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Based on interview and record review, the facility failed to ensure compliance with State Laws, when one of 30 patients, Patient 5, was not tested for MRSA (methicillin-resistant Staphylococcus aureus or bacteria resistant to several antibiotics) upon direct transfer and admission from another general acute care hospital.

This failure could potentially have led to a missed diagnosis for Patient 5, delayed treatment, and further spread the resistant bacteria to other susceptible patients, families, visitors, and staff.

Findings:

According to the Centers for Disease Control and Prevention (CDC), MRSA can lead to life-threatening infections if not treated, and can spread quickly if not properly identified.

The Health and Safety Code 1255.8(b)(1)(B) read, "Each patient who is admitted to a facility shall be tested for MRSA in the following cases, within 24 hours of admission when it has been documented that the patient has been previously discharged from a general acute care hospital within 30 days prior to the current hospital admission."

During a concurrent interview and record review with the Director of Nurses (DON), on 10/13/16, at 10 am, the DON stated Patient 5 was transferred from another general acute care hospital and admitted to the hospital on 8/10/16. The DON was unable to find documentation of an order for the MRSA test on the admitting physician order set, dated 8/10/16. The DON was unable to locate results for MRSA screening tests in Patient 5's record.

The facility policy and procedure, titled, "MRSA (Methicillin Resistant Staphylococcus Aureus) Screening Cultures" with a last review date of 3/2016, indicated "All patients admitted to LTAC (Long Term Acute Care) that do not have MRSA identified on their facesheet (admission document containing pertinent patient information such as name and diagnosis) will be tested for MRSA within 24 hours of admission."

Based on observations, staff interview and record review, the hospital's Governing Body (GB) failed to effectively govern the hospital and ensure compliance with federal regulations, as evidenced by:

1. The GB failed to ensure nursing services were well organized to meet the needs of patients. Refer to A020, A385, findings 1-19, A386, findings 1-2, A395, findings 1a-4, A396, findings 1a-5, A131, findings 1-2, A154, A405, findings 1-2, A749, findings 1-4, and 6, A800, findings 1-3.

2. The GB failed to ensure the provision of safe and effective pharmaceutical services. Refer to A405, findings 1-2, A490, findings 1-5, A491, findings 1-4, A500, findings 1-3, A501, findings 1-2, and A508, findings 1-2.

3. The GB failed to ensure the hospital had developed, implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. Refer to A263, A273 and A283, findings 1-3.

4. The GB failed to ensure that physicians were credentialed for the procedures they were to provide. Refer to A341.

5. The GB failed to ensure the Medical Staff Bylaws were enforced for the content of a history and physical. Refer to A353.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of services was in compliance with the statutorily mandated Condition of Participation for Governing Body.

Based on staff interview and document review, the hospital's Governing Body (GB) failed to ensure the hospital had developed, implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program, as evidenced by:

1. The quality program did not include performance indicators to measure key care processes to ensure compliance with regulatory and professional standards. Refer to A273.

2. The quality program failed to take actions on performance indicators that did not meet professional standards. Refer to A283, findings 1-3.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of services was in compliance with the statutorily mandated Condition of Participation for Quality Assessment and Performance Improvement.

Based on observation, interview, and record review, the hospital failed to ensure that nursing services were furnished or supervised by a registered nurse and consistent with nationally accepted standards of practice as evidenced by:

1. The nursing service failed to have a policy and competency assessment for staff applying upper torso (chest) postural supports. This failure resulted in one of 30 sampled patients (Patient 11) being restrained. Refer to A386, finding 1, and A 54.

2. The nursing service did not have a well organized system for the insertion of catheters (tubes in the arm) for long term medication administration. Refer to A386, finding 2, A553, and A131, finding 2 and 3.

3. The nursing service failed to ensure physician's orders were obtained and care planning was in place for patient tubes, drains, and intravenous (in the vein) lines for seven of 30 sampled patients (Patients 1, 5, 17, 21, 22, 24, and 27). Refer to A395, findings 1a, 1c, 1e, 1g, 1h, 2; and A 396, findings 1a-3, and 4b.

4. The nursing service failed to ensure that contract nurses followed measures to control the spread of infections for three of 30 sampled patients (Patients 5, 13, and 26). Refer to A749, findings 1, 2, 3, 4b, and 4e.

5. Thirteen of 30 sampled patients did not have adequate care planning to meet the patients' needs (Patients 1, 5, 9, 10, 11, 12, 13, 16, 17, 21, 22, 24, and 27). Refer to A396, findings 1a-5.

6. The nursing service failed to ensure consent verification was obtained for two wound debridement (cutting away of dead tissue to improve healing of a wound) procedure for one of 30 sampled patients (Patient 12) Refer to A131, finding 1.

7. The nursing service failed to verify that consent was obtained for the insertion of a midline catheter for one of 30 sampled patients (Patient 10). Refer to A131, finding 2.

8. The nursing service failed to verify that consent was obtained for the insertion of a peripherally inserted central catheter (PICC) for one of 30 sampled patients (Patient 24). Refer to A131, finding 3.

9. Nursing service failed to ensure early discharge planning for three of 30 sampled patients (Patients, 10, 11, and 12). Refer to A800, findings 1-3.

10. Nursing staff failed to ensure one of 30 sampled patients was for tested for methicillin resistant staphylococcus aureus (MRSA, an antibiotic resistant bacteria) upon admission as required by State law. (Patient 5) Refer to A020.

11. Nursing staff failed to document the maintenance of contact isolation for one of 30 sampled patients (Patient 13). Refer to A 395, finding 4, and A449.

12. The nursing service failed to ensure a critical lab value was reported to the physician within the required time frame for one of 30 patients (Patient 1). Refer to A395, finding 1b.

13. The nursing service failed to ensure that one of 30 patients (Patient 1) Jackson Pratt drain (J/P, suction bulb with long thin tubing placed in the body) had physician orders, care plans, and consistent nursing assessment and documentation. Refer to A395 finding 1a.

14. The nursing services failed to ensure that PICC lines for three of 30 patients (Patients 21, 22, and 24) had physician orders, nursing care orders, complete and accurate flow sheets, and dressings that where dated and timed. Refer to A395, findings 1c, 1e, and 1g.

15. The nursing service failed to ensure that one of 30 patients (Patient 21) wound care orders were followed. Refer to A395, finding 1d.

16. The nursing service failed to ensure that one of 30 sampled patients (Patient 24) had orders for the care, maintenance, and removal of a nasogastric tube (NG, tube into stomach). Refer to A395, finding 1h.

17. The nursing service failed to ensure for one of 30 sampled patients (Patient 23) specialty bed was being used properly. Refer to A395, finding 1f.

18. One of 30 sampled patients did not have a pain assessment before or after receiving pain medication. (Patient 11) Refer to A395, finding 3.

19. Two of 30 patients' medications were not administered in accordance with physicians' orders. (Patients 6 and 15) Refer to A405, findings 1-2.

The cumulative effect of these systemic problems had the potential to compromise the health of patients, cause injury or harm to patients due to inaccurate patient assessments, cross contamination, infection, and improper wound care; and resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Nursing Services.

Based on interview and record review, the hospital failed to ensure that patient's rights for three of 30 sampled patients were observed when:

1. Patient 12 record had debridement (removal of damaged tissue) procedures that did not have a written or verbal consent documented.

2. Patient 10 had a midline catheter inserted (a long tube inserted in the arm veins used for intravenous (IV, in the vein) medications and blood draws) but the consent was for another procedure.

3. Patient 24 had a peripherally inserted central catheter (PICC, special IV for medications, blood draws, and nutrition, that goes from the upper arm to the large vein right directly above the heart) inserted without a consent.

These failures had the potential for patients to not be fully informed and participate in the decisions regarding their healthcare.

Findings:

1. On 10/13/16, Patient 12's record was reviewed. Patient 12 was admitted to the hospital on 8/26/16 with diagnoses that included sepsis (blood infection), diabetes (high blood sugars), and left foot and ankle bone infections. Patient 12's record indicated he had several wounds on his left leg that required debridement. Debridement is the surgical or medical removal of dead, damaged, or infected tissue to improve the healing potential of the remaining healthy tissue. Patient 12's record contained medical progress notes that indicated that debridement had been performed on 9/9 and 9/19/16. Patient 12's record did not contain a consent verification for debridement for these dates. Patient 12's procedure records, dictated by the physician for these dates, did not contain evidence of verbal consent.

On 10/13/16, the hospital policy, titled, "Consent for Invasive Procedures," dated 9/2015, read, "A signed Procedural Consent form will be obtained for all operative and invasive procedures from the patient/ legal representative by hospital personnel... Documentation of the patient's mutual understanding and agreement for care, treatment and services is by way of the patient's signature... Informed consents will be obtained for the following invasive procedures... H. Debridement."

On 10/13/16 at 10:30 am, Wound Care Nurse O stated the wound care team only gets an initial consent for wound debridement and uses that consent for subsequent debridements.

On 10/13/16 at 10:35 am, Administrative (Admin) Nurse N acknowledged that consents should be obtained prior to each debridement procedure.

2. On 10/12/16, Patient 10's record was reviewed. Patient 10 was admitted to the hospital on 9/22/16 with diagnoses that included blood infection, diabetes, and chronic venous thromboembolism (blood clots). Patient 10 had a physician's order, dated 10/6/16, to insert a PICC line insertion. Patient 10's record indicated that she was educated and consented to a PICC line insertion. The consent read, "A peripherally inserted central catheter (PICC) is a long, soft plastic tube known as a catheter. It is inserted into one of the large veins of the arm near the bend of the elbow. It is then slid into the vein until the tip sits in a large vein just above the heart... it may remain in place for several weeks or months..."

Patient 10's procedure record, dated 10/6/16, indicated that a midline catheter, not a PICC, was inserted. Patient 10's record contained no evidence that a midline catheter was ordered or consented to by Patient 10.

On 10/12/16, the hospital policy, titled, Central Venous Access Device (CVAD) and Midline Catheter Care and Maintenance," dated 2/2016, read, "A midline catheter is considered a deep peripheral IV (arm), not a central line. Midline catheters are short-term use (less than 20 days) peripheral infusion devices with tips terminating (ending) in either the basilic, cephalic, or brachial vein distal to the shoulder (in the arm, not near the heart). A midline catheter may be used for some antibiotics (medication to treat infection) and to sample blood."

On 10/12/16 at 3 pm, PICC Nurse A stated he discussed the PICC versus a midline catheter for Patient 10 with the physician. PICC Nurse A acknowledged that Patient 10's record did not contain evidence of a discussion nor a physician's order for a midline catheter. PICC Nurse A further stated that he always used the PICC consent form for a midline catheter. PICC Nurse A acknowledged that the consent did not contain the correct information to educate the patient for a midline catheter consent.

On 10/12/16 at 3:30 pm, Admin Nurse K acknowledged that the consent for Patient 10 was correct to the physician's order for a PICC catheter insertion but was not correct for the procedure performed (a midline catheter) and the education provided.

3. A review of Patient 24's clinical record revealed Patient 24 was admitted on 9/16/16 with diagnoses that included respiratory failure, pneumonia (lung infection), and schizoaffective disorder (mental disorder affecting ability to comprehend reality).

On 10/12/16, at 10:47 am, Patient 24 was observed sitting on his bed with unkept hair and yellowish skin.

On 10/18/16, at 11:06 am, Charge Nurse (CN) reviewed Patient 24's orders which revealed that on 9/20/16 an "insert PICC line" order was entered. CN reviewed the paper and computer record and was unable to locate a consent for the PICC line. CN stated that PICC lines require consent and that the line should not have been placed without it.





36893

Based on observation, interview, and record review, the hospital failed to ensure that one of 30 sampled patients was free from restraint when a torso support (a postural support, a vest-like cloth support with Velcro straps used to prevent the upper body from leaning forward) was applied backwards with the Velcro straps on the back of the wheelchair, thus restraining Patient 11 because he was unable to remove the torso support.

Findings:

On 10/12/16, the hospital policy titled, "Restraint Use", dated 3/2016, read, "A restraint may only be used if needed to improve the patient's and/or other person's safety, less restrictive and nonphysical interventions have been determined to be ineffective, and the restraint does not cause unnecessary physical discomfort, harm, or pain, and is easily removable in an emergency... Direct care staff is trained and competent in application... Definition of a restraint: Any manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely. Note: If the manual methods or physical/mechanical device/equipment can be removed intentionally by the patient in the same manner it was applied then the device is not considered a restraint... Exclusions to Restraint policy include the following: ... Adaptive devices: ... Do not use a postural support belt on a patient who is unwilling or unable to follow instructions and is at risk of a fall or re-injury from self release."

On 10/12/16 at 10:15 am, during the initial tour, Patient 11 was observed in a wheelchair with a torso support applied with the Velcro release in the back of the wheelchair, thus restraining Patient 11 to the wheelchair. In a concurrent interview, Patient 11 stated that this torso support was to prevent him from falling. Patient 11 was observed again on 10/12/16 at 8:40 am, with the torso support applied incorrectly with the Velcro straps in the back of the wheelchair causing it to restrain Patient 11. In a concurrent interview, Administrative (Admin) Nurse N acknowledged that the Torso support was applied incorrectly and was restraining Patient 11.

On 10/12/16, Patient 11's record was reviewed with Admin Nurse N. Patient 11's record indicated that he was admitted to the hospital on 10/3/16 with diagnoses that included aspiration pneumonia (infection from swallowing food or liquids into the lungs) and a developmental disorder requiring him to live in a group home for support. Patient 11's record did not contain nursing assessments indicating the need for the torso support, therapy or nursing care plan interventions for a torso support, nor records for when it was applied and for how long. Patient 11's record did not contain a care plan for his cognitive (the mental processes of perception, memory, judgment, and reasoning) or developmental disability. Patient 11's record contained a care plan for fall risk with risk of injury. Admin Nurse N acknowledged that Patient 11's record did not contain any care plans that would indicate the intervention of a torso support, nor the assessment of his cognitive disability to assess the ability to remove the restraint.

A review of the restraint competency file for two nursing staff that cared for Patient 11 on 10/12/16 (Registered Nurse, RN M and Certified Nurse Assistant, CNA L) demonstrated they both had completed a competency test and return demonstration for restraint application documented during orientation on 1/28/16, and both scored 100 percent accurate. Neither file contained testing, discussion or demonstration of the proper application of the torso support. The competency test did not include information about the torso support. Admin Nurse K acknowledged that competency in torso support application was not included in the written restraint competency documentation. Admin Nurse K further acknowledged that there was no policy for the torso support for nursing staff to reference.

On 10/18/16 at 11:15 am, Admin Nurse K stated the restraint competency and return demonstration was reviewed during orientation and annually thereafter. Admin Nurse K further stated that the use of the torso support for postural support is also reviewed with this competency with a return demonstration.

Based on interview and record review, the hospital failed to ensure a robust and effective quality assessment and performance improvement (QAPI) program which accurately reflected the depth and scope of pharmaceutical, nursing, and health information management services.

Failure to develop a comprehensive program that identified opportunities for improvement may result in compromised outcomes for a patient census of 47.

Findings:

During the survey, deficient practices were noted in the pharmaceutical, nursing, and health record services. Refer to A385, A490, A449, A553, and A800.

In an interview and quality program record review on 10/19/16 at 9 am with the Quality Improvement/Risk Manager (QIRM), she was asked to describe the hospital's performance improvement program. She stated they had monitoring performance improvement projects and hospital-wide indicators. Additionally, departments are to be monitoring at least one indicator of performance. Results of this monitoring were presented at the QAPI Committee meeting monthly, with each department presenting once a quarter on a rotating basis.

Review of the Pharmacy Dashboard for hospital quality indicators indicated from January through July 2016 the pharmacy dispensed 292,974 doses of medication; and six total adverse drug reactions were reported for the 7 month time period.

QIRM was asked about consistency of Adverse Drug Reaction (ADR) reporting in accordance with the hospital policy (including pharmacy follow up of "trigger drug" (high risk drugs with adverse events) reports) and she stated they were trying to improve this area and acknowledged that the volume of reporting was low and the current ADR review was not adequate to assess deficient practices and opportunities for improvement in patient care.

QIRM was asked about performance indicators for the following deficient practices and she acknowledged that they were not reported into the program:

- Annual tuberculosis testing/screening completion;
- Verification of patient isolation for drug resistant organisms;
- Staff compliance with isolation precaution adherence;
- Adequacy of patient care plans;
- Adequacy of pain management;
- Nursing verification of high risk drugs;
- Appropriateness of postural supports;
- Timeliness of radiology reports;
- Authentication of verbal/telephone orders within 48 hours;
- Accuracy of the medical record;
- Timeliness of discharge evaluations; and
- Accuracy of consents for procedures and surgeries.

On 10/19/16, the hospital Performance Improvement Plan, dated 1/2016, read under Objectives, "To fulfill regulatory requirements in order to achieve and maintain licensure ... and fulfill requirements of the Medicare Conditions of Participation... The QAPI (Committee) responsibilities include... Identifying and monitoring the hospital-wide performance measures."

In an interview on 10/19/16 at 9 am, QIRM acknowledged the QAPI program would have to be more robust to ensure compliance with the Medicare Conditions of Participation.

Based on interview and record review, the hospital failed to ensure the Quality Assessment and Improvement Program took actions to improve performance.

1. The hospital failed to take actions on deficient practices identified in a California Board of Pharmacy report.

2. The hospital failed to take effective actions to correct Contract Agency D performance of preventive infection control measures such a handwashing and isolation precautions.

3. The hospital failed to ensure the Quality Assessment and Improvement Program took actions to improve performance. Refer to A490 and A454.

These failures allowed deficient practices to persist that could negatively impact patients' health status.

Findings:

During the survey, deficient practices were noted in the pharmaceutical and health record services. Refer to A490 and A454.

On 10/19/16, the hospital Performance Improvement Plan, dated 1/2016, read under Objectives, "To fulfill regulatory requirements in order to achieve and maintain licensure ... and fulfill requirements of the Medicare Conditions of Participation... The QAPI (Committee) responsibilities include... Evaluating the effectiveness of action taken to improve a process."

In an interview and quality program record review on 10/19/16 at 9 am with the Quality Improvement /Risk Manager (QIRM), she was asked to describe the hospital's performance improvement program. QIRM stated that results of this monitoring are presented at the QAPI Committee meeting monthly with each department presenting once a quarter on a rotating basis.


1. QIRM was asked if complaints or reports from oversight agencies were reported to the QAPI Committee. QIRM replied that they were reported and monitoring was instituted to ensure the deficient practices were corrected. When asked about a California Board of Pharmacy 3/2016 report with deficient practices identified in pharmacy sterile compounding processes (the preparation of ingredients into a medication personalized for the patient), QIRM stated this report was not presented to the QAPI committee. QIRM was unaware of any performance improvement indicators for sterile compounding as a result of this survey. QIRM confirmed that actions had not been taken to effectively correct previously identified and persistent deficient sterile compounding. (Refer to A490 and A501).

2. Review of the 2016 QAPI minutes demonstrated the hospital required contract vendors to attend the QAPI Committee. The minutes indicated that there was repeated instances that infection control measures were not adhered to by Contract Agency D. The minutes indicated discussion and further monitoring but no further actions were taken to improve performance for Contract Agency D.

On 10/18/16 at 2 pm, Patient 26's room was observed to have a sign posted outside the door indicating the patient was on contact precautions (measures to stop the spread of infection by not directly touching the patient with bare skin), and gloves and gown were required upon entering the room. Concurrently, Contract Nurse G was observed entering Patient 26's room without sanitizing or washing his hands, or putting on gloves and gown. (Refer to A749, item 1 for further details).

On 10/18/16 at 2:10 pm, Administrative (Admin) Nurse D confirmed that Contract Nurse G was from Contract Agency D and acknowledged that the hospital had known of these infection control failures but had not taken action to correct it.


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3. During the survey, deficient practices were noted in the pharmaceutical and health record services. Refer to A490 and A454.

In an interview and quality program record review on 10/19/16 at 9 am with the Quality Improvement /Risk Manager (QIRM), she was asked to describe the hospital's performance improvement program. Results of this monitoring are presented at the QAPI Committee meeting monthly with each department presenting once a quarter on a rotating basis.

During a review of the hospital pharmacy's sterile (germfree) compounding quality assurance program (on 10/18/16 at 3:30 p.m.) the Director of Pharmacy (DOP) stated in March 2016 the Board of Pharmacy (BOP) had identified deficits related to compliance with end product sterility and potency testing every 4 months during their sterile compounding pharmacy re-licensure visit (in accordance with hospital policy); the DOP provided a copy of the BOP's 3/1/16 inspection report. The DOP indicated he had changed the policy to annual end product testing in March 2016.

During an interview on 10/19/16, the Chief Nursing Officer (CNO) verified the revised March 2016 "Intravenous Admixture" policy provided by the DOP had not been approved by the hospital's medical staff committees.

QIRM was asked if complaints or reports from oversight agencies were reported to the QAPI Committee. QIRM replied that they were reported and monitoring was instituted to ensure the deficient practices were corrected. With regard to the aforementioned California Board of Pharmacy 3/2016 report with deficient practices identified in pharmacy sterile compounding processes (the preparation of ingredients into a medication personalized for the patient), QIRM stated this report was not presented to the QAPI committee. QIRM she was unaware of any performance improvement indicators for sterile compounding as a result of this survey. QIRM confirmed that actions had not been taken to effectively correct previously identified and present deficient sterile compounding practices. (Refer to A490, and A501).

Based on interview and record review, the facility failed to ensure and evaluate a physician's request for specific procedures to be performed at the time of new appointment, for one of five medical staff (MD 1) files reviewed. This failure potentially could have led to procedures being performed without the required competencies of staff and without the necessary equipment to perform the procedure, ultimately placing the patient at harm.

Findings:

Medical staff files were reviewed on 10/13/16, at 4:05 pm. The Medical Specialists Privilege Request Form submitted by the physician (MD 1) requested a new appointment, consulting privileges (no admitting privileges) and "Gastroenterology" under "other specialities not identified." No documentation was included in the file requesting specific procedures to be performed, such as colonoscopy (procedure performed with a special scope to view the bowels), EGD (procedure performed with a special scope to view the upper digestive tract), placement of PEG tubes (procedure to place a feeding tube through the abdominal wall into the stomach), or the use of sedation, etc.

During an interview on 10/13/16, at 4:05 pm, the Medical Staff Coordinator (MS) confirmed the "third page" and final page of the new appointment request for MD 1, was not in the file. Documentation in the file indicated that the Governing Board approved the new appointment on 3/10/16. The MS confirmed MD 1 requested to perform procedures on inpatients, as well as outpatients.

The facility Medical Staff Bylaws for the hospital, with an approval date of 9/14/16, indicated in Article 5.1, "every Practitioner providing direct clinical services...shall be entitled to exercise only those setting-specific Privileges granted to him or her." Article 5.3-1 Requests indicated "each application for appointment...must contain a request for the specific Privileges desired by the applicant." Article 5.3-2(a) indicated "Privileges shall be evaluated on the basis of the Hospital's needs and ability to support the requested Privileges."

Based on interview and record review the hospital failed to follow their bylaws when the history and physical's (H&P, current and past health information) for one of 30 patients (Patient 1) did not include the Jackson/Pratt drain (J/P, bulb on the end of a flexible tube inserted into the body to drain away fluids).

These failures resulted in the J/P drain being overlooked and could have resulted in infection and/or a decline in condition.

Findings:

Patient 1's record was reviewed. The record contained two separate admissions to the hospital on 8/9/16 and 10/4/16. Patient 1's diagnoses included necrotizing fasciitis (bacterial that eats flesh), a left groin wound, and a below the knee amputation (BKA) of the left leg. Patient 1's J/P drain was not included in either H&P, and there were no physician orders for the care and maintenance of the drain.

On 10/12/16, at 12:04 pm, Patient 1 was observed with an inflated J/P drain that extended below the right side of the gown. Patient 1's nurse, Registered Nurse (RN) P, stated that the bulb should be compressed to be functional. RN P stated that for the last week the drain would not stay compressed, and was not draining fluids. RN P stated that the physician had been notified.

On 10/12/16, at 12:20 pm, Administrative (Admin) Nurse N reviewed Patient 1's record and verified that both H&P's failed to mention the J/P drain. Admin Nurse N also verified that the record did not contain orders for care and maintenance of the drain. Admin Nurse N stated that the H&P should contain all drains inserted into a patient, and a plan of care by the physician be developed from that information.

A review of the facility Medical Staff Bylaws, Article 3, effective 9/2016, indicate that a H&P examination must include: History of present illness, past medical history, family history, social history, medications, allergies, review of systems, physical examination, conclusions/impressions, and a planned course of treatment.

Based on interview and record review, the hospital failed to have a well organized nursing service as follows:

1. The hospital failed to develop a nursing policy and written competency for upper torso (chest) postural support. This failure resulted in the improper application on two consecutive days of a "postural support" that resulted in one of 30 sampled patients (Patient 11) being restrained to his wheelchair which had the potential for skin breakdown and psychological harm to occur.

2. The nursing service did not have a well organized system for the insertion of PICC (peripherally inserted central venous catheter, a tube into the arm for administration of medication) and midline catheters (tube into the arm for medication administration) for 6 of 30 sampled patients (Patients 10, 14, 21, 22, 24, and 27); and failed to implement the PICC insertion policy for Patient 14's catheter tip placement confirmation. This failure had the potential for improperly positioned PICC tip which can result in vein and/or heart damage and life threatening changes in condition.

Findings:

1. On 10/12/16 at 11:25 am, Patient 11 was observed in his wheelchair with a cloth device that was similar to a vest that was secured at the back of the wheelchair with a Velcro strip. Patient 11 was asked what this device was for, and he responded that it in use because he would fall. When asked if he could remove the vest, he stated he could not. Patient 11 was accepting of having to wear the device and it did not disturb him.

On 10/121/6, Patient 11's record was reviewed. Patient 11 was admitted to the hospital on 10/6/16 with diagnoses that included aspiration pneumonia (food or secretions swallowed into the lungs, causing infection) and developmental delay, requiring that he normally live in a specialized group setting. Patient 11's record did not contain a nursing assessment, care plan, or a physician's order for a postural support.

Review of the hospital's restraint competency material, showed that the hospital failed to have a written competency test and return demonstration documentation for the torso support. Review of Registered Nurse M and Certified Nurse Assistant L's competency documentation indicated they had passed the restraint competency with 100 percent accuracy but did not have Patient 11's torso support applied correctly. (Refer to A154 for further details).

In an interview on 10/13/16 at 9:30 am, Administrative Nurse D stated the hospital did not have a policy for postural supports and acknowledged the competency assessment had not been effective for the nurses caring for Patient 11.

2. On 10/19/16, Patient 14's record was reviewed. Patient 14 was admitted to the hospital on 9/25/16 with diagnoses that included a non-healing abdominal wound. Patient 14's record contained a physician's order for a PICC insertion, dated 9/28/16. Patient 14's record contained a PICC Insertion Record which indicated the PICC line was inserted on 9/28/16 at 3:15 pm and a chest x-ray was obtained to confirm the proper tip placement. This record did not indicate a physician had read the chest x-ray or that the 3CG Tip Confirmation System (a medical system to verify proper placement) was used to verify tip placement. Patient 14's record did not contain evidence of radiologist interpretations of two chest x-rays performed immediately after the procedure, 21 days later. Patient 14's record did not contain an "Okay to use PICC" order. Patient 14's record demonstrated that the PICC line had been used since 9/28/16, for medication administration.

Review of the hospital policy, titled, "PICC Insertion," dated 3/2016, read, "Order a portable Chest X-ray for Superior Vena Cava (proper vein) placement verification if not using the 3CG Tip Confirmation System ...Verification of tip placement is needed before catheter use."

In an interview on 10/19/16 at 8:45 am, PICC Nurse A stated he confirms tip placement using the portable x-ray at his discretion and only uses the radiologist interpretation if he was unsure of the placement. PICC nurse A further stated that after tip placement was confirmed, he was responsible for placing an "Okay to use PICC" order in the electronic record indicating that it was okay to use the line for medication administration. PICC Nurse A stated he was trained by doing an on-line course and was mentored by the hospital's previous PICC Nurse. When asked if he thought reading x-rays was in his nursing scope of practice, he replied "No" but stated he felt his five years of experience allowed him to discern appropriate placement. When asked if x-ray interpretation was in the nursing scope of practice, he replied "No".

Review of Patient 10, 22, 24, and 27's records showed that PICC/midline insertion consents for Patient 10 and 24, midline care plans for Patient 27, Patient 22 did not have the correct insertion date documented, Patients 21, 22, and 24 did not have care plans or "okay to use orders". (Refer to A131, finding 2, A396, finding 5b, A553 and A395, findings 1c, 1e, and 1g).

In an interview on 10/19/16 at 9:10 am, the Chief Nursing Officer (CNO) reviewed Patient 14's record and stated there had been an interface problem with the radiology electronic record. CNO confirmed Patient 14's record had not contained an "Okay to use" order and nursing had started using the line for medication administration without it. CNO was told of the above findings and acknowledged the PICC/midline catheter insertion system "needed some work".

Based on observation, interview, and record review, the hospital failed to ensure that the nursing care was supervised and evaluated for eight of 30 sampled patients as follows:

1a. Patient 1's Jackson/Pratt (JP, to drain fluids away) drain did not have a care plan, physician orders, completed intake and output (I&O), or consistent nursing assessments.

1b. Patient 1 did not have critical lab values reported to the physician in a timely manner.

1c. Patient 21's peripherally inserted central catheters (PICC, special tube inserted into the upper arm to deliver medications, fluids, and nutrition) line had a loose dressing, no orders, and no care plan.

1d. Patient 21's wound care orders were not followed.

1e. Patient 22's PICC line had an incorrect flow sheet, a dressing with no date and time, and no orders.

1f. Patient 23 was positioned on a specialty bed in a position not recommended by the manufacturer.

1g. Patient 24 had a PICC line with no consent and no nursing care orders.

1h. Patient 24 had a nasogastric (NG, thin flexible tube through the nose and down into the stomach) tube with incorrect or missing orders, which was removed without a physician order.

2. Patient 17 did not have physician's orders or a care plan for the care and maintenance of a biliary drain (tube into the abdomen to remove fluids).

3. Patient 11 did not have a pain assessment prior to and after receiving a pain medication.

4. Patient 13's record did not contain physician's orders, a care plan or any documentation for an MRSA (Methicillin Resistant Staphyloccocus Aureus- a bacteria that cannot be easily treated with antibiotics) positive status nor were any infection control precautions ordered or maintained during Patient 13's stay.

Findings:

1a. Patient 1's record was reviewed. Patient 1 was admitted to the hospital on 10/4/16 with diagnoses of necrotizing fasciitis (flesh eating bacteria), left groin wound, and a left below the knee amputation (BKA), wound care orders, and a JP drain.

On 10/12/16, at 12:04 pm, Patient 1 was observed in the hospital bed, with an inflated J/P drain extended below the right side of her gown. Patient 1's nurse, Registered Nurse (RN) P, stated that the bulb should be compressed, that without compression it would not remove the fluids from the body. RN P stated that it had been like that for a week, the physician had been notified but no changes had been made.

On 10/12/16, at 12:20 pm, Administrative (Admin) Nurse N reviewed Patient 1's record and verified that both H&P's failed to mention the J/P drain. Admin Nurse N also verified that the record did not contain orders for care and maintenance of the drain, the I&O (Intake and Output, a record of fluids) section was incomplete, and each shift did not have nursing assessments of drainage amounts every shift. Admin Nurse K verified that the care given, and documented, should have been complete, accurate, and done as frequently as policy dictated.

1b. Patient 1's record contained evidence of a critical lab template, dated 10/9/16 at 7:52 am, which indicated that a critically low level of potassium (chemical that makes heart and muscles function) had been reported to the hospital at 1:30 am. The template showed that the physician was contacted over four hours later (5:15 am) with the potassium level.

On 10/18/16, at 10:40 am, Charge Nurse (CN) reviewed the record and stated that the policy directed to report critical lab results to the physician within one half hour of receiving them. CN stated that the policy was not followed.

The hospital policy and procedure titled "Reporting of critical results of tests and diagnostic procedures", revised 7/16, indicated "critical test results...may represent life-threatening values" and will be "communicated to the ordering/covering physician within thirty minutes."

1c. Patient 21's record was reviewed. Patient 21 was admitted to the hospital on 9/28/16 with diagnoses that included respiratory (lung) failure and brain injury secondary to multiple gunshot wounds. The record did not contain evidence of a physician order or a care plan for a PICC line.

On 10/12/16, at 10:35 am, Patient 21 was observed lying in bed, on his left upper arm was an undated PICC line dressing with one corner not secured to the skin.

On 10/12/16, at 10:55 am, Admin Nurse N confirmed that Patient 21's dressing was undated, un-timed, and loose. Admin Nurse N stated that a loose dressing was not sterile, and presented a risk for infection.

On 10/18/16, at 12 pm, CN reviewed Patient 21's record and confirmed it did not contain evidence of a care plan, physician order for use, nursing care orders, or orders for flushes (to keep IV working) on the medication administration record (MAR).

1d. Patient 21's record revealed an admit date of 9/28/16 with diagnoses that included respiratory failure and a brain injury secondary to multiple gunshot wounds. The record did not contain orders or a care plan for his PICC line.

On 10/12/16, at 10:35 am, Patient 21 was observed lying on the bed, with a family member (FM) seated next to the bed. Patient 21's right upper chest had a raw open area on it. The FM stated that the previous night someone had changed the dressing on Patient 21's tracheotomy (surgical hole in neck to breath through) and placed the tape over the scab on his right upper chest. FM stated when they removed the tape they peeled the scab off, leaving the area re-damaged.

Patient 21's record contained a wound care order, dated 9/29/16, at 0900, that read "do not cover the small scab below the right upper chest; leave open to air."

On 10/12/16, at 10:55 am, Admin Nurse N confirmed Patient 21 should not have had tape placed over a scab.

1e. Patient 22's record was reveiwed. Patient 22 was admitted to the hospital on 9/26/16 with diagnoses that included right leg cellulitis and sepsis (infection that has spread to the blood). Patient 22 was receiving IV (intravenous-in the vein) antibiotics through a PICC line.

On 10/12/16, at 11:15, Patient 22 was observed sitting on the bed; the PICC line dressing on the left upper arm had no date or time on it. In a concurrent interview. Patient 22 stated that the dressing had been changed by nursing staff during night.

During an interview with Admin Nurse K, on 10/13/16, at 10:47 am, she reviewed the orders and confirmed there was no "okay to use" order, or nursing care orders for the PICC line. Admin Nurse K reviewed the undated PICC line flowsheet which indicated that the PICC was placed on 9/25/16.

A review of the pre-admission assessment form (filled out by the transferring acute care hospital), dated 9/26/16, revealed that the PICC line was placed on 9/19/16. Admin Nurse K confirmed that the insertion date on the flowsheet was incorrect. Admin Nurse K reviewed the PICC line flow sheet and indicated that the last documented dressing change on 10/4/15, was not up to date.

On 10/13/16, at 11:25 am, the PICC nurse (nurse specializing in PICC lines) stated that a PICC line dressing should be changed once a week, or as needed. The PICC nurse stated that the facility did not need physician orders to continue a PICC line when a patient was admitted to the hospital if "the patient needs it". The PICC line nurse stated that the insertion date did not matter unless there was some kind of issue with the line.

On 10/13/16, at 11:30 am, the Director of Quality stated there that the hospital had no PICC line policy.

On 10/18/16, at 11:35 am, CN stated that nursing should never use a PICC line without an "okay to use PICC line" order from the physician. CN stated that nursing should have orders for the care and maintenance of the PICC line, CN confirmed there record did not contain evidence of orders.

On 18/18/16, at 11:45 am, the Infection Control nurse (IC, tracks infections in the hospital) stated that the insertion date of a PICC line is important for tracking and reporting purposes.

The Department of Health and Human Services guidance on PICC lines, updated 3/2015, indicated "In the context of the care of the patient requiring PICC insertion, maintenance, and withdrawal, the nurse is responsible and accountable for: Verifying that orders are written by a duly authorized prescriber."

1f. Patient 23's record was reviewed. Patient 23 was admitted to the hospital on 9/2/16 on life support, with diagnoses of respiratory failure and hypoxia (low oxygen).

On 10/12/16, at 10:35 am, Patient 23 was observed lying flat on the bed with a pillow under both calves which resulted in the heels not touching the bed. There was a sign posted above the bed that read "do not float the heels". In a concurrent interview, Admin Nurse N stated that Patient 23's special mattress moved air around to shift pressure and prevent skin breakdown. Admin Nurse N stated that when the heels are propped up on pillows the bed is not capable of doing what it was designed to do which could result in skin breakdown. Admin Nurse N reviewed the record and stated Patient 23's legs should not have been placed on pillows.

A review of the manufacturer's information revealed that the Recover Air 3000 Elite was designed to wick moisture away from the skin, prevent skin breakdown, and comes equipped with a "integrated air foot cushion".

1g. Patient 24's record was reviewed. Patient 24 was admitted to the hospital on 9/16/16 with diagnoses that included respiratory failure, pneumonia (lung infection), schizoaffective disorder (mental disorder affecting ability to comprehend reality).

On 10/18/16, at 11:06 am, CN reviewed Patient 24's record which revealed an order, dated 9/20/16, to insert a PICC line. The order was entered on 9/20/16. CN reviewed the paper chart and was unable to locate a consent for the PICC line. CN also reviewed the computer record and was unable to locate an "okay to use order" or nursing care orders. CN stated that consent and orders should have been obtained prior to use.


1h. On 10/12/16, at 10:47 am, Patient 24 was observed with an NG tube inserted into the left nostril.

On 10/18/16, at 11:06 am, Charge Nurse (CN) reviewed Patient 24's record which revealed an order, dated 9/20/16, to insert a "small bore feeding tube" (a tube similar to an NG tube, except that it ends in the small intestine (instead of the stomach). CN confirmed that Patient 24 should have had an order to "insert NG tube", and also orders for the care and maintenance of the NG tube.

On 10/18/16, at 11 am, Patient 24 was observed without a feeding tube.

On 10/18/16, at 11:06 am, CN reviewed Patient 24's record which contained no evidence of a physicians order to remove the feeding tube. CN verified that nursing needed an order to remove Patient 24's NG tube.


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2. During observation on 10/12/16, at 11:07 am, Patient 17 was in bed, eyes closed, with family at the bedside.

Patient 17's record was reviewed on 10/13/16, at 2:34 pm. The physician's dictated history and physical (H&P), dated 10/05/16, indicated Patient 17 was admitted to the hospital for a bile duct infection (infection of the drainage system that carries enzymes from the liver and gallbladder into the area of the small intestine to help dissolve fat), pancreatic (secretes enzymes into the small intestine to help breakdown food and helps regulate blood sugars) cancer with metastasis (the spread of cancer to other organs) to the bile duct, and had a bile duct drain in place.

Patient 17's nursing admission assessment, dated 10/5/16, at 7:52 pm, indicated the bile duct drain was clamped. The nursing assessments dated 10/05/16 through 10/12/16 indicated the bile duct drain was in place and was clamped.

Patient 17's Input and Output record was reviewed from 10/5/16 through 10/12/16. There was no documentation of the drain or liquid recorded for the drain on the output record.

The physician's dictated progress notes, dated, 10/5/16 through 10/12/16 indicated a"chronic biliary drain" was in place for Patient 17.

During an concurrent interview and record review with the Director of Nursing (DON), on 10/13/16 at 2:34 pm, she was unable to find orders for the care and maintenance of the biliary duct drain or a care plan for the drain, in Patient 17's record. The DON confirmed there should be physicians orders for care and maintenance and a care plan in place for the drain.


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3. On 10/13/16, Patient 11's record was reviewed. Patient 11 was admitted to the hospital on 10/6/16 with diagnoses that included aspiration pneumonia (food or secretions swallowed into the lungs, causing infection) and developmental delay requiring that he normally live in a specialized group setting. Patient 11's record contained a physician's order, dated 10/6/16, for Tylenol 650 milligrams prn (as needed) for mild pain rated from 1-3 (on a scale of 10 with 10 being the worst pain). Patient 11's medication record indicated Tylenol was administered on 10/12/16 at 5:34 am. Patient 11's record did not indicate a description of the pain level before or after this administration.

On 10/13/16, the hospital policy titled Pain Management, dated 4/2012, indicated pain intensity will be assessed with each new report of pain and after each pain management intervention using the 0 to 10 scale.

In an interview on 10/13/16 at 8:40 pm, Administrative (Admin) Nurse N acknowledged that Patient 11's record did not demonstrate the documentation of pain scale before and after pain medication administration as required by policy.

4. On 10/13/16, Patient 13's record was reviewed. Patient 13 was admitted to the hospital on 9/23/16 with diagnoses that included renal (kidney) failure. Patient 13 had an admission assessment that indicated that isolation precautions, specifically contact precautions (such as wearing gown and gloves) were in place. Patient 13's record contained an admission screening test for MRSA that was positive and indicated that a physician's order should be obtained for contact precautions. Patient 13's record did not contain physician's orders, a care plan or any documentation that these precautions were ordered or maintained during Patient 13's stay.

The facility policy and procedure, titled, "MRSA (Methicillin Resistant Staphylococcus Aureus) Screening Cultures" with a last review date of 3/2016, indicated "All patients admitted to LTAC (Long Term Acute Care) that do not have MRSA identified on their facesheet (admission and demographic information) will be tested for MRSA within 24 hours of admission... Positive results: a. The patient will be palced on contact isolation. b. The physician will be notified of the positive screening culture and the need for isolation"

On 10/13/16 at 4:15 pm, Registered Nurse E and Administrative Nurse F reviewed Patient 13's record and in a concurrent interview acknowledged that there was no documentation that isolation precautions were maintained for Patient 13.

Based on observation, interview, and record review, the hospital failed to ensure 13 of 30 sampled patients had current and comprehensive nursing care plans as follows:

1a. Patient 1 did not have a care plan for a Jackson/Pratt drain (J/P surgically placed suction bulb that withdraws fluid from under the skin).

1b. Patients 21, 22, and 24 did not have care plans for their peripherally inserted central catheters (PICC, special tube inserted into the upper arm to deliver medications, fluids, and nutrition) lines.

1c. Patient 24 did not have a care plan for a nasogastric tube (NG, tube into the stomach via the nose to provide nutrition and hydration).

2. Patient 5 did not have a care plan for a feeding tube.

3. Patient 17 did not have a care plan for a biliary drain (a tube into the abdomen to drain excess fluid).

4a. Patient 11 did not have a care plan for a torso support, developmental delay, and blood clot prevention.

4b. Patient 27 did not have a care plan for blood clot prevention, contact isolation (measures to prevent the spread of infection), and a midline catheter (a tube into the arm to administer medications and fluids).

4c. Patient 10 did not have a care plan for blood clot prevention.

4d. Patient 12 did not have a care plan for blood clot prevention.

4e. Patient 13 did not have a care plan for contact isolation (such as wearing gown and gloves to prevent the spread of infection).

5. Patients 9 and 16 did not have a plan of care related to their insulin-dependent diabetes mellitus, with the potential for lack of individualized assessment, planning (including treatment goals), implementation, care coordination and evaluation; including recognition and consistent clinical interventions for signs, symptoms and treatment of high or low blood sugars.

These failures had the potential for the spread of infection, and adverse changes in patient's health status.

Findings:

1a. Patient 1's record was reviewed. Patient 1 was admitted to the hospital on 10/4/16 with diagnoses of necrotizing fasciitis (flesh eating bacteria), left groin wound, and a left below the knee amputation (BKA), wound care orders, and a JP drain. There was no evidence of a JP care plan.

On 10/7/16 Patient 1 was observed in the hospital bed, with an inflated J/P drain extended below the right side of her gown.

In an interview on 10/12/16, at 12:20 pm, Administrative (Admin) Nurse N reviewed the record and confirmed it did not contain a care plan for the JP drain.

1b. Patient 21's record was reviewed. Patient 21 was admitted to the hospital on 9/28/16 with diagnoses that included respiratory failure and brain injury secondary to multiple gunshot wounds. Patient 21 had an order for a PICC lin but the record did not contain evidence of a care plan for his PICC line.

On 10/18/16, at 12 pm, Admin Nurse N reveiwed Patient 21's record and in a concurrent interview confirmed that there was no care plan for a PICC line.

Patient 22's record was reviewed. Patient 22 was admitted to the hospital on 9/26/16 with diagnoses that included abscess of the right ankle, pulmonary emboli (clot in lung) and treatment with IV antibiotics through a PICC line. The record did not contain evidence of a PICC line care plan.

On 10/13/16, at 10:47 am, Admin Nurse K reviewed the record and in a conrrent interview, confirmed there was no PICC care plan.

Patient 24's record was reviewed. Patient 24 was admitted to the hospital on 9/22/16 with diagnoses of respiratory failure, chronic obstructive pulmonary disease (COPD, irreversible lung damage), and the need for long term IV antibiotics via a PICC line. There was no evidence of a PICC care plan.

On 10/18/16, at 11:35 am, Charge Nurse (CN) reveiwed Patient 24's record and in a conrrent interview confirmed there was no PICC care plan.

1c. Patient 24's record was reviewed. Patient 24's record did not contain evidence of a nasogastric (NG , tube from nose to stomach to deliver medication, hydration, and nutrition) tube care plan.

On 10/18/16, at 11:35 am, CN reviewed Patient 24's record and in a concurrent interview confirmed there was no NG care plan.


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2. During observation on 10/12/16, at 11:25 am, Patient 5 had a tube feeding (medical device used to provide nutrition to patients who cannot eat, are unable to swallow safely, or need nutritional supplementation), tube feeding pump and water connected to the pump at her bedside. Patient 5 was not able to communicate and participate in an interview.

Patient 5's record was reviewed on 10/13/16, at 10 am. The physician's dictated history and physical (H&P) dated 8/11/16, indicated Patient 5 was admitted to the hospital for progressive supranuclear palsy (problems with walking, balance and eye movements, caused by deterioration of cells in areas of the brain that control body movement and thinking), respiratory failure, and diabetes.

Review of Patient 5's record indicated Patient 5 had a PEG (a tube passed directly into the stomach through the abdominal wall) and required tube feeding for nutrition. The physician orders dated 10/12/16, indicated Patient 5 was NPO (nothing by mouth), with a continuous tube feeding rate running at 65 ml/hr (milliliters/hour). An "Altered Nutrition Status" care plan was started for Patient 5 on admission and included items for weekly weights, labs, assessment of response to the tube feeding, etc. Documentation in the record showed that the care plan was "removed" on 9/25/16 for unknown reasons. There was no other nutritional care plan added back to the record.

During an interview on 10/18/16, at 11:36 am, with the Director of Nursing Services (DON), she confirmed the "Altered Nutritional Status" care plan was "removed" and not replaced from Patient 5's record. The DON stated the nurse who removed the care plan was not on duty today and she was not sure why it would have been removed.

3. During observation on 10/12/16, at 11:07 am, Patient 17 was in bed, eyes closed, with family at the bedside.

Patient 17's record was reviewed on 10/13/16, at 2:34 pm. The physician's dictated H&P dated 10/5/16, indicated Patient 17 was admitted to the hospital for a bile duct infection (infection of the drainage system that carries enzymes from the liver and gallbladder into the area of the small intestine to help dissolve fat), pancreatic (organ that secretes enzymes into the small intestine to help breakdown food and helps regulate blood sugars) cancer with metastasis (the spread of cancer to other organs) to the bile duct, and had a bile duct drain in place.

The nursing admission assessment, dated 10/05/16 at 7:52 pm, indicated the bile duct drain was clamped. The nursing assessments dated 10/05/16 through 10/12/16 indicated the bile duct drain was in place and was clamped.

During an concurrent interview and review of Patient 17's record with the DON, she was unable to find a care plan for the biliary duct drain. The DON confirmed there should be a care plan in place.



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4. a. On 10/13/16, Patient 11's record was reviewed. The record indicated that Patient 11 had a developmental delay. There were physician orders for warfarin for (blood) clot prevention, and occupational therapy for the improvement of activities of daily living (ADLs) such as dressing, bathing, etc. Patient 11's record did not contain a care plan for the nursing oversight of cognitive issues such as developmental delay, risk of deep vein thrombosis (DVT, blood clots), or impaired ADLs.

Patient 11 was observed on 10/131/16 with a torso support in place. (Refer to A154 for additional details). Patient 11's record did not contain care plan interventions for upper torso weakness or fall risk that included the use of a postural support such as the torso support.

On 10/13/16 at 8:40 am, Admininstrative (Admin) Nurse N demonstrated that these care plans were readily available in the hospital's electronic medical record for assignment to Patient 11. Admin Nurse N acknowledged Patient 11's care plans did not include the above items.

4. b. On 10/19/16, Patient 27's record was reviewed. The record contained evidence that Patient 27 had a history of DVT with an anticoagulation medication (Lovenox) ordered for clot prevention, MRSA (Methicillin Resistant Staphyloccocus Aureus-a bacteria that is hard to treat with antibiotics) infection, and had a midline catheter. Patient 27's record did not contain a care plan for these items.

In an interview on 10/19/16 at 10:50 am, Admin Nurse N acknowledged that Patient 27's care plan was incomplete to provide adequate oversight for the care required for blood clots, infection and catheter care.

4.c. On 10/12/16, Patients 10's record was reviewed. The record contained evidence of the use mechanical intervention such sequential compression devices (SCDs, compression stockings) for the prevention of DVTs (Deep Vein Thrombosis-blood clot). Patients 10's record did not contain a care plan for the risk of DVT.

In an interview on 10/12/16 at 3:30 pm, Admin Nurse K acknowledged the care plan for Patient 10 was incomplete for risk of DVT.

4. d. On 10/13/16, Patient 12's record was reviewed. The record contained physician orders for an anticoagulation medication (Lovenox) ordered for clot prevention. Patient 12's record did not contain care plan for DVT prevention.

In an interview on 10/13/16 at 10:20 am, Admin Nurse N acknowledged that Patient 12's record did not include a care plan for the risk of DVT.

4.e. On 10/13/16, Patient 13's record was reviewed. The record contained evidence of MRSA infection. (Refer to A749, item 3 for further details). Patient 13's record did not contain a care plan for contact isolation.

In an interview on 10/13/16 at 4:15 pm, Registered Nurse E and Administrative Nurse F reviewed Patient 13's record and acknowledged no care plan was present for isolation.




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5. Review of the facility policy "Assessment and Reassessment," revised March 2011, indicated under item 6: "Upon completion of the initial assessment, the RN (Registered Nurse) shall initiate an individualized, prioritized plan of care within 8 hours of patient admission ...9. The plan of care will be reviewed every shift and revised as the patient's condition or diagnosis changes. Licensed nursing staff will document the patient's progress toward active problems/goals every shift."

Review of the facility policy titled, "Care Planning (CM)," revised January 2016, indicated: "The Case Managers will establish a written plan of care for each patient which will include a detailed treatment plan." The policy further indicated: "1.d. The team should use the problem list to create an individualized, comprehensive treatment plan, which reflects short and long term goals and barriers/contingencies."

5.a. Closed clinical record review indicated Patient 16 was an 83 year-old admitted to the hospital on 8/31/16 with diagnoses including sepsis and insulin-dependent diabetes mellitus. Patient 16's admission physician orders included orders for Lantus 27 units daily at bedtime (long acting basal insulin) and regular (short-acting) insulin sliding scale, the amount to be administered determined by fingerstick blood sugar readings before meals and at bedtime.

Review of Patient 16's eMAR (electronic medication administration record) indicated on 9/15/15 licensed nursing staff administered Patient 16's scheduled bedtime dose of Lantus 27 units, along with 2 units of regular insulin for a fingerstick blood sugar of 138 mg/dL (milligrams per deciliter), in accordance with the physician's orders. Review of Patient 16's dietary intake (on the same day) indicated 75% of breakfast, 50% of lunch and 25% of dinner was consumed.

Lexicomp ONLINE, a nationally recognized drug information source, indicated hypoglycemia was the most common adverse effect from insulin; and may result from changes in meal pattern. The monograph further indicated profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death.

Further record review indicated Patient 16 experienced an episode of low blood sugar (54 mg/dL, normal fasting blood sugar is 70 to 100 mg/dL) by laboratory assessment on 9/16/16 at 5:29 am; and 46 mg/dL by fingerstick on 9/16/16 at 6:50 am Patient 16 was found unresponsive and unarousable and required a reversal agent (intravenous 50% dextrose in water, a source of sugar).

During an interview on 10/14/16 at 10:30 am, the Chief Nursing Officer (CNO) confirmed Patient 16's clinical record findings. When asked if Patient 16's clinical record included a multidisciplinary diabetes mellitus plan of care that would have addressed the use of insulin and meal intake concerns related to hypoglycemia prevention; or nursing interventions for signs and symptoms of low blood sugar, the CNO confirmed no diabetes plan of care had been developed for Patient 16.

5.b. Clinical record review indicated Patient 9 was admitted to the hospital on 10/5/16 with diagnoses including sepsis, pneumonia and poorly controlled insulin-dependent diabetes. Patient 9's physician orders included an order (dated 10/8/16) for regular insulin via intravenous infusion pump.

During an interview on 10/13/16 at 4:30 pm, the CNO confirmed Patient 9's clinical record findings. When asked if Patient 9's clinical record included a diabetes mellitus plan of care that addressed his poorly controlled disease process, insulin risks, and to ensure license nurses would document his progress toward reaching his blood sugar goals, the CNO confirmed no diabetes plan of care had been developed for Patient 9.

Based on observation, interview and record review two of 30 sampled patients' medications were not administered in accordance with physicians' orders when:

1. Patient 15 was administered two doses of duplicate potent opiate (narcotic for pain) medications (Lortab elixir (liquid) and hydromorphone injection) simultaneously by licensed nursing staff. As a result, Patient 15 required two doses of an intravenous opiate reversal medication (Narcan), mechanical ventilation, and immediate intervention by the hospital's rapid response care team due to altered level of consciousness and a deteriorated condition.

2. Patient 6's Probiotic 10, a probiotic (supplement to improve stomach bacteria) was ordered to be administered orally and was given via gastrostomy tube (GT, a tube implanted in the stomach for administration of medications and nutritional formula), with the potential for an error in administration.

Findings:

Review of the hospital policy titled, "Medication Management," dated March 2003, indicated under Medication Error Reduction Program: "1. A 'Medication Error' is defined as any variation from a prescription or drug order not corrected prior to furnishing the drug to the patient."

1a. Clinical record review indicated Patient 15 was admitted to the hospital on 8/24/16 with diagnoses including a severe neurological spine injury (related to landing on his back on a fence after a 20 foot fall from a ladder), respiratory failure and COPD (chronic obstructive pulmonary disease). Patient 15 had a tracheostomy (surgical formation of an opening into the trachea, or windpipe, through the neck to allow the passage of air) and was to be weaned off the mechanical ventilator (machine that supports breathing). Patient 15's physician orders included Lortab elixir 15 mL (milliliters, containing 10 mg of hydrocodone, an opiate medication indicated for moderate pain, combined with 300 mg acetaminophen, a mild pain reliever, per 15 mL) via GT every 4 hours as needed for pain level of 4 to 10 (dated 8/26/16); and hydromorphone (potent opiate indicated for severe pain) 1 mg (milligram) intravenously as needed for severe pain unrelieved by Lortab elixir. The medication orders did not specify the time period required after the Lortab elixir was administered before intravenous hydromorphone could be given by licensed nursing staff.

Review of the hospital policy titled, "Pain Management: LTAC (long-term acute care)," dated December 2005, pain intensity was assessed by licensed nursing staff prior to medication administration using the numeric 0 (zero) to 10 scale; moderate pain was assessed by at a level of 4 to 6 and severe pain at 7 to 10.

Review of Patient 15's 9/10/16 eMAR (electronic medication administration record) indicated the following medications were administered within an approximate 4.25 hour time period while Patient 15 was receiving supplemental oxygen but off the mechanical ventilator:

Patient 15's eMAR indicated Lortab elixir 15 mL via GT and hydromorphone 1 mg intravenously were administered by a day shift licensed nurse at 5:17 pm for a pain level of 7. Review of the hospital's automated dispensing cabinet electronic record indicated the nurse withdrew the Lortab elixir at 5:13 pm and 12 seconds and the hydrocodone at 5:13 pm and 31 seconds. Licensed nursing staff obtained orders for Ativan 0.5 mg intravenously for Patient 15's anxiety and administered doses at 7:59 pm and 8:24 pm

According to Lexicomp ONLINE, a nationally recognized drug information source, Ativan, an anti-anxiety medication, is a CNS (central nervous system) depressant and may enhance the CNS depressant effects of opioids. The source indicated this combination should be avoided when possible.

Patient 15's eMAR further indicated a licensed night shift nurse administered hydromorphone 1 mg intravenously at 9:41 pm and Lortab elixir via GT at 9:42 pm for a pain level of 7. Review of the hospital's automated dispensing cabinet electronic record indicated the nurse withdrew the hydromorphone at 9:35 pm and 40 seconds and the Lortab at 9:35 pm and 51 seconds.

Lexicomp ONLINE indicated adverse effects related to hydrocodone and hydromorphone included CNS depression (sedation, or decreased mental alertness); respiratory depression (slowed breathing); hypotension (low blood pressure) and miosis (constriction of the pupils of the eye). The source further indicated use with caution in patients with decreased respiratory reserve or COPD.

Review of Patient 15's clinical record Patient Care Notes indicated on 9/10/16 at 10:30 pm the rapid response team was summoned due to Patient 15's "unresponsiveness, pinpoint pupils, depressed respiratory rate and hypotension ...Resp (respiratory) rate 8 (normal 12 - 20), unresponsive to sternal rub (assessment for level of consciousness by rubbing the sternum of the chest with a closed fist to create pain)." Review of the Rapid Response Team Care Record indicated Patient 15's blood pressure was low at 78/50 (normal 120 systolic/80 diastolic); and oxygen saturation (a measure of the extent of oxygen binding hemoglobin in the blood, normally 95 - 100%) was low at 88%. The document indicated Narcan 0.4 mg was administered intravenously, resulting in increased responsiveness; and Patient 15 was placed back on continuous mechanical ventilation.
An additional Patient Care Note (dated 9/11/16 at 1:13 am) indicated an additional dose of Narcan 0.2 mg was administered intravenously for a low blood pressure of 86/58 and heart rate of 52 (normal 60 - 100 beats per minute).

During an interview on 10/14/16 at approximately 9:20 pm, the Chief Nursing Officer (CNO) verified Patient 15's clinical record findings and indicated both the 9/10/16 day and night shift nurses probably did not allow sufficient time after the Lortab elixir was administered before they gave the intravenous hydromorphone. The CNO acknowledged opiate excess resulted in Patient 15's clinical decline and need for Narcan.

During a follow-up interview on 10/14/16 at 11:25 am, the CNO confirmed both the 9/10/16 day and night shift licensed nurses had not adhered to the physician's order when both the Lortab elixir and intravenous hydromorphone were given together at 5:17 pm and 9:41/9:42 pm, respectively.

During an interview on 10/18/16 at 11:10 am, the Director of Nursing (DON) indicated neither the day nor night shift nurses who provided care and medications to Patient 15 on 9/10/16 were available for an interview.

1b. Review of the facility policy titled, "Unusual Occurrence Reports and Mandatory Reporting," dated March 1997, indicated: "3. The circumstances surrounding an adverse event ...will be reported on an Unusual Occurrence Report (UOR) in order to identify and analyze the cause of the incident, prevent future incidents and minimize the risk of loss from events which have already occurred ...15. Events such as, but not limited to, the following will be documented on an UOR: A. Medication or intravenous errors."

During an interview on 10/14/16 at 10:30 pm, the DON confirmed a UOR, or medication error report, had not been completed after Patient 15's two errors in duplicate opiate administration (Lortab elixir and intravenous hydromorphone) the afternoon and evening of 9/10/16.

1c. Review of Patient 15's Adverse Drug Reaction (ADR) Report related to the administration of Narcan on 9/10/16 (indicating Registered Pharmacist (RPh) 2 had generated the report on 9/12/16 at 3 pm), provided by the CNO, indicated RPh 2 handwrote "Dilaudid/Lortab" under "Suspected Drug/Dose/Route/Frequency" and checked a box indicating "Increased Sedation." Under Comments, RPh documented, "Naloxone given - pt (patient) came around quickly."

During an interview on 10/14/16 at 11:15 am, the CNO confirmed Patient 15's 9/12/16 ADR Report lacked clinical accuracy regarding the two instances of duplicate opiate administration resulting in Narcan administration on 9/10/16, as Patient 15's Patient Care Notes indicated he had exhibited altered level of consciousness; not increased sedation.

During an interview on 10/18/16 at 11:40 am RPh 2, who confirmed completion of the aforementioned ADR Report on 9/12/16, indicated he had reviewed Patient 15's medications; 9/10/16 rapid response team information; and had spoken with licensed nurses. RPh 2 acknowledged he not completed a thorough review of 9/10/16 licensed nursing documentation in Patient 15's clinical record; or considered that errors in opiate administration had resulted in the need for Narcan. RPh 2 confirmed he had not generated a UOR based on Patient 15's two episodes of duplicate opiate administration by licensed nursing staff on 9/10/16.

2. On 10/13/16 at approximately 5:20 pm, during an observation of medication administration, Licensed Nurse (LN) 1 was observed to open a capsule of Probiotic 10, mix it with approximately 30 mL of water, and administer the mixture to Patient 6 via GT. LN 1 stated Patient 6's eMAR indicated oral administration of Probiotic 10, but it could only be given via GT because Patient 6 had a tracheostomy and was "NPO" (not receiving nutrition, fluids or medications by mouth).

Review of Patient 6's current physician orders indicated orders for Probiotic 10 (three times daily), dated 10/7/16; levothyroxine 100 mcg daily (thyroid supplement), dated 9/11/16; and loratadine 10 mg daily as needed (antihistamine indicated for seasonal allergies), dated 10/4/16, were ordered to be administered by mouth.

During an interview on 10/13/16 at 5:40 pm the Director of Nursing (DON) confirmed Patient 6's Probiotic 10, Levothyroxine and loratadine had been ordered to be administered by mouth; and licensed nursing staff should have clarified the orders with the prescriber. The DON further confirmed Patient 6 did not have a physician's order indicating his "NPO" status.

Review of the facility policy titled, "Medication Administration," dated March 2003, indicated: "6. Prior to administering medication, the health care professional must ...E. Verify the medication is administered at the proper time, prescribed dose, and correct route." The policy further indicated with regard to Incomplete/Unclear/Illegible Orders: "If a medication order is incomplete, unclear, contains unacceptable abbreviations, or is illegible, the individual who wrote the order should be contacted, and the order clarified accordingly."

Based on interview and record review, the hospital failed to ensure that one of 24 patients (Patient 13) with isolation precautions (to prevent spread of infection) had the maintenance of those precautions documented in the patient record. This failure had the potential for the spread of infection from the failure to maintain isolation precautions.

Findings:

On 10/13/16, Patient 13's record was reviewed. Patient 13 was admitted to the hospital on 9/23/16 with diagnoses that included renal (kidney) failure. Patient 13 had an admission assessment that indicated that isolation precautions, specifically contact precautions (gloves and gowns when touching patient or patient's environmental surfaces) were in place. Patient 13's record contained an admission screening test for MRSA (methicillin resistant staphylococcus aureus-a hard to treat bacteria) that was positive and indicated that contact precautions should be started. Patient 13's record did not contain physician's orders, a care plan or any documentation that these precautions were ordered or maintained during Patient 13's stay.

The hospital policy, titled, "Medical Record Documentation Requirements," dated 4/2015, read, "All medical records will contain documentation to substantiate care and treatment provided... The medical record will contain the following... Records of assessment and intervention..."

In an interview on 10/13/16 at 4:15 pm, Registered Nurse E and Administrative Nurse F reviewed Patient 13's record and acknowledged that there was no documentation that isolation precautions were maintained for Patient 13.

Based on interview and record review, the facility failed to ensure timely authentication of telephone or verbal orders for six of 30 sampled patients (Patients 1, 4, 5, 9, 15, and 30) and six patients outside the sample (Patients 31, 32, 33, 34, 35, and 36) when:

1. Patient 4's Transfer Form was not authenticated by the physician giving the order.

2. Patients 1, 5, 9, 15, 30, 31, 32, 33, 34, 35, and 36 had verbal/ telephone orders greater than 48 hours that had not been authenticated.

These delays could potentially lead to an incomplete and inaccurate medical record for reviewing or determining next levels of care and patient condition.

Findings:

1. Patient 4's record was reviewed on 10/12/16. Patient 4 was admitted to the hospital on 8/15/16 with diagnoses that included chronic lyphocytic leukemia (bone marrow cancer), anemia (low iron in the blood were the body cannot produce enough red blood cells), and thrombocytopenia (low platelets that help clot blood).

During a concurrent interview and record review on 10/12/16, the Director of Nursing Services (DON) confirmed the Patient Transfer Form for Patient 4, dated 9/6/16, 30 days later, had not been authenticated by the physician with date, time, or signature.

The hospital policy and procedure, titled "Medical Record Documentation Requirements," last reviewed 4/2015, indicated "Telephone orders must be authenticated by the prescribing physician according to state law and hospital policy time frames. In the absence of a state law specifying the time frame for authentication of telephone orders, the order needs to be authenticated within 48 hours, effective 1/26/13."



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2. On 10/13/16 at 11:50 am, the Health Information Management (HIM) Director ran a short report regarding verbal orders that had not been signed by physicians. The report dated 10/8 to 10/12/16 indicated that the following patients had verbal orders that had not been signed within 48 hours:

Patient 1 had one order, dated 10/10/16;
Patient 9 had four orders, dated 10/8/16 and six orders dated 10/10/16;
Patient 15 had one order, dated 10/10/16;
Patient 30 had two orders, dated 10/8/16 and three orders dated 10/10/16;
Patient 31 had one order, dated 10/10/16;
Patient 32 had one order, dated 10/10/16;
Patient 33 had one order, dated 10/9/16;
Patient 34 had one order, dated 10/10/16;
Patient 35 had one order, dated 10/10/16; and
Patient 36 had two orders, dated 10/8/16.

In a concurrent interview, HIM Director acknowledged that the above verbal orders were not signed by the practitioner within 48 hours.

Based on observation, interview, record and facility document review, the hospital failed to ensure that pharmaceutical services met the needs of the patients as policies and procedures to provide safe and effective use of drugs were not implemented as evidenced by the following:

1. Medications were administered in accordance with the order of the practitioner and facility policy. Refer to A405.

2. Medications were stored in accordance with accepted professional principles, manufacturer guidelines and facility policy. Refer to A491.

3. Medications were controlled, distributed and administered to provide patient safety as evidenced by: clarification of physician orders to prevent medication errors and adverse reactions; following established policies and procedures for high risk/high alert medication storage and distribution; and double licensed nursing verification of narcotic and insulin infusion dosage changes. Refer to A500.

4. Compounding, packaging and dispensing of sterile dosage forms was performed consistent with national standards of practice. Refer to A501.

5. The facility developed and implemented effective reporting systems for the identification of medication errors and adverse drug reactions. Refer to A508.

The cumulative effects of these systemic problems had the potential to result in medication errors and adverse effects which could subsequently lead to harm, disability, and death of patients.

Based on observation, interview and record review the hospital failed to ensure medication storage areas were administered in accordance with accepted professional principles when:

1. Policies and procedures regarding proper storage of pharmaceuticals were not implemented when two of RSI portable containers (rapid sequence intubation, or emergency airway placement after induction of sedation and paralysis) were observed stored in the LTAC (Long Term Acute Care) South medication room refrigerator, each containing six injectable medications labeled (by the manufacturer) for storage at room temperature.

2. A one liter bag of intravenous dextrose 5% (percent) solution was observed stored outside of its protective overwrap for an unspecified period of time in one of four medication rooms, with the potential for fluid evaporation and change in dextrose concentration.

3. A one liter bottle of preservative-free sterile water for irrigation, in use for Patient 6's gastrostomy tube flushes, did not contain documentation indicating a beyond use date.

4. Two of four portable emergency medication and supply carts contained supplies of prefilled normal (0.9%) saline syringes that were not labeled with expiration dates in accordance with facility policy.

As a result, patients were potentially administered expired, degraded, contaminated or ineffective product or medications.

Findings:

1. On 10/12/16 at 3 pm, during an inspection of the LTAC South medication room, accompanied by the Chief Nursing Officer (CNO), the displayed medication refrigerator temperature was observed to be 4.8 degrees C (Celsius, equivalent to 40.6 degrees F, Fahrenheit). The refrigerator was observed to contain two green plastic boxes with secured clear lids, labeled as "RSI Kits." Each plastic box contents included the following six injectable medications affixed with the following manufacturer's storage temperature labeling:

Two Calcium Chloride 10% 10 mL (milliliters) vials (for low blood calcium or elevated potassium): "Store at controlled room temperature, 15 to 30 degrees C (59 to 86 degrees F)."

Two Naloxone 1 mg/mL (milligram per milliliters) prefilled syringes (opiate (narcotic) reversal agent): "Store at 25 degrees C (77 degrees F); excursions OK 15 to 30 degrees C (59 to 86 degrees F)."

One Vecuronium 20 mg dry powder vial (paralytic agent, causes paralysis): no storage temperature was delineated on the vial; the manufacturer's package insert labeling indicated storage 20 to 25 degrees C, equivalent to controlled room temperature (68 to 77 degrees F).

One Flumazenil 0.5 mg/5 mL vial (reversal agent for benzodiazepines (sedative), or minor tranquilizers):"Store at 20 to 25 degrees C (68 to 77 degrees F)."

One Etomidate 40 mg/20 mL vial (for induction of general anesthesia):"Store at 20 to 25 degrees C (68 to 77 degrees F)."

One normal (0.9%) saline prefilled syringe: "Store at 15 to 30 degrees C (59 to 86 degrees F)."

During a concurrent interview, the CNO confirmed the medication room refrigerator temperature and that the six aforementioned medications contained within the RSI Kits should be stored at controlled room temperature as indicated by the various manufacturers.

During an interview on 10/12/16 at 3:50 pm, Pharmacist (RPh) 1 indicated not being aware if various manufacturers had been contacted as to whether the six aforementioned RSI Kit medications (labeled for room temperature storage) could safely be stored at refrigerated temperatures.

Review of the hospital policy titled,"Medication Management," dated March 2003, indicated under Storage of Medications and Biologicals,"a. From time of receipt in the Pharmacy to patient administration, medications and biologicals are stored according to manufacturer specifications ...c. Room temperature medications are stored between 59 to 86 degrees Fahrenheit."

2. On 10/12/16 at 3:15 pm, during an inspection of the LTAC North station medication room, accompanied by the CNO, a one liter (equivalent to 1000 mL) bag of intravenous 5% dextrose solution was observed stored outside its protective overwrap in a blue bin containing similar solutions with intact overwraps.

During a concurrent interview, the CNO confirmed the observation and indicated the inability to determine when the solution's protective overwrap was removed.

Review of the hospital policy titled, "Medication Management," dated March 2003, indicated under Storage of Medications and Biologicals,"a. From time of receipt in the Pharmacy to patient administration, medications and biologicals are stored according to manufacturer specifications."

During an interview on 10/12/16 at 3:35 pm Pharmacy Technician (PharmTech) indicated liter bags of intravenous 5% dextrose could be stored outside of their protective overwrap for 30 days.

Review of the solution manufacturer's written correspondence with the hospital (dated 10/13/16) indicated:"Product stability once the overwrap has been removed is dependent on several factors ...The overwrap serves as a protective barrier to control the amount of water that evaporates from the solution. Once the overwrap is removed, the rate of evaporation increases ...Products equal to or greater than 50 mL were projected to meet their specifications at the expiration date in overwrap, including 30 days outside of the overwrap. See Table 1 for applicable products." Table 1 indicated the guidance pertained to 1000 mL bags of intravenous 5% dextrose solution.

3. On 10/13/16 at approximately 5:20 pm, during an observation of medication administration, Licensed Nurse (LN) 1 was observed to pour clear liquid from a 1000 mL plastic container with manufacturer's labeling indicating the bottle contained sterile water for irrigation; the bottle contained approximately 500 mL of liquid. LN 1 used the solution to flush Patient 6's gastrostomy tube (GT, a tube implanted in the stomach for administration of medications and nutritional formula) and dilute medication for administration. During a concurrent interview, LN 1 confirmed she had not opened the container and was unsure when it had first been accessed; LN 1 further confirmed the bottle was not labeled with a date of first use or "use by" date.

Further inspection of the sterile water for irrigation manufacturer's product labeling indicated the product was a single-dose container; the product did not contain a bacteriostat (chemical added to arrest bacterial growth); and the unused portion should be discarded.

During an interview on 10/13/16 at 5:35 pm the Director of Nursing (DON) indicated the night shift usually changed out the bottles of sterile water for patients with GT flush orders; and the bottles were used over a 24 hour period prior to discarding.

During a follow up interview on 10/14/16 at 12:30 pm the DON confirmed the hospital did not have a written policy regarding dating and use of sterile water for irrigation when used over a 24 hour period for GT flushes.

4a. On 10/12/16 at 12:15 pm, during an inspection of the hospital's sealed portable emergency supply cart ("crash cart") on LTAC South, accompanied by the CNO, the face of Drawer #3 was observed to contain a label indicating,"Next Expiration Date," followed by a blank space. Inspection of the cart's Drawer #3 contents indicated twelve injectable 10 mL (milliliters) prefilled normal (0.9%) saline syringes were stored within; with an earliest expiration date of 9/1/17.

During a concurrent interview, the Chief Nursing Officer (CNO) confirmed an expiration date for the saline flush syringes should have been documented on the face of Drawer #3.

4b. On 10/12/16 at 3:20 pm, during an inspection of the hospital's sealed crash cart on LTAC North, accompanied by the CNO, the face of Drawer #3 was observed to contain a label indicating,"Next Expiration Date," followed by a blank space. Inspection of the cart's Drawer #3 contents indicated fifteen injectable 10 mL prefilled normal saline syringes were stored within; with an earliest expiration date of 6/1/17.

During a concurrent interview, the CNO confirmed an expiration date for the saline prefilled syringes should have been documented on the face of Drawer #3.

Review of the hospital policy titled, "Crash Cart Check" revised September 2015, indicated,"Crash cart checks are necessary to ensure emergency supplies are intact and all required supplies are present ... Examine outdates indicated on the outside of each drawer to validate there are no outdated items in the cart."

Based on observation, interview, clinical record, and facility document review, the hospital failed to develop and implement policies and procedures to promote safe use of medications to protect patients from potential adverse consequences associated with their use. As a result the facility:

1. Failed to clarify and evaluate a physician's order for duplicate opiates (narcotics), thereby exposing one of 30 patients (Patient 15) to administration errors and an adverse drug reaction.

2. Failed to follow policies and procedure for high risk/high alert medication storage and distribution.

3. Failed to follow policies and procedures for licensed nursing double checks of high risk/high alert medication infusion dosage changes (narcotic and insulin) for 2 of 30 patients (Patients 9 and 22).

These failed practices had a potential to result in medication errors which could subsequently lead to harm, disability, and death of patients.


Findings:

1a. Clinical record review indicated Patient 15 was admitted to the hospital on 8/24/16 with diagnoses including a severe neurological spine injury (related to landing on his back on a fence after a 20 foot fall from a ladder), respiratory failure and COPD (chronic obstructive pulmonary disease). Patient 15 had a tracheostomy (surgical formation of an opening into the trachea, or windpipe, through the neck to allow the passage of air) and was to be weaned off the mechanical ventilator (machine that supports breathing).

Patient 15's physician orders included Lortab elixir 15 mL (milliliters, containing 10 mg of hydrocodone, an opiate medication indicated for moderate pain, combined with 300 mg acetaminophen, a mild pain reliever, per 15 mL) via GT every 4 hours as needed for pain level of 4 to 10 (dated 8/26/16); and hydromorphone (potent opiate indicated for severe pain) 1 mg (milligram) intravenously as needed for severe pain unrelieved by Lortab elixir.

The pain medication orders did not specify the time period required after the Lortab elixir was administered before intravenous hydromorphone could be given by licensed nursing staff.

Review of the hospital policy titled, "Pain Management: LTAC (long-term acute care)," dated December 2005, indicated pain intensity was assessed by licensed nursing staff prior to medication administration using the numeric 0 (zero) to 10 scale; moderate pain was assessed at a level of 4 to 6 and severe pain at 7 to 10.

Registered Pharmacist (RPh) 1 verified Patient 15's duplicate pain medication orders on 8/26/16 at 12:35 pm without clarifying the sequence of administration in accordance with the hospital's pain management policy.

Review of the hospital policy "Medication Management," dated March 2003, indicated: "If Pharmacy receives an order that is incomplete, unclear, or illegible, it shall not be prepared and/or dispensed until the order is clarified."

Review of Patient 15's 9/10/16 eMAR (electronic medication administration record) indicated the following medications were administered within an approximate 4.25 hour time period while Patient 15 was receiving supplemental oxygen but off the mechanical ventilator:

Patient 15's eMAR indicated Lortab elixir 15 mL via GT and hydromorphone 1 mg intravenously were administered by a day shift licensed nurse at 5:17 pm for a pain level of 7. Review of the hospital's automated dispensing cabinet electronic record indicated the nurse withdrew the Lortab elixir at 5:13 pm and 12 seconds and the hydrocodone at 5:13 pm and 31 seconds. Licensed nursing staff obtained orders for Ativan 0.5 mg intravenously for Patient 15's anxiety and administered doses at 7:59 pm and 8:24 pm.

According to Lexicomp ONLINE, a nationally recognized drug information source, Ativan, an anti-anxiety medication, is a CNS depressant and may enhance the CNS depressant effects of opioids. The source indicated this combination should be avoided when possible.

Patient 15's eMAR further indicated a licensed night shift nurse administered hydromorphone 1 mg intravenously at 9:41 pm and Lortab elixir via GT at 9:42 pm for a pain level of 7. Review of the hospital's automated dispensing cabinet electronic record indicated the nurse withdrew the hydromorphone at 9:35 pm and 40 seconds and the Lortab at 9:35 pm and 51 seconds.

Lexicomp ONLINE indicated adverse effects related to hydrocodone and hydromorphone included CNS depression (sedation, or decreased mental alertness); respiratory depression (slowed breathing); hypotension (low blood pressure) and miosis (constriction of the pupils of the eye). The source further indicated use with caution in patients with decreased respiratory reserve or COPD.

Review of Patient 15's clinical record Patient Care Notes indicated on 9/10/16 at 10:30 pm the rapid response team was summoned due to Patient 15's "unresponsiveness, pinpoint pupils, depressed respiratory rate and hypotension ...Resp (respiratory) rate 8 (normal 12 - 20), unresponsive to sternal rub (assessment for level of consciousness by rubbing the sternum of the chest with a closed fist to create pain)." Review of the LTAC Rapid Response Team Care Record indicated Patient 15's blood pressure was low at 78/50 (normal 120 systolic/80 diastolic); and oxygen saturation (a measure of the extent of oxygen binding hemoglobin in the blood, normally 95 - 100%) was low at 88%. The document indicated Narcan 0.4 mg was administered intravenously, resulting in increased responsiveness; and Patient 15 was placed back on continuous mechanical ventilation.

An additional Patient Care Note (dated 9/11/16 at 1:13 am) indicated an additional dose of Narcan 0.2 mg was administered intravenously for a low blood pressure of 86/58 and heart rate of 52 (normal 60 - 100 beats per minute).

During an interview on 10/14/16 at approximately 9:20 am, the Chief Nursing Officer (CNO) verified Patient 15's clinical record findings and indicated both the 9/10/16 day and night shift nurses probably did not allow sufficient time after the Lortab elixir was administered before they gave the intravenous hydromorphone. The CNO acknowledged opiate excess resulted in Patient 15's clinical decline and need for Narcan.

During an interview on 10/18/16 at 10:50 am, the CNO confirmed Patient 15's 8/26/16 physician orders for Lortab elixir, indicated for a pain level of 4 to 10, followed by hydromorphone for unrelieved pain, did not follow facility the hospital's current pain policy, as pain scales should have been defined for both orders. The CNO indicated Registered Phamacist (RPh) 1, who had verified Patient 15's 8/26/16 orders for Lortab elixir and intravenous hydromorphone, was unavailable for an interview.

2. The Interdisciplinary Safe Medication Use Expert Committee of the United States Pharmacopoeia (USP) 2006 has recommended hospitals institute special safeguards in the storage, labeling and use of neuromuscular blocking (paralytic, causes paralysis) medications.

In 2008 and 2014, The Institute for Safe Medication Practices (ISMP), included neuromuscular blocking agents among its list of "High Alert" drugs which have a heightened risk of causing significant patient harm when used in error.

a. During an inspection of the pharmacy refrigerator on 10/12/16 at 3:45 pm, accompanied by RPh 1, a supply of Rocuronium 10mg/mL (milligrams per milliliter) 5 mL vials were observed stored in their manufacturer's cardboard box. The vial tops were printed with the following manufacturer labeling: "Paralyzing agent." The vials were not segregated from other medications in the refrigerator in separate bins; nor did the boxes contain cautionary labeling as a high risk/high alert medication. During a concurrent interview, RPh 1 confirmed the observation.

b. On 10/12/16 at 3 pm, during an inspection of the LTAC South medication room, accompanied by the CNO, the refrigerator was observed to contain two green plastic boxes with secured clear lids, labeled as "RSI Kits." The contents of each kit included a 5 mL vial of Rocuronium 10 mg/mL. The lid or storage compartment did not contain cautionary labeling as a high risk/high alert medication. During a concurrent interview, the CNO confirmed the observation.

3. Review of the hospital policy titled, "High Risk/High Alert Medications," revised February 2015, indicated neuromuscular-blocking agents were included in the approved list of high-risk/high alert medications. The policy indicated: "2. Medications that appear on the list will be identified in the pharmacy as such on the front of the medication bins. 3. Medications from the list that are stocked in the pharmacy will be stored in medication bins of color to distinguish them from other medications ...6. Protocols and precautions are established for the safe and efficient storage, preparation, distribution and administration of each high alert medication."


Review of the hospital policy titled, "High Risk/High Alert Medications," revised February 2015, indicated: "High Risk/High Alert Medications are medications known to be error-prone or which pose a significant hazard to the patient if not properly handled ...High Alert Medications include but are not limited to 1. Insulin. 2. Intravenous opiates and narcotics in ...PCA (patient controlled analgesia)." Under Procedure, the policy further indicated: "11. Prior to the administration of specifically identified High Risk Medication, 2 licensed individuals must verify that the correct medication, dosage and medication form are given. The 2 licensed individuals must document this review by signing the signature lines provided on the MAR/eMAR 9medication administration record or electronic medication administration record0. "

a. Clinical record review indicated Patient 22 was admitted to the hospital on 9/26/16 with diagnoses including sepsis (bacterial toxins in the bloodstream resulting in infection), right ankle abscess, multiple leg wounds and narcotic dependence. Patient 22's physician orders included an order (dated 9/29/16) for Hydromorphone 0.2 mg (milligram) bolus intravenously every 30 minutes as needed for pain via PCA infusion pump. When a PCA pump is used, the patient is able to control the frequency of narcotic administration in accordance with the physician's order.

Review of the hospital policy titled,"Patient Controlled Analgesia - Intravenous," dated March 2003, indicated, under item 7: "Two RNs (Registered Nurses) or one RN and an LVN (Licensed Vocational Nurse) are responsible for independent double checks of the physician order and PCA pump programming of rate, concentration, and dose settings when a when a bolus dose is administered ...and at hand-off (i.e. change of shift). "

Review of Patient 22's Intravenous Patient Controlled Analgesia (PCA) Flow Sheet for the time period 9/29/16 to 10/18/16 indicated consistent administration of bolus doses; and that one license nurse (not two nurses as required) initialed at change of shift on 9/30/16 (5:30 am); 10/1/16 (6 pm); 10/2/16 (6 pm); 10/8/16 (6 am); 10/14/16 (4:35 pm/8:30 pm); and 10/15/16 (4 pm/8 pm).

During an interview on 10/18/16 at 2 pm, the Chief Nursing Officer (CNO) confirmed the six aforementioned licensed nursing documentation omissions that would have ensured fulfillment of the requirement that a second nurse independently double check Patient 22's hydromorphone infusion PCA pump programming to ensure rate, concentration and dose accuracy.

b. Clinical record review indicated Patient 9 was admitted to the hospital on 10/5/16 with diagnoses including sepsis, pneumonia and poorly controlled insulin-dependent diabetes. Patient 9's physician orders included an order (dated 10/8/16) for regular insulin via intravenous infusion pump, to initiate at 1 unit per hour, then increase or decrease the infusion rate based on specific blood sugar parameters.

Review of Patient 9's Insulin Drip Flow Sheet indicated the following licensed nursing instructions: "Two nurses must verify the drug AND settings of the pump with every rate change ... "

Further review of Patient 9's Insulin Drip Flow Sheet, dated 10/8/16 (12:30 pm) through 10/9/16 (9 pm) indicated one licensed nurse (not two nurses as required) initialed insulin dose rate changes on 10/9/16 at 7:15 am (increased from 18.3 to 18.6 units per hour) and 10/9/16 at 6:15 pm (increased from 4.5 to 4.8 units per hour).

During an interview on 10/13/16 at approximately 4:30 pm, the CNO confirmed the two aforementioned licensed nurse documentation omissions that would have ensured fulfillment of the requirement that a second nurse independently check Patient 9's insulin infusion and pump settings.

Based on observation, interview and facility document review, the hospital failed to ensure all pharmaceutical compounding, packaging and dispensing was performed consistent with national standards of practice when hospital policies and procedures were not developed and implemented for sterile (germfree) compounded (mixed) intravenous (injected through the vein) medications as evidenced by:

1. Two compounded morphine sulfate and one hydrocodone (potent injectable narcotic medications) multi-dose intravenous pump (CADD®) cassette reservoirs, stored at room temperature, were labeled with a beyond use date (BUD) of 30 days and improperly labeled without a date of compounding, not in accordance with the hospital policy or USP <797> requirements (United States Pharmacopoeia, Chapter 797, a national standard of practice describing conditions and practices for compounding sterile preparations); and the hospital was unable to provide master formulas or intravenous compounding logs for the products.

2. Three 100 mL (milliliter) minibags of normal (0.9%) saline with were observed stored in the pharmacy with affixed (via mixing adapter) vials of injectable piperacillin/tazobactam sterile powder without auxiliary labeling indicating manufacturer beyond use dating (BUD).

As a result, hospital patients could potentially receive contaminated intravenous products leading to severe infections.

Findings:

1a. During an inspection of the pharmacy's narcotic storage (room temperature) cabinet on 10/12/16 at approximately 11:20 am, accompanied by Registered Pharmacist (RPh) 1, two multi-dose intravenous PCA (patient controlled analgesia) pump CADD® cassette reservoirs containing fluid were observed adjacent to injectable vials of morphine on one of the shelves. The cassettes contained a pharmacy label indicating: "MORPHINE SULFATE CADD 5 mg/mL (milligrams per mL) 50 mL;" the cassette labeling further indicated 0.9% NS (normal saline) had been used for dilution of morphine; two manufacturer names, lot numbers, bar coding and an expiration date of 11/5/16. Further inspection of the cabinet indicated a box containing one multi-dose intravenous CADD® cassette reservoir containing fluid stored with injectable vials of hydromorphone. The cassette contained a pharmacy label indicating: "HYDROMORPHONE (generic for Dilaudid) 1 mg/mL 50 mL *CADD*." The cassette labeling further indicated one manufacturer name, a lot number, bar coding and an expiration date of 11/5/16. The date of compounding was not delineated on the labeling of all three cassettes. During a concurrent interview, RPh 1 confirmed the observation and stated the pharmacy had followed sterile compounding standards of practice regarding expiration, or BUDs.

During a continued interview, RPh 1 provided a "Dilaudid CADD 50 mg/ 50 mL" inventory management document (dated 9/28/16 to 10/8/16) indicating a total of eight hydromorphone 1 mg/mL 50 mL cassette reservoirs were compounded during that time period. RPh 1 confirmed the hydromorphone cassette reservoir observed in the narcotic storage cabinet was compounded on 10/7/16 and was labeled with a 30 day expiration dating. RPh 1 further provided a "Morphine CADD 250 mg/50 mL" inventory management document (dated 8/2/16 to 10/7/16) indicating 14 morphine sulfate 5 mg/mL 50 mL cassette reservoirs were compounded during that time period. RPh 2 confirmed the two morphine sulfate cassette reservoirs observed in the narcotic storage cabinet were compounded on 10/7/16 and were labeled with a 30 day expiration dating.

During an interview on 10/13/16 at 10:40 am RPh 2 indicated he thought the pharmacy had confirmed extended stability by using "Trissel's," a textbook resource (Handbook on Injectable Drugs, 17th Edition, by Lawrence A. Trissel); RPh 2 further indicated he was unsure how the BUD was determined. When asked for approved current master formulas for the morphine sulfate 250 mg/50 mL and hydromorphone 50 mg/50 mL cassette reservoirs, RPh 2 provided an undated document for hydromorphone PCA that indicated the compounded product should be stored in the refrigerator; the stability at room or refrigerated temperature was not delineated. RPh 2 acknowledged the master formula document was not finalized. No master formula was provided for the morphine sulfate 250 mg/50 mL cassette reservoir.

During an interview on 10/18/16 at 3:20 pm the Director of Pharmacy (DOP) confirmed no master formulas had been implemented for the hydromorphone 50 mg/50 mL or morphine sulfate 250 mg/50 mL cassette reservoirs.

Review of the facility policy "Intravenous Admixture (05.01.07a)," revised May 2015, indicated, "1. The pharmacy will follow the guidelines, standards, and requirements for the compounded sterile products (CSP's) according to state pharmacy laws and regulations and the U.S. Pharmacopeia (USP), Chapter <797> ...4. It is the responsibility of the pharmacist to ensure that ...Packaging is appropriate for stability and sterility ...Labels are appropriate and complete ...Beyond-use date [sic] are appropriate and based on valid scientific criteria." The policy further stipulated under item IV. B: "Medications will not be compounded until a Written Master Formula has been prepared which includes active ingredients, equipment used, expiration dates, inactive ingredients, and a description of the process to prepare the drug." With regard to intravenous product labeling, the policy indicated under item E: "The pharmacist will review and ensure the accuracy of the final product label for the following information ...(2) date and time of preparation." The policy further indicated, with regard to beyond use dating for sterile product, low-risk compounded product stability could not exceed 48 hours at room temperature or 14 days under refrigeration.

USP Chapter <797>, dated 2012, defined low-risk compounding as transferring, measuring or manipulating not more than three commercially manufactured packages of sterile products to prepare the CSPs.

1b. Further review of the facility policy "Intravenous Admixture (05.01.07a), revised May 2015, indicated under item B: "A record of each compounded drug is documented on the IV (intravenous) Compounding Log and contains the following information: date made and expiration date, drugs and diluents used, manufacturer, lot #, expiration date, quantity, initials of person making and checking the product, and order number."

Review of the hospital pharmacy's sterile compounding logs for October 2016 indicated no documents were provided for the compounded morphine sulfate or hydromorphone cassette reservoirs observed in the pharmacy on 10/12/16 (that were allegedly compounded on 10/7/16).

During an interview on 10/19/16 at 10:50 am, the DOP confirmed no sterile compounding logs were generated for the morphine sulfate 250 mg/50 mL or hydromorphone 50 mg/50 mL cassette reservoirs compounded on 10/7/16, as they are prepared in advance of need and are not patient specific. The DOP further confirmed labeling of the cassettes (with the date and time of compounding) was not performed consistent with facility policy; and BUDs were not implemented consistent with facility policy or USP Section <797> guidelines.

2. During an inspection of the injectable storage area of the pharmacy on 10/12/16 at 11:50 am, accompanied by RPh 1, a plastic bin was observed to contain three minibags (stored outside of their manufacturer overwrap) of injectable normal (0.9%) saline with docked (via mixing adapter) vials of piperacillin/tazobactam sterile powder. No auxiliary labeling was observed on any of the minibags indicating manufacturer BUD. During a concurrent interview, RPh 1 and PharmTech stated they were unable to determine when the piperacillin/tazobactam vials had been docked to the saline minibags via the mixing adapter.

Review of the written manufacturer product guidance, communicated to the hospital on 10/12/16, indicated: "Once assembled, the product should be used promptly ...the stability of an assembled but not reconstituted (product name) assembly is dependent on two criteria; the out of overwrap stability and the ability of the vial adapter spike-to-stopper interface to maintain an integral microbial barrier ...the results of these evaluations support the storage of the assembled but not reconstituted (product name) assembly for up to ...thirty (30) days at room temperature (25ºC/77ºF) for the 100 mL size containers. "

Based on observation, interview and facility document review, the hospital failed to ensure drug administration errors and adverse drug reactions were immediately reported to the attending physician and Quality Assurance and Performance Improvement (QAPI) program when:

1. One of 30 sampled patients (Patient 15) was administered two doses of duplicate potent opiate medications (Lortab elixir and hydromorphone injection) simultaneously by licensed nursing staff not in accordance with the physician's order; as a result, Patient 15 required two doses of an opiate reversal medication (Narcan), mechanical ventilation, and immediate intervention by the hospital's rapid response care team. A medication error report was not initiated in accordance with hospital policy.

2. An adverse drug reaction (ADR) report was not initiated for an episode of hypoglycemia requiring an intravenous (injected into the vein) reversal medication (50% dextrose injection, a source of sugar), intervention by the rapid response team and insulin dosage reduction for one of 30 sampled patients (Patient 16), with the potential for a reoccurrence and convulsions, unconsciousness, temporary or permanent brain damage, or even death.


Findings:

1. Review of the hospital policy titled, "Medication Management," dated March 2003, indicated under Medication Error Reduction Program: "1. A 'Medication Error' is defined as any variation from a prescription or drug order not corrected prior to furnishing the drug to the patient."

1a. Clinical record review indicated Patient 15 was admitted to the hospital on 8/24/16 with diagnoses including a severe neurological spine injury (related to landing on his back on a fence after a 20 foot fall from a ladder), respiratory failure and COPD (chronic obstructive pulmonary disease). Patient 15 had a tracheostomy (surgical formation of an opening into the trachea, or windpipe, through the neck to allow the passage of air) and was to be weaned off the mechanical ventilator (machine that supports breathing). Patient 15's physician orders included Lortab elixir 15 mL (milliliters, containing 10 mg of hydrocodone, an opiate medication indicated for moderate pain, combined with 300 mg acetaminophen, a mild pain reliever, per 15 mL) via GT every 4 hours as needed for pain level of 4 to 10 (dated 8/26/16); and hydromorphone (potent opiate indicated for severe pain) 1 mg (milligram) intravenously as needed for severe pain unrelieved by Lortab elixir. The medication orders did not specify the time period required after the Lortab elixir was administered before intravenous hydromorphone could be given by licensed nursing staff.

Review of the hospital policy titled, "Pain Management: LTAC (long-term acute care)," dated December 2005, indicated pain intensity was assessed by licensed nursing staff prior to medication administration using the numeric 0 (zero) to 10 scale; moderate pain was assessed at a level of 4 to 6 and severe pain at 7 to 10.

Review of Patient 15's 9/10/16 eMAR (electronic medication administration record) indicated the following medications were administered within an approximate 4.25 hour time period while Patient 15 was receiving supplemental oxygen but off the mechanical ventilator:

Patient 15's eMAR indicated Lortab elixir 15 mL via GT and hydromorphone 1mg intravenously were administered by a day shift licensed nurse at 5:17 pm for a pain level of 7. Review of the hospital's automated dispensing cabinet electronic record indicated the nurse withdrew the Lortab elixir at 5:13pm and 12 seconds and the hydrocodone at 5:13 pm and 31 seconds. Licensed nursing staff obtained orders for Ativan 0.5 mg intravenously for Patient 15's anxiety and administered doses at 7:59 pm and 8:24 pm.


According to Lexicomp ONLINE, Ativan, an anti-anxiety medication, is a CNS depressant and may enhance the CNS depressant effects of opioids. The source indicated this combination should be avoided when possible.

Patient 15's eMAR further indicated a licensed night shift nurse administered hydromorphone 1 mg intravenously at 9:41 pm and Lortab elixir via GT at 9:42 pm for a pain level of 7. Review of the hospital's automated dispensing cabinet electronic record indicated the nurse withdrew the hydromorphone at 9:35 pm and 40 seconds and the Lortab at 9:35 pm and 51 seconds.

Lexicomp ONLINE, a nationally recognized drug information source, indicated adverse effects related to hydrocodone and hydromorphone included CNS depression (sedation, or decreased mental alertness); respiratory depression (slowed breathing); hypotension (low blood pressure) and miosis (constriction of the pupils of the eye). The source further indicated use with caution in patients with decreased respiratory reserve or COPD.

Review of Patient 15's clinical record Patient Care Notes indicated on 9/10/16 at 10:30 pm the rapid response team was summoned due to Patient 15's "unresponsiveness, pinpoint pupils, depressed respiratory rate and hypotension ...Resp (respiratory) rate 8 (normal 12 - 20), unresponsive to sternal rub (assessment for level of consciousness by rubbing the sternum of the chest with a closed fist to create pain). " Review of the LTAC Rapid Response Team Care Record indicated Patient 15 ' s blood pressure was low at 78/50 (normal 120 systolic/80 diastolic); and oxygen saturation (a measure of the extent of oxygen binding hemoglobin in the blood, normally 95 - 100%) was low at 88%. The document indicated Narcan 0.4 mg was administered intravenously, resulting in increased responsiveness; and Patient 15 was placed back on continuous mechanical ventilation.

An additional Patient Care Note (dated 9/11/16 at 1:13 am) indicated an additional dose of Narcan 0.2 mg was administered intravenously for a low blood pressure of 86/58 and heart rate of 52 (normal 60 - 100 beats per minute).

During an interview on 10/14/16 at approximately 9:20 pm the Chief Nursing Officer (CNO) verified Patient 15's clinical record findings and indicated both the 9/10/16 day and night shift nurses probably did not allow sufficient time after the Lortab elixir was administered before they gave the intravenous hydromorphone. The CNO acknowledged opiate excess resulted in Patient 15's clinical decline and need for Narcan.

During a follow-up interview on 10/14/16 at 11:25 am the CNO confirmed both the 9/10/16 day and night shift licensed nurses had not adhered to the physician's order when both the Lortab elixir and intravenous hydromorphone were given together at 5:17 pm and 9:41/9:42 pm, respectively.

During an interview on 10/18/16 at 11:10 am the Director of Nursing (DON) indicated neither the day nor night shift nurses who provided care and medications to Patient 15 on 9/10/16 were available for an interview.

1b. Review of the hospitl policy titled "Unusual Occurrence Reports and Mandatory Reporting," dated March 1997, indicated: "3. The circumstances surrounding an adverse event ...will be reported on an Unusual Occurrence Report (UOR) in order to identify and analyze the cause of the incident, prevent future incidents and minimize the risk of loss from events which have already occurred ...15. Events such as, but not limited to, the following will be documented on an UOR: A. Medication or intravenous errors."

During an interview on 10/14/16 at 10:30 pm the DON confirmed a UOR, or medication error report, had not been completed pursuant to Patient 15's two errors in duplicate opiate administration (Lortab elixir and intravenous hydromorphine) the afternoon and evening of 9/10/16.

1c. Review of Patient 15's Adverse Drug Reaction (ADR) Report related to the administration of Narcan on 9/10/16 (indicating Registered Pharmacist (RPh) 2 had generated the report on 9/12/16 at 3 pm), provided by the CNO, indicated RPh 2 handwrote "Dilaudid/Lortab" under "Suspected Drug/Dose/Route/Frequency" and checked a box indicating "Increased Sedation." Under Comments, RPh documented, "Naloxone given - pt (patient) came around quickly."

During an interview on 10/14/16 at 11:15 am the CNO confirmed Patient 15's 9/12/16 ADR Report lacked clinical accuracy regarding the two instances of duplicate opiate administration resulting in Narcan administration on 9/10/16, as Patient 15's Patient Care Notes indicated he had exhibited altered level of consciousness; not increased sedation.

During an interview on 10/18/16 at 11:40 a.m. RPh 2, who confirmed completion of the aforementioned ADR Report on 9/12/16, indicated he had reviewed Patient 15's medications; 9/10/16 rapid response team information; and had spoken with licensed nurses. RPh 2 acknowledged he not completed a thorough review of 9/10/16 licensed nursing documentation in Patient 15's clinical record; or considered that errors in opiate administration had resulted in the need for Narcan. RPh 2 confirmed he had not generated a UOR based on Patient 15's two episodes of duplicate opiate administration by licensed nursing staff on 9/10/16.

2. Closed clinical record review indicated Patient 16 was an 83 year-old admitted to the hospital on 8/31/16 with diagnoses including sepsis and insulin-dependent diabetes mellitus. Patient 16's admission physician orders included orders for Lantus 27 units daily at bedtime (long acting basal insulin) and regular (short- acting) insulin sliding scale, the amount to be administered determined by fingerstick blood sugar readings before meals and at bedtime.

Review of Patient 16's eMAR (electronic medication administration record) indicated on 9/15/15 licensed nursing staff administered Patient 16's scheduled bedtime dose of Lantus 27 units, along with 2 units of regular insulin for a fingerstick blood sugar of 138 mg/dL (milligrams per deciliter), in accordance with the physician ' s orders. Review of Patient 16's dietary intake (on the same day) indicated 75% of breakfast, 50% of lunch and 25% of dinner was consumed.

Lexicomp ONLINE, a nationally recognized drug information source, indicated hypoglycemia was the most common adverse effect from insulin; and may result from changes in meal pattern. The source further indicated profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death.

Further record review indicated Patient 16 experienced an episode of low blood sugar (54 mg/dL, normal fasting blood sugar is 70 to 100 mg/dL) by laboratory assessment on 9/16/16 at 5:29 am; and 46 mg/dL by fingerstick on 9/16/16 at 6:50 am. Patient 16 was found unresponsive and unarousable and required a reversal agent, 50 mL of D50W (intravenous 50% dextrose in water, a source of sugar); and intervention by the hospital's rapid response team.

On 9/16/16 Patient 16's Lantus insulin dosage was decreased (by approximately 55.5%) from 27 units to 15 units at bedtime.

During an interview on 10/14/16 at 10:30 am, the CNO confirmed Patient 16's clinical record findings and adverse drug reaction indicating insulin excess in the presence of reduced meal intake. The CNO further confirmed Patient 16 ' s bedtime Lantus dosage was decreased.

The CNO provided a summary report of reversal agents administered in the month of September 2016 (dated 10/3/16) that included Patient 16's D50W (on page 4). The document included a handwritten note indicating: " LTAC (Long Term Acute Care unit) ...too much insulin? No ADE. "

Review of the hospital policy titled, "Adverse Drug Reactions'" revised November 2011, indicated: "A. An ADR is any unexpected, unintended, undesired, or excessive response to a medication that ...requires modifying the dose ...Necessitates supportive treatment ...Results in temporary ...harm ..." The policy further indicated, "2. The Department of Pharmacy will conduct an ADR surveillance system composed of the following ...B. A concurrent surveillance system of monitoring 'alerting' orders. Alerting orders include the use of 'trigger' drugs that are used to treat common ADR's ...abrupt discontinuation or decreases in dosage of a drug...When these types of orders are detected the pharmacist will ...2) Follow-up to ensure that the Adverse Drug Reaction Reporting form is completed, the ADR analysis is completed and that the Director of Quality/Risk Management is notified."

During an interview on 10/18/16 at 11:55 am the Director of Pharmacy (DOP) confirmed he had generated the September 2016 summary report of reversal agents administered; and had handwritten the note on page 4 after reviewing Patient 16's pharmacy dispensing record indicating the 9/16/16 administration of D50W and Lantus insulin dosage decrease. The DOP acknowledged he had not reviewed Patient 16's clinical record nursing documentation, meal intake or blood sugar assessments. The DOP further confirmed he had not generated an adverse drug reaction report, and stated he "assumes the QIRM (Quality Improvement/Risk Manager) will track it down" and depended on nursing staff to complete ADR reports. The DOP indicated part of his focus was to ensure the reporting was completed; and stated it was "not always done. "

Based on interview and record review, the hospital failed to ensure that a contract provider for off-site radiological services prepared written interpretations of radiological images taken after the insertion of a PICC line (peripherally inserted central venous catheter, used for long term administration of drugs and fluids, and for obtaining blood samples) for one of 30 sampled patients. (Patient 14) This failure resulted in nurses using a PICC line without a radiologist's confirmation of (catheter) tip placement which could result in vein/heart damage and condition changes that are life threatening if the tip was not positioned correctly.

Findings:

On 10/19/16, Patient 14's record was reviewed. Patient 14 was admitted to the hospital on 9/25/16 with diagnoses that included a non-healing abdominal wound. Patient 14's record contained a physician's order for a PICC insertion, dated 9/28/16. Patient 14's record contained a PICC Insertion Record which indicated the PICC line was inserted on 9/28/16 at 3:15 pm and a chest x-ray was obtained to confirm the proper tip placement. This record did not indicate a physician had read the chest x-ray to verify tip placement. Patient 14's record did not contain evidence of radiologist interpretations of two chest x-rays performed immediately after the procedure. (Refer to A386, item 2 for further details).

The hospital policy, titled, "PICC Insertion," dated 3/2016, read, "Order a portable Chest X-ray for Superior Vena Cava (proper vein) placement verification if not using the 3CG Tip Confirmation System ...Verification of tip placement is needed before catheter use."

On 10/19/16, the hospital was asked for and provided a radiologist report for the two above x-rays which had to be faxed from the off-site provider to the hospital.

In an interview on 10/19/16 at 9:45 am, the Chief Nursing Officer (CNO) confirmed that Patient 14's record did not contain radiologist confirmation of PICC tip placement for Patient 14. CNO stated the hospital had recently encountered computer problems with the off-site contract provider.

Based on observation, interview and record review, the hospital failed to ensure that the infection control program policies for controlling the spread of infections were implemented for three of 30 sampled patients (Patients 5, 13, and 26) and for ensuring infection control precautions were folllwed when:

1. Contract Nurse F failed to use contact isolation precautions (gloves and gowns when touching patient or patient's environmental surfaces to prevent the spread of antibiotic resistant infection) for Patient 26.

2. Patient 26's visitor did not use contact precautions when visiting Patient 26.

3. Patient 13 required contact isolation precautions and Patient 13's record did not contain a care plan or documentation that these precautions were maintained.

4. Environmental Services (EVS) staff were terminally (at the end of a patient stay) cleaning Patient 13's room without using proper contact isolation precautions.

5. Administrative Staff I did not have evidence of a current tuberculosis (TB, a contagious lung disease) test in their personnel file.

6. Patient 5 was not tested for MRSA (Methicillin Resistant Staphyloccocus Aureus, a organism that is very resistant to antibiotic treatment) upon admission.

These failures had the potential for the spread of communicable disease that could result in patients decline in health status.

Findings:

1. On 10/18/16, Patient 26's record was reviewed. Patient 26 was admitted to the hospital on 10/11/16 with diagnoses that included a MRSA cellulitis (infection of the skin and tissues) of the lower extremities.

On 10/18/16 at 2 pm, Patient 26's room had a sign posted outside the door indicating the patient was on contact precautions, and gloves and gown were required upon entering the room. Concurrently, Contract Nurse G was observed entering Patient 26's room without sanitizing or washing his hands, or putting on gloves and gown. Contract Nurse G moved a walker and the bedside table and then when he realized he was being observed put on gloves and gown, without first washing his hands.

In a concurrent interview, Contract Nurse G initially denied the surveyor's observations but then reluctantly agreed he had not followed contact precautions and did not wash his hands. Contract Nurse G continued to proceed with setting up the room for a dialysis treatment (to remove waste products from the blood for kidney failure patients) and did not sanitize or wash his hands.

On 10/13/16, the hospital policy, titled, "Antibiotic Resistant Organisms: Care of the Patient," dated 4/2015, read, "Patients who are found to be .. infected with Methicillin Resistant Staph Aureus (MRSA) ... shall be placed on contact precautions during their length of stay... Gowns and gloves must be worn by all staff entering the room."

In an interview on 10/18/16 at 2:10 pm, Administrative (Admin) Nurse D acknowledged that that this behavior of not wearing gown or gloves was not consistent with the hospital policy.

2. On 10/19/16 at 8:25 am, a visitor was observed in Patient 26's room and was not wearing gown or gloves.

On 10/13/16, the hospital policy, titled, "Antibiotic Resistant Organisms: Care of the Patient," dated 4/2015, indicated visitors were to be educated in and use the same precautions as the staff.

In a concurrent interview, Licensed Nurse H stated the policy was for the visitors to be educated on contact precautions and for the nursing staff to enforce those measures.

4. On 10/13/16, Patient 13's record was reviewed. Patient 13 was admitted to the hospital on 9/23/16 with diagnoses that included renal (kidney) failure. Patient 13 had an admission assessment that indicated that isolation precautions, specifically contact precautions were in place. Patient 13's record contained an admission screening test for MRSA that was positive and indicated that a physician's order should be obtained for contact precautions. Patient 13's record did not contain physician's orders, a care plan or any documentation that these precautions were ordered or maintained during Patient 13's stay.

The hospital policy, titled, "Medical Record Documentation Requirements," dated 4/2015, read, "All medical records will contain documentation to substantiate care and treatment provided... The medical record will contain the following... Records of assessment and intervention..."

On 10/13/16 at 4:15 pm, Registered Nurse E and Administrative Nurse F reviewed Patient 13's record and acknowledged that there was no documentation that isolation precautions were maintained for Patient 13.

4. On 10/12/16 at 11:30 am, Patient 13's room was observed being terminally cleaned by two EVS staff wearing gloves and no gown. The contact precautions sign was turned over in the holder leaving a blank page. When asked if the patient had been on isolation precautions, EVS Staff A stated "no". When asked how he knew, EVS A stated that the precautions sign remains on the outside of the door and then they use a different process.

In a concurrent interview, Admin Nurse K stated she did not believe Patient 13 had been on contact isolation.

A review of Patient 13's record indicated she was positive for MRSA and should have been on contact precautions. (Refer to A749, item 3 for further details).

On 10/13/16 at 4:15 pm, Admin Nurse F acknowledged that the contact precautions sign should have been posted for the EVS staff to know they were to take precautions when cleaning the room to reduce the risk of infection to future patients in this room.

On 10/13/16, the hospital policy, titled, "Terminal Cleaning of a Patient Room," dated 3/2016, read, "Isolation Room Procedure - Terminal clean isolation room at discharge and/or when removing patient from isolation. 1. Curtains come down/place in plastic bag take to washer. 2. Mop wall and ceiling with bleach. Spray citrus-solve (disinfectant spray) around edges of room."

5. On 10/12/16, Admin Staff I's personnel record was reviewed and did not contain a current TB test.

On 10/13/16, the hospital policy, titled, "Tuberculosis and Airborne Transmissible Disease (ATD) Exposure Control Plan," dated 4/2016, read, "TB prevention training shall be provided to all employees... will include.. TB screening.."

On 10/13/16 at 9 am, Admin Staff J stated TB screening and testing was performed annually for all staff. Admin Staff J acknowledged that Admin Staff I's TB test was not current for this year.

Based on interview and record review, the hospital failed to ensure that three of 30 sampled patients had early identification of discharge planning needs. (Patients 10, 11, and 12) These failures place patients at risk for for an unsuccessful discharge and readmission.

Findings:

On 10/13/16, the hospital policy titled, "Discharge Planning," dated 1/2016, read, "Within two (2) business days of admission, the Case Manager will identify discharge planning needs for all patients.. will develop a discharge plan, ...The Case Manager will complete weekly routine reassessment... for the appropriateness of the discharge plan.

1. On 10/13/16, Patient 12's record was reviewed. Patient 12 was admitted to the hospital on 8/26/16 with diagnoses that included sepsis (blood infection), diabetes (high blood sugars), and left foot and ankle bone infections. Patient 12's record did not contain a discharge planning assessment of needs within two business days of admission.

On 10/13/16 at 9:40 am, Administrative (Admin) Nurse N acknowledged Patient 12's record did not contain a discharge planning assessment of needs within two business days of admission.

2. On 10/12/16, Patient 10's record was reviewed. Patient 10 was admitted on 9/22/16 with diagnoses that included blood infection, diabetes, and chronic venous thromboembolism. Patient 10's record did not contain a discharge planning assessment of needs within two business days of admission.

On 10/12/16 at 3 pm, Admin Nurse K acknowledged Patient 10's record did not contain a discharge planning assessment of needs within two business days of admission.

3. On 10/13/16, Patient 11's record was reviewed. Patient 11 was admitted to the hospital on 10/6/16 with diagnoses that included aspiration pneumonia and developmental delay requiring that he normally live in a specialized group setting.

On 10/13/16 at 8:40 am, Admin Nurse N acknowledged Patient 11's record did not contain a discharge planning assessment of needs within two business days of admission.

Based on observation, interview, and record review, the facility failed to follow the respiratory care department policy and procedure for two of 30 sampled patients (Patients 20 and 23) when:

1. Patient 20's high flow oxygen was not humidified (running the oxygen through water).

This failure resulted in Patient 20 having a dry nose and mouth.

2. Patient 23's endotracheal (ET, tube into lungs) suction catheter was set above the recommended setting.

This failure had the potential to result in the delicate cells of the lungs being damaged during suctioning (removal of mucus and phlegm via a thin tube).

Findings:

1. Patient 20's record was reviewd. Patient 20 was admitted to the hospital on 9/23/16 with diagnoses that included respiratory failure and sleep apnea (periods of not breathing while asleep).

On 10/12/16, at 10:48 am, Patient 20 was obsereved sitting up on the bed with oxygen tubing in the nose. The gauge on the wall indicated Patient 20 was receiving oxygen at five liters per minute. The Respiratory Therapist (RTT) was at the bedside and in a concurrent interview, stated that when the oxygen rate is above two liters a minute it should be humidified to prevent the patients nose and mouth from drying out. Patient 20 then stated his nose was very dry, and that he had experienced a bloody nose as a result.

On 10/13/15 at 9:15 am, the Director of Respiratory Therapy (DRT) confirmed that it was the policy of the hospital to humidify oxygen that is flowing more than two to three liters a minute.

The hospital's policy and procedure titled, "oxygen set up (wall)" directed that for "high flow systems" the RT staff will "attach a pre-filled humidifier".

2. Patient 24's record was reviewed. Patient 24 was admitted to the hospital on 9/2/15 on a ventilator (life support machine that sends air into the lungs through a tube, and pulls it back out) diagnoses that included, respiratory failure and hypoxia (not enough oxygen).

In an interview on 10/12/16, at 10:35 am, Patient 24 was obsereved lying in bed with the ventilator (breathing machine) attached to him. The ET suction catheter was attached to the suction head on the wall. The gauge read "full suction".

In an interview on 10/13/16, at 9:15 am, the DRT stated that when a suction gauge reads "full suction" it provides suction around 200 millimeters of mercury (mmHg). The DRT stated that the proper way to provide suction to a patient is the give them extra oxygen, and suction the lungs for 10 to 15 seconds with a suction of 150 mmHg or less. The DRT confirmed that using higher suction can damage the lungs, cause bleeding, and increase the risk of infection.

The ET suction policy and procedure the hospital provided was an excerpt from Fundamentals of Respiratory Care (10th edition) that revealed ET suction should be "150 mmHg or less."