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.

HEALDSBURG DISTRICT HOSPITAL 1375 UNIVERSITY AVENUE HEALDSBURG, CA 95448 Aug. 12, 2016
VIOLATION: AGREEMENTS - LIST OF SERVICES Tag No: C0291
Based on observation, interview, and document review, the hospital failed to have a contract arranging for compounding (mixing) services with Pharm P (a pharmacist). This failure resulted in the potential for patients to be exposed to hospital services which did not meet the pharmaceutical service general requirements.

Findings:

During a tour of the pharmacy on 7/11/16 at 11:30 a.m. a refrigerator was observed. The contents of the refrigerator contained topical LETS (numbing agent) gel compounded by an outside compounding pharmacy (Pharm P).

During an interview on 7/13/16 at 1:50 p.m., the quality director, Administrative Staff A stated that the facility did not have a contract in place with Pharm P.

Review of facility policy "Contract Summary" dated 11/14 indicated "It is the hospital policy that a Contract Summary form must be completed for every new, renewed, contract prior to CEO (chief executive officer) approval."
VIOLATION: ORGANIZATIONAL STRUCTURE Tag No: C0240
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the facility failed to ensure the organizational structure that the governing body ensured the facility's quality health care as evidenced by:

1. The facility did not develop and implement policies and procedures when emergency department staff were not aware of [DIAGNOSES REDACTED] (MH, is an inherited muscle disorder triggered by certain drugs including succinylcholine and volatile anesthetics that may cause a fast-acting life-threatening crisis) procedures and location of MH cart and supplies. (Cross reference: C 0271 finding #1)

2. The facility did not implement policies and procedures regarding PCA (patient controlled analgesia; it allows a patient to self-administer small amounts of pain medications through the vein as needed) monitoring, order for restraints and the use of restraints, pain assessment for response to pain medications, and indications for PRN (as needed) medication use. (Cross reference: C 0271 findings #2 - 7)

3. The facility did not have a standardized procedure that ensured medical oversight for PICC (A PICC is a peripherally inserted central catheter that is threaded through a vein in the arm and rests in the large vessel just above the heart; the PICC is used to deliver medication and intravenous fluids) procedures. (Cross reference: C 0271 finding #8)

4. The facility did not identify and implement action plans to ensure periodic staff competency evaluations. (Cross reference: C 0336 finding #3)

5. The facility did not develop a plan to evaluate and assess their processes, procedures and system in the medications administration process to reduce or prevent medication errors. (Cross reference: C 0336 finding #5a)

6. The facility did not ensure process so that all medication errors were regularly analyzed via multi-disciplinary committee which included professionals from pharmaceuticals, nursing, medical and administration. (Cross reference: C 0336 finding #5b)

7. The facility did not ensure safe use and storage of medications (Cross reference: C 0276)

8. The facility did not review all policies annually. (Cross reference: C 0272 and C 0334)

9. The facility did not ensure a functioning infection control program/committee and implement infection control practices. (Cross reference: C 0278)

10. The facility did not ensure a contract arranged with the pharmacist who provided compounding (mixing) services. (Cross reference: C 0291)

The governing body's failure to ensure the facility's quality health care had the potential to endanger patients' health and safety. The Condition of Participation for Organizational Structure was not met.
VIOLATION: GOVERNING BODY Tag No: C0241
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the governing body failed to ensure all policies governing the facility's operation for quality health care were reviewed, revised to meet the standard practices, and implemented as evidenced by:

1. The facility did not develop and implement policies and procedures when emergency department staff were not aware of [DIAGNOSES REDACTED] (MH, is an inherited muscle disorder triggered by certain drugs including succinylcholine and volatile anesthetics that may cause a fast-acting life-threatening crisis) procedures and location of MH cart and supplies. (Cross reference: C 0271 finding #1)

2. The facility did not implement policies and procedures regarding PCA (patient controlled analgesia; it allows a patient to self-administer small amounts of pain medications through the vein as needed) monitoring, order for restraints and the use of restraints, pain assessment for response to pain medications, and indications for PRN (as needed) medication use. (Cross reference: C 0271 findings #2 - 7)

3. The facility did not have a standardized procedure that ensured medical oversight for PICC (A PICC is a peripherally inserted central catheter that is threaded through a vein in the arm and rests in the large vessel just above the heart; the PICC is used to deliver medication and intravenous fluids) procedures. (Cross reference: C 0271 finding #8)

4. The facility did not identify and implement action plans to ensure periodic staff competency evaluations. (Cross reference: C 0336 finding #3)

5. The facility did not develop a plan to evaluate and assess their processes, procedures and system in the medications administration process to reduce or prevent medication errors. (Cross reference: C 0336 finding #5a)

6. The facility did not ensure process so that all medication errors were regularly analyze via multi-disciplinary committee which included professionals from pharmaceuticals, nursing, medical and administration. (Cross reference: C 0336 finding #5b)

7. The facility did not ensure safe use and storage of medications (Cross reference: C 0276)

8. The facility did not review all policies annually. (Cross reference: C 0272 and C 0334)

9. The facility did not ensure a functioning infection control program/committee and implement infection control practices. (Cross reference: C 0278)

10. The facility did not ensure a contract arranged with the pharmacist who provided compounding (mixing) services. Cross reference: C 0291)

These failures prevented the governing body provided adequate oversight for the facility's operation and providing quality health care to the patients.

Findings:

During an interview on 8/12/16, at 1:40 p.m., Governing Body NNN stated the governing body members met at least monthly and received monthly report from the facility. Governing Body NNN stated the governing body relied on the facility report to look at concerns. Governing Body NNN stated the governing body was not aware of the following:

1. The facility did not have an infection control committee/program integrated in QA program and this should be a concern.

2. The facility did not review all policies annually. Governing Body NNN stated policies review process was initiated by facility staff and brought it to the governing body for review and approval. Governing Body NNN stated it was important to review all the policies.

3. The facility did not have staff periodic competency evaluation in staff's files.

4. The facility had multiple pharmacy issues/deficient practices.

The bylaws of the health care district dated 10/28/15, indicated "The Board (governing body of the District) shall be responsible for the operation of the Facilities owned, leased or operated by the District, according to the best interests of the public health, and shall make and enforce all rules, regulations and bylaws necessary for the administration, government, protection and maintenance of the Facilities under the Board's management and all property belonging thereto, and may prescribe the terms upon which patients may be admitted thereto..."
VIOLATION: PROVISION OF SERVICES Tag No: C0270
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview, and record review, the facility failed to ensure that the Condition of Participation for Provision of Services was met when:

1. The facility failed to ensure they had an effective, active and a systematic infection control surveillance program in place for identifying, investigating and controlling infections (Refer to C-0278, finding 3).

2. The hospital did not have a method for determining the humidity level in their central sterile area (an area where surgical instruments are sterilized and processed), central sterile storage (storage area for sterile supplies), and decontamination room (Refer to C-0278 Finding 1).

3. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards when the hospital failed to ensure there was no presence of spotting and staining on 2 of 2 processed surgical trays (previously cleaned, disinfected and sterilized surgical instruments) (Refer to C-0278 Finding 2).

4. The hospital failed to ensure a Central Service Technician (CST 1) followed Nationally Recognized Infection Control standards and manufacturer directions for use when cleaning and disinfecting surgical instruments (Refer to C-0278 Finding 4).

5. The hospital failed to ensure each step for high level disinfecting (HLD - complete elimination of all microorganisms in or on an instrument, except for small spores), was performed when an Ultrasound Technician (UT 1) failed to perform HLD of vaginal probes (a transducer used to perform a medical ultrasound by inserting the probe through the vagina to visualize pelvic cavity organs), according to manufacturer directions for use (Refer to C-0278 Finding 5).

6. The hospital failed to identify, adopt and effectively utilize nationally recognized infection control standards, such as the Association for Professionals in Infection Control and Epidemiology (APIC) , Center for Disease Control (CDC as the national recognized standards that " drive " the EOC (environment of care) program (Refer to C-0278 Finding 6).

7. Failed to provide effective Infection Control monitoring and surveillance of areas designated as restricted and semi-restricted and failed to provide training for staff to recognize and implement facility adopted AORN standards for restricted and semi-restricted (sterile and sub-sterile) areas (Refer to C-0278 Finding 7).





8. The facility did not have a physician lead for the antimicrobial stewardship committee and the facility staff did not follow infection control practices. (Cross reference: C 0278 findings #8 - 20)

9. The facility did not develop and implement policies and procedures when emergency department staff were not aware of [DIAGNOSES REDACTED] (MH, is an inherited muscle disorder triggered by certain drugs including succinylcholine and volatile anesthetics that may cause a fast-acting life-threatening crisis) procedures and location of MH cart and supplies. (Cross reference: C 0271 finding #1)

10. The facility did not implement policies and procedures regarding PCA (patient controlled analgesia; it allows a patient to self-administer small amounts of pain medications through the vein as needed) monitoring, order for restraints and the use of restraints, pain assessment for response to pain medications, as needed medication orders. (Cross reference: C 0271 findings #2 - 7)

11. The facility did not have a standardized procedure that ensure medical oversight for PICC (A PICC is a peripherally inserted central catheter that is threaded through a vein in the arm and rests in the large vessel just above the heart; the PICC is used to deliver medication and intravenous fluids) procedures. (Cross reference: C 0271 finding #8)

12. The facility did not identify and implement action plans to ensure periodic staff competency evaluations. (Cross reference: C 0336 finding #3)

13. The facility did not develop a plan to evaluate and assess their processes, procedures and system in the medications administration process to reduce or prevent medication errors. (Cross reference: C 0336 finding #5a)

14. The facility did not ensure process so that all medication errors were regularly analyzed via multi-disciplinary committee which included professionals from pharmaceuticals, nursing, medical and administration. (Cross reference: C 0336 finding #5b)

15. The facility did not ensure safe use and storage of medications (Cross reference: C 0276)

16. The facility did not review all policies annually. (Cross reference: C 0272 and C 0334)

17. The facility did not ensure a contract arranged with the pharmacist who provided compounding (mixing) services. (Cross reference: C 0291)

18. The facility did not ensure medications were administered as ordered, medications orders were completed, and verbal/telephone orders were authenticated in a timely manner. (Cross reference: C 0297), and

19 The facility did not ensure patient care plans were current. (Cross reference: C 0298)

The cumulative effect of these systemic problems had the potential to transmit infectious microorganisms to patients and increased the risk of infections to all patients who received care in the facility. The cumulative effect of these systemic problems also had the potential to endanger patients' health and safety. The facility failed to deliver care in a safe setting in order to be in compliance with the Condition of Participation for Provision of Services - 485.635.
VIOLATION: PATIENT CARE POLICIES Tag No: C0271
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview and document and record review, the facility failed to develop and implement policies and procedures when:

1) Emergency department staff were not aware of [DIAGNOSES REDACTED] (MH, is an inherited muscle disorder triggered by certain drugs including succinylcholine and volatile anesthetics that may cause a fast-acting life-threatening crisis) procedures and location of MH cart and supplies including chilled saline. This failure had the potential of not being able to manage an MH crisis timely, resulting in serious injury or death to a patient.

2) PCA (patient controlled analgesia; it allows a patient to self-administer small amounts of pain medications through the vein as needed) monitoring was not done for Patient 5 and 6 in accordance with facility policy. This failure had the potential of not detecting serious adverse effects from medications including over sedation and respiratory depression,

3) Ensure that the order for restraints were completed and were not written on as needed bases for one patient (Patient 2),

4) Ensure that restraints were used appropriately with clinical justification and in a safer manner,

5) Ensure that pain was assessed to evaluate response to interventions. Pain was not evaluated about 33% of the time when Patient 1 was administered morphine (pain medication) to control pain,

6) Ensure that pain response to intervention was assessed for Patient 1 when methadone (pain medication) was administered three times every day,

7) Ensure that the need, indication for use, for administering as needed medication (diphenhydramine) was established before the medication was administered.
Such failures placed patients at increased risk of potential treatment failure and resulting harm associated with uncontrolled pain, side effects of medications, or restraints associated side effect.

8) The facility did not have a standardized procedure that provided adequate medical oversight for a PICC nurse (a specially trained registered nurse) to read a chest radiograph (x-ray), verify proper PICC line placement, and determine the line was safe for initial use. (A PICC is a peripherally inserted central catheter that is threaded through a vein in the arm and rests in the large vessel just above the heart; the PICC is used to deliver medication and intravenous fluids). This failure caused lack of physician oversight for a medical procedure (reading and interpreting an x-ray) performed by a nurse and potentially decreased the safety of patients who had a PICC line placed.


Findings:

1) On 7/11/16 at 12:45 p.m. succinylcholine (paralytic agent used in anesthesia and a potential precipitant for MH) vial was observed in the ED refrigerator.

On 7/11/16 at 5:20 p.m. an MH cart was observed in the OR (operating room) corridor. The contents list on the MH cart indicated the refrigerator contained 6 bags of 0.9% sodium chloride (NS, normal saline solution, used for cooling an MH patient) 1000 ml (milliliter) and insulin (for reducing potassium levels the blood potassium level can rise during the breakdown of muscle in an MH crisis, and if it rises too much, the conduction of electrical impulses in the heart can be adversely affected, potentially causing the heart to stop beating).

In a concurrent observation and interview on 7/11/16 at 5:20 p.m. the Director of Pharmacy (DOP) was unable to open the refrigerator to verify it contained the NS and insulin, as it was locked.

During an interview on 7/11/16 at 5:30 p.m. the CNO stated she was trying to call the OR director to find out how to get access to the chilled saline in the refrigerator.

Review of MHAUS ([DIAGNOSES REDACTED] Association of the United States, also used as a reference source by the facility) website www.mhaus.org <http://www.mhaus.org> indicated "The MH crisis is a biochemical chain reaction response, "triggered" by commonly used general anesthetics and the paralyzing agent succinylcholine (a neuromuscular blocker), within the skeletal muscles of susceptible individuals. The general signs of the MH crisis include increased heart rate, greatly increased body metabolism, muscle rigidity and/or fever that may exceed 110 degrees F along with muscle breakdown, derangements of body chemicals and increased acid content in the blood. Severe complications include: cardiac arrest, brain damage, internal bleeding or failure of other body systems. Thus, death, primarily due to a secondary cardiovascular collapse, can result."

During an interview on 7/11/16 at 5:35 p.m. the ED nurse manager (Management Staff C) was asked by surveyor where the MH supplies were kept. Management Staff C stated she would have to call the pharmacy (pharmacy was not open 24 hours) to find out or check in the Omnicell (facility's automated dispensing cabinet).

During an interview on 7/11/16 at 5:40 p.m. ED nurse (Licensed Staff G) was asked by the surveyor where the MH supplies were kept and she stated from her previous job experiences at another facility the MH supplies were most likely kept in the OR. Licensed Staff G was not able to locate the chilled saline or insulin in the OR.

On 7/11/16 at 5:55 p.m. the CNO stated she was not able to get in touch with the OR director to find out how to get access to the chilled saline. The CNO was informed that ED nurse manager and staff were not aware of the MH cart supplies location.

On 7/12/16 at 1:57 p.m. the OR Director (Licensed Staff E) stated the keys for the MH refrigerator supplies were kept in the ED after hours. Surveyor informed Licensed Staff E that ED staff were unable to locate the MH supplies.

During an interview on 7/13/16 at 8:25 a.m. ED nurse (Licensed Staff H) stated MH supplies were probably in the OR. Licensed Staff H was not aware where the chilled saline would be and stated no information had been given to her regarding the MH cart and MH procedures that she could recall.

On 7/13/16 at 8:35 a.m. ED nurse (Licensed Staff J) stated he had worked in ED for "decades." Licensed Staff J was unfamiliar with MH procedures and location of supplies and stated "we do have fluid warmers" (MH crisis management involves cooling patient's core temperature). Licensed Staff J stated succinylcholine was used in the ED for rapid sequence intubation (RSI, is a medical procedure involving a prompt induction of general anesthesia and placing a tube through the windpipe to help breathe) and he had administered succinylcholine to patients in the past.

Review of the list of patients for whom succinylcholine was removed from the ED Omnicell from 1/1/16 to 7/13/16 indicated a total of four patients.


Review of facility policy "Management of [DIAGNOSES REDACTED] Event" reviewed date 9/15 indicated "All licensed Surgery staff are responsible for understanding the mechanism of MH and the required drugs and supplies. All items will be centrally located for emergency response...It is an emergent and potentially lethal syndrome caused by a hypermetabolic state that can be precipitated by...depolarizing muscle relaxants, such as succinylcholine...Actively cool the hyperthermic patient. Use cold IV saline..." The policy did not include ED staff.

2a) Review of Patient 5's clinical record with Licensed Staff F indicated Patient 5 was admitted to the facility on [DATE] and her physician orders dated 5/4/16 included morphine (opioid for pain) PCA.
Review of Patient 5's medication administration record (MAR) indicated the PCA was initiated at 8:43 a.m. Patient 5's vital signs were assessed as follows:
-9:48 a.m. (over 1 hour later) respiratory rate was monitored.
-12:51 p.m. (3 hours later) respiratory rate was monitored.
-3:25 p.m. (2 hours later) respiratory rate, blood oxygen saturation and pain scale were monitored.
Review of facility policy "Patient Controlled Analgesia (PCA)" reviewed date 11/14 indicated "After initiation of the PCA the primary RN (registered nurse) will document...respiratory rate, oxygen saturation level, pain level, level of sedation...every 15 minutes x 4...then once every (1) hour x4...Once every (4) hours until PCA is discontinued...Level of sedation will be monitored every (1-2) hours through the first 12 hours of the PCA."
During an interview on 7/12/16 at 3:35 p.m. Licensed Staff F confirmed that monitoring was not done after PCA initiation for Patient 5 per facility policy. Licensed Staff F acknowledged that no level of sedation was documented for Patient 5.

ISMP, Institute of Safe Medication Practice a resource also used in the hospital (for example in the medication error reduction program plan) indicated in an article titled "Fatal PCA adverse events continue to happen... Better patient monitoring is essential to prevent harm" dated 5/10/13 "Hospitals may want to monitor patients more frequently at night, as opioid-induced respiratory depression is more common between midnight and 6 a.m."

2b) Review of Patient 6's clinical record indicated he was an [AGE] year old admitted to the facility on [DATE] and his physician orders dated 5/9/16 included morphine PCA.

Review of Patient 6's MAR indicated morphine PCA was initiated on 5/9/16 at 12:45 p.m. and the respiratory rate and oxygen saturation were monitored at 3:47 p.m.(3 hours later) and pain scale was monitored at 8:10 p.m. (over 7 hours after initiation of PCA) and level of sedation was not documented as monitored.

The manufacturer insert for morphine indicated "Elderly patients may be more susceptible to respiratory depression and/or respiratory arrest following administration of morphine."






3) On 7/12/16 at 10:19 a.m., the clinical record for Patient 2 was reviewed with Licensed Staff F (LS F). The record revealed that Patient 2 had orders for restraints, written on 7/9/16. Further review of the order showed that the facility had a standard order form for physical restraints. The order had 4 different sections with different components under each section that can be selected by placing a check mark in front of the ones ordered. In the second section or the order, "Restraint Indicators" nothing was checked. Also none of the boxes were checked in the fourth section under the "Types of Restraints."

Review of "Medhost" notes where restraints comments, assessments, monitoring are documented showed documentation that the restraints were ordered on [DATE] for Patient 2 because the patient was "trying to pull out IV" line from the left arm. And that Patient 2 pulled out the IV in the emergency department. Additional comments describing what occurred to indicate the use of restraints included "some swearing" and saying "jumbled words".

If the [AGE] year old patient was trying to pull the IV line, using restraints, to prevent him from doing that would be considered medically necessary intervention, but the facility had to try alternative and less restrictive methods to solve the issue before resorting to use of the restraints. The measures that were attempted before using the restraints: "asked if he needed to urinate, continued to yell." Such intervention was not applicable to the situation the restraints were used.

If the [AGE] year old patient was trying to pull the IV line from his left arm, then restraining his right arm would be consider appropriate. The document included the type of restrains applied as follow: "Soft Limb Left Upper Extremity Soft Limb Right Upper Extremity Soft Limb Left Lower Extremity Soft Limb Right Lower Extremity." It was not clear how the [AGE] year old would be using his left arm, left leg, or right leg to pull the line from the left arm; therefore, restraining all four limbs would not be considered the least restrictive measure or would be considered appropriate for this situation.

4) On 7/12/16 at 10:19 a.m., the clinical record for Patient 2 was reviewed with Licensed Staff F (LS F). The record revealed that Patient 2, a [AGE] year old was given Haldol (an antipsychotic medication) as chemical restraints to control his behavior. The order was written on 7/9/16 at 11:06 a.m., for 2.5 milligrams of Haldol to be given by injection into the muscle every six hours as needed for agitation and anxiety.
Further review of the electronic medical record with LS F, showed in the medication administration record that Patient 2 was administered Haldol as follows:
On 7/9/16 at 11:09 for being "less combative but continues to yell."
On 7/9/16 at 18:53 for "shaking fist and yelling - call my mother."
On 7/10/16 at 3:09 for "moderate decrease in agitation notes at this time." and
On 7/11/16 at 00:55 for "agitation, anxiety"

Additional documentation in the Patient Care Notes, dated 7/9/16 at 18:49, showed documentation that the resident was "agitated and asking for the phone book ... shaking his fist..." for which the doctor was "notified of increased agitation and although the QT [heart rhythm] prolonged (the doctor) advised give additional dose of Haldol."

There was no documented clinical justification for putting the patient at risk of sudden death, which is a side effect related to Haldol use in the elderly population. According to the manufacturer's information, Haldol has a boxed warning, which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling for a medication. Boxed warnings document potential problems that can lead to serious injury or death. Haldol boxed warning that states: Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death ... Most deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious ..."

The warning of the medication, according to Lexi.com, (medication reference online) included the following: "Cases of sudden death, QT prolongation, and torsades de pointes (a fatal irregular rhythm) have been reported with haloperidol use; risk may be increased with doses exceeding recommendations and/or intravenous administration (off-label route) of intramuscular lactate injection...."

Review of the facility's policy titled, Use of Medical Restraints, revised 6/16, showed the following: "All patients have the right to be free from restraints or seclusion; of any form...All patients have the right to be free from restraints or seclusion that is not medical or legally necessary. Restraints or seclusion may only be imposed to insure the immediate physical safely of the patient, a staff member, or others ..."

5) On 7/12/16, at approximately 11 a.m., the clinical record for Patient 1 was reviewed with Licensed Staff F (LS F). Patient 1 had pain issues for which the patient was prescribed morphine. The order was written on 7/7/16 for morphine 2 milligrams to be given intravenously every 6 hours as needed for pain.

On 7/13/16 at approximately 11 a.m.., a concurrent review the medication administration record (MAR) with LS F, revealed documentation that pain assessment was not completed regularly. From 7/7/16 until 7/11/16, thirteen doses of morphine were administered to Patient 1. Four times the pain assessment was not completed after administering the medication, on 7/8/16 at 08:33 and 14:19, and on 7/9/16 08:33, and 14:44. Thirty percent of the time (four out of thirteen times), the response to pain management interventions (administration of pain medication) was not completed.

6) On 7/12/16, at approximately 11 a.m., the clinical record for Patient 1 was reviewed with Licensed Staff F (LS F). Patient 1 had pain issues for which the patient was prescribed methadone. The order was written on 7/9/16, for methadone 20 milligrams to be given by mouth every 8 hours.

On 7/13/16 at approximately 11 a.m., a concurrent review of the medication administration record (MAR) with LS F, revealed that pain assessment was not completed in association with administration of methadone. Methadone is a strong pain medication that has a boxed warning. The boxed warning for methadone documents association with fatal heart abnormal rhythms: "...serious arrhythmias (eg. torsades de pointes) have occurred during treatment. Most cases involve patients being treated for pain with large, multiple daily doses...May cause serious, life-threatening, or fatal respiratory depression."

Patient 1 was receiving both morphine and methadone concomitantly, which could exacerbate the respiratory depression side effect associated with use of both medications.

On 7/13/16 at approximately 10:40 a.m., Licensed Staff O stated on interview that for scheduled, routine pain medication, it is not expected to document pain assessment. However, for pain medication ordered on as needed bases, the expectation is to have pre and post assessment.

Evaluating response to pain medication serves to evaluate the 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 or methadone, such as sedation or decrease in respiratory rate.

Regardless of how the pain medication is orders, on as needed bases or on routinely, evaluation of the pain and its response to medications is essential to ensure the safety and comfort of patients.

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 followings:
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.

The facility's policy, titled, Patients with Pain, Standard of Care, last reviewed by the facility on 1/14, was reviewed. The policy included:
"Patients pain is reassessed:
1. After intervention for pain relief (e.g., 15-60 minutes after medication)
2. With each new report of pain
3. As needed, but at a minimum of every shift....
a. Monitor patient's response to medications..."


7) On 7/11/16, at approximately 11 a.m., the clinical record for Patient 1 was reviewed with Licensed Staff F (LS F). Patient 1 had a telephone order for diphenhydramine (medication for allergies) written on 7/2/16. The order was for diphenhydramine 25 mg to be given intravenously every 6 hours as needed to itching. Further review of the order showed no additional comments or any specifics regarding the itching.

On 7/13/16 at approximately 11 a.m., a concurrent review with LS F of Patient Care Notes from 7/1/16 until 7/13/ 16, revealed no documentation related to ordering of diphenhydramine or what actually happened to necessitate ordering it. The medication administration record showed that diphenhydramine was administered for several days even after the patient "reports no itching," "denies itching," or stated that "itching is gone."






8) During an interview on 7-14-16 at 11:15 a.m., Licensed Staff X stated he was a PICC nurse. Licensed Staff X stated he inserted PICC lines in patients and then determined correct placement of the line by chest X-ray. He stated he performed a "wet reading" where he read the X-ray to verify correct line placement and then cleared the line (determined the line was safe to utilize) for initial use. Licensed Staff X stated the physician read the chest X-ray later the day of line placement or the following day (after the nurse had cleared the line for use). When asked if the physician ever disagreed with his evaluation of line placement, Licensed Staff X stated, "yes."

During an interview on 7/14/16 at 2:15 p.m., Licensed Staff F stated to "clear the line for use" meant the nurses could use the PICC.

Review of PICC nurse job description (dated 3/1/16) indicated the nurse placed the PICC line. The job description did not indicate the PICC nurse was allowed to read a chest X-ray to determine the line was safe for initial use.

Review of facility policy titled, "Peripherally Inserted Central Catheter (PICC), effective date 1/27/16, indicated the tip of the PICC placement must be confirmed via chest X-ray prior to initiation of therapy. The document indicated the nurse must demonstrate competency reading ten radiographs correctly against the radiologist (physician) official read. The policy did not indicate the PICC nurse could independently determine the line was safe for initial use.

During an interview on 8/11/16 at 3:25 p.m., Licensed Staff X stated he had been trained to place PICC lines when he worked at a company in another state. When asked if anyone at this facility had observed him place a PICC line, to verify his competency prior to working independently, he stated no one had. He stated a physician had observed him place a PICC on a manikin, not an actual patient. When asked if a physician had verified his competency reading a chest x-ray prior to working independently, he stated no physician had.

When asked if he ever needed to reposition a PICC line after he had determined it was properly placed (because the physician's reading of the chest x-ray differed from his), Licensed Staff X stated he had. He stated he recently needed to reposition the PICC line (based on the physician read) on a patient who had physical abnormalities due to a birth defect.

Review of Patient 23's medical record revealed he had a PICC line placed by Licensed Staff X on 7/1/16 at 2:48 a.m. Licensed Staff QQ documented the PICC was inserted and, "verified by CXR (chest x-ray) at 0300 (3:00 a.m.) on 7/1/16." Review of physician chest x-ray report indicated Physician RR documented PICC line placement was verified by chest x-ray on 7/1/16 at 8:35 a.m. Review of the medication administration record indicated Licensed Staff QQ administered Vancomycin (antibiotic) in 250 cc's (cubic centimeters equaling approximately 8.5 ounces) of saline (salt) solution to Patient 23 on 7/1/16 at 4:15 a.m. (over five hours before Physician RR documented verification of PICC line placement).

Review of facility policy titled, "Standardized Procedure: PICC" (revised 9/2015) indicated RN's who have demonstrated competency in PICC placement may insert PICCs. The policy indicated the nurse would be trained by another competent PICC nurse and have successfully completed at least three PICC's with another competent PICC nurse.

Under the subtitle, "Procedure," #7. Obtain chest x-ray and stat [immediately] read of x-ray. The policy does not indicate the PICC nurse may read the x-ray and clear the PICC line for initial use. Under the subtitle, "Requirements," indicated, "3. RNs must demonstrate competency in placement of PICC catheters" and, "4. ...knowledge and competency will be assessed by qualified preceptor initially and annually."
VIOLATION: PATIENT CARE POLICIES Tag No: C0272
Based on interview and record review, the facility failed to ensure all policies were reviewed at least annually. This failure had the potential for the facility staff to follow policies that were not up-to-date standard practices potentially compromised patient care and patient's health safety.

Findings:

During a concurrent interview and record review of facility's policies on 8/10/16, at 2:20 p.m., Administrative Staff A stated the facility should review all the policies annually. Administrative Staff A stated the facility did not review policies in three departments including Hospitalwide-Clinical, IV (intravenous), and Respiratory in 2015 because there were "so many changes" needed for the policies and they "run out of time."

During an interview on 8/11/16, at 8:30 a.m., Administrative Staff A stated the Hospitalwide-Clinical policies were not reviewed in 2014 (These policies were not reviewed in 2014 and 2015). Administrative Staff A stated the policies should be reviewed by the managers of the department, medical staff committee, medical executive committee, and finally approved by the governing body.

The Hospitalwide-Clinical Policies and Procedures Approval Spreadsheet, dated 2015, revealed that there were 157 policies included in the Hospitalwide-Clinical department.

The Respiratory Therapy Policies and Procedures Review and Approval Spreadsheet, dated 10/2014 revealed there were 51 policies in the Respiratory Department.

The IV Policies and Procedure Review and Approval Spreadsheet, dated 8/2016, indicated there were 13 policies in the IV department.

During an interview on 8/12/16, at 9:50 a.m., Management Staff B, whose name was listed in the policy and procedure review spreadsheet for IV policies review, stated she reviewed policies and procedures for the medical/surgical department every year. Management Staff B stated she was told the PICC nurse reviewed the IV policies.

During an interview on 8/12/16, at 10:10 a.m., the Chief Nursing Officer stated some policies and procedures were not reviewed. The Chief Nursing Officer stated staff were busy and "didn't get to it." She stated "That's the best answer I can give it to you." The Chief Nursing Officer stated she was coordinating the Hospitalwide-Clinical policies and procedures and there were many policies and many people working on the policies. She stated she knew the existing policy review system was not working and was changing the system. The Chief Nursing Officer stated the IV policies were assigned to Management Staff B but Management Staff B did not know anything about it; therefore, the IV policies were assigned to the PICC nurse this year 2016 and were waiting for Governing Body's approval. The Chief Nursing Officer stated the Respiratory policies were assigned to the department manager but the department manager did not know how to write the policy and procedure. The Chief Nursing Officer stated she helped the Respirator department manager to write the policies this year 2016 and were waiting for Governing Body's approval.

The facility's policy and procedure titled "POLICY AND PROCEDURE MANAGEMENT PROCESS," revised 2/16, indicated "All [name of the facility] policies and procedures (P&P) will be in compliance with regulatory agencies and will be reviewed as required...As a critical access hospital, all patient care related policies will be reviewed annually..."
VIOLATION: POLICIES - DRUG MANAGEMENT Tag No: C0276
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview and record review, the facility failed to ensure safe use and storage of medications as evidenced by the following:

1. Allowing use of medications in a manner that was inconsistent with manufacture's specification when Haldol with risk of causing sudden death was used for an elder patient, in the presence of risk factors such as prolonged QT (abnormality in the heart electrical signal causing irregular heart rhythm),

2- The policies for writing clear and complete medication orders were not implemented:
a. The as needed blood pressure medications ordered for Patient 2 did not have specific parameters to indicated when to use which of the medications. The orders did not have prioritization numbers assigned to them as indicated in the policy.
b. Mupirocin, the antibiotic topical order for Patient 1 did not include the area to which to be applied.
c. Diphenhydramine, a medication for itching was ordered for Patient 1 without any documented clinical justification for its use.
d. The physical restrains order form was not completed to specify the type of restraints to be used or the indication for use,

3. Maintenance of the equipment that was used to prepare sterile (free from bacteria and living microorganisms) injectable medications was not completed in accordance with the policy and the manufacture's specification,

4. There was no system used to readily identify controlled substance misuse, and detect potential abuse and diversion as resolved discrepancies of controlled substance were not periodically evaluated to look for trend of identify potential misuse,

5. Policies that addressed facility's practices were not written clearly or updated to reflect current practices. Some of these policies were duplicative or confusing,

6. Emergency medication supplies were not sealed by the pharmacist in accordance with state regulations. Such failure did not ensure availability of emergency medications and 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.

7. Emergency drug supplies were not checked on regular bases. Such failure did not ensure availability of emergency medications and 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.

8. Expired, or unusable medications were not removed from supplies and left available for use, inconsistent with facility's policies medications. Such failure had the potential to put patients at risk of receiving ineffective, contaminated, or expired medications and increased risk for treatment failure and patient harm.

9. Procedures for safe and effective use of medications were implemented when a physician order contained a facility identified "Do not use abbreviation" in the directions of a fentanyl (opioid for pain) patch on two separate admissions for Patient 4. This failure had the potential of causing medication errors and exposing the patient to side effects of the medication including over sedation and respiratory depression.

Such failures put patients at increased risk of developing adverse consequences and potential for patient's harm from using medications in unsafe manner especially in the absence of current clear policies for such practices.

Findings:

1. On 7/12/16 at 10:19 a.m., the clinical record for Patient 2 was reviewed with Licensed Staff F (LS F). The record revealed that Patient 2 a [AGE] year old was given Haldol (an antipsychotic medication) as chemical restraints to control his behavior. The order was written on 7/9/16 at 11:06 a.m., for 2.5 milligrams of Haldol to be given by injection into the muscle every six hours as needed for agitation and anxiety.

Review of the electronic record for Patient 2 with LS F, showed no documented evidence of agitation or combative behaviors to necessitate ordering Haldol. Further review of the electronic medical record showed that the medication was administered multiple times for yelling and wanting the phone book. According to the medication admiration record, Patient 2 was administered Haldol as follow:
On 7/9/16 at 11:09 for being "less combative but continues to yell."
On 7/9/16 at 18:53 for "shaking fist and yelling - call my mother."
On 7/10/16 at 3:09 for "moderate decrease in agitation notes at this time." and
On 7/11/16 at 00:55 for "agitation, anxiety"

Additional documentation in the Patient Care Notes, dated 7/9/16 at 18:49, showed documentation that the patient was "agitated and asking for the phone book ... shaking his fist..." for which the doctor was "notified of increased agitation and although the QT prolonged ( the doctor) advised give additional dose of Haldol."

There was no documented clinical justification for putting the patient at risk of sudden death, which is a side effect related to Haldol use in the elderly population.

According to the manufacturer's specification, Haldol has a boxed warning, which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling for a medication. Boxed warnings document potential problems that can lead to serious injury or death. Haldol boxed warning that states: Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death ... Most deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious ..." The warning of the medication, according to Lexi.com, (medication reference online) included the following: "Cases of sudden death, QT prolongation, and torsades de pointes (a fatal irregular rhythm) have been reported with haloperidol use; risk may be increased with doses exceeding recommendations and/or intravenous administration (off-label route) of intramuscular lactate injection...."

There was no documented evidence of pharmacy or nursing intervention for the use of Haldol in an elder patient in light of the increased risk of developing dysrhythmia and potential death.


2- The facility's policy for writing clear orders was not implemented:
2. a. On 7/12/16 at 10:19 a.m., the clinical record for Patient 2 was reviewed with Licensed Staff F (LS F). The record revealed that Patient 2 was receiving two different medications to control blood pressure. Both medications were ordered on the same day 7/9/16, at the same time, at 14:33, and by the same physician. One order was for enalaprilat, a blood pressure medication that centrally inhibits constriction of the blood vessels. The order was for 2.5 mg of enalaprilat to be given every 6 hours as needed for hypertension (high blood pressure). There were no additional comments or directions for the exact situation, or the conditions for which to give this medication.

The other order was for hydralazine, a medication to reduce blood pressure by dilating the blood vessels. The order was for 10 milligrams (mg) every 6 hours as needed for hypertension. In the comment section of this order there was directions to give the medication as needed for systolic blood pressure higher than 160 .

Both medications were ordered on the same day for the same indication. The as needed blood pressure medications did not have specific parameters to indicated when to use which of the medications. There was no safety measure such as maximum doses not to be exceeded or when to contact the physician. There was no documented evidence that any of these orders were clarified by nursing or pharmacy staff.

Review of the facility's policy titled, Medication Management, revised 11/15, showed, on page 5 of 6, under expectation for prn orders the following:
"Will include the indication for use; ie, pain nausea, etc.
* Will require prioritization (ie, 1st, 2nd, or "if"-state conditions(s)) based on the prescribers clinical interpretation of the patient's condition
* If it is determined that the parameters are not clear or cannot be interpreted by the Nurse or Pharmacist- the prescriber IS TO BE CALLED for clarification."

2. b. On 7/12/16, at approximately 11 a.m., the clinical record for Patient 1 was reviewed with Licensed Staff F (LS F). Patient 1 was receiving multiple medications including topical antibiotic for ulcer of the foot. Mupirocin 2%, also known as Bactroban, was ordered, on 6/26/16, to be administered every day. Concurrent review of the electronic record with LS F, including the details of the order, showed no additional notes or instructions to specify where the antibiotic topical medication to be applied. There was no documented evidence that the order was clarified by nurses or pharmacy staff.

2. c. On 7/12/16, at approximately 11 a.m., the clinical record for Patient 1 was reviewed with Licensed Staff F (LS F). Patient 1 had a telephone order for diphenhydramine (medication for allergies) written on 7/2/16. The order was for diphenhydramine 25 mg to be given intravenously every 6 hours as needed to itching. Further review of the order showed no additional comments or specification for the itching. There was no documented evidence that the order was clarified by nurses or pharmacy staff.

2. d. On 7/12/16 at 10:19 a.m., the clinical record for Patient 2 was reviewed with Licensed Staff F (LS F). The record revealed that Patient 2 had orders for restraints written on 7/9/16. Further review of the order showed that the facility had a standard order form for physical restraints. The order had four different sections, with different components under each section that can be selected by placing a check mark in front of the ones ordered. In the second and the fourth section, none of the boxes were checked. In the second section "Restraint Indicators" nothing was checked, and under the fourth section "Types of Restraints" nothing was checked either.

The order for restraints was not completed: It did not specify the types of restraints to be used or the reason (indication) for which to be used. There were six options for restraints, and three options under the indicators for use to chose from.

Review of the facility's policy titled, Use of Medical Restraints, revised 6/16, showed that the following under PRN (as needed) Ordering or Restraints and Seclusion: "Order for the use of restraints or seclusion must never be written as a standing order or on as needed bases."
Leaving nine components in the order unspecified constitute an as needed bases order. Such order was not specified based on evaluation of the patient. There was no documentation of what necessitated the use of restraints. There was no evidence of "... management of violent or self-destructive behavior that jeopardize the immediate physical safety of the patient, staff or others" as stated in the policy.

There was no documented evidence that the order was clarified by nursing or pharmacy staff.

3. On 7/11/16 at approximately 11 a.m., in the presence of Pharm P (a licensed pharmacist), the pharmacy area was inspected. In a designated room in the pharmacy, the device (glovebox, also known as Isolator) used for preparing sterile medications injectable was observed. Pharm S (a pharmacy staff) explained that the gloves for this device are changed on daily bases or more when needed, and the sleeves (where the arms of the operator are inserted) and the rings that hold the sleeves in place are changed every six months.

On 7/12/16 at approximately 3 p.m., the IV ROOM cleaning log was reviewed; IV is short for intravenous (intended to be giving through veins). The log had designated columns for documenting what was done, the date it was completed, and the initial of the person completing the task. The IV room cleaning logs were reviewed; there was no initials indicating that the sleeves were changed in March 2016 as stated by pharmacy staff. In fact, eleven months were reviewed, but none of them had documentation that the sleeves were changed every 6 month in accordance with the facility's policy and the device manual.

4. On 7/11/16 at 12:40 p.m., accompanied with MS B, the emergency department medication room was inspected. At the same time, Licensed Staff K, (LS K) was asked to show the system for access and storage of control substance. LS K demonstrated removal of controlled substance and explained the system for having to count what is in the drawer and entered in that number in the medication automated dispensing cabinet (ADC). Licensed Staff K explained that if there was an error in counting, the ADC will generate a discrepancy report. Facility Staff are expected to resolve discrepancies before the end of their shift; LS K added that two nurses have to count the medication and entered the number into the ADC, and cosign; such action would resolve the discrepancy. But, if the discrepancy was not resolved, then, the manager would be involved in the resolution process, as a manager can back track and check the activities of removal of medications.

On 7/11/16 at approximately 4 p.m., the Director of Pharmacy explained that they track on daily bases all discrepancies. She added that the information are used for education purposes. The DOP stated that the discrepancies are evaluated to ensure every removal of medication is accounted for. For controlled substance, the DOP stated that if a discrepancy is not resolved within a specific time frame, staff access is deactivated, so that staff has to contact the manager or the pharmacist for the electronic access to be reestablished, at which time the discrepancies are addressed with that staff.

To resolve a discrepancy, according to facility practice, a nurse can get another nurse to count and cosign for the current count.

The discrepancy report from 4/1/16 to 7/12/16 was reviewed and the documented reasons for discrepancies had comments that were very general such as, error in count, miscount, and wrong count. There was no documented evidence that the facility looked at these resolved discrepancy to evaluate what exactly happened. These resolved discrepancies were not tracked or trended to identify potential misuse, abuse or diversion.

On the discrepancy report from 4/1/16 to 7/12/16, Dilaudid 2 milligrams/milliliter, (a very strong pain medication also known as hydromorphone) appeared on the report. From 6/4/16 at 11:19 p.m., until 6/6/16 at 6:48 a.m., there were discrepancies for six vials involving three patients. The DOP stated that pharmacy staff that checks these reports completes cycle counts to confirm the amount present.

Ensuring accuracy of the final count is not a true resolution because it does not address what actually happened: Was there an order for the medication for that specific patient? What was the dose, and how often was it to be administered? What was actually administered, what was wasted, and was there a co-signature for the waste? There was no documented evidence that clinical records were evaluated to validate what was removed, the discrepancy, and the resolution.

When requested the policy for controlled substance accountability, four difference policies were provided:
Controlled Drugs: Anesthesia, revised 10/11;
Controlled Drugs: Administration, no revision date, but last reviewed on 6/15;
Controlled Drugs: Management, revised 11/14; and
Controlled Drugs: Inventories DEA and State of California, no revision date, but last reviewed on 6/15. Only the Controlled Drugs: Anesthesia, revised 10/11, addressed discrepancies and included a specific procedure for random verifications of entries to compare the amount administered with the removal record.

5. The facility had multiple polices for the same concerns, but these policies were different and sometimes conflicting or did not bridge the gap found in another. The presence of multiple polices can be confusing to staff as evidenced by the following examples:

a. When asked for the policy addressing monitoring of refrigerated medications three policies were presented:
Medication Storage - General, revised on 11/14,
Storage Temperatures, revised 6/15, and
Automated Medication Dispensing Systems (AQMDS) and Automated Dispensing Units (OmniCell), effective 5/11/15,

If a staff person found a medication refrigerator temperature out of range, and pulled the policy to see what to do; the employee would find the following in one of the policies: In the Automated Medication Dispensing Systems (AQMDS) and Automated Dispensing Units (OmniCell), effective 5/11/15 included:"The temperature of all medication refrigerators attached to the AMDUs are continuously monitored and can remotely notify appropriate personal when not in the specified USP temperature range (36-46 F/3-8 C)." However, this policy did not refer to the other policies which addressed monitoring refrigerator not attached to AMDUs. The Storage Temperatures policy, revised 6/15, addressed monitoring refrigerators not attached to the AMDUs: "If temperatures deviate from the acceptable range, pharmacy or the pharmacist on call, shall be notified before an adjustment shall be made by the personnel noting the deviation." But if an employee pulled one policy and did not know about there others, the staff would not be clear on what procedure to follow or what to do.

b. There were two duplicative policies existed for medications management.
Medication Management Orders: General, revised on 6/15, and
Medication Management, revised 11/15.
These policies did not refer to one another for compellation and did not have a clear title to distinguish them apart and make it clear and easy for staff to know which policy addresses what issue. Medication Management revised 11/15, addressed physician computerized order entry (CPOE) but without actually looking at the policy, it is impossible to know what the policy addressed.

6. On 7/11/16 at approximately 12 p.m., accompanied with Licensed Staff L (LS L) the emergency medication supply (crash cart) in the medical surgical nursing station was inspected. The crash cart was in the hallway and had four different drawers locked individually with plastic breakable seals; the medication drawer had a green color sealed. LS L explained that the pharmacist locks the medication drawer (green seal) and nurses check and lock the other drawers.

Medications such as intravenous (intended to be giving through veins) solutions and lidocaine (used to numb the skin for procedures) were seen in the other drawers of the cart that were checked and sealed by nurses on regular bases.

This practice was represented in the facility's policy, titled Crash Carts (Maintaining Supplies, Equipment and Medications), revised 12/05. However, the policy did address the medications included in the other drawer in the crash carts and how to ensure that these drawers (since they contained prescription items in the) were sealed by a pharmacist. Having nurse's check and seal medications in the emergency crash cart is not consistent with the state regulation.

7. On 7/11/16 at 12:40 p.m., accompanied with MS B, the emergency department medication room was inspected. In the medication refrigerator, was a small clear plastic container, locked with breakable seal that had CroFab in it. CroFab is an antivenin used for management of patients with snake bites. The box had an orange colored label on indicating that it was filled on 4/2016 and checked on 5/15/16. Emergency drug supply should be checked regularly (no less frequently than every 30 days) by a pharmacist. But there was no documented evidence the supply was checked in June or July.

The facility's policy, titled, Crash Carts (Maintaining Supplies, Equipment and Medications), revised 12/05 was reviewed. The policy did not include the different type of emergency medications such as the [DIAGNOSES REDACTED] crash cart, pediatric crash cart, or the CroFab kit or the requirements that these supplies were to be checked on regular bases.

8a. On 7/11/16 at 11:45 a.m., accompanied by Management Staff B (MS B), the medical surgical (Med-Surg) medication room was inspected. A one liter bag of Dextrose (sugar) intravenous (intended to be giving through veins) solution was observed on the shelf to be removed from its protective outer wrap. Once removed from the outer wrap, the solution is are considered stored under modified storage conditions and is usable for a shorter period of time.

According to the manufacturer's directions for use, the outer wrap of the solution container should not be removed until the product is needed for use as the outer wrap protects the container from damage and prevent evaporation of the content.
Management Staff B took the bag and stated that it should have been dated. In the absence of removal date, it is not possible to know if the bag was usable or not.

The facility's Policy, titled Sterile Products: Storage, revised 6/15 was reviewed. The policy included the following: "Outer Wrappers are remover, the following retention requirements apply: If the outer wrapper is removed prior to use and the IV bad is not labeled, the bag will be discarded. "
It was not known when the outer wrap was removed; the bag was not labeled with the open date, and inconsistent with facility's policy, the bag was available for use.

8b. On 7/11/16 at 11:45 a.m., accompanied by MS B, a bottle of Latanoprost 0.005 % eye drops, used for reduction of pressure in the eyes in patients with glaucoma was seen in the Med-Surg. medication refrigerator. The bottle was in use, labeled for a specific patient, and it had a sticker specifically to write the open date on it. But there was no open date. The manufacturer's specification for storage of this produce is as follow: "Store intact bottles under refrigeration at 2C to 8C (36F to 46F). Protect from light. Once opened, the container may be stored at room temperature up to 25C (77F) for 6 weeks."

The policy addressing storage of medication was requested, and several policies were provided and reviewed. However, the procedure about writing the open date on the bottle was not found in any of the policies that were reviewed.

8c. On 7/11/16 at 11:45 a.m., accompanied by MS B, a bottle of Lantus, a type of insulin used to control blood sugar, was seen in the Med-Surg medication refrigerator. The insulin was in use, labeled for a specific patient, and it had a sticker specifically to write the open date on it. The open date was not documented, the label for that was blank. According to the manufacturer's recommendations for storage and use of Lantus, "...Once punctured (in use), store vials refrigerated or at room temperature <30C (<86F) and use within 28 days." RN C stated that according the policy for medication storage, they can keep Lantus for 28 days. In the absence of the open date, it was not possible to know if Lantus was usable or expired.

The facility's Policy, titled Sterile Compounding: Single -Dose and Multiple Dose Container & CSP Risk Levels & Immediate Use CSP, effective date, 10/15 was reviewed. The policy included the procedure for multiple - dose vials and addressed the (beyond use date) BUD as follow:
"The BUD after initially entering or opening (e.g., needle punctured) is 28 days unless otherwise specified by the manufacturer."

8d. On 7/11/16 at 12:40 p.m., accompanied with MS B, the emergency department medication room was inspected. A single dose vial of Toradol 30 milligram (medication used for inflammation and pain control) was seen, there were puncture marks indicated that it had been used.

The facility's Policy, titled Sterile Compounding: Single -Dose and Multiple Dose Container & CSP Risk Levels & Immediate Use CSP, effective date, 10/15 was reviewed. The policy included the procedure for handling single dose vials. The policy had the following: "Opened or needle-punctured single- dose containers shall be used within 1 hour if opened in worse than ISO class 5 air quality and any remaining contents must be discarded." International Standards Organization (ISO) class 5 is a designation for a cleanroom environment with very limited number/size of particles allowed in the air; such area is used to prepare sterile injectable medication.






9. Review of Patient 4's clinical record indicated for two of her admissions dated 5/28/16 and 6/24/16 her physician orders included fentanyl patch 100 micrograms (mcg) to be applied "QOD" (an abbreviation for every other day).

Review of facility policy "Abbreviations, Medical: "Do Not Use" reviewed date 10/15 included an addendum A that indicated "Nurses and Physicians Please Note: These handwritten abbreviations must not be used, effective immediately ...QOD...Approved Alternative: Every other day or "even days" or "odd days...Common Error...the "O" can be mistaken for the "I".The result is that med is given QID (four times a day instead of every other day)."

During an interview on 7/12/16 at 5:20 p.m. the Director of Pharmacy, DOP stated that the expectation was for the pharmacist to call the physician and get the "Do Not Use" abbreviation of QOD changed to every 48 hours.

Fentanyl patch is a high potency opioid used for pain and has a boxed warning which is the strongest warning the FDA (food and drug administration) can require a pharmaceutical company to place on the labeling of a prescription drug, or in literature describing it. Following is part of the black box warning: "Respiratory depression and death may occur with use of fentanyl transdermal system, even when fentanyl transdermal system has been used as recommended and not misused or abused."
VIOLATION: POLICIES - INFECTION CONTROL Tag No: C0278
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, the hospital failed to provide a functional and sanitary environment when infection control practices were not implemented in accordance with hospital policy and nationally recognized standards. The hospital also failed to ensure they had an effective, active and a systematic infection control surveillance program in place for identifying, investigating and controlling infections. Consequently, the hospital:

1. The hospital did not have a method for determining the humidity level in their central sterile area (an area where surgical instruments are sterilized and processed), central sterile storage (storage area for sterile supplies), and decontamination room.

2. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards when the hospital failed to ensure there was no presence of spotting and staining on 2 of 2 processed surgical trays (previously cleaned, disinfected and sterilized surgical instruments).

3. The facility failed to ensure they had an effective, active and a systematic infection control surveillance program in place for identifying, investigating and controlling infections.

4. The hospital failed to ensure a Central Service Technician (CST 1) followed Nationally Recognized Infection Control standards and manufacturer directions for use when cleaning and disinfecting surgical instruments.

5. The hospital failed to ensure each step for high level disinfecting (HLD - complete elimination of all microorganisms in or on an instrument, except for small spores), was performed when an Ultrasound Technician (UT 1) failed to perform HLD of vaginal probes (a transducer used to perform a medical ultrasound by inserting the probe through the vagina to visualize pelvic cavity organs), according to manufacturer directions for use.

6. The hospital failed to identify, adopt and effectively utilize nationally recognized infection control standards, such as the Association for Professionals in Infection Control and Epidemiology (APIC) , Center for Disease Control (CDC as the national recognized standards that "drive" the EOC (environment of care) program.

7. Failed to provide effective Infection Control monitoring and surveillance of areas designated as restricted and semi-restricted and failed to provide training for staff to recognize and implement facility adopted AORN standards for restricted and semi-restricted (sterile and sub-sterile) areas.

8. The facility did not have a physician supervised antimicrobial stewardship committee.

9. The facility did not follow policies and procedures to maintain recommended humidity levels in the two operating rooms (OR). This failure had the potential for growth of bacterial contaminants resulting in the risk of infection.

10. facility failed to implement policies and procedures for infection control when Licensed Staff X failed to garb appropriately when attending to a patient in contact precautions isolation room (used to reduce transmission of infection). This failure had the potential of spreading infections due to cross contamination.

11. Staff did not follow the facility's policis to use the glucometer on a patient in a contact precaution room.

12. Staff did not properly clean the emergency exam rooms.

13. Staff did not properly dispose the used syringe.

14. Employee's files did not contain current vaccination records.

15. Staff did not properly clean the isolation room.

16. The facility staff were not current with annual [DIAGNOSES REDACTED] screening per facility policy and regulations.

17. The facility did not accurately or completely screen 2 of 30 sampled patients (24, 30) for Methicillin-resistant Staphylococcus aureus (MRSA), a bacterium responsible for several difficult-to-treat infections in humans, and immunizations. These failures had the potential for undetected infection to compromise patients' healing process, and to potentially spread infection among the remaining inpatient population.

18. Staff did not properly wear gown and dispose the infectious materials in a room with[DIAGNOSES REDACTED] contact precaution.

19. Staff did not change gloves and wash hands between procedures and patients when providing patient care in a[DIAGNOSES REDACTED] contact precaution room.

C diff (Clostridium difficile) is a bacterium in feces that causes watery diarrhea and is a frequent cause of antibiotic associated diarrhea, with the potential for widespread exposure of pathogenic organisms to all patients. Contact precautions are rules and procedures that staff and visitors must follow when they are in the room of a patient who has been diagnosed with [DIAGNOSES REDACTED]

20. Staff's personnel files did not contain complete health screening and vaccination records.

Theses failures could have resulted cross contaminations and a wide spread of infection among patients.

Findings:

1. On 8/8/16 at 2:30 PM, during an interview, with the Infection Control Preventionist (ICP) and a concurrent observation of the central sterile area, the ICP stated that the facility adopted the Association of peri-Operative Registered Nurses (AORN), Centers for Disease Control (CDC), among others, as their nationally accepted infection control guidelines.

a. During an immediate tour of central sterile, the electronic temperature gauge registered 79.3 degrees Fahrenheit and within 15 minutes the temperature gauge registered 79.9 degrees. An immediate interview was conducted with a Central Sterile Technician (CST 1), who verified the findings and stated that they have had problems maintaining the temperature less than 74 degrees Fahrenheit as indicated by AAMI (Association for the Advancement of Medical Instrumentation - a nationally recognized organization for advancing the development and safe and effective use of medical technology).

b. During the same tour, at 2:55 PM, an observation was made of the Central Sterile Storage area; the room contained many sterile supplies and had no method of determining the temperature or humidity level of the room. According to Licensed Staff E, the area was converted from a patient unit to an area for storage of sterile supplies and had no method for obtaining temperatures or humidity levels.

c. At 3:25 PM, the decontamination and Processing Room (a working area where equipment and supplies used for the examination of the gastrointestinal tract and surgical instruments are cleaned and disinfected) was also toured and the temperature registered 75.6F but there was no method of determining the humidity level. The temperature was verified with Licensed Staff E and CST 1. Licensed Staff E stated that they did no monitor the humidity level in the decontamination room.

No daily temperature or humidity logs or policies relevant to temperature and humidity for the Central Sterile Storage area and the Decontamination and Processing Room were available.

According to the CDC "Healthcare Infection Control Practices Advisory Committee Guideline for Disinfection and Sterilization in Healthcare Facilities", the "sterile storage area should have controlled temperatures and may be as high as 75 degrees Fahrenheit and the relative humidity should be 30% to 60% in all work areas except sterile storage, where the relative humidity should not exceed 70%" . According to AAMI Standards (AAMI ST79), temperatures and humidity levels should be monitored in all areas of sterile processing.


2. On 8/8/16 at 2:55 PM, a tour and observation of the hospital's Central Sterile Processing Department was conducted with the ICP, who stated that the facility adopted the Association of peri-Operative Registered Nurses (AORN), Centers for Disease Control (CDC), among others, as their nationally accepted infection control guidelines.
Licensed Staff E and CST 1 were present during the observation and informed that surgical instrument packages which had already been processed (sterilized) would need to be opened and inspected. A major tray (a tray which contained multiple sterile instruments) was opened and found to have four surgical instruments with brown staining and one Minor tray contained 5 surgical instruments with brown staining. CST 1 stated, she was unsure of what the brown stains were but thought they could be "over usage" of the instruments. CST 1 also indicated that she didn't think they could remove the stains, as she attempted to scratch off the brown stains but was unsuccessful. A policy for inspection of surgical instruments was requested however CST 1 indicated that she did not think they had one and none was provided during the survey.

AORN (2016), "Guidelines for Cleaning and Care of Surgical Instruments," specifies, "When surfaces cannot be contacted by cleaning solution, thorough cleaning cannot be achieved; thus, these surfaces can retain organic material and debris. These retained materials can prevent contact of cleaning solutions and disinfecting or sterilizing agents with instrument surfaces; reduce the effectiveness of subsequent disinfection or sterilization processes..."


3. A record review on 8/8/16 at 3 PM was conducted of a hospital policy titled, "Infection Prevention and Control Plan, revised on 1/16", indicated the hospital had an Infection Control Program/Committee.
On 8/9/16 at 10:50 AM, the hospital Infection Control Preventionist (ICP) was interviewed and stated that they did not have a formal infection control committee/program or meeting minutes for the last three (3) years.
During an interview on 8/9/16 at 11:10 AM, with two members of the hospital Quality Improvement Committee (Administrative Staff A and the Chief Nursing Officer-CNO) they both stated that for approximately 3 years, the hospital did not have a formal infection control program/committee and acknowledged their policy indicated that they had one.

4. On 8/8/16 at 3:30 PM, a tour and observation was made of the hospital's decontamination room (a room where they clean dirty surgical instruments) with the ICP, Licensed Staff E and CST 1. CST 1 was present and was asked to demonstrate how she cleaned the dirty surgical instruments. The CST indicated that she had some dirty instruments that she was getting ready to process.

During a previous interview, on the same day, the ICP and CST 1 stated, the facility adopted the Association of Peri-Operative Registered Nurses (AORN), Centers for Disease Control (CDC), among others, as their nationally accepted infection control guidelines.

During the observation of CST 1 cleaning the dirty instruments, the following concerns were identified:

a) She removed approximately 25 to 30 various types of surgical instruments from a plastic bin, separating them and placed approximately 15 surgical instruments into a small sink filled with water, and a cleaner and pre-soak solution (Multi Enzymatic Detergent {Pressoak}) and the rest she placed to the side of the sink on top of a towel. CST 1 did not submerge all surgical instruments in the water to allow them to soak for "at least 2 minutes, per manufacturer recommendations."

b) She did not premeasure the water or the detergent and stated she was unsure of how much water she used and "about this much, half sink full" to two pumps of detergent.

c) CST 1 stated that she separated the "used" instruments from the "non used" instruments. She was asked to provide a clear explanation of "used" from "non used". She stated that the surgical instruments that were not used for a surgery are not soaked and scrubbed, but the "used" instruments were. CST 1 also stated that although, the instruments were opened during a procedure but not used, they did not have to go through the soaking and scrubbing process.

d) CST 1 scrubbed the instruments above the water and under the running water using a small brush.

The directions for use of the detergent stipulated the following:
"Add - 1 U.S. fluid ounce of Multi Enzymatic Detergent to 1 U.S. gallon (7-8ml/l) of water (warm). For heavy organic load, 2 U.S. ounces per 2 U.S. gallon (15.6 ml/L) of water may be required. Soak the instruments for at least two minutes ..."
According to AORN, guideline for cleaning and care of surgical instruments, "if an instrument is opened onto the sterile field in the operating or procedure room should be cleaned and decontaminated whether or not they have been used. Airborne microorganisms may come in contact with instruments that have not been used. Scrubbed persons may touch and contaminate instruments without being aware of it. Instruments that were used may come in contact with unused items. Contamination of unused instruments on the sterile field can occur without the occurrence being noticed."

A policy was requested for cleaning and disinfecting of instruments but was not provided by the end of survey.

5. On 8/9/16 at 11:10 AM, accompanied by the ICP, an observation was conducted of an imaging room of one of the hospitals outpatient clinics. An ultrasound technician (UT 1), who was present, was asked to demonstrate the HLD process of vaginal probes (a transducer used to perform a medical ultrasound by inserting the probe through the vagina to visualize pelvic cavity organs).

UT 1 stated that they used "Revital Ox Disinfectant" and proceeded to demonstrate the process. The following concern was identified:

No thermometer was located near or in the disinfectant and UT 1 stated that they did not have to obtain the temperature of the disinfectant.

On 8/9/16 at 11:30 AM, a record review was obtained of the manufacture directions for use, provide by the facility. The document stipulated, "INDICATIONS FOR USE:..High level disinfection is achieved when all surfaces have been contacted for eight minutes at a temperature of 20 degrees Celsius/68 degrees Fahrenheit ...) Under the section titled, "HIGH LEVEL DISINFECTION: Once the instrument has been immersed and all surfaces in contact with the disinfectant solution, soak the instrument for 8 minutes at 20 degrees Celsius ..."

A hospital policy was requested; the policy, "Trans-Vaginal L Probe & TEE Probe Cleaning and Handling, dated 12/15 as reviewed", did not mention to obtain the temperature of the solution and did not reference the manufacturers name.

6. During an interview with the ICP, she was asked which nationally recognized infection control guidelines they adopted and followed. The ICP stated, Association of Peri-Operative Registered Nurses (AORN), Centers for Disease Control (CDC), among others, as their nationally accepted infection control guidelines.

During the survey, from 8/8/16 to 8/12/16 at various times, multiple hospital infection control policies were reviewed. The policies which were reviewed, did not reference any nationally recognized infection control guidelines. The following policies among others were reviewed and showed the following:
"Decontamination of sterile instruments and trays requiring hospital wide transport, last reviewed 9/15." reference: "hospitalwide transporting/cleaning/disinfecting medical equipment".

"Operating Room Air Exchanges, reviewed 9/15" provided no references.

"Blood Glucose Monitoring: Infection Control Procedures, revised 8/15" provided no references.

"Patient Room - Occupied, Cleaning, reviewed 11/15" provided no references.

"Patient Room - Discharge/Transfer, Cleaning, reviewed 11/14," provided no references.

"Patient Care Equipment, Cleaning of, reviewed 1/16," provided no references.

"Surgery Department, Cleaning, reviewed 11/15," provided no references.

"Cleaning and Disinfection of Movable Medical Equipment/Devices, reviewed 1/16," provided no references.
"Infection Control Practices, last reviewed 9/15," provided no references.

On 8/10/16 at 10:50 AM, during an interview with the ICP, she indicated that she realized some of their policies did not reference nationally recognized infection control guidelines and was in the process of hiring a full time infection control staff because she was only at the hospital two times a week.

7. Observation 1: On 8/8/16 during a tour of the Central Sterile Storage, at 2:55 PM and accompanied by the ICP, CST 1, and Licensed Staff E, the following was observed:

The room contained many sterile supplies
No signage observed to identify if the area was considered a restricted, semi-restricted or unrestricted
There was an opened door in the back of the room, not labeled, and adjacent to multiple sterile items
Inside the room was a toilet without a cover, a sink, a trashcan, and a red biohazard bin.

During an immediate interview with Licensed Staff E, he stated that the area used to be a patient unit which was converted to sterile storage but he was unsure when the conversion occurred. Licensed Staff E also stated that the area was a restricted area and only accessible to Operating Room staff.

During the same time, an interview was conducted with the ICP who stated that the door located in the back of the room was a bathroom and that the door was always locked. The ICP observed surveyor open the door and stated that it was usually locked. Licensed Staff E said that he believed only female staff used the bathroom. ICP and CST 1 indicated that AORN was one of the hospital's national infection control standards adopted by the hospital.

Observation 2: On 8/8/16 at 3:30 PM, after CST 1 completed cleaning and decontaminating dirty surgical instruments in the decontamination room, she did not wash her hands and did not use hand sanitizer. CST 1 walked out of the decontamination room, crossed a red tape lined area (signifying a restricted area, located in the OR {operating room}) and proceeded to wash her hands in the surgical staff scrub sink (where OR staff wash their hands prior to performing surgeries).

In a subsequent interview, CST 1 indicated that other than the sink which was used to decontaminate dirty surgical instruments, they did not have a hand washing sink located in the decontamination room and the hand sanitizer was located across from decontamination room on a staff ' s desk. The ICP indicated that she did not realize they did not have a hand washing sink in the decontamination room or near it.

A documentation review of The Perioperative Standards and Recommended Practices published by the AORN (Association of Perioperative Registered Nurses), 2014 edition indicated "Traffic patterns should be designed to facilitate movement of patients and personnel into, through and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls and surgical attire required. The semi-restricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite. Traffic in this area is limited to authorized personnel and patients. The restricted area includes operating rooms, procedure rooms, and the clean core area."

A hospital policy was requested from the ICP, for restricted vs unrestricted areas, but was not provided during the course of the survey.






8. On 7/11/16 at 3:30 p.m., the Director of Pharmacy (DOP), stated on interview that she was not responsible for the antimicrobial stewardship program and that there was no one leading it since January 2016.

On 7/13/16 at approximately 4:30 p.m., Administrative Staff A, (AS A) confirmed during interview that the facility does not have a physician lead for the antimicrobial stewardship committee. AS A added that the physician that was qualified and trained and lead the committee in the past, resigned in December 2015, and they do not have anyone yet.





9. A tour of the surgery department was conducted on 7/12/16 at 1:57 p.m. During a concurrent interview the Director of Surgery (Licensed Staff E) stated that humidity levels were manually monitored and logged every morning.

Review of facility policy "Thermal Environment" review date 9/15 indicated "Purpose a. To provide information and guidance in regard to proper temperature and humidity to...reduce airborne bacteria and other hazards...Humidity...of 30% to 60% shall be maintained."

Review of the humidity logs with the perioperative secretary, Staff Q on 7/13/16 at 8:10 a.m. indicated "Humidity Should Be Between 30% & 70%." Staff Q stated that she manually monitored and logged the humidity levels and would only report to facilities department for correction if the humidity was under 30% or over 70%. Staff Q stated she was not aware of the policy that indicated the humidity range to be 30% to 60%.

Review of the humidity logs from December 2015 to July 2016 indicated that from December 7th 2015 till [DATE]th 2015 the humidity levels ranged from 62% to 68% in OR 1. There were four other dates where humidity was over 60% and not reported. Staff Q stated she would not have notified facilities to correct humidity levels as the form required levels of over 70% to be reported.

During an interview on 7/13/16 at 10:20 a.m. Licensed Staff E acknowledged that the facility policy on monitoring humidity in OR did not match the process.

Recommended Practices for a Safe Environment of Care, published by "The Association of Perioperative Registered Nurses (AORN)," 2012, indicated "Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating room...High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures performed."

10. On 7/11/16 at 12:20 p.m., observation of Patient 23's room revealed a sign on the outside indicating it was a contact precautions isolation room and gowning was required. Licensed Staff X was observed in Patient 23's room with a gown not tied up in the back.
During an interview on 7/11/16, at 12:21 p.m., Licensed Staff X stated he should have tied the gown in the back but did not. Licensed staff X was a PICC (Peripherally Inserted Central Catheter, a thin, soft plastic tube inserted into a vein that allows patient to receive medicines and fluids) nurse.
Review of Patient 23's clinical record indicated he was admitted to the facility on [DATE] and was diagnosed Methicillin-resistant Staphylococcus aureus (MRSA, bacteria that is resistant to many antibiotics and can cause life-threatening bloodstream infections, pneumonia and surgical site infections).
Review of CDC (Centers for Disease Control and Prevention)Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007 <http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf> indicated "GOWN Fully cover torso from neck to knees, arms to end of wrist, and wrap around the back Fasten in back at neck and waist. "





11. During an interview on 7/11/16 at 12:45 p.m., Licensed Staff V was asked how she performed a blood sugar check (determine patient's blood sugar level using a handheld device called a glucometer) on a patient in a contact precaution room (patient with contagious infection who is isolated in his/her room). She stated she would use a disposable pipette (small plastic tube to hold blood) to obtain a sample of the patient's blood (and refrain from taking the glucometer into the contact precaution room). She stated she may alternately take the glucometer into the room and wipe it down with a bleach wipe when she was finished to clean the machine.

During an interview on 7/14/16 at 2:14 p.m., Licensed Staff F stated it was expected that nurses use a pipette when checking blood sugars on patients in contact precaution rooms and refrain from bringing the glucometer into the room. She stated she had seen nurses bring glucometers into contact precaution rooms and later wipe them off with bleach. During the same interview, Administrative Staff A stated if a variance in nurse practice existed regarding blood sugar checks in contact precaution rooms, then the practice by the nurses needed to be standardized.

During an interview on 8/9/16 at 9:30 a.m., Licensed Staff G was asked how she would sanitize a glucometer for a patient on contact precautions. She stated cleaning would be handled the same way in which she routinely cleaned the glucometer. She stated she would use a purple top (disposable hospital sanitizer wipe) and wipe the glucometer off before and after use.

During an interview on 8/9/16 at 9:35 a.m., Management Staff W stated the glucometer should stay outside a contact precaution room and the nurse should use a pipette to obtain a blood sample, and drop it directly on the glucometer. She stated the glucometer should be cleaned before and after use with the purple top sanitizer.

Review of facility policy titled, "Cleaning and Disinfection of Movable Medical Equipment/Devices," reviewed 1/2016, indicated all movable medical equipment must be adequately cleaned and disinfected with a hospital-approved germicidal agent before and after each patient use. The list included blood glucose monitoring equipment.

Review of facility policy titled, "Blood Glucose Monitoring: Infection Control Procedures," (revised 8/2015) indicated the glucometer exterior should not be cleaned with bleach. The policy further indicated that when used with patients on contact precautions, the glucometer should be covered with a Bio-hazard bag, a hole created where the test strip can be placed, and the bio-hazard bag discarded before leaving the room.

12. During a tour of the emergency department on 7/12/16 at 10:22 a.m., exam room 1 had a sheet in the linen hamper and trash in the garbage can. Manager Staff C stated the room was a clean room (ready for the next patient) and the sheet in the hamper was from the previous patient. She stated when a patient was discharged from the unit, the nurse or technician would use a purple top wipe (antimicrobial wipe) to surface clean (the bed and chair, table). She stated the floors were not cleaned unless they had been soiled. She stated maintenance cleaned the rooms every shift and when a "terminal clean" was needed (she described terminal clean to include rooms where patient's had bleeding or diarrhea or rooms that had contained maternity patients).

During a tour of the emergency department on 8/9/16 at 9:20 a.m., trash was located in room 8's two garbage cans. Emergency Department Tech Y (ED Tech Y) stated room 8 was ready to go (ready for the next patient).

Review of facility document titled, "Patient Room - Discharge/Transfer, Cleaning" (reviewed 11/15) indicated all patient rooms will be cleaned by Environmental Service Department when a patient had been discharged or transferred. The policy indicated the cleaning procedure included, but was not limited to, emptying the waste containers and damp mopping the floor with a hospital approved germicidal solution.

13. During a tour of the emergency department and concurrent interview on 8/9/16 at 9:20 a.m., a syringe containing clear fluid was located in the covered garbage can in room 8. The Infection Control Preventionist was asked what type of fluid the syringe contained but was unable to identify the fluid.

During an interview on 8/12/16 at 2:20 p.m., the CNO stated all used syringes should be put into a sharps container (puncture-resistant and leak-proof container used to dispose used needles and other sharp instruments), not a garbage can.

Review of facility policy titled, "Sharps, Disposal Of" (reviewed 11/2015) indicated sharp disposal, "....including needles, syringes, knife blades, and open ampules of medication" was intended to prevent injury and exposure to bloodborne infections. The policy indicated, "under no circumstances shall sharps be discarded into waste or trash containers."

14. Review of employee files revealed Licensed Staff E and Radiology Staff Z had no documentation that indicated they were vaccinated (vaccine providing immunity to a particular disease) for tDAP [tDAP vaccine protects against tetanus, [DIAGNOSES REDACTED], and pertussis ([DIAGNOSES REDACTED] )].

During an interview on 8/11/16 at 2:15 p.m., the CNO stated Radiology Staff Z did not remember when she was last vaccinated for tDAP. The CNO stated Licensed Staff E reported he had been vaccinated for tDAP but had no documentation in which to verify his vaccination status.
Review of facility policy titled, "Health Screening Requirements For Healthcare Workers" (revised 10/2015) indicated health screening was done to prevent transmission of communicable/contagious diseased to patients, visitors or co-workers. Review of subtitle, "Procedure" indicated, "VI. Pertussis: Immunity wanes after vaccination. It will be required to show vaccination within 10 years."

According to the CDC, healthcare workers (HCWs) should get appropriate vaccines to reduce the chance that they would spread vaccine-preventable diseases. The CDC recommends HCWs are up-to-date with recommended vaccines including tetanus, [DIAGNOSES REDACTED], and pertussis. (http://www.cdc.gov/vaccines/adults/rec-vac/hcw.html).





15. A policy review on 7/12/16 at 9 a.m., "Isolation Patient Room - Occupied, Cleaning," reviewed 11/15, did not specify when and how gloves should be used, or changed out.

During an interview on 7/12/16 at 10:48 a.m., when asked to describe how the facility trained her to clean an isolation room, Cleaning Staff EE stated she changed gloves and changed out cleaning cloths as she proceeded to clean around the room clockwise, starting high and going low. Cleaning Staff EE stated a new cloth and gloves were used on the bathroom, and the toilet should be done last. Staff EE stated floors were done last by starting at the far corner of the room and ending at the door, at which time garbage bags were tied at the door, and placed in a zippered compartment on the side of the cleaning cart, which was left outside the room. Cleaning Staff EE stated gown and gloves were removed with the inside portion of the gown outward and balled up, and placed in cleaning cart trash.

During an observation of staff cleaning an isolation room (Room 117), on 7/13/16 at 11:30 a.m., Cleaning Staff FF used one pair of gloves during the entire process of cleaning, and when she cleaned the bathroom, she started with the toilet first, and finished with the sink. Twice during the cleaning process, Cleaning Staff FF came to the door and retrieved items from the cleaning cart parked outside the isolation room. Cleaning Staff FF opened a door at the bottom of the cleaning cart with her dirty right glove, to get more cloths and to get soaking mop heads with her dirty gloves. At 11:46 a.m., Cleaning Staff FF came to the doorway and reached out with her dirty gloves to unzip and place trash in the zipped trash area of the cart. Without changing gloves, Cleaning Staff FF touched the top of the cart and the side with both her left and right dirty gloved hands. Cleaning Staff FF removed a dustbin and broom hanging on the cart with her gloved hands and returned them after using, without changing gloves, disinfecting the items she had just used, or wiping the cart she touched. When asked how often she changed gloves in an isolation room, Cleaning Staff FF stated she just used one pair of gloves, and that she usually did the toilet last when cleaning the bathroom. After removing her protective wear, Cleaning Staff FF washed her hands, returned to her cleaning cart, and touched surfaces on the cleaning cart with her bare hands that she had recently touched with her dirty gloved hands.

16. Definition: The national Center of Disease Control and Prevention, at http://www.cdc.gov/tb/default.htm, updated 5/6/2016, indicated [DIAGNOSES REDACTED] is an infectious disease caused by the bacterium [DIAGNOSES REDACTED]. [DIAGNOSES REDACTED] generally affects the lungs, but can also affect other parts of the body. Most infections do not have symptoms, known as latent [DIAGNOSES REDACTED]. About 10% of latent infections progress to active disease which, if left untreated, kills about half of those infected. The classic symptoms of [DIAGNOSES REDACTED]
VIOLATION: EMERGENCY PROCEDURES Tag No: C0284
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview, and document review, the facility failed to ensure that:

1. MH ([DIAGNOSES REDACTED]), is an inherited muscle disorder triggered by certain drugs including succinylcholine (a depolarizing muscle relaxant by keeping muscles from contracting) and volatile anesthetics ( liquid anesthetics that at room temperature evaporate to a vapor which, when inhaled is capable of producing general anesthesia that can cause a fast-acting life-threatening crisis). The facility failed to ensure that emergency supplies were readily available to emergency department staff when ED staff were unable to locate the MH supplies. This failure had the potential of not being able to manage an MH crisis timely, likely to cause serious injury or death to a patient.

2. Policies and procedures for emergency drug supplies and emergency services included the contents of the emergency drug surpluses. Such failure did not ensure availability of emergency medications and 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.

Findings:

1. On 7/11/16 at 12:45 p.m. succinylcholine (paralytic agent used in anesthesia and a potential precipitant for MH) vial was observed in the ED refrigerator.

On 7/11/16 at 5:20 p.m. an MH cart was observed in the OR (operating room) corridor. The contents list on the MH cart indicated the refrigerator contained 6 bags of 0.9% sodium chloride (NS, normal saline solution, used for cooling an MH patient) 1000 ml (milliliter) and insulin (for reducing potassium levels the blood potassium level can rise during the breakdown of muscle in an MH crisis, and if it rises too much, the conduction of electrical impulses in the heart can be adversely affected, potentially causing the heart to stop beating).

In a concurrent observation and interview the director of pharmacy, DOP was unable to open the refrigerator to verify it contained the NS and insulin, as it was locked.

During an interview on 7/11/16 at 5:30 p.m. the chief nursing officer, CNO stated she was trying to call the OR director to find out how to get access to the chilled saline in the refrigerator.

Review of MHAUS ([DIAGNOSES REDACTED] Association of the United States, also used as a reference source by the facility) website www.mhaus.org <http://www.mhaus.org> indicated "The MH crisis is a biochemical chain reaction response, "triggered" by commonly used general anesthetics and the paralyzing agent succinylcholine (a neuromuscular blocker), within the skeletal muscles of susceptible individuals. The general signs of the MH crisis include increased heart rate, greatly increased body metabolism, muscle rigidity and/or fever that may exceed 110 degrees F along with muscle breakdown, derangements of body chemicals and increased acid content in the blood. Severe complications include: cardiac arrest, brain damage, internal bleeding or failure of other body systems. Thus, death, primarily due to a secondary cardiovascular collapse, can result."

During an interview on 7/11/16 at 5:35 p.m. the ED nurse manager, Management Staff C was asked by surveyor where the MH supplies were kept. Management Staff C stated she would have to call the pharmacy (pharmacy was not open 24 hours) to find out or check in the Omnicell (facility's automated dispensing cabinet).

During an interview on 7/11/16 at 5:40 p.m. ED nurse, Licensed Staff G was asked by the surveyor where the MH supplies were kept and she stated from her previous job experiences at another facility the MH supplies were most likely kept in the OR. Licensed Staff G was not able to locate the chilled saline or insulin in the OR.

On 7/11/16 at 5:55 p.m. the CNO stated she was not able to get in touch with the OR director to find out how to get access to the chilled saline. The CNO was informed that ED nurse manager and staff were not aware of the MH cart supplies location.

On 7/12/16 at 1:57 p.m. the OR director, Licensed Staff E stated the keys for the MH refrigerator supplies were kept in the ED after hours. Surveyor informed Licensed Staff E that ED staff were unable to locate the MH supplies.

During an interview on 7/13/16 at 8:25 a.m. ED nurse, Licensed Staff H stated MH supplies were probably in the OR. Licensed Staff H was not aware where the chilled saline would be and stated no information had been given to her regarding the MH cart and MH procedures that she could recall.

On 7/13/16 at 8:35 a.m. ED nurse, Licensed Staff J stated he had worked in ED for "decades." Licensed Staff J was unfamiliar with MH procedures and location of supplies and stated "we do have fluid warmers" (MH crisis management involves cooling patient's core temperature). Licensed Staff J stated succinylcholine was used in the ED for rapid sequence intubation (RSI, is a medical procedure involving a prompt induction of general anesthesia and placing a tube through the windpipe to help breathe) and he had administered succinylcholine to patients in the past.

Review of the list of patients for whom succinylcholine was removed from the ED Omnicell from 1/1/16 to 7/13/16 indicated a total of four patients.

Review of facility policy "Management of [DIAGNOSES REDACTED] Event" reviewed date 9/15 indicated "All licensed Surgery staff are responsible for understanding the mechanism of MH and the required drugs and supplies. All items will be centrally located for emergency response....It is an emergent and potentially lethal syndrome caused by a hypermetabolic state that can be precipitated by...depolarizing muscle relaxants, such as succinylcholine ...Actively cool the hyperthermic patient. Use cold IV saline..." The policy did not include ED or other departments where succinylcholine was used.





2a. On 7/11/16 at approximately 12 p.m., accompanied with Licensed Staff L (LS L) the emergency medication supply (crash cart) in the medical surgical nursing station was inspected. Observation of the content of the medication drawer and comparing that to the content list placed outside the crash cart, showed inconsistency between the list on the outside, a blank sheet and the list that was placed with medications in the medication drawer in the crash cart.

The list inside the crash cart had a line through Procainamide (medication used to treat irregular heart rhythm) and a hand written note "Out of Stock." The list posted on the outside of the cart did not have any of the changes. Similarly there was a line through (highlight) lidocaine (medication to treat irregular heart rhythm) premixed bag indicating that it was not filled, and "Out of Stock" hand written comment.

2b. On 7/11/16 at 5 p.m., accompanied with the Director of Pharmacy, inspection of the [DIAGNOSES REDACTED] emergency medication cart showed that the list outside the cart did not match the content within. The list indicated that the cart should contain one vial of procainamide (used to treat irregular heart beat), but there were none in the cart.

2c. On 7/13/16 at 8:25 a.m., accompanied with Licensed Staff H, inspection of the pediatric (children) crash car in the emergency department showed that the list outside the crash cart did not match the content within as follow:

The list indicated that the cart should contain one vial of procainamide (used to treat irregular heart beat), but there were none in the cart. The fill list had a line through procainamide and an a hand written note indicating the medication was "Not Available"

The list indicated that the cart should contain two syringes of sodium bicarbonate (generally alkalinizing agent, used to reduce acidity), but there was only one syringe in the cart. The quantity on the fill list, was modified to 1 instead on 2, the date the form was last revised was 5/3/16, whereas the master list (the list outside the crash cart) was last modified on 1/21/14.

LS H confirmed the observation for the pediatric crash cart.

The policies for emergency medications were reviewed. Three policies were presented and reviewed:
Crash Carts (Maintaining Supplies, Equipment and Medications), revised 12/05;\
Emergency: [DIAGNOSES REDACTED] revised 6/15; and
Emergency Drugs revised 6/15. None of the policies had the emergency medication content list included in it.

Additionally, the facility's policy, titled, Crash Carts (Maintaining Supplies, Equipment and Medications), revised 12/05 was reviewed. The policy did not include the different type of emergency medication supplies kept in the facility such as the [DIAGNOSES REDACTED] crash cart, pediatric crash cart, or the CroFab kit (kit with medication that neutralizes snake venom) , or the list of medications each of these cart should contain.
VIOLATION: NURSING SERVICES Tag No: C0294
Based on interview and record review, the facility failed to verify the competency of a PICC nurse (specially trained registered nurse) to place a PICC, read a chest radiograph (X-ray), verify proper PICC line placement, and determine the line was safe for initial use prior to the nurse performing these tasks independently. (A PICC is a peripherally inserted central catheter that is threaded through a vein in the arm and rests in the large vessel just above the heart; the PICC is used to deliver medication and intravenous fluids).

These failures caused lack of physician oversight for a medical procedure (reading and interpreting an x-ray) performed by a nurse and potentially decreased the safety of patients who had a PICC line placed.

Findings:

During an interview on 7-14-16 at 11:15 a.m., Licensed Staff X stated he was a PICC nurse. Licensed Staff X stated after he placed a PICC line, he got a chest X-ray to determine correct placement of the line. He stated he performed a "wet reading" where he read the X-ray to verify correct line placement and then cleared the line (determined the line was safe to utilize) for initial use. Licensed Staff X stated a physician read the chest X-ray later the day of line placement or the following day. When asked if the physician ever disagreed with his evaluation of line placement, Licensed Staff X stated, "yes."

During an interview on 8/11/16 at 3:25 p.m., Licensed Staff X stated he had been trained to place PICC lines when he worked at a company in another state. When asked if anyone at this facility had observed him place a PICC line, to verify his competency prior to working independently, he stated no one had. He stated a physician had observed him place a PICC on a manikin, not an actual patient. When asked if a physician had verified his competency reading a chest x-ray prior to working independently, he stated no physician had.

During an interview on 8/12/16 at 11:10 a.m., the CNO stated the facility had not evaluated Licensed Staff X's competency reading chest x-rays prior to allowing him to perform the function independently. She stated a physician had observed Licensed Staff X place a PICC on a manikin, not an actual patient, prior to him functioning independently.

Review of facility document titled, "PICC Nurse Competency" (dated 2/22/15) indicated Licensed Staff X had performed PICC competency for a physician, including PICC insertion and ordering a chest x-ray (not reading and interpreting a chest x-ray).

Review of facility policy titled, "Standardized Procedure: PICC" (revised 9/2015) indicated RN's who have demonstrated ....competency in PICC placement may insert PICCs. The policy indicated the nurse would be trained by another competent PICC nurse and have successfully completed at least three PICC's with another competent PICC nurse.

Under the subtitle, "Procedure," #7. Obtain chest x-ray and stat read of x-ray. The policy did not indicate the PICC nurse was allowed to read the x-ray and clear the PICC line for initial use. Under the subtitle, "Requirements," indicated, "3. RNs must demonstrate competency in placement of PICC catheters" and, "4. ...knowledge and competency will be assessed by qualified preceptor initially and annually."
VIOLATION: NURSING SERVICES - DRUG ADMINISTRATION Tag No: C0297
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on clinical record and policy review and staff interview, the facility failed to ensure:

1. Medications were administered as order for two patients, (Patient 1 and Patient 2). Patient 1's antibiotic treatments were not applied for several days. Patient 2's medication for blood pressure was not administered as ordered. In addition, Patient 2's intravenous fluids were stopped without a physician order to do so. Such failure put patients at risks for potential treatment failure and resulting consequences when medications are not administering as intended.

2. Medications orders were completed and included all the elements for a completed order. Patient 2 was ordered high blood presser medication on as needed bases without any specific directions for how many doses to give and when to stop. Patient 2 also had an order for restraints that was not completed. Such failure put patients at risks for potential treatment failure and resulting consequences when medications or restraints are used inappropriately or not administering as intended.

3. Verbal/telephone orders were authenticated (co-singed) in a timely manner in accordance with the facility's policy. Such failure put patients at risks for potential medication errors, treatment failure, and potential for harm resulting from delay in confirmation of medications orders.

Findings:

1a. On 7/12/16, at approximately 11 a.m., the clinical record for Patient 1 was reviewed with Licensed Staff F (LS F). Patient 1 was [AGE] years old that was admitted for acute renal failure and was receiving multiple medications including topical antibiotic for ulcer of the foot. Mupirocin 2%, also known as Bactroban, was ordered, on 6/26/16, to be administered every day.

Review of the electronic medication administration record (MAR) showed that within the duration of Patient 1's stay: from 6/26/16 to 7/11/16, there were nine days showing "missed doses" indicating that the medicine was not applied. On 7/3/16 there was a comment entered later in the day indicating the medication was applies by the doctor. However, for the remaining eight "missing dose," there were no documentation indicating administration of the medication or explaining the reason for not administering it. More than 50% of the time (Eight of 15 days), Bactoban was not applied. During interview with LS F, it was stated that the doctor changed the dressing and applied the medication; however, concurrent review of the electronic medical record showed three entries on (7/1/16, 7/3/16, and 7/6/16) by Doctor D (Dr. D, but none of these entries showed documentation that the medication was applies.

1b. On 7/12/16 at 10:19 a.m., the clinical record for Patient 2 was reviewed with Licensed Staff F (LS F). The record revealed that Patient 2 was receiving two different medications to control blood pressure. Both medications were ordered on the same day 7/9/16, at the same time, at 14:33, and by the same physician.
One order was for hydralazine (also known as Apresoline) a medication to reduce blood pressure by dilating the blood vessels. The order was for 10 milligrams (mg) every 6 hours as needed for hypertension. In the comment section of this order there was directions to give the medication as needed for systolic blood pressure higher than 160. The other order was for Enalaprilat (also known as Vasotec), a blood pressure medication that centrally inhibits constriction of the blood vessels. The order was for 2.5 mg of enalaprilat to be given every 6 hours as needed for hypertension (high blood pressure). There were no additional comments or directions for giving this medication.

On 7/13/16 at 12 noon, concurrent review of the medication administration record for Patient 2 with LS F showed that the enalaprilat was administered two times when systolic blood pressure was 196 and 177, in which cases hydralazine should have been administered according to the order by the physician and the blood pressure measurement.

1c. On 7/12/16 at 9 a.m., Patient 2 was observed receiving the morning medication. Licensed Staff M (LS M) was asked about the rate of the intravenous (IV) fluids that was hung on the IV pole. LS M stated that the IV fluid were "unhooked" (disconnected) when Patient 2 got up, so he does not tangle with it. On 7/12/16 at 10:19 a.m., the electronic medical record for Patient 2 was reviewed with Licensed Staff F (LS F). Review of the medications orders showed a physician order, dated 7/10/16, for D5 1/2 NS (sugar and salt) IV solutions to be given at 75 milliliter /hour. The order was active (on-going); there was no physician order to discontinue the IV fluid. LS F confirmed that the order was active and it had not been discontinue. LS M stopped (unhooked) the D5 1/2 NS infusion that was supposed to be infused at 75 milliliter/hour without a physician order.

2a. On 7/12/16 at 10:19 a.m., the clinical record for Patient 2 was reviewed with Licensed Staff F (LS F). The record revealed that Patient 2 was receiving two different medications to control blood pressure. Both medications were ordered on the same day 7/9/16, at the same time, at 14:33, and by the same physician. One order was for Enalaprilat (also known as Vasotec), a blood pressure medication that centrally inhibits constriction of the blood vessels. The order was for 2.5 mg of enalaprilat to be given every 6 hours as needed for hypertension (high blood pressure). There were no additional comments or directions for giving this medication. There was no safety measure such as maximum doses not to be exceeded, a goal for treatment, or when to contact the physician.

2b. On 7/12/16 at 10:19 a.m., the clinical record for Patient 2 was reviewed with Licensed Staff F (LS F). The record revealed that Patient 2 had orders for restraints written on 7/9/16. Further review of the order showed that the facility had a standard order form for physical restraints. The order had four different sections with different components under each section that can be selected by placing a check mark in front of the ones ordered. In the second and the fourth section, none of the boxes were checked. Under the second section were the "Restraint Indicators," but nothing was checked. Similarly, under the fourth section for the "Types of Restraints" nothing was checked.
The order for restraints was not completed: It did not specify the types of restraints to be used or the reason (indication) for which to be used. The order had nine different components to choose from: six options for the type restraints and three options under the indication for use.

Review of the facility's policy titled, Use of Medical Restraints, revised 6/16, and showed that the following under PRN (as needed) Ordering or Restraints and Seclusion: "Order for the use of restraints or seclusion must never be written as a standing order or on as needed bases." Leaving nine components in the order unspecified may constitute an as needed order. Such orders were not specifically ordered based on evaluation of the patient and documentation of what necessitate the use of restraints "for the management of violent or self-destructive behavior that jeopardize the immediate physical safety of the patient, staff or others" as indicated by the policy.

3. On 7/12/16, at approximately 11 a.m., the clinical record for Patient 1 was reviewed with Licensed Staff F (LS F). Patient 1 had a telephone order for diphenhydramine (medication for allergies) written on 7/2/16. The order was for diphenhydramine 25 mg to be given intravenously every 6 hours as needed to itching. LS F confirmed that the order was not co-singed.

Review of the facility's policy for Medication Management Orders: General, revised on 6/15, showed the following regarding of authentication of Verbal or telephone orders: "Medication or biologicals must be authenticated within 48 hours."

Additionally, the policy titled, Telephone Orders and Verbal Orders, revised 9/14 was reviewed. The policy included the following:
If the telephone /verbal order remain unsigned past forty-eight (48) hours from receipt, the nursing staff will place a call to the attending physician and request same-day authentication."
VIOLATION: NURSING SERVICES - CARE PLANS Tag No: C0298
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, clinical record review, and facility document review, the facility failed to keep the care plan current for 4 of 30 sampled patients (Sampled Patient 21, 22, 28, 30), when facility nurses failed to: 1) design and implement customized interventions for Sampled Patient 21's intravenous PICC noncompliance, which had the potential to lead to self-injury and infection; 2) Sample Patient 22's diabetic noncompliance, which had the potential to lead to metabolic instability, and; 3) Sampled Patient 28's, and 30's, nursing care plans were not completed and closed upon discharge, indicating an inaccurate inpatient status.

Findings:

1. During a medical chart review on 7/13/16 at 1 p.m., admission records indicated Sampled Patient 21 had been admitted to med-surg unit from the emergency department on 6/24/16, for a diagnosis of pneumonia. "Review of Systems," included fatigue, restless leg syndrome, and irritability. A nursing note, dated 6/30/16 at 4 a.m., indicated nursing administered medication to Sampled Patient 21 after she complained of restlessness, anxiety, and restless leg syndrome. A nursing notes, dated 7/4/16 at 3:20 a.m., indicated nursing caught Sampled Patient 21 smoking in her room against hospital policy. Nursing did not individualize Sampled Patient 21's care plan to reflect fatigue, or general anxiety related to an inability to smoke, as problem areas requiring planned interventions.

Nursing notes indicated Sampled Patient 21 had itched, pulled at, and pulled out, a peripherally inserted central catheter (PICC) (placed upon admission in order to receive antibiotics) on 7/4/16 at 12 p.m., and 7/8/16 at 3:15 a.m. Nursing care plans identified infection from pneumonia, and impaired skin integrity due to sedentary positioning, or inadequate hydration, but had not been updated to reflect potential infection from non-compliance with PICC care.

2. During a medical chart review on 7/13/16 at 2:42 p.m., admission records, dated 7/5/16, indicated Sampled Patient 22 diagnosis included diabetes. A nursing note, dated 7/9/16 at 9:30 p.m., indicated Sampled Patient 22 refused Humulin (a concentrated insulin administered to control high blood sugar). The nursing care plan did not include Diabetes as a problem requiring interventions, or planning.

During an interview on 7/13/16 at 11:10 a.m., Licensed Staff AA stated the facility had identified the software program used for nursing plans as inadequate and incomplete, but agreed nursing should have reviewed and updated patient care plans from available options, which did include diabetes.

3. During a medical chart review on 7/14/16 a 3:51 p.m., "Patient Demographics," indicated Sampled Patient 28 had been discharged on [DATE]. Sampled Patient 28's nursing "Care Plans" had an active status, and had not been reviewed, updated, and completed after discharge.

During a medical chart review on 7/14/16 at 4:06 p.m., "Patient Demographics," indicated Sampled Patient 30 had been discharged on [DATE]. Sampled Patient 28's nursing "Care Plans" had an active status, and had not been reviewed, updated, and completed after discharge.

During an interview on 7/14/16 at 4:06 p.m., Licensed Staff AA stated nursing care plans should be reviewed and completed upon patient discharge.

The facility's "Patient Multi-Disciplinary Plan of Care and Education Plan," revised 11/11, reviewed 6/13, indicated patients plan of care should be based on patient's immediate and anticipated problems; assessed and updated, and; upon discharge staff should document whether discharge goals were resolved, or unresolved.
VIOLATION: PERIODIC EVALUATION & QA REVIEW Tag No: C0330
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the facility failed to ensure periodic review of all policies and a functioning quality assurance (QA) program as evidenced by:

1. The facility did not ensure all policies were evaluated, reviewed and/or revised annually. (Cross reference: C 0334)

2. The facility did not identify and implement action plans to address staff's lacking knowledge of [DIAGNOSES REDACTED] (MH) procedures and inability to locate the MH emergency supplies. (Cross reference: C 0271 and C 0284, finding #1)

3. The facility did not identify and implement action plans to address multiple infection control deficient practices. (Cross reference: C 0278)

4. The facility did not identify and implement action plans to ensure periodic staff competency evaluation. (Cross reference: C 0278 finding #19)

5. The facility did not identify and implement action plans to ensure medical oversight for PICC (A PICC is a peripherally inserted central catheter that is threaded through a vein in the arm and rests in the large vessel just above the heart; the PICC is used to deliver medication and intravenous fluids) procedures and ensure competency of the PICC nurse. (Cross reference: C 0271 finding #8, and C 0294)

6. The facility did not develop a plan to evaluate and assess their processes, procedures and system in the medications administration process to reduce or prevent medication errors. Such failure would allow medication errors to occur, reach patients, and lead to harm without active interventions to prevent or reduce such errors. (Cross reference: C 0336 finding 5a)

7. The facility did not ensure process so that all medication errors were regularly analyze via multi-disciplinary committee which included professionals from pharmaceuticals, nursing, medical and administration. (Cross reference: C 0336 finding 5b)

The facility's failure to ensure periodic review of all policies and failures to identify and address deficient practices had the potential to endanger patients' health and safety. The Condition of Participation for Periodic Evaluation and Quality Assurance Review was not met.
VIOLATION: PERIODIC EVALUATION OF POLICIES Tag No: C0334
Based on interview and record review, the facility failed to ensure all the policies were evaluated, reviewed and/or revised annually. This failure had the potential for the facility staff to follow policies that were not up-to-date standard practice potentially compromised patient care and patient's health and safety.

Findings:

During a concurrent interview and record review of facility's policies on 8/10/16, at 2:20 p.m., Administrative Staff A stated the facility should review all the policies annually. Administrative Staff A stated the facility did not review policies in three departments including Hospitalwide-Clinical, IV (intravenous), and Respiratory in 2015 because there were "so many changes" needed for the policies and they "run out of time."

During an interview on 8/11/16, at 8:30 a.m., Administrative Staff A stated the Hospitalwide-Clinical policies were not reviewed in 2014 (These policies were not reviewed in 2014 and 2015). Administrative Staff A stated the policies should be reviewed by the managers of the department, medical staff committee, medical executive committee, and finally approved by the governing body.

The Hospitalwide-Clinical Policies and Procedures Approval Spreadsheet, dated 2015, revealed that there were 157 policies included in the Hospitalwide-Clinical department.

The Respiratory Therapy Policies and Procedures Review and Approval Spreadsheet, dated 10/2014 revealed there were 51 policies in the Respiratory Department.

The IV Policies and Procedure Review and Approval Spreadsheet, dated 8/2016, indicated there were 13 policies in the IV department.

During an interview on 8/12/16, at 9:50 a.m., Management Staff B, whose name was listed in the policy and procedure review spreadsheet for IV policies review, stated she reviewed policies and procedures for the medical/surgical department every year. Management Staff B stated she was told the PICC nurse reviewed the IV policies.

During an interview on 8/12/16, at 10:10 a.m., the Chief Nursing Officer stated some policies and procedures were not reviewed. The Chief Nursing Officer stated staff were busy and "didn't get to it." She stated "That's the best answer I can give it to you." The Chief Nursing Officer stated she was coordinating the Hospitalwide-Clinical policies and procedures and there were many policies and many people working on the policies. She stated she knew the existing policy review system was not working and was changing the system. The Chief Nursing Officer stated the IV policies were assigned to Management Staff B but Management Staff B did not know anything about it; therefore, the IV policies were assigned to the PICC nurse this year 2016 and were waiting for Governing Body's approval. The Chief Nursing Officer stated the Respiratory policies were assigned to the department manager but the department manager did not know how to write the policy and procedure. The Chief Nursing Officer stated she helped the Respiratory department manager to write the policies this year 2016 and were waiting for Governing Body's approval.

The facility's policy and procedure titled "POLICY AND PROCEDURE MANAGEMENT PROCESS," revised 2/16, indicated "All [name of the facility] policies and procedures (P&P) will be in compliance with regulatory agencies and will be reviewed as required...As a critical access hospital, all patient care related policies will be reviewed annually..."

The facility's policy and procedure titled "QUALITY ASSESSMENT REVIEW AND PERIODIC EVALUATION," reviewed 6/16/16, indicated "It is the policy of the [name of the facility] to assure quality assessment and performance improvement through a systematic, coordinated, and continuous approach to improving care and services...[name of the facility] carries out ongoing evaluation of its services. An Annual Evaluation includes a review of...health care policies..."
VIOLATION: QA - QUALITY OF PATIENT CARE Tag No: C0336
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility's quality assurance (QA) committee failed to identify quality deficiencies and develop corrective plans as evidenced by:

1. Failure to identify and implement action plans to address staff's lacking knowledge of [DIAGNOSES REDACTED] (MH) procedures and inability to locate the MH emergency supplies. (Cross reference: C 0271 and C 0284, finding #1)

2. Failure to identify and implement action plans to address multiple infection control deficient practices. (Cross reference: C 0278)

3. Failure to identify and implement action plans to ensure periodic staff competency evaluation. (Cross reference: C 0278 finding #19)

4. Failure to identify and implement action plans to ensure medical oversight for PICC (A PICC is a peripherally inserted central catheter that is threaded through a vein in the arm and rests in the large vessel just above the heart; the PICC is used to deliver medication and intravenous fluids) procedures and ensure competency of the Licensed Staff X, PICC nurse. (Cross reference: C 0271 finding #8, and C 0294)

5a. Failure to develop a plan to evaluate and assess their processes, procedures and system in the medications administration process to reduce or prevent medication errors. Such failure would allow medication errors to occur, reach patients, and lead to harm without active interventions to prevent or reduce such errors.

5b. Failure to ensure process so that all medication errors were regularly analyzed via multi-disciplinary committee which included professionals from pharmaceuticals, nursing, medical and administration.

These failures prevented the QA committee from addressing issues and developing action plans to correct quality deficiencies; therefore, the QA committee was not able to determine effectiveness of changes to be implemented.

Findings:

1. During an interview regarding QA program on 8/12/16, at 11:15 a.m., both the Chief Nursing Officer (CNO) and Administrative Staff A stated the facility was not aware that the staff's lacking knowledge of MH procedures and that the MH supplies were not accessible to staff.

2. During an interview regarding QA program for infection control on 8/10/16, at 11:10 a.m., both the CNO and Administrative Staff A stated that for approximately three years, the facility did not have a formal infection control program/committee. Administrative Staff A stated the facility had a clinical function committee, which was not specific for infection control. Administrative Staff A stated the facility needed to create an infection control committee.

3. During a concurrent personnel record review and interview with Administrative Staff A on 8/11/16, at 11:40 a.m., Unlicensed Staff MM (a registry staff)'s personal file did not contain documentation for orientation, competency evaluation, and background check. Administrative Staff A stated the facility should have kept the above documentation in the personnel file, but the facility did not have the above documentation for all registry staff members.

During an interview regarding QA program on 8/12/16, at 11:15 a.m., with the Chief Nursing Officer (CNO) and Administrative Staff A, the CNO stated the facility have acknowledged the problems of the registry staff's personnel files. The CNO stated the facility had an informal action plan and had sent out to people for actions. The CNO stated she would provide a copy of the emailed document.

The emailed document facility provided titled "Registry Onboarding and Orientation," dated 7/25/16, did not indicate a plan for staff periodic competency evaluation.

The facility's policy and procedure titled "QUALITY ASSESSMENT REVIEW AND PERIODIC EVALUATION," reviewed 6/16, indicated "It is the policy of [name of the facility] to assure quality assessment and performance improvement through a systematic, coordinated, and continuous approach to improving care and services...[name of the facility] has a quality assessment program to evaluate the quality and appropriateness of the diagnosis and treatment furnished at [name of the facility] and of the treatment outcomes. The program required that...Infections and medication therapy are evaluated..."





4. During an interview on 8/12/16 at 11:10 a.m., the CNO was asked if the facility was aware Licensed Staff X had needed to reposition a PICC line after he had determined it was safe to use (because physician line verification differed from his). The CNO stated she was not aware of that. When asked if the facility had monitored and tracked the incidence of discrepancy between physician and PICC nurse verification of PICC line placement, Administrative Staff A stated the facility had not. She stated the facility should be monitoring those incidence.

During an interview on 8/12/16, at 11:10 a.m., the CNO stated the facility had not evaluated Licensed Staff X's competency reading chest x-rays prior to allowing him to perform the function independently.






5. On 7/12/17 at 10 a.m., during a meeting with the Chief Nursing Office (CNO), the director of pharmacy (DOP), and Administrative Staff A (AS A), the MERP (medication error reduction plan) was requested to evaluate the hospital plan for assessment of the eleven procedures or systems that could contribute to errors in the administration of medication. The MERP policy was presented. The policy titled Medication Error reduction Program, revised 11/14. The policy included the following: "The Medication Error reduction Program (MERP) will address the 11 main areas of medication errors:
1. Prescribing
2. Order Communication
3. Product Labeling
4. Packaging / Nomenclature
5. Compounding
6. Dispensing
7. Distribution
8. Administration
9. Education
10. Monitoring
11. Use."

The facility did not provide any evidence of how these eleven elements were being evaluated or addressed to reduce medication errors.
From 7/11/16 thru 7/13/16, there were multiple weaknesses and vulnerabilities that have caused or have the potential to cause medication error that the facility did not include in their MERP for assessment or improvement.

The facility adopted an electronic system for scanning medication and patient arm band to reduce the potential for medication error. On 7/12/16 at 8:50 a.m., during medication pass observation, Licensed Staff N (LS N) was administering medications and while scanning the medication, LS N stated that the medications may not scan. LS N in the presence of another Licensed Staff L (LS L) who was there to co-sign administration of other medications had two medications there did not scan. When asked what they do in situations like this, LS N stated that they visually confirm the medication and the computer program allows them to document administration.

On 7/13/16, at approximately 11 a.m., another Licensed Staff O (LS O) was asked about scanning medications and how frequent that was occurring. LS O could not quantify the occurrence, but said that it happened. And when she was asked if pharmacy and administration are aware of this situation, LS O affirmed.

Bypassing the mechanism (electronic system for scanning patients and medications) that was put adopted for the purpose of ensuring accurate medication administration and reducing or eliminating the occurrence of medication error, is not conducive to patient safety.

For the facility not to include an ongoing evaluation and assessment of this new strategy they adopted which is a front and center of the medication error reduction elements is a backward step and clear evidence of lack of assessment of the MERP elements.

5b. On 7/12/17 at 10 a.m., during a meeting with the Chief Nursing Office (CNO), the director of pharmacy (DOP), and Administrative Staff A (AS A), the DOP stated that for analysis of medication errors, two members the hospital's MERC (medication error reduction committee): the DOP and AS A evaluate and trend medication errors, then medication errors that were classified at C or higher are presented the MERC committee for discussion and analysis. The hospital uses the NCC MERP classification system for of the medication errors. NCC MERP is the National Coordinating Council for Medication Error Reporting and Prevention, its system for classification medication error stats with A, no error and has I for error that may have contributed to the death of a patient.

Although it was stated that all medication errors are evaluated, trended an analyzed, but excluding the circumstance that had potential for errors, Category A, and the error that did not reach the patient, Category B (near misses), violates the law for having a multidisciplinary process for trending and analyzing all medication errors.