stated on telephone interview that when he came to the hospital once a month, he checked controlled substance accountability and patient's records for drug usage. Pharm stated that he reviewed clinical records to see that controlled substance removed from the supply was accounted for by administration documention on the Medication Administration Record (MAR). Pharm was asked if he kept these charts audits, and he said that he did audits for survey finding.

On 6/29/16 at approximately 11 am, both the DON and Registered Nurse C (RN) checked the Drug Room (pharmacy) multiple binder for the chart audits. There was a binder where audits from 2012, were filed in. But there was no evidence or any audits after 2012. There was a Quality Assurance (QA) project binder that had no evidence of any clinical record audits or QA project.

3. On 2/29/16 at 9:50 am, the Quality Assurance Coordinator who was also known as (HIM Supervisor) was interviewed, and the Quality assurance monthly reports were reviewed. The report included four indicators related to pharmacy:
1. Refrigerator/ Freezer temperatures
2. Narcotic documentation
3. Consent Forms
4. Outdated medical supplies.

The reports for five months (January 2016 until May 2016) showed 100% compliance in all indicators. When the HIM supervisor asked if there was any process validations, like a spot check of refrigerator temperature, random evaluation of some clinical records to evaluate controlled substance use, or checking of expiration date of medications in different areas of the hospital, HIM supervisor said that they do not. That they take the employees word (documentation) for it.

The log for monitoring the temperature for the refrigerator where medications are stored, for April 2016 showed documentation of multiple days that the temperature was not monitored (blank) or the temperature was out of the acceptable range. In addition, during the survey there were many expired medications found in multiple areas of the hospital.

4. On 6/29/16 at 10 am, in the presence of Director of Nursing (DON), the pharmacist (Pharm) stated on telephone interview that he had not received any reports of medication error or ADR this year. Pharm was asked if there was any in-service training or educations to help staff identify and therefore report medication related issues (med errors or ADR). Pharm stated that there had not been any in-service or training for the past 2 years.

On 6/29/16, the pharmacist reports were requested and five Monthly Consultant Pharmacist Reports were provided from January until May 2016. Review of these reports showed for "Adverse Drug Reactions: None received." However, the documentation for medication error reports was conflicting with what Pharm stated on interview. The document could not be validated because staff that were no longer working in the hospital and were not available for interview.
5. On 6/29/16 at approximately 4 pm, the clinical record for Patient 7 was concurrently reviewed with Registered Nurse C (RN C). Patient 7 had orders for pain medications. RN C stated on interview that the pain assessments before and after administration of pain medications were not expected for routine (scheduled) pain medications. Review of the medication administration record showed no documentation of pain assessment associated with administration of the twice daily morphine doses.

On 6/29/16 at approximately 9 am, concurrent review of Patient 1's record with a hospital's medical record person (MR 1) showed that Patient 1 was in the Emergency Department (ED) on 6/24/16 for a pain issue. Patient 1 was an adult who came to the ED at 2041 (8:41 pm) for pain which was related to a bone fracture. Review of the electronic and the paper record with MR 1 showed initial pain assessment for Patient 1, at 2051 (8:51 pm). The pain was rated as severe (8 out of 10), but there was no additional documentation for assessing the pain after that time. It was not clear or documented in the record if Patient 1 who came to the ED for pain related issues, (severe pain, at level 8) was discharged with the same severe pain (level 8) or if the pain was controlled and managed before discharge.

According to the Nursing Practice Act, Section 2725, the registered nurse provides "direct and indirect patient care services to insure patients' comfort. It also states that proper management of patient's pain is a nursing function incorporated within nurse's role as a patient advocate.

According to the Board of Registered Nursing, the nursing function of appropriate pain management includes, but is not limited to the following:
1. Assessing pain and evaluating response to pain management interventions using a standard pain management scale based on patient self-report.
2. Intervening to treat pain before the pain becomes severe.
3. Documenting pain assessment, intervention, and evaluation activities in a clear and concise manner, and
4. Intervening to minimize drug side effects.

Review of the hospital's policy titled: Pain Assessment, approved on 5/2000 and updated on 06/2009, showed the following: "For Acute/Extended Care patients- pain assessment will be documented on the Vital Sign Flowsheet, and addressed in the Nurse's notes, if applicable." However, there was no specific procedure on how and when to assess pain if a patient is receiving pain medication on as needed or regular bases. The policy was not updated to reflect the new process of using the electronic medical record.

"A pain assessment will be completed on all ... patients within this hospital. The pain assessment will be completed when the vital signs are taken and more frequently if needed. The pain assessment will be documented within the vital signs on the ER records."

Evaluating response to medication serves to evaluate effectiveness of therapy; to ensure that the intended effects, (controlling pain, or reducing it severity) is achieved. Monitoring therapy also serves for early detection and recognition of side effects or toxic effects associated with morphine, such as sedation or decrease in respiratory rate. There was no system in place to ensure safety of medication administration and meeting patient's need for pain control and management.





6. On 6/29/16 at 9 am, a tour of the clinic revealed a large box (approximately 18 inches (in.) by 18 in. by 18 in.) full of expired medications on a counter in the utility room. Eight expired medications were also found in the cupboard above the clinic nurse RN G's desk, one expired vaccine in the clinic refrigerator, four expired narcotics in the clinic narcotic storage drawer, and 19 expired medications in a cupboard in the medication room, 13 of which were patient prescriptions, and one patient prescription that was lorazapam, that should be handled as a scheduled drug (see below). Some of the patient prescription medications had very old expirations dates, dating back as far as 4/6/12, over four years ago. Hospital supplied medications had expirations dates back to 1/2013, over three years ago.

During the clinic tour, the narcotic drawer contained a package of 10 Dilaudid (narcotic pain medication) 2 mg injectables. The drawer also contained a form titled "Narcotic Count Sheet" which listed dates down the left hand column and had two signature columns, a column labeled 'Correct Count" and a column labeled Incorrect and description. The dates were seven days apart starting on 3/7/16 , 3/14/16, and so on. The form was signed by RN G every seven days through 6/6/16 with an "OK" marked in the correct count column and no signatures were present on 6/13, 6/20 or 6/27/16. The form had no evidence of two signature accountability for narcotics, when or who the medication was dispensed and administered to, and what the count of medication actually was.

On 6/29/16 at 11 am, the hospital Quality Assurance Coordinator presented an indicator grid that was presented to the governing body. This grid indicated that the performance of medication storage temperatures, the drugs in the emergency carts matched the list in the policy and and on the cart, monitoring of expiration dates, and clinic drug storage and expired medications were reported as in compliance at 100% (percent) for each month from January 2016 thru May 2016. This grid was not consistent with the data collected by the hospital and the observed results of surveyor tours.

Other items had varied performance on this grid such as Crash Cart outdated drugs at 76 to 90% compliance reported but no action plans accompanied the report so the governing body would be apprised of the efforts to correct non-compliance.

In a concurrent interview, the Quality Assurance Coordinator could not account for the above discrepancies.
VIOLATION: QA - MEDS & INFECTIONS Tag No: C0338
Based on interview and record review, the hospital failed to ensure that nosocomial infections (infections acquired in the hospital) and medication therapy were evaluated. This failure had the potential for correctable problems to persist and negatively impact patient health.

Findings:

On 6/28/16, the Governing Body (GB) minutes and quality indicator grid were reviewed. There was no evidence of an infection control program or medication therapy report for the last six months.

The hospital's Medical Staff Bylaws, dated 2014, read, "The purpose of the Infection Control Committee and Sub-Committee is to develop and monitor the Hospital's infection control porgram, and the Staff's treatment of infectious diseases, including review of the clinical use of antimicrobials (antibiotics to combat bacterial and other infections)...The Infection Control Sub-Committee shall meet at least every other month and report to the Medical Staff Committee..."

On 6/28/16 at 2:40 pm, Physician 2 confirmed the above finding and stated the person responsible for the infection control program left the hospital several months ago and files for the program had not yet been found.