HospitalInspections.org

Based on observations, staff interviews and document review, the facility failed to maintain patient privacy when unattended electronic medical records (computer screens) with patient information were observed at the nurses' station unattended on 4/8/13.

Findings:

During an Initial Tour of the Progressive Care Unit on 4/8/13 at 9:30 a.m., a computer screen at the nurses' station with a patient's name and clinical information was visible to the public.

In a concurrent interview with the Risk Manager (RMR), when asked if it was appropriate for the computer screen to be open to patient information and unattended, the RMR responded, "No, the person should have signed off". The RMR was observed closing the screen and logging off.

On 4/8/13 at 4 p.m. an observation was made of the nurses' station on the Progressive Care Unit. The electronic medical record was open to a patient's Medication Administration Record. The computer was observed to be unattended and visible to the public.

Review of a 6/12/12 facility policy titled "Patient's Rights and Responsibilities" stated: "You have a right to confidential treatment of all communications and records pertaining to your care and stay in the hospital".
According to website "http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities /index.html", "individuals, organizations, and agencies that meet the definition of a covered entity under Health Insurance Information Portability and Accountability Act (HIPAA) must comply with the Rules' requirements to protect the privacy and security of health information and must provide individuals with certain rights with respect to their health information".

Based on staff interview and document review, the medical staff failed to comply with bylaws criteria for granting clinical tasks (privileges) when procedural sedation and core emergency medicine privileges were granted to 1 of 2 Emergency Department (ED) physicians reviewed (MD 2) without verifying MD 2 was qualified and currently competent to perform them. This failure put patients at risk for adverse outcomes related to care performed by unqualified physicians.

Findings:

Review of the Medical Staff Bylaws, approved 9/27/12, under item 5.4-2 documented, "The Medical Staff shall make an objective and evidence based decision with regard to each request for Privileges ... shall be evaluated on the basis of the Member's education, training, experience, current demonstrated professional competence and judgment."

In a collaborative review of medical staff files with the Medical Staff Coordinator (MSC) on 4/9/13 at 9 a.m., the files of two ED physicians (Medical Doctor-MD 1 and MD 2) were inspected:

MD 1 maintained Board-certification in Emergency Medicine after completing residency training in emergency medicine. As part of his Board-certification, he was required to periodically demonstrate skills in managing difficult airways of patients, and to manage physical conditions similar to patients under the effects of general anesthesia. Among the clinical tasks MD 1 was authorized to perform on hospital patients was a privilege called deep sedation. Deep sedation is the administration of drugs to minimize pain and discomfort during surgical procedures, drugs that depress a patient's arousal and awareness responses just shy of being anesthetized. Deep sedation carries risk for rendering a patient unconscious with compromise to heart and lung and brain function if not provided with medical support for those functions.

MD 2 had no documented evidence of education and training in emergency medicine, and was not Board-certified in Emergency Medicine or any other field where ongoing skill competency would be maintained for managing airways and the effects of general anesthesia. Yet, MD 2 was authorized to perform the full range of emergency medicine privileges, including moderate and deep sedation. Moderate sedation is a lesser level of depressed consciousness and awareness than that of deep sedation, but also used for procedural comfort. Core emergency privileges included treatment of critically ill or injured patients of all ages, including a number of invasive procedures that required specialized education and training. The MSC produced no evidence that MD 2 was qualified by education, training, or special certifications to perform the necessary skills connected to moderate and deep sedation. The MSC produced no evidence of current competence for those skills. The MSC produced no evidence that MD 2 was qualified and currently competent to perform the entire range of core emergency medicine privileges.

The MSC indicated that the Anesthesia Service was responsible and approved the privilege requirements for moderate and deep sedation care in all parts of the hospital, including the ED. The qualification requirements documented on the Special Procedures - Procedural Sedation privilege form were: A) Residency trained in Emergency Medicine and/or Board Certified in Emergency Medicine, or B) Competency in airway management as evidenced by one of the following and completion of the Procedural Sedation Written Examination:

- Airway competency certificate from GSSA facility (affiliate owned by same corporation);
- Current ATLS (Advanced Trauma Life Support) certificate;
- Current National Airway Course certificate;
- Certificate from nationally recognized certification course in airway management skills;
- Performing ten or more endotracheal intubations (insertion of a plastic tube through the mouth into the windpipe to provide an airway) or bronchoscopies (insertion of tubes into the airway) in previous 2 years.

MD 2's file contained an ATLS certificate from 1996 (expired), but no current airway management certificates. MD 2's file contained a sedation written examination from his previous appointment cycle in 2011, but not current for the renewal of privileges cycle. No proctoring (observations of care by a qualified individual) specific to sedation care (adults or children) was documented. The Procedural Sedation privilege form itself did not include current competence in airway management or life support skills as requirements to continue/renew either moderate or deep sedation privileges. The requirements did not include competence in specialized skills to treat children separate from adults, as the categories were all-inclusive for both age groups.

Review of the American Society of Anesthesiologists (ASA) Advisory on Granting Privileges for Deep Sedation for Non-anesthesiologist Sedation Practitioners, approved 10/20/10, emphasized the need to maintain current knowledge, skills and competency in performing this type of care, including the management skills for difficult airways and patients who are under the effects of a deeper than intended level of sedation (general anesthesia). The ASA's Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Providers, approved 10/26/11, similarly framed the qualifications to include current knowledge, skills, and demonstrated proficiency in airway management, including certifications in life support for children if administering sedation care to children. "Separate privileging is required for the care of pediatric patients."

In an interview on 4/10/13 at 12:30 p.m. with MD 10, an anesthesiologist who served as previous Chief of the Anesthesia Service, MD 10 indicated that the hospital's anesthesia service was responsible to oversee all procedural sedation care throughout the hospital. MD 10 indicated that the guidance for hospital sedation policies, trainings, and privilege requirements should be based on the standards and practices recommended by the ASA, with consideration of the positions of other specialty organizations on an issue by issue basis that would not compromise patient safety. MD 10 agreed that MD 2's file lacked evidence of the qualifications to administer and supervise moderate and deep sedation, including for the care of children. MD 10 acknowledged that endotracheal intubation skill was not equal to airway management skill. MD 10 agreed that the existing sedation privilege requirements also did not conform to anesthesia standards for sedation care.

In an interview with the Vice President of Nursing (VPN) on 4/11/13 at 9:30 a.m., she presented an undated, unnumbered draft of a policy titled Procedural Sedation which she said was the policy currently in use. The VPN acknowledged this draft had not as yet been finally approved by the medical staff and governing body. In review of this policy, there was no requirement for privileged sedation-anesthesia providers to possess airway management skills, to demonstrate current knowledge or proficiency in managing patients under the effects of a deeper than intended level of sedation, nor to possess current competence in the rescue of children if they treated children. The policy draft listed no current organizational standards of practice on which it was based.

Review of a policy statement approved January 13, 2011 by the American College of Emergency Physicians (ACEP) titled "Sedation in the Emergency Department," recommended, "Institutional and departmental guidelines related to the sedation of patients should include credentialing and verification of competency of providers, selection and preparation of patients, informed consent, equipment and monitoring requirements, staff training and competency verification, criteria for discharge, and continuous quality improvement."

In an interview on 4/10/13 at 1:40 p.m. with MD 1, who served as Chief of Staff and a previous ED Medical Director, MD 1 acknowledged that the file for MD 2 did not document education, training, or current certifications as evidence of qualifications and current competence for moderate or deep sedation care (e.g. airway management proficiency, life support rescue skills for children). MD 1 acknowledged that MD 2 regularly performed the full scope of emergency medicine tasks that the Board-certified emergency medicine physicians performed; yet, MD 2's file contained no documented evidence of formal education, training, certifications, or other sources to show MD 2 was qualified or maintained current competence for the core ED tasks, including high risk care for children.

Based on staff interviews, medical record and document review:
1. The nursing nutrition screens for five of six patients reviewed for nutrition care did not capture nutrition problems identified for Patients 7, 8, 9, 10 and 12. These failures either resulted in delays or had the potential to result in delays in the implementation of nutrition interventions that benefit hospitalized patients and help prevent further decline in medical status.
2. A patient on Total Parenteral Nutrition (TPN - nutrition delivered directly to the bloodstream) did not receive appropriate weight monitoring while on the TPN. This failure had the potential to result in inaccurate nutrition assessments and monitoring.
3. In five of six patient records reviewed, the admission weight was recorded as a "stated" weight rather than an actual weight for Patients 7, 8, 9, 11 and 12. This had the potential to result in inaccurate nutrition and pharmacy assessment and monitoring.

Findings:

1. A review of the hospital's policy titled, "Patient Assessment/Reassessment and Care Planning" (undated) indicated that "Patients shall have an Adult Admission History and Physical Assessment form completed by an RN within twenty-four hours of admission to the department....Patients meeting the criteria for a referral to a specific service (i.e. Nutrition Services, Social Services, Spiritual Care, etc) will receive an assessment by the service within the time frame described..."

a. The medical record for Patient 7 was reviewed on 4/8/13. According to the History and Physical (H&P) dated 4/6/12, the date of admission, the assessment stated "Severe enterocolitis exacerbation (inflammation of the digestive tract)....Could not keep any food down because of persistent nausea and vomiting....Severe protein calorie malnutrition. We will need to find a way to improve the patient's nutrition..."

A review of the nursing initial nutrition screen for Patient 7 dated 4/6/13 indicated, no eating difficulties, home diet was listed as regular, appetite was listed as "good" and no nutrition risk factors were identified.

During an interview with the Lead Dietitian (LD) on 4/8/13 at 1:00 p.m., she verified that the nutrition screen was not accurate. She verified that the inaccurate nursing nutrition screen had the potential to delay a nutrition assessment and appropriate nutrition interventions for this high nutrition risk patient.

During an interview with Medical Surgical Manager (MSM) on 4/9/13 at 9:50 a.m. she verified that the nutrition screen completed by nursing was not accurate. She was unable to state why the high nutrition risk patient did not trigger for any nutrition risk factors.

b. The medical record for Patient 8 was reviewed on 4/8/13. According to the H&P dated 4/4/13, the date of admission, the patient was transferred from a skilled nursing facility with altered mentation (confusion), increased somnolence (drowsiness). The assessment and plan stated, "Moderate protein calorie malnutrition. We will get dietitian consultation. We will supplement her diet."

A review of the nursing initial nutrition screen for Patient 8 dated 4/4/13 indicated no eating difficulties, modified independence in feeding ability, appetite was fair and no nutrition risk factors were triggered for a dietitian consult.

During an interview with the LD the same day at 2:00 p.m., she verified that the nursing nutrition screen did not trigger a dietitian consult. She acknowledged that a dietitian still had not evaluated the patient 4 days after her admission. She could not explain why a patient with a diagnosis of protein calorie malnutrition would not be evaluated by a dietitian before 4 days after admission.

During an interview with MSM on 4/9/13 at 9:50 a.m. she verified that the nutrition screen completed by nursing was not accurate. She was unable to state why the high nutrition risk patient did not trigger for any nutrition risk factors.

c. The medical record for Patient 9 was reviewed on 4/8/13. According to the H&P dated 4/3/13, the day after the patient was admitted, the patient appeared confused. He was unable to answer questions. He was a 93 year old male admitted on 4/2/13 with a hip fracture.

A review of the nursing initial nutrition screen for Patient 9 dated 4/3/13 indicated appetite was "good", he was completely independent with feeding, he had no eating difficulties and he had no nutrition risk factors. Further review indicated that the patient was confused, family was not at bedside and family was not answering the phone.

During an interview with the MSM on 4/9/13 at 9:55 a.m., she stated that if a patient was unable to answer the nutrition related questions, as in this case, "unable to assess" should have been triggered and this would have triggered a dietitian consult. She could not explain why this did not happen. She verified that the patient was seen on 4/3/13 by the Speech Therapist for swallowing difficulty and was unable to feed himself.

During a concurrent interview with the LD, she verified that swallowing difficulties can be an indication of nutrition risk and should be evaluated by the dietitian.

d. The medical record for Patient 10 was reviewed on 4/8/13. According to the H&P dated 4/2/13, the same day of admission, the patient's chief complaint was nausea with dry heaves and diarrhea for 2-1/2 weeks. One of his admitting diagnoses was gastroenteritis (inflammation of the gasto-intestinal tract which includes nausea, vomiting and diarrhea).

A review of the nursing initial nutrition screen for Patient 10 dated 4/2/13 indicated no eating difficulties, a good appetite and no nutrition risk factors were identified. No dietitian consult was triggered.

During an interview with the MSM on 4/9/13 at 9:55 a.m., she was unable to explain why a patient admitted with a 2-1/2 week history of nausea, vomiting and diarrhea would not trigger a dietitian consult and no nutrition risk triggers were identified.

e. The medical record for Patient 12 was reviewed on 4/9/13. According to the H&P dated 2/26/13, same date of admission, the patient was admitted to the hospital with suspected aspiration pneumonia (food, fluids or stomach juices entering in the airway) with possible dysphagia (difficulty swallowing) from a previous stroke.

A review of the nursing initial nutrition screen for Patient 12 dated 3/26/13 indicated the patient had swallowing/dysphagia. The swallowing difficulty risk factor was not noted in the area of the screen that would have triggered a consult. No dietitian consult was ordered as was required with swallowing difficulties.

During an interview with the MSM on 4/9/13 at 10 a.m., she verified that swallowing difficulties was not triggered on the nutrition risk screen and it should have been.

2. The medical record for Patient 11 was reviewed on 4/9/13. The patient was admitted to the hospital on 2/27/13 with diagnoses that included small bowel obstruction (partial or complete blockage of the small intestines) requiring surgery on 3/3/13. The patient received TPN for nutrition starting on 3/2/13 and continuing until about 3/13/13.

Further review of the weights recorded in the medical record indicated an admission weight of 48 kilograms (kg) (105.6 pounds (lbs)). Follow-up weights were recorded as follows:
3/3/13 - 59 kg (129.8 lbs)
3/4/13 - 65.8 kg (144.8 lbs)
3/5/13 - 64.2 kg (141.2 lbs)
3/6/13 - 63.6 kg (139.9 lbs)
Daily weights were not recorded for 7 of 11 days.

A review of the hospital's policy titled, "Total Parenteral/Peripheral Parenteral Nutrition" (dated 8/10) indicated that daily weights were required for ongoing assessment of patients on TPN.

During an interview with the Medical Surgical Director (MSD) on 4/9/13 at 9:40 a.m., she stated that patients in the Medical Surgical nursing unit who are on TPN are not routinely weighed daily. She was not aware of the hospital's policy to weigh patients daily who receive TPN.

3. The medical record for Patients 7, 8, 9, 11 and 12 were reviewed on 4/8/13 and 4/9/13. The Adult Assessment Histories were reviewed for admission heights and weights. In all these records, the admission weight was recorded as a "stated" weight.

During an interview with the MSD on 4/9/13 at 9:40 a.m., she stated that an actual weight should be recorded whenever possible, depending on the ability of the patient to be weighed. She was unable to explain why many of the admission weights recorded on the patients reviewed were "stated" weights. She acknowledged that accurate weights were important for nutrition assessments and monitoring, as well as drug dosages.

Based on staff interview and medical record review, the hospital failed to ensure medications were prepared and administered as ordered by the physician or in accordance with the hospital's policy and procedures, when:

1. Staff failed to document pain re-assessment after pain medication administrations for 5 of 48 sampled patients (Patient 7, 25, 26, 43, and 44). The failure demonstrated the lack of evaluation for drug effectiveness and adverse effects, and may have delayed pain interventions for patients;

2. Staff failed to document assessment of sedation level and pain level in the medical record as often as indicated by the hospital policy for the PCA (patient controlled analgesia) use for three of three patients (Patient 16, 29, and 30) who were receiving PCAs. The failure demonstrated the lack of timely assessment and monitoring for PCA use;

3. Staff failed to administer medications as ordered by the physician for two patients (Patient 15 and 40). For Patient 15, there were two administration errors related to the administration of insulin (a medication used to decrease blood sugar). For Patient 40, the order for norepinephrine (a medication given intravenously to control the blood pressure in critical care patients) was not carried out as ordered;

4. Staff failed to document the removal of an old fentanyl patch (a potent narcotic applied to the skin) before applying a new patch, at two separate applications, for one of three patients (Patient 45) who were receiving fentanyl patches. Removal of the old patch is critical to prevent accidental narcotic overdose for patients.

Findings:

1. A review of Emergency Department (ED) patient medical records (Patients 7, 25, and 26) was conducted with the Clinical Pharmacist (CP) and the Pharmacy Director (PD) on 4/8/13. The review reflected Patient 7 had three physician orders for morphine (a potent pain medication) 4 milligrams (mg) each to be given intravenously (IV) at three separate times on 4/6/13. Three doses were given according to the medication administration record(MAR). However, there were no documented pain re-assessments following each morphine administration. The record documented the patient had moderate to severe pain, with pain scores 10, 5, and 9, respectively (pain scale 0 - 10; 0 equals no pain - 10 equal worst pain possible) at the time of medication administration.

Similarly, Patient 25 came into the ED for chest pain on 4/6/13. He had three physician orders for intravenous Dilaudid (a potent narcotic) 1 mg each at three separate times. The record showed the pain score was consistently 10 (worst possible pain) at the time of each Dilaudid administration. However, there was no documented pain re-assessment for two of three Dilaudid administrations for Patient 25.

Patient 26 came into the ED for abdominal pain and had a physician order for Dilaudid 1 mg IV x 1, which she received shortly after midnight on 4/5/13. The pain score documented at the Dilaudid administration was 9 (severe). There was no documented evidence of pain re-assessment after the Dilaudid administration for Patient 26.

During the review on 4/8/13 at 5:10 p.m., the CP and the PD confirmed there was no pain re-assessment documentation following pain medication administrations for Patients 7, 25, and 26. The CP said the nursing staff was to conduct the pain re-assessment within 15 minutes of IV pain medication administration and document it in the MAR.

Patient 43 was a pediatric patient who came into the ED for fracture of the right arm on 4/6/13. The patient was given Motrin (to treat pain and swelling) at 9:37 p.m., at which time the documented pain score was 10. Shortly after midnight (on 4/7/13), he was prescribed morphine 1 mg for a pain score of 8. There was no documented evidence pain re-assessment was conducted following the use of Motrin or morphine for Patient 42. The CP and the PD confirmed this on 4/11/13 at 10:45 a.m.

Patient 44 was a pediatric patient who came into the ED for tongue laceration on 1/29/13. She was given Tylenol 240 mg for pain at 4:53 p.m. There was no documented evidence pain assessment was done prior to and after the Tylenol administration. The CP and the PD confirmed this on 4/11/13 at 11:15 a.m.

The hospital policy entitled "PAIN MANAGEMENT," dated 2/10, stipulated: "Evaluate and document drug effectiveness within 15 minutes of administration of parenteral (through the veins) analgesic dose, 30 minutes of oral and intramuscular analgesic dose..." Under Document Administration of the "Medication Management: Administration" policy and procedures, dated 7/11, it indicated, "3. Patient pain level before and after pain mediation administration will be documented using 0 - 10 scale on the EMAR."

2. The hospital policy on "Patient Controlled Analgesia," dated 12/12, stipulated the following under Assessment for the use of PCA:
"4. Initial and ongoing patient vital sign assessment will include:...
- pain score
- sedation score using the Modified Ramsey Scale
5. Assess and document the above:
- At the start of PCA therapy
- 15-30 minutes after each dosage increase
- 15-30 minutes after each bolus
- Every 2 hours for 12 hours after initiation
- Every 4 hours or more frequently when
indicated for the duration of PCA therapy"

A review of Patient 16's electronic medical record (EMR) at the Progressive Care Unit (PCU) with the ICU/PCU Director (IPD) and the CP on 4/9/13 at 9:40 a.m. revealed the patient came into the hospital for shortness of breath and body pain. She was prescribed Dilaudid PCA, which was initiated at 10:46 a.m. on 4/5/13. The record showed the patient continued to be on the PCA from 4/5/13 to the day of review (4 days, or about 95 hours). However, the PCA flow sheet reflected the nursing staff only documented the sedation level during a period of 10 hours, from 4/6/13 at 8 p.m. to 4/7/13 at 6 a.m. The IPD said the staff should have documented the sedation level at initiation, every 2 hours for 12 hours after initiation, then every 4 hours for the duration of therapy. She said there had been recent in-services on assessing and documenting the sedation level using a new sedation score, but she was not sure why the staff did not carry it out. She agreed the staff did not document the sedation assessment as often as indicated by the hospital policy.

On 4/9/13 at 5 p.m., a retrospective review of Patient 29's EMR with the CP revealed the patient came into the hospital for a right hip replacement. She was prescribed Dilaudid PCA on 2/21/13 while at the Medical/Surgical Unit (MSU). It was discontinued on 2/24/13. The record showed there was no documented sedation assessment at the start of the PCA. The staff only documented the sedation assessment at every 12 hours intervals, at 6 a.m. and 6 p.m. (shift change), during the PCA therapy. Furthermore, the pain score was not documented as often as indicated by the policy. There was a time period when the pain assessment score was not documented for 14 hours.

The information above was verified with the Medical Surgical Manager (MSM) on 4/10/13 at 8:15 a.m. at the MSU in the presence of the CP.

Patient 30's EMR was reviewed with the MSM and the CP on 4/10/13 at 9 a.m. at the MSU. The patient came into the hospital for a revision of the left hip (to replace a worn out hip replacement implant), and had a physician order for Dilaudid PCA from 3/25/13 at 2 p.m. to 3/27/13 at 7 a.m. The record showed the only time staff documented a sedation score was at 3/25/13 at 6 p.m. The pain score documentation was also inconsistent; there were time periods when they were documented as long as 11 hours apart.

During the review above, the MSM said there had been confusion for the Medical Surgical staff regarding which sedation scale to use, whether it was the Modified Ramsey scale or the Pasero Opioid Sedation Scale, so nursing staff were told to hold off on the sedation assessment until the in-service in April (2013). She agreed, however, the hospital policy stipulated the assessment and documentation (as described above) and the staff were not carrying it out as per policy. She also acknowledged the staff were not documenting pain assessments as often as stipulated.

3. A review of Patient 15's EMR with the CP took place on 4/9/13 at 10:45 a.m. at the MSU. The patient came into the hospital for peripheral vascular disease and cellulitis (skin infection). While at the PCU, she was prescribed insulin coverage via sliding scale (set of instructions for administering insulin dosages) based on specific blood sugar readings before meals and at bedtime. The record showed: on 4/6/13 at 9 p.m., when the blood sugar (BS)was at 271 and requiring 2 units of insulin administration (per sliding scale order), the MAR showed only 1 unit of insulin was given. Again on 4/8/13 at 8 a.m., when the BS was 178 and requiring 1 unit of insulin, the MAR documented insulin sliding scale "not given."

The above was verified with a PCU nurse (RN 3) in the presence of the CP on 4/9/13 at 2:30 p.m. RN 3 said one of the nursing staff involved in the insulin administration above said she misread the sliding scale protocol, hence the error. The CP and RN 3 confirmed the staff was not carrying the insulin slide scale as ordered at two different administrations for Patient 15.

On 4/10/13 at 2 p.m., a review of Patient 40's EMR was conducted at the Intensive Care Unit (ICU) with the CP and the PD. The patient was admitted to the hospital with multiple diagnoses including septic shock (a life-threatening condition in which the blood pressure can drop dramatically) and was placed in the ICU. On 3/18/13, the patient had a physician order for norepinephrine, to start at 2 mcg (microgram)/min (minute), and to make changes in the rate (to titrate) to maintain the mean arterial pressure (MAP) above 60. The record showed the norepinephrine was started at 2 mcg/min with the MAP at 59. Two minutes after initiation, the rate was increased to 2.5 mcg/min, and the MAP reached 61 (above 60). However, the record showed the rate was continually increased in 0.5 mcg/min increments until it reached 5 mcg/min, despite the fact that the MAP was already above 60 when the rate was at 2.5 mcg/min.

An ICU nurse (RN 4) was interviewed during this review. She said one would normally titrate norepinephrine based on the systolic blood pressure (SBP) and/or MAP, not just MAP alone. She explained the nurse who cared for the patient might have increased the norepinephrine rate based on the patient's SBP (it being low) although the MAP was already above 60. The CP and PD said the order should have been clarified to include the SBP parameter. Since no SBP parameter was included in the order, they agreed the norepinephrine order for Patient 40 was not carried out.

4. A review of Patient 46's EMR took place on 4/11/13 at 8:20 a.m. with the CP and the PD. It revealed the patient was admitted to the hospital for right knee surgery. The patient had been on a fentanyl 75 mcg/hr patch (the patch delivers 75 micrograms/hour) prior to hospital admission. During the hospital stay, the physician prescribed fentanyl 75 mcg/hr to be applied every 48 hours for pain on 4/2/13 and increased the dose to 100 mcg/hr a day later, on 4/3/13. Review of the MAR showed a new patch of 75 mcg/hr was applied on 4/2/13, and 100 mcg/hr patch was applied on 4/3/13, as ordered. However, there was no documentation of the removal of the old patch on 4/2/13 and on 4/3/13 prior to the application of the new patch. Both CP and PD said, per hospital policy, the nursing staff were required to document in the MAR the removal of the old fentanyl patch whenever they applied a new patch.

According to the Packet Insert (the full prescribing information) for fentanyl transdermal patch, "a considerable amount of active fentanyl remains in DURAGESIC (brand name for fentanyl) even after use as directed." (www.duragesic.com)

The hospital policy titled "FENTANYL TRANSDERMAL ORDERING AND ADMINISTRATION," dated 7/11, indicated the following under Administration: "2. Label fentanyl patch with date, time and initials and document location of the patch on the electronic medication administration record (eMAR). 3. Always remove the old patch before applying new patch."

Based on staff interviews, clinical record and document review, the entity failed to maintain a comprehensive clinical record when:

1. A breathing treatment given to Patient 42 was not noted until 42 hours after administration,
2. A procedural consent for pediatric Patient 44 was not dated or timed and the relationship of the consenting adult to the patient not noted, and
3. Two unsuccessful blood gas attempts were not documented for Patient 22.

Findings:

1. Review of Patient 42's 4/5/13 admission "History and Physical" revealed a chief complaint of "worsening shortness of breath." The physician assessment noted "acute-on-chronic respiratory failure," "bilateral [affecting both sides] lower lobe pneumonia/atelectasis [partial or complete collapse of part or all of a lung], acute-on-chronic recurrent pleural effusions [excess fluid around the lungs]," "chronic obstructive pulmonary disease with acute exacerbation [worsening of a lung disease which makes breathing difficult]," "chronic cough" and "rule out underlying lung cancer." The medical plan of care included, "Bronchodilators with nebulization" [medication to open the large airways administered in the form of an inhaled mist]. At 8:52 p.m., 4/5/13, the physician ordered breathing treatments every 6 hours for Patient 42.

During a 12:13 p.m., 4/9/13 review with the Director, Respiratory Services (DRS), Patient 42's clinical record revealed an inhalation treatment given at 6:45 a.m., 4/8/13. The next treatment was documented as given 12 hours later at 6:50 p.m., 4/8/13. In a concurrent interview, the DRS stated, "I'm not sure why [the 12:50 p.m. treatment] wasn't charted."

2. Review of 4 year-old Patient 44's clinical record revealed a "Consent to Surgery or Special Procedure" for "Procedural sedation and repair of tongue laceration." The consent read in part, "If signed by other than patient, indicate name and relationship...;" this area of the consent was left blank. In addition, the consent was not dated or timed.

In an 11 a.m., 4/10/13 interview, an Emergency Department Clinical Coordinator (EDCC) stated it was a nursing responsibility to ensure a consent included date, time and in the case of a pediatric patient, the relationship of the representative to the patient.

3. Review of Patient 22's clinical record revealed a diagnosis of drug overdose leading to respiratory failure. Unresponsive in the Emergency Department, she required placement of a tube into the windpipe to maintain an airway and respiratory support from a ventilator at 8:50 p.m., 4/4/13. An arterial blood gas (ABG, a test for oxygen and carbon dioxide to determine how well the lungs are working) was ordered at 8:50 p.m., 4/4/13 but not drawn until 10 p.m. A 10 p.m. note in Patient 22's chart stated, "ABG obtained late, prior RT [respiratory therapist] unable to obtain sample...." No documentation from the RT making earlier arterial puncture attempts was located in the clinical record.

Review of the undated "Arterial Blood Gas [ABG] Sampling" policy and procedure reflected no documentation guidelines for any aspect of the procedure.

Review of the 10/10 nursing policy/procedure "IV Peripheral Insertion Procedure," however, indicated "Each unsuccessful attempt must be documented, including location, site condition...."

In a 7:48 a.m., 4/11/13 interview, the DRS stated there were no requirements for Respiratory Care Practitioners to document failed arterial blood gas attempts. After discussion of the hospital's requirement for IV insertion attempts to be documented, the DRS added, "I think [documentation of attempts] is a good idea."

The "Arterial Blood Gas Sampling Policy" was amended 4/11/13 to read, "Documentation: a. All attempts in obtaining an ABG will be documented in the patient's electronic medical record."

Based on observation, interview, and record review, the hospital failed to store medications within the temperature range specified on the manufacturer's packaging to maintain drug integrity, stability, and effectiveness. The failure had the potential to expose patients to the ineffective treatment of serious infections due to the use of expired and/or less than labeled strength.

Findings:

During a tour on 4/8/13 at 11:45 a.m. with the Pharmacy Director (PD) and the Clinical Pharmacist (CP), the medication freezer was identified. The digital display on the freezer showed the temperature inside was - 15.9 (negative 15.9) degrees Celsius. The inspection of the freezer showed it contained numerous counts of frozen premixed antibiotics (medications to treat serious infections): Vancomycin Injection Solution, Zosyn Injection Solution, and Azactam Injection Solution. The storage instructions on these antibiotics' labels indicated to store them at -20 degrees Celsius or below. The PD said the freezer temperature had been set from -20 to - 2 degrees Celsius for a long time. She and the CP agreed such temperature setting did not meet the manufacturer's specification for storage of the frozen antibiotics.

The hospital's current policy on "Medication Control and Storage Inspections," dated 1/13, indicated: "The proper temperature range for a freezer containing medication is (-4° to 14°F [Fahrenheit] or -20° to -2° C [Celsius])." During the same pharmacy visit, the pharmacy staff agreed the policy needed to be changed to meet the manufacturer's storage specification.

Based on interview and record review, the facility failed to ensure there was documented evidence two syringes of morphine (a potent narcotic) 4 milligrams (mg) removed from the automated dispensing cabinet (ADC) by nursing staff were accurately accounted for two sampled patients (Patients 7 and 24). This resulted in the hospital not having an accurate record of narcotic distribution/administration.

Findings:

A review of Patient 7 and Patient 24's electronic medical records took place on 4/8/13 at 3:10 p.m. with the Pharmacy Director (PD), the Clinical Pharmacist (CP), and the Emergency Services Manager (ESM).

Patient 7 came into the Emergency Department (ED) on 4/6/13 for abdominal pain. During the stay at the ED, she was prescribed three doses of morphine (a potent narcotic for pain reduction), each 4 mg, at three separate times. The ADC usage report showed four syringes of morphine 4 mg each were removed for patient administration; three were removed by RN 5 and one by another ED nurse. The medication administration record (MAR) showed RN 5 gave only two doses of morphine 4 mg to the patient, leaving one dose unaccounted for. There was no documented evidence of morphine wastage.

Patient 24 came into the ED on 4/7/13 for fever and testicular pain. During the ED stay, he was prescribed one dose of morphine 4 mg for pain; a one time "stat" order (a physician order to be carried out immediately). The ADC usage report showed RN 5 removed two doses of morphine 4 mg each at two separate times under Patient 24's name. The MAR showed one dose was given to the patient right after it was ordered; however, there was no documented evidence what happened to the other dose. There was no physician order for the second dose, and there was no documented evidence of wastage.

In a concurrent interview, the ESM verified two doses of morphine 4 mg were not accounted for.

Based on observation, staff interview, and document review, the hospital failed to ensure expired medications were removed from patient care area and failed to ensure opened multi-dose vials of medications were labeled with an open date or expiration date. The failure had the potential for patients to be given expired medications.

Findings:

On 4/8/13 at 11 a.m., a visit to the pharmacy was conducted with the presence of the Pharmacy Director (PD) and the Clinical Pharmacist (CP). An inspection of the medication refrigerator found two expired medications: cephalexin (an antibiotic) oral suspension which expired 4/4/13, and Tamiflu (for treatment of a flu) oral suspension which expired 4/2/13. The inspection of the medication refrigerator also found five opened multi-dose vials (two folic acid vials, one multi trace element vial, one regular insulin vial, and one gentamicin vial) without open date or expiration date. The PD said staff was to label any opened multi-dose vial with an expiration date 28 days from opening. She agreed the vials were not usable since the open date or expiration date was not present.

On 4/8/13 at 2:05 p.m., an inspection of the medication refrigerator at the Emergency Department in the presence of the CP found an opened PPD (a multi-dose solution, to test for tuberculosis) solution without an open date or expiration date. The CP acknowledged it was no longer usable.

During a Tour of the Operating Room (OR) on 4/9/13 at 8:25 a.m., an anesthesia cart located in OR Room 2 was inspected. A multidose 10 cubic centimeters (cc) vial of Rocurium Bromide 0.5% (a potent muscle relaxant) was noted to be opened in the top drawer. The seal had been removed and approximately 3 cc of the product remained in the vial. In a concurrent interview with an Anesthesia Technician (AT 1), she stated she was responsible for maintaining the integrity of the anesthesia carts. AT 1 stated she inspected the carts daily and removed any vials not labeled when opened by the Anesthesiologist. AT 1 stated she had not as yet inspected the anesthesia cart in Room 2 on this day.

On 4/9/13 at 2:15 p.m., an inspection of the medication refrigerator at the Operating Room (OR) in the presence of multiple OR staff and the CP found an insulin vial which expired 3/19/13. The OR staff and the CP acknowledged the medication had expired.

The hospital policy entitled "Intravenous Sterile Admixture Program," approved 12/10, indicated the following under Multiple Dose Vial (MDV):
"Opened MDVs on the nursing units are discarded after 28 days or manufacturer's expiration date, whichever is less...
"In the pharmacy... the following information is required on the bottle when a new MDV is opened or reconstituted:
1. date of reconstitution or date of seal broken..."

Based on observations, interviews and record reviews, the Nutrition Services Manager was not effective in the daily management of the Nutrition Services Department when:
1. The dietary Staff was not knowledgeable about testing of the sanitizer concentration for the pot washing sink and for sanitizing of food contact surfaces and the concentration was not adequate for proper sanitation.
2. The hospital's disaster food plan was not comprehensive and was not adequate to meet the needs of the patients.
3. The manager failed to identify, track, measure and analyze opportunities for improvement of services and patient care issues within the hospital's quality assurance/performance improvement program.

These failures resulted in unsanitary conditions in the nutrition services department, the potential that the nutrition needs of the patients would not be met during a disaster, and the continuation of patient care practices that resulted in delays in appropriate nutrition care being delivered.

Findings:

1. During an observation and interview in the kitchen on 4/8/13 at 9:45 a.m., Food Service Worker 1 (FSW 1) filled the third sink of the three-compartment sink used for washing pots and pans with a sanitizer solution. The sanitizer solution was premixed through a machine calibrated by the chemical supplier. FSW 1 diluted the premixed sanitizer in half by running water into the sink with the pre-mixed sanitizer. She also stated that it was her usual practice to dilute the premixed sanitizer when filling the sink. Later the same day at 3:40 p.m., when the service technician (supplier of the sanitizer chemical) tested the concentration of the premixed sanitizer he determined the concentration to be too low to effectively sanitize the pots and pans. This test was conducted prior to the hospital practice of further diluting the solution. Also, the sanitizer was mixed with hot water. FSW 1 lacked knowledge on the proper method to test the sanitizer concentration when it was noted that the instructions for the test strips required a water temperature of 65-75 º F (Fahrenheit).

During an interview with the NSM the same day at 10 a.m., she did not know the proper manufacturer's instructions for testing the concentration of the sanitizer. She stated that she had not trained the staff on the proper directions for ensuring the concentration of the sanitizer was appropriate for effective sanitation. The same sanitizer dispenser was also used for sanitizing of food contact surfaces.

A review of the hospital's policy for the three-compartment sink revealed no staff directions for how to properly test the concentration of the sanitizer. Directions for properly testing the sanitizer were posted above the sink, but were not being followed by staff.

2. A review of the hospital's disaster food plan revealed that in the event of a disaster there was no disaster menu as part of the plan. The disaster food plan included ration bars that provided 1,200 calories and 9 grams of protein a day for 3 days for patients, staff and visitors.

During an interview with the NSM on 4/8/13 at 10:30 a.m., she verified that 9 grams of protein a day was a severe restriction in protein and the plan did not include other sources of protein. She was unable to explain how the protein needs of medically compromised patients could be met with 9 grams a day.

3. During the course of the survey, issues affecting the timely and accurate nutrition assessment of patients were identified (refer to A395):
· In five of six patient reviews, nursing initial nutrition screens were not accurate resulting in, or potentially resulting in, a delay in nutrition assessments and interventions by the dietitian.
· In five of six patient reviews, actual weights of patients were not recorded on admission, instead "stated" weights were recorded.

During an interview with the Lead Dietitian (LD) and the NSM on 4/9/13 at 2:30 p.m., the Nutrition Services Department quality plan was reviewed. The NSM stated that their current plan was not robust and would require updating. The LD verified that she and her staff had identified the above issues as problems. She also acknowledged that these prevented the dietitians from ensuring timely and accurate assessments and nutrition interventions for patients. She stated that she had conducted "informal" studies in the past and used these to have discussions with Nursing Managers. She stated that when she did this, she would see improvement for a time and then things would digress. She verified that she had not addressed these issues through the hospital's PIMs program (Performance Improvement Management).

During an interview with the Director of Quality Management (DQM) on 4/10/13 at 3 p.m., she stated that she was not aware that the LD and NSM were having these issues and were not addressing them through the PIMs process. She stated that these patient care issues would be better addressed through the PIMs process.

Based on interviews and record reviews, the hospital failed to ensure:
1. The patient menus met the needs of the patients when the menus failed to meet national standards for fiber requirements set by the Food and Nutrition Board, Institute of Medicine (IoM). This failure resulted in inadequate fiber intake by hospitalized patients and the potential to result in constipation.

2. Patient 10, who was determined to require a dysphagia diet (a mechanically altered diet for swallowing difficulty), received inappropriate diet and liquid textures. This failure had the potential to result in choking, aspiration (swallowing down the windpipe) and inadequate nutrition in this patient.

3. The nutrition needs for three of six patients reviewed for nutrition care were met when the nutrition assessments and interventions by the dietitian were not completed in a timely manner. (Patients 8, 9 and 10). These failures resulted in a delay in the implementation of nutrition interventions needed to meet their nutritional needs.


Findings:

1. According to the 2005 Dietary Reference Intakes (DRIs): Recommended Dietary Allowances and Adequate Intakes from the Food and Nutrition Board, IoM, total fiber needs for males greater than 30 years is 30 grams of fiber daily. For females age 31-50 the need is for 25 grams and greater than 50 years is 21 grams daily.

According to the IoM, fiber has many benefits in the diet including: normalizing bowel movements, maintaining bowel health, lowering cholesterol levels, helping control blood sugar levels and aiding in achieving healthy weight.

A review of the hospital menus nutrition analysis revealed that for regular consistency diets provided at the facility (excluding Renal diets) the dietary fiber contents of the diets ranged from 15.6 grams to 17.3 grams of dietary fiber daily.

A review of the hospital's policy titled, "Patient Menus and Special Diets" (undated) revealed that "Patient menus are developed by Manager/Lead Clinical Dietitian in accordance with the department of Nutrition and Food Services Nutrition Care Manual and Dietary Reference Intakes (DRIs)/Recommended Dietary Allowances (RDA) of the Food and Nutrition Board of the National Research Council of the National Academy of Sciences." It further stated "In development of the menu and therapeutic diet modifications, the following factors are considered but are not limited to: ...Nutritional Adequacy."

During an interview with the Lead Dietitian (LD) on 4/9/13 at 2:20 p.m., she verified that the menus do not meet the DRIs for fiber. She was unable to state why there was inadequate fiber included in the diets provided to patients. She stated she needed to work on including more fiber rich foods on the menus.

2. A review of the medical record for Patient 10 revealed that he was admitted to the hospital on 4/2/13 with diagnoses that included a hip fracture and was noted to have some confusion. A bedside swallowing evaluation completed on 4/3/13 by the Speech Therapist indicated that the "Pt (patient) presented with delayed swallow response and significant s/s (signs and symptoms) of aspiration (when) given thin liquids. Pt's chewing was also slowed..." Based on the evaluation, the recommendation was for a chopped texture diet (easy to chew) and nectar thick liquids. Thicker liquids can sometimes be easier to swallow correctly than thin liquids.

A review of the physician orders revealed an order on 4/3/13 for Dysphagia diet/Chopped/Nectar Thick liquids. Another order was noted on 4/7/13 at 11:34 a.m. for a Regular diet (no texture modification and no thickened liquids). The patient received 4 regular texture meals with thin liquids between 4/7 and 4/8/13.

A review of the Speech Therapy Progress Note dated 4/8/13 at 10:08 a.m. stated, "Noted Pt transferred to PCU (Progressive Care Unit) and diet was changed to regular with thin liquids upon transfer. Spoke with RN regarding need for change to modified diet/liquids..."

During an interview with the RN 7, the nurse in charge of Patient 10's care, on 4/8/13 at 3:30 p.m., she verified that the Speech Therapist had asked her to get the diet order changed. She further stated that she had to call the physician to get the order changed and she had not done that yet. She stated that asking the physician to change the diet order was "not a priority" because the patient wasn't eating much. RN 7 was asked if she thought the patient wasn't eating much because he was having difficulty with chewing and swallowing a regular diet and she stated that the patient was eating poorly at home. She confirmed that the patient received a regular texture diet with thin liquids at breakfast and lunch on 4/8/13.

3. a. The medical record for Patient 8 was reviewed on 4/8/13. The patient was admitted to the hospital on 4/4/13 with diagnoses that included Moderate Protein Calorie Malnutrition according to the History and Physical (H&P) dated 4/4/13. The H&P indicated the plan was to get a dietitian consultation and to supplement the patient's diet.

A review of the physician's orders showed an order for a Regular diet on 4/4/13. On 4/7/13 (3 days later) a nutritional supplement was ordered, Chocolate Ensure with meals.

A review of the patient's meal intakes (recorded in percentage of meal consumed) as of 4/8/13 revealed the following:
4/5/13 - breakfast-25%, lunch-30%, dinner-10%
4/6/13 - breakfast-30%, lunch-50%, dinner-not recorded
4/7/13 - breakfast-50%, lunch-40%, dinner-not recorded
4/8/13 - breakfast-40%

A review of the Nursing Adult Admission Assessment, Initial Nutrition screen dated 4/4/13 indicated that the patient's appetite was "fair", her feeding ability was "modified independence" and no nutrition risk factors were identified.

During an interview with the LD on 4/8/13 at 2 p.m., she stated that there was no nutrition assessment of the patient completed by the dietitian. She stated that a nutrition assessment was scheduled to occur that day (4/8/13). She could not explain why a dietitian consult was not ordered by the physician when the patient was admitted. She also could not explain why a diagnosis of Protein Calorie Malnutrition was not communicated to the dietitians so that a nutrition assessment and interventions were implemented when it was identified on admission.

b. The medical record for Patient 9 was reviewed on 4/8/13. The patient was admitted to the hospital on 4/2/13 with diagnoses that included acute hepatitis (liver failure), acute renal (kidney) failure, dehydration and gastroenteritis (inflammation of the gastro-intestinal tract which includes nausea, vomiting and diarrhea). According to the H&P dated 4/2/13 the patient had severe nausea with dry heaves and diarrhea for 2-1/2 weeks prior to admission. A review of the physician's orders showed a diet order for a Consistent Carbohydrate (diabetic), Renal diet on 4/4/13.

During an interview with the LD on 4/8/13 at 2:20 p.m., she stated that a Consistent Carbohydrate, Renal diet provided 1800 calories and 60 grams of protein daily. She verified that there was no nutrition assessment in the medical record for Patient 9, six days after he was admitted.

A review of the Nursing Adult Admission Assessment, Initial Nutrition screen dated 4/2/13 revealed that the patient's appetite was listed as "good" and that no nutrition risk factors were identified on admission.

On 4/9/13 at 11:00 a.m., the medical record was again reviewed and a nutrition assessment had been completed on 4/8/13 at 3:44 p.m., six days after Patient 9 was admitted. The nutrition assessment indicated that the patient's estimated nutrition needs were 2000 calories and 75 grams of protein daily. The assessment indicated that the patient stated he was hungry on the current diet that provided 1800 calories. The dietitian recommended increasing the calories in the patient's diet by increasing the amount of carbohydrates at each meal to provide 2000 calories. There was no recommendation to address the discrepancy between the amount of protein provided in the diet (60 grams) and the estimated nutrition needs (75 grams).

c. The medical record for Patient 10 was reviewed on 4/8/13. The patient was admitted to the hospital on 4/2/13 with diagnoses that included a hip fracture, dehydration and acute renal failure. The H&P dated 4/3/13 indicated that the patient appeared confused.

A review of the Nursing Adult Admission Assessment, Initial Nutrition screen dated 4/2/13 revealed that the patient was on a regular diet at home, had a good appetite, was completely independent with feeding and had no nutrition risk factors.

A review of the Speech Therapy Swallow Evaluation note dated 4/3/13 indicated that Patient 10 required full feeding assistance. It further stated that the "Pt [patient] presented with delayed swallow response and significant s/s [signs and symptoms] of aspiration [when] given thin liquids. Pt's chewing was also slowed..." Based on the evaluation, the recommendation was for a chopped texture diet (easy to chew) and nectar thick liquids.

A physician's order for a chopped diet with nectar thick liquids was noted on 4/3/13. Also noted was a physician's order for a regular diet on 4/7/13.

A review of the Speech Therapy Progress Note dated 4/8/13 at 10:08 a.m. indicated, "Noted Pt transferred to PCU (Progressive Care Unit) and diet was changed to regular with thin liquids upon transfer. Spoke with RN regarding need for change to modified diet/liquids..." The order was not changed at the time of the review on 4/8/13 at 3 p.m.

A review of the patient's meal intakes (recorded in percentage of meal consumed) as of 4/8/13 revealed the following:
4/3/13 - breakfast-not recorded, lunch-30%, dinner-75%
4/4/13 - breakfast-not recorded, lunch-not recorded, dinner-not allowed to eat
4/5/13 - breakfast-not allowed to eat, lunch-not allowed to eat, dinner-100%
4/6/13 - breakfast-30%, lunch-not recorded, dinner-50%
4/7/13 - breakfast-not allowed to eat, lunch-75%, dinner-30%
4/8/13 - breakfast-15%, lunch-25%

During an interview with the LD on 4/8/13 at 3:05 p.m., she stated that there was no nutrition assessment in the medical record for Patient 10 even though he was admitted 6 days earlier. She verified that the patient's diet remained a regular diet despite the Speech Therapist's request to change the order back to chopped with nectar thick liquids. She also verified that many of Patient 10's meal intakes were not recorded.

On 4/9/13 the medical record for Patient 10 was reviewed again. A nutrition assessment dated 4/8/13 at 5:10 p.m., 6 days after the patient was admitted, was noted. The assessment indicated a nutrition recommendation for the patient to receive a nutritional supplement two times a day to maximize nutritional intake. The assessment also noted the patient complained of not having a bowel movement for many days and didn't feel like eating. The nurse was informed so the physician could be called.

Based on observations, interviews, and record reviews the hospital failed to develop an emergency/disaster food plan and maintain supplies that would provide for the well-being of the patients in the event of a disaster. This failure had the potential to result in inadequate nutrition for already medically compromised patients during a disaster.

Findings:

During an observation of the hospital's disaster food supplies on 4/8/12 at 10:30 a.m., 79 cases of ration bars were noted in a storage shed in the parking lot. Each case contained 10 packages with 9 ration bars each.

During a review of the hospital's disaster food policy on 4/8/13 at 10:30 a.m., it indicated that during a disaster where power was not available, safe perishable food would be used first using the attached Sample Disaster Menu. There was no attached Sample Disaster Menu.

During a concurrent interview with the Nutrition Services Manager (NSM), she stated that the facility had purchased food ration bars that would provide for the nutrition needs of patients, staff and visitors for three days followin a disaster. She stated that the plan was to feed approximately 800 people (patients, staff and visitors) for three days with the ration bars. Each person would receive 3 bars a day plus water.

A review of the ration bar product information revealed that each bar contained 400 calories and 3 grams of protein. Three bars a day would provide 1,200 calories and 9 grams of protein. The protein source listed in the product ingredients was from flour, which is a not a high biological value protein source (complete protein).

During a concurrent interview with the Lead Dietitian (LD), she verified that 9 grams of protein was considered very restricted. She verified that 9 grams of low biological value protein would not meet the needs of a hospitalized patient population which generally has an increased need for protein.

In a further concurrent interview with the NSM, she stated that during a disaster, the ration bars would provide minimal nutrients for the patients, staff and visitors. She stated that was the plan of the hospital during an extended disaster when perishable foods were no longer safe to use due to no power and no deliveries of food would be possible.

Based on observation, staff interview, and document review, the hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases when:
1. Disinfectant wet times were not maintained in accordance with manufacturer's instructions.
2. The integrity of breathing circuit bags were compromised by piercing them with hooks.
3. A cart of step stools in an Operating Room was dusty.
4. Cracks were observed on an Operating Room table pad, a bassinet pad, and an OB (obstetrics) room chair.

These failures exposed patients to the potential for the spread of infectious disease.

Findings:
1. During observations and a concurrent interview on 4/8/13 at 9:20 a.m., during a terminal cleaning of a patient room, an Environmental Services staff person (EVS 1) stated the disinfecting wet time of Oxivir (a hydrogen peroxide based disinfectant cleaner) was 5 minutes, per manufacturer's guidelines. However, large, dry areas were observed on the bed pad and bedside table within 4 minutes of application. EVS 1 was asked about the facility's training and practices to ensure disinfecting wet times. EVS 1 explained that if the product begins to dry before the disinfecting wet time was met; the product must be reapplied. During the observation, she did not reapply the Oxivir when it began to dry before the 5 minute wet time.
In an interview with the Infection Control Preventivist (ICP) on 4/8/13 9:30 a.m., the ICP confirmed the dry areas of the bed pad and bedside table require a 5 minute disinfecting wet time, which was not met.
During concurrent observation and interview with EVS 2 on 4/10/13 at 1:45 PM, during a terminal cleaning of a patient room, EVS 2 stated the disinfecting wet time of Oxivir was 5 minutes. Large, dry areas were observed on a light pole, stool, couch, chair, IV pole and pump, prior the 5 minute wet time requirement. EVS 2 was asked about the facility's training and practices to ensure disinfecting wet times in accordance with manufacturer's instructions. EVS 2 explained that if the product begins to dry before the disinfecting wet time was met, the product must be reapplied. EVS 2 did not reapply the Oxivir when it began to dry before the 5 minute wet time.
In an interview with the Infection Control Preventivist (ICP) on 4/8/13 9:30 a.m., the ICP confirmed the dry areas of the light pole, stool, couch, chair, IV pole and pump; the manufacturer's instructions for Oxivir require a 5 minute disinfecting wet time and; the requirement was not met.
According to the Healthcare Infection Control Practices Advisory Committee, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008), "by law, users must follow all applicable label instructions of products registered by the Environmental Protection Agency, including the specified contact times for surface disinfectants".
2. During a concurrent observation and interview with Anesthesia Tech 1 (AT 1) on 4/9/13 at 9 a.m., packaged breathing circuits (an assembly of ports and tubes that connect the patient's airway to the anesthesia machine and delivers oxygen and other gases to the patient) were observed hanging from hooks on the side of the anesthesia carts in Operating Rooms 1 and 2. The hooks pierced the sealed packaging of the 11 bags observed. AT 1 confirmed the breathing circuit packaging, as received from the manufacturer, did not provide a hole for hanging; the packaging should remain closed until use and; the tubing should remain clean.
According to the Association of periOperative Registered Nurses, Preoperative Standards and Recommended Practices, Recommended Practices for Cleaning, Handling, and Processing Anesthesia Equipment (2013), anesthesia equipment that comes in contact with mucous membranes should be sterilized or undergo high-level disinfection before use.
3. During a concurrent observation and interview with AT 1 on 4/9/13 at 8:30 a.m., a dusty cart of step stools was observed in Operating Room 2. AT 1 confirmed the presence of dust and removed the cart.
According to the Association of periOperative Registered Nurses, Perioperative Standards and Recommended Practices, Recommended Practices for Environmental Cleaning in the Perioperative Setting (2013), dust is known to contain human skin and hair, fabric fibers, pollens, mold, fungi, insect parts, glove powder, and paper fibers among other things.
4. During a concurrent observation and interview with RN 2 on 4/9/13, at 8:30 a.m., 11 cracks (10 covered with cloth tape) were observed on an Operating Room pad. Registered Nurse 2 (RN 2) confirmed the observation and stated "It should have been recovered. The tape is not good practice".
During an observation and interview on 4/10/13 at 2:15 PM with the ICP, cracks were observed on a bassinet pad in an OB room. The ICP confirmed the observation and the inability to ensure disinfection of the bassinet pad.
During an observation and interview with ICP on 4/11/13 at 11:45 a.m., a chair pad in OB room #218 was observed to have 4 cracks, each approximately 1 inch long. ICP confirmed the observation and the inability to ensure disinfection of the chair pad.
According to the Healthcare Infection Control Practices Advisory Committee, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008), Environmental surfaces can become contaminated with infectious agents and contribute to the spread of health-care-associated infections, potentially contributing to cross-transmission by health-care personnel hand contact with contaminated surfaces, medical equipment, or patients. The removal of microbes is a component in controlling health-care-associated infections. Surface type, for example, porous, uneven, cracked, or pitted, affects cleaning effectiveness because the surface irregularities can shield microorganisms from disinfection products.
According to the Healthcare Infection Control Practices Advisory Committee, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008), by law, users must follow all applicable label instructions of products registered by the Environmental Protection Agency, including the surface description.

Based on observations, interviews and record reviews, the hospital failed ensure that there were infection control measures in place to prevent the development of food borne illness and cross contamination to food service. Also, the hospital failed to have a thorough infection control surveillance system that monitored the conditions and practices of the dietetics services staff. By not having these measures and a thorough surveillance system, potentially hazardous foods had been stored, prepared and distributed under unsafe and unsanitary conditions and there was potential for such continuation in the absence of identification and remediation.

Findings:

1. During a concurrent observation and interview on 4/8/13 at 9:45 a.m. with Food Service Worker 1 (FSW 1) in the kitchen, she demonstrated how she washed pots and pans in the three compartment sink. She filled the third sink with pre-mixed sanitizer solution that was mixed with hot water. She added additional warm water out of the faucet and stated that the sanitizer solution was too hot so she added more warm water to cool it down. Once the sink was filled with premixed sanitizer and additional water, the temperature of the water was tested and was 108º F (Fahrenheit) . She further demonstrated how she tested the contents of the sink to ensure the proper sanitizer concentration by immersing the test strip in the sink for 3 seconds.

A review of the manufacturer's instructions for the test strips indicated that the solution must be between 65-75º F and the strip must be immersed in the solution for 10 seconds before reading.

During an interview with FSW 2 the same day at 10 a.m., she stated she used the same premixed sanitizer solution to sanitize the food contact surfaces in the cafeteria and throughout the kitchen.

During an interview the same day at 3:40 p.m. with the outside service technician that serviced the sanitizer dispenser, he stated that the temperature of the water must be 65-75 ºF in order to get an accurate reading when testing the concentration of the solution with the test strips. Increased water temperature would result in a false reading. He further confirmed the strip must be immersed for 10 seconds for an accurate reading. He used a liquid test to determine the concentration of the sanitizer that he stated was more accurate. The test determined that the concentration of the premixed sanitizer was too low at 100 parts per million (ppm). It should be 150-400 ppm. He confirmed that FSW 1's practice of further diluting the premixed sanitizer resulted in ineffective sanitizing of the pots and pans. He also confirmed that at 100 ppm, food contact surfaces were not being effectively sanitized.

A review of the hospital's policy titled, "Pot Washing - Three Compartment Sink" (undated) instructed the staff to "sanitize items in third sink using a pH strip (used to measure the acid and base properties of a solution) to test for appropriate concentration of 150-400 ppm." There was no guidance to the staff regarding how to properly use the test strips and the proper temperature of the water when testing.

During an interview with the Nutrition Services Manager (NSM) the same day at 4 p.m., she stated that she was not aware that the concentration of the sanitizer was not correct and the practice of the staff was to dilute the premixed sanitizer. She stated that she had not in-serviced the staff on properly sanitizing pots and pans and food contact surfaces or testing the sanitizer concentration.

2. During an observation of the ice machine in the cafeteria on 4/8/13 at 10:20 a.m., a water drain hose from the ice machine did not maintain an air gap between the end of the hose and the floor drain.

According to the FDA Food Code, an air gap between the water supply inlet and the flood level rim of the plumbing fixture, equipment or non-food equipment shall be at least twice the diameter of the water supply inlet and may not be less than one inch. The purpose of an air gap is to prevent backflow of sewage water in the event of a negative water pressure event.

During an interview with the Engineering Lead (EL) on 4/8/13 at 10:25 a.m., he verified that there was not an air gap and that there should be one. He further stated that the housekeeping staff was responsible for the daily cleaning of the outside of the ice machines and the engineering staff was responsible for cleaning the interior of the machines. He stated that ice machines were cleaned by the engineering staff every three months.

During an interview with Environmental Services Staff 1(EVS 1) on 4/9/13 at 1:10 p.m., she stated that she cleaned the ice machine spouts daily in the PCU (Progressive Care Unit) Nursing Station with Oxivir Five 16, one-step disinfectant cleaner.

During an interview with Environmental Services Staff 2 (EVS 2) on 4/9/13 at 1:40 p.m., she stated that she does not clean the spouts on the ice machine. She cleans the outside of the machine only.

During an observation of the ice machine on the Medical Surgical Nursing Unit on 4/9/13 at 1:45 p.m., a clean paper towel swipe of the water dispenser spout produced a moderate amount of black/brown residue. The finding was verified by the Lead Dietitian (LD) and the Medical Surgical Director (MSD).

A review of the hospital's policy titled, "Ice Machine Cleaning and Sanitizing" (undated) revealed that under Environmental Services, "Ice machine dispenser spouts are cleaned daily with a hospital approved sanitizer solution."

A review of the manufacturer's information on Oxivir Five 16, one-step disinfectant cleaner did not indicate it was a food safe cleaner-sanitizer or that it was approved for use on food contact surfaces.

A review of the manufacturer's manual for the ice machine located in the Post Anesthesia Care Unit (PACU) indicated that the ice storage bin should be removed for cleaning and sanitizing weekly.

During an interview with the EL on 4/9/13 at 3 p.m., he confirmed that he was not aware of the ice machine manufacturer's instructions. He stated that the ice storage bin on the PACU station ice machine was cleaned every three months during the regular scheduled cleaning of the ice machine, not weekly.

During a concurrent interview with the EL, the Infection Control Preventionist (ICP) and the EVS Director (EVSD) on 4/10/13 at 8:30 a.m., the ICP and the EVSD were not aware that Oxivir Five 16, one-step disinfectant cleaner was not a food safe disinfectant. The EVSD stated that his staff was instructed to clean the outside of the ice machines only. He did not expect his staff to clean the inside of the spouts. All three verified that the cleaning instructions for the ice machine were not clear and may have resulted in the residue build-up on the water spout in the Medical Surgical Nursing Unit.

3. During an observation and concurrent interview with the NSM on 4/9/13 at 2:00 p.m. in the kitchen freezer, previously cooked beef tenderloin dated 4/4/13 was noted. The NSM stated that it was leftover from a Medical Staff function on 4/4/13. She stated that it should have been cooled down safely and documentation of the safe cooling should be on the Cool Down Log.

According to the 2009 FDA Food Code, cooked potentially hazardous food (such as beef) shall be cooled within 2 hours from 135 degrees F to 70 degrees F, and within a total of 6 hours from 135 degrees F to 41 degrees F. It further stated that if food was not cooled in accordance to this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness.

A concurrent review of the hospital's "Cool Down Log" showed that the safe cool down of the beef tenderloin was not documented. The NSM stated that the log reviewed was the April log and the beef tenderloin cooling should have been documented on it. She was unable to explain why safe cooling of the beef was not documented.

4. During an observation and concurrent interview with the NSM on 4/8/13 at 9:10 a.m. in the kitchen, three trays of cut fresh fruit were dated 4/4/13. The NSM stated that the date on the trays indicated the date that the fruit was opened. She further stated that the policy was to discard the trays of cut fruit 3 days after opening. She stated that the fruit should have been discarded on 4/7/13.

Also noted was a container labeled "Chicken Roux Thickener - 3/28/13". The NSM stated that she did not have a policy or was aware of the shelf life for the roux. She stated that the cooks made the roux and that it should have been discarded.

A review of the Hospital's Nutrition Services policy titled, "Storage Procedures" (undated) did not reveal any guidance to staff regarding shelf life of the fresh cut fruit or the roux.

Based on staff interview, medical record and document review, the hospital failed to ensure that a complete and accurate examination and assessment of the patient (history and physical examination, H&P), performed by a qualified individual and updated by the surgeon, to reflect the current condition of the patient, was documented prior to the surgery in accordance with medical staff rules and regulations and acceptable standards of practice for 1 of 3 surgical patients in the emergency department (ED) reviewed (Patient 43). This failure resulted in the potential to not recognize the need for additional intraoperative support or consultation, in order to arrange for a safe surgery and anesthesia plan and to minimize the risk for adverse outcomes for Patient 43.

Findings:

1. The medical record for Patient 43 was reviewed with the ED Director (EDD) on 4/10/13 at 3 p.m. Patient 43, age 18 months, presented to the Emergency Department (ED) on 4/6/13 for pain and deformity of the right wrist occurring after he fell out of his crib onto a hardwood floor earlier that evening. A physician assistant (PA) documented a brief assessment at 9:31 p.m., ordered x-rays of the injured arm, and an oral pain reliever. Pain scale was documented at the maximum level (10/10) on arrival, and again 10/10 2 hours later. A narcotic pain medication was injected into Patient 43's muscle at midnight. At 1 a.m. orders were issued by MD 11 for staff to set up to reduce the broken bones of Patient 43's right arm. At 2 a.m., a general anesthetic medication (ketamine) was administered by MD 11 into a plastic tube that was inserted into Patient 43's vein, followed by the painful procedure of setting the broken bones. No pre-surgical H&P was documented by MD 11 in MD 11's preliminary note (only a copy and paste of the PA note), which was the only note available to staff as of 4/10/13 at 3 p.m.

The EDD, in a concurrent interview, acknowledged that there was no documented evidence of a pre-surgical H&P performed by the physician prior to the procedure.

In review of the Medical Staff Rules and Regulations, approved by the Governing Body 9/27/12, Pages 19-21, there was stipulation of the requirement for a full or abbreviated history and physical (H & P) to be performed by the physician prior to a procedure done under moderate or deep sedation. This H & P would include, at a minimum, the chief complaint, the medications to be given, history pertinent to the procedure and an appropriate assessment of the cardio-respiratory status.

The Rules and Regulations further directed, on Page 21, that the physician may utilize a history and physical performed by another physician (does not stipulate that this may be a Physician Assistant), but must conduct a second examination for any changes in the patient's condition and/or to confirm the information provided.

In review of a document titled Adult Procedural Sedation Practice, A Study Guide for Physicians, undated, Page 8-10, acknowledged by the hospital as the procedural sedation self study guide used for physicians, the pre-sedation assessment was defined to include:
a. A current H & P
b. Review of current medication history.
c. Allergies
d. Airway assessment
e. ASA classification (American Society of Anesthesiologists' Physical Status Classification System assessment of preoperative patient health done prior to selecting the anesthetic)
f. NPO status (when patient last ate or drank)
g. Vital signs
h. Baseline oxygen saturation.

The document, on Page 10, further described patients at high risk of complications to include a patient who has received prior sedation/analgesic medications (such as morphine) within the previous 12 hours.

In an interview with the Vice President of Nursing (VPN) on 4/11/13 at 9:30 a.m., she presented an undated, unnumbered draft of a policy titled Procedural Sedation which she said was the policy currently in use. The VPN acknowledged this draft had not as yet been finally approved by the medical staff and governing body. In review of this policy, there was stipulation on Page 4 that the Registered Nurse, in the pre-procedural assessment, would "b) assure physician has documented...update H & P, and pre-sedation assessment including airway assessment and assigned ASA score."

Review of the California Code of Regulations Title 22, a state standard for general acute care hospitals, under Chapter 1, section 70223(d)(1) documented that prior to commencing surgery the person responsible for administering anesthesia, or the surgeon if a general anesthetic is not to be administered, shall verify ... and ascertain that a record of an interval medical history and physical examination performed and recorded within the previous 24 hours appeared in the patient's medical record.

Review of a chapter from the online Merck Manual for Professionals (a nationally recognized reference for medical practice) titled Preoperative Evaluation retrieved at documented that a preoperative evaluation was intended to minimize surgical risk by identifying correctable abnormalities and by determining whether additional monitoring was needed or whether a procedure should be delayed so to better control an underlying disorder. The preoperative physical examination should include not only the areas affected by the surgical procedure but also the cardiopulmonary system and a search for any signs of ongoing infection (e.g. lungs, skin). Surgical risk factors were identified to include age greater than 70 years, heart attack within 6 months, poorly controlled heart failure, other heart diseases, co-existing infections, poor gas exchange in the lungs, low blood potassium level, and low blood protein level.

Review of standard ST-25 from the American College of Surgeons (ACS) titled "ACS Statement on Principles Underlying Perioperative Responsibility," retrieved from , under item 4 documented that the surgeon was responsible for the proper preoperative preparation of the patient. Minimizing the risk of operation, while providing maximal opportunity for a satisfactory outcome, required full appreciation by the surgeon of the patient's condition. Item 5 noted that the surgeon was responsible for the safe and competent performance of the operation. Part of this responsibility included planning for the operation with the anesthesiologist in order to ensure anesthesia that was best for the patient.

Based on staff interview, medical record and document review, the hospital failed to ensure that anesthesia services were well-organized and administered by qualified personnel, in accordance with acceptable standards of practice for all locations where monitored anesthesia care (MAC), including deep sedation, was delivered when:

A. An unqualified anesthesia provider was routinely performing deep sedation in the Emergency Department (ED). Refer to A-1001.

B. The Procedural Sedation Policy for patients, including children, receiving anesthesia care, including deep sedation, in all designated locations of the hospital did not clearly define the physician's responsibility to screen patients for high risk and therefore guide practices for needs and resources. Refer to A-1002.

C. Pre-anesthesia assessments, including the features of each patient's airway and risk for anesthesia, were not documented for all patients. Refer to A-1003.

D. There was no cumulative intra-operative record for anesthesia care in the ED to allow for all parameters monitored to be viewed simultaneously in order for the timely recognition and reporting of changes in conditions or complications of the procedure. Refer to A-1004.

E. The Procedural Sedation Policy did not define the requirements of the physician to perform and document a post anesthesia evaluation for patients receiving deep sedation in any area of the hospital. Refer to A - 1005.

In addition, the Anesthesia Service had failed to develop indicators for monitoring procedural sedation, including moderate and deep sedation, performed in the ED. Therefore the Anesthesia Service was not reviewing a problem prone circumstance whereby a single provider was administering deep sedation and at the same time performing a procedure in the ED.

These failures put patients at risk for unsafe anesthesia care by persons lacking the skills to manage the effects of deep sedation, and for delays in recognition and rescue interventions for adverse effects of anesthesia treatments.

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Conditions of Participation.

Based on staff interview, medical record and document review, the hospital failed to ensure anesthesia services were appropriately organized in accordance with acceptable standards of practice when one of two medical staff files reviewed revealed an unqualified person (a Medical Doctor, MD 2) was granted privileges and regularly performed anesthesia services, including moderate and deep sedation, in the Emergency Department (ED). This failure put patients at risk for unsafe anesthesia care by an unqualified person.

Findings:

Review of the Medical Staff Bylaws, approved 9/27/12, under item 5.4-2 documented, "The Medical Staff shall make an objective and evidence based decision with regard to each request for Privileges ... shall be evaluated on the basis of the Member's education, training, experience, current demonstrated professional competence and judgement."

In a collaborative review of medical staff files and interview with the Medical Staff Coordinator (MSC) on 4/9/13 at 9 a.m., the files of two ED physicians (MD 1 and MD 2) were reviewed.

The MSC indicated that the Anesthesia Service was responsible for and approved the privilege requirements for moderate and deep sedation care in all parts of the hospital, including the ED. The qualification requirements documented on the Special Procedures - Procedural Sedation privilege form were: A) Residency trained in Emergency Medicine and/or Board Certified in Emergency Medicine, or B) Competency in airway management as evidenced by one of the following and completion of the Procedural Sedation Written Examination:
- Airway competency certificate from GSSA facility [affiliate owned by same corporation];
- Current ATLS (Advanced Trauma Life Support) certificate;
- Current National Airway Course certificate;
- Certificate from nationally recognized certification course in airway management skills;
- Performing ten or more endotracheal intubations (insertion of a plastic tube into the windpipe to provide an airway) or bronchoscopies (insertion of tubes into the airway) in previous 2 years.

File review indicated MD 2, a contracted family practice physician who had worked in the ED for 10 years, was not Board-certified and had no documented evidence of education and training in Emergency Medicine or any other field where ongoing skill competency would be maintained for managing airways and the effects of general anesthesia. The MSC produced no evidence that MD 2 was qualified by education, training or special certifications to perform the necessary skills for monitored anesthesia care, including deep sedation, nor current competency for those skills. MD 2's file contained an expired ATLS certificate from 1996, but no current airway management certificates. MD 2's file contained a sedation written examination from his previous appointment cycle in 2011, but not current for the renewal of privileges cycle. No proctoring (observations of care by a qualified individual) specific to sedation care (adults or children) was documented.

In an interview on 4/10/13 at 12:30 p.m., an anesthesiologist who had previously served as the Chief of the Anesthesia Service (MD 10) indicated that the hospital's Anesthesia Service was responsible to oversee all procedural sedation care throughout the hospital. MD 10 indicated that the guidance for hospital sedation policies, trainings, and privilege requirements should be based on the standards and practices recommended by the American Society of Anesthesiologists (ASA), with consideration of the positions of other specialty organizations (for example, the American College of Emergency Physicians - ACEP) on an issue by issue basis that would not compromise patient safety. MD 10 acknowledged that MD 2's file lacked evidence of the qualifications to administer and supervise moderate and deep sedation, including for the care of children. MD 10 acknowledged that endotracheal intubation skill was not equal to airway management skill.

Review of the ASA Advisory on Granting Privileges for Deep Sedation for Non-anesthesiologist Sedation Practitioners, approved 10/20/10, emphasized the need to maintain current knowledge, skills and competency in performing this type of care, including the management skills for difficult airways and patients who are under the effects of a deeper than intended level of sedation (general anesthesia). The ASA's Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Providers, approved 10/26/11, similarly framed the qualifications to include current knowledge, skills, and demonstrated proficiency in airway management, including certifications in life support for children if administering sedation care to children. "Separate privileging is required for the care of pediatric patients."

In an interview on 4/10/13 at 1:40 p.m. with MD 1, who served as Chief of Staff and was a previous ED department chair, MD 1 acknowledged that the file for MD 2 did not provide documentation of education, training, or current certifications as evidence of qualifications and current competence for moderate or deep sedation care (e.g. airway management proficiency, life support rescue skills for children).

In an interview with the Vice President of Nursing (VPN) on 4/11/13 at 9:30 a.m., she presented an undated, unnumbered draft of a policy titled Procedural Sedation which she said was the policy currently in use. The VPN acknowledged this draft had not as yet been finally approved by the Anesthesia Service, the Emergency Medicine Committee, the Medical Executive Committee or the Governing Body. In review of this policy, there was no requirement for privileged sedation-anesthesia providers to possess airway management skills, to demonstrate current knowledge or proficiency in managing patients under the effects of a deeper than intended level of sedation, nor to possess current competence in the rescue of children. The policy draft did not denote the ASA or the ACEP as resources used in determining that education, training and certifications required met current professional standards for the qualifications to administer and supervise MAC, including deep sedation.

The Pediatric Sedation Research Consortium published its first report in 2006, "The Incidence and Nature of Adverse Events During Pediatric Sedation/Anesthesia for Procedures Outside the Operating Room," which identified "one concerning event per 29 sedation encounters (among all drugs, all procedures)." The Consortium emphasized that "the pediatric population represents the highest risk, lowest error tolerance subgroup. Pediatric patients require sedation/anesthesia more often than adults ... must be "deeper" than that given to adults to achieve acceptable "conditions" during a procedure. Most important, because of their physiology, children are at higher risk for respiratory depression (compromise of breathing) and life-threatening hypoxia (low oxygen level in blood).

Review of an ACEP policy statement (approved January 13, 2011) titled "Sedation in the Emergency Department," recommended, "Institutional and departmental guidelines related to the sedation of patients should include credentialing and verification of competency of providers, selection and preparation of patients, informed consent, equipment and monitoring requirements, staff training and competency verification, criteria for discharge, and continuous quality improvement."




29821

Based on staff interview, medical record and document review, the hospital failed to ensure the Anesthesia Service developed policies, based on current nationally recognized standards to screen the needs of high risk patients, and guide hospital practices to utilize the hospital resources for patients in all areas of the hospital who receive anesthesia services, including deep sedation. This failure put patients receiving anesthesia services at risk for adverse events (i.e. over-sedation that produces compromise to heart and lung function, choking on stomach contents, blockage of the air passage) related to the delivery of anesthesia services.

Findings:

The Procedural Sedation Policy, acknowledged by hospital leadership as the current practice, was identified as a draft, was undated and unnumbered, and had not been approved by the Anesthesia Service, the Emergency Medicine Committee, the Medical Executive Committee or the Governing Body. This was the only hospital policy that addressed anesthesia care and did not distinguish differences in processes, needs or resources in different locations of the hospital where anesthesia services (moderate and deep sedation) were provided (i.e. the Emergency Department (ED) or the GI (gastroenterology) Department. [Moderate sedation/analgesia is the administration of drugs to reduce pain and awareness during a surgical procedure while remaining easily aroused. Deep sedation is the administration of drugs to reduce pain and awareness during a surgical procedure; the intended depth of sedation makes a patient not easily aroused but can respond purposefully to repeated or painful stimulation; the drive to breathe may be impaired.]

In review of this policy, the Pre-Procedure, Intra-procedure and Post-Procedure responsibilities were all defined as the responsibilities of a Registered Nurse (RN).

a) Pre-Procedure: The RN was tasked to "b) assure the physician had documented informed consent, update H&P [history and physical examination, a type of physician assessment], and pre-sedation assessment including airway assessment, and assigned ASA score [American Society of Anesthesiologists' Physical Status Classification System assessment of preoperative patient health done prior to selecting the anesthetic]".
b) Intra-Procedure: The RN was tasked to monitor the patient's physiological status and on Page 6, "Collaborate with physician for treatment of over sedation. Obtain orders for reversal agent and administer reversal agent for desired effect."
c) Post-Procedure: The RN was tasked to "assess the respiratory rate, heart rate, oxygen saturation, blood pressure, ETCO2 (exhaled carbon dioxide levels) and level of sedation" throughout the recovery period and discharge the adult or pediatric patient when the defined parameters were met.

All teaching and discharge instructions, including all documentation was delegated to an RN.

1. ED practices were not in accordance with acceptable standards with appropriate oversight by Anesthesia Services. The needs and resources for anesthesia care for moderate and deep sedation were not well-defined in the Procedural Sedation policy.

Multiple interviews were conducted with anesthesiologists and ED physicians (Medical Doctors - MD 1, MD 4, MD 10, MD 11) who held leadership positions (current and former Anesthesia Service Directors, current and former Medical Directors of the ED) during the period from 4/8/13 - 4/11/13 in which they stated that ED physicians routinely utilized deep sedation to perform procedures on patients in the ED, including children. Generally, an ED physician administered the medication AND performed the procedure while an RN monitored the patient. Although a Respiratory Care Practicioner (RCP) was required to be present for deep sedation, the RCP was not a qualified anesthesia provider. The physician directors said the RN would observe the patient including the patient's vital signs (which could be automatically downloaded from the monitor into the medical record), color, ventilation effectiveness and level of sedation. There was not routinely another nurse in the room to assist the physician with the procedure or retrieve supplies, adjust equipment, position the patient or provide additional nursing tasks as needed. The staff acknowledged that there had been situations whereby the RN monitoring the patient stepped away from the bedside to retrieve a supply or adjust equipment. Likewise if the physician began the procedure and the level of sedation became inadequate, the physician may have to leave the patient's surgical site several times to re-administer medication, particularly if given in incremental doses.

Although these physicians universally agreed that it would be preferable to have two physicians present (one to perform the procedure, one assigned as the anesthesia provider), they stated ED procedures a) may be emergent with no time to obtain on call anesthesia or consultant services, or b) so short and uncomplicated that a separate anesthesia provider was not necessary.

In an interview on 4/10/13 at 12:30 p.m. with MD 10, who previously served as the Chair of the Anesthesia Service, he acknowledged the current policy for procedural sedation did not specify how "flexible" anesthesia care standards would be applied in the ED. He stated he had compromised with the ED physicians to allow the RN and RCP to provide monitoring for very brief procedures where the physician would not be interrupted during surgery but this was never defined in the policy.

MD 10 further acknowledged he had researched current standards for the management of patients, including children, in the ED, but these had not been incorporated into the new policy, which listed no current standards of practice after 2007.

In an interview on 4/10/13 at 1:40 p.m., an ED physician (MD 1), who also served as the Chief of Staff, stated for all but three hours a day there was only one physician assigned to work in the ED. During the night hours, no other qualified anesthesia practitioners were immediately available to ED patients. MD 1 stated that an anesthesia staff member was not required to be in the hospital 24 hours; however, there was an anesthesiologist who could be called to the ED if needed (on-call). MD 1 acknowledged, however, that an anesthesiologist had never been called to the ED to assist with anesthesia care for moderate or deep sedation. MD 1 stated "CMS [Centers for Medicare-Medicaid Services] allows single provider administration and monitoring [of anesthesia care]" in the ED. MD 1 presented no documentation from CMS with such language.

In a subsequent interview with MD 1 on 4/10/13 at 4:30 p.m., he stated the ED had identified the specific types of procedures where a single physician could be used and referred to it as a "list" which was "in the policy". In review of the policy, there was no "list" and this was confirmed by the Quality Director on 4/10/13 at 5:30 p.m. MD 1 further stated no quality monitoring or peer review of procedural sedation had been conducted on any of the procedural sedation cases in the ED.

In a further interview with MD 10 (an anesthesiologist) on 4/10/13 at 7 p.m., he again reiterated the ED physician should not need to interrupt surgery or be distracted with the responsibility to monitor and provide early recognition and interventions for adverse side effects from the sedation or the surgery.

Review of the ASA's "Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists," published April 2002 and listed as a reference in the hospital's Procedural Sedation policy (presented as current but not approved), cautioned about the rapid, profound decreases in level of consciousness and heart/lung function that can occur with the administration of deep sedation drugs. The effects of ketamine in particular included obstruction of the airway, spasm of the vocal chords, and choking on stomach secretions into the lungs. The unique properties of ketamine made observation of the depth of sedation unreliable. No drugs are available to reverse the effects of ketamine. Certain patients were at increased risk for complications related to sedation/analgesia, (e.g. extremes of age, co-existing diseases, drug/alcohol abuse); the risks were decreased when preprocedure consultation with appropriate specialists, and the likelihood of satisfactory outcomes were increased. "For deep sedation, the consultants agree that the immediate availability of [an anesthesiologist] improves the likelihood of satisfactory sedation and that it will decrease the likelihood of adverse outcomes."

Review of a policy statement approved January 13, 2011 by the American College of Emergency Physicians (ACEP) titled "Sedation in the Emergency Department," recommended, "Institutional and departmental guidelines related to the sedation of patients should include credentialing and verification of competency of providers, selection and preparation of patients, informed consent, equipment and monitoring requirements, staff training and competency verification, criteria for discharge, and continuous quality improvement."

In an interview with the Director of Anesthesia Services (MD 4) and an anesthesiologist (MD 10) on 4/11/13 at 2:39 p.m., MD 4 acknowledged the Anesthesia Service was responsible for anesthesia care provided in all locations of the hospital. MD 4 acknowledged the policy did not stipulate under what circumstances a single provider (the ED physician) could perform a procedure while administering the anesthesia for deep sedation. MD 4 stated this was "the first policy I had done" and "there was not a lot of good literature on emergency sedation". MD 10 agreed it was hard to determine if an ED case was truly an emergency if several hours had passed between the first provider exam and the surgery. This was exemplified in the case of Patient 43, an 18 month old with a fractured wrist, triaged as an urgent versus emergent acuity, who waited 5 hours after arrival to have his fracture reduced. Both anesthesiologists acknowledged the ED physician was given the autonomy to determine if any additional needs or resources were needed on a case to case basis rather than what components of the pre-anesthesia evaluation might place the patient at high risk and require either an anesthesiologist consult, presence of the anesthesiologist, or the presence of another physician, for example an orthopedist, to perform the procedure itself. MD 4 stated none of the anesthesiologists had ever been called for a consult or to come to the ED to assist with procedural sedation. MD 10 stated if they were ever called to assist with procedural sedation by the ED, they would take the patient to the Operating Room for the procedure.

Review of the Call Schedule for specialists available to the ED 24 hours/day indicated that a bone specialist, two anesthesiologists (one for pregnant patients), and several other specialists could be called to the hospital and utilized to perform surgical or anesthesia services for ED patients who did not require immediate surgical interventions.

Review of a statement published by the American Society for Anesthesiologists titled "The Organization of an Anesthesia Department," last amended 10/22/08, under item II-D-2 for administrative responsibilities, directed:

The director of the anesthesia department should be responsible for the following medically related administrative functions in a manner similar to directors of other clinical departments and should be a permanent voting member of the Executive Committee ...

2. Monitoring the quality of anesthesia care rendered throughout the hospital, including surgical, obstetrical, emergency, outpatient, psychiatric and special procedures areas. The ASA Documentation of Anesthesia Care should be followed in order to provide the factual basis for such monitoring.

Item II-D-5 further directed:

5. Ensuring evaluation of the quality of anesthesia care throughout the hospital through a structured quality committee composed of members of the department.

Review of a standard titled "Clinical Policy: Evidence-Based Approach to Pharmacologic Agents Used in Pediatric Sedation and Analgesia in the Emergency Department," published in the Annals of Emergency Medicine, October 2004, by the Emergency Medical Services for Children Program, a multidisciplinary panel funded by the US Dept of Health and Human Services, Maternal and Child Health Bureau, noted that the standards for anesthesia care were applicable whenever moderate or deep sedation was to be given.

2. GI Department sedation practices were not defined in policy.

In a tour of Surgery on 4/9/13, the Vice President of Medical Affairs (VPMA) confirmed
three colonoscopies were scheduled to be done in surgery that week. There were no colonoscopies scheduled to be done in the GI Department.

MD 10, in an interview on 4/11/13 at 2:40 p.m. stated anesthesiologists do deep sedation in the Operating Room for GI procedures on patients "with complex medical baggage" (i.e. patients with serious co-existing conditions or high risk for adverse events related to surgery or anesthesia).

Both anesthesiologists (MD 4 and MD 10) acknowledged the Procedural Sedation Policy did not address what defined a high risk GI patient nor how the determination would be made for moderate sedation (administered by the RN in the GI Department) versus deep sedation (administered by the anesthesiologist in the operating room).

3. Procedural Sedation Policy did not ensure sufficient qualified staff were utilized for all sedation procedures.

In an interview on 4/10/13 at 12:30 p.m., MD 10 indicated that monitoring of sedation patients (whether moderate or deep, whether performed by an RN or qualified anesthesia provider) should be continuously provided without interruption to obtain drugs or supplies, or perform surgical tasks (such as assisting in the surgery). MD 10 indicated that safety practices as reflected in policies should be generally guided by the principles of the ASA, with consideration of other specialty organizations which did not compromise patient safety.

MD 10 concurred with the position of the ASA in its Advisory on Granting Privileges for Administration of Deep Sedation to Non-anesthesiologist Sedation Practitioners, approved 10/20/10, that "any professional who administers and monitors deep sedation must be dedicated to that task."

The recently revised draft policy Procedural Sedation, undated, unnumbered was acknowledged by the Vice President of Nursing (VPN) and the ED Director (EDD) on 4/11/13 at 10:30 a.m. as the policy currently being followed, however revealed this policy had not been approved by the Anesthesia Committee, the Emergency Medicine Committee, the Medical Executive Committee or the Board of Directors.

On Page 2 of the policy, there was stipulation: "3. Sufficient numbers of qualified personnel (in addition to the Licensed Independent Practitioner (LIP) performing the procedure) are present during procedures using moderate or deep sedation to...b. Provide the moderate or deep sedation and c. Assist the provider with the procedure"

On Page 5, the policy directed that the ED physician would determine if an additional staff member [other than the physician and one RN] should be present for maintaining an airway in a patient who has a higher probability of losing his/her ability to maintain a patent airway and protective reflexes or an additional ACLS [Advanced Certification Life Support] qualified RN.

On Page 6 of the policy, under Medication, the following was noted: "b) The physician must administer medications to induce deep sedation. These medications may include: Ketamine, Brevitol, and Propofol. However, in Addendum A in an area titled Deep Sedation Agents, Page 10, there was stipulation: "Physician will administer deep sedation agents. In the Emergency Department the RN who is certified in Procedural Sedation may administer Ketamine or Propofol when the physician is in immediate attendance at the patient's bedside." These two areas of the policy were in conflict regarding the ability of the RN to administer a drug for deep sedation.

Evidence that a qualified anesthesia provider administered deep sedation to Patient 44 during an ED procedure was not found in the clinical record. Review of Patient 44's Medication Record revealed two sedatives, ketamine and Propofol, were administered by an ED nurse (RN 2) at 8:19 p.m., 1/29/13 before a procedure to repair a lacerated tongue. Physician documentation on the "Emergency Documentation - MD" form stated, "Procedural sedation: Propofol and Ketamine, IV. See nurse's notes."

In a 10:53 a.m., 4/10/13 interview, an ED Clinical Coordinator (EDCC) stated that Propofol and ketamine were to be administered only by physicians. He indicated the RN documenting medications during the procedure should note physician-administered medications as "performed by" the physician in the medical record. He stated he was "not finding documentation" in Patient 44's medical record to provide evidence that the Propofol and ketamine were given by the physician.

Further review of the Procedural Sedation policy indicated, "The director of anesthesia services is responsible for...Specifying the minimum qualifications of each category of practitioner who is permitted to provide anesthesia services that are not subject to the anesthesia administration requirements of 42 CFR [Code of Federal Regulations] 482.52(a) ...The physician must administer medications to induce deep sedation. These medications may include ketamine, Brevitol and Propofol. "

Review of 42 CFR (Code of Federal Regulations published by CMS) 482.52(a) stated, "General anesthesia, regional anesthesia and monitored anesthesia, including deep sedation/analgesia, may only be administered by: A qualified anesthesiologist...An MD or DO [Doctor of Osteopathy]...A dentist, oral surgeon or podiatrist who is qualified...A CRNA [Certified Registered Nurse Anesthetist]...An anesthesiologist's assistant...." An ED RN was not listed as qualified to administer deep sedation, yet, the hospital policy permitted the practice.

A 4/08 Annals of Emergency Medicine (Volume 51, Number 4) advised providers, "Appropriate monitoring and assessment are critical for safe and effective procedural sedation and analgesia."

Based on interview, medical record and document review, the hospital failed to ensure that pre-anesthesia assessments included documentation of the features of each patient's airway and risk for anesthesia, in accordance with hospital training and nationally recognized standards of practice for 2 of 3 emergency department (ED) records reviewed (Patients 43 and 45). This failure put patients at risk for lack of preparedness to support high risk patients during surgeries that utilized anesthesia care, or delays in recognition of complications for high risk patients.

Findings:

1. Review of the medical record with the ED Director (EDD) on 4/10/13 at 4:30 p.m. indicated that Patient 43, age 18 months, presented to the ED on 4/6/13 for pain and deformity of the right wrist occurring after he fell out of his crib onto a hardwood floor earlier that evening. Shortly after arrival, a physician assistant documented an assessment at 9:31 p.m., ordered x-rays of the injured arm, and ordered an oral pain reliever. Pain scale score was documented at the maximum level (10/10) on arrival, and again, 10/10, 2 hours later. A narcotic pain medication was injected into Patient 43's muscle at midnight. At 1 a.m. orders were issued by MD 11 for staff to set up to realign the broken bones of Patient 43's right arm. At 2:07 a.m., an anesthetic medication (ketamine) was administered by MD 11 into Patient 43's intravenous (IV) line prior to setting the broken bones. No pre-anesthesia evaluation, including an airway assessment with the ASA Class score, was documented by MD 11 prior to the procedure.

ASA Class refers to an assessment of physical health developed by the American Society of Anesthesiologists to be performed prior to selecting an anesthetic; ASA Class scores partly correlate with surgical and anesthetic outcomes.

Features of an airway assessment (as referenced in the April 2002 ASA Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists) would include mouth opening, neck shape and motion, heart sounds and rhythm, and lung sounds.

The use of ketamine or any other drug classified by the FDA as a general anesthetic agent as part of procedural care requires care (at a minimum) consistent with deep sedation. Deep sedation is the administration of drugs to reduce pain and awareness during a surgical procedure. The intended depth of sedation makes a patient not easily aroused but can respond purposefully to repeated or painful stimulation. The drive to breathe may be impaired.

Further review of the medical record indicated that on arrival at 9:20 p.m. ED staff assigned Patient 43 as "urgent" for priority to be evaluated and treated by the sole ED physician (MD 11). Since a physician assessment by MD 11 was not documented on the day of surgery, the record could not confirm when MD 11 actually evaluated Patient 43. The treatment requiring anesthesia care was not performed until 4.6 hours after arrival, indicating the treatment was not emergent or immediately life-saving. Yet, no assessment of the need to consult with an anesthesia department provider as part of the pre-anesthesia process was documented.

2. Review of the medical record with the ED Director (EDD) on 4/10/13 at 4:30 p.m. indicated that Patient 45, a five year old, presented to the ED on 4/1/13 with pain and deformity of the left arm following a fall from a trampoline. There was no documentation of an airway assessment, including the ASA score, prior to the reduction of the fracture under deep sedation with ketamine.

ED staff assigned a priority level of "non-urgent" to Patient 45 on arrival at 8:11 p.m. Anesthesia and procedural care for Patient 45's broken arm was performed at 11:22 p.m., 4.1 hours after arrival as a non-emergent, non-life-saving treatment. No assessment of the need to consult with an anesthesia department provider as part of the pre-anesthesia process was documented.

In review of a document titled Adult Procedural Sedation Practice, A Study Guide for Physicians, undated, Page 8-10, acknowledged by the hospital as the procedural sedation self study guide used by physicians, the pre-sedation assessment was defined to include:
a. A current History and Physical (H & P)
b. Review of current medication history
c. Allergies
d. Airway assessment
e. ASA classification
f. NPO ("nil per os," whether patient has had recent oral intake) status
g. Vital signs
h. Baseline oxygen saturation (oxygen level in blood).

The document, on Page 10, further described patients at high risk of complications to include a patient who has received prior sedation/analgesic medications (such as narcotic given to Patient 43 above) within the previous 12 hours.

In an interview on 4/10/13 at 12:30 p.m., MD 10, an anesthesiologist and previous Chief of Anesthesia Services, indicated that the hospital's anesthesia service was responsible to oversee all procedural sedation care throughout the hospital. MD 10 indicated that the guidance for hospital sedation policies, trainings, and privilege requirements should be based on the standards and practices recommended by the American Society of Anesthesiologists.

In a 4/08 Annals of Emergency Medicine (Volume 51, Number 4) article titled, "Clinical Policy: Critical Issues in the Sedation of Pediatric Patients in the Emergency Department,"
providers were advised, "Appropriate monitoring and assessment are critical for safe and effective procedural sedation and analgesia..."

Review of the American Society for Anesthesiologists (ASA) statement titled "Advisory on Granting Privileges for Administration of Deep Sedation to Non-Anesthesiologist Sedation Practitioners," approved 10/20/10, indicated in section 3.3 that the sedation practitioner should perform a physical examination to assess risks and co-existing conditions, including assessment of the airway for anatomic and mobility features suggestive of a difficult airway to manage. A commonly used system to describe some findings of the assessment is called a Malampati score. ASA Class also designates particular aspects of a patient's risk to tolerate surgery and anesthesia. Section 3.3 specified some high risk patients who would benefit by sedation provided by an anesthesia professional to include morbidly obese patients, elderly patients, pregnant patients, patients with severe systemic diseases, patients whose airways get obstructed when they sleep, and patients with very full stomach contents.

The Pediatric Sedation Research Consortium published its first report in 2006, "The Incidence and Nature of Adverse Events During Pediatric Sedation/Anesthesia for Procedures Outside the Operating Room," which identified "one concerning event per 29 sedation encounters (among all drugs, all procedures)." The Consortium emphasized that "the pediatric population represents the highest risk, lowest error tolerance subgroup. Pediatric patients require sedation/anesthesia more often than adults ... must be "deeper" than that given to adults to achieve acceptable "conditions" during a procedure. Most important, because of their physiology, children are at higher risk for respiratory depression (compromise of breathing) and life-threatening hypoxia (low oxygen level in blood).

Review of the hospital's Procedural Sedation Policy (undated, unapproved, and presented as current practice with the Vice President of Nursing on 4/11/13 at 9:30 a.m.) did not disclose direction to the non-anesthesiologist deep sedation provider for when (circumstances, high risk conditions) to consult with an anesthesia professional. There was no direction for the physician to perform a pre-anesthesia assessment and document prior to initiating anesthesia and surgical care. There was, however, stipulation on Page 4 that the Registered Nurse, in the pre-procedural assessment, would "b) assure physician has documented...updated H & P, and pre-sedation assessment including airway assessment and assigned ASA score."

Review of the National Integrated Accreditation for Healthcare Organization (NIAHO) standards for assessments prior to anesthesia services indicated that a pre-anesthesia or pre-sedation evaluation must be performed and documented, by an individual qualified and privileged to administer anesthesia/sedation, not more than 48 hours prior to surgery or procedure requiring anesthesia services (included moderate sedation). This evaluation must include airway assessment, anesthesia risk assessment and anesthesia drug and allergy history.

Based on staff interview, medical record and document review, the hospital failed to ensure that a complete and accurate intraoperative anesthesia record, in accordance with acceptable standards of care, was provided for three of three sampled pediatric patients (Patients 43, 44, 45) receiving deep sedation during procedures in the Emergency Department (ED).

This failure put patients at risk for a delay in recognizing the need to rescue a patient from a deeper-than-intended level of sedation and therefore created a potential for an adverse outcome.

Findings:

Review of the undated administrative "Procedural Sedation Policy" provided the following definition of "Deep sedation/Analgesia:" "A drug induced depression of consciousness, during which patients cannot be easily aroused but respond purposefully after repeated or painful stimulation. The ability to independently maintain ventilatory (breathing) function may be impaired. Patients may require assistance in maintaining a patent [open] airway and spontaneous ventilation may be inadequate....Deep Sedation may be used for short-term surgical, therapeutic, or diagnostic procedures in which deeper sedation is necessary due to the increased pain or discomfort associated with the procedure (e.g....orthopedic reductions [bone realignments] or the type of drug necessary to sedate the patient produces a deeper level of sedation...."

The "Procedural Sedation Policy" required the following Registered Nurse (RN) documentation during the procedure: "Each patient's physiological status will be monitored during sedation. 1. Oxygen saturation, continuous waveform ETCO2 [the amount of carbon dioxide exhaled at the end of a breath, a measure of cardiorespiratory function] and cardiac rhythm will be monitored continuously. 2. The following will be assessed at a minimum of every 5-minute intervals or more frequently if needed: Blood pressure, Respiratory (breathing) Rate, Heart Rate and level of sedation (LOS). Pain assessment if patient demonstrates pain."

1. Review of the medical record noted Patient 43 was an 18 month-old brought to the ED at 9:20 p.m., 4/6/13 with an arm injury (fractures of two bones of the forearm) after falling from his crib. His initial pain score was rated by his nurse as 10/10, using the FLACC (Face, Legs, Activity, Cry, Consolability) Pain Scale, with 10 representing maximal pain.

The first pre-procedure baseline vital signs recorded for Patient 43 were at 1:50 a.m., 4/7/13, when his heart rate was 112 beats per minute (bpm) and blood pressure (BP) was 120/62. A normal resting heart rate for a 1-2 year old child is 80-120 bpm (http://www.nlm.nih.gov/medlineplus/ency/article/003399.htm); normal BP range is 85-106/37-61 (http://www.heart.org/idc/groups/heart-public/@wcm/@ecc/ documents/downloadable/ucm_436697.pdf).
Immediate preprocedure vital signs included a heart rate of 115 and a BP of 115/57. Patient 43 received the anesthetic drug ketamine, 10 milligrams (mg.) at 2:07 a.m., 4/7/13 before undergoing the procedure to realign his fractures. Four minutes after the ketamine was given, his heart rate had risen to 192 and his BP to 139/71. Patient 43's heart rate gradually slowed but remained 163 immediately post-procedure at 2:40 a.m., 4/7/13. No nursing or physician documentation addressed the abnormal vital signs. In his "Final Report," the physician stated, "The patient tolerated the reduction [realignment] and the sedation well with no complications."
The Procedural Sedation Policy directed the RN to notify the physician for significant changes from baseline in heart and breathing rates. However, the policy only outlined specific reportable age-related changes on the lower end of heart and breathing rates and not the upper end.
Review of Patient 43's medical record indicated the following intraprocedural documentation missing per policy:
a. A gap of sedation level monitoring occurred between 2:14 a.m. and 2:27 a.m. with an increase in sedation by one of the three scales documented which was not addressed by RN or MD. The sedation level remained minimal even during the peak effect of the ketamine, suggesting the ketamine was ineffective and the procedure occurred without its benefit, or the monitoring did not capture the effect.
b. No baseline ETCO2 and first ETCO2 not noted until 4 minutes after the sedative was given. The ETCO2 level was abnormally low when the breathing rate was also low (had fallen from 24 to 11 breaths per minute). The relationship between these two measurements should be opposite so that when the breathing rate is low the ETCO2 level is high, and vice versa. No explanation was documented in the record.
c. No cardiac rhythm noted.
d. No documented evidence physician was aware of accelerated heart rates to 192 and elevated blood pressures,
e. A 13-minute gap in all aspects of monitoring between 2:14 a.m. - 2:27 a.m.

Nursing notes documented that Patient 43 did not waken for at least 30 minutes and sustained rapid heart rates throughout the procedure, a prolonged period of drug effect beyond what is expected from the manufacturer, without documented explanation or interventions in response to the altered condition. The ketamine drug manufacturer literature noted that the onset of anesthetic effect occurs within 30 seconds of administration into the vein, and lasts for 5-10 minutes.

2. Patient 44 was a 16.2 kilogram (kg.) 4 year-old who presented to the ED at 3:22 p.m., 1/29/13, with a lacerated tongue. Her initial pain score was rated by her nurse as 10/10, using the FLACC Scale. Patient 44 received two IV anesthetic drugs, propofol 50 mg. and ketamine 20 mg., between 7:20 p.m. - 7:26 p.m., 1/29/13, prior to the repair of her tongue. The procedure concluded at 7:42 p.m.

During a review of Patient 44's medical record, the following intraprocedural documentation was not found:
a. Level of sedation was not noted between 7:26 p.m. and 7:57 p.m., a gap of 30 minutes,
b. Pain was not documented from 3:28 p.m. until 8:20 p.m., and
c. Cardiac rhythm was not documented during the procedure.

Patient 44 was not moving arms or legs at 7:26 p.m. but the next assessment of movement was not documented until 7:57 p.m., 30 minutes later, suggesting a prolonged effect of the multiple anesthetic medications or failure to monitor their effects.

Review of the undated Procedural Sedation Policy Attachment B indicated that propofol was not listed on the sedation drugs recommended for children. Ketamine was listed for children. The duration of action or anesthetic effect of each medication was not documented to guide anticipation for the drug wearing off during a procedure, or to guide how long to monitor following the procedure.

3. Patient 45 was a 22.6 kg. 5 year-old brought to the ED at 8:11 p.m., 4/1/13 with wrist swelling after a fall from a trampoline. Her initial pain score was rated by her nurse as 4/5, using the Wong-Baker FACES pain scoring tool, with 5 being maximal pain.

At 11:22 p.m., 4/1/13, Patient 45 received 30 mg. of the anesthetic ketamine prior to the procedure to realign her arm fracture. The procedure ended at 11:40 p.m., 4/1/13.

During a review of Patient 45's medical record, intraprocedural documentation of the cardiac rhythm was not found.

In a collaborative record review of the care for Patients 43, 44, and 45 with the ED Director (EDD) on 4/10/11 at 7:30 p.m., she acknowledged that the deep sedation elements of monitoring were fragmented and dispersed among several electronic page files, not simultaneously visible to the person responsible to recognize early adverse changes or trends that would prompt medical interventions to support heart, lung or brain function. For example, one electronic page file contained vital sign measurements for heart rate, breathing rate, blood pressure, and blood oxygen level. A separate electronic page file contained the results of blood oxygen and exhaled carbon dioxide gas levels. A separate electronic page file contained a scoring system to reflect whether a patient moved voluntarily or when stimulated, the patient's depth of breathing, the patient's blood pressure compared to baseline, the patient's level of consciousness, and how depressed the blood oxygen level was. A separate electronic page file contained a different scoring system for the level of sedation. A separate page noted pain level. The frequency of entries for each electronic page file was not consistent for all measurements, and did not conform to 5 minute intervals (minimal) during the procedures for Patients 43, 44, or 45.

In an interview with an ED Clinical Coordinator (EDCC) on 4/11/13 at 10:30 a.m., he acknowledged the parameters monitored by the RN during procedural sedation in the ED were documented in different places in the computerized medical record. The EDCC stated any nursing notes of intolerance to medications or the procedure, any adverse events or changes in patient condition or any communication with the physician could also be located, if noted, in different sections of the clinical record. The EDCC also stated the nurse had the option to "import" [download] vital signs directly from the monitoring system into the electronic medical record. The EDCC acknowledged there was no way to identify whether vital signs had been reviewed in real time unless documented as such. The EDCC stated ED physicians administered deep sedation medications, however, nurses were responsible for recording them.

In a 2:30 p.m., 4/11/13 interview, MD 4 stated there was no single intraoperative record used for the monitoring of patients under deep sedation in the ED but acknowledged that another department (gastroenterology) utilized a single form which displayed all the features of anesthesia monitoring simultaneously.

Review of the American Society of Anesthesiologist (ASA) Standards for Basic Anesthetic Monitoring, effective 7/1/11, directed under item I that anesthesia care monitoring (included deep sedation monitoring) be performed and documented by qualified anesthesia personnel, present in the room throughout the conduct of the care. Item 2.2 emphasized continuous assessment of color and oxygen level. Item 3.2.4 read, "During moderate or deep sedation the adequacy of ventilation shall be evaluated by continual observation of qualitative clinical signs and monitoring for the presence of exhaled carbon dioxide." Item 4.2.1 documented, "Every patient shall have the electrocardiogram (device that measures heart rhythm) continuously displayed from the beginning of anesthesia until preparing to leave the anesthetizing location." A time-based documentation (every 5 minutes at a minimum) of vital signs and assessments was standard. The standard did not permit substituting direct assessment of the patient with machine print-outs of vital sign measurements.

Review of the ASA's "Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists," published April 2002 and listed as a reference in the hospital's Procedural Sedation policy (presented as current but not approved), strongly advised the use of contemporaneous (measurements taken in real time throughout the period of monitoring) recordings, "manual recording ensures that an individual caring for the patient is aware of changes in patient status in a timely fashion." In addition, the ASA recommended that sedative/analgesic drugs be given in small, incremental doses, to allow for sufficient time to elapse to assess the effect of each dose before additional drug administration.

Review of a standard titled Clinical Policy: Evidence-Based Approach to Pharmacologic Agents Used in Pediatric Sedation and Analgesia in the Emergency Department, published in the Annals of Emergency Medicine, October 2004, by the Emergency Medical Services for Children Program, a multidisciplinary panel funded by the US Dept of Health and Human Services, Maternal and Child Health Bureau, noted that deep sedation for procedures in children was often necessary and intended. The EMSA group also strongly urged that additional safety measures be taken for head positioning, supplemental oxygen, occasional bag-valve-mask ventilatory support, and measures to address laryngospasm when ketamine or propofol were used for pediatric procedures.

Review of a policy statement approved January 13, 2011 by the American College of Emergency Physicians (ACEP) titled "Sedation in the Emergency Department," recommended, "To minimize complications, the appropriate drugs and dosages must be chosen and administered in an appropriately monitored setting, and a patient evaluation should be performed before, during, and after their use."

Based on interview, clinical record and document review, the anesthesia provider failed to document a comprehensive post-anesthesia evaluation for three of three Sampled Patients (Patients 43, 44, 45) who received deep sedation in the Emergency Department (ED). This failure put patients at risk for continued or harmful effects of anesthesia drugs at the time of discharge from the ED.

Findings:

Review of the undated, unnumbered, draft Procedural Sedation Policy revealed the following definition of "Deep sedation/Analgesia:" "A drug induced depression of consciousness, during which patients cannot be easily aroused but respond purposefully after repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent [open] airway and spontaneous ventilation may be inadequate....Deep Sedation may be used for short-term surgical, therapeutic, or diagnostic procedures in which deeper sedation is necessary due to the increased pain or discomfort associated with the procedure (e.g....orthopedic reductions [bone realignments] or the type of drug necessary to sedate the patient produces a deeper level of sedation...."

The Procedural Sedation Policy required the following nursing documentation post-procedure: "Immediately post-procedure assess respiratory rate, heart rate, oxygen saturation, blood pressure...ETCO2 [the amount of carbon dioxide exhaled at the end of a breath, a measure of cardiorespiratory function] and LOS [level of sedation] and then reassess at 5, 10 and then every 15 minutes during recovery phase or more frequently if indicated." The policy did not address physician responsibilities in the post-procedure patient evaluation.

1. Patient 43 was an 18 month-old brought to the ED at 9:20 p.m., 4/6/13 with an arm injury after falling from his crib. His initial recorded blood pressure at 1:50 a.m., 4/7/13 was 120/62 and his heart rate was 112 beats per minute (bpm). According to the 18th edition of Nelson's Textbook of Pediatrics (Philadelphia: Saunders Elsevier, 2007, page 389) the normal range for heart rate in children 1-3 years of age is 70-110 bpm; the normal breathing rate is 20-30, and normal blood pressure range is 90-105/55-70.

At 2:07 a.m., 4/7/13, the physician administered an anesthetic ketamine, 10 milligrams (mg.) prior to a procedure to realign Patient 43's fractures.

Review of the American Society of Anesthesiologists' (ASA) Practice Guidelines for Postanesthetic Care (2002) recommended routine post-anesthesia physician assessment and monitoring of patient condition that included respiratory function (respiratory rate, airway patency and oxygen saturation), cardiovascular function (pulse rate and blood pressure), mental status, temperature, pain, nausea and vomiting.

Review of Patient 43's clinical record indicated missing evaluation elements including pain, temperature, nausea and vomiting.

The RN recorded blood pressures and heart rates for 29 minutes after Patient 43's procedure ended. The patient was discharged with a persistently elevated heart rate of 149. No nursing or physician note explained the abnormal vital signs or measures taken to address them.

The Procedural Sedation Policy provided direction for post-procedure monitoring time when narcotics & reversal agents were administered but did not address the expected duration of monitoring after receipt of an anesthetic agent.

2. Patient 44 was a 4 year-old who presented to the ED at 3:22 p.m., 1/29/13, with a lacerated tongue. Patient 44 received two anesthetics (injected into a vein), propofol 50 mg. and ketamine 20 mg., between 7:20 p.m. - 7:26 p.m., 1/29/13, prior to the repair of her tongue.

A review of Patient 44's medical record failed to locate post-anesthesia physician evaluation elements for temperature, nausea and vomiting. Missing nursing documentation included levels of sedation post-procedure.

3. Patient 45 was a 5 year-old brought to the ED at 8:11 p.m., 4/1/13 with wrist swelling after a fall from a trampoline. At 11:22 p.m., 4/1/13, the physician administered 30 mg. of ketamine to Patient 45 prior to the beginning of the procedure to realign her fractured arm.

During a review of Patient 45's medical record, missing post-anesthesia physician evaluation elements included airway assessment, heart rate, blood pressure, respiratory rate, temperature, pain, nausea and vomiting.

Although Patient 45 was monitored for 26 minutes following the conclusion of the procedure at 11:40 p.m., she was discharged with an elevated heart rate of 122 and BP 126/81. A previously recorded resting heart rate was 80, and BP was 118/69. According to the 18th edition of Nelson's Textbook of Pediatrics (Philadelphia: Saunders Elsevier, 2007, page 389) the normal range for heart rate in children 3-6 years of age is 65-110 bpm; and normal blood pressure range is 95-110/60-75. No nursing or physician note explained the abnormal vital sign or measures taken to address it. A post-anesthesia patient assessment was not documented for Patient 45 by the anesthesia provider prior to discharge.

During an 11 a.m., 4/11/13 interview, an Emergency Department Clinical Coordinator (EDCC) stated it was the doctor's responsibility to document a preprocedural assessment, reaction to procedural sedation, a procedural note and post-procedure monitoring results.

A 4/08 Annals of Emergency Medicine (Volume 51, Number 4) advised providers, "Appropriate monitoring and assessment are critical for safe and effective procedural sedation and analgesia."

Review of the American Society for Anesthesiologists (ASA) standard titled "Documentation of Anesthesia Care," last amended 10/15/03, directed under item III that each patient record should include documentation by a qualified anesthesia provider (in addition to any non-physician monitoring) of:

A. Patient evaluation on discharge from the postanesthesia care unit.
B. A time-based record of vital signs and level of consciousness.
C. A time-based record of drugs administered, their dosage and route of administration.
D. Type and amounts of intravenous fluids administered.
E. Any unusual events including postanesthesia or postprocedural complications.
F. Postanesthesia visits.

Review of the National Integrated Accreditation for Healthcare Organization (NIAHO) standards for assessments prior to anesthesia services indicated that a post-anesthesia or post-sedation evaluation must be completed and documented within 48 hours after surgery by the individual who administered the anesthesia, or if approved by the medical staff, by any individual qualified and credentialed to administer anesthesia. The post-anesthesia evaluation must be completed in accordance with State law and hospital policies and procedures approved by the medical staff. The post-evaluation must meet current standards of care any time general, regional or monitored anesthesia has been administered. If a patient is discharged less than 48 hours after the procedure, completion and documentation of the post-anesthesia evaluation is still required.

Review of a policy statement approved January 13, 2011 by the American College of Emergency Physicians (ACEP) titled "Sedation in the Emergency Department," recommended, "To minimize complications, the appropriate drugs and dosages must be chosen and administered in an appropriately monitored setting, and a patient evaluation should be performed before, during, and after their use."

Based on observation, staff interview, medical record and document review, the hospital failed to ensure the Emergency Department (ED) and the Obstetrical Service (OB) integrated their services effectively and timely in the management of pregnant patients who presented with an acute medical condition when there was a delay in a physician assessing a pre term (under 38 weeks gestational age) patient (Patient 1) which resulted in a delayed diagnosis of a septic condition and an admission to the Intensive Care Unit.

Findings:

Review of the medical record indicated that Patient 1 presented to the ED on 3/8/12 at 9:16 p.m. with complaints of fever, chills, cough, chest pain, shortness of breath and decreased fetal (fetus, unborn child) movement. Patient 1 was 28 weeks pregnant (term pregnancy = 40 weeks). An ED nurse documented a set of vital sign measurements that included a significantly elevated heart rate (158 beats per minute), elevated temperature (99.9 degree Fahrenheit) and 20 respirations per minute. Patient 1's blood pressure was 97/60 and her oxygen saturation level (amount of oxygen in the blood) was 95% (95%-98% = normal). No physical assessments for Patient 1's heart, lungs, circulation, or movements were documented. The ED physician was not notified of Patient 1's medical status. Patient 1 was sent to the obstetric unit (labor and delivery, L&D) for evaluation.

A triage nurse (RN 10) documented arrival to labor and delivery at 9:35 p.m. with complaints of decreased fetal movement for the past eight hours. Patient 1 stated she had a cough/fever/chills and felt "achey" for the past five days. An external device/test to measure heart rate and activity of the fetus (FHR) was documented at 30 minute intervals for 2 hours between 10 p.m. and midnight, and fetal accelerations (fetal movement) were confirmed. However, Patient 1's heart rate remained elevated , her breathing rate became elevated and breathing was described as "shallow", and her blood pressure fell below normal at times. Patient 1 was described as anxious and restless. At 10:20 p.m., RN 10 telephoned MD 5 (an obstetrician who was on call for MD 6) to communicate that Patient 1's heart rate was elevated, her blood pressure was decreased, and it was difficult to accurately assess the fetal condition because mother and fetus had very similar (high) heart rates. MD 5 directed RN 10 to observe Patient 1 for a longer period of fetal monitoring to determine if the initial measurements were accurate. MD 5 gave orders for blood tests and to administer fluids into Patient 1's vein (to correct dehydration if that was the reason for the low blood pressure and high heart rate). At 11:30 p.m. MD 5 was updated by telephone and directed that Patient 1 be evaluated by a hospitalist or return to the ED.

An entry at 12:37 a.m. indicated that Patient 1 returned to the ED. However, no vital sign measurements or ED care was entered into the medical record until 1:37 a.m., when Patient 1's heart rate (125 beats per minute) and breathing rate (26 per minute) were again elevated, and blood pressure remained decreased (83/33). At this time, Patient 1's blood oxygen level was now decreased to 93%. At 1:38 a.m., a nursing entry noted "chills [with] rigor, heart rate [greater than] 90, respiratory rate [greater than] 20," Patient 1 met criteria for a severe infection.

The first direct assessment of Patient 1 by a physician was documented at 2:30 a.m., more than 5 hours after Patient 1 arrived to the hospital. No further monitoring of Patient 1's fetus was documented after midnight, until 8 a.m. Vital sign measurements were documented hourly starting at 3 a.m., showing persistently elevated heart rate, elevated breathing rate, and low blood pressure, despite large amounts of fluid administrations into Patient 1's vein, oxygen to breathe, medicine to open the small airways of the lungs, and morphine (a narcotic pain reliever). MD 2, an ED physician, directed care between 2:30 a.m. and 5:30 a.m., during which time tests showed pneumonia in the right lung and possible infection in the blood. Antibiotic medications were administered. A hospitalist (MD 8) documented an admission note to the intensive care unit (ICU) at 5:36 a.m. No further communications with MD 5, or any obstetrical physician consultant, was documented until 8 a.m.

Patient 1 arrived to the ICU at 6:30 a.m. with persistent compromise to her breathing and heart function. A critical care medicine physician, MD 9, documented at 7:44 a.m. that Patient 1 had difficulty breathing at rest with cough and fever, 28 week pregnancy, assessed with severe blood infection and shock. Patient 1 was anxious and short of breath. Treatments included more fluids, a medicine to raise blood pressure, and a device to force air pressure and oxygen into the lungs (BiPAP). The next documented fetal monitoring at 8 a.m. noted a slight decrease in the "reactivity" or vigor of the fetus. An obstetrician, MD 6, evaluated Patient 1 in the ICU at 8:20 a.m., and continued with close oversight and intermittent imaging tests to evaluate the fetus in addition to the external monitoring system (FHR). Between 8 a.m. and noon, Patient 1's condition worsened and more treatments to support her blood pressure, oxygen, and effectiveness of breathing were tried. At 1:30 p.m., she was too unstable to transfer to a nearby tertiary center with high risk maternal fetal physician consultants as Patient 1 was considered to be unstable and required the support of a breathing machine. The fetal monitor displayed a "flat strip" showing the fetus was compromised. At 3:04 p.m., MD 6 performed a Cesarean Section (a surgical procedure to open the abdomen and deliver the fetus) under general anesthesia at the bedside in the ICU. A team from the neonatal intensive care unit at the tertiary center arrived in advance to care for the premature infant, who was "somewhat floppy" at the time of the delivery. The Apgar Scores (an assessment of the newborn done at one and five minutes following birth) were both under five (out of a 10/10 score).

In an interview on 4/9/13 at 1:45 p.m., MD 5 stated that the information she received from the triage nurse on 3/8/12 led her to believe Patient 1 was "not that sick." MD 5 did expect L&D nursing staff to examine patients well enough to determine if a patient faced critical compromise of vital body functions, such as examining the heart and lungs if the patient complained of a breathing problem or high heart rate. MD 5 also expected Patient 1 to be evaluated by a physician at the hospital soon after she directed L&D nursing staff to arrange for that, without a delay of 3 more hours before Patient 1 was seen by an ED physician. MD 5 stated that ED physicians were expected to readily contact the patient's obstetrician or the obstetrician on call when managing critically ill pregnant patients. If ED staff asked the obstetrician for guidance in evaluating or treating a sick pregnant patient, MD 5 had access to the services of a nearby maternal-fetal medicine (MFM) specialist group, and could also facilitate transfer to a hospital that offered MFM services. MD 5 acknowledged that no current formal hospital policy or process required co-management of critically sick pregnant patients, and the decision to make contact with an obstetric consultant rested with the primary (ED or hospitalist) physician caring for the sick pregnant patient.

In an interview on 4/10/13 at 9:30 a.m., a licensed L&D nurse (RN 1) acknowledged she was the nurse who triaged Patient 1 in L&D on the night of 3/8/12. RN 1 stated she was concerned about Patient 1's tachycardia, shallow respirations and low blood pressure. RN 1 acknowledged there was no documentation of heart and lung sounds. RN 1 stated she called MD 5 because "I wanted to hydrate her" to see if she could get a "better b/p [blood pressure]" and thought some "tests" should be done. RN 1 acknowledged the tests were not ordered to be done "stat" (a term used to alert the lab to perform the tests immediately). RN 1 stated she did not feel it necessary for MD 5 to come in to assess Patient 1 as "I was satisfied it wasn't an OB problem". RN 1 revealed she completed a "hand off form" and called the ED to get a room number prior to transporting Patient 1 to the ED. RN 1 recalled placing Patient 1 in an ED room but did not recall notifying the nurse or physician in the ED that Patient 1 had arrived.

In an interview on 4/8/13 at 3:30 p.m., an ED physician (MD 2) acknowledged he had treated Patient 1 during the night of 4/9/13. MD 2 acknowledged "there was a delay in my first chance of seeing her" as she (Patient 1) "was downplaying the seriousness of her illness". MD 2 stated Patient 1 did not state she was as sick as the test results were showing. MD 2 stated he ordered medications, a chest x-ray and labs 'that had not been done". MD 1 stated at 4:22 a.m., he ordered Patient 1 to be admitted to the Intensive Care Unit (ICU) with a diagnosis of pneumonia in pregnancy and early sepsis. Between 4:40 a.m. and 5 a.m., MD 2 stated he consulted with the hospitalist. MD 2 stated he did not consult at any time with the obstetrician as "my concern is her". MD 2 further revealed he would have called the obstetrician if he had any questions but "we didn't need help with her pregnancy". MD 2 stated he did not consider the need to transport to a high risk maternal fetal unit as he "did not expect patient one to deliver" and the primary issue was pneumonia. MD 2 acknowledged the status of the fetus was not evaluated at any time during the approximately eight hours spent in the ED.

In an interview on 4/9/13 at 2:15 p.m., MD 6 (an obstetrician) stated that meetings were held with members of the OB and ED departments following Patient 1's events. MD 6 indicated that medical staff and department managers identified problems related to a (1) delay in a physician assessment when Patient 1 was moved between ED and L&D, (2) decisions over where a sick pregnant patient should get care or best have her needs met, (3) recognition of blood infections in pregnant patients, and (4) processes to determine whether a critically ill pregnant patient should be transferred to a hospital with higher levels of care for both mother and baby. MD 6 also stated that he did reach out to MFM specialists once he became involved with Patient 1's care in the ICU and was assisted to make care decisions, such as to get the baby delivered once Patient 1's condition continued to deteriorate (which would compromise the viability of the baby). MD 6 agreed that the hospital did not have the resources to best manage Patient 1's needs (a special care unit for premature babies). Transferring Patient 1 before she became so unstable would have been preferred.

Both MD 5 and MD 6 stated that critically ill pregnant patients are not routinely cared for in the hospital's ICU, that Patient 1 was the first that they could recall. Neither MD 5 nor MD 6 could describe procedures for arranging for ICU care of pregnant patients developed by the obstetric department.

In an interview on 4/9/13 at 3 p.m., the Quality Director stated that a formal analysis of the events related to Patient 1's care was conducted. Solutions were developed from input by obstetric and ED representatives, and adopted as new or revised policies. The Quality Director allowed, however, that recent training for the identification of sepsis in the pregnant patient had just been completed, but not as yet implemented in the obstetrical service.

Based on observation, interview, clinical record and document review, the entity failed to provide rehabilitation services when patients missed physician-ordered treatments on 20 of 100 days between 1/1/13 - 4/10/13.

Findings:

After a tour of the Rehabilitation Services Department, the undated "Inpatient Rehabilitation Services Prioritization of Patients" policy was reviewed. It revealed, "A shortage of qualified staff or an unusually high demand for services may necessitate that patient service is prioritized...When unavoidable circumstances result in a situation where the caseload exceeds staffing capabilities, patients are prioritized and triaged...In the event that circumstances require cancellation of patient treatments, the therapist, utilizing priority guidelines, determines which patients are cancelled after considering the resources as well as the needs of the program...Patients may be triaged based on frequency of treatment versus cancellation of treatment (e.g. reducing treatment to daily from twice a day). Consideration is given to reducing the length of the treatment sessions in order to accommodate more patients...."

Review of "Acute Care PT [Physical Therapy] and OT [Occupational Therapy] Triage Lists" data from 1/1/13 - 4/10/13 provided by the Rehabilitation Services Director (RSD) indicated ed the following numbers of patients who missed physician-ordered treatments on the days noted: 9 patients on 1/4/13, 2 on 1/5/13, 5 on 1/6/13, 3 on 1/7/13, 1 on 1/9/13, 1 on 1/13/13, 5 on 1/17/13, 3 on 1/18/13, 1 on 1/29/13, 4 on 2/3/13, 3 on 2/8/13, 2 on 2/19/13, 7 on 2/24/13, 3 on 2/27/13, 2 on 3/5/13, 5 on 3/6/13, 4 on 3/8/13, 5 on 3/12/13, 5 on 4/7/13 and 1 on 4/9/13.

In 10:28 a.m. and 4:46 p.m., 4/9/13 interviews, the RSD indicated the triage lists were not retained and she would be unable to easily identify which patient treatments had been cancelled. She stated that missed treatments were not currently documented in clinical records and physicians were not notified of cancelled treatments but "it would be a reasonable thing to do to let the doctor know via the medical record."

Review of the undated "Rehabilitation Services Scope of Services" revealed, "Daily staffing is based upon anticipated amount (number of hours) and type (evaluation or treatment and acuity) of patient volume as well as department operations activities pre-scheduled to occur. Additional staff can be obtained through accessing per diem lists or by offering additional hours to part-time employees, float staff or by arrangement with agency staff."

Based on interview and document review, the entity failed to have in place a physician Medical Director for Respiratory Care Services.

Findings:

In a 1:05 p.m., 4/10/13 interview, the ICU Medical Director (ICUMD) stated the name of a physician colleague as the Medical Director for Respiratory Care Services.

At 1:12 p.m., 4/10/13, the Director, Respiratory Services (DRS) indicated the ICU Medical Director also served as the Respiratory Care Services Medical Director.

Review of the "Professional Services Coverage Agreement" with the ICU Medical Director's group, effective 10/16/12, revealed a contract for ICU Director services but did not include Respiratory Care Services Department directorship.

In a 1:29 p.m, 4/10/13 interview, the DRS stated that when the ICU Director assumed his duties, two expiring contracts for ICU and Respiratory Services directorships were to have been combined into a single new contract. The DRS stated, "Legal is facilitating the change and [the ICU Director] said he'd have no problems agreeing to be the Medical Director [for Respiratory Care Services]."

Based on observation, interview, medical record and document review, the entity failed to provide respiratory care services as ordered when two of six Sampled Patients reviewed (Patients 20 and 21) missed ordered treatments.

Findings:

After a tour of the Cardiopulmonary Department, a review of six clinical records of patients receiving respiratory care treatments on 4/9/13 indicated two patients missed treatments or had delays in physician-ordered treatments.

1. 90 year-old Patient 21's clinical record review reflected chief complaints of shortness of breath and altered mental status. Her 4/5/13 admission "History and Physical" included the following assessment and plan: "Acute respiratory failure...due to pulmonary edema [abnormal buildup of fluid in the lungs' air sacs] and congestive heart failure...possibility of underlying pneumonia...We will have Respiratory Therapy give the patient some breathing treatments..." At 4:12 a.m., 4/7/13, a physician order changed her breathing treatment frequency to every 6 hours; at 1:29 p.m., 4/7/13, the order was amended again to a frequency of every 8 hours.

During a 12:13 p.m., 4/9/13 review with the Director, Respiratory Services (DRS), Patient 21's clinical record revealed an inhalation treatment given at 11:40 a.m., 4/7/13. The next treatment, due at 8 p.m. was documented as given at 11 p.m., 4/7/13. In a concurrent interview, the DRS stated, "I don't see any note" regarding why the 8 p.m. treatment was delayed.

2. Patient 20 was admitted for abdominal surgery 4/2/13 and at 7:13 p.m., 4/3/13, was ordered to have post-operative breathing treatments every 4 hours while awake.

During a 12:13 p.m., 4/9/13 review with the DRS, Patient 20's clinical record revealed an inhalation treatment given at 6:30 a.m., 4/4/13 with the following treatment not given until 3:10 p.m., 4/4/13. In a concurrent interview, the DRS stated, "I'm not sure why [the 10:30 treatment] was missed."

On 4/7/13, a noon treatment was documented as given to Patient 20. Another treatment was not documented until 7:10 p.m. The DRS commented he was "not sure why" the 4 p.m. treatment was missed or not documented.

A breathing treatment was given to Patient 20 at 11:30 a.m., 4/8/13 with the following treatment at 6:55 p.m., 4/8/13. The DRS stated, "There are no comments [in the medical record] why the 3 p.m. treatment wasn't done."

Review of the undated "Respiratory Therapy Scope of Services" revealed "treatments" as a "Key Function" of the department. "Performance Expectations" outlined within the "Respiratory Care Practioner" job description included "Standard Therapy: Performs and monitors...respiratory care procedures...."

Based on staff interview and document review, the entity failed to assure the competency of respiratory services personnel drawing blood gases.

Findings:

Review of an undated "Respiratory Therapy Scope of Services" revealed, "Diagnostic activities include...Obtaining arterial blood gas samples...Respiratory Therapy is staffed with appropriate qualified personnel. The specific qualifications are outlined in staff job descriptions...Staff performance and competency are evaluated at least annually...."

Review of the "Respiratory Care Practitioner" (RCP) job description revealed as one of the 10 "Performance Expectations," "Arterial Blood Gases: Obtains and reports arterial blood gases."

Review of an undated Respiratory Care Services "Arterial Blood Gas Sampling" policy and procedure indicated, "All staff RCPs will be competent in the performance of arterial blood gas sampling. Such competency is determined by performance of three blood gas samples via direct observation by another staff RCP." The policy named three potential artery puncture sites: radial (wrist), brachial (inner arm at elbow) and femoral (groin). The procedure described the technique used with each site, describing the "femoral artery puncture" as follows: "If the radial or brachial artery is not accessible, then the femoral artery may be utilized...It may also be associated with more bleeding problems post puncture. Large amounts of blood may be extravasated [leaked] into the femoral triangle before this can be appreciated. The femoral vein...is located immediately medial [toward the middle of the body] to the artery. At times it is difficult to determine if the artery or vein has been punctured...." Complications of arterial puncture described included hematoma (collection of blood outside a blood vessel), nerve damage or thrombus (blood clot inside the vessel).

Review of five RCP "New Employee Orientation Checklists" showed "Arterial blood gas puncture" was "Reviewed and Understands Policies and Procedures." The sites of blood gas punctures were not noted, however. Four of five checklists did not indicate the numbers of punctures observed and the "Proctor Initials" box beside the skill completion date was blank in two of five checklists. A 3/11/13 "Arterial Blood Gas Competency" indicated the RCPs had demonstrated "understanding of proper sampling technique" but did not indicate what blood gas site was used during the competency observation.

In a 7:48 a.m., 4/11/13 interview, the Director of Respiratory Services (DRS) acknowledged the orientation checklists and competencies did not state the numbers or sites of punctures observed and thus did not document staff training for all three sites. He stated staff would "only do femorals in emergent situations" under physician supervision but acknowledged such circumstances might not permit adequate clinical oversight.

In a 4/11/13 memorandum to the RCP's, the DRS wrote, "The Arterial Blood Gas Sampling Policy and Procedure has been revised...We are no longer doing Femoral Artery Punctures under any circumstances...."

Based on staff interview and document review, the medical staff failed to comply with bylaws criteria for granting clinical tasks (privileges) when procedural sedation and core emergency medicine privileges were granted to 1 of 2 Emergency Department (ED) physicians reviewed (MD 2) without verifying MD 2 was qualified and currently competent to perform them. This failure put patients at risk for adverse outcomes related to care performed by unqualified physicians.

Findings:

Review of the Medical Staff Bylaws, approved 9/27/12, under item 5.4-2 documented, "The Medical Staff shall make an objective and evidence based decision with regard to each request for Privileges ... shall be evaluated on the basis of the Member's education, training, experience, current demonstrated professional competence and judgment."

In a collaborative review of medical staff files with the Medical Staff Coordinator (MSC) on 4/9/13 at 9 a.m., the files of two ED physicians (Medical Doctor-MD 1 and MD 2) were inspected:

MD 1 maintained Board-certification in Emergency Medicine after completing residency training in emergency medicine. As part of his Board-certification, he was required to periodically demonstrate skills in managing difficult airways of patients, and to manage physical conditions similar to patients under the effects of general anesthesia. Among the clinical tasks MD 1 was authorized to perform on hospital patients was a privilege called deep sedation. Deep sedation is the administration of drugs to minimize pain and discomfort during surgical procedures, drugs that depress a patient's arousal and awareness responses just shy of being anesthetized. Deep sedation carries risk for rendering a patient unconscious with compromise to heart and lung and brain function if not provided with medical support for those functions.

MD 2 had no documented evidence of education and training in emergency medicine, and was not Board-certified in Emergency Medicine or any other field where ongoing skill competency would be maintained for managing airways and the effects of general anesthesia. Yet, MD 2 was authorized to perform the full range of emergency medicine privileges, including moderate and deep sedation. Moderate sedation is a lesser level of depressed consciousness and awareness than that of deep sedation, but also used for procedural comfort. Core emergency privileges included treatment of critically ill or injured patients of all ages, including a number of invasive procedures that required specialized education and training. The MSC produced no evidence that MD 2 was qualified by education, training, or special certifications to perform the necessary skills connected to moderate and deep sedation. The MSC produced no evidence of current competence for those skills. The MSC produced no evidence that MD 2 was qualified and currently competent to perform the entire range of core emergency medicine privileges.

The MSC indicated that the Anesthesia Service was responsible and approved the privilege requirements for moderate and deep sedation care in all parts of the hospital, including the ED. The qualification requirements documented on the Special Procedures - Procedural Sedation privilege form were: A) Residency trained in Emergency Medicine and/or Board Certified in Emergency Medicine, or B) Competency in airway management as evidenced by one of the following and completion of the Procedural Sedation Written Examination:

- Airway competency certificate from GSSA facility (affiliate owned by same corporation);
- Current ATLS (Advanced Trauma Life Support) certificate;
- Current National Airway Course certificate;
- Certificate from nationally recognized certification course in airway management skills;
- Performing ten or more endotracheal intubations (insertion of a plastic tube through the mouth into the windpipe to provide an airway) or bronchoscopies (insertion of tubes into the airway) in previous 2 years.

MD 2's file contained an ATLS certificate from 1996 (expired), but no current airway management certificates. MD 2's file contained a sedation written examination from his previous appointment cycle in 2011, but not current for the renewal of privileges cycle. No proctoring (observations of care by a qualified individual) specific to sedation care (adults or children) was documented. The Procedural Sedation privilege form itself did not include current competence in airway management or life support skills as requirements to continue/renew either moderate or deep sedation privileges. The requirements did not include competence in specialized skills to treat children separate from adults, as the categories were all-inclusive for both age groups.

Review of the American Society of Anesthesiologists (ASA) Advisory on Granting Privileges for Deep Sedation for Non-anesthesiologist Sedation Practitioners, approved 10/20/10, emphasized the need to maintain current knowledge, skills and competency in performing this type of care, including the management skills for difficult airways and patients who are under the effects of a deeper than intended level of sedation (general anesthesia). The ASA's Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Providers, approved 10/26/11, similarly framed the qualifications to include current knowledge, skills, and demonstrated proficiency in airway management, including certifications in life support for children if administering sedation care to children. "Separate privileging is required for the care of pediatric patients."

In an interview on 4/10/13 at 12:30 p.m. with MD 10, an anesthesiologist who served as previous Chief of the Anesthesia Service, MD 10 indicated that the hospital's anesthesia service was responsible to oversee all procedural sedation care throughout the hospital. MD 10 indicated that the guidance for hospital sedation policies, trainings, and privilege requirements should be based on the standards and practices recommended by the ASA, with consideration of the positions of other specialty organizations on an issue by issue basis that would not compromise patient safety. MD 10 agreed that MD 2's file lacked evidence of the qualifications to administer and supervise moderate and deep sedation, including for the care of children. MD 10 acknowledged that endotracheal intubation skill was not equal to airway management skill. MD 10 agreed that the existing sedation privilege requirements also did not conform to anesthesia standards for sedation care.

In an interview with the Vice President of Nursing (VPN) on 4/11/13 at 9:30 a.m., she presented an undated, unnumbered draft of a policy titled Procedural Sedation which she said was the policy currently in use. The VPN acknowledged this draft had not as yet been finally approved by the medical staff and governing body. In review of this policy, there was no requirement for privileged sedation-anesthesia providers to possess airway management skills, to demonstrate current knowledge or proficiency in managing patients under the effects of a deeper than intended level of sedation, nor to possess current competence in the rescue of children if they treated children. The policy draft listed no current organizational standards of practice on which it was based.

Review of a policy statement approved January 13, 2011 by the American College of Emergency Physicians (ACEP) titled "Sedation in the Emergency Department," recommended, "Institutional and departmental guidelines related to the sedation of patients should include credentialing and verification of competency of providers, selection and preparation of patients, informed consent, equipment and monitoring requirements, staff training and competency verification, criteria for discharge, and continuous quality improvement."

In an interview on 4/10/13 at 1:40 p.m. with MD 1, who served as Chief of Staff and a previous ED Medical Director, MD 1 acknowledged that the file for MD 2 did not document education, training, or current certifications as evidence of qualifications and current competence for moderate or deep sedation care (e.g

Based on staff interviews, medical record and document review:
1. The nursing nutrition screens for five of six patients reviewed for nutrition care did not capture nutrition problems identified for Patients 7, 8, 9, 10 and 12. These failures either resulted in delays or had the potential to result in delays in the implementation of nutrition interventions that benefit hospitalized patients and help prevent further decline in medical status.
2. A patient on Total Parenteral Nutrition (TPN - nutrition delivered directly to the bloodstream) did not receive appropriate weight monitoring while on the TPN. This failure had the potential to result in inaccurate nutrition assessments and monitoring.
3. In five of six patient records reviewed, the admission weight was recorded as a "stated" weight rather than an actual weight for Patients 7, 8, 9, 11 and 12. This had the potential to result in inaccurate nutrition and pharmacy assessment and monitoring.

Findings:

1. A review of the hospital's policy titled, "Patient Assessment/Reassessment and Care Planning" (undated) indicated that "Patients shall have an Adult Admission History and Physical Assessment form completed by an RN within twenty-four hours of admission to the department....Patients meeting the criteria for a referral to a specific service (i.e. Nutrition Services, Social Services, Spiritual Care, etc) will receive an assessment by the service within the time frame described..."

a. The medical record for Patient 7 was reviewed on 4/8/13. According to the History and Physical (H&P) dated 4/6/12, the date of admission, the assessment stated "Severe enterocolitis exacerbation (inflammation of the digestive tract)....Could not keep any food down because of persistent nausea and vomiting....Severe protein calorie malnutrition. We will need to find a way to improve the patient's nutrition..."

A review of the nursing initial nutrition screen for Patient 7 dated 4/6/13 indicated, no eating difficulties, home diet was listed as regular, appetite was listed as "good" and no nutrition risk factors were identified.

During an interview with the Lead Dietitian (LD) on 4/8/13 at 1:00 p.m., she verified that the nutrition screen was not accurate. She verified that the inaccurate nursing nutrition screen had the potential to delay a nutrition assessment and appropriate nutrition interventions for this high nutrition risk patient.

During an interview with Medical Surgical Manager (MSM) on 4/9/13 at 9:50 a.m. she verified that the nutrition screen completed by nursing was not accurate. She was unable to state why the high nutrition risk patient did not trigger for any nutrition risk factors.

b. The medical record for Patient 8 was reviewed on 4/8/13. According to the H&P dated 4/4/13, the date of admission, the patient was transferred from a skilled nursing facility with altered mentation (confusion), increased somnolence (drowsiness). The assessment and plan stated, "Moderate protein calorie malnutrition. We will get dietitian consultation. We will supplement her diet."

A review of the nursing initial nutrition screen for Patient 8 dated 4/4/13 indicated no eating difficulties, modified independence in feeding ability, appetite was fair and no nutrition risk factors were triggered for a dietitian consult.

During an interview with the LD the same day at 2:00 p.m., she verified that the nursing nutrition screen did not trigger a dietitian consult. She acknowledged that a dietitian still had not evaluated the patient 4 days after her admission. She could not explain why a patient with a diagnosis of protein calorie malnutrition would not be evaluated by a dietitian before 4 days after admission.

During an interview with MSM on 4/9/13 at 9:50 a.m. she verified that the nutrition screen completed by nursing was not accurate. She was unable to state why the high nutrition risk patient did not trigger for any nutrition risk factors.

c. The medical record for Patient 9 was reviewed on 4/8/13. According to the H&P dated 4/3/13, the day after the patient was admitted, the patient appeared confused. He was unable to answer questions. He was a 93 year old male admitted on 4/2/13 with a hip fracture.

A review of the nursing initial nutrition screen for Patient 9 dated 4/3/13 indicated appetite was "good", he was completely independent with feeding, he had no eating difficulties and he had no nutrition risk factors. Further review indicated that the patient was confused, family was not at bedside and family was not answering the phone.

During an interview with the MSM on 4/9/13 at 9:55 a.m., she stated that if a patient was unable to answer the nutrition related questions, as in this case, "unable to assess" should have been triggered and this would have triggered a dietitian consult. She could not explain why this did not happen. She verified that the patient was seen on 4/3/13 by the Speech Therapist for swallowing difficulty and was unable to feed himself.

During a concurrent interview with the LD, she verified that swallowing difficulties can be an indication of nutrition risk and should be evaluated by the dietitian.

d. The medical record for Patient 10 was reviewed on 4/8/13. According to the H&P dated 4/2/13, the same day of admission, the patient's chief complaint was nausea with dry heaves and diarrhea for 2-1/2 weeks. One of his admitting diagnoses was gastroenteritis (inflammation of the gasto-intestinal tract which includes nausea, vomiting and diarrhea).

A review of the nursing initial nutrition screen for Patient 10 dated 4/2/13 indicated no eating difficulties, a good appetite and no nutrition risk factors were identified. No dietitian consult was triggered.

During an interview with the MSM on 4/9/13 at 9:55 a.m., she was unable to explain why a patient admitted with a 2-1/2 week history of nausea, vomiting and diarrhea would not trigger a dietitian consult and no nutrition risk triggers were identified.

e. The medical record for Patient 12 was reviewed on 4/9/13. According to the H&P dated 2/26/13, same date of admission, the patient was admitted to the hospital with suspected aspiration pneumonia (food, fluids or stomach juices entering in the airway) with possible dysphagia (difficulty swallowing) from a previous stroke.

A review of the nursing initial nutrition screen for Patient 12 dated 3/26/13 indicated the patient had swallowing/dysphagia. The swallowing difficulty risk factor was not noted in the area of the screen that would have triggered a consult. No dietitian consult was ordered as was required with swallowing difficulties.

During an interview with the MSM on 4/9/13 at 10 a.m., she verified that swallowing difficulties was not triggered on the nutrition risk screen and it should have been.

2. The medical record for Patient 11 was reviewed on 4/9/13. The patient was admitted to the hospital on 2/27/13 with diagnoses that included small bowel obstruction (partial or complete blockage of the small intestines) requiring surgery on 3/3/13. The patient received TPN for nutrition starting on 3/2/13 and continuing until about 3/13/13.

Further review of the weights recorded in the medical record indicated an admission weight of 48 kilograms (kg) (105.6 pounds (lbs)). Follow-up weights were recorded as follows:
3/3/13 - 59 kg (129.8 lbs)
3/4/13 - 65.8 kg (144.8 lbs)
3/5/13 - 64.2 kg (141.2 lbs)
3/6/13 - 63.6 kg (139.9 lbs)
Daily weights were not recorded for 7 of 11 days.

A review of the hospital's policy titled, "Total Parenteral/Peripheral Parenteral Nutrition" (dated 8/10) indicated that daily weights were required for ongoing assessment of patients on TPN.

During an interview with the Medical Surgical Director (MSD) on 4/9/13 at 9:40 a.m., she stated that patients in the Medical Surgical nursing unit who are on TPN are not routinely weighed daily. She was not aware of the hospital's policy to weigh patients daily who receive TPN.

3. The medical record for Patients 7, 8, 9, 11 and 12 were reviewed on 4/8/13 and 4/9/13. The Adult Assessment Histories were reviewed for admission heights and weights. In all these records, the admission

Based on staff interview and medical record review, the hospital failed to ensure medications were prepared and administered as ordered by the physician or in accordance with the hospital's policy and procedures, when:

1. Staff failed to document pain re-assessment after pain medication administrations for 5 of 48 sampled patients (Patient 7, 25, 26, 43, and 44). The failure demonstrated the lack of evaluation for drug effectiveness and adverse effects, and may have delayed pain interventions for patients;

2. Staff failed to document assessment of sedation level and pain level in the medical record as often as indicated by the hospital policy for the PCA (patient controlled analgesia) use for three of three patients (Patient 16, 29, and 30) who were receiving PCAs. The failure demonstrated the lack of timely assessment and monitoring for PCA use;

3. Staff failed to administer medications as ordered by the physician for two patients (Patient 15 and 40). For Patient 15, there were two administration errors related to the administration of insulin (a medication used to decrease blood sugar). For Patient 40, the order for norepinephrine (a medication given intravenously to control the blood pressure in critical care patients) was not carried out as ordered;

4. Staff failed to document the removal of an old fentanyl patch (a potent narcotic applied to the skin) before applying a new patch, at two separate applications, for one of three patients (Patient 45) who were receiving fentanyl patches. Removal of the old patch is critical to prevent accidental narcotic overdose for patients.

Findings:

1. A review of Emergency Department (ED) patient medical records (Patients 7, 25, and 26) was conducted with the Clinical Pharmacist (CP) and the Pharmacy Director (PD) on 4/8/13. The review reflected Patient 7 had three physician orders for morphine (a potent pain medication) 4 milligrams (mg) each to be given intravenously (IV) at three separate times on 4/6/13. Three doses were given according to the medication administration record(MAR). However, there were no documented pain re-assessments following each morphine administration. The record documented the patient had moderate to severe pain, with pain scores 10, 5, and 9, respectively (pain scale 0 - 10; 0 equals no pain - 10 equal worst pain possible) at the time of medication administration.

Similarly, Patient 25 came into the ED for chest pain on 4/6/13. He had three physician orders for intravenous Dilaudid (a potent narcotic) 1 mg each at three separate times. The record showed the pain score was consistently 10 (worst possible pain) at the time of each Dilaudid administration. However, there was no documented pain re-assessment for two of three Dilaudid administrations for Patient 25.

Patient 26 came into the ED for abdominal pain and had a physician order for Dilaudid 1 mg IV x 1, which she received shortly after midnight on 4/5/13. The pain score documented at the Dilaudid administration was 9 (severe). There was no documented evidence of pain re-assessment after the Dilaudid administration for Patient 26.

During the review on 4/8/13 at 5:10 p.m., the CP and the PD confirmed there was no pain re-assessment documentation following pain medication administrations for Patients 7, 25, and 26. The CP said the nursing staff was to conduct the pain re-assessment within 15 minutes of IV pain medication administration and document it in the MAR.

Patient 43 was a pediatric patient who came into the ED for fracture of the right arm on 4/6/13. The patient was given Motrin (to treat pain and swelling) at 9:37 p.m., at which time the documented pain score was 10. Shortly after midnight (on 4/7/13), he was prescribed morphine 1 mg for a pain score of 8. There was no documented evidence pain re-assessment was conducted following the use of Motrin or morphine for Patient 42. The CP and the PD confirmed this on 4/11/13 at 10:45 a.m.

Patient 44 was a pediatric patient who came into the ED for tongue laceration on 1/29/13. She was given Tylenol 240 mg for pain at 4:53 p.m. There was no documented evidence pain assessment was done prior to and after the Tylenol administration. The CP and the PD confirmed this on 4/11/13 at 11:15 a.m.

The hospital policy entitled "PAIN MANAGEMENT," dated 2/10, stipulated: "Evaluate and document drug effectiveness within 15 minutes of administration of parenteral (through the veins) analgesic dose, 30 minutes of oral and intramuscular analgesic dose..." Under Document Administration of the "Medication Management: Administration" policy and procedures, dated 7/11, it indicated, "3. Patient pain level before and after pain mediation administration will be documented using 0 - 10 scale on the EMAR."

2. The hospital policy on "Patient Controlled Analgesia," dated 12/12, stipulated the following under Assessment for the use of PCA:
"4. Initial and ongoing patient vital sign assessment will include:...
- pain score
- sedation score using the Modified Ramsey Scale
5. Assess and document the above:
- At the start of PCA therapy
- 15-30 minutes after each dosage increase
- 15-30 minutes after each bolus
- Every 2 hours for 12 hours after initiation
- Every 4 hours or more frequently when
indicated for the duration of PCA therapy"

A review of Patient 16's electronic medical record (EMR) at the Progressive Care Unit (PCU) with the ICU/PCU Director (IPD) and the CP on 4/9/13 at 9:40 a.m. revealed the patient came into the hospital for shortness of breath and body pain. She was prescribed Dilaudid PCA, which was initiated at 10:46 a.m. on 4/5/13. The record showed the patient continued to be on the PCA from 4/5/13 to the day of review (4 days, or about 95 hours). However, the PCA flow sheet reflected the nursing staff only documented the sedation level during a period of 10 hours, from 4/6/13 at 8 p.m. to 4/7/13 at 6 a.m. The IPD said the staff should have documented the sedation level at initiation, every 2 hours for 12 hours after initiation, then every 4 hours for the duration of therapy. She said there had been recent in-services on assessing and documenting the sedation level using a new sedation score, but she was not sure why the staff did not carry it out. She agreed the staff did not document the sedation assessment as often as indicated by the hospital policy.

On 4/9/13 at 5 p.m., a retrospective review of Patient 29's EMR with the CP revealed the patient came into the hospital for a right hip replacement. She was prescribed Dilaudid PCA on 2/21/13 while at the Medical/Surgical Unit (MSU). It was discontinued on 2/24/13. The record showed there was no documented sedation assessment at the start of the PCA. The staff only documented the sedation assessment at every 12 hours intervals, at 6 a.m. and 6 p.m. (shift change), during the PCA therapy. Furthermore, the pain score was not documented as often as indicated by the policy. There was a time period when the pain assessment score was not documented for 14 hours.

The information above was verified with the Medical Surgical Manager (MSM) on 4/10/13 at 8:15 a.m. at the MSU in the presence of the CP.

Patient 30's EMR was reviewed with the MSM and the CP on 4/10/13 at 9 a.m. at the MSU. The patient came into the hospital for a revision of the left hip (to replace a worn out hip replacement implant), and had a physician order for Dilaudid PCA from 3/25/13 at 2 p.m. to 3/27/13 at 7 a.m. The record showed the only time staff documented a sedation score was at 3/25/13 at 6 p.m. The pain score documentation was also inconsistent; there were time periods when they were documented as long as 11 hours apart.

During the review above, the MSM said there had been confusion for the Medical Surgical staff regarding which sedation scale to use, whether it was the Modified Ramsey scale or the Pasero Opioid Sedation Scale, so nursing staff were told to hold off on the sedation assessment until the in-service in April (2013). She agreed, however, the hospital policy stipulated the assessment and documentation (as described above) and the staff were not carrying it out

Based on interviews and record reviews, the hospital failed to ensure:
1. The patient menus met the needs of the patients when the menus failed to meet national standards for fiber requirements set by the Food and Nutrition Board, Institute of Medicine (IoM). This failure resulted in inadequate fiber intake by hospitalized patients and the potential to result in constipation.

2. Patient 10, who was determined to require a dysphagia diet (a mechanically altered diet for swallowing difficulty), received inappropriate diet and liquid textures. This failure had the potential to result in choking, aspiration (swallowing down the windpipe) and inadequate nutrition in this patient.

3. The nutrition needs for three of six patients reviewed for nutrition care were met when the nutrition assessments and interventions by the dietitian were not completed in a timely manner. (Patients 8, 9 and 10). These failures resulted in a delay in the implementation of nutrition interventions needed to meet their nutritional needs.


Findings:

1. According to the 2005 Dietary Reference Intakes (DRIs): Recommended Dietary Allowances and Adequate Intakes from the Food and Nutrition Board, IoM, total fiber needs for males greater than 30 years is 30 grams of fiber daily. For females age 31-50 the need is for 25 grams and greater than 50 years is 21 grams daily.

According to the IoM, fiber has many benefits in the diet including: normalizing bowel movements, maintaining bowel health, lowering cholesterol levels, helping control blood sugar levels and aiding in achieving healthy weight.

A review of the hospital menus nutrition analysis revealed that for regular consistency diets provided at the facility (excluding Renal diets) the dietary fiber contents of the diets ranged from 15.6 grams to 17.3 grams of dietary fiber daily.

A review of the hospital's policy titled, "Patient Menus and Special Diets" (undated) revealed that "Patient menus are developed by Manager/Lead Clinical Dietitian in accordance with the department of Nutrition and Food Services Nutrition Care Manual and Dietary Reference Intakes (DRIs)/Recommended Dietary Allowances (RDA) of the Food and Nutrition Board of the National Research Council of the National Academy of Sciences." It further stated "In development of the menu and therapeutic diet modifications, the following factors are considered but are not limited to: ...Nutritional Adequacy."

During an interview with the Lead Dietitian (LD) on 4/9/13 at 2:20 p.m., she verified that the menus do not meet the DRIs for fiber. She was unable to state why there was inadequate fiber included in the diets provided to patients. She stated she needed to work on including more fiber rich foods on the menus.

2. A review of the medical record for Patient 10 revealed that he was admitted to the hospital on 4/2/13 with diagnoses that included a hip fracture and was noted to have some confusion. A bedside swallowing evaluation completed on 4/3/13 by the Speech Therapist indicated that the "Pt (patient) presented with delayed swallow response and significant s/s (signs and symptoms) of aspiration (when) given thin liquids. Pt's chewing was also slowed..." Based on the evaluation, the recommendation was for a chopped texture diet (easy to chew) and nectar thick liquids. Thicker liquids can sometimes be easier to swallow correctly than thin liquids.

A review of the physician orders revealed an order on 4/3/13 for Dysphagia diet/Chopped/Nectar Thick liquids. Another order was noted on 4/7/13 at 11:34 a.m. for a Regular diet (no texture modification and no thickened liquids). The patient received 4 regular texture meals with thin liquids between 4/7 and 4/8/13.

A review of the Speech Therapy Progress Note dated 4/8/13 at 10:08 a.m. stated, "Noted Pt transferred to PCU (Progressive Care Unit) and diet was changed to regular with thin liquids upon transfer. Spoke with RN regarding need for change to modified diet/liquids..."

During an interview with the RN 7, the nurse in charge of Patient 10's care, on 4/8/13 at 3:30 p.m., she verified that the Speech Therapist had asked her to get the diet order changed. She further stated that she had to call the physician to get the order changed and she had not done that yet. She stated that asking the physician to change the diet order was "not a priority" because the patient wasn't eating much. RN 7 was asked if she thought the patient wasn't eating much because he was having difficulty with chewing and swallowing a regular diet and she stated that the patient was eating poorly at home. She confirmed that the patient received a regular texture diet with thin liquids at breakfast and lunch on 4/8/13.

3. a. The medical record for Patient 8 was reviewed on 4/8/13. The patient was admitted to the hospital on 4/4/13 with diagnoses that included Moderate Protein Calorie Malnutrition according to the History and Physical (H&P) dated 4/4/13. The H&P indicated the plan was to get a dietitian consultation and to supplement the patient's diet.

A review of the physician's orders showed an order for a Regular diet on 4/4/13. On 4/7/13 (3 days later) a nutritional supplement was ordered, Chocolate Ensure with meals.

A review of the patient's meal intakes (recorded in percentage of meal consumed) as of 4/8/13 revealed the following:
4/5/13 - breakfast-25%, lunch-30%, dinner-10%
4/6/13 - breakfast-30%, lunch-50%, dinner-not recorded
4/7/13 - breakfast-50%, lunch-40%, dinner-not recorded
4/8/13 - breakfast-40%

A review of the Nursing Adult Admission Assessment, Initial Nutrition screen dated 4/4/13 indicated that the patient's appetite was "fair", her feeding ability was "modified independence" and no nutrition risk factors were identified.

During an interview with the LD on 4/8/13 at 2 p.m., she stated that there was no nutrition assessment of the patient completed by the dietitian. She stated that a nutrition assessment was scheduled to occur that day (4/8/13). She could not explain why a dietitian consult was not ordered by the physician when the patient was admitted. She also could not explain why a diagnosis of Protein Calorie Malnutrition was not communicated to the dietitians so that a nutrition assessment and interventions were implemented when it was identified on admission.

b. The medical record for Patient 9 was reviewed on 4/8/13. The patient was admitted to the hospital on 4/2/13 with diagnoses that included acute hepatitis (liver failure), acute renal (kidney) failure, dehydration and gastroenteritis (inflammation of the gastro-intestinal tract which includes nausea, vomiting and diarrhea). According to the H&P dated 4/2/13 the patient had severe nausea with dry heaves and diarrhea for 2-1/2 weeks prior to admission. A review of the physician's orders showed a diet order for a Consistent Carbohydrate (diabetic), Renal diet on 4/4/13.

During an interview with the LD on 4/8/13 at 2:20 p.m., she stated that a Consistent Carbohydrate, Renal diet provided 1800 calories and 60 grams of protein daily. She verified that there was no nutrition assessment in the medical record for Patient 9, six days after he was admitted.

A review of the Nursing Adult Admission Assessment, Initial Nutrition screen dated 4/2/13 revealed that the patient's appetite was listed as "good" and that no nutrition risk factors were identified on admission.

On 4/9/13 at 11:00 a.m., the medical record was again reviewed and a nutrition assessment had been completed on 4/8/13 at 3:44 p.m., six days after Patient 9 was admitted. The nutrition assessment indicated that the patient's estimated nutrition needs were 2000 calories and 75 grams of protein daily. The assessment indicated that the patient stated he was hungry on the current diet that provided 1800 calories. The dietitian recommended increasing the calories in the patient's diet by increasing the amount of carbohydrates at each meal to provide 2000 calories. There was no recommendation to address the discrepancy between the amount of protein provided in the diet (60 grams) and the estimated nutrition needs (75 grams).

c. The medical record for Pati

Based on observations, interviews and record reviews, the hospital failed ensure that there were infection control measures in place to prevent the development of food borne illness and cross contamination to food service. Also, the hospital failed to have a thorough infection control surveillance system that monitored the conditions and practices of the dietetics services staff. By not having these measures and a thorough surveillance system, potentially hazardous foods had been stored, prepared and distributed under unsafe and unsanitary conditions and there was potential for such continuation in the absence of identification and remediation.

Findings:

1. During a concurrent observation and interview on 4/8/13 at 9:45 a.m. with Food Service Worker 1 (FSW 1) in the kitchen, she demonstrated how she washed pots and pans in the three compartment sink. She filled the third sink with pre-mixed sanitizer solution that was mixed with hot water. She added additional warm water out of the faucet and stated that the sanitizer solution was too hot so she added more warm water to cool it down. Once the sink was filled with premixed sanitizer and additional water, the temperature of the water was tested and was 108º F (Fahrenheit) . She further demonstrated how she tested the contents of the sink to ensure the proper sanitizer concentration by immersing the test strip in the sink for 3 seconds.

A review of the manufacturer's instructions for the test strips indicated that the solution must be between 65-75º F and the strip must be immersed in the solution for 10 seconds before reading.

During an interview with FSW 2 the same day at 10 a.m., she stated she used the same premixed sanitizer solution to sanitize the food contact surfaces in the cafeteria and throughout the kitchen.

During an interview the same day at 3:40 p.m. with the outside service technician that serviced the sanitizer dispenser, he stated that the temperature of the water must be 65-75 ºF in order to get an accurate reading when testing the concentration of the solution with the test strips. Increased water temperature would result in a false reading. He further confirmed the strip must be immersed for 10 seconds for an accurate reading. He used a liquid test to determine the concentration of the sanitizer that he stated was more accurate. The test determined that the concentration of the premixed sanitizer was too low at 100 parts per million (ppm). It should be 150-400 ppm. He confirmed that FSW 1's practice of further diluting the premixed sanitizer resulted in ineffective sanitizing of the pots and pans. He also confirmed that at 100 ppm, food contact surfaces were not being effectively sanitized.

A review of the hospital's policy titled, "Pot Washing - Three Compartment Sink" (undated) instructed the staff to "sanitize items in third sink using a pH strip (used to measure the acid and base properties of a solution) to test for appropriate concentration of 150-400 ppm." There was no guidance to the staff regarding how to properly use the test strips and the proper temperature of the water when testing.

During an interview with the Nutrition Services Manager (NSM) the same day at 4 p.m., she stated that she was not aware that the concentration of the sanitizer was not correct and the practice of the staff was to dilute the premixed sanitizer. She stated that she had not in-serviced the staff on properly sanitizing pots and pans and food contact surfaces or testing the sanitizer concentration.

2. During an observation of the ice machine in the cafeteria on 4/8/13 at 10:20 a.m., a water drain hose from the ice machine did not maintain an air gap between the end of the hose and the floor drain.

According to the FDA Food Code, an air gap between the water supply inlet and the flood level rim of the plumbing fixture, equipment or non-food equipment shall be at least twice the diameter of the water supply inlet and may not be less than one inch. The purpose of an air gap is to prevent backflow of sewage water in the event of a negative water pressure event.

During an interview with the Engineering Lead (EL) on 4/8/13 at 10:25 a.m., he verified that there was not an air gap and that there should be one. He further stated that the housekeeping staff was responsible for the daily cleaning of the outside of the ice machines and the engineering staff was responsible for cleaning the interior of the machines. He stated that ice machines were cleaned by the engineering staff every three months.

During an interview with Environmental Services Staff 1(EVS 1) on 4/9/13 at 1:10 p.m., she stated that she cleaned the ice machine spouts daily in the PCU (Progressive Care Unit) Nursing Station with Oxivir Five 16, one-step disinfectant cleaner.

During an interview with Environmental Services Staff 2 (EVS 2) on 4/9/13 at 1:40 p.m., she stated that she does not clean the spouts on the ice machine. She cleans the outside of the machine only.

During an observation of the ice machine on the Medical Surgical Nursing Unit on 4/9/13 at 1:45 p.m., a clean paper towel swipe of the water dispenser spout produced a moderate amount of black/brown residue. The finding was verified by the Lead Dietitian (LD) and the Medical Surgical Director (MSD).

A review of the hospital's policy titled, "Ice Machine Cleaning and Sanitizing" (undated) revealed that under Environmental Services, "Ice machine dispenser spouts are cleaned daily with a hospital approved sanitizer solution."

A review of the manufacturer's information on Oxivir Five 16, one-step disinfectant cleaner did not indicate it was a food safe cleaner-sanitizer or that it was approved for use on food contact surfaces.

A review of the manufacturer's manual for the ice machine located in the Post Anesthesia Care Unit (PACU) indicated that the ice storage bin should be removed for cleaning and sanitizing weekly.

During an interview with the EL on 4/9/13 at 3 p.m., he confirmed that he was not aware of the ice machine manufacturer's instructions. He stated that the ice storage bin on the PACU station ice machine was cleaned every three months during the regular scheduled cleaning of the ice machine, not weekly.

During a concurrent interview with the EL, the Infection Control Preventionist (ICP) and the EVS Director (EVSD) on 4/10/13 at 8:30 a.m., the ICP and the EVSD were not aware that Oxivir Five 16, one-step disinfectant cleaner was not a food safe disinfectant. The EVSD stated that his staff was instructed to clean the outside of the ice machines only. He did not expect his staff to clean the inside of the spouts. All three verified that the cleaning instructions for the ice machine were not clear and may have resulted in the residue build-up on the water spout in the Medical Surgical Nursing Unit.

3. During an observation and concurrent interview with the NSM on 4/9/13 at 2:00 p.m. in the kitchen freezer, previously cooked beef tenderloin dated 4/4/13 was noted. The NSM stated that it was leftover from a Medical Staff function on 4/4/13. She stated that it should have been cooled down safely and documentation of the safe cooling should be on the Cool Down Log.

According to the 2009 FDA Food Code, cooked potentially hazardous food (such as beef) shall be cooled within 2 hours from 135 degrees F to 70 degrees F, and within a total of 6 hours from 135 degrees F to 41 degrees F. It further stated that if food was not cooled in accordance to this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness.

A concurrent review of the hospital's "Cool Down Log" showed that the safe cool down of the beef tenderloin was not documented. The NSM stated that the log reviewed was the April log and the beef tenderloin cooling should have been documented on it. She was unable to explain why safe cooling of the beef was not documented.

4. During an observation and concurrent interview with the NSM on 4/8/13 at 9:10 a.m. in the kitchen, three trays of cut fresh fruit were dated 4/4/13. The NSM stated that the date on the trays indicated the date that the fruit was opened. She further stated t

Based on staff interview, medical record and document review, the hospital failed to ensure anesthesia services were appropriately organized in accordance with acceptable standards of practice when one of two medical staff files reviewed revealed an unqualified person (a Medical Doctor, MD 2) was granted privileges and regularly performed anesthesia services, including moderate and deep sedation, in the Emergency Department (ED). This failure put patients at risk for unsafe anesthesia care by an unqualified person.

Findings:

Review of the Medical Staff Bylaws, approved 9/27/12, under item 5.4-2 documented, "The Medical Staff shall make an objective and evidence based decision with regard to each request for Privileges ... shall be evaluated on the basis of the Member's education, training, experience, current demonstrated professional competence and judgement."

In a collaborative review of medical staff files and interview with the Medical Staff Coordinator (MSC) on 4/9/13 at 9 a.m., the files of two ED physicians (MD 1 and MD 2) were reviewed.

The MSC indicated that the Anesthesia Service was responsible for and approved the privilege requirements for moderate and deep sedation care in all parts of the hospital, including the ED. The qualification requirements documented on the Special Procedures - Procedural Sedation privilege form were: A) Residency trained in Emergency Medicine and/or Board Certified in Emergency Medicine, or B) Competency in airway management as evidenced by one of the following and completion of the Procedural Sedation Written Examination:
- Airway competency certificate from GSSA facility [affiliate owned by same corporation];
- Current ATLS (Advanced Trauma Life Support) certificate;
- Current National Airway Course certificate;
- Certificate from nationally recognized certification course in airway management skills;
- Performing ten or more endotracheal intubations (insertion of a plastic tube into the windpipe to provide an airway) or bronchoscopies (insertion of tubes into the airway) in previous 2 years.

File review indicated MD 2, a contracted family practice physician who had worked in the ED for 10 years, was not Board-certified and had no documented evidence of education and training in Emergency Medicine or any other field where ongoing skill competency would be maintained for managing airways and the effects of general anesthesia. The MSC produced no evidence that MD 2 was qualified by education, training or special certifications to perform the necessary skills for monitored anesthesia care, including deep sedation, nor current competency for those skills. MD 2's file contained an expired ATLS certificate from 1996, but no current airway management certificates. MD 2's file contained a sedation written examination from his previous appointment cycle in 2011, but not current for the renewal of privileges cycle. No proctoring (observations of care by a qualified individual) specific to sedation care (adults or children) was documented.

In an interview on 4/10/13 at 12:30 p.m., an anesthesiologist who had previously served as the Chief of the Anesthesia Service (MD 10) indicated that the hospital's Anesthesia Service was responsible to oversee all procedural sedation care throughout the hospital. MD 10 indicated that the guidance for hospital sedation policies, trainings, and privilege requirements should be based on the standards and practices recommended by the American Society of Anesthesiologists (ASA), with consideration of the positions of other specialty organizations (for example, the American College of Emergency Physicians - ACEP) on an issue by issue basis that would not compromise patient safety. MD 10 acknowledged that MD 2's file lacked evidence of the qualifications to administer and supervise moderate and deep sedation, including for the care of children. MD 10 acknowledged that endotracheal intubation skill was not equal to airway management skill.

Review of the ASA Advisory on Granting Privileges for Deep Sedation for Non-anesthesiologist Sedation Practitioners, approved 10/20/10, emphasized the need to maintain current knowledge, skills and competency in performing this type of care, including the management skills for difficult airways and patients who are under the effects of a deeper than intended level of sedation (general anesthesia). The ASA's Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Providers, approved 10/26/11, similarly framed the qualifications to include current knowledge, skills, and demonstrated proficiency in airway management, including certifications in life support for children if administering sedation care to children. "Separate privileging is required for the care of pediatric patients."

In an interview on 4/10/13 at 1:40 p.m. with MD 1, who served as Chief of Staff and was a previous ED department chair, MD 1 acknowledged that the file for MD 2 did not provide documentation of education, training, or current certifications as evidence of qualifications and current competence for moderate or deep sedation care (e.g. airway management proficiency, life support rescue skills for children).

In an interview with the Vice President of Nursing (VPN) on 4/11/13 at 9:30 a.m., she presented an undated, unnumbered draft of a policy titled Procedural Sedation which she said was the policy currently in use. The VPN acknowledged this draft had not as yet been finally approved by the Anesthesia Service, the Emergency Medicine Committee, the Medical Executive Committee or the Governing Body. In review of this policy, there was no requirement for privileged sedation-anesthesia providers to possess airway management skills, to demonstrate current knowledge or proficiency in managing patients under the effects of a deeper than intended level of sedation, nor to possess current competence in the rescue of children. The policy draft did not denote the ASA or the ACEP as resources used in determining that education, training and certifications required met current professional standards for the qualifications to administer and supervise MAC, including deep sedation.

The Pediatric Sedation Research Consortium published its first report in 2006, "The Incidence and Nature of Adverse Events During Pediatric Sedation/Anesthesia for Procedures Outside the Operating Room," which identified "one concerning event per 29 sedation encounters (among all drugs, all procedures)." The Consortium emphasized that "the pediatric population represents the highest risk, lowest error tolerance subgroup. Pediatric patients require sedation/anesthesia more often than adults ... must be "deeper" than that given to adults to achieve acceptable "conditions" during a procedure. Most important, because of their physiology, children are at higher risk for respiratory depression (compromise of breathing) and life-threatening hypoxia (low oxygen level in blood).

Review of an ACEP policy statement (approved January 13, 2011) titled "Sedation in the Emergency Department," recommended, "Institutional and departmental guidelines related to the sedation of patients should include credentialing and verification of competency of providers, selection and preparation of patients, informed consent, equipment and monitoring requirements, staff training and competency verification, criteria for discharge, and continuous quality improvement."




29821

Based on staff interview, medical record and document review, the hospital failed to ensure the Anesthesia Service developed policies, based on current nationally recognized standards to screen the needs of high risk patients, and guide hospital practices to utilize the hospital resources for patients in all areas of the hospital who receive anesthesia services, including deep sedation. This failure put patients receiving anesthesia services at risk for adverse events (i.e. over-sedation that produces compromise to heart and lung function, choking on stomach contents, blockage of the air passage) related to the delivery of anesthesia services.

Findings:

The Procedural Sedation Policy, acknowledged by hospital leadership as the current practice, was identified as a draft, was undated and unnumbered, and had not been approved by the Anesthesia Service, the Emergency Medicine Committee, the Medical Executive Committee or the Governing Body. This was the only hospital policy that addressed anesthesia care and did not distinguish differences in processes, needs or resources in different locations of the hospital where anesthesia services (moderate and deep sedation) were provided (i.e. the Emergency Department (ED) or the GI (gastroenterology) Department. [Moderate sedation/analgesia is the administration of drugs to reduce pain and awareness during a surgical procedure while remaining easily aroused. Deep sedation is the administration of drugs to reduce pain and awareness during a surgical procedure; the intended depth of sedation makes a patient not easily aroused but can respond purposefully to repeated or painful stimulation; the drive to breathe may be impaired.]

In review of this policy, the Pre-Procedure, Intra-procedure and Post-Procedure responsibilities were all defined as the responsibilities of a Registered Nurse (RN).

a) Pre-Procedure: The RN was tasked to "b) assure the physician had documented informed consent, update H&P [history and physical examination, a type of physician assessment], and pre-sedation assessment including airway assessment, and assigned ASA score [American Society of Anesthesiologists' Physical Status Classification System assessment of preoperative patient health done prior to selecting the anesthetic]".
b) Intra-Procedure: The RN was tasked to monitor the patient's physiological status and on Page 6, "Collaborate with physician for treatment of over sedation. Obtain orders for reversal agent and administer reversal agent for desired effect."
c) Post-Procedure: The RN was tasked to "assess the respiratory rate, heart rate, oxygen saturation, blood pressure, ETCO2 (exhaled carbon dioxide levels) and level of sedation" throughout the recovery period and discharge the adult or pediatric patient when the defined parameters were met.

All teaching and discharge instructions, including all documentation was delegated to an RN.

1. ED practices were not in accordance with acceptable standards with appropriate oversight by Anesthesia Services. The needs and resources for anesthesia care for moderate and deep sedation were not well-defined in the Procedural Sedation policy.

Multiple interviews were conducted with anesthesiologists and ED physicians (Medical Doctors - MD 1, MD 4, MD 10, MD 11) who held leadership positions (current and former Anesthesia Service Directors, current and former Medical Directors of the ED) during the period from 4/8/13 - 4/11/13 in which they stated that ED physicians routinely utilized deep sedation to perform procedures on patients in the ED, including children. Generally, an ED physician administered the medication AND performed the procedure while an RN monitored the patient. Although a Respiratory Care Practicioner (RCP) was required to be present for deep sedation, the RCP was not a qualified anesthesia provider. The physician directors said the RN would observe the patient including the patient's vital signs (which could be automatically downloaded from the monitor into the medical record), color, ventilation effectiveness and level of sedation. There was not routinely another nurse in the room to assist the physician with the procedure or retrieve supplies, adjust equipment, position the patient or provide additional nursing tasks as needed. The staff acknowledged that there had been situations whereby the RN monitoring the patient stepped away from the bedside to retrieve a supply or adjust equipment. Likewise if the physician began the procedure and the level of sedation became inadequate, the physician may have to leave the patient's surgical site several times to re-administer medication, particularly if given in incremental doses.

Although these physicians universally agreed that it would be preferable to have two physicians present (one to perform the procedure, one assigned as the anesthesia provider), they stated ED procedures a) may be emergent with no time to obtain on call anesthesia or consultant services, or b) so short and uncomplicated that a separate anesthesia provider was not necessary.

In an interview on 4/10/13 at 12:30 p.m. with MD 10, who previously served as the Chair of the Anesthesia Service, he acknowledged the current policy for procedural sedation did not specify how "flexible" anesthesia care standards would be applied in the ED. He stated he had compromised with the ED physicians to allow the RN and RCP to provide monitoring for very brief procedures where the physician would not be interrupted during surgery but this was never defined in the policy.

MD 10 further acknowledged he had researched current standards for the management of patients, including children, in the ED, but these had not been incorporated into the new policy, which listed no current standards of practice after 2007.

In an interview on 4/10/13 at 1:40 p.m., an ED physician (MD 1), who also served as the Chief of Staff, stated for all but three hours a day there was only one physician assigned to work in the ED. During the night hours, no other qualified anesthesia practitioners were immediately available to ED patients. MD 1 stated that an anesthesia staff member was not required to be in the hospital 24 hours; however, there was an anesthesiologist who could be called to the ED if needed (on-call). MD 1 acknowledged, however, that an anesthesiologist had never been called to the ED to assist with anesthesia care for moderate or deep sedation. MD 1 stated "CMS [Centers for Medicare-Medicaid Services] allows single provider administration and monitoring [of anesthesia care]" in the ED. MD 1 presented no documentation from CMS with such language.

In a subsequent interview with MD 1 on 4/10/13 at 4:30 p.m., he stated the ED had identified the specific types of procedures where a single physician could be used and referred to it as a "list" which was "in the policy". In review of the policy, there was no "list" and this was confirmed by the Quality Director on 4/10/13 at 5:30 p.m. MD 1 further stated no quality monitoring or peer review of procedural sedation had been conducted on any of the procedural sedation cases in the ED.

In a further interview with MD 10 (an anesthesiologist) on 4/10/13 at 7 p.m., he again reiterated the ED physician should not need to interrupt surgery or be distracted with the responsibility to monitor and provide early recognition and interventions for adverse side effects from the sedation or the surgery.

Review of the ASA's "Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists," published April 2002 and listed as a reference in the hospital's Procedural Sedation policy (presented as current but not approved), cautioned about the rapid, profound decreases in level of consciousness and heart/lung function that can occur with the administration of deep sedation drugs. The effects of ketamine in particular included obstruction of the airway, spasm of the vocal chords, and choking on stomach secretions into the lungs. The unique properties of ketamine made observation of the depth of sedation unreliable. No drugs are available to reverse the effects of ketamine. Certain patients were at increased risk for complications

Based on interview, medical record and document review, the hospital failed to ensure that pre-anesthesia assessments included documentation of the features of each patient's airway and risk for anesthesia, in accordance with hospital training and nationally recognized standards of practice for 2 of 3 emergency department (ED) records reviewed (Patients 43 and 45). This failure put patients at risk for lack of preparedness to support high risk patients during surgeries that utilized anesthesia care, or delays in recognition of complications for high risk patients.

Findings:

1. Review of the medical record with the ED Director (EDD) on 4/10/13 at 4:30 p.m. indicated that Patient 43, age 18 months, presented to the ED on 4/6/13 for pain and deformity of the right wrist occurring after he fell out of his crib onto a hardwood floor earlier that evening. Shortly after arrival, a physician assistant documented an assessment at 9:31 p.m., ordered x-rays of the injured arm, and ordered an oral pain reliever. Pain scale score was documented at the maximum level (10/10) on arrival, and again, 10/10, 2 hours later. A narcotic pain medication was injected into Patient 43's muscle at midnight. At 1 a.m. orders were issued by MD 11 for staff to set up to realign the broken bones of Patient 43's right arm. At 2:07 a.m., an anesthetic medication (ketamine) was administered by MD 11 into Patient 43's intravenous (IV) line prior to setting the broken bones. No pre-anesthesia evaluation, including an airway assessment with the ASA Class score, was documented by MD 11 prior to the procedure.

ASA Class refers to an assessment of physical health developed by the American Society of Anesthesiologists to be performed prior to selecting an anesthetic; ASA Class scores partly correlate with surgical and anesthetic outcomes.

Features of an airway assessment (as referenced in the April 2002 ASA Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists) would include mouth opening, neck shape and motion, heart sounds and rhythm, and lung sounds.

The use of ketamine or any other drug classified by the FDA as a general anesthetic agent as part of procedural care requires care (at a minimum) consistent with deep sedation. Deep sedation is the administration of drugs to reduce pain and awareness during a surgical procedure. The intended depth of sedation makes a patient not easily aroused but can respond purposefully to repeated or painful stimulation. The drive to breathe may be impaired.

Further review of the medical record indicated that on arrival at 9:20 p.m. ED staff assigned Patient 43 as "urgent" for priority to be evaluated and treated by the sole ED physician (MD 11). Since a physician assessment by MD 11 was not documented on the day of surgery, the record could not confirm when MD 11 actually evaluated Patient 43. The treatment requiring anesthesia care was not performed until 4.6 hours after arrival, indicating the treatment was not emergent or immediately life-saving. Yet, no assessment of the need to consult with an anesthesia department provider as part of the pre-anesthesia process was documented.

2. Review of the medical record with the ED Director (EDD) on 4/10/13 at 4:30 p.m. indicated that Patient 45, a five year old, presented to the ED on 4/1/13 with pain and deformity of the left arm following a fall from a trampoline. There was no documentation of an airway assessment, including the ASA score, prior to the reduction of the fracture under deep sedation with ketamine.

ED staff assigned a priority level of "non-urgent" to Patient 45 on arrival at 8:11 p.m. Anesthesia and procedural care for Patient 45's broken arm was performed at 11:22 p.m., 4.1 hours after arrival as a non-emergent, non-life-saving treatment. No assessment of the need to consult with an anesthesia department provider as part of the pre-anesthesia process was documented.

In review of a document titled Adult Procedural Sedation Practice, A Study Guide for Physicians, undated, Page 8-10, acknowledged by the hospital as the procedural sedation self study guide used by physicians, the pre-sedation assessment was defined to include:
a. A current History and Physical (H & P)
b. Review of current medication history
c. Allergies
d. Airway assessment
e. ASA classification
f. NPO ("nil per os," whether patient has had recent oral intake) status
g. Vital signs
h. Baseline oxygen saturation (oxygen level in blood).

The document, on Page 10, further described patients at high risk of complications to include a patient who has received prior sedation/analgesic medications (such as narcotic given to Patient 43 above) within the previous 12 hours.

In an interview on 4/10/13 at 12:30 p.m., MD 10, an anesthesiologist and previous Chief of Anesthesia Services, indicated that the hospital's anesthesia service was responsible to oversee all procedural sedation care throughout the hospital. MD 10 indicated that the guidance for hospital sedation policies, trainings, and privilege requirements should be based on the standards and practices recommended by the American Society of Anesthesiologists.

In a 4/08 Annals of Emergency Medicine (Volume 51, Number 4) article titled, "Clinical Policy: Critical Issues in the Sedation of Pediatric Patients in the Emergency Department,"
providers were advised, "Appropriate monitoring and assessment are critical for safe and effective procedural sedation and analgesia..."

Review of the American Society for Anesthesiologists (ASA) statement titled "Advisory on Granting Privileges for Administration of Deep Sedation to Non-Anesthesiologist Sedation Practitioners," approved 10/20/10, indicated in section 3.3 that the sedation practitioner should perform a physical examination to assess risks and co-existing conditions, including assessment of the airway for anatomic and mobility features suggestive of a difficult airway to manage. A commonly used system to describe some findings of the assessment is called a Malampati score. ASA Class also designates particular aspects of a patient's risk to tolerate surgery and anesthesia. Section 3.3 specified some high risk patients who would benefit by sedation provided by an anesthesia professional to include morbidly obese patients, elderly patients, pregnant patients, patients with severe systemic diseases, patients whose airways get obstructed when they sleep, and patients with very full stomach contents.

The Pediatric Sedation Research Consortium published its first report in 2006, "The Incidence and Nature of Adverse Events During Pediatric Sedation/Anesthesia for Procedures Outside the Operating Room," which identified "one concerning event per 29 sedation encounters (among all drugs, all procedures)." The Consortium emphasized that "the pediatric population represents the highest risk, lowest error tolerance subgroup. Pediatric patients require sedation/anesthesia more often than adults ... must be "deeper" than that given to adults to achieve acceptable "conditions" during a procedure. Most important, because of their physiology, children are at higher risk for respiratory depression (compromise of breathing) and life-threatening hypoxia (low oxygen level in blood).

Review of the hospital's Procedural Sedation Policy (undated, unapproved, and presented as current practice with the Vice President of Nursing on 4/11/13 at 9:30 a.m.) did not disclose direction to the non-anesthesiologist deep sedation provider for when (circumstances, high risk conditions) to consult with an anesthesia professional. There was no direction for the physician to perform a pre-anesthesia assessment and document prior to initiating anesthesia and surgical care. There was, however, stipulation on Page 4 that the Registered Nurse, in the pre-procedural assessment, would "b) assure physician has documented...updated H & P, and pre-sedation assessment including airway assessment and assigned ASA score."

Review of the National Integrated Accreditation for Healthcare Organization (NIAHO) standards for assessments prior to anesthesia services indicated that a pre-anesthesia or pre-sedation evaluation must be performed and

Based on staff interview, medical record and document review, the hospital failed to ensure that a complete and accurate intraoperative anesthesia record, in accordance with acceptable standards of care, was provided for three of three sampled pediatric patients (Patients 43, 44, 45) receiving deep sedation during procedures in the Emergency Department (ED).

This failure put patients at risk for a delay in recognizing the need to rescue a patient from a deeper-than-intended level of sedation and therefore created a potential for an adverse outcome.

Findings:

Review of the undated administrative "Procedural Sedation Policy" provided the following definition of "Deep sedation/Analgesia:" "A drug induced depression of consciousness, during which patients cannot be easily aroused but respond purposefully after repeated or painful stimulation. The ability to independently maintain ventilatory (breathing) function may be impaired. Patients may require assistance in maintaining a patent [open] airway and spontaneous ventilation may be inadequate....Deep Sedation may be used for short-term surgical, therapeutic, or diagnostic procedures in which deeper sedation is necessary due to the increased pain or discomfort associated with the procedure (e.g....orthopedic reductions [bone realignments] or the type of drug necessary to sedate the patient produces a deeper level of sedation...."

The "Procedural Sedation Policy" required the following Registered Nurse (RN) documentation during the procedure: "Each patient's physiological status will be monitored during sedation. 1. Oxygen saturation, continuous waveform ETCO2 [the amount of carbon dioxide exhaled at the end of a breath, a measure of cardiorespiratory function] and cardiac rhythm will be monitored continuously. 2. The following will be assessed at a minimum of every 5-minute intervals or more frequently if needed: Blood pressure, Respiratory (breathing) Rate, Heart Rate and level of sedation (LOS). Pain assessment if patient demonstrates pain."

1. Review of the medical record noted Patient 43 was an 18 month-old brought to the ED at 9:20 p.m., 4/6/13 with an arm injury (fractures of two bones of the forearm) after falling from his crib. His initial pain score was rated by his nurse as 10/10, using the FLACC (Face, Legs, Activity, Cry, Consolability) Pain Scale, with 10 representing maximal pain.

The first pre-procedure baseline vital signs recorded for Patient 43 were at 1:50 a.m., 4/7/13, when his heart rate was 112 beats per minute (bpm) and blood pressure (BP) was 120/62. A normal resting heart rate for a 1-2 year old child is 80-120 bpm (http://www.nlm.nih.gov/medlineplus/ency/article/003399.htm); normal BP range is 85-106/37-61 (http://www.heart.org/idc/groups/heart-public/@wcm/@ecc/ documents/downloadable/ucm_436697.pdf).
Immediate preprocedure vital signs included a heart rate of 115 and a BP of 115/57. Patient 43 received the anesthetic drug ketamine, 10 milligrams (mg.) at 2:07 a.m., 4/7/13 before undergoing the procedure to realign his fractures. Four minutes after the ketamine was given, his heart rate had risen to 192 and his BP to 139/71. Patient 43's heart rate gradually slowed but remained 163 immediately post-procedure at 2:40 a.m., 4/7/13. No nursing or physician documentation addressed the abnormal vital signs. In his "Final Report," the physician stated, "The patient tolerated the reduction [realignment] and the sedation well with no complications."
The Procedural Sedation Policy directed the RN to notify the physician for significant changes from baseline in heart and breathing rates. However, the policy only outlined specific reportable age-related changes on the lower end of heart and breathing rates and not the upper end.
Review of Patient 43's medical record indicated the following intraprocedural documentation missing per policy:
a. A gap of sedation level monitoring occurred between 2:14 a.m. and 2:27 a.m. with an increase in sedation by one of the three scales documented which was not addressed by RN or MD. The sedation level remained minimal even during the peak effect of the ketamine, suggesting the ketamine was ineffective and the procedure occurred without its benefit, or the monitoring did not capture the effect.
b. No baseline ETCO2 and first ETCO2 not noted until 4 minutes after the sedative was given. The ETCO2 level was abnormally low when the breathing rate was also low (had fallen from 24 to 11 breaths per minute). The relationship between these two measurements should be opposite so that when the breathing rate is low the ETCO2 level is high, and vice versa. No explanation was documented in the record.
c. No cardiac rhythm noted.
d. No documented evidence physician was aware of accelerated heart rates to 192 and elevated blood pressures,
e. A 13-minute gap in all aspects of monitoring between 2:14 a.m. - 2:27 a.m.

Nursing notes documented that Patient 43 did not waken for at least 30 minutes and sustained rapid heart rates throughout the procedure, a prolonged period of drug effect beyond what is expected from the manufacturer, without documented explanation or interventions in response to the altered condition. The ketamine drug manufacturer literature noted that the onset of anesthetic effect occurs within 30 seconds of administration into the vein, and lasts for 5-10 minutes.

2. Patient 44 was a 16.2 kilogram (kg.) 4 year-old who presented to the ED at 3:22 p.m., 1/29/13, with a lacerated tongue. Her initial pain score was rated by her nurse as 10/10, using the FLACC Scale. Patient 44 received two IV anesthetic drugs, propofol 50 mg. and ketamine 20 mg., between 7:20 p.m. - 7:26 p.m., 1/29/13, prior to the repair of her tongue. The procedure concluded at 7:42 p.m.

During a review of Patient 44's medical record, the following intraprocedural documentation was not found:
a. Level of sedation was not noted between 7:26 p.m. and 7:57 p.m., a gap of 30 minutes,
b. Pain was not documented from 3:28 p.m. until 8:20 p.m., and
c. Cardiac rhythm was not documented during the procedure.

Patient 44 was not moving arms or legs at 7:26 p.m. but the next assessment of movement was not documented until 7:57 p.m., 30 minutes later, suggesting a prolonged effect of the multiple anesthetic medications or failure to monitor their effects.

Review of the undated Procedural Sedation Policy Attachment B indicated that propofol was not listed on the sedation drugs recommended for children. Ketamine was listed for children. The duration of action or anesthetic effect of each medication was not documented to guide anticipation for the drug wearing off during a procedure, or to guide how long to monitor following the procedure.

3. Patient 45 was a 22.6 kg. 5 year-old brought to the ED at 8:11 p.m., 4/1/13 with wrist swelling after a fall from a trampoline. Her initial pain score was rated by her nurse as 4/5, using the Wong-Baker FACES pain scoring tool, with 5 being maximal pain.

At 11:22 p.m., 4/1/13, Patient 45 received 30 mg. of the anesthetic ketamine prior to the procedure to realign her arm fracture. The procedure ended at 11:40 p.m., 4/1/13.

During a review of Patient 45's medical record, intraprocedural documentation of the cardiac rhythm was not found.

In a collaborative record review of the care for Patients 43, 44, and 45 with the ED Director (EDD) on 4/10/11 at 7:30 p.m., she acknowledged that the deep sedation elements of monitoring were fragmented and dispersed among several electronic page files, not simultaneously visible to the person responsible to recognize early adverse changes or trends that would prompt medical interventions to support heart, lung or brain function. For example, one electronic page file contained vital sign measurements for heart rate, breathing rate, blood pressure, and blood oxygen level. A separate electronic page file contained the results of blood oxygen and exhaled carbon dioxide gas levels. A separate electronic page file contained a scoring system to reflect whether a patient moved voluntarily or when stimulated, the patient's depth of breathing, the patient's blood pressure compared to baseline, t

Based on observation, staff interview, medical record and document review, the hospital failed to ensure the Emergency Department (ED) and the Obstetrical Service (OB) integrated their services effectively and timely in the management of pregnant patients who presented with an acute medical condition when there was a delay in a physician assessing a pre term (under 38 weeks gestational age) patient (Patient 1) which resulted in a delayed diagnosis of a septic condition and an admission to the Intensive Care Unit.

Findings:

Review of the medical record indicated that Patient 1 presented to the ED on 3/8/12 at 9:16 p.m. with complaints of fever, chills, cough, chest pain, shortness of breath and decreased fetal (fetus, unborn child) movement. Patient 1 was 28 weeks pregnant (term pregnancy = 40 weeks). An ED nurse documented a set of vital sign measurements that included a significantly elevated heart rate (158 beats per minute), elevated temperature (99.9 degree Fahrenheit) and 20 respirations per minute. Patient 1's blood pressure was 97/60 and her oxygen saturation level (amount of oxygen in the blood) was 95% (95%-98% = normal). No physical assessments for Patient 1's heart, lungs, circulation, or movements were documented. The ED physician was not notified of Patient 1's medical status. Patient 1 was sent to the obstetric unit (labor and delivery, L&D) for evaluation.

A triage nurse (RN 10) documented arrival to labor and delivery at 9:35 p.m. with complaints of decreased fetal movement for the past eight hours. Patient 1 stated she had a cough/fever/chills and felt "achey" for the past five days. An external device/test to measure heart rate and activity of the fetus (FHR) was documented at 30 minute intervals for 2 hours between 10 p.m. and midnight, and fetal accelerations (fetal movement) were confirmed. However, Patient 1's heart rate remained elevated , her breathing rate became elevated and breathing was described as "shallow", and her blood pressure fell below normal at times. Patient 1 was described as anxious and restless. At 10:20 p.m., RN 10 telephoned MD 5 (an obstetrician who was on call for MD 6) to communicate that Patient 1's heart rate was elevated, her blood pressure was decreased, and it was difficult to accurately assess the fetal condition because mother and fetus had very similar (high) heart rates. MD 5 directed RN 10 to observe Patient 1 for a longer period of fetal monitoring to determine if the initial measurements were accurate. MD 5 gave orders for blood tests and to administer fluids into Patient 1's vein (to correct dehydration if that was the reason for the low blood pressure and high heart rate). At 11:30 p.m. MD 5 was updated by telephone and directed that Patient 1 be evaluated by a hospitalist or return to the ED.

An entry at 12:37 a.m. indicated that Patient 1 returned to the ED. However, no vital sign measurements or ED care was entered into the medical record until 1:37 a.m., when Patient 1's heart rate (125 beats per minute) and breathing rate (26 per minute) were again elevated, and blood pressure remained decreased (83/33). At this time, Patient 1's blood oxygen level was now decreased to 93%. At 1:38 a.m., a nursing entry noted "chills [with] rigor, heart rate [greater than] 90, respiratory rate [greater than] 20," Patient 1 met criteria for a severe infection.

The first direct assessment of Patient 1 by a physician was documented at 2:30 a.m., more than 5 hours after Patient 1 arrived to the hospital. No further monitoring of Patient 1's fetus was documented after midnight, until 8 a.m. Vital sign measurements were documented hourly starting at 3 a.m., showing persistently elevated heart rate, elevated breathing rate, and low blood pressure, despite large amounts of fluid administrations into Patient 1's vein, oxygen to breathe, medicine to open the small airways of the lungs, and morphine (a narcotic pain reliever). MD 2, an ED physician, directed care between 2:30 a.m. and 5:30 a.m., during which time tests showed pneumonia in the right lung and possible infection in the blood. Antibiotic medications were administered. A hospitalist (MD 8) documented an admission note to the intensive care unit (ICU) at 5:36 a.m. No further communications with MD 5, or any obstetrical physician consultant, was documented until 8 a.m.

Patient 1 arrived to the ICU at 6:30 a.m. with persistent compromise to her breathing and heart function. A critical care medicine physician, MD 9, documented at 7:44 a.m. that Patient 1 had difficulty breathing at rest with cough and fever, 28 week pregnancy, assessed with severe blood infection and shock. Patient 1 was anxious and short of breath. Treatments included more fluids, a medicine to raise blood pressure, and a device to force air pressure and oxygen into the lungs (BiPAP). The next documented fetal monitoring at 8 a.m. noted a slight decrease in the "reactivity" or vigor of the fetus. An obstetrician, MD 6, evaluated Patient 1 in the ICU at 8:20 a.m., and continued with close oversight and intermittent imaging tests to evaluate the fetus in addition to the external monitoring system (FHR). Between 8 a.m. and noon, Patient 1's condition worsened and more treatments to support her blood pressure, oxygen, and effectiveness of breathing were tried. At 1:30 p.m., she was too unstable to transfer to a nearby tertiary center with high risk maternal fetal physician consultants as Patient 1 was considered to be unstable and required the support of a breathing machine. The fetal monitor displayed a "flat strip" showing the fetus was compromised. At 3:04 p.m., MD 6 performed a Cesarean Section (a surgical procedure to open the abdomen and deliver the fetus) under general anesthesia at the bedside in the ICU. A team from the neonatal intensive care unit at the tertiary center arrived in advance to care for the premature infant, who was "somewhat floppy" at the time of the delivery. The Apgar Scores (an assessment of the newborn done at one and five minutes following birth) were both under five (out of a 10/10 score).

In an interview on 4/9/13 at 1:45 p.m., MD 5 stated that the information she received from the triage nurse on 3/8/12 led her to believe Patient 1 was "not that sick." MD 5 did expect L&D nursing staff to examine patients well enough to determine if a patient faced critical compromise of vital body functions, such as examining the heart and lungs if the patient complained of a breathing problem or high heart rate. MD 5 also expected Patient 1 to be evaluated by a physician at the hospital soon after she directed L&D nursing staff to arrange for that, without a delay of 3 more hours before Patient 1 was seen by an ED physician. MD 5 stated that ED physicians were expected to readily contact the patient's obstetrician or the obstetrician on call when managing critically ill pregnant patients. If ED staff asked the obstetrician for guidance in evaluating or treating a sick pregnant patient, MD 5 had access to the services of a nearby maternal-fetal medicine (MFM) specialist group, and could also facilitate transfer to a hospital that offered MFM services. MD 5 acknowledged that no current formal hospital policy or process required co-management of critically sick pregnant patients, and the decision to make contact with an obstetric consultant rested with the primary (ED or hospitalist) physician caring for the sick pregnant patient.

In an interview on 4/10/13 at 9:30 a.m., a licensed L&D nurse (RN 1) acknowledged she was the nurse who triaged Patient 1 in L&D on the night of 3/8/12. RN 1 stated she was concerned about Patient 1's tachycardia, shallow respirations and low blood pressure. RN 1 acknowledged there was no documentation of heart and lung sounds. RN 1 stated she called MD 5 because "I wanted to hydrate her" to see if she could get a "better b/p [blood pressure]" and thought some "tests" should be done. RN 1 acknowledged the tests were not ordered to be done "stat" (a term used to alert the lab to perform the tests immediately). RN 1 stated she did not feel it necessary for MD 5 to come in to assess Patient 1 as "I was satisfied it wasn't an OB prob