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Based on review of the Medical Staff Rules and Regulations, Policy and Procedure MCP 321.3, Policy and Procedure MCP 524.1 and staff interview:

1. The hospital failed to ensure that stop order polices documented in the Medical Staff Rules and Regulations and those found in Policy and Procedure MCP 321.3 (as approved by the Pharmacy and Therapeutics Committee) were in agreement as to when drug therapy should be stopped and which medications were involved.

2. The hospital failed to ensure that Policy and Procedure MCP321.3 was in agreement with the Federal Regulation 42 Code of Federal Regulations Section 482.25(b)(g) [A0507] as required by hospital Policy and Procedure MCP 524.1. Policy and Procedure MCP 321.3, Procedure E(7) did not provide for discontinuation of medications after a period determined by the medical staff, it only provided for review of those orders with no guarantee that the reviews would be conducted in all cases and therapy reevaluated at that time as to whether the therapy would be continued or would be stopped according to the individual prescribing physician's judgment.

Findings:

On 12/11/13 a review of the Medical Staff Rules and Regulations (Approved 10/22/13) indicated that under the section entitled "Orders" Rule 1(e) documented: "Orders for narcotics and hypnotic drugs are valid for a maximum of seven (7) days. Automatic stop orders will apply to other controlled substances as directed by the Pharmacy and Therapeutics Committee." Narcotics is a general designation for medications that can be used to relieve pain and that are subject to abuse while hypnotics are drugs used to induce sleep. Under "Medical Staff Committees" it provided for a Pharmacy and Therapeutics Committee (page 28) and authorized that committee at #1, page 29, to: "Develop and review written policies and procedures annually for establishment of safe and effective systems for procurement, storage, labeling, distribution, dispensing and use of drugs".

On 12/12/13 a review of Policy and Procedure MCP 321.3 entitled Patient Treatment and Medication Orders (Original approved date: 5/17/83, Revised 2/6/13) indicated Procedure A(9) stipulated: "Authorizing provider responsibilities [include]: Respond to 'Review/Expiring Order' alerts by reviewing, discontinuing and updating orders". Procedure E(7) stipulated: "Automatic review for medication orders: If not specified or limited otherwise, orders will be flagged for review in 30 days except: orders for antimicrobials will be flagged for review after 14 days." The last page of this document indicated that the Pharmacy and Therapeutics Committee approved this policy on 2/5/13 and that the Medical Staff Executive Committee approved this policy on 2/6/13.

The surveyor pointed out the discrepancy between the Medical Staff Rules and Regulations and Policy and Procedure MCP 321.3 to Hospital A's Inpatient Assistant Director of Pharmacy and Hospital A's Inpatient Pharmacy Manager during an interview he conducted with them on 12/12/13 at 3:27 P.M. Hospital A's Inpatient Assistant Director of Pharmacy stated that there had been no automatic stop order policy since the EPIC medical information system had been implemented at the hospital. She stated that there was no hard stop for medications used in the hospital except for Ketoralac (used to treat pain and for which the manufacturer documents in a boxed warning that the medication should not be used longer than five days secondary to potential serious side effects) which hospital assigned a five day stop date and Alvimopan (used to accelerate recovery of intestinal function following bowel surgery but which as a boxed warning recommending limiting use to 15 doses) which the hospital assigned a three day stop date. She stated that narcotics did not have a hard stop.

With respect to Policy and Procedure MCP 321.3: Procedure E(7) both Hospital A's Inpatient Pharmacy Manager and Assistant Director of Pharmacy stated that the hospital had not created a process for pharmacists to check to see if physicians had acted on the orders flagged for review. They stated if physicians did not act on these orders the orders would continue on as active orders in a given patient's medication profile.

On 12/13/13, a review of Policy and Procedure MCP 524.1 entitled (hospital name) Health System Organization (Original approved date: 10/1/98, Revised: 10/25/13) indicated that under "Procedures and Responsibilities" it addressed the responsibilities of the Medical Staff at Procedure 3. Procedure 3(d) stipulated: "The Medical Staff Bylaws shall provide for appointment of standing and special committees sufficient, at minimum, to fulfill, the standards/requirements of ...the Federal government" (sic).

On 12/13/13 at 8:27 A.M., during an interview of the Director of Regulatory Affairs, he stated that the organized Medical Staff derived its authority from the Governing Body to fulfill its role. He reviewed the above documented Medical Staff Rules and Regulations and Policy and Procedure MCP 321.3 and stated that the Medical Staff rule regarding stopping narcotics and hypnotics was not in agreement with the provision for review of medication orders found in Policy and Procedure MCP 321.3 found under Procedure E(7).

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Based on interview, document and record review, the hospital failed to ensure that there was documented evidence in 1 of 5 sampled patients' (21) medical record that she was informed that a biliary stent (a plastic or metal tube that is inserted into a bile duct to relieve narrowing of the duct), that was inserted in her right common iliac artery (one of two arterial branches of the abdominal aorta - the main artery of the body), had not been approved by the Food and Drug Administration (FDA) for vascular (vessels that carry blood) use.

Findings:

Patient 21 was admitted to Hospital B on 7/18/12 for treatment of chest pain according to her Admission Facesheet. A review of Patient 21's medical record was conducted on 8/9/13 at 3:20 P.M. On 7/18/12, Patient 21 underwent a Distal Aortogram (placement of a catheter in the aorta and injection of contrast material to identify obstruction) with Bilateral Lower Extremity Run-off and Stenting of the Right Common Iliac Artery. A Consent to Surgery or Special procedure was signed by Patient 21 on 7/18/12 at 10:15 A.M. According to a Physician's Progress Note, dated 7/18/12, an Omnilink .035 Biliary (relating to the bile duct that delivers bile from the liver and gall bladder to the small intestine) Stent System was inserted in Patient 21's Right Common Iliac Artery because of a 90% blockage of the artery.

A review of a letter from the FDA, dated June 15, 2001 and addressed to the manufacturer of the Omnilink .035 Biliary Stent System, indicated that the Biliary Stent System was approved by the FDA for "use in the palliation (easing the severity of the disease without removing the cause) of malignant neoplasms (cancerous tumor that tends to spread to other parts of the body) in the biliary tree (path by which bile is secreted)." The letter also indicated that "The safety and effectiveness of this device for use in the vascular system has not been established."

A review of the hospital's policy and procedure, entitled "Investigational Drugs, Devices and Procedures" and dated 10/17/13, indicated that the definition of an "Investigational Drug, Biologic, Device : A new or non-FDA approved drug, biologic or device (can be approved drug/device, but not for particular indication i. e. off label use." The policy also indicated that use of these devices required "Signed Informed Consent."

On 12/11/13 at 1:55 P.M., an interview with the Director of Nursing (DON) at Hospital B was conducted. The DON stated that the biliary stent that was used on Patient 21 met the definition of an investigational device "off label" use. She further stated that she did not know whether or not Patient 21 had been informed regarding the "off label" use of the biliary stent.

On 12/12/13 at 8:15 A.M., an interview was conducted with the physician (MD 1) who inserted the Biliary Stent into Patient 21's right common iliac artery. MD 1 explained that all the stents, from the mid 1990s, used in the peripheral vascular system, were Biliary Stents until about 3 to 4 years ago when the FDA started to approve these stents for vascular use. MD 1 stated that, at the time of Patient 21's procedure, the Omnilink .035 Biliary Stent System was the only balloon expanding stent being used in the cath Lab. MD 1 also stated that "it was not commonly done to inform patients" that when a Biliary Stent was inserted in a patient's peripheral vasculature that the FDA had not approved the stent for this use.

There was no documented evidence in Patient 21's medical record that the patient had been informed that the stent that was placed in her right common iliac artery was not approved by the FDA for vascular use.

Based on observation, interview and document review, Hospital A's staff in the Emergency Department (ED) failed to safeguard a work station on wheels when the work station was left unattended allowing accessibility to confidential patient information belonging to all 23 ED patients (ED census at the time), by anyone who passed by or was present in the room. The failure to safeguard work station on wheels by ED staff could potentially lead to the unauthorized access of confidential patient information. All patients have the right to the confidentiality of their medical records.

Findings:

On 12/9/13 beginning at 10:00 A.M., a tour of the ED was conducted with the Nursing Director of Critical Care and the Quality Compliance Specialist (QCS 11). Observations were conducted in the ED waiting room. There were 3 patients who were sitting in the waiting room at the time. A work station on wheels was observed unattended, powered "on", the ED Manager (ED dashboard of patients) was seen on the screen and accessible.

On 12/9/13 at 10:03 A.M., the ED technician/greeter (EDT 11) was interviewed. EDT 11 stated that he should have logged off the work station on wheels when he left the waiting room. He acknowledged that when he left the work station unattended, anyone who passed by or was present in the room, had the capability and accessibility of reviewing confidential patient information.

A review of the hospital's policy entitled "Patients' Rights and Responsibilities", dated 4/18/13, was conducted on 12/12/13. The policy indicated that "Confidential treatment of all communications and records pertaining to their care and stay in the hospital."

An interview with the Director of Emergency Services (DES) was conducted on 12/11/13 at 1:03 P.M. The DES stated that EDT 11 should have been logged off from the work station on wheels when left unattended, in effort to ensure the confidentiality of patient information.

Based on document review and staff interview, the hospital failed to ensure that the Health Information Services (HIS) quality assurance/performance improvement efforts were communicated to and evaluated by the hospital's oversight committee and governing body.

Findings:

The Health Information Services (medical records department) Quality Assurance/Performance Improvement Plan 2013/2014 was reviewed on 12/11/13. The Plan covered all the major aspects of the department, such as document scanning, files area, record completion, and coding services; as well as the services performed by outside (contracted) vendors for release of information and medical transcription functions. It also stated that "Annual and routine quality checks are conducted. Findings are shared with line staff and incorporated into the discussion and goal-setting plans at the time of evaluation."

During an interview with HIS Staff 51 on 12/11/13 beginning at 1:45 P.M., she stated that the findings of the quality checks were not shared with either the Medical Records and Informatics committee or the Quality Council (which had been confirmed by a review of their minutes for 2013 done on 12/10/13).

Based on observation, interview, and record review, the hospital failed to ensure that the registered nurses had adequate oversight of the nursing care provided for 1 of 44 sampled patients (2) when the nurses did not follow the hospital's protocol, and administered 100 milliliters (ml) of free water flushes during tube feedings every 6 hours without a physician's order. Administering free water flushes over the amount covered by the nursing protocol required a physician's order. Without the written physician's order, it was difficult to determine whether or not the physician actually ordered the free water flushes and when. In addition, administering free water flushes over the amount set by the nursing protocol may negatively impact a patient who did not need the extra fluids.

Hospital A's Registered Nurses (RNs) in the Emergency Department (ED) failed to ensure that fall risk assessments were complete, and included all the required elements to comprehensively determine a patient's fall risk status, for 3 of 44 sampled patients (13, 14, 15), in accordance with the hospital's ED Standards of Care. The failure to address all elements of a fall risk assessment could lead to an inaccurate evaluation of a patient's fall risk status, which in turn could prevent staff from implementing the appropriate safety interventions to prevent a patient fall.


Findings:

1. A tour of the 9th floor PCU (progressive care unit - a unit comprised of medical surgical and telemetry patients) was conducted on 12/10/13 at 8:30 A.M. On 12/10/13 at 8:35 A.M., Patient 2 was observed sleeping in bed. The patient's tube feeding was running at 80 ml/hr (milliliters per hour) and the water flush was programmed to run at 100 ml every 6 hours according to the tube feeding machine.

A review of Patient 2's medical record was conducted on 12/10/13 at 8:40 A.M. Patient 2 was admitted to Hospital A on 10/16/13 per the Facesheet.

A review of the physician's order, dated 11/21/13 at 5:19 P.M., indicated an order for Peptamen AF (tube feeding formula) to be given at 20 ml/hour with a goal rate of 80 ml/hr. However, there was no written physician's order related to the 100 ml every 6 hours free water flush.

A joint record review and interview with registered nurse (RN) 3 was conducted on 12/10/13 at 8:45 A.M. RN 3 stated that Patient 2 was just transferred from the intensive care unit early that morning. RN 3 stated that the report she received from the outgoing nurse was that the patient was receiving 100 ml of free water flush every 6 hours to keep the feeding tube patent. RN 3 acknowledged that there was no written physician's order in the patient's electronic medical record related to the free water flush. RN 3 stated that the nursing protocol addressed water flushes of 30 mls every 4 hours. However, RN 3 stated that anything over the amount stated in the nursing protocol required a physician's order.

A review of Patient 2's flowsheet indicated that the 100 ml free water flushes were being given every 6 hours without a written physician's order.

A review of the hospital's "Best Practice Guidelines for Gastrointestinal" was conducted on 12/10/13 at 3:30 P.M. The guidelines indicated that, "Flush enteral tube using 20-30 ml water every four hours, before and after medication administration, whenever feeding is interrupted, held or discontinued to maintain patency and decrease the incidence of enteral tubing occlusions." The hospital's guidelines did not indicate a process related to water flushes over 30 mls.

A joint record review and interview with nurse manager (NM) 2 was conducted on 12/11/13 at 11:28 A.M. NM 2 stated that he reviewed Patient 2's electronic medical record. He acknowledged that there was no written physician's order related to the 100 ml every 6 hours free water flushes. NM 2 stated that a written physician's order related to the 100 ml free water flushes should have been documented on the patient's electronic medical record prior to the administration of the water flushes.


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2. A review of Patient 13's medical record was conducted on 12/9/13 beginning at 10:59 A.M. with the ED Manager (EDM). Patient 13 was admitted to Hospital A's ED on 12/9/13 due to a fall after a syncopal (also known as syncope, a temporary loss of consciousness caused by a fall in blood pressure) event per the ED Note dated 12/9/13 at 12:01 A.M. According to the Fall Risk Assessment performed on 12/9/13 at 12:08 A.M., the following assessment elements were completed: patient age; altered level of consciousness; and mobility. There was no documented evidence to demonstrate the following fall risk elements were assessed for Patient 13: history of a recent fall in the last six months; high risk co-morbidities; functional disability; and medications.

An interview with RN 11 was conducted on 12/9/13 beginning at 1:43 P.M. RN 11 stated that when fall risk assessments were performed in the ED, the following required criterias were assessed to determine a patient's fall risk status: patient age; history of a recent fall in the last 6 months; high risk co-morbidities; functional disability; altered level of consciousness; mobility; and medications. She acknowledged that the fall risk assessment performed on 12/9/13 at 12:08 A.M. by RN 12 contained blanks and that there was no documented evidence to demonstrate that all required fall risk criterias were assessed.

A review of the hospital's ED Standards of Patient Care FY (fiscal year) 2012/2013 was conducted on 12/12/13. The Standards indicated that the hospital's goal was to prevent injury and provide a safe environment for all patients in their care. Per the same Standards under Assessment Data, it stipulated that "Identify patients that are at risk for falls at initial assessment. The following criteria will be considered when classifying patients as fall risk

-Increased age, especially > (greater than) 75 years
-History of a recent fall within the last six months
-High Risk co-morbidities: e.g. (example) dementia, hip fracture,
Parkinson's, arthritis, depression
-Functional disability: e.g. patient uses an assistive device
-Altered level of consciousness or cognitive impairment (e.g. clinical
intoxication)
-Gait, balance, visual impairment (demonstrated unsteady gait)
-Recent use of contributing medications (e.g. sedatives, narcotics)".

According to the Standards under Interventions/Documentation, "Implement safety precautions and interventions as appropriate."

An interview with the EDM was conducted on 12/17/13 at 10:00 A.M. The EDM acknowledged that Patient 13's fall risk assessment did not contain documented evidence to demonstrate that required fall risk criterias were assessed by the RN.

3. A review of Patient 14's medical record was conducted on 12/9/13 at 2:22 P.M. with RN 11. Patient 14 was admitted to Hospital A's ED on 12/9/13 due to a nosebleed per the ED NOTE dated 12/9/13 at 5:13 A.M. According to Patient 14's Fall Risk Assessment performed on 12/9/13 at 5:12 A.M., the following fall risk criterias were blank: history of a recent fall in the last 6 months; high risk co-morbidities; functional disability; altered level of consciousness and medications. Patient 14 did not meet the fall risk criteria based on this assessment.

According to Patient 14's Fall Risk Assessment performed on 12/9/13 at 7:30 A.M., two hours after the initial fall risk assessment, there were no blanks and it indicated that the patient was on one or more high fall risk drugs. RN 11 determined that Patient 14 was a fall risk from her assessment contrary to RN 12's Fall Risk Assessment dated 12/9/13 at 5:12 A.M.

An interview with RN 11 was conducted on 12/9/13 beginning at 1:43 P.M. RN 11 stated that when fall risk assessments were performed in the ED, the following required criterias were assessed to determine a patient's fall risk status: patient age; history of a recent fall in the last 6 months; high risk co-morbidities; functional disability; altered level of consciousness; mobility; and medications. She acknowledged that the fall risk assessment performed on 12/9/13 at 5:13 A.M. by RN 12 contained blanks and that there was no documented evidence to demonstrate that all required fall risk criterias were assessed.

A review of the hospital's ED Standards of Patient Care FY (fiscal year) 2012/2013 was conducted on 12/12/13. The Standards indicated that the hospital's goal was to prevent injury and provide a safe environment for all patients in their care. Per the same Standards under Assessment Data, it stipulated that "Identify patients that are at risk for falls at initial assessment. The following criteria will be considered when classifying patients as fall risk

-Increased age, especially > (greater than) 75 years
-History of a recent fall within the last six months
-High Risk co-morbidities: e.g. (example) dementia, hip fracture,
Parkinson's, arthritis, depression
-Functional disability: e.g. patient uses an assistive device
-Altered level of consciousness or cognitive impairment (e.g. clinical
intoxication)
-Gait, balance, visual impairment (demonstrated unsteady gait)
-Recent use of contributing medications (e.g. sedatives, narcotics)".

According to the Standards under Interventions/Documentation, "Implement safety precautions and interventions as appropriate."

An interview with the EDM was conducted on 12/17/13 at 10:00 A.M. The EDM acknowledged that Patient 13's fall risk assessment did not contain documented evidence to demonstrate that required fall risk criterias were assessed by the RN.

4. A review of the Patient 15's medical record was conducted on 12/9/13 at 2:33 P.M. Patient 15 was admitted to Hospital A's ED on 12/9/13 due to abdominal pain per the ED Note dated 12/9/13 at 4:18 A.M. According to Patient 15's Fall Risk Assessment dated 12/9/13 at 4:17 P.M., all the fall risk criterias were left blank except for that the patient's age was filled in.

An interview with RN 11 was conducted on 12/9/13 beginning at 1:43 P.M. RN 11 stated that when fall risk assessments were performed in the ED, the following required criterias were assessed to determine a patient's fall risk status: patient age; history of a recent fall in the last 6 months; high risk co-morbidities; functional disability; altered level of consciousness; mobility; and medications. She acknowledged that the fall risk assessment performed on 12/9/13 at 4:17 A.M. by RN 12 contained blanks and that there was no documented evidence to demonstrate that all required fall risk criterias were assessed.

A review of the hospital's ED Standards of Patient Care FY (fiscal year) 2012/2013 was conducted on 12/12/13. The Standards indicated that the hospital's goal was to prevent injury and provide a safe environment for all patients in their care. Per the same Standards under Assessment Data, it stipulated that "Identify patients that are at risk for falls at initial assessment. The following criteria will be considered when classifying patients as fall risk

-Increased age, especially > (greater than) 75 years
-History of a recent fall within the last six months
-High Risk co-morbidities: e.g. (example) dementia, hip fracture,
Parkinson's, arthritis, depression
-Functional disability: e.g. patient uses an assistive device
-Altered level of consciousness or cognitive impairment (e.g. clinical
intoxication)
-Gait, balance, visual impairment (demonstrated unsteady gait)
-Recent use of contributing medications (e.g. sedatives, narcotics)".

According to the Standards under Interventions/Documentation, "Implement safety precautions and interventions as appropriate."

An interview with the EDM was conducted on 12/17/13 at 10:00 A.M. The EDM acknowledged that Patient 13's fall risk assessment did not contain documented evidence to demonstrate that required fall risk criterias were assessed by the RN.

Based on observation, interview, and record review, the hospital failed to ensure that 4 of 44 sampled patients' (1, 41, 42, 43) pain status were reassessed after the administration of pain medication, in accordance with the hospital's own policy and procedure. On two occasions, Patient 1 was given a narcotic pain medication to address the patient's pain. However, there was no documented evidence that would indicate that the patient's pain status was reassessed after the medication was administered. Patient 41, Patient 42 and Patient 43's pain reassessments were not performed after the administration of pain medications. Failure to reassess the patients' pain status after the administration of the pain medication prevented staff and other healthcare providers' the ability to determine the effectiveness of the pain medication administered and the patients' comfort level.

In addition, the hospital failed to ensure that there was consistent documentation related to the characteristics of a Jackson-Pratt (JP - an enclosed drainage system for surgical sites) drain, for 1 of 44 sampled patients (41). The lack of documentation prevented staff and other healthcare providers to effectively determine the healing stages (progression or deterioration) of the incisional site, in an effort to ensure continuity of care.

Furthermore, the hospital failed to ensure that the wound location was consistently and accurately assessed, for 1 of 44 sampled patients (44). Patient 44's flowsheets indicated that the location of the wound was on the right shoulder however, according to the wound nurse's documentation and an observation of the patient's wound, the wound was located on the right lower scapula. The failure to document consistently and accurately had the potential to negatively impact the patient's continuity of care related to a wound. The inconsistent and inaccurate documentation could potentially mislead and impede the communication of pertinent information amongst healthcare providers.

Lastly, the hospital failed to ensure that intake and output (I&O) documentation was accurately completed related to the administration of IV Ancef (intravenous antibiotics), for 1 of 44 sampled patients (43) in accordance with the physician's order. Patient 43's I&O documentation did not reflect the administration of the IV Ancef. The failure to document the patient's IV Ancef in the I&O flowsheet had the potential to impede in communicating the actual intake total to the healthcare providers, in an effort to ensure continuity of care for a patient who was on strict I&Os.

Findings:

1. A tour of Hospital A's 11 West Transplant and Medical/Surgical Unit was conducted with the nurse manager (NM) 1 on 12/9/13 at 10:05 A.M. Patient 1 was observed lying in bed.

Patient 1's medical record was reviewed on 12/9/13 at 10:30 A.M. Patient 1 was admitted to Hospital A on 12/4/13 with diagnoses that included tongue ulcer per the History and Physical, dated 12/4/13.

A review of the Physician's Order sheet indicated that Tramadol (pain medication) 25 milligrams (mg) tablet every 6 hours as needed for mild pain (pain score of 1-3) and moderate pain (pain score of 4-6) was ordered on 12/4/13 at 5:28 P.M.

A review of Patient 1's flowsheet related to pain screening, dated 12/6/13, indicated that the patient complained of mouth pain on 12/6/13 at 11:15 A.M. and 8:51 P.M. On both occasions, the patient complained of pain at a rate of 6 (moderate pain) and was given pain medication.

A review of Patient 1's medication administration record (MAR), dated 12/6/13, indicated that the patient was given Tramadol 25 mg tablet on 12/6/13 at 11:15 A.M. and 8:53 P.M. However, there was no documented evidence in the patient's medical record that the patient's pain status was reassessed after the pain medication was administered on both occasions.

A joint record review and interview with registered nurse (RN) 1, the nurse who gave Patient 1's pain medication on 12/6/13 at 11:15 A.M., was conducted on 12/9/13 at 11:18 A.M. RN 1 stated that on 12/6/13 at 11:15 A.M., Patient 1 complained of mouth pain due to an ulcer on the tongue. RN 1 stated that she gave the patient Tramadol 25 mg tablet to address the patient's pain. However, RN 1 acknowledged that there was no documented evidence that the patient's pain status was reassessed following the administration of the oral pain medication. RN 1 stated that if an oral pain medication was given to a patient, a reassessment of the patient's pain status should be done within 2 hours following the administration of the pain medication.

The hospital's policy and procedure titled "Pain Management Policy" was reviewed on 12/9/13. The policy and procedure indicated that, "E. The patient's pain is reassessed by the medical/nursing staff to determine the effectiveness of the pain management strategies.... (iii) Within 2 hours following oral administration." This policy was not followed when Patient 1's pain status was not reassessed within 2 hours following the administration of an oral pain medication to determine the medication's effectiveness.








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2. A tour of the 6th floor medical surgical unit with the nurse manager (NM) 41 was conducted on 12/11/13 at 8:30 A.M.

A review of Patient 41's medical record was conducted with NM 41 and registered nurse (RN) 42 on 12/11/13 at 8:50 A.M. Patient 41 was admitted to Hospital A on 11/21/13 with back pain endorsed by the patient as 7 out of 10 pain scale according to the History and Physical, dated 11/21/13.

A review of Patient 41's Pre Operative Note, dated 11/28/13, indicated "Thoracic ("T" - back bone) spine epidural abscess (a local collection of pus in the area between the bones of the skull or spine and the membranes covering the spinal cord) and bacteremia (bacterial infection in the blood)." Per the same Note, it indicated "Procedure performed, laminectomies (back surgery), T9, T8, T7, T6, and partial T5, irrigation and debridement (removal of dead tissue and foreign matter), epidural abscess..."

A review of Patient 41's physician's orders, dated 11/21/13, indicated that an order for oxycodone-acetaminophen (percocet - narcotic pain medication) 5-325 mg (miligram) 2 tablets by mouth every 4 hours PRN (as needed) for severe pain (pain score 7-10).

A review of Patient 41's flowsheet related to pain screening, dated 11/26/13 at 3:40 P.M., the pain assessment indicated that the patient complained of back pain on the left side, at a rate of "8" (severe pain) and was given oral pain medication. However, there was no documented evidence to demonstrate that the patient's pain status was reassessed after the oral pain medication was administered.

A review of Patient 41's medication administration record (MAR), dated 11/26/13, indicated that percocet 5-325 mg 2 tablets were administered at 3:30 P.M. Per the same MAR, Patient 41 was given 2 tablets of percocet for severe pain on 11/26/13 at 9:16 P.M.

A review of Patient 41's Plan of Care (CP), dated 11/28/13, indicated that pain will be assessed per policy.

An interview and joint record review with NM 41 and RN 42 was conducted on 12/11/13 at 8:50 A.M. NM 41 and RN 42 both acknowledged that Patient 41's pain status was not reassessed following the administration of the oral pain medication.

A review of the hospital's policy entitled "Pain Management Policy", dated 2/17/11, was reviewed on 12/11/13. The policy indicated "P.4 E. The patient's pain is reassessed by the medical/nursing staff to determine the effectiveness of the pain management strategies. (ii) within 2 hours following oral administration." This policy was not followed when Patient 41's pain status was not reassessed within 2 hours following the administration of an oral pain medication to determine the medication's effectiveness.

3. A tour of the 8th floor nursing unit with the nurse manager (NM) 43 and registered nurse (RN) 44 was conducted on 12/12/13 at 9:33 A.M.

A review of Patient 42's medical record was conducted with NM 43 and RN 44 on 12/12/13 at 9:56 A.M. Patient 42 was admitted to Hospital A on 11/16/13 status post a motor vehicle accident with sustained abrasions and spine tenderness according to the History and Physical, dated 11/16/13.

A review of Patient 42's physician orders, dated 12/3/13, indicated an order for acetaminophen (Tylenol - pain medication) tablet 650 mg (milligram) every 6 hours via NG tube (nasogastric tube - a feeding tube that enters through the nose and into the stomach) PRN (as needed) for mild pain (pain score 1-3) and moderate pain (pain score 4-6).

A review of Patient 42's medication administration record (MAR) with NM 41 and RN 42 was conducted on 12/12/13 at 9:56 A.M. The MAR, dated 12/10/13, indicated that Tylenol 650 mg was given at 3:54 P.M.

A review of Patient 42's flowsheet related to pain screening, dated 12/10/13 at 3:54 P.M., the pain assessment indicated that the patient complained of mid-back pain, at a rate of "4" and was given pain medication through the NG tube. However, there was no documented evidence to demonstrate that the patient's pain status was reassessed after the pain medication was administered.

A review of the hospital's policy entitled "Pain Management Policy", dated 2/17/11, was reviewed. The policy indicated "P.4 E. The patient's pain is reassessed by the medical/nursing staff to determine the effectiveness of the pain management strategies. (ii) within 2 hours following oral administration."

An interview and joint record review with NM 43 and Nursing Director of Patient Care (NDPC) was conducted on 12/12/13 at 10:40 A.M. NM 43 and NDPC stated that the hospital's Pain Management Policy indicated that patient's pain assessments should be reassessed 1-2 hours after the administration of oral medication and 1 hour after intravenous (IV) medications.

4. A tour of the 8th floor nursing unit with the nurse manager (NM) 43 and registered nurse (RN) 44 was conducted on 12/12/13 at 9:33 A.M.

A review of Patient 43's medical record was conducted with NM 43 and RN 45 on 12/12/13 at 10:50 A.M. Patient 43 was admitted to Hospital A on 12/1/13 due to complications from a recent revision of right total hip arthroplasty (hip surgery) per the Orthopedic Surgery History and Physical Note, dated 12/1/13.

A review of Patient 43's physician's order, dated 12/2/13 at 5:48 P.M., indicated an order for oxycodone (narcotic pain medication) 15 mg (milligrams) by mouth, every 4 hours PRN (as needed) for severe pain (pain score 7-10) and oxycodone 10 mg tablet every 4 hours PRN for moderate pain (pain score 4-6). A physician's order, dated 12/3/13 at 9:45 A.M., indicated an order for dilaudid (narcotic pain medication) 1 mg IV (intravenous) every 3 hours PRN for severe pain (pain score 7-10 for breakthrough severe pain only).

A review of Patient 43's flowsheet related to pain screening, dated 12/3/13 at 8:17 A.M., the pain assessment indicated that the patient complained of right hip pain, at a rate of "7" (severe pain) and was given an oral pain medication. There was no documented evidence to demonstrate that a pain reassessment was performed after the administration of the oral pain medication. Per a flowsheet dated 12/7/13 at 8:34 A.M., Patient 43 complained of pain in the right hip, a rate of "4" (moderate pain) and was medicated at 8:35 A.M. with an oral pain medication. There was no documented evidence to demonstrate that a pain reassessment had been performed on Patient 43 after the pain medication was administered. According to a flowsheet, dated 12/10/13 at 10:16 A.M., the patient complained of leg and hip pain, at a rate of "7" (severe pain) and was given oral pain medication at 10:17 A.M. There was no documented evidence to demonstrate that a pain reassessment was performed after the administration of pain medication.

An interview and joint record review with NM 43 was conducted 12/12/13 at 1:19 P.M. NM 43 acknowledged that the hospital's pain management policy related to pain assessments were not followed.

A review of the hospital's policy entitled "Pain Management Policy", dated 2/17/11, was reviewed. The policy indicated "P.4 E. The patient's pain is reassessed by the medical/nursing staff to determine the effectiveness of the pain management strategies. (ii) within 2 hours following oral administration."

5. A tour of the 6th floor medical surgical unit with the nurse manager (NM) 41 was conducted on 12/11/13 at 8:30 A.M.

A review of Patient 41's medical record was conducted with NM 41 and registered nurse (RN) 42 on 12/11/13 at 8:50 A.M. Patient 41 was admitted to Hospital A on 11/21/13 with back pain endorsed by the patient as 7 out of 10 pain scale according to the physician's History and Physical, dated 11/21/13.

A review of Patient 41's Pre Operative Note, dated 11/28/13, indicated "Thoracic ("T" - back bone) spine epidural abscess (a local collection of pus in part of the body) and bacteremia (bacterial infection in the blood)." Per the same Note, it indicated "Procedure performed, laminectomies (back surgery), T9, T8, T7, T6, and partial T5, irrigation and debridement (removal of dead tissue and foreign matter), epidural abscess..." Per the same Note, "A 7 mm (millimeter) flat drain was placed deep into the dorsal (back) fascia (layer of fibrous tissue)."

A review of Patient 41's flowsheet related the closed suction drain (Jackson-Pratt - JP), indicated that the following elements will be assessed: site description, dressing type, dressing status, drainage appearance, status, intake - flush, and output. According to the same flowsheet, there was documented evidence to demonstrate that Patient 41's output was assessed on the following dates and times: 11/28/13 at 3:43 P.M.; 11/29/13 at 2:13 A.M., 2:45 P.M., 9:20 P.M.; 11/30/13 at 5:13 A.M.; and 12/1/13 at 5:30 A.M. However, there was no documented evidence to demonstrate that all the elements related to the assessment of the closed suction drain were performed.

An interview and joint record review was conducted with RN 42 and NM 41 on 12/11/13 at 10:30 A.M. RN 42 stated that the "JP drain should be documented each shift to ensure correct placement, drainage appearance, accurate observations for abnormal bleeding, and overall consistency and appearance of the drainage." NM 41 and RN 42 acknowledged that there was no documented evidence that the JP drain assessments were completed each shift.

An interview and joint document review with the Director of Regulatory Affairs (DRA) was conducted on 12/17/13 at 11:40 A.M. The hospital's document entitled "Reference of Clinical Management and Interdisciplinary Assessment and Reassessment of Patients", dated 10/15/13, indicated that a complete head to toe assessment was performed every shift. The DRA acknowledged that there was no documented evidence to demonstrate that Patient 41's JP drain assessments were completed each shift.

6. A tour of the 6th floor medical surgical unit with the nurse manager (NM) 46 on 12/17/13 at 3:10 P.M.

A review of Patient 44's medical record was conducted with NM 46 on 12/17/13 at 3:20 P.M. Patient 44 was admitted to Hospital A on 10/27/13 per the Facesheet. Per the History and Physical, dated 10/27/13, Patient 44 had a right upper back ulcer.

On 12/17/13 at 3:30 P.M., an observation of Patient 44's wound was conducted. Patient 44's wound had an open area located on the right scapula. The wound bed was brownish yellow in color, no drainage noted and measured approximately at 3 cm (centimeters) x 5 cm. Though, the observation of the wound was conducted, the exact measurement of the wound was not obtained due to Patient 44's refusal.

A review of Patient 44's medical record was conducted on 12/17/13 at 4:00 P.M. The Wound Consult Note, dated 11/8/13, indicated "open area below right scapula from prior thoracotomy (an incision in the pleural space of the chest)."

A review of Patient 44's flowsheet related to skin assessments, indicated from the time of admission 10/27/13 to 12/17/13, the nursing staff's documented assessments of the wound's location was "shoulder right: posterior". However, this was contrary to the Wound Consult Note, dated 11/8/13, which indicated that the open area was located below the right scapula.

A telephone interview with the wound nurse (WN) 41 was conducted on 12/17/13 at 4:22 P.M. WN 41 stated that Patient 44's open area was located on the right lower scapula. She stated that the nursing staff's documentation of shoulder, right posterior was not consistent with the actual location of the open area. She acknowledged that the documented assessment of the open area's location was inaccurate.

A concurrent interview was conducted with NM 46 and RN 47 on 12/17/13 at 5:10 P.M. NM 46 and RN 47 acknowledged that Patient 44's open area was located on the right scapula. They both acknowledged that the documentation of Patient 44's open area location was not accurate.

An interview and joint document review with the Director of Regulatory Affairs (DRA) was conducted on 12/17/13 at 11:40 A.M. The hospital's document entitled "Practice Guidelines for Skin" was reviewed. The document indicated guidelines to assess with each dressing change, the location of the wound and to document it. The DRA acknowledged that Patient 44's documented assessment of the open area location by the nursing staff was inaccurate and not in accordance with their guidelines.

7. A tour of the 8th floor nursing unit with the nurse manager (NM) 43 and registered nurse (RN) 44 was conducted on 12/12/13 at 9:33 A.M.

A review of Patient 43's medical record was conducted on 12/12/13 at 10:50 A.M. Patient 43 was admitted to Hospital A on 12/1/13 due to complications from a recent revision of right total hip arthroplasty (hip surgery) according to the Orthopedic Surgery History and Physical Note, dated 12/1/13.

A review of Patient 43's physician's order, dated 12/2/13 at 1:59 P.M., indicated strict intake and output monitoring. Another physician's order, dated 12/2/13 at 4:00 P.M., indicated that Patient 43 was to be given Ancef (antibiotic) 50 ml (milliliter) IVPB (intravenous piggy back) every 8 hours at 100 ml/hr (hour) over 30 minutes.

A review of Patient 43's flowsheet related to intake and output, indicated that the Ancef administered and its total volume given was not consistently documented on the following dates: 12/3/13, 12/4/13, 12/5/13, 12/6/13, 12/7/13, 12/9/13, 12/10/13, 12/11/13, and 12/12/13.

An interview with NM 43 was conducted on 12/12/13 at 1:19 P.M. NM 43 acknowledged that the ordered ancef dose of 50 ml was not consistently documented as ordered every 8 hours to total 150 ml in a 24 hour period and recorded in the strict intake and output.

An interview with RN 48 was conducted on 12/12/13 at 1:45 P.M. RN 48 stated that the nursing staff should have documented the piggy bag infusion manually into Patient 43's intake and output IV section of the flowsheet. RN 48 acknowledged that the inconsistent documentation did not follow the physician's orders for strict intake and output monitoring.

Based on interview, record and document review, Hospital A's Registered Nurses (RNs) in the surgical intensive care unit (SICU) and cardiac care unit (CCU), failed to ensure that physician's orders were documented in the medical record when continuous infusions of propofol (sedative/general anesthetic drug) were increased and decreased on separate occasions, and a continuous infusion of fentanyl (a narcotic analgesic) was increased, for 2 of 44 sampled patients (11, 12). The failure to ensure that physician's orders were documented in the patients' medical records by the RNs made it difficult to determine whether or not the physician actually prescribed the documented medical treatment plan. In addition, the failure of RNs to implement medication policies and procedures and physician orders increased the potential for patient harm.

The Emergency Department (ED) RNs at Hospital A failed to ensure that a physician's order was obtained for the administration of oxygen therapy, for 1 of 44 sampled patients (13) in accordance with the hospital's ED Standard of Patient Care. There was documentation found in Patient 13's medical record that oxygen therapy was administered on two occasions without a physician's order. Lack of a physician's order made it difficult to determine whether or not the physician actually prescribed the documented medical treatment plan.

Hospital B failed to ensure that physician orders were implemented for 1 of 44 sampled patients (61). Patient 61 had an order to receive Ropivacaine, which was an anesthetic agent used for managing pain. There was another order to monitor this patient for the effect of the medication every 8 hours. There was no documented evidence that the patient was monitored every 8 hours as ordered by the physician. Failure to monitor patients put patients at risk of developing unwanted side effects that go undetected, and placed the patient at risk of harm due to lack of consciousness or problem breathing.

Lastly, Hospital A failed to ensure that the medication administration was in accordance with the physician's order. During the observation of registered nurse (RN) 71 passing ten medications to one patient (Patient 71) on the 6th Floor Medical/Surgical Unit, RN 71 made one error out of ten opportunities for error. RN 71 announced she would give 2 units of Humalog Insulin to Patient 71 but examination of the syringe indicated she had drawn up approximately 2.5 units.

Humalog Insulin is a rapid acting insulin used to lower high blood sugar levels in response to eating a meal that patients with diabetes mellitus (a disturbance in the ability to utilize sugar secondary to problems with insulin secretion or response to insulin) may experience after eating a meal.

Findings:

1. A review of Patient 11's medical record was conducted 12/10/13 beginning at 9:04 A.M. Patient 11 was admitted to Hospital A on 12/8/13 with multiple stab wounds per the Facesheet, dated 12/8/13.

On 12/9/13 at 12:45 A.M., Physician 11 ordered the administration of a continuous Propofol infusion. Per the order, the Propofol was to be
started at 30 micrograms (mcg) per kilogram per minute (mcg/kg/min). RNs were to titrate the infusion rate up and down by 10 mcg. every 1 minute to achieve a target RASS score of 0 (zero) to negative 2 (-2). (RASS score: Richmond Agitation-Sedation Scale; A numerical score, ranging from +4 (very combative) to -5 (unarousable) assigned to a patient which relies on patient behavior and movement to determine the level of sedation). The maximum rate was 60 mcg/kg/min. Infusion was to be turned off if: MAP (mean arterial pressure) < (less than) 60 mmHg (millimeters of mercury). The physician was to be notified if patient was not meeting the goal.

According to Patient 11's Doc Flowsheet, dated 12/9/13 at 3:48 A.M., the propofol infusion was increased from 40 mcg/kg/min to 60 mcg/kg/min and then decreased to 30 mcg/kg/min at 5:00 A.M. on the same day.

An interview and joint record review was conducted with RN 13 on 12/10/13 beginning at 2:37 P.M. RN 13 had explained that Patient 11 had multiple stab wounds and Physician 12 performed a treatment (an irrigation and suturing procedure) at the time that caused the patient to go "wild". She stated that Physician 12 instructed her to "increase" (titrate up) the propofol drip to 60 mcg/kg/min and then after the procedure to "decrease" (titrate down) the propofol to 30 mcg/kg/min. She stated that she did not ensure that the physician's order was in Patient 11's medical record in accordance with the hospital's policy.

A review of the hospital's policy entitled "High Risk Medications", dated 10/18/12 was conducted. The policy defined a high risk medication as one that had the potential to cause severe life-threatening side effects, and/or required special monitoring. Propofol was listed as high risk medication.

A review of the hospital's policy entitled "Patient Treatment and Medication Orders", dated 2/6/13 was conducted. Per the policy, medications and treatments should be administered as ordered by prescribers. The policy also indicated that "Verbal or telephone orders may be initiated only by an authorized provider." Also, the policy stipulated that "Review each patient record each shift to see that all orders are appropriately recorded, signed, complied with, and counter-signatures obtained, if necessary."

On 12/11/13 at 2:46 P.M., an interview was conducted with the SICU Nurse Manager (NM 11). NM 11 acknowledged that she spoke with Physician 12 who recalled Patient 11 and the verbal instructions he gave to RN 13. She stated that Physician 12 was aware that the physician's order should have been in the patient's medical record and it did not happen. NM 11 acknowledged that Physician 12 and RN 13 both had a responsibility to ensure that the physician's order related to the Propofol infusion increase and decrease should have been in Patient 11's medical record.

2. A review of Patient 12's medical record was conducted 12/10/13 at 2:17 P.M. Patient 12 was admitted to Hospital A status post cardiac arrest per the History & Physical, dated 12/5/13.

On 12/9/13 at 5:22 A.M., Physician 13 ordered the administration of a continuous Propofol infusion. Per the order, the Propofol was to be
started at 50 micrograms (mcg) per kilogram per minute (mcg/kg/min). RNs were not to titrate the continuous infusion of Propofol. The goal was minimal myoclonic (seizure type) jerks. The infusion was to be turned off if: SBP (systolic blood pressure) < (greater than) 100 mmHg (millimeters of mercury) and to notify the physician. The physician was also to be notified if patient was not meeting the goal.

According to Patient 12's Doc Flowsheet, dated 12/9/13 at 9:30 A.M., the propofol infusion was decreased from 50 mcg/kg/min to 40 mcg/kg/min.

A Nurse's Note, dated 12/9/13 at 9:30 A.M., indicated that Physician 14 verbally ordered Propofol to run at 40 mcg/kg/min and that the "MICU" (medicine team of physicians) team would update this in Patient 12's electronic medical record to reflect current rate.

There was no documented evidence found in Patient 12's medical record to demonstrate that a physician's order had been entered by anyone related to the Propofol rate change on 12/9/13 at 9:30 A.M.

A review of the hospital's policy entitled "High Risk Medications", dated 10/18/12 was conducted. The policy defined a high risk medication as one that had the potential to cause severe life-threatening side effects, and/or required special monitoring. Propofol was listed as high risk medication.

A review of the hospital's policy entitled "Patient Treatment and Medication Orders", dated 2/6/13 was conducted. Per the policy, medications and treatments should be administered as ordered by prescribers. The policy also indicated that "Verbal or telephone orders may be initiated only by an authorized provider." Also, the policy stipulated that the nursing staff's responsibility was to "Review each patient record each shift to see that all orders are appropriately recorded, signed, complied with, and counter-signatures obtained, if necessary."

A interview with the CCU Nurse Manager (NM 12) was conducted on 12/11/13 at 2:27 P.M. NM 12 acknowledged that the verbal order should have been entered by Physician 14 and it was the nursing staff's responsibility to ensure that the physician's order related to the Propofol rate decrease was in Patient 12's medical record in accordance with the hospital's policy.

3. A review of Patient 11's medical record was conducted 12/10/13 beginning at 9:04 A.M. Patient 11 was admitted to Hospital A on 12/8/13 with multiple stab wounds per the Facesheet dated 12/8/13.

On 12/9/13 at 12:45 A.M., Physician 11 ordered the administration of a continuous Fentanyl infusion. Per the order, the Fentanyl was to be
started at 50 micrograms (mcg) per hour (mcg/hr). RNs were to titrate the infusion rate up by 25 mcg/hr every 60 minutes if patient was not at goal and two or more boluses have been given. RNs were to titrate down by 25 mcg/hr every 60 minutes to maintain goal at lowest infusion rate. The maximum rate was 200 mcg/hr. The physician was to be notified if patient was not meeting the goal.

According to Patient 11's Doc Flowsheet, dated 12/9/13 at 3:49 A.M., the Fentanyl infusion was increased from 50 mcg/hr to 150 mcg/hr and then decreased to 50 mcg/hr at 5:00 A.M. on the same day.

An interview and joint record review was conducted with RN 13 on 12/10/13 beginning at 2:37 A.M. RN 13 had explained that Patient 11 had multiple stab wounds and Physician 12 performed a treatment (an irrigation and suturing procedure) at the time that caused the patient to go "wild". She stated that Physician 12 instructed her to "increase" (titrate up) the Fentanyl drip to 150 mcg/hr and then after the procedure to "decrease" (titrate down) the Fentanyl drip to 50 mcg/hr. She stated that she did not ensure that the physician's order was in Patient 11's medical record in accordance with the hospital's policy.

A review of the hospital's policy entitled "Patient Treatment and Medication Orders", dated 2/6/13 was conducted. Per the policy, medications and treatments should be administered as ordered by prescribers. The policy also indicated that "Verbal or telephone orders may be initiated only by an authorized provider." Also, the policy stipulated that nursing staff's responsibility was to "Review each patient record each shift to see that all orders are appropriately recorded, signed, complied with, and counter-signatures obtained, if necessary."

On 12/11/13 at 2:46 P.M., an interview was conducted with the SICU Nurse Manager (NM 11). NM 11 acknowledged that she spoke with Physician 12 who recalled Patient 11 and the verbal instructions he gave to RN 13. She stated that Physician 12 was aware that the physician order should have been in the patient's medical record and it did not happen. NM 11 acknowledged that Physician 12 and RN 13 both had a responsibility to ensure that the physician's order related to the Fentanyl infusion increase and decrease should been in Patient 11's medical record.

4. A review of Patient 13's medical record was conducted on 12/9/13 beginning at 10:59 A.M. with the ED Manager (EDM). Patient 13 was admitted to Hospital A's ED on 12/9/13 due to a fall after a syncopal (also known as syncope, a temporary loss of consciousness caused by a fall in blood pressure) event per the ED Note, dated 12/9/13 at 12:01 A.M. According to the Patient Care Timeline under Vitals/Screening, Patient 13's oxygen saturation (a measure of how much oxygen the blood is carrying) was 87% (percent) and respiratory rate was 20. Per the same Timeline dated 12/9/13 at 12:48 A.M., Patient 13 was on oxygen therapy via nasal cannula, oxygen flow at 6 l/min (liters/minute) for an oxygen saturation of 92% in a sitting position.

On 12/9/13 at 1:37 A.M. and 2:09 A.M., Patient 13 was on oxygen therapy via nasal cannula, oxygen flow at 4 l/min for oxygen saturations of 91% and 93% in a sitting position.

According to an ED Note, dated 12/9/13 at 7:20 A.M., Patient 13 had oxygen therapy via nasal cannula at 4 l/min with an oxygen saturation of 98%. There was no documented evidence to demonstrate that a physician's order was obtained for the administration of oxygen therapy in accordance with the hospital's ED Standards of Care.

An interview with RN 11 was conducted on 12/9/13 at 1:43 P.M. She acknowledged that there was no documented evidence in Patient 13's medical record to demonstrate that a physician's order had been obtained for the administration of oxygen therapy at 6 l/min and 4 l/min.

A review of the hospital's ED Standards of Patient Care FY (fiscal year) 2012-2013 was conducted. The Standards stipulated that "Administer oxygen therapy, as indicated by nurse protocol order or physician order."

An interview with the EDM was conducted on 12/9/13 at 1:55 P.M. The EDM stated that there should have been documented evidence found in Patient 13's medical record to demonstrate that a nurse driven protocol was implemented which would have included a physician's authorization for the treatment or a clear physician's order indicating the administration of oxygen therapy. She acknowledged that neither was found in Patient 13's medical record which was not in accordance with the ED Standards of Care.








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5. On 12/11/13 at approximately 9:00 A.M. at Hospital B, a review of the record for patient 61, revealed an order, on 12/9/13 at 9:30 A.M., for Ropivacaine by infusion at 6 mg (milligrams) every hour and as needed. Part of the order set was instructions to monitor for neurological checks every 4 hours. Neurological checks according to the order included assessments of motor (movement) and sensory (feeling, sensation) function. There was another order, on 12/9/13 at 7:06 P.M., modifying the neurological checks (neuro-checks) to every 8 hours.
Concurrent review of the record with Pharmacist (Pharm) 61 and the Director of Nursing (DON) revealed that neurological checks were not completed in accordance with the physician's order on 12/9/13.
On 12/9/13, there was documentation of two neurological checks at 1:46 P.M. and 9:00 P.M. There was no documented evidence that neuro-checks were completed every four hours between 9:30 A.M. and 7:06 P.M., (the time the order was changed.)
There was no documented evidence of neuro-checks every 8 hours on 12/10/13. There record showed documentation of neuro-checks at 7:24 A.M. and 8:33 P.M.



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6. On 12/10/13 at 9:24 A.M., RN 71 drew up Humalog Insulin to give to Patient 71 and stated she planned to give 2 units of insulin. Inspection of the insulin syringe indicated that the plunger of the syringe was about one-half the distance between the 2 unit and the 3 unit marking. When informed of this RN 71 pushed on the plunger of the syringe and expressed a drop of insulin from the top of the hypodermic needle attached to the syringe. Inspection of the syringe at that time indicated that the plunger was at the 2 unit mark. At that point RN 71 administered the medication to Patient 71.

On 12/10/13, a review of Patient 71's electronic medical record indicated that a physician had ordered that Patient 71 receive 2 units of Humalog Insulin three times daily with meals.

Based on medical record review and staff interview, the hospital failed to ensure that all entries were complete, dated, and timed in 3 of 9 records reviewed.

Findings:

The following records were reviewed on the afternoon of 12/12/13 and the findings were confirmed concurrently by Staff 52:

1) Records 55 and 56 were patients in the Emergency Department and each contained the form, "Leaving Hospital Against Advice." In Record 55, the patient signed the form, but the date and time were not documented in the space provided; and a witness did not sign, date, and time the form in the spaces provided. In Record 56, the section to document the "Reason for leaving prior to medical exam" had not been completed, and the time that the patient had signed the form was blank.

2) Record 57 contained the form, "Information and Consent for Oral Psychotropic Medication." This was a paper consent that the patient signed and it had been scanned into the electronic record. There were two more of these consents; however, they were clearly identified as belonging to two other different patients. Staff 52 stated that these two other consents were apparently scanned into the wrong patient's record; thus leaving those two other records incomplete.

Based on document review and staff interview, the hospital failed to ensure that medical records were completed within 14 (fourteen) days following discharge, as required by the medical staff bylaws, rules and regulations.

Findings:

On 12/10/13, the Medical Staff Rules and Regulations, last approved 10/22/13, were reviewed. Section 6, "Preparation of Medical Records," states: "No medical record shall be filed until it is completed. The medical record for each patient must be completed, authenticated by the date and signature of the author of the note and filed within 14 days of discharge."

The Medical Record Statistics Form was received and reviewed with HIS Staff 51 on 12/11/13 at 1:30 P.M. On 11/30/13, the total number of delinquent medical records (those not completed within 14 days of discharge) was 167. The average monthly discharge rate of all inpatient and ambulatory surgery cases was 4989. HIS Staff 51 also provided a separate breakdown of these 167 delinquent records as follows: 80 discharge summaries, 32 history and physicals, and 55 surgery (operative) reports that still needed to be completed. On 12/10/13, this surveyor had reviewed the Medical Records and Informatics committee minutes of 10/7/13 which stated that there were 2087 inpatient verbal orders given, with 80% signed within 48 hours of discharge. HIS Staff 51 explained that the medical record staff did not count the unsigned telephone/verbal orders in with this delinquent number; nor do they monitor records to ensure that all orders have been eventually signed by a physician. On 12/12/13 at 1:00 P.M, HIS Staff 51 provided a printed report listing the discharge dates for each delinquent record; there were 21 reports for patients who were discharged in 2013 (some more than a year ago) that still had not been completed by a physician.

Based on inspection of five of seven products that the hospital obtained from Compounding Pharmacy A phenylephrine (used to support blood pressure) prefilled syringes [PFSs], ephedrine (used to support blood pressure) PFSs, hydromorphone (pain reliever) PFSs, fentanyl (pain reliever) intravenous (IV) bag, and a fentanyl/bupivacaine (local anesthetic) epidural [the space between the vertebrae and the membrane covered spinal cord] solution in the Surgery Department Satellite and on patient care units, observation of a Biological Safety Cabinet (BSC) labeled as Hood #4 at Hospital A's Pharmacy Intravenous (IV) Compounding Room, observation of a pharmacy technician compounding IV solutions in an IV Hood labeled as Hood #1 in the IV Room, staff interview, and review of the pharmacy policy regarding compounded sterile products (CSPs):

1. The pharmacy management was not able to ensure the quality of each lot of the products they obtained from Compounding Pharmacy A before they were used on patients (see finding 1 below).

2. The hospital failed to ensure that pharmacy management knew what units of measurement were used for a Magnehelic gauge (used to measure pressure differentials between to areas) located on the front of the hood or what normal readings were. BSCs are used to compound IV chemotherapeutic agents which are medications used to treat cancer and which have significant toxicities. The BSC was designed to protect staff and the environment in which the hood is located from contamination created by aerosols of these chemotherapeutic agents created in the hood during the compounding process. Gauges were put on hoods for a reason and it was important to know exactly what the function may be in case it was there to monitor a critical function of the hood (see finding 2 below).

3. The pharmacy management failed to ensure that a policy was developed and/or implemented:

a. that "clearly" provided for wearing of facial hair covers (as opposed to face masks) by pharmacy staff with beards (facial hair) when making CSPs in a protected environment such as an IV hood and

b. failed to implement the procedure in hospital policy that stipulated staff covered all the hair on their head (with hair caps) as required by United States Pharmacopeia (USP) Chapter 797.

USP 797 establishes minimum standards to assure the safe production of CSPs. The hospital policy implied the use of facial hair covers but facial hair covers were not explicitly documented in the policy except with reference to their removal when leaving the compounding area. It did stipulate that head hair needed be covered. The HC Inpatient Director of Pharmacy identified USP 797 as a standard that the Pharmacy Department would follow whenever it could. USP 797 documents that failure of staff to wear personal protective equipment (PPE: hair caps, shoe covers, gowns, facial hair covers, face masks, and gloves worn by staff to prevent contamination of CSPs during the compounding process) as required by this chapter could result in contamination of IV solutions with bacteria shed from staff while compounding these solutions. IV hoods contain high efficiency particulate air (HEPA) filters used to create a clean environment in which CSPs are compounded.

Findings:

1. The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines ...USP ' s drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP/NF). The USP/NF revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death to patients that could result from microbial contamination and excessive bacterial toxins among other things." The chapter defined three risk categories for CPSs compounded under the conditions stipulated by this chapter: low risk, medium risk, and high risk. Low and medium risk CSPs were compounded using only sterile components while high risk CSPs were compounded with products that were not sterile and must be sterilized during the compounding process. USP 797 stipulated that low risk CSPs may be assigned the following beyond use dates (BUDs: date and time beyond which a product may not be stored or transported) in the absence of passing a sterility test as documented in USP Chapter 71: 48 hours under controlled room temperature, 14 days under refrigeration, and 45 days frozen. Medium risk CSPs may be assigned the following BUDs in the absence of passing a sterility test as documented in USP Chapter 71: 30 hours under controlled room temperature, 9 days under refrigeration, and 45 days frozen. High risk CSPs may be assigned the following BUDs in the absence of passing a sterility test: 24 hours at controlled room temperature, 3 days under refrigeration, and 45 days frozen.

The American Society of Health System Pharmacists is a nationally recognized organization that sets standards of practice for hospital pharmacies. This organization has published ASHP GUIDELINES ON OUTSOURCING STERILE COMPOUNDING SERVICES. Under "Services Provided by Compounding Pharmacies" it documented that: "A compounding pharmacy registered as a drug establishment [with the FDA] may apply for a labeler code that allows it to create National Drug Code (NDC) numbers for its products. These NDC numbers do not indicate FDA approval or that a New Drug Application has been filed, nor do they indicate a higher degree of quality ...Ascertaining that a preparation is labeled with an NDC number is therefore not a substitute for the due diligence required to verify a compounding pharmacy's quality processes (e.g. USP 797, current good manufacturing processes)".

On 12/10/13 at 3:24 P.M. during an interview of the HC Inpatient Director of Pharmacy, he stated he stated that the hospital followed the hospital policy regarding IV compounding and the hospital followed USP 797 when it was possible.

On 12/11/13 at 8:47 A.M. during an interview of the Pharmacy Buyer, she stated that the hospital bought compounded IV products from Compounding Pharmacy A: specifically pre-filled syringes (PFSs) for the Anesthesia Service and PFSs of opioid (having the properties of opium) medications used for patient controlled analgesia (PCA: a process where a patient may self-administer as needed pain relieving medications via a programed IV pump programed by nursing staff to deliver this medication within set intervals established by the prescribing physician).

On 12/11/13 at 10:27 A.M. a review of the a copy of the order sheet the hospital used to order medications from Compounding Pharmacy A indicated the pharmacy ordered the following opioid medications from Compounding Pharmacy A:

Hydromorphone 0.2milligrams/milliliter (mg/ml) in normal saline (NS: 0.9% sodium chloride) in 50 ml PFSs for use in PCA.

Morphine Sulfate 1 mg/ml in NS 50 ml PFSs for use in PCA.

Fentanyl 10 micrograms (mcg)/ml in NS 1 ml PFSs for use in a syringe pump.

Fentanyl 10 mcg/ml in 250 ml NS IV bag for use as a pain relieving drip.

Fentanyl 2 mcg/ml and bupivacaine preservative free 0.1% in 250 ml NS IV bag for use as an epidural (given for infiltration of the epidural space of the spinal cord via a programmed pump).

Hydromorphone, morphine sulfate, and fentanyl are Schedule II (high potential for abuse) opioid pain relievers. Bupivacaine is a local anesthetic.

During an interview of Pharmacist 73 in the Pharmacy on 12/11/13 at 10:27 A.M. he verified that the pharmacy currently ordered the above five products from Compounding Pharmacy A. He stated that the hospital had to place an order for a minimum quantity of each product as established by Compounding Pharmacy A. During an interview of the Pharmacy Buyer at that time, she stated the hospital also bought two types of PFSs for the Anesthesia Service and that all such syringes were stored in the Surgery Department.

On 12/11/13 at 10:42 A.M., during an interview of Pharmacist 74 in the Surgery Department Satellite Pharmacy located in the Surgery Department, she stated Compounding Pharmacy A provided phenylephrine and ephedrine PFSs for use in the Surgery Department (both medications are used to support blood pressure). She stated that she placed these syringes in hospital approved anesthesia trays. During an interview of Pharmacy Tech 75 at that time she estimated that the Surgery Department went through approximately 500 phenylephrine PFSs/month (used on patients or expired and removed from stock) and approximately 100 to 150 ephedrine PFSs/month (used on patients or expired and removed from stock).

On 12/11/13 at 10:42 A.M., an inspection of the Surgery Department Satellite Pharmacy indicated it contained the following PFSs from Compounding Pharmacy A stored in bins in the satellite pharmacy at room temperature:

Phenylephrine 100mcg/ml in 10 ml of NS: 13 such PFSs. Inspection of one lot number of these PFSs, lot: 17-33761, indicated all four of these syringes were labeled to expire 1/16/14 (36 days later).

Ephedrine 5 mg/ml in 10ml PFSs: 20 such PFSs. Inspection of one lot number of these PFSs, lot: 17-33762, indicated all four of these syringes were labeled to expire 1/16/14 (36 days later). Compounding Pharmacy A ' s name appeared on the labels of these PFSs.

On 12/11/13 at 1:30 P.M., the surveyor inspected an IV fentanyl/bupivacaine epidural solution that had just been removed from Patient 76 on the Labor and Delivery Service. It was an IV bag of fentanyl 2 mcg/ml and bupivacaine 1% and Compounding Pharmacy A's name appeared on the label. It was labeled to expire 12/25/13 (14 days later). This observation was verified by interview of the HC Inpatient Pharmacy Manager.

On 12/11/13 at 1:41 P.M., the surveyor observed a 50 ml PFSs of hydromorphone 0.2 mg/ml being infused into Patient 77 via a programed pump. The PFS was labeled to expire 1/9/14 (29 days later). This observation was verified by interview of the HC Inpatient Pharmacy Manager.

On 12/11/13 at 1:55 P.M., the surveyor observed a 50 ml PFSs of hydromorphone 0.2 mg/ml being infused into Patient 78 via a programed pump labeled to expire 12/15/13 (4 days later). This observation was verified by interview of the HC Inpatient Pharmacy Manager.

On 12/11/13 at 2:05 P.M., the surveyor observed a 250 ml IV bag of fentanyl 10 mcg/ml infusing into Patient 79 and Compounding Pharmacy A's name appeared on the label. It was labeled to expire 1/9/14 (29 days later). This observation was verified by interview of the HC Inpatient Pharmacy Manager.

On 12/11/13 at 2:23 P.M., during an interview of the HC Inpatient Pharmacy Manager, she agreed that the above solutions had BUDs that were beyond those permitted by USP 797 regarding sterility in the absence of further sterility testing as documented in USP 797. She also stated these medications were obtained in bulk from Compounding Pharmacy A in the absence of prescriptions written by a specific physician for a specific patient.

On 12/11/13 at 2:23 P.M., during an interview of the Pharmacy Buyer, she stated she had asked Compounding Pharmacy A for stability and sterility data but had been informed that this was proprietary data and would not provide it unless asked by a regulatory agency for it. She stated she could not assure the quality of the products the surveyor observed in the hospital for use in patients by lot number.

On 12/11/13 at 3 P.M., during an interview of the Chief Pharmacist, he stated he did not disagree with the ASHP published guidelines regarding compounding pharmacies in that hospitals must assure the quality of the medications obtained from these pharmacies. He stated that Compounding Pharmacy A should provide lot specific potency and sterility data for each lot of medication used by the hospital. He stated he felt that the hospital did not have the data that supported the quality of individual medications obtained from Compounding Pharmacy.

2. The USP/NF revised general chapter <797> entitled Pharmaceutical Compounding-Sterile Preparations documents in the subsection "Equipment", found under the section entitled "Elements of Quality Control" indicated that "It is necessary that equipment, apparatus, and devices used to compound a CSP be consistently capable of operating properly and within acceptable tolerance limits. Written procedures outlining ...monitoring for proper function ...are established and followed ...Training (of staff) includes gaining the ability to determine whether any item of equipment is operating properly or is malfunctioning."

On 12/10/12, a review of Chapter 18 of the Department of Pharmacy Policies and Procedures entitled Compunded Sterile Products (Original Date: 06/10/04, Last Revised: 6/22/12) indicated that "The PIC (Pharmacist in Charge: the person listed on the Pharmacy License issued by the Board of Pharmacy as the person who is in charge of and responsible for the pharmacy) is responsible for maintaining an implementing written policies and procedures assuring the quality of the CSP prepared at his/her pharmacy... " In Section 02, "Sterile Compounding Facilities and Equipment", Procedure F (1) it documented: "Sterile Compounding Environment (SCE) is certified every 6 months and appropriately maintained for daily use" but there was nothing in the procedure that specifically applied to reading gauges that were located on IV hoods and how to interpret those readings.

On 12/10/13 at 2:28 P.M., an inspection of a Biological Safety Cabinet labeled as Hood #4 at the Hospital A Pharmacy IV Room indicated that the manufacturer had installed a Magnehelic Gauge located on the front of the hood (used to measure pressure differentials between two areas). During an interview of the HC Pharmacy Manager at that time, she stated she was responsible for the operation of the pharmacy. She stated she did not know what units of measurement were used on the Magnehelic Gauge nor did she know what considered a normal reading. She stated that this hood was used to compound chemotherapeutic agents and was supposed to be maintained at a negative pressure with respect to the environment in which the pharmacy staff located the BSC. At that time the surveyor noted the gauge documented a reading of 0.11 inches of water (the face of the gauge indicated it was measured in inches of water).

On 12/10/13 at 2:50 P.M., during an interview of Staff Pharmacist 71 (identified at that time by the HC Pharmacy Inpatient Manager as one of the main evening pharmacists assigned to work in the IV room), he stated he did not know what units of measurement were used on the Magnehelic Gauge nor did he know what was considered a normal reading.

3. USP 797 documents in the subsection entitled "Personnel Cleansing and Garbing" found under the section entitled "Environmental Quality and Control" indicated that, " ...the correct donning of PPE (Personal Protective Equipment) by compounding personnel constitute the first major step in preventing microbial contamination in CSPs ...Squamous (skin) cells are normally shed from the human body at a rate of [one million] or more per hour, and those skin particles are laden with microorganisms ...Personnel shall don ...facial hair covers (e.g., beard covers in addition to face masks), and face masks .... "

On 12/10/12, a review of Chapter 18 of the Department of Pharmacy Policies and Procedures entitled Compunded Sterile Products (Original Date: 06/10/04, Last Revised: 6/22/12) indicated that "The PIC (Pharmacist in Charge: the person listed on the Pharmacy License issued by the Board of Pharmacy as the person who is in charge of and responsible for the pharmacy) is responsible for maintaining an implementing written policies and procedures assuring the quality of the CSP prepared at his/her pharmacy ... " In, Section 03, "Personnel Education, Training, Competency and Attire" Procedure B (9) referred to facial hair covers (and) face masks being replaced with new one upon re-entering the compounding area. However, this was the only place where the policy specifically named facial hair masks (or the other elements of PPE: gowns, shoe covers, hair covers, face masks, gloves, and eye shields). Under Procedure B(2) it documented donning PPE in an order that proceeded from dirtiest to cleanest but it did not name the individual PPE items. Under Procedure B(4) it documented that "Head and facial hair must be covered" but nowhere did it specifically mention facial hair covers by name as a piece of PPE to be donned by staff with facial hair prior to compounding CSPs (except as noted above).

On 12/10/13 at 3 P.M., during an inspection of Hospital A Pharmacy IV Room, the surveyor noted a person compounding in an IV Hood labeled as Hood #1. He identified himself as Pharmacy Technician 72. He was wearing all the PPEs required by USP 797 except a facial hair cover. The surveyor noted that facial hair (a beard) covered Pharmacy Technician's right and left face starting from the hairline in front of both of his ears down both cheeks to the point where a face mask covered the rest of his face. The bottom of the face mask was not tied around the back of his neck. The surveyor noted that the hair covering for the top of his head did not cover all of his hair and some of the lower part of his hair was visible in back between the bottom of the hair cap and his neck. These observations were verified by interview of the HC Inpatient Pharmacy Manager at that time who stated she was not aware of the requirement for the use of a facial hair cover (for staff with beards) in addition to a face mask when compounding CSPs in the IV Room.

On 12/10/13 at 3:24 P.M., during an interview of the HC Inpatient Director of Pharmacy, he stated that the hospital followed the hospital policy regarding IV compounding and the hospital followed USP 797 when it was possible. He stated that facial hair covers were not in the policy and he stated he felt it was possible for the hospital to meet the USP 797 requirement for staff with beards to wear a facial hair cover (in addition to a face mask).

Based on observation, policy review, and staff interview, the facility failed to ensure that medications were administered in a safe and effective manner as evidence by the followings:
1. Nursing staff were trained and ready to handle lifesaving procedures. Two (LN 62 and LN 63) of six nurses did not accurately measure a pediatric dose of medication (epinephrine) used to stimulate the heart and increase the rate and the blood pressure, in an unresponsive patient (code blue). One nurse prepared one tenth of the dose for a hypothetical pediatric code, and the second nurse prepared 10 times the dose. Such failures placed pediatric patients at risk for poor outcomes and reduced the chance of their survival.
Facility staff did not implement their policies and procedures for ensuring readiness of emergency crash cart.
2. They failed to properly check the defibrillator (a device used in emergencies to deliver electric shocks to restart the heart or correct its abnormal rhythm) to ensure it was in a working condition.
3. They failed to verify and document the lock number on the outside of the cart, to ensure that it was intact and ready for use.
4. Fentanyl patch, a potent pain medication delivered through patches applied to the skin, was used in a manner inconsistent with the manufacturer's specifications. The dose was increased too quickly, for Patient 62. The dose of the patch was increased from 100 mcg (micrograms)/hr (hour) to 150 mcg/hr within 24 hours. The patient was not given the time for two applications (6 days) before the increasing the dose.
5. The facility failed to develop policies that were consistent in all type settings. The policy for recalled products in ambulatory care setting included contacting patients if they receive recalled products. The same policy for inpatient setting, did not have similar language to inform patients or their physicians.

Findings:

1. a. On 12/11/13, at about 2:30 P.M., during inspection of the emergency room at Hospital B, a Broselow cart was inspected. Broselow system is a commercial product designed for management of pediatric emergencies. The Broselow tape simplifies determination of medication dosages and equipment sizes used for children by measuring the child length against the tape. The tape has colored zones with information about doses of medications and sizes of equipment. The Broselow cart is color-coded matching the color zones of the tape, which serves as quick guide for clinicians to identifying appropriate doses of medications and location of supplies in the cart. Facility staff LN 62, in presence of Pharm 61 and the ED manager (LN 70) confirmed that the facility receives and treats pediatric (children) patients in the emergency room. The nurse (LN 62) was asked to demonstrate what would be done a pediatric code.
Presented by a hypothetical situation that a pediatric patient, weight unknown was brought to the emergency room, LN 62 correctly used the tape to estimate of the weight of the patient. Referring to tape where the estimated weight was, she was asked to prepare a dose of epinephrine (medication used in code situations to increase blood flow). LN 62 checked the Boselow tape and said that she would prepare 0.1 milligram (mg) of Epinephrine. The nurse had to go to the nursing station and retrieve small syringes to enable her to draw the small dose. The dose the nurse read was correct. The nurse drew 0.1 milliliter (mL). Epinephrine comes in prepackaged formulation for codes at a concentration of 0.1 milligrams in one milliliter. The nurse drew 0.1 mL instead of 1 mL; the drawn amount would have provided 0.01 milligram instead of 0.1 milligram.
The dose of epinephrine that LN 62 have prepared was one tenth (10 times smaller) than the correct dose.
1. b. On 12/11/13, at approximately 3 P.M., LN 63 was asked to perform similar demonstration for a simulated pediatric emergency. The nurse successfully used the Broselow tape to estimate the weight of the hypothetical patient. The nurse was asked to draw the dose of epinephrine for a hypothetical 10-kilogram patient. The nurse checked the tape, read the dose listed on top of the tape, and asked if she was expected to proceed for actually preparing the dose. When she was told to do so, she opened the box containing epinephrine, looked at it and said that this is the dose. She clarified that she would give the whole vial "the dose is one; I would give the whole vial."
The "vial" is the barrel of the syringe and it contained 10 milliliter (1 milligram) of epinephrine. The one-milligram dose would be 10 times the dose for that hypothetical patient.
Both nurses that were asked for the demonstrations confirmed on interview that the hospital runs practice codes (mock codes). When LN 63 was asked if they draw up the medication during the code, she said that they did not. They just "pretended."
The nurses did not draw, quickly or accurately, the dose for a specific patient (according to weight). Considering the importance of time in a code situation, every second counts. Any delays jeopardize the chance of reviving the patient. The nurses were not able to identify correct doses of medications, which depended on the concentration such as epinephrine. Giving 10 times less than the needed dose result in treatment failure: failure to revive the patient and giving 10 times the dose of epinephrine (overdose) could also be lethal: irregular heartbeat or bleeding in the brain.
2. On 12/10/13 at approximately 3 P.M. at Hospital B, the crash cart in the radiology department was inspected in the presence of the facility pharmacist (Pharm 61). The facility had a system in place to check the emergency cart (which contains medications and equipment used in emergencies such as reviving patients when they become unresponsive and stop breathing). The emergency cart checklist included directions to staff on what to ensure that the cart and its contents were intact and ready for use.
The form included directions to check the crash cart daily. The daily check included the following: "battery in defibrillator and back-up batteries in battery changing station are fully charged (solid green light) and plugged in ... Self -test and cable check must be performed with defibrillator unplugged from the wall. Confirm that there is paper properly loaded in the defibrillator." Defibrillator is a device used in emergencies to deliver electric shocks to restart the heart or correct its abnormal rhythm.
On 12/10/13 at approximately 3 P.M., in the presence, of Pharm 61, radiology technician staff, (FS 64) was asked to demonstrate how to check the defibrillator. FS 64 indicated that she was not familiar with the process. Three other technician staff from radiology was present at that time and was asked to demonstrate if they knew how, but none did. FS 64 without unplugging the device from the power source turn the defibrillator, and without modifying the setting (amount of electricity to be delivered) proceeded to discharge. She was asked to turn off the device. A fifth radiological technician (FS 65) came hurriedly and did the demonstration. He stated that he was in a hurry because he had a patient in the other room.
3. On 12/10/13 at approximately 3 P.M. at Hospital B, the crash cart in the radiology department was inspected in the presence of the facility pharmacist (Pharm 61). The facility had a system in place to check the emergency cart. The emergency cart check list included directions to staff on what to do and had designated spaces to document the lock number verifying that the cart was intact and contained the medications and equipment listed.
The form included directions to "Sign name indicating that contents on exterior of the cart were checked, not expired, and complete. All medication trays/sections of carts/kits must be sealed, and locked with a blue lock by a pharmacist. Please write each applicable lock number next to the nurse signature."
It was observed that the number of the lock on the crash cart did not match the lock number documented on the sheet. The observation was confirmed with Pharm 61.
The facility's policy MCP 3.1 titled, "Code Blue - Adult/Pediatric" dated June 20, 2013, was reviewed. The policy included the followings: "Confirmation and documentation of blue lock number on the Code Blue Cart. If the lock number does not match or the cart is expired, Central Services must be called for a replacement cart."
A hospital management staff, DON (Director of Nursing), brought documentation indicating that expired medications were removed from the crash cart, on 12/6/13, and the lock was changed that day. However, radiology staff continued to write the previous lock number. There was no evidence of contacting Central Services, as the lock did not match for four days.

4. On 12/11/13 approximately at 9 A.M. at Hospital B, the record for Patient 62 was reviewed with facility staff (Pharm 61). The record revealed a 64-year-old patient was admitted, on 11/28/13, with history of chronic pain. Patient 62 was receiving fentanyl patch (opioid type medication, that in a patch form which is applied to the skin).
The fentanyl patch, also known as fentanyl transdermal system, contained fentanyl, a potent synthetic opioid medication used to treat pain. This medication has a boxed warning which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for the fentanyl patch documents that it has potentially fatal respiratory depression.
The package insert included caution for using this medication in the elderly, as they may be more sensitive to adverse effects.
In addition, for dose titration, the package insert included that the dosage should not be titrated more frequently than every 3 days after the initial dose or every 6 days thereafter. Patients should wear a consistent fentanyl dosage through two applications (6 days) before dosage increase based on supplemental opiate dosages can be estimated.
Review of the record with Pharm 61 revealed that Patient 62 was admitted on fentanyl patch, on 11/29/13, at 75 microgram per hour. The dose was increased to 100 mcg/hr (micrograms per hour) on 12/1/13. On 12/2/13, an order was written to increase the fentanyl dose to 150 mcg/hr.
The increase of the dose was inconsistent with the labeling instruction for fentanyl patch. The dose was increased within about 24 hours from 100 to 150. Patient 62 was not allowed two applications (6 days) before the dose was increased. Pharm 61 stated on interview on 12/11/13 that palliative care team was consulted on this patient and the dose was increased based on their recommendation. Review of the pharmacist intervention notes, revealed no documentation that the increase in dose was questioned or justified.

5. On 12/13/13 at approximately 10:00 A.M., the facility process for handling recalled medications was evaluated. Pharm 66 explained the process and presented the facility policy "Drug Recall" revision date, 9-13-13.
Review of the policy revealed the procedure for "Class I Recall of Medication Dispensed to Ambulatory Patients." The procedure included the followings:
"...3. Contact the prescriber and consult with him/her on appropriate course of follow- up action ...
4. If deemed appropriate, contact the patient to inform him/her about the recall and about the recommended course of action. ..."
The policy did not include similar procedures for inpatient settings. The "Class I Recall Process" included steps to identifying where the recalled product was located or distributed, steps on how to collect and return the product. The policy did not include any directions for identifying patients that may have received the recalled products. Additionally, there were no directions for contacting the prescriber or the patient in case of exposure.

Based on inspection of two of two medication rooms in the Emergency Department (ED) and staff interview, the hospital failed to ensure one out of the two rooms (Medication Room #2) was secured: the nursing station that housed Medication Room #2 was not occupied by staff and the door to Medication Room #2 was unlocked. Medication Room #2 contained intravenous (IV) solutions and topical disinfectant and antiseptic compounds and medications in unlocked cabinets.

Findings:

On 12/12/13 at 9:01 A.M., an inspection of the ED Medication Room #2 indicated that the door to the medication room was not locked. The nursing station was not staffed as there were no patients in that area of the ED.

a. Inspection of the medication room indicated that it contained several IV bags, used for fluid replacement as ordered by a physician, in an unlocked cabinet as follows:

Two 1000 ml IV bags of normal saline (NS: 0.9% sodium chloride solution)

Two 1000ml IV bags of 0.45% NS

Two 1000 ml IV bags of Lactated Ringers (LR)

Two 1000ml IV bags of 5% dextrose (D5) 1/2 NS

Two 1000ml IV bags of D5/LR

One 1000ml IV bag of D5/ 1/2 NS with 20 milliequivalents of potassium chloride (potassium chloride is a salt found mainly inside cells and needs to be replenished daily)

Three 500 ml IV bags of NS

Three 250 ml IV bags of NS

One 250 ml IV bag of 5% dextrose in Water

Two 100 ml IV piggyback bags (used to infuse other medications added to the bag) of NS

One 50 ml IV piggyback bag of NS

b. The room also had an unlocked cabinet that contained the following compounds and medications:

Seven 16 ounce bottles of povidone/iodine (a topical disinfectant)

Two 16 ounce bottles of 70% isopropyl alcohol (a topical disinfectant)

One 16 ounce bottle of 3% hydrogen peroxide (a topical antiseptic medication)

The above observations were verified by interview of the HC Inpatient Director of Pharmacy who stated these compounds and medications were in the active stock of this medication room.

Based on inspection of two of two medication rooms (Medication Rooms #1 and #2) in the Emergency Department (ED) and staff interview, the hospital failed to ensure that expired or otherwise unusable intravenous (IV) solutions and disinfecting agents were available for patient use in each of these rooms.

Findings:

1. On 12/12/13 at 9:01 A.M., an inspection of the ED Medication Room #2 indicated that:

a. One out of 22 IV solutions stored in that room had expired. One 1000 ml IV bag of 5% dextrose in 0.45% sodium chloride had a manufacturer's expiration date of 11/13 printed on the bag (it had expired 12 days previously).

b. Two out of two bottles of 70% isopropyl alcohol (a topical disinfectant) were expired or otherwise unusable: one bottle of isopropyl alcohol had a manufacturer's expiration date of 09/13 printed on the bottle (it had expired 2? months earlier) and the second bottle of isopropyl alcohol had an unreadable expiration date so staff would not be able to determine when the bottle expired. This rendered this topical disinfecting agent unusable.

These observations were verified by interview at that time of the Inpatient Director of Pharmacy and stated that these items were among the active stock in the medication room.

2. On 12/12/13 at 9:35 A.M,. an inspection of Medication Room #1 indicated that one 50 ml IV piggyback bag of NS out of a total of 14 such bags had a torn overwrap. These IV bags had overwraps provided by the manufacturer to prevent excessive water evaporation through the plastic wall of the IV bags. As long as the overwrap remained intact and the solution was stored under conditions specified by the manufacturer, these solutions would remain good for use until the printed expiration date on the label. The manufacturer of these IV bags, Manufacturer B, had documented in a letter available to providers upon request that once the overwrap on 50 ml IV solutions was compromised the solution has a beyond use date of 15 days.

This observation of the compromised overwrap was verified by interview at that time of the Inpatient Director of Pharmacy and the Inpatient Pharmacy Manager.

Based on review of a hospital policy and procedure and interview of two inpatient pharmacy managers the hospital failed to create a process that would result in discontinuation of medications in a patient medication profiles after a reasonable period of time as determined by the medical staff of the hospital. Only two medications, Ketorolac (used to treat pain and for which the manufacturer documents in a boxed warning that the medication should not be used longer than five days secondary to potential serious side effects) and Alvimopan (used to accelerate recovery of intestinal function following bowel surgery but which as a boxed warning recommending limiting use to 15 doses) had hard stops and both drugs had boxed warnings (the most serious warning required by the Food and Drug Administration [FDA] to be placed in FDA approved product labeling in regards to situations or side effects that could result in serious injury or death). Neither of these medications were mentioned in the policies regarding stopping medications.

Findings:

On 12/12/13 a review of Policy and Procedure MCP 321.3 entitled Patient Treatment and Medication (Original approved date: 5/17/83, Revised 2/6/13) indicated Procedure A(9) stipulated: "Authorizing provider responsibilities [include]: Respond to 'Review/Expiring Order' alerts by reviewing, discontinuing and updating orders". Procedure E(7) stipulated: "Automatic review for medication orders: If not specified or limited otherwise, orders will be flagged for review in 30 days except: orders for antimicrobials will be flagged for review after 14 days."

On 12/12/13 at 3:27 P.M., during an interview of Hospital A's Inpatient Assistant Director of Pharmacy, she stated that there had been no automatic stop order policy since the EPIC medical information system had been implanted at the hospital. She stated that there was no hard stop for medications used in the hospital except for Ketoralac to which the hospital assigned a five day stop date and Alvimopan to which the hospital assigned a three day stop date. She stated that narcotics did not have a hard stop.

With respect to Policy and Procedure MCP 321.3: Procedure E(7) both the Inpatient Pharmacy Manager and the Assistant Director of Pharmacy stated that the hospital had not created a process for pharmacists to check to see if physicians had acted on the orders flagged for review. They stated if physicians did not act on these orders the orders would continue on as active orders in a given patient's medication profile.

Based on observation, interview and record review, the Food Service Director at Hospital A failed to ensure that potentially hazardous food was dated, and cooled down, in accordance with hospital policy to ensure food safety.
Findings:
On 12/9/13 at 9:20 A.M., in the walk- in refrigerator in the kitchen were two full-sized pans of cooked "rice & peas;12/9/13 - 12/14/13", per the label on the pan.
Inside the same walk-in refrigerator which dietary staff referred to as the "Food Bank", were two full-sized pans of cooked bow tie pasta, dated "12/5 - 12/10."
The Executive Chef verified that two rice and peas and bow tie pasta was previously cooked in the hospital's kitchen. The Executive Chef said the above items should have been cooled-down, and should be on a cool-down log.
At that time, the Executive Chef reviewed the cool down logs and said that the bow tie pasta was not documented on the cool down log, per hospital policy.
The Executive Chef said that the rice and peas were not cooked on 12/9/13, and said that was cooked on 12/5/13, and he had not known why the item was dated as being cooked on 12/9/13.
The Executive Chef, and Cook 1, said that after the food was cooked, the food would be given to a food service worker who was responsible to cool down the food via a blast chiller.
On 12/9/13 at 9:44 A.M., a food service worker (FSW 32) said that he checked that morning to make sure all the food items were dated. He said the rice & peas did not have a label with a food product name or date, so he just randomly made a label up with a random date of 12/9/13. FSW 32 verified that he had not cooled down the rice & peas on 12/9/13, and per the Executive Chef the food item was actually rice & beans.
According to the direction located on the blast chiller temperature log [cool-down log], "All cooked Foods that are not immediately served will be cooled in accordance with temperature/time limits listed below. Cooling/time safe range for Food items: Under 70 degrees within 2 hours & 40 degrees or under with an additional 4 hours for a total of 6 hours ... "
The hospital's policy and procedure entitled Food Production (Policy 4.4, Effective Date: December 1, 2010) indicated, "Chilling- To maintain peak product quality in terms of appearance, texture, aroma, taste and microbiological control, hot foods are placed in a blast-chiller as quickly as possible after removal from the ovens, broilers or tilt fry pans. The temperature zone where most microbial growth occurs is 140 degrees F to 40 degrees F. It is necessary to bring the center mass of all food through this "danger zone" in no more than a total of six hours. At the end of the first two hours the temperature is required to be 70 degrees or below. At the end of the four-hour period the temperature is required to be below 41 degrees, for a total cool down time not to exceed 6 hours. Any foods items not meeting the requirement will be discarded. Once the temperature falls below 40 degrees F, the rate of growth is slowed considerably for the majority of pathogenic organisms."

Based on interview and record review, Hospital A failed to ensure that a Registerd Dietitian completed a comprehensive nutrition assessment as it related to fluid assessment for 1 of 56 sampled patients (37) receiving tube feeding. Hospital A failed to ensure that the Food and Nutrition Department policies and procedures governing services provided incorporated the Neuropsychiatry Behavioral Medicine Unit, and the Senior Behavioral Unit. The hospital had not developed a system for dietetic services to obtain patient food preferences for each patient in order to implement hospital policy.
Findings:
1. On 12/9/13 at 3:08 P.M., Patient 37's medical record was reviewed. Patient 37 was admitted to Hospital A on 12/5/13.
On 12/6/13 a physician ordered "Diet Tube Feeding 24 hours Glucerna 1.2."
On 12/6/13, a Registered Dietitian (RD) completed a "Clinical Nutrition Initial Assessment" for Patient 37. Per the RD note the tube feeding prescription of Glucerna 1.2 @ 65 ml [milliliter]/hr x 24 hours provided 1, 872 calories, 94 grams of protein and 1, 256 ml of free water (the amount of formula content that is water).
On the same note the RD assessed Patient 37's fluid needs to be 1,613 - 1,935 ml/day. The RD noted, "Pt's mother confirms receiving additional free- H2O." There was no further assessment by the RD to determine other sources of fluid the patient was receiving, and the quantity in order to complete the nutrition assessment to determine if the patient was receiving adequate fluids as compared to the assessed fluid needs.
On 12/9/3 at 3:15 P.M., the RD (RD 38) who completed the above initial nutrition assessment was interviewed. RD 38 verified that she had not determined the quantity of other sources of fluid that Patient 38 may have received, and had not completed a comprehensive nutrition assessment as it related to Patient 37's assessed fluid needs.
RD 38 said, "I remember that I did see free water hanging, but I do not know how much the patient was receiving."
The Clinical Nutrition Manager (CNM) was present for the above record review, and interview with RD 38, and said, "I would expect the fluid deficit [that was noted in the nutrition assessment] to be addressed."
During the same interview, RD 38 was asked where she would obtain information from Patient 37's medical record on quantity of water flush being provided by nursing via the feeding tube. RD 38 said, "I think nurse's put it on the intake/output screen on the line titled "TF Total Rate/Vol - Inake (ml)." RD 38 could not explain how she would know how much of the total volume was actually tube feeding infusion with calories and protein, versus free water with that method of documentation of water flush.
On 12/9/13 at 3:56 P.M., LN 39 was the nurse assigned to Patient 37, at the time of the interview. LN 39 said that she could provide 30 cc (cubic centimeter) of free water before and after medication, and said, "I will do that twice per my shift." LN 39 also said that Patient 37 was receiving free water that was hanging at 30 ml every 4 hours. LN 39 said there was not a physician's order for the above free water because it was per a "tube feeding protocol."
LN 39 said that she would document the above free water on the intake and output screen on the line titled "TF Total Rate/Vol - Inake (ml)." LN 39 asked another nurse if that was correct, and that nurse said, "I would document the free water on the additional intake line." The nurse manager of the 10 east unit was asked where nurses were to document free water flush given via the feeding tube, and she shrugged her shoulders indicating that she was unsure.
LN 39 reviewed the input and output (I & O) monitoring for Patient 37, which was ordered by the physician on 12/5/13, and verified that there was lacking complete I & O documentation since ordered.
The CNM was present for the above interviews and acknowledged that there seemed to be a disconnect between the "tube feeding protocol", and the RD's knowledge of this protocol as it related to the RDs assessment of fluid status. In addition, there were inconsistencies on how and where a nurse would document free water flush being given. This would impede the ability of an RD to obtain complete and accurate fluid intake for a patient as it related to fluid assessment, which was a compenent of a nutrition assessment.
The hospital's policy and procedure entitled Nutritional Assessment (Policy 14.10, review date: 10/2013) indicated, "Purpose: To define the process for documentation of a Nutritional Assessment in the medical record ..., Patients with orders for EN [enteral nutrition] will receive an assessment by the Registered Dietitian ..., The following parameters are considered as part of the nutrition assessment: Assessment and Monitoring Parameters; Fluid, energy, protein, micronutrient provision, estimated requirements; percent of requirements met, recommendations to achieve goals ...,evaluation of actual intake ..."
2. On 12/11/13 at 1:38 P.M., Patient 32's medical record was reviewed. Patient 32 was admitted to the Neuropsychiatry Behavioral Medicine Unit (NBMU) on 12/7/13 for depression per the Facesheet. Patient 32 also had leukemia that was in remission per the history and physical.
According to Patient 32's nutrition care plan as of 12/1213, "Patient hasn't been eating or drinking well."
On 12/8/13 a physician ordered Beneprotein (protein powder) 2 times daily, per physician's orders.
The Clinical Nutrition Manager (CNM) reviewed Patient 32's medical record and said that the physician had not ordered a pre-albumin, or albumin level.
On 12/10/13, a physician ordered Ensure Plus 3 times daily before meals.
Patient 32's nutrition care plan developed by a registered nurse included the following;
1. Assess nutritional history and review food allergies within 24-hrs, 2. Request consult if needed (under detail was listed -dietician, pharmacist, diabetic educator, speech therapist, 3. Evaluate weight, weight-loss/gain ..., 5. Assess nutrient losses ....
The CNM was asked how the food and nutrition department was involved in the nutritional care of this patient. The CNM said that the regular diet and supplements ordered were provided by the food and nutrition department, but if there was not a nutrition consult ordered, then there would be no further involvement from the food and nutrition department. Other than 8:00 P.M. snacks that are delivered to the unit for nursing to offer to patients, as appropriate. The CNM confirmed that a nutrition consult had not been ordered for Patient 32.
The CNM was asked if Patient 32's nutritional intake was meeting her needs, and the CNM acknowledged that there had not been a nutrition assessment completed to determine if her needs were met, even though the interdisciplinary team had identified that the patient was not "eating or drinking well." According to a cencus list provided by the CNM, Patient 32 was 5 '2 ",and 105 pounds at time of admission.
In addition, LN 34 and the Nurse Psychiatric Manager (NPM) verified that there was no documentation that Beneprotein had been provided 2 times daily since ordered on 12/8/13.
The CNM was asked if dietary staff had obtained Patient 32's food preferences, and he said, "No." The CNM repeated that the food and nutrition department only had involvement with the Patient's nutritional care in the NBMU if there was a nutrition consult ordered.
The CNM said he spoke with the clinical Dietitians and they acknowledged they rarely received nutrition consult orders to assess the nutritional status of a patient located in the NBMU.
According to the hospital' policy and procedure entitled Nutritional Assessment (Policy 14.10, reviewed 10/2013) included a Nutrition Services Nutritional Prioritization Schedule that assisted the RD's, and the dietetic technician, registered staff on when to perform nutritional related services. However, according to the CNM the policy and services applied to all patients admitted to the hospital, except for the Neuropsychiatry Behavioral Medicine Unit, and the Senior Behavioral Unit.
On 12/12/13 at 2:54 P.M., the Medical Director said that the above policy and nutrition services should apply in the same manner with the patients that were located at the Neuropsychiatry Behavioral Medicine Unit, and the Senior Behavioral Unit as it had to other patients admitted to the hospital.
In addition, the hospital's policy and procedure entitled Menu Heading, Distribution and Collection (Policy 5.6) indicated, "If patients are unable to fill out menus themselves, the Tray Passer and/or the Dietitian will help patients with menus or they will be completed by CBORD (a software program used by the food and nutrition department) menu modification system considering patients' food preferences, dietary restrictions ... "
On 12/11/13 at 3:40 P.M., the Patient Services Manager at Hospital A reviewed the food prefernce area that was located in CBORD and 11 of 11 patient's reviewed had blank information under the category of food preferences in CBORD.
On 12/11/13 at 3:40 P.M., the Patient Services Manager at Hospital A verified that there was not a system in place for dietary staff to obtain each patients food likes and dislikes, as appropriate, not only in the Neuropsychiatry Behavioral Medicine Unit, and the Senior Behavioral Unit, but hospital-wide.
The CNM verified that the hospital's dietary staff had not had a system in place to obtain patient food preferences, if there was not a nutrition consult ordered for the Neuropsychiatry Behavioral Medicine Unit, and the Senior Behavioral Unit, and hospital-wide.
During the same interview, the CNM clarified that the PADB (Patient Assessment Data Base completed by nursing staff) had an area for nursing to screen and obtain overall preference for diet type. The question on the PADB indicated, "Do you have any dietary preferences we should know about (ie. Vegetarian, kosher, vegan, etc.)? " However, the CNM was unable to establish that the question included food preferences in terms of likes and dislikes for the majority of patients admitted to the hospital.
The hospital's document entitled Best Practice Guidelines for Gastrointestinal (last reviewed 8/2013), page 3, clarified the screening question on the PADB was to capture "Cultural and/or spiritual preferences are assessed and documented on the PADB." The CNM was able to show patient response examples in which the question on the PADB captured whether a patient preferred vegetarian, kosher, or no pork products, to assist the physician in ordering a correct diet type.
The hospital had not developed a system to ensure the same nutrition services would be applied to all patients admitted to the hospital, and had not developed a system to obtain patient food preferences to include food likes and dislikes.

Based on observation, interview and record review, Hospital A and Hospital B failed to ensure that a therapeutic diet, 80 gram protein renal diet, was served in accordance with the planned menu that was developed to be in accordance with the physician's therapeutic diet order, for 1 of 44 sampled patients (31). In addition, the hospital failed to document that nutritional supplements were provided to 2 of 44 sampled patients (2, 41) as ordered by the practitioner responsible for the care of the patient. Failure to give patients ordered diets and nutritional supplements could negatively impact the nutritional status of medically fragile patients.

Findings:

1. On 12/9/13 at 10:30 A.M., lunch preparation tray line was observed.
The dietary staff preparing the patients lunches used a spreadsheet that indicated food item and quantity to provide for regular and therapeutic diets. The spreadsheet indicated that 5 oz (ounce) of grilled chicken should be served for a therapeutic diet order of "Renal 80 (a special diet for kidney disease with 80 grams of protein daily)."
Patient 31's lunch meal tray ticket indicated, "Diet: Renal Dialysis (the process of removing waste products and excess fluid from the body) 80 Pro". A food service worker (FSW 33) placed a piece of grilled chicken on the plate. The piece of chicken did not appear to be 5 ounces (oz).
A dietary employee weighed the piece of grilled chicken from Patient 31's lunch tray and it was 3.2 ounces, observed by the Executive Chef (EC), and the Food Service Director (FSD). The FSD and the EC confirmed that all of the grilled pieces of chicken that were on the tray line were about 3 oz of protein.
The FSD acknowledged that the spreadsheet should have been followed, as it was based on the therapeutic diet order and nutrient analysis to ensure that an 80 gram protein renal diet was provided in accordance with the physician's order for lunch on that day.
On 12/10/13 at 11:00 A.M., lunch tray line observation was conducted at Hospital B. Hospital B's patient menus for that day were the same patient menus that were served at Hospital A the day before, on 12/9/13. The FSD verified that patients on a 80 gram protein renal diet were being served approximately 3 oz. of protein, instead of the planned 5 oz of protein, just as it occurred at Hospital A.
Per the hospital's Definitions of Hospital-Specific Diet Order Regimens (Policy 14.8), "Renal dialysis (80 gm protein, 2 gm sodium, 2 gm potassium, low phosphorous) Indications: For patients with impaired renal function requiring hemodialysis (a procedure for removing metabolic waste products or toxic substances from the bloodstream by dialysis)."
The hospital's policy and procedure entitled Food Production (Policy 4.3, reviewed 2/1/11) indicated, "Policy: To meet dietary requirements through proper food production. Purpose: To insure proper menu planning that will achieve the nutrition and cultural needs of the patients ..., products will be based on menu requirements ..., serve foods with appropriate utensils in proper quantity ..."
2. On 12/11/13 at 1:38 P.M., Patient 32's medical record was reviewed. Patient 32 was admitted to the Neuropsychiatry Behavioral Medicine Unit (NBMU) on 12/7/13 for depression per the Facesheet.
On 12/8/13, a physician ordered Beneprotein (protein powder) 2 times daily, per physician's orders.
On 12/11/13 at 2:25 P.M., licensed nurse (LN) 34 reviewed Patient 32's physician's orders and was asked to show where the Beneprotein was documented as being provided to Patient 32. LN 34 said that there was no documentation in Patient 32's medical record that the Beneprotein had been provided. LN 34 said that it should have been documented on the "Doc Flowsheets" under a category of "Dietary Supplements", and sub-category of "Diet Supplements."
During the same interview, the Nurse Psychiatric Manager (NPM) verified that there was a physician's order for Beneprotein ordered in the evening on 12/8/13.
The NPM reviewed various locations in Patient 32's medical record, including nurse's progress notes, nutrition care plan and doc flowsheets, and verified that there was no documentation that Beneprotein had been provided 2 times daily since ordered on 12/8/13.
According to the hospital's policy and procedure entitled Patient Treatment and Medication Orders (MCP 321.3), Effective/February 6, 2013, "B. Nursing Service Responsibilities; 1. Review each patient record each shift to see that all orders are appropriately recorded..."



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3. A tour of Hospital A's 11 West nursing unit was conducted with the nurse manager (NM) 1 on 12/9/13 at 10:05 A.M. Patient 1 was observed lying in bed. The patient was not interviewable.

Patient 1's medical record was reviewed on 12/9/13 at 10:30 A.M. Patient 1 was admitted to Hospital A on 12/4/13 with diagnoses that included cirrhosis of the liver (characterized by replacement of liver tissue by scar tissue) per the History and Physical, dated 12/4/13. Per the same report, the patient's albumin level (the most abundant protein in human blood plasma) was 3.1 (normal range was at 3.5 - 5.2 g/dL [grams per deciliter]).

A review of the physician's order sheet indicated that, on 12/7/13 at 6:56 P.M., an order was written to give Patient 1 Beneprotein (nutritional supplement) three times a day. The physician's order also indicated that the Beneprotein was to be given to the patient starting 12/8/13 at 7:00 A.M.

A review of the Clinical Nutrition Screen, dated 12/7/13, indicated that Patient 1's albumin level was 3.3 g/dL.

A review of Patient 1's flowsheet, dated 12/8/13, showed no documented evidence that the ordered Beneprotein was given to the patient in the morning and at noon. The "Diet Supplements" section of the flowsheet was blank from 4:49 A.M. until 3:19 P.M. on 12/8/13.

A joint record review and interview with registered nurse (RN) 2 was conducted on 12/9/13 at 11:45 A.M. RN 2 acknowledged that there was no documented evidence that Patient 1 was given the ordered Beneprotein in the morning and at noon on 12/8/13.

According to the hospital's policy and procedure entitled Patient Treatment and Medication Orders (MCP 321.3), Effective/February 6, 2013, "B. Nursing Service Responsibilities; 1. Review each patient record each shift to see that all orders are appropriately recorded..." This policy was not followed when there was no documented evidence to demonstrate that the Beneprotein was administered to Patient 1 in accordance with the physician's order.

The lack of documentation pertaining to the administration of the supplement made it difficult to determine if: 1)Patient 1's supplement was not administered by the staff; 2) the patient refused the supplement; or 3) the nurses failed to document the supplement administration.













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Based on observation, interview, and record review, the hospital failed to provide Standards of infection Control when the facility failed to provide Infection Control policies specific to a department, service, and location in regard to the use of Multi-dose vials. Including when the facility failed to evaluate, revise and/ or create policies related to the Multi-dose vials used in patient rooms when accessing bar coding procedure that required the healthcare staff to bring the Multi-dose vial into the patient room. The lack of a written policy and procedure related to the use of a Multi-dose vial resulted in inconsistent practices by the healthcare staff. The facility failed to adhere to nationally recognized standards of infection control, such as current CDC guidelines and recommendations regarding the accessing of Multi-dose vials in patient rooms.

Findings:
1. On 12/11/13 located on the 6th floor of Hospital A at 10:30 A.M. in concurrent interviews registered nurse (RN) 81 and Infection Preventionist (IPII) 1 indicated that it was hospital policy for Multi-dose vials to be brought into the patient room by medical staff to utilize the barcode to be scanned (to ensure correct medication is used) at patient bedside and then drawn up for administration. The medication vial is then cleaned and returned to the medication dispenser (Pyxis).

On 12/11/13 at 10:45 A.M., RN 81 was observed to demonstrate administration of insulin to the patient in room 608. The RN retrieved a vial of insulin from the Pyxis using the patient's identification information. When the RN carried the multiple dose vial to the door of room 608, He stated, "the next step is to take the medication into the patient's room and scan the barcode with the patient's wrist band to ensure correct medication is used." The RN indicated when at the bedside and after scanning was completed, the RN draws up the medication for administration. The RN simulated using a "Cavi 1" disinfectant cloth to clean the vial. He then placed the vial back into the Pyxis. This concluded the demonstration.

The IPII 1 indicated the RN 81 was correct in his demonstration of the administration of medication in multi-dose vials. The IPII 1 indicated alcohol would be used to clean the vial top. IPII 1 stated, "They have to wipe it down. That is all we can control."

During the demonstration provided by RN 81, on 12/11/13 at 10:45 A.M., the observation revealed the patient in room 608 was on contact precautions acknowledged by RN 81 reading the signs placed on the outside of the patient's room. The IPII 1 looked up the patient number on her list of isolation patients and confirmed the patient was on contact precautions for VRE. Both IPII 1 and RN 81 stated the policy for taking multi-dose vials into a patient room was the same for all patients including the isolation patient. Both confirmed cleaning the vial was all that was needed to place the vial back into dispenser for the use of the next patient.

In concurrent interviews on 12/12/2013 at 11:00 A.M., Infection Preventionist Director (IPD) 1, IPIIl 1 and IPII 1 stated that multi-dose vials were not provided for patient specific use in the facility. IPD 1 indicated that they did not have a policy specifically addressing the use of multi-dose vials being accessed in patient care areas or a policy regarding multi-dose vial use in any capacity other than recognized as patient equipment. IPD 1 stated that she felt the policies regarding patient equipment were sufficient to address the needs of staff regarding multi-dose vial use.

A review of policy and procedures on 12/12/2013 at 11:00 A.M. produced by IPD 1 revealed two policies and procedures: The first was titled, "Cleaning- Routine Cleaning of all Patient Care Equipment" and the second was titled, "Disinfecting and Sterilization Guidelines of Patient Care Equipment, Instruments and Environment". Neither of the policies was applicable to the administration of a medicine from a multi-dose vial. The facility failed to provide a policy and procedure for the use of Multi-dose medicine vials.

In a concurrent interview on 12/12/2013 at 11:00 A.M., IPD 1 stated, the hospital followed the CDC (Center for Disease Control and Prevention) and APIC (Association for Professionals in Infection Control and Epidemiology) as the National Recognized Standard. The practice of accessing multi-dose vials (used for multiple patients) in immediate patient treatment area was in contradiction to the CDC guidelines Titled, "Multi-dose vials-Safe Practices for Medical Injections FAQ ...Questions about Multi-dose vials". APIC, throughout the standards discouraged Multi-dose vial use.

A review of National Recognized Standards, including the hospital's self-identified CDC Standard followed by the hospital revealed, CDC 2013 website www.cdc.org ,conducted on 12/10/2013 at 9:00 A.M., indicated "Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should not be kept or accessed in the immediate patient treatment area. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters the immediate patient treatment area, it should be dedicated to that patient only and discarded after use."



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2. During a tour of the burn step down unit at Hospital A on 12/12/13 at 11:00 A.M., an interview was conducted with registered nurse (RN) 21. She stated that if a patient required a medication from a multi-dose vial that the vial would be brought to the patient room to have the barcode scanned at the bedside. She stated that this vial would be placed in a clean bag and kept in a drawer at the patient bedside and only used for that patient.
During a tour of the cardiac outpatient clinic at Hospital B on 12/16/13 at 10:30 A.M., An interview with RN 22 was conducted. She stated that if a patient required a medication from a multi-dose vial that the medication would be drawn up into a syringe that was labeled and then that syringe would be administered to the patient. She stated that the multi-dose vial did not leave the medication room.
During a tour of the post-transplant unit at Hospital B on 12/16/13 at 11:00 A.M., an interview was conducted with RN 23. She stated that if a patient required a medication from a multi-dose vial that the vial would be brought to the patient room to have the barcode scanned at the bedside. She stated that the multi-dose medication vial would then be wiped with alcohol and then returned to the Pyxis (a medication storage device).
A policy and procedure pertaining to the hospital's use of multi-dose vials was requested. However, the hospital did not have a written policy that addressed the use of multi-dose vials. The lack of a written policy and procedure related to multi-dose vials resulted in inconsistent practices amongst the healthcare staff.

Based on observation, interview and record review, Hospital B failed to ensure that a food grade safe chemical was used inside of one microwave located in a nourishment room. Hospital B failed to ensure that there was a clear delineation on who would be responsible for cleaning of the microwaves in nourishment rooms. The failure to use food grade safe cleaners in microwaves had the potential to contaminate the food items that would be placed in them.
Findings:
On 12/10/13 at 3:00 P.M., the nourishment room located at 3A of the cardiovascular unit, was observed. There was a refrigerator and microwave available that hospital staff could use for patient needs. Dietary staff 35 (DS 35) said that dietary staff was responsible for cleaning of the refrigerator only, and that housekeeping was responsible for cleaning the microwave.
On 12/10/13 at 3:05 P.M., Custodian (C36) was located in front of a patient's room and was standing by the utility cart that contained the housekeeping supplies. C36 was asked what she was responsible to clean inside of the nourishment room. C36 listed the microwave, along with other items such as the floor.
C36 was asked how she cleaned the microwave, and what products she used. C36 held up a spray bottle that was labeled "Emerel", and said that she used that to spray on the plate of the microwave. There was no indication on the label from the manufacturer that a food contact surface was an indication for the product's use.
On 12/12/13 at 10:55 A.M., via telephone interview, a representative from the manufacturer of the product Emerel said that the cleaner was not food grade, and was not appropriate for use to clean inside of a microwave.
On 12/12/13 at 11:48 P.M., the Director of Environmental Services (EVS) said that the custodian should not be cleaning the microwave because it was not the responsibility of EVS.
On 12/12/13 at 1:15 P.M., the Assistant Director (AD) at Hospital A said that it was the Food and Nutrition Department's responsibility to assign a dietary employee to clean the microwaves in the nourishment rooms for Hospital A and Hospital B.
The AD provided a policy entitled Cleaning - Routine Cleaning of All Patient Care Equipment (reviewed 9/13) that indicated, "Patient/Pantry Refrigerators (Nutrition Services)." The AD acknowledged that the policy was not clear on who had the responsibility to clean the microwaves in the nourishment room, as microwaves were not listed in the policy.
On 12/12/13 at 1:26 P.M., DS 35 who had recently had an interim role as the AD at Hospital B said that it was her understanding that dietary staff were to clean the refrigerators in the nourishment rooms, and not the microwaves.
The hospital had not provided clear communication to hospital staff as to who was responsible to ensure the microwaves were cleaned, and the appropriate cleaner/sanitizer to use, to ensure infection control practices were maintained.