HospitalInspections.org

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Based on observation, staff interview, and document review, the hospital failed to effectively govern the activities and conduct of the hospital staff to provide quality care in a safe environment for all patients as evidenced by:

A. The hospital failed to ensure that processes of care and operations, including several previously cited as deficient practices, were measured, analyzed and tracked as quality indicators to demonstrate implementation of corrective actions and sustaining safe care practices. Refer to A 263.

B. The hospital failed to ensure that nursing services were furnished or supervised by a registered nurse and consistent with nationally accepted standards of practice. Refer to A 385.

C. The hospital failed to ensure safe, effective pharmaceutical services that the met the needs of the patients. Refer to A 490.

D. The hospital failed to ensure that medical staff physicians were assessing patients prior to cardiac catheter procedures using moderate sedation (per facility's rules and regulations. Refer to A 940.

These failures resulted in a potential for increased infections, adverse medication episodes, and other adverse events for all patients. The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Governing Body.

Based on observation, staff interview, medical record and document review, the hospital failed to ensure an active, effective, ongoing data-driven surveillance of patient care practices (i.e. practices that carried high risk to patient safety), through its Quality Assessment and Performance Improvement (QAPI) program, reflecting the complexity of the hospital's organization and services, in all locations, in order to minimize those risks to all patients as evidenced by the failure to ensure:

1. Adequacy of pre-surgical assessments by physician staff to address each surgical patient's risks (co-existing conditions) for surgery. Refer to A 267, Item 1a.

2. Availability of nursing and non-nursing staff to meet physician orders for sitter (safety companions). Refer to A 267, Item1b.

3. The adequacy of nursing care plans and that care provided to patients followed physicians orders and accepted standards of practice. Refer to A 267, Item 1c.

4. Monitoring of visitor compliance with isolation precautions and nurse instruction of visitors on those precautions. Refer to A 267, Item 1d.

5. Monitoring of physician oversight for patients receiving wound care. Refer to A 267, Item 1e.

6. Interdisciplinary review and analysis for pressure ulcer patients. Refer to A 267, item 2.

7. Monitoring high risk, problem prone drugs. Refer to A 285, findings 1-6.

These failures put patients at risk for substandard care, adverse events, infections, pressure ulcers, poor patient outcomes and risks to patient safety. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Quality Assessment and Performance Improvement.



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26611

Based on staff interview and document review, the hospital failed to ensure that processes of care and operations, including several previously cited as deficient practices, were measured, analyzed and tracked as quality indicators to demonstrate implementation of corrective actions and sustaining safe care practices. Documented evidence was lacking to show the following care processes were effectively evaluated when continued evidence of regulatory violations were identified:

1a. Adequacy of pre-surgical assessments by physician staff to address each surgical patient's risks (co-existing conditions) for surgery. Refer to A 952.

b. Availability of nursing and non-nursing staff to meet physician orders for sitter (safety companions). Refer to A 392

c. Adequacy of nursing care plans and care provided to patients in accordance with physicians orders and accepted standards of practice. Refer to A 396.

d. Monitoring of visitor compliance with isolation precautions and nurse instruction of visitors on those precautions. Refer to A 749

2. Interdisciplinary review and analysis for pressure ulcer patients.

These failures resulted in continued care practices that jeopardized patient outcomes and safety.

Findings:

1. In an interview on 4/25/13 at 2:30 p.m. with the Chief Quality Officer (CQO) and the Director of Quality Management (DQM), the quality program documentation was reviewed. The following deficient practices were not measured as part of the quality program despite previous citations for deficient practice:

a. The presence and adequacy of pre-surgical assessments by physicians for patients, prior to cardiac catheterization. Refer to A 952.

b. The adequacy of staff to meet the patients needs for patients requiring a sitter. Refer to A 392.

c. The presence and adequacy of care plans for wound patients. Refer to A 396.

d. The education of visitors regarding isolation precautions and the compliance of visitors with those precautions. Refer to A 749

In a concurrent interview, CQO and DQM acknowledged that the above items were not actively measured as part of the facility's quality assessment and performance improvement plan.

DQM was asked specifically about the comprehensiveness of the wound care program QAPI. DQM stated there were specific measures for Braden scale interrater reliability, repositioning for moderate and high risk patients, and pressure reduction. When asked if there was any case analysis to see if wound patients were receiving the expected standards of care, DM was unsure if the Wound Committee had done any overall analysis of the patient care.

2. In an interview with Nurse Manager (NM) 24 on 4/25/13 at 4:40 pm, she stated that while there was an interdisciplinary team which included dieticians, nurses, and wound care specialists that met regularly to discuss pressure ulcer policy and review prevalence data. NM 24 stated there was no coordinated interdisciplinary review of individual cases or analysis of compliance with standards of care for patients who had or experienced pressure ulcers.


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Based on staff interview and document, medical record and policy reviews, the facility failed to focus their performance improvement on high-risk or problem-prone areas as evidenced by:

1. Failure to assess high risk situations, where patients are found unresponsive and need to be given rescue agents, to evaluate causes and use the information to prevent similar occurrences.
2 . Failure to administer medications in accordance with the manufacturer's specifications (Patient 132). Refer to A 500, item 1.
3. Failure to monitor high risk medications such as digoxin (heart medication) for possible toxicity (Patient 131). Refer to A 500, item 2.
4. Failure to ensure that medication was used appropriately to treat infections, by doing lab tests to ensure that the bacteria are sensitive to the antibiotic used (Patient 131). Refer to 500, item 3.
5. Failure to ensure that staff implemented policies and procedures for timely assessment of pain after interventions (Patients 132 and 133). Refer to A 500, item 4.
6 . Failure to ensure accuracy of medical records (Patients 132, 133 and 123). Refer to A 438, items 1-3.

Findings:

1. The facility process for evaluating the use rescue agents, such as Narcan, was evaluated. Narcan is a rescue agent for opiate/opioid type medication that reverses sedation and respiratory depression associated with excessive use of opiate, like morphine. Review of two of two records revealed lack of evidence that the events preceding use of Narcan were documented and a follow up evaluation were attempted in efforts to prevent similar occurrences for other patients.

a. On 4/23/13, review of the record for Patient 134 with Pharm Tech 2 revealed that the 68 year old patient was admitted on 3/7/13. On 3/16/13, Patient 134 was given Narcan. PharmTech 2 stated that she follows up to ensure that an "occurrence" was reported; that she compiles the list of items related to use of rescue agents, such as the physician was present or contacted, the email alert went out to alert key staff of such situation, and checking the medication administration record for potential use of offending agents (opiates/narcotics in this case).

PharmTech2 presented documentation that on 3/14/13, Patient 134 was found unresponsive and was given Narcan. The collated documents had the list of documents that PharmTech2 is supposed to collect.

On 4/23/13 at 4 pm., record review revealed no documentation of the patient's condition or how the situation escalated to indicate the need for use of Narcan. On 3/14/13 at 8:05 am, nurse's notes documented that "pt. condition too lethargic" and "Dr ... orders for Narcan 0.4 mg ..."

Additional review of nurse's notes on 3/13/13 at 8:59 am, indicated that the patient responded. "Patient wakes up immediately after Narcan ..."

On 4/23/13 at 4 pm, a concurrent interview with the DP, NDP, and PharmTech2 was conducted. During the interview, these staff were asked about the process for follow up on the above case, it was stated that a quality staff person, QS1, does the follow up.

However, there was no documented evidence that this case was evaluated to determine the cause of this occurrence. There was no documented evidence that a pharmacist evaluated this case to see if the medication doses were appropriate for this patient (68 year old), her medical condition (renal failure requiring dialysis), or if there were multiple medications that caused the same side effects (sedations). In addition, there was documented evidence that this case was evaluated by nurses, to see if there were any changes in this patient's condition that possibly contributed to the episode of unresponsiveness.

b. Similarly, on 4/23/13, the record for Patient 135 was reviewed and revealed that the 75 year old patient was admitted on 3/21/13. On 3/26/13 at 19:45 (7:45 pm), Patient 135 was found unresponsive to verbal or painful stimuli ..." Patient 135 was given Narcan at 20:30 (8:30 pm). There was no documentation by the nurses to demonstrate what happened or the sequence of events that led to the need for Narcan administration.

There was no documented evidence that this case was evaluated to determine the cause of the occurrence or that a pharmacist evaluated this case to see if the medication doses were appropriate for this patient (75 year old), for her medical condition, or if there were multiple medications with the same side effects (sedations) that were prescribed at the same time. There was documented evidence that this case was evaluated by nurses, to see if there were any changes in the patient's condition that possibly contributed to the episode of unresponsiveness or that other assessments were completed to see if the episode was preventable.

The facility process for evaluating use of using rescue agents such as Narcan was evaluated. Narcan is a rescue agent for opiate/opioid type medication that reverses sedation and respiratory depression associated with excessive use of opiate, like morphine. Review of two of two records revealed lack of evidence that the events preceding use of Narcan were documented and a follow up evaluation were attempted in efforts to percent similar occurrence for other patients.

2. On 4/24/13, review of the electronic record for Patient 123 revealed that the patient was receiving Precedex, also known as Dexmedetomidine Hydrochloride. Precedex is a medication used for sedation of intubated and mechanically ventilated patients. According to the manufacturer, this medication should not be used for more than 24 hours. "In adults 18 years of age or older, the usual initial dosage of dexmedetomidine is 1 mcg/kg given IV as a loading infusion over 10 minutes, followed by a maintenance infusion of 0.2-0.7 mcg/kg per hour for no longer than 24 hours. Dexmedetomidine has been administered by continuous IV infusion in mechanically ventilated patients prior to extubation, during extubation, and post-extubation; it is not necessary to discontinue the drug prior to extubation provided that the duration of the infusion does not exceed 24 hours. "

The order was written on 3/14/13 and continued well beyond the manufacturer's 24 hour restriction. There was no documented evidence or clinical rational for the prolonged use.

The guidelines for intravenous medications (from facility policy 631.4: IV Medications), had Precedex listed. However, under comment and monitoring considerations, there was no restriction for the duration of its use.

The order for Precedex was on a preprinted form titled, "CRITICAL CARE IV MEDS (SEDATIVES)," revised 01/09. The preprinted order did not have any notations or directions limiting the use of Precedex to 24 hours.

On 4/25/13, PharmD3 and NDP were asked to provide any supportive information that may have been presented when this medication was added to the hospital formulary; however, no information was presented to address this issue.

3. a. On 4/23/13 at 10 am, a concurrent review of the record with RN 65 revealed that Patient 131 had an order for Digoxin, a medication used for heart failure. Patient 131 was receiving Digoxin prior to admission. Concurrent review of the record with RN 65 revealed no evidence that Digoxin blood level had been obtained or ordered. Digoxin has a narrow therapeutic index, which means that the effective level and the toxic level are close to each other. The range between effective and toxic levels is very narrow. The therapeutic Digoxin level is 0.5-0.8 ng/ml (nanograms per milliliter). Nano gram (ng) is a miniscule amount; it is one-billionth (1/1,000,000,000) of a gram.

Digoxin can quickly reach toxic concentrations in patients with renal failure. According to the drug information, Lexicom online: "Elderly are at risk for toxicity due to age-related changes; volume of distribution is diminished significantly; half-life is increased as a result of decreased total body clearance. Additionally, elderly frequently have concomitant diseases which affect the pharmacokinetics in digitalis glycosides; hypo- and hyperthyroidism and renal function decline will affect clearance of digoxin ... "

Patient 131 was an 89 year old. On 4/22/13, her serum creatinine was 1.12; considering age alone, this patient would have compromised renal function.

Monitoring Digoxin level is essential to ensure efficacy (level within the therapeutic range) and to prevent toxicity. Checking the level becomes more critical when the patient receives medications that potentially interact with Digoxin and cause accumulation of the drug and toxicity such as Spironolactone, a diuretic (water pill), which Patient 131 was also receiving. According to Lexicomp, an online drug resource, "Potassium-Sparing Diuretics may increase the serum concentration of Cardiac Glycosides. This particular effect may be unique to Spironolactone: May increase the serum concentration of Digoxin. "

On 4/25/13, a follow up interview with PharmD3 revealed that Patient 131's Digoxin level had not been checked.

3. b. On 4/23/13 at 10 am, a concurrent review of the record with RN 65 revealed that Patient 131 was receiving two broad-spectrum antibiotics: Zyvox which is used to treat pneumonia, skin infections, and brain abscess amongst other conditions and Cefipime which is used for skin, lung, and urinary tract infections, in addition to brain abscess and other conditions. During record review, RN 65 was asked about the lab data related to the infection, specifically, if there were any ordered or completed labs such as culture and sensitivity to check the appropriateness of the selected therapy (the two antibiotics that Patient 131 was receiving). RN 65, in the presence of the CCO, stated that there were no such labs and clarified that they were trying to treat Patient 131's urinary tract infection and cellulitis (skin infection caused by bacteria).

On 4/23/13 at 4pm., PharmD3 and NDP were asked about pharmacist evaluations of orders and interventions on therapy specific to Patient 131. It was stated that the hospital did not have infectious disease pharmacists. PharmD3 said that he would follow up to see if there were any interventions or any labs ordered or completed for this patient.

On 4/25/13, mid-morning, in a follow up interview for this concern, PharmD3 presented evidence that a lab test was ordered on 4/23/13, and the sample was collected on 4/23/13 at 22:00, after therapy appropriateness concerns were raised by the surveyor with staff, which was three days after initiation of therapy.

4. Review of nursing documentation of pain medication and pain reassessment revealed that the reassessment was not completed, in accordance with facility policy.

a. On 4/22/13 at 3 pm, review of the record for Patient 132 with facility pharmacy staff DP and Pharm Tech 4, revealed:

Patient 132 had an order for Dilaudid (pain medication) for 2 milligrams to be given by mouth every 4 hours when needed for pain. Review of the medication administration record (MAR) revealed on 3/29/13, four Dilaudid doses were administered at #1 at7:49 am, #2 at 12:09 noon, #3 at 16:58 (4:58 pm) and # 4 at 20:37 (8:37 pm). Pain reassessments following these administered doses were documented on 3/30/13 at the following times: # 1 at 00:46 (over 16 hours later), # 2 at 00:46 (over 12 hours later), #3 at 0036 (over 7 hours later), and #4 at 00:36 (over 4 hours later). These pain reassessments were not completed within one hour of administration.

Similarly, Patient 132 had an order, dated 3/19/13, to receive Dilaudid 1 milligram by injection, every 2 hours as needed for pain. On 3/20/13, a dose was administered at 10:12 am. The nursing pain reassessment was documented on the same day at 17:13, which was almost 9 hours after medication administration.

b. On 4/23/13 at 3 pm, a concurrent review of Patient 133's record with Nurse Manager (NM) 17 revealed that the patient had a history of chronic pain. The patient had an order, on 3/26/13, for Lortab 5/500 (hydrocodone/acetaminophen), to receive one or two tablets every 6 hours, as needed for pain. NM 17 stated that on 3/27/13 the pain was assessed about 4 hours after for the dose given at noon, and about 10 hours after the dose given around 6 pm (17:55).

Facility staff did not follow the pain assessment policy for reevaluation of pain after pain medication administration. According to the facility's policy titled, "Pain Management- Hospital wide" and approved 8/24/12, "The patient's pain will be re-assessed within 60 minutes of administration of a PRN medication."

5. A review of medical records for Patients 132, 133, and 123 revealed the following inaccuracies:

a. On 4/22/13 at 3 pm, Patient 132's record was reviewed with DP and Pharm Tech 4. Patient 132's record revealed that Patient 132 had an order for Dilaudid for 2 milligrams to be given by mouth every 4 hours, as needed for pain. Review of the MAR revealed that, on 3/29/13, four Dilaudid doses were administered at: 7:49 am, 12:09 noon, 16:58 (4:58 pm) and 20:37 (8:37 pm). On the MAR, pain reassessments were documented following these doses.

On 4/22/13 at 3:30 pm, Pharm Tech 4 stated that pain documentation may be completed in the electronic medical record HED (Horizon Expert Documentation). In a follow up discussion with NM 17 on 4/23/13, NM 17 acknowledged that documentation in the HED did not match the MAR.

On 3/29/13, according to the MAR, a 2 milligram dose of Dilaudid was administered at 12:09, for a pain scale of 7 and pain reassessment after midnight to be zero. However, the HED documentation showed pain was reassessed to be a pain scale level of 3. And, contrary to the MAR, the HED had documentation that the 12:09 noon dose was refused. NM 17 reviewed the record and did not find any documented evidence explaining the discrepancy or a reason for medication refusal. It was not clear if the medication was given or was refused. NM 17 stated that it might have been that the nurse clicked the box for refused instead of medicated by mistake, as both boxes on the computer screens were positioned one above the other.

b. On 4/23/13 at 3 pm, a concurrent review of the record for Patient 133 with NM 17 revealed that the patient had a history of chronic pain. The patient had an order on 3/26/13 for Lortab 5/500 (hydrocodone/acetaminophen), to receive one or two tablets every 6 hours, as needed for pain. NM 17 revealed that on 3/27/13, two doses were given at noon and 6 pm. The MAR had documented reassessment of the pain.

According to the facility policy titled, "Pain Management- Hospital wide," approved 8/24/12, nurses are supposed to document pain assessment and re-assessment on the HED. "Reassessment of the patient's pain should be documented in the PAIN section of the patient record."

Further evaluation of the HED revealed a documentation that the dose was refused.

NM 17 reviewed the record, but did not find any documented evidence explaining the discrepancy or the reason for medication refusal. It was not clear if the medication was given or was refused.

c. On 4/24/13, in the afternoon, review of the electronic record for Patient 123 revealed that the patient was receiving Precedex, also known as Dexmedetomidine Hydrochloride. Precedex is a medication used for sedation of intubated and mechanically ventilated patients. According to the manufacturer, this medication is given by intravenous infusion of 0.2-0.7 mcg/kg per hour, for no longer than 24 hours.

On 4/24/13, review of the electronic record revealed documentation on the flow sheet that on 3/17/13, this medication was given at 200 mcg/kg/hr which is 285 -1000 times the recommended rate. The 200 mcg/kg/hr rate was entered three times on the flow sheet.

The nurse that completed the documentation was not available for interview on site. However, on 3/25/13 at 14:40, DRM, indicated that he spoke with the nurse by phone and the nurse said that the documentation was "an entry error on the electronic record [and that the nurse] offered to make a late entry clarifying the documentation. "

Based on observation, interview, and record review, the facility failed to ensure that the medical history and physical examination (H & P) be completed no more than 30 days, prior to scheduled procedures, for 3 of 3 sampled patients. (Patients 141, 142, and 143) This failure may result in inaccurate documentation of patients conditions and status, prior to a procedure.

Findings:

On 4/22/13 at 9:40 am, Patient 142 was observed lying supine on a table in the center of the Cardiac Cath Suite. A heart monitor was on the patient monitoring his heart rhythm and rate, blood pressure, and oxygen saturation level (assessment tool for oxygen level in blood). A sterile prep (disinfection of entry site) to the expected entry sites was observed being performed by Nurse Manager (NM) 18, then sterile drapes were placed around the entry sites. The surgical checklist (a list of required documentation and third review by nursing) was signed off as completed by Registered Nurse (RN) 68. The record contained a H & P, dated 3/22/13 (31 days) and no interval update. When the 31 day H & P was brought to RN 68's attention, she stated that she had calculated the date from 3/23/13, when Medical Staff Member (MSM) 61 signed off the H & P and confirmed the H & P occurred on 3/22/13.

On 4/22/13 at 10:05 am, MSM 61 entered the Cardiac Cath Suite. MSM 61 was informed he needed to do another H & P, since the current one was over 30 days. MSM 61 was observed reviewing Patient 142's record. MSM 61 did not speak to the patient. The "Time Out" procedure to confirm the correct patient, procedure, and pertinent information was discussed with the team members at 10:13 am.

A review of the record after the procedure provided documentation that MSM 61 conducted a H & P at 10:10 am (while Patient 142 was in Cardiac Cath Suite prepped for the procedure) and an interval update to the H & P was documented at the same time. A Mallampati Scale (a visual clinical instrument used to assess the ease of obtaining an airway by direct observation), was documented as Class II by MSM 61 at 10:10 am. From the time when MSM 61 entered the procedure room to the beginning of the procedure, there was no physical exam conducted by MSM 61 for Patient 142, as required by facility policy and nationally recognized standards of practice.

On 4/22/13, three procedures were scheduled in Cardiac Cath Lab for Medical Staff Member (MSM) 61:
Patient 141 had a H & P conducted on 1/30/13, 82 days prior to procedure.
Patient 142 had a H & P conducted on 3/22/13, 31 days prior to procedure.
Patient 143 had a H & P conducted on 2/15/13, 66 days prior to procedure.

In an interview on 4/22/13 at 2:10 am, MSM 61 stated that it was "very rare" to have a H & P occur greater than 30 days, prior to the scheduled procedures in Cardiac Cath Lab. He stated that he conducted the H & P while Patient 142 was lying under sterile drapes on the table. MSM 61 stated that he did the best he could, but was limited in conducting the physical exam due to the position of the patient and sterile drapes prevented him from doing a complete history and physical. He stated he did not talk to the patient, but was able to get the necessary information from his record. During the interview, MSM 61 was notified via telephone that he had to conduct another H & P.

According to the facility's Medical Staff Rules and Regulations, dated 8/12, "A-3 A medical history and physical examination is to be completed no more than 30 days, prior to or within 24 hours after inpatient admission. For a medical history and physical examination that was completed within 30 days prior to inpatient admission, an update documenting any changes in the patient's condition is completed within 24 hours after inpatient admission or prior to surgery...A - 4 A history and physical is required for all patients with the exception of outpatients presenting for treatment or procedures covered by the Conditions of Admission form which do not require a separate consent. The history and physical must contain: 1) history of present illness; 2) medical and surgical history, medications, and allergies; 3) physical exam; 4) impression; 5) plan. Chief complaint, review of systems, family history, and social history should be included when pertinent but not necessarily under separate headings."

Based on observation, interview, and record review, the facility failed to ensure that an updated examination of the patient was conducted when the History and Physical (H & P) was completed within 30 days, before the procedure for 10 of 10 Medical Staff Members (MSM 61, 62, 63, 64, 65, 66, 67, 68, 69, and 70). This failure may result in not identifying potential problems that could result in complications.

Findings:

On 4/22/13 at 9:40 am, Patient 142 was observed lying supine on a table in the center of the Cardiac Cath Suite. A heart monitor was on the patient monitoring his heart rhythm and rate, blood pressure, and oxygen saturation level (assessment tool for oxygen level in blood). A sterile prep (disinfection of entry site) to the expected entry sites was observed to be performed by Nurse Manager (NM) 18, then sterile drapes were placed around the entry sites. The surgical checklist (list of required documentation and third review by nursing) was signed off as completed by Registered Nurse (RN) 68. The record contained a H & P, dated 3/22/13, (31 days) and there was no interval update (Refer to A 359).

On 4/22/13 at 10:05 am, MSM 61 entered the Cardiac Cath Suite. MSM 61 was observed reviewing Patient 142's record. MSM 61 did not speak to the patient. The "Time Out" procedure to confirm the correct patient, procedure, and pertinent information was discussed with the team members at 10:13 am.

A review of the record after the procedure provided documentation that MSM 61 conducted an interval update at 10:10 am (while Patient 142 was in Cardiac Cath Suite prepped for the procedure). A Mallampati Scale (a visual clinical instrument used to assess the ease of obtaining an airway by direct observation) was documented as Class II by MSM 61 at 10:10 am. From the time when MSM 61 entered the procedure room to the beginning of the procedure, there was no physical exam conducted by MSM 61 for Patient 142 as required by facility policy and nationally recognized standards of practice.

Two confidential interviews conducted on 4/24 and 4/25/13, confirmed that the normal practice for all Cardiac Cath procedures was that the medical staff members (MSM 61 through 70) always conducted their interval updates while the patients were on the procedure table, draped, and ready for the procedure. Both stated that it would be impossible to conduct an updated examination of the patient while they were positioned on the table for the procedure. In all other procedures, the interval update was conducted in the preoperative area before the patient was taken into the procedure room.

In an interview on 4/25/13 at 9:30 am, MSM 62 stated he thought the "new regulation," interval update assessment prior to patients entering the Cardiac Cath suite, was not practical for the doctors and that other health facilities were not requiring the interval update, prior to patients entering the procedure room. The "new regulation" referred to by MSM 62 had been in effect since 10/17/08.

According to the facility's Medical Staff Rules and Regulations, dated 8/12, "A-3 ...For a medical history and physical examination that was completed within 30 days prior to inpatient admission, an update documenting any changes in the patient's condition is completed within 24 hours after inpatient admission or prior to surgery."

According to "Procedural Anesthesia/Analgesia - Adult-Hospitalwide," dated 9/24/12, "F. Mallampati Scale - a standardized classification tool to predict ease of intubation (breathing tube) based on a visual assessment by the physician of the anatomy of the oral (mouth) cavity."

In an interview on 4/25/13 at 3:45 pm, the Director of Quality Management stated that the expectation would be that the physician would have the patient open their mouth to evaluate Mallampati Scale.

Based on observation, interview, and record/document review, the facility failed to ensure that the individual nursing needs of each patient were met, medical records were complete, and verbal/telephone orders were authenticated within 48 hours, for 17 of 42 patients within the sample, in the following instances:

1. The facility failed to provide adequate nursing care to meet the individual needs of each patient. (Patients 123, 125, 115, 116, 144, 148, 149) Refer to A 392, Items 1 - 5.

2. The facility failed to ensure care plans were developed, current, and implemented. (Patient's 112, 119, 127, 144, 115, 105, and 120) Refer to A 396, Items 1 - 4.

3. The facility failed to ensure that medications were administered as ordered (Patient 115). Refer to A 405.

4. The facility failed to ensure the medical records were accurate. (Patients 123, 132, and 133) Refer to A 438, Items 1 - 3.

5. The facility failed to ensure that the medical record entries were documented completely and/or authenticated by the person responsible for providing the service. (Patients 112, 125, 151, and 152) Refer to A 450, Items 1 - 5.

6. The facility failed to ensure that verbal/telephone physician's orders were authenticated within 48 hours. (Patients 111, 116, 132, and 133) Refer to Items 1 - 4.

These failures resulted in the increased potential for patients to not have care provided that may be needed and ordered and cause harm to the physical, mental, and psychosocial well-being of each patient. The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Nursing Services.




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Based on observation, interview, and record review, the hospital failed to ensure that nursing staff provided accurate assessments, interventions, implemented physicians' orders, and notified physicians of pressure ulcers for seven of 42 sampled patients when:

1. Patient 123 had five pressure ulcers identified that were not reported to the physician and were not assessed by the wound care team.
2. Patient 125 had an unstageable pressure ulcer that was not accurately identified by the wound care team.
3. Patient 115 was not provided a sitter (safety companion), as the physician ordered.
4. Patient 116 did not have a urinal emptied for an extended period of time.
5. Patients 144, 148, and 149 did not have accurate scoring of their risk for pressure ulcers.

These failures resulted in Patient 123's wounds not being treated and had the potential for patient to not have accurate and timely pressure ulcer treatment, due to in accurate assessments of risk and pressure ulcer stage/wound type. Patients were at risk of undetected complications, infections, pain, prolonged medical care, and disfigurement due to lack of provided physician ordered assessments and care.

Surveyors identified deficient practices related to accuracy of nursing assessment of pressure ulcers, failure to report newly developed wounds to the physician, and failure to provide preventative care and treatment for patients with pressure ulcers or who are at risk for pressure ulcers. An additional concern was raised as to how knowledgeable physicians were regarding the presence of patient wounds, because of the lack of notations regarding patients' wounds in their history and physicals and progress notes (Patient 104). Due to concerns as to whether patients were being appropriately assessed and newly developed pressure ulcers reported to the physician, an Immediate Jeopardy was declared on 4/24/13 at 5:49 pm with the Chief Executive Officer, Chief Nursing Officer, Chief Quality Officer, Director of Quality Management, and Director of Risk Management.

The hospital implemented a plan of corrective action to remove the immediate concern that patients were not being assessed thoroughly and that newly identified concerns were not being reported to the physician. This plan of corrective action ensured all patients currently admitted to the hospital were evaluated with a head to toe assessment to identify pressure ulcers, deep tissue injuries, and unstageable pressure ulcers using nationally accepted definitions (see item 1 below for definitions) and reported to the physician. Additionally, patient records were evaluated for corresponding documentation by physicians that they were aware of the patients' wound status. On 4/25/13, the survey nurse team evaluated ten random patients to determine the accuracy of the facility's pressure ulcer assessments and the physician documentation of newly identified and worsening pressure ulcers.

The Immediate Jeopardy was abated on 4/25/13 at 4:30 pm after the facility implemented a corrective action plan to ensure the patients' immediate safety. Refer to A 392, item 1.

Findings:

1. During record review on 4/23/13, the face sheet (demographic information) indicated that Patient 123 was 45 years old and admitted to the facility on 2/25/13 with a diagnosis of respiratory failure. The record indicated that Patient 123 was intubated (tube inserted into the mouth extending into the trachea to maintain an open airway for breathing and/or assistance in breathing) in the emergency room, placed on a ventilator (automatic machine to help patients breathe) and taken to ICU (Intensive Care Unit) for further care and treatment.

Patient 123's record contained an admission assessment record, completed and documented by a licensed ICU nurse (RN 76), that indicated upon admission to the ICU at 10:50 am, Patient 123's skin integrity (condition) was warm and dry, normal, and intact. The documentation noted that Patient 123's skin condition on the back, buttocks, heels and ears was intact (no wounds or open areas visible).

Patient 123 had been identified for the investigation of an entity reported incident (CA00350248) related to an unstageable wound at the base of Patient 123's tracheostomy (trach - a hard curved tube inserted through the front, lower part of the neck directly into the trachea used when the patient must be intubated for long periods of time) cuff. Respiratory care notes documented tracheostomy care provided each day and on 4/2/13 at 3:15 pm, the respiratory care staff member (RST 1) indicated that a pressure ulcer was visible. The note indicated RST 1 notified the nurse and charge nurse of the wound and "suggested to take pictures and get the wound care team involved." All photographs taken for Patient 123 were requested for review and obtained from medical records on 4/23/13.

Review of the tracheostomy wound photograph suggested that the wound may have been caused by friction of the tracheostomy cuff against the sutures at the base until the sutures broke and allowed the wound to open. Further information from the medical record indicated the tracheostomy tube was removed later that same day, on 4/2/13.

Patient 123's record contained wound care notes, dated 4/3/13 and timed 3 pm, that indicated the Wound Nurse (WRN 4) was called to evaluate a "new area" consisting of an unstageable wound secondary to the trach resting pressure over the left side of the clavicle (collar bone) with slough to the wound bed measuring 0.2 centimeters (cm) x 0.6 cm x 0.5 cm. Patient 123's record further indicated that WRN 4 then discussed the plan of care for this wound with the staff RN and Patient 123, and checked the "other" dressings to a midline incision on the abdomen and a colostomy (surgical opening through the abdomen to make an outside connection for elimination of bowel waste) for which WRN 4 was providing treatment. There was no documentation of any other wounds on Patient 123's skin that had been identified, noted, or treated by the wound care team.

The tracheostomy wound was determined to be unavoidable and not a pressure ulcer related to Patient 123 being awake, alert, and mobile. This activity increased the friction of the trach against the sutures until the sutures ruptured and the wound opened. Patient 123 requested that the trach be removed that day.

The WRN 4 documented another visitation note on 4/5/13, the day before Patient 123's discharge on 4/6/13, that indicated the colostomy on the abdomen was patent (open and functional), the abdominal incision was intact with skin staples visible, and the wound to Patient 123's neck at the trach site was healing with 50% granulation (new connective tissue granules which indicate wound healing) and 50% eschar to the base of the wound which then measured 0.3 cm x 1.9 cm x 0.3 cm. There was no documentation of any other wounds that had been present and healed or were still present.

During a review of all the wound photographs taken for Patient 123, this surveyor identified six other photographs, dated in March 2013, of wounds that were classified as a minimum of Stage III (a coccyx wound) to Unstageable (to both feet and the left ear with eschar in varying stages of healing and/or removal).

During document review of the facility's "Mandatory Nursing Practice Review," (undated, pages 3 and 4), the following definitions were provided:
1. Stage III wounds have full thickness tissue loss where subcutaneous (the lowest layer of fatty tissue in the skin) tissue may be visible but bone, tendon, or muscle are not.
2. An unstageable wound is a full thickness tissue loss in which the base is covered by slough (yellow, tan, grey, green or brown) and/or eschar (tan, brown, or black).

The eschar or slough may appear as a scab (thick coagulated crust) or a fibrous covering that is stuck to the base or other area of a wound (Stedman's Medical Dictionary, 25th edition; Baltimore, MD; 1990, pg. 5536).

The National Pressure Ulcer Advisory Panel lists on their website, the following definition of Stage III pressure ulcers, unstageable pressure ulcers and deep tissue injury:
Category/Stage III: Full thickness skin lossFull thickness tissue loss. Subcutaneous fat may be visible but bone, tendon or muscle are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunneling. The depth of a Category/Stage III pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput and malleolus do not have (adipose) subcutaneous tissue and Category/Stage III ulcers can be shallow. In contrast, areas of significant adiposity can develop extremely deep Category/Stage III pressure ulcers. Bone/tendon is not visible or directly palpable.
Unstageable/Unclassified: Full thickness skin or tissue loss - depth unknownFull thickness tissue loss in which actual depth of the ulcer is completely obscured by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed. Until enough slough and/or eschar are removed to expose the base of the wound, the true depth cannot be determined; but it will be either a Category/Stage III or IV. Stable (dry, adherent, intact without erythema or fluctuance) eschar on the heels serves as "the body's natural (biological) cover" and should not be removed.
Suspected Deep Tissue Injury - depth unknownPurple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear. The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue. Deep tissue injury may be difficult to detect in individuals with dark skin tones. Evolution may include a thin blister over a dark wound bed. The wound may further evolve and become covered by thin eschar. Evolution may be rapid exposing additional layers of tissue even with optimal treatment.

The first photos taken of Patient 123's pressure ulcers were dated 3/14/13 and timed at 1 pm. There were two photos on page 8 of 17 of the facility's skin/ostomy progress notes labeled, "*1 MEDIA*." The bottom photo was labeled as coccyx with the ruler directly beneath the wound. The ruler placement indicated the measurement for length was 2 cm and width approximated at 1 cm (with no ruler edge directly next to it). The depth of the wound was not able to be approximated and there was no photographed measurement of the depth. The photo of the coccyx wound did indicate there was a definite depth to the wound that was more than just superficial. The visual evidence of actual depth that is beyond a Stage II would make this wound at least a Stage III pressure ulcer.

The first notation in the nursing notes that indicated Patient 123 had any pressure ulcers was in the electronic medical records under Adult Admission Assessment, dated 3/14/13 and timed 1 pm. This entry, by a licensed nurse (RN 77), indicated the wound to the coccyx measured 2 cm x 1 cm and was superficial. RN 77 then documented she applied Nutrishield ointment (an skin protection ointment) to the wound. The electronic entry also indicated the physician was notified but no documentation of the time of the call or to whom the report was made was found in Patient 123's record. A pressure ulcer care order sheet, dated 3/14/13, was noted in Patient 123's medical record with "Stage I or II Pressure Ulcer" marked and "Use skin protective barrier twice daily and PRN" was also marked.

The second page of the pressure ulcer care order sheet included entries that could be marked if needed and included the instructions to notify the wound care team if a Stage II pressure ulcer or greater was present. This was not checked and a referral for a wound care team consult was never found for the wounds to Patient 123's coccyx, left ear, or his feet as identified in the photos, dated 3/14 and 3/17/13.

A second photo of the coccyx wound was labeled as taken on 3/17/13 at 1 am. This photo revealed the wound had extended in width to 1.5 cm and the depth was more visible with eschar at the base indicating the wound would be rated as unstageable because the true depth of the tissue damage underneath the eschar could not be determined until the eschar was removed.

On 3/16/13 at 8 pm, the nurses assessment notes, documented by RN 77 for Patient 123, indicated the buttocks were reddened and blanchable but with no notation of the ulcer to the coccyx. RN 77 documented there was a "small abrasion" (scrape cautioned by friction) on the left ear. No measurements were noted in the record and no notification to the physician was found in the records.

Two photographs on page 11 of 17 for Media, dated 3/17/13 and timed 1 am, visualized the left ear from a full picture of the outer ear on the top photo and a picture of the side and under view of the left ear as the ear was held over by a gloved hand. The top photo indicated there was an area of black eschar approximately 1 cm from the top of the outer ear cartilage in a triangular shape at the base. Measurement of the length was 3 millimeter (mm - 0.1 cm) with a depth of 3 mm. The total width could not be determined from the picture. The photo also visualized three more areas of eschar starting from the middle of the outer ear cartilage and extending towards the base of the ear. The largest eschar was 2 cm long. The total width could not be determined by the photo. On the edge of the ear cartilage just above the largest eschar were two other areas of eschar that measured 0.5 cm x 0.5 cm and 0.5 cm x 0.4 cm. With the presence of eschar, the wounds to the left ear would be rated as unstageable.

Two photographs that were attached to page 12 of 17 for Media, dated 3/21/13 and timed 10:35 am, revealed darkened areas on the bottom outer halves of each foot extending from the center of the foot to the outer edge and rising in width as the discoloration nears the outer edge. From the photo itself, it could not be determined if this was eschar or deep tissue injuries caused by excessive prolonged pressure to each of these areas of Patient 123's feet.

During an interview on 4/24/13 at 8:30 am, WRN 4 was shown the photos of the wounds to Patient 123's bilateral feet. WRN 4 stated the wounds were probably caused by the intermittent pressure boots that had been applied too tight. WRN 4 stated she could not tell from the photo if the injury was a deep tissue injury or eschar. WRN 4 stated she was not aware that Patient 4 had these injuries to his feet and that they had not been reported to the wound care team.

In the physician's progress notes for Patient 123, documentation of visits made by the wound care team (WRN 3) were found for the dates of 3/8, 3/22, 3/27, and 3/29/13 that indicated the wound care team was following Patient 123 for a colostomy that resulted from surgery on 3/7/13 and a wound vac (machine attached to a wound to remove excess drainage and promote healing) to an open abdominal wound post surgery. In the notes of WRN 3 it was determined and documented that Patient 123 was a high risk for pressure ulcers related to his multiple health problems. There was no evidence in Patient 123's documentation of any other skin conditions in the wound care team notes to the physician. Patient 123's record contained no documentation by the physician in his progress notes that he was aware of the pressure ulcers to Patient 123's coccyx, left ear, or bilateral feet.

Wound care team notes, by WRN 4, were found in the physician's progress notes on 4/3/13 and 4/5/13 for Patient 123 that indicated they were notified for the opening of the skin beneath the lower edge of the trach to assess the wound and teach the nurses and Patient 123 how to care for the wound. Patient 123's record indicated he was discharged from the facility on 4/6/13 with no documentation of the outcome of the pressure ulcers to his coccyx, left ear, and injuries to his bilateral feet.

During a concurrent interview on 4/24/13 at 8 am, the wounds that Patient 123 had were discussed with two wound care nurses (WRN 3 and WRN 4) and the photographs of the wounds to Patient 123's coccyx, left ear, and bilateral feet were shown to each wound nurse. Both WRN 3 and WRN 4 stated they were unaware of any other wounds to Patient 123 except for his abdominal wound with the wound vac, his colostomy, and lastly his trach site. Both WRN's stated the Stage III to Patient 123's coccyx, his left ear wound, and the injuries to his feet were not reported to them.

During an interview on 4/24/13 at 12:10 pm, WRN 3 acknowledged the photograph of Patient 123's coccyx wound was a pressure ulcer that was "greater than a Stage II." When asked if her answer meant the ulcer was at least a Stage III, since there are no stage levels between II and III, WRN 3 did not reply. WRN 3 stated that when the wound nurse first gets the referral and goes to see the patient they try to do a full body assessment. When asked if full body assessments had been completed by the WRN's would the pictured wounds have been found, WRN 3 stated, "Yes."

WRN 4 stated that for each visit to wound care patients a full body assessment should be done. WRN 4 acknowledged that when visits were made to Patient 123 on 3/8/13, 3/15/13 (documentation for visit made on 3/15/13 was missing), 3/22/13, and 3/27/13, if full body assessments had been completed, the pressure wounds to Patient 123's left ear, bilateral feet, and his coccyx would have been identified and wound specific treatment ordered.

WRN 3 stated the wound nurses usually return once a week to reassess the patients with wounds and had a full assessment been done by the wound nurse on the 3/15/13 visit, the wound on Patient 123's coccyx should have been found. WRN 3 stated the staff that found the wound on the coccyx should have known the wound was more that a Stage 1, and at least a Stage II by the description, and the physician should have been notified for orders to bring in the wound care team for an assessment. WRN 3 stated all the licensed nurses have gone through inservices and mandatory training for the recognition, staging, and treatment of pressure ulcers and they should all know how and what to report and when they need to report it. The inservices and training has been going on routinely during January, February, and March of 2013.

On 4/24/13 at 4:30 pm, the survey team met to discuss a systemic failure regarding patients at risk for and having pressure ulcers. Nursing surveyors identified problems with nursing assessments, using the Braden scale, being accurate to identify patients at risk for pressure ulcers, thus potentially not receiving appropriate care to prevent pressure ulcers. Nursing staff had identified pressure ulcers for Patient 123, and the physician and wound care team were not notified. The wound care team provided care for Patient 123, but failed to do head to toe assessments of skin integrity and thorough record reviews, thus missing the five pressure ulcers that had developed. As a result, Patient 123's pressure ulcers were not treated sufficiently. Concerns were identified regarding patients in the emergency department with pressure ulcers not being repositioned every two hours, as outlined in the hospital policy. Concerns were expressed, due to the wound care team not accurately staging and identifying pressure ulcers and deep tissue injuries, according to nationally accepted definitions.

An additional concern was raised after Patient 104's record review, because patients identified with pressure ulcers did not have physicians providing a physical exam of the wounds and were not including pressure ulcers on their documented problems list, thus potentially not being aware of pressure ulcers or supervising their care. Patient 104 was admitted on 4/16/13 after a fall and being down for several days. Patient 104 had eight wounds; some were very deep pressure ulcers. Three physicians conducted history and physical or consultative examinations. One physician did not mention any of Patient 104's wounds and all three physicians did not include physical examination data of the patient's wounds. Only one of the three physicians included wounds in the problem list. Progress notes did not regularly mention the presence of Patient 104's pressure ulcers.

The survey team evaluated these concerns and determined that these systemic failures placed patients at current risk for unidentified pressure ulcers and resulting risk of infection, pain, prolonged medical care, and disfigurement. Due to the systemic nature of these failures and the fact that these failures had been identified previously through numerous complaints and recent surveys, an Immediate Jeopardy was declared on 4/24/13 at 5:49 pm with the Chief Executive Officer, the Chief Nursing Officer, The Chief Quality Officer, the Director of Quality Management, and the Director of Risk Management present.

The hospital implemented a plan of corrective action to address the immediate patient risk that included the immediate evaluation of all patients admitted to the hospital with a head to toe assessment to identify pressure ulcers, deep tissue injuries, and unstageable pressure ulcers, using nationally accepted definitions and reported to the physician. Additionally, those patient records were evaluated for corresponding documentation by physicians that they were aware of the patients' wound status. The survey nurse team evaluated ten random patients to evaluate the accuracy of the facility's pressure ulcer assessments and the physician documentation of newly identified and worsening pressure ulcers.

The Immediate Jeopardy was abated on 4/25/13 at 4:30 pm, after the facility implemented a corrective action plan to ensure the patient's immediate safety with the Chief Executive Officer, the Chief Quality Officer, and the Director of Quality Management.

2. During record review on 4/24/13, the face sheet indicated that Patient 125 was 69 years old and admitted to the facility on 4/7/13 with diagnoses that included new onset seizures (spontaneous, uncontrolled movements of the extremities, body, and head caused by unique misfiring of brain activity) and uncontrolled diabetes.

While in the emergency department, Patient 125 was sedated, intubated, and sent to the intensive care unit for admission. The admission assessment documented in the electronic record for Patient 125 by an intensive care nurse (RN 78) indicated that Patient 125 had a high risk for pressure ulcers with a Braden Scale (a measurement tool used by licensed staff to determine the risk factor for overall skin integrity) score of 12. The initial admission assessment indicated there were no open or closed wounds that were visualized on Patient 125's body.

A photograph with Patient 125's medical record number on it with the date of 4/14/13, was identified in Patient 125's floor chart. There was no documented time or initials of the staff member taking the photo nor a signature below the entry for the photo mounted on the progress notes for Skin/Ostomy. The documentation read, "popped blister above coccyx." There was no further notation that described how the blister popped or who popped it. The original blister had been located just above the coccyx and slightly onto the right upper buttock. The photo showed a moderately large area at the top of where the blister had been that was dark purple to black in color that did not allow visualization of the wound bed below. This was consistent with the definition of an unstageable pressure wound since the upper covering of the popped blister was adhered to the skin of Patient 125 and the base of the wound was not visible.

During a concurrent interview with WRN 3 and WRN 4 on 4/24/13 at 8 am, WRN 3 was shown the photo of Patient 125's coccyx wound and stated the wound was not considered an unstageable wound but a deep tissue injury (DTI) because you don't know how deep the injury is until the covering of the wound comes off and you see the base. WRN 4 stated the original blister was "probably" caused by friction/shear but, "when the area becomes unstageable it is referred to in the wound care notes as DTI."

A wound care note in the physician's progress notes, dated 4/15/13 and timed 10:45 am, indicated that the wound, at the time WRN 3's assessment was completed, was identified as "a ruptured red roofed blister measuring 4.5 x 1.8 cm" with no depth. The next day, 4/16/13 timed at 12:49 pm, a form labeled, "Pressure Ulcer Present On Admission Notification" was written for Patient 125's physician notifying him that Patient 125 had a pressure ulcer on the sacral coccygeal area that was a suspected deep tissue injury.

Patient 125's admission assessment on 4/7/13, when she was admitted to ICU, indicated there were no open areas or problems with her skin condition at that time. On 4/14/13, a photograph indicated a blister was popped and clearly showed a darkened area at the top of the blistered area that covered the base of the wound. The covering over the base of the wound made it impossible to see the condition and depth of the wound base thus making it unstageable.

A photograph taken on 4/21/13 at 8 am, indicated the wound was covered by a thickened crusty layer that obscured the base of the wound with no change in the size of the wound. This was evidence of an unstageable wound.

On 4/22/13 at 5:06 pm, a wound care team note written by WCN 3 identified the wound on the coccyx/buttock as "unstageable (DTI) pressure ulcer to buttock."

On 4/25/13 at 8:30 am, Patient 125 was identified, in the assessments completed as part of the Immediate Jeopardy plan of corrective actions, as one of the inpatients with an unstageable pressure ulcer on her coccyx.

During an observation on 4/25/13 at 11:15 am, Patient 125 rolled to her left side and the care RN exposed Patient 125's buttocks and coccyx. The thick crusted eschar was no longer visible. An area of thin eschar, 1.5 cm x 0.7 cm, was visible in the center of light pink surrounding tissue that had been under the previous eschar.


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3. On 4/24/13, Patient 115's record was reviewed. Patient 115 was admitted to the facility on 3/28/14 for narcotic intoxication. Patient 115's record contained Emergency Department (ED) Nursing Notes that indicated that Patient 115 had previously been under psychiatric care, would benefit from psychiatric care, and that she had thought of hurting herself or ending her life. A further screening assessment called a SAD PERSONS score of 8 (indicating she was a high risk for harming herself or suicide) was noted in the ED notes. The record indicated a sitter was ordered by the physician in the ED, and again after Patient 115 was admitted at 10:20 am.

On 4/24/13, the facility's policy titled, "Suicide Risk Assessment and Precautions - Nursing," dated 4/4/12, indicated, "Patients ages 14 years and older ... seen in the Emergency will be screened for suicide risk by the nurse who completes the initial assessment. Screening will consist of asking 2 brief questions related to history of psychiatric care, severe depression, and current or past suicidal ideations. ... Patients who answer affirmative to history of psychiatric care... will be further screened for suicide risk using the SAD PERSONS acronym (scale)... If the SAD PERSONS score is 8 or higher, ... a sitter will be provided until the Licensed Independent Practitioner clearly documents the patient is no longer at high risk."

Patient 115's record did not contain documentation of a sitter on 3/29/13 from 1910 (7:10 pm) to 3/30/13 at 8:30 am, and no sitter from 3/30/13 at 1910 to 3/31/13 at 8:10 am.

Patient 115's record further contained nurses notes, dated 3/31/13 at 7 am, which indicated that Patient 15's physician was notified of the lack of a sitter and that he confirmed he still wanted a sitter ordered for Patient 115.

On 4/24/13 at 4 pm, Registered Nurse 69 confirmed that a sitter was not provided for Patient 115 on the night shifts of 3/29/13 and 3/30/13.

On 4/24/13 at 8:20 am, Nurse Manager (NM) 19 reviewed Patient 115's record and the nurse staffing records for 3/29/13 and 3/30/13. NM acknowledged that there was no evidence that a sitter had been provided, as ordered by the physician.

4. On 4/22/13 at 10:05 am, Patient 107's bedside table was noted to have a urinal, containing approximately 400 milliliters of urine, sitting on top of the table. One hour later, at 11:05 am, the urinal was still present, containing the urine.

On 4/22/13 at 10:05 am, NM 22 was asked what her expectation of staff was for emptying urinals. NM 22 stated the nurses are to round on their patients every hour and they should take care of it then. She stated that hourly rounding had not been documented.

At 11:05 am, the Chief Nursing Officer was shown Patient 107's urinal and stated that the urinal should have been emptied.



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5. On 4/25/13 at 11:35 am, Patient 149 was observed lying on his left side with a breathing tube connected to a ventilation machine in the Critical Care Unit. He was moving his feet attempting to remove the soft foot boots that were for protecting his heels from skin breakdown. He had a large bruise on the inside and outside area of his right foot.

In a concurrent interview, RN 73 stated she assessed Patient 149 to have a Braden Score of 13 (Moderate Risk). Patient 149 had just had his sedation drip turned off for the last hour and was able to move and turn himself entirely, so he was given a 3 out of 4 score for mobility.

Sedation intravenous drips were commonly used for patients requiring a breathing machine so that they can rest and recover. Normal practice was to allow the patient to wake up for one hour a day to evaluate the patient's condition and status. During the sedation period, the patient does not have the capacity to turn or resist the breathing machine and relies on nursing staff to reposition them at least every 2 hours.

The Braden Scale is a clinically validated tool that allows health care providers to reliably score a patient's level of risk for developing pressure ulcers. Depending on the score of the patient, several interventions would be initiated to prevent skin breakdown. Six areas assessed in the Braden Score include: Sensory Perception; Moisture; Activity; Mobility; Nutrition; and Friction and Shear.

According to the policy, "Skin Assessment - Nursing," dated 8/31/11, under Policy, "A. All patients' skin care needs are addressed through complete assessment of the patient's skin and risk factors for potential impairment of skin integrity upon admission and daily except in the Critical Care Units which is each shift...For all patients with Braden score 14 or less or at high risk for skin breakdown due to other conditions, initiate wound and skin care protocol orders...Dietitian receives automatic report of patients with Braden Scale Score of 12 or less who also have a nutrition score of 2 or less and will consult on these patients."

Under Braden Scale for Predicting Pressure Sore Risk, Mobility Scale lists
"1. Completely Immobile Does not make even slight changes in body or extremity position without assistance;
2. Very limited Makes occasional slight changes in body or extremity position but unable to make frequent or significant changes independently;
3. Slightly Limited Makes frequent through slight changes in body or extremity position independently; and
4. No Limitation Makes major and frequent changes in position without assistance."

After reviewing the description of scoring for mobility and that the evaluation was for the past 12 hours, RN 73 stated that Patient 149 should be scored lower than a "3."

The Braden score would then be a 12 and a dietitian would be consulted on this patient.

6. On 4/25/13 at 11 am, Patient 148 was observed sitting up in bed, eyes closed, with a nasogastric tube on low intermittent suction. He had been admitted the previous day with a history of diarrhea, urinary tract infection, and fever. He had nothing by mouth since his admission on 4/24/13 at 6:58 am. Patient 148 had a reddened buttocks.

In a concurrent interview, RN 72 stated she assessed Patient 148 to have a Braden Score of 16 (Mild Risk). She stated that his nutrition was scored 2 out of 4 since he had been eating at home before his hospitalization, even though he had not eaten in the last 24 hours. RN 72 stated she gave him a score of 3 out of 4 for mobility because he was able to mo

Based on observation, interview and record review, the facility failed to ensure that care plans were developed, kept current, and implemented for seven of 42 sampled patients, as evidenced by:

1. Patient 112 was not repositioned as required by policy.

2. Patients 119, 127 and 144 did not have comprehensive care plans developed.

3. Patient 115 did not have neuro checks done as ordered by the physician.

4. Patients 105 and 120 failed to have their nurses respond to patient care equipment alarms.

These failures had the potential for patients to not receive needed care and suffer adverse consequences.

Findings:

1. On 4/24/13, Patient 112's record was reviewed. Patient 112 was seen in the emergency room on 4/2/13 for pneumonia and admitted to the hospital for further treatment. Patient 112's record contained emergency department nursing notes, dated 4/2/13 and timed 10:08 am, which indicated that Patient 112 had an unstageable pressure ulcer and was high risk for pressure ulcers based on his Braden Scale score of 11. Patient 112's record did not contain a care plan for his pressure ulcer. There was no evidence that Patient 112 was repositioned while he was in the emergency department from 9:20 am to 3:13 pm (approximately 6 hours).

On 4/24/13, the facility policy titled, "Prevention of Pressure Ulcer," dated 6/22/11, read, "Document position of the patient at least every one to two hours for moderate risk patients (Braden Scale 12 or less) indicating the position they are in: 1. Back, 2. Right, 3. Left."

On 4/24/13 at 1130 am, Nurse Manager (NM) 20 reviewed Patient 112's record and confirmed that Patient 112 was not turned every one to two hours, as indicated in the policy.

2. On 4/25/13, Patient 127's record was reviewed. Patient 127's record indicated that she had an unstageable pressure ulcer on her right heel. Patient 127's record did not contain a care plan for the care of her pressure ulcer.

On 4/24/13, the facility policy titled, "Prevention of Pressure Ulcer," dated 6/22/11, read, "Initiate and update care plan as needed."

On 4/25/13 at 11:15 am, NM 17 reviewed Patient 127's record and acknowledged that Patient 127's record did not contain a care plan for her pressure ulcer.

3. On 4/25/13, Patient 119's record was reviewed. Patient 119's record indicated that she had a a skin tear to her left hand. Patient 119's record did not have a care plan developed for the care of her skin tear.

On 4/25/13 at 11:25 am, NM 17 reviewed Patient 127's record and acknowledged that Patient 127's record did not contain a care plan specific to the skin tear.

4. On 4/24/13, Patient 115's record was reviewed. Patient 115 was admitted on 3/28/14 for narcotic intoxication. Patient 115's record contained a physician's order, dated 3/28/12, for nursing staff to conduct neuro checks (assessments of nerve function) every six hours. Patient 115's record did not contain documented neuro checks every six hours, as ordered. Nursing documentation showed neuro check were conducted as follows:
3/29/13 at 7:47 am to 7:10 pm (over 11 hours);
3/31/13 from 8 am to 7 pm (11 hours); and
3/31 at 7 pm to 4/1/13 at 8 am (13 hours).

On 4/24/13 at 9:15 am am, Nurse Manager (NM) 19 reviewed Patient 115's record, and acknowledged that there was no evidence that neuro checks were provided every six hours, as ordered by the physician.

5. a. On 4/22/13 at 10 am, Patient 105 was asked about the care he had received from the facility. Patient 105 complained that while he was in the emergency department, his intravenous pump was beeping for two hours and he couldn't get anyone to turn it off.

5. b. On 4/22/13 from 11:10 am to 11:40 am, Patient 120 was observed in the emergency room and had a continuous alarm sounding.

On 4/22/13 at 11:40 am, NM 21 was asked about the alarm. NM 21 asked a nurse who was sitting just outside Patient 120's room what the alarm was signaling. NM 21 found that Patient 120 was admitted for high blood pressure and the alarm was sounding because the Patient had high blood pressure. NM 21 acknowledged that "alarm fatigue" was a problem and that caregivers can tune out the alarms, thus reducing their effectiveness to alert the caregivers to potential patient problems. NM 21 stated that the patient should not have to endure the continuous alarm and that the alarm parameters could be changed to align with the treatment goals for Patient 120.

On 4/22/13 at 4:20 pm, when asked if there was a policy for responding to alarms, the Director of Quality Management responded that the facility did not have one.



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6. Patient 144 was admitted for a scheduled Cardiac Cath Procedure on 4/23/13. A review of the care plan for potential fear/anxiety and potential knowledge deficit of pre and postoperative care disclosed that the care plan problem was circled, "Unknown outcome of surgery and/or anesthesia." There were no initials of the staff person implementing the identified interventions and the evaluation of the preoperative teaching was left blank.

In an interview and record review on 4/23/13 at 2:20 pm, RN 75 stated that the plan of care for Patient 144 for potential fear/anxiety and potential knowledge deficit was incomplete.

Based on staff interview and record review, the facility failed to ensure that medication (insulin for the treatment of abnormal blood surgar levels) was given, as ordered by the physician, for one of 42 sampled patients (Patient 132).

Failure to administer insulin to Patient 132 resulted in an abnormally high blood sugar level (normal range 70- 120 mg/dl). Elevated blood sugar levels can damage vital organs and may lead to kidney failure and blindness.

Findings:

On 4/23/13 at 11:00 am, the record for Patient 132 was reviewed with Nurse Manager (NM) 17. Patient 132 had a history of diabetes and a physician's order to check blood sugar levels every six hours and to administer sliding scale insulin, based on the blood sugar level results. The order for sliding scale insulin instructed to give a specific amount of insulin corresponding to blood sugar levels. The order included directions to give 3 units of insulin for blood sugar levels between 201 and 250 mg/dl. On 3/20/13 at 1800, the Medication Administration Record (MAR) for Patient 132 contained no evidence that insulin was given to treat Patient 132's elevated blood sugar level of 218 mg/dl, which would require an administered insulin dose of 3 units.

In a concurrent interview, NM 17 confirmed that no insulin was given for Patient 132's elevated blood sugar level of 218. NM 17 did not find any documented justification or clinical rational for not administering the insulin.



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Based on interview and record review, the facility failed to ensure that medication was given in accordance with physician orders for one of 42 sampled patients.

1. Blood pressure medication was held due to low blood pressure and the physician was not notified. (Patient 115)

This failure had the potential for the patient to have adverse drug reactions and poor clinical outcomes.

Findings:

1. On 4/24/13, Patient 115's record was reviewed. Patient 115 was admitted on 3/28/14 for narcotic intoxication. Patient 115's record contained a physician's order, dated 3/28/12 and timed 9:20 am, for clonidine (for blood pressure) 0.4 milligrams (mg) every six hours for three days. Patient 115's record indicated that she did not receive clonidine on 3/28 at 11:48 pm, 3/29 at 6 am, and 3/30/13 at 00:30 am. The clonidine order did not contain parameters for when to hold the medication. In all three of the above times, Patient 115's blood pressure was below normal. Patient 115's record did not contain any evidence that the physician was notified of the low blood pressure or the holding of the clonidine.

Review of the hospital's policy and procedure titled, "Orders, Transcription and Requisition - Nursing," dated 8/24/12, indicated all patients shall have specific, written orders for therapeutic care written by the physician/provider or his/her designee.

On 4/24/13 at 9:45 am, Nurse Manager (NM) 19 reviewed Patient 115's record and acknowledged that the
physician should have been notified of the low blood pressures and parameters for holding the clonidine should have been obtained from the physician.

When asked if the hospital had a policy that outlined blood pressure parameters for when medications should be held and the physician notified, NM 19 said that there was no such policy.



22456

Based on record review and staff interview, the facility failed to ensure that medical records were accurate for Patients 123, 132, and 133.

1. The medical record for Patient 123 was not accurate in documenting the rate for Precedex, a medication used in the ICU for sedating a patient. The rate for the infusion of Precedex was documented as 200 mcg/kg/hr, which is about 300-1000 times the recommended rate (0.2-0.7 mcg/kg/hr).

2. The Medication Administration Record (MAR)for Patient 132 did not match the documentation in the Horizon Entry Documentation (HED - the electronic medical record system).

3. The MAR for Patient 133 did not match the documentation in the HED for the administration and/or refusal of a pain medication.

Inaccurate record keeping can result in confusion, not meeting the needs of patients, and potentially lead to medication error and consequently patients harm.

Findings:

1. On 4/24/13, review of the electronic record for Patient 123 revealed that the patient was receiving Precedex, also known as dexmedetomidine hydrochloride. Precedex is a medication used for sedation of intubated and mechanically ventilated patients. According to the manufacturer this medication is given by intravenously infusion of 0.2-0.7 mcg/kg per hour for no longer than 24 hours.

On 4/24/13, in the afternoon, review of the electronic revealed documentation on the nursing flow sheet for Patient 123, that on 3/17/13, this medication was given at 200 mcg/kg/hr which is 285 -1000 times the recommended rate. The 200 mcg/kg/hr rate was entered three separate times on the flow sheet.

The nurse that completed the documentation was not available for interview on site. However, on 3/25/13 at 14:40, the Director of Risk Management (DRM), indicated that he spoke with the nurse by phone and the nurse said that the documentation was "an entry error on the electronic record [and that the nurse] offered to make late entry clarifying the documentation."

2. Facility utilized the SAM (safe administration medication system), an electronic hand held device, which requires an initial pain scale when pain medications are given. So in order to proceed with administration of pain medication, a pain scale must be entered into SAM. The device also alerts nurses to reevaluate pain in one hour from medication administration. The information from the SAM transmitted to the electronic MAR.

During record review, it was pointed out that pain re-assessment may be documented in different areas in the record, such as the medication administration record (MAR) and the HED (Horizon Expert Documentation), the electronic medical record. Facility nurse NM17 clarified that that nursing assessments and reassessment of pain should be found in the HED as nurses actively chart notes, vital sings, and pain scales there.

On 4/22/13 at approximately 3 pm, review of the record for Patient 132 with facility pharmacy staff (DP and Pharmacy Tech 4), revealed that Patient 132 was a 46 year old, and had multiple medical issues including chronic pain and multiple physician orders for pain medications. Patient 132 had an order for Dilaudid (pain medication) for 2 milligrams to be given by mouth every 4 hours when needed for pain.

Review of the medication administration record (MAR) revealed on 3/29/13, four Dilaudid doses were administered at the following times: 7:49 am, 12:09 pm, 16:58 (4:58 pm), and 20:37 (8:37 pm). The pain reassessments following these doses were documented on 3/30/13, at the following times: 00:46 (12:46 am), 00:46 (12:46 am), 00:36 (12;36 am), and 00:36 (12:36 am).

A follow up with NM17, on 4/23/13, revealed that documentation in the HED did not match the MAR. On 3/29/13, according to the MAR, a 2 milligram dose of Dilaudid was administered at 12:09 pm, for a pain scale level of 7. The pain was reassessed on 3/30/13, after midnight, to be at a zero level and documented as a zero on the MAR.

However, the HED documentation showed the pain scale level was reassessed to be a 3. Also, but contrary to the MAR, the HED had documentation that this dose (at 12:09 pm) was refused. Facility staff NM17 reviewed the record and did not find any documented evidence explaining the discrepancy or the reason for medication refusal. It was not clear if the medication was given or was refused. NM17 offered that it might have been that the nurse clicked the box for refused instead of medicated by mistake, as both boxes on the computer screens were positioned one above the other.

3. On 4/23/13 at 3 pm, a concurrent review of the record for Patient 133 with facility staff, NM17, revealed that the patient had a history of chronic pain. On 3/26/13, the patient had an order for pain medication written by her physician for Lortab 5/500, which is a combination of hydrocodone/acetaminophen, to be given one or to tablets every 6 hours as needed for pain. A concurrent review of the record with NM17, on 4/23/13 at about 3 pm, revealed that on 3/27/13, the pain was reassessed about 4 hours after for the dose was given at noon, and about 10 hours after the does was given at 5:55 pm.

Further evaluation of the record revealed that on the HED, where the nurses are supposed to document pain assessment and re-assessment according to the facility's policy, documentation that the 5:55 pm dose was refused. NM17 reviewed the record but did not find any documented evidence explaining the discrepancy or a reason for the medication refusal. It was not clear if the medication was given or was refused.




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26611

Based on interview and record review, the facility failed to ensure that four of 42 sampled patient records were dated, timed, and/or authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, and documentation of defibrillator function checks was incomplete:

1. Patient 152 was refusing tube feeding (a feeding tube is a medical device used to provide nutrition to patients through their gut who can not obtain nutrition by mouth) for 72 hours, and there was no documentation of a discontinued order for tube feeding.

2. A physician's order for tube feeding was amended by a second person with the Registered Dietitian's recommendations for the duration (Patient 151).

3. Patient 112's wound photo was not dated, timed, or signed with the title by the person taking the photo.

4. Patient 125's wound photo was not dated, timed, or signed/initialed with the title by the person that took the photo. Documented entry below photo was not signed with the title by the person that wrote the entry.

5. The defibrillator record check sheets for two adult crash carts in the emergency room had blank spaces where staff should have verified they checked the defibrillator.

Findings:

1. Patient 152 was admitted to the hospital on 4/13/13 with a diagnosis of small bowel obstruction. Review of the critical care note, dated 4/14/13, indicated Patient 152 was taken to the operating room for exploratory laparotomy (surgery to examine the abdominal organs), ileal resection (portion of the small intestine known as the ileum is removed and the healthy ends of the small intestines are surgically reattached), and cholecystectomy (removal of the gallbladder).

Review of the physician's orders, dated 4/15/13, indicated a nutrition consult for tube feeding to begin and keep at 20 milliliters (ml) per hour and do not go to goal. Review of physician's orders, dated 4/15/13, indicated to clarify the tube feeding formula, Nepro. Review of the physician's orders, dated 4/16/13 at 9:50 am, indicated to discontinue the NGT (nasogastric feeding tube, passed through the nostril, down the esophagus and into the stomach) and begin gastric feeding tube (tube surgically placed into the stomach) at 20 ml per hour. Review of the physician's orders, dated 4/16/13 at 11:00 am, indicated to increase tube feeding to 40 ml per hour, if tolerated that rate, then increase to 55 ml per hour after 12 hours. Review of the physician's orders, dated 4/18/13, indicated a full liquid diet.

On 4/22/13 at 3:30 pm, an interview was conducted with RN 70. RN 70 stated Patient 152 was not receiving tube feeding because she was refusing it. RN 70 indicated there should be a physician's order to discontinue the tube feeding.

On 4/23/13 at 8:52 am, an interview was conducted with RN 70. RN 70 stated that Patient 152 had been refusing the tube feeding since 4/19 or 4/20/13 and that when the nursing staff notified the physician that the patient was refusing the tube feeding, then they should have gotten an order to discontinue it. RN 70 stated at the 24 hour chart check they should have realized there was no discontinue order.

Review of the hospital's policy and procedure, titled, "Orders, Transcription and Requisition - Nursing" dated 8/24/12, indicated all patients shall have specific, written orders for therapeutic care written by the physician/provider or his/her designee. Review of the hospital's policy and procedure, titled, "Clinical SVS-Nutrition Care Order and Status Change-FNS" dated 4/22/13, indicated a nutrition care order is accepted upon the written order of a physician. It indicated the order remains in effect until a Nutrition Care Order change is received.

2. Patient 151 was admitted to the hospital on 4/16/13 with an intracerebral (brain) bleed. Review of the physician's orders, dated 4/21/13 at 2:02 pm, indicated Nepro (tube feeding formula for people on dialysis) NG or OG (orogastric feeding tube, passed through the mouth down the esophagus and into the stomach), start at 10 ml per hour increase by 10 ml per hour every eight hours to goal of 50 ml per hour times 20 hours for a total volume of 1,000 ml in 24 hours at the goal rate and flush with 30 ml of free water every four hours. The order was written in two different handwritings.

On 4/23/13 at 11:08 am, an interview was conducted with the Monitor Tech (MT) 1. MT 1 stated the physician's order was written during rounds and was done part by the physician and part by the Registered Dietitian (RD). MT 1 stated it should have been clarified and that the order was not clarified correctly.

On 4/23/13 at 2:10 pm, an interview was conducted with the RD (IPSM Fremont). IPSM Fremont stated she finished the physician's order during rounds because the physician wanted her to finish the order with all the details. She acknowledged that was not the proper format to clarify or continue the order with her recommendations.

Review of the hospital's policy and procedure titled, "Orders, Transcription and Requisition - Nursing" dated 8/24/12, indicated the RD had the discretion to communicate his/her recommendations to physicians by either of the following methods: calling the physician for a telephone order; writing the recommendation on physician order form for physician signature.




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3. On 4/24/13, Patient 112's record was reviewed. Patient 112 was seen in the emergency room on 4/2/13 for pneumonia and admitted to the hospital for further treatment. Patient 112's record contained a picture of Patient 112's pressure ulcer which did not have a date and time taken, nor the title or signature of the person who took the picture.

On 4/24/13 at 11:30 am, Nurse Manager 21 reviewed Patient 112's record and acknowledged that the wound photo did not have the date, time, and person who took the photo.



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4. On 4/24/13, Patient 125's medical record was reviewed. Patient 125 was admitted to the facility on 4/7/13 for a new onset of seizures and uncontrolled diabetes. A photograph of a wound on Patient 125's coccyx (tailbone) was found in the medical record on Unit 4 Main that was missing the time, location, and initials and title of the person that took the photo.

On 4/24/13 at 12:30 pm, Wound Nurse (WRN) 4 reviewed Patient 112's record and acknowledged that the wound photo did not have documentation to include the date, time, and initials and title of the person who took the photo.

5. During the initial tour of the facility on 4/22/13 from 8:15 am through 10:45 am, the "Crash Cart Check Records" located on two adult crash carts in the emergency room were reviewed. The record documentation was incomplete and did not indicate that the defibrillator, cart locks, and all crash cart outer equipment was intact and present had been checked. One cart's record had 9 of 21 signatures missing from the evening/night shifts for the month of April, 2013. The second cart's record sheet had 4 of 21 signatures missing.

On 4/22/13 at 8:40 am, the Nursing Manager of the Emergency Department (NM 21) reviewed the crash cart records for both carts and acknowledged the signatures were missing and that, according to facility policy, the staff that checks the crash carts each shift are supposed to sign the record.





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11389

Based on interview and record review, the facility failed to ensure that verbal/telephone orders were authenticated within 48 hours (two days) for four of 42 sampled patients. (Patients 111, 116, 132, and 133) This failure had the potential for miscommunicated orders to go undetected and potentially cause patients' harm.

Findings:

1. On 4/23/13 at approximately 11 am, Patient 132's record was reviewed with Nurse Manager (NM) 17. Patient 132's record contained a telephone order, dated 3/20/13, that was authenticated by the prescriber on 3/26/13, seven days later.

Patient 132's record contained a telephone order for a ventilator (breathing machine) setting, dated 3/18/13, that was authenticated by the prescriber on 3/21/13, three days later.

The verbal order form had specific instructions that directed physicians to cosign the order within 48 hours.

The facility policy, titled, "Orders, Transcription and Requisition," dated 8/24/12, read, "According to FRHG (hospital's parent organization) Medical Staff Bylaws, verbal/telephone orders must be verified and signed (by hand with date/time or electronically) by the physician who gave the order within 48 hours."

In a concurrent interview, NM 17 acknowledged that the above two orders were not authenticated by the physician within 48 hours.

2. On 4/23/13 at 2:45 pm, Patient 133's record was reviewed with NM 17. Patient 133's record contained telephone orders for acetaminophen and morphine (for pain), dated 3/28/13, that was authenticated by
the physician on 4/1/13, four days later.

In a concurrent interview, NM 17 acknowledged the above verbal order was authenticated greater than 48 hours later.



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3. On 4/24/13, Patient 111's record was reviewed. Patient 111's record contained a verbal order, dated 3/24/13 and timed 1330 (1:30 pm), for Dilaudid (for pain). Patient 111's record indicated that the order was authenticated by the physician on 3/29/13 at 1349 (1:49 pm - greater than 120 hours later).

On 4/24/13 at 11 am, the Health Information Management Director (HIMD) reviewed Patient 111's record and confirmed the authentication date was correct. HIMD acknowledged that the above verbal order for Dilaudid was not authenticated within 48 hours.

4. On 4/23/13, Patient 116's record was reviewed. Patient 116's record contained a verbal order, dated 4/18/13 and timed 1317 (1 :17 pm) for Motrin (for pain) and an order to discontinue Dilaudid. Patient 116's record indicated that the verbal order was authenticated by the physician on 4/21/13 at 8:11 pm (greater than 76 hours later).

On 4/24/13 at 10:15 am, Nurse Manager 21 reviewed Patient 116's record and acknowledged that the above verbal orders for Motrin and Dilaudid were not authenticated within 48 hours.



22456

Based on interview and record review, the facility failed to ensure that one of 42 sampled patients had a history and physical (H&P) examination placed in the record within 24 hours of admission. (Patient 112). This failure has the potential for additional risk for patients due to a failure to communicate conditions that would affect the patients' overall condition.

Findings:

On 4/24/13, Patient 112's record was reviewed. Patient 112 was admitted to the facility on 4/2/13 with a diagnosis of pneumonia. Patient 112's record did not contain any evidence of a completed H&P.

On 4/24/13 at 3 pm, the Health Information Manager Director reviewed Patient 112's record, dictation logs, and unfiled records, and acknowledged that a H&P should have been done, but was not.

Based on observation, interview, and records and policy review, the hospital failed to ensure that medications were controlled and administered in a manner that ensures patient safety as evidenced by the following:

1. Medications were not given in accordance with manufacturer's specification, Precedex for Patient 123. Refer to A 500, item 1.

2. The blood level for heart medication, Digoxin, with a narrow therapeutic index was not checked to ensure efficacy and percent toxicity for Patient 131. Refer to A 500, item 2.

3. Failure to ensure that culture and sensitivity tests were conducted to ensure antibiotics (medications to treat infections) were used appropriately for Patient 131. Refer to tag A 500, item 3.

4. Pain assessment was not completed in accordance with facility's policy, Patient 132 and 133. Refer to A 500, items 4 and 5.

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

Based on clinical record review and staff interview, the facility failed to ensure patient safety for four of 42 sampled patients as evidenced by the following:

1. Failure to administer medications in accordance with manufacturer's specification, when Precedex (a sedative medication) was administered to Patient 123, well beyond 24 hours without any documented justification or clinical rational.

2. Failure to monitor blood levels (to ensure effectiveness and prevent toxicity) for a heart medication, Digoxin, for Patient 131.

3. Failure to ensure that antibiotics (medications to treat infections) were used appropriately for Patient 131. The patient was given two antibiotics for a urinary tract and a skin infection without checking culture and sensitivities to ensure that the organism was sensitive to the antibiotics used.

4. Failure to implement policy and procedure for pain management for Patients 132 and 133, as pain was not reassessed timely.

Failure to administer medications in safe manner can lead to patient harm or death.

Findings:

1. On 4/24/13, review of the electronic record for Patient 123 revealed that the patient was receiving Precedex, also known as dexmedetomidine hydrochloride. Precedex is a medication used for sedation of intubated (a tube through the mouth into the trachea to keep the patient's airway open) and mechanically ventilated patients. According to the manufacturer this medication should not be used more than 24 hours. The package insert read, "In adults 18 years of age or older, the usual initial dosage of dexmedetomidine is 1 mcg/kg given IV as a loading infusion over 10 minutes, followed by a maintenance infusion of 0.2-0.7 mcg/kg per hour for no longer than 24 hours. Dexmedetomidine has been administered by continuous IV infusion in mechanically ventilated patients prior to extubation, during extubation, and post-extubation; it is not necessary to discontinue the drug prior to extubation provided that the duration of the infusion does not exceed 24 hours. "

Patient 123's Precedex order was written on 3/14/13 and continued for days, well beyond 24 hours restrictions. There was no documented evidence or clinical rational for the prolonged use. There was no documented evidence of a pharmacist's intervention for ordering the medication without a duration limit. In addition, there was no documented evidence of a nurse's intervention when the medication was administered day after day, long beyond the 24 hours.

On 4/224/13 at approximately 4 pm, Pharmacy Director (PharmD) 3 was asked about clinical justifications for using the medications inconsistent with the manufacture's labeling, and he was unable to to provide documented evidence for such use.

The guidelines for intravenous medications (from facility policy 631.4: IV Medications), had Precedex listed. However, under comment and monitoring considerations, there was no restriction for the duration of its use.

The order for Precedex was on a preprinted form "CRITICAL CARE IV MEDS (SEDATIVES)," revised 01/09. The preprinted order did not have any notations or directions limiting the use of Precedex to 24 hours.

On 4/25/13 at approximately 11:30 am, PharmD 3 and the New Director of Pharmacy (NDP) were asked about and for any supportive information that may have been presented when this medication was added to the hospital formulary; however, no information was presented to address this issue.

The Precedex package insert read, "Adverse reactions associated with infusions greater than 24 hours in duration include ARDS (a severe respiratory condition which is 90% fatal if not treated), respiratory failure, and agitation.

2. On 4/23/13 at 8:45 am, on 2 Central nursing station, Patient 131 was observed receiving her morning medication. A concurrent review of the record with RN 65 revealed that Patient 131 had an order for Digoxin, a medication used for heart failure. Patient 131 was receiving Digoxin prior to admission. Concurrent review of the record with RN 65 revealed no evidence of Digoxin blood levels were obtained or ordered. Digoxin has a narrow therapeutic index, which means that the range between effective and toxic levels is very narrow. The therapeutic Digoxin level is 0.5-0.8 ng/ml (nanograms per milliliter). Nano gram (ng) is a minuscule amount; it is one-billionth (1/1,000,000,000) of a gram.

Digoxin can quickly reach toxic concentrations in patients with renal failure. According to the drug information, Lexicom online: "Elderly are at risk for toxicity due to age-related changes; volume of distribution is diminished significantly; half-life is increased as a result of decreased total body clearance. Additionally, elderly frequently have concomitant diseases which affect the pharmacokinetics in digitalis glycosides; hypo- and hyperthyroidism and renal function decline will affect clearance of Digoxin ... "

Patient 131 was an 89 year old. On 4/22/13, her serum creatinine was 1.12 (most commonly used test to determine kidney function, normal for women is between 0.6 mg/dl to 1.1 mg/dl but is adjusted for age and weight); considering age alone, this patient would have had compromised renal (kidney) function.

On 4/25/13, a follow up interview with facility staff revealed that Digoxin levels were not checked. Monitoring the level is essential to ensure efficacy (level within the therapeutic range) and to prevent toxicity. Checking the level becomes more essential when the patient receives medications that potentially interact with Digoxin and cause accumulation of the drug and toxicity such as Spironolactone, a diuretic (water pill) which Patient 131 was also receiving. According to Lexicom, a drug resource online, accessed 5/8/13, "Potassium-Sparing Diuretics may increase the serum concentration of Cardiac Glycosides. This particular effect may be unique to Spironolactone: May increase the serum concentration of Digoxin. "

3. On 4/23/13 at 8:45 am, on 2 Central, Patient 131 was observed receiving her medication. A concurrent review of the record with RN 65 revealed that Patient 131 was receiving two broad spectrum antibiotics: Zyvox which is used to treat pneumonia, skin infections, and brain abscess amongst other conditions and Cefipime which is also used for skin, lung, and urinary tract infections, in addition to brain abscess and other usages. During record review, RN 65 was asked about the lab data related to the infection, specifically, if there were any ordered or completed labs such as culture and sensitivity to check the appropriateness of selected antibiotic therapy. RN 65, in the presence of the Chief Operating Officer, stated that there were no such labs. But the nurse clarified that they were trying to treat a urinary tract infection and cellulitis (skin infection caused by bacteria).

On 4/23/13 at 4pm, PharmD 3 and NDP were asked about a pharmacist's evaluation of orders and intervention on therapy specific to Patient 131; it was stated that the hospital did not have an infectious disease pharmacist. PharmD 3 said that he would follow up to see if there were any interventions or any labs ordered or completed for this patient.

On 4/25/13, after follow up by PharmD 3, evidence was presented that a lab test was ordered on 4/23/13. The sample was collected on 4/23/13 at 22:00, clearly after therapy appropriateness concerns were raised by the surveyor with staff, which was three days after initiation of therapy.

4. On 4/22/13 at 3 pm, review of the record for Patient 132, with facility pharmacy staff (DP and Pharm Tech 4), revealed that Patient 132 had an order for Dilaudid (pain medication) with 2 milligrams to be given by mouth every 4 hours when needed for pain.

Review of the medication administration record (MAR) revealed on 3/29/13, four Dilaudid doses were administered at the following times: 7:49 am, 12:09 noon, 16:58 (4:58 pm) and 20:37 (8:37 pm). The pain reassessments following these doses were documented on 3/30/13 at the following times: 00:46 (12:46 am), 00:46 (12:46 am), 0036 (12:36 am), and 0036 (12:36 am). These pain reassessments were completed about 17 hours, 12.5 hours, 7 hours, and 4 hours after the medication was administered.

Similarly, Patient 132 had an order, dated 3/19/13, to receive Dilaudid 1 milligram by injection, every 2 hours as needed for pain. On 3/20/13, a dose was administered at 10:12 am. The pain reassessment was documented on the same day at 17:13 (5:13 pm), which was almost 9 hours after medication administration.

Facility staff did not follow the pain assessment policy for reevaluation of pain after pain medication administration. According to the facility policy titled "Pain Management- Hospital wide" and approved 8/24/12, "The patient's pain will be re-assessed within 60 minutes of administration of a PRN medication."

On 4/22/13 at 3:30 pm, facility staff Pharmacy Technician 4 indicated that pain documentation may be completed in the electronic medical record HED (Horizon Expert Documentation).

A follow up with NM 17 on 4/23/13 revealed that documentation in the HED did not match the MAR. On 3/29/13, according to the MAR, a 2 milligram dose of Dilaudid was administered at 12:09, for a pain scale of 7; the pain was reassessed on 3/30/13 after midnight to be at zero level. However, the HED documentation showed pain was reassesses to be a pain scale level of 3.

Not only that, but contrary to the MAR, the HED had documentation that this dose (at 12:09) was refused. Nurse Manager (NM) 17 reviewed the record and did not find any documented evidence explaining the discrepancy or the reason for medication refusal. It was not clear if the medication was given or was refused. NM 17 offered that it might have been that the nurse clicked the box for refused instead of medicated by mistake, as both boxes on the computer screens were positioned one above the other.

According to the facility policy titled "Pain Management- Hospital wide" and approved 8/24/12: "Reassessment of the patient's pain should be documented in the PAIN section of the patient record."

5. On 4/23/13 at 3 pm, a concurrent review of the record for Patient 133, with NM 17, revealed that the patient had a history of chronic pain. Patient 133 had an order, written by her physician on 3/26/13, for the pain medication, Lortab 5/500 (hydrocodone/acetaminophen), to receive one or two tablets every 6 hours as needed for pain. Patient 133's record indicated that on 3/27/13, the pain was reassessed about 4 hours after for a dose given at noon and the pain level was reassessed about 10 hours after a dose was given at 5:55 pm.

Further evaluation of the HED, where the nurses are supposed to document pain assessment and re-assessment according to facility's policy, revealed a documentation that a dose was refused. NM 17 reviewed the record, but did not find any documented evidence explaining the discrepancy or the reason for medication refusal. It was not clear if the medication was given or was refused.



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22710

Based on observation, interview, and record review, the facility failed to ensure that the hospital was maintained in a clean and orderly manner.

1. Pantry drawers were loaded with debris and dust on Units 3 Main and 3 West.
2. A electrical closet on Unit 3 West contained large clumps of dust.
3. A cabinet in the emergency room medication room contained unlabeled and undated fluid container, a biohazard bag with outdated and contaminated culture bottles, and four dead insects on the bottom shelf.
4. A plastic container with loose powder and a small scoop in the powder was located on the far right ,back edge of the medication room counter.

This failure had the potential for infection.

Findings:

1. a. On 4/22/13 at 9:45 am, during a tour of the Unit 3 West patient food storage area, a drawer with bags of coffee was observed to had a layer of coffee grounds throughout the drawer.

In a concurrent interview, the Chief Nursing Officer (CNO) acknowledged that the drawers were not kept sanitary.

1. b. On 4/22/13 at 10:20 am, during a tour of the Unit 3 Main patient food storage area, three drawers that contained patient food supplies (such as plastic silverware, salt and pepper, crackers, etc.) were found to have a layer of dust throughout the drawers.

In a concurrent interview, the CNO acknowledged that the drawers were not kept sanitary.

2. On 4/22/13 at 10:15 am, an electrical closet on 3 West across from patient rooms was observed to have several large clumps of dust accumulated on the floor.

In a concurrent interview, the CNO acknowledged that the electrical closet had not been kept sanitary.



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3. During the initial tour of the facility on 4/22/13 at 9:15 am, the following items were found in a floor level cabinet next to a small refrigerator:

a. On the first shelf a plastic cup/container with 8 ounces of a thick, dark liquid substance was found that was undated and unidentified.

b. On the first shelf to the left of the unidentified liquid was a small plastic biohazard bag that was dirty and dingy. The bag contained six outdated microtainers for cultures and two 40 milliliter (ml) long neck bottle/vials that are used for cultures also. The culture vials each had large quantities of solid crystal particulate matter that rested on the bottom of both vials with the yellow fluid of the vials above the crystals.

c. On the bottom of the shelf, along the far back, right corner were 4 dead insects.

During an interview on 4/22/13 at 9:30 am, NM 21 the acknowledged the above findings and stated the liquid should have been labeled and dated, the biohazard bag should have been thrown out, and that she would have evironmental services come to clean the insects out of the cabinet and inform the environmental manager of the insects found.

4. During the initial tour of the emergency room medication room on 4/22/13 at 9:30 am, a 6 inch (in) x 6 in x 8 in plastic container was on the counter in the far right, back edge corner and overlapping the edge of the sink. The lid of the container was not tightly sealed and had a crack on two of the sides od the lid.

The container contained a light yellowish, white powder (filled about 2 in up from the bottom of the container) and had a small plastic scoop (3 in long) in the powder. The container was labeled as Crystal Light powder but not dated.

On top of the lid were two strips of paper with insructions that read:
"Lemonade must remain in original package at all times. It is not acceptable to dump lemonade and then scoop."

There was no mention of the scoop not being stored in the lemonade that had been poured out. This had the potential to contaminate the lemonade powder and cause infection and/or illness to patients that received the powder.

During an interview on 4/22/13/ at 9:40 am, NM 21 acknowledged the container of Chrystal Light powder and threw the container away.

Based on observation, interview, and record review, the facility failed to ensure the proper temperature controls for a freezer were maintained and acted upon. This failure could result in food-borne illnesses.

Findings:

On 4/22/13 at 10:30 am, the 3 Main freezer temperature log for 4/2013 was reviewed. The log read, "Record freezer temperature -- must be 0 degrees Fahrenheit or below...Use Action column to indicate corrective action steps if temperatures are not in proper ranges." The log contained four entries on day shifts for 4/3, 4/10, 4/16, and 4/21/13 which were greater than zero degrees. No action was recorded on any on these temperatures.

In a concurrent interview with Dietary Services Supervisor A, she acknowledged that there was no action recorded for the temperatures that exceeded zero degrees.

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26611

Based on observation, interview, and record review, the facility failed to ensure that systems for controlling infections were followed for two of 42 sampled patients.

1. A nurse was not wearing gloves when entering a contact isolation patient room. (Patient 113)
2. Visitors were not wearing gowns and gloves in contact precaution rooms. (Patients 106 and 113)

These failures had the potential for antibiotic resistant infections to be spread to other patients, staff, and visitors.

Findings:

1. On 4/22/13 at 9 am, Patient 113's room had a sign posted outside the room notifying those that entered that Patient 113 was on contact precautions (to prevent the spread of antibiotic resistant organisms) and that gown and gloves must be worn upon entering the room. Concurrently, Registered Nurse (RN) 71 was observed entering Patient 113's room without gloves on, to provide dialysis (a procedure to filter wastes from the blood).

On 4/22/13, the facility policy titled, "Isolation Precautions & Categories," dated 8/8/12, read, "Contact Precautions... Visitors - Report to Nurses Station Before Entering Room..wear gloves when entering room... wear gown when entering room."

In a concurrent interview, the Chief Nursing Officer (CNO) acknowledged that RN 71 should have had gloves on when entering Patient 113's room.

2. a. On 4/22/13 at 9 am, two visitors were present in Patient 113's room, neither were wearing gown and gloves. One visitor was an infant, and the other visitor spoke Spanish as a primary language.

In a concurrent interview, the CNO acknowledged that Patient 113's visitors should have had gown and gloves on while in Patient 113's room, to protect them from and to prevent the spread of antibiotic resistant bacteria to others.

2. b. On 4/22/13 at 10:15 am, Patient 106's room had a sign posted outside the room notifying those that entered that Patient 106 was on contact precautions. Three visitors were present in Patient 106's room without gown and gloves on. At least one of the visitors spoke Spanish as their primary language.

In a concurrent interview, the CNO acknowledged that Patient 106's visitors should have had gown and gloves on.

On 4/24/13, the Quality Council minutes for 4/9/13 were reviewed. Infection control education was presented, titled, "Caring Enough to Prevent Infection - Isolation Precautions." This education did not contain any mention of how visitors should observe isolations precautions or how nurses were to instruct visitors on isolation precautions.


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17065

Based on observation, interview, and record review, the facility failed to ensure that medical staff physicians were assessing patients, prior to cardiac catheter procedures, using moderate sedation (per facility's rules and regulations) as evidenced by:

1. All Cardiologists (Medical Staff Members -MSM 61, 62, 63, 64, 65, 66, 67, 68, 69, and 70), priviledged to conduct Cardiac Catheterization (a procedure to view the blood vessels of the heart), were conducting incomplete interval updates to the history and physical (H & P) in the Cath Lab Suite. (Refer to A 359 and A 952);

2. MSM 61 was not conducting a complete H & P's when notified that the H & P was older than the required 30 days, prior to the procedure. (Refer to A 358 and A 952); and

3. Nursing staff failed to monitor Patient 132 after administration of Versed (sedation) and fentanyl (potent narcotic), during and after the procedure, per nationally recognized standards. (Refer to 951, item 1);

4. Nurisng staff failed to ensure that Conscious Sedation policies were implemented for three of three sampled Cardiac Catheterization procedure patients (Patients 141, 142, and 143) and the policy failed to direct nursing staff on what to do when the history and physical (H&P) was not done timely and the update examination (interval update) was not complete with a physical examination (Patients 141, 142, and 143). (Refer to A 951, item 2)

These failures had the potential for patients to not be fully evaluated for safety, prior to the procedures, and for patients to not receive adequate monitoring during and after the procedure (under conscious sedation) which could result in undetected problems and could harm patients.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide surgical services in a safe and effective manner, and in accordance with the statutorily-mandated Condition for Coverage for Surgical Services.

Based on interview and record review, the facility failed to ensure that policies were followed for four of four sampled procedure patients (three cardiac catheterization (cath - procedure to view the blood vessels of the heart) procedure patients and one intubation (breathing tube) patient) and directed staff what to do when the history and physical (H&P) was not done timely and the update examination (interval update) was not complete with a physical examination. (Patients 132, 141, 142, and 143)

1. Standards for monitoring the effects of conscious sedation drugs were not followed. (Patient 132)

2. Nursing staff failed to follow policies related to H&P and interval updates for patients having a cardiac catheterization. (Patients 141, 142, and 143)

3. The facility policy did not direct staff what to do if H&P and interval updates were not present or complete.

These failures can lead to patient harm due to changes in the patient condition can go undetected.

Findings:

1. Patient 132 was admitted on 3/16/13. She was given Fentanyl, a potent narcotic, and Versed, a sedation for the placement of a breathing tube. There was no documented evidence that the patient was monitored for blood pressure, respiratory rate, and heart rate during and after the procedure.

In an interview and record review on 4/25/13 at 3:30 pm, NM 7 stated that there were no documented vital signs monitored after Fentanyl and Versed were administered on 3/16/13.

Fentanyl and Versed are known conscious sedation medications, when administered together, can cause severe respiratory and central nervous system depression. Both had a US Boxed Warning to use with extreme caution, have appropriate resuscitative equipment and qualified personnel for administration and monitoring.

According to American periOperative Registered Nurse (AORN) Perioperative Standards and Recommended Practices 2012 Edition, under Moderate Sedation/Analgesia, Recommendation, "Recommendation I- The perioperative registered nurse should continuously monitor the patient throughout the procedure...Recommendation VII - The perioperative registered nurse should monitor the patient who receives moderate sedation/analgesia postoperatively." No exceptions were provided.

According to the policy, "Procedural Anesthesia/Analgesia - Adult-Hospitalwide," dated 9/24/12, under Policy, "F. For Moderate Sedation Procedures, in addition to the physician who is credentialed for moderate sedation who is performing the procedure and supervising the sedation, there will be one registered nurse (sedation nurse) who has validated competency and required training to administer medications...upon direct order of the physician and a second RN as the circulator...O. Intra-procedure Monitoring: Cardiac rhythm, vital signs (except temperature) including oxygen saturation,...sedation level and pain level are to be monitored and recorded every 2-5 minutes throughout the duration of the procedure...P. Immediate Post-procedure Monitoring: Post-procedure monitoring for both inpatient and outpatient will include vital signs will be assessed and documented every 5 minutes X (for) 20 minutes."

2. According to the facility's Medical Staff Rules and Regulations, dated 8/12, read, "A-3 A medical history and physical examination is to be completed no more than 30 days prior to or within 24 hours after inpatient admission. For a medical history and physical examination that was completed within 30 days prior to inpatient admission, an update documenting any changes in the patient's condition is completed within 24 hours after inpatient admission or prior to surgery...A - 4 A history and physical is required for all patients with the exception of outpatients presenting for treatment or procedures covered by the Conditions of Admission form which do not require a separate consent. The history and physical must contain: 1) history of present illness; 2) medical and surgical history, medications, and allergies; 3) physical exam; 4) impression; 5) plan. Chief complaint, review of systems, family history, and social history should be included when pertinent but not necessarily under separate headings."

The facility policy, titled, "Procedural Anesthesia/Analgesia - Adult-Hospitalwide," dated 9/24/12, read, "Verify that H&P is on the chart ...Assure all of the following have been documented prior to the start of the procedure or (Underlined) before the patient is moved to the procedure area ... Mallampati Scale ...Interval update to the History and Physical per hospital policy and medical staff rules and regulations." The facility policy does not direct the nurses doing the above record review what to do if the H&P is greater than 30 days old and what to do if a physical examination for the interval update is not done completely.

On 4/22/13, MSM 61 had three (Patients 141, 142, and 143) scheduled cardiac cath procedures for 4/22/13. All three patients had documented H&P's greater than 30 days which went undetected by nursing staff. A physical examination was not conducted for the interval update for Patient 142. Patients 141, 142, and 143 had H&P ' s had short form H&Ps that were incomplete with current physical examination information. Confidential interviews revealed that the routine practice for all cardiac cath patients was to have their interval update performed by the physician in the cardiac cath while the patient was draped from neck to feet with sterile drapes, thus not allowing a physical examination to update the information gathered on the H&P. Refer to A 952 for more information.

In an interview on 4/24/13 at 2:40 pm, Nurse Manager (NM) 19 acknowledged that the nursing staff had a long history of not being compliant with the policy for assuring all required information is present on the patient record prior to cardiac catheterizations. NM 19 stated for all other procedures that the nurses prepared patients for, they followed the policy. NM 19 stated that patients without all the required information should not proceed to the procedure.

Based on observation, interview, and record review, the facility failed to ensure that a medical history and physical examination (H & P) was completed and documented no more than 30 days before the scheduled Cardiac Catheterization (Cath) Procedure and an updated examination (interval update) by the physician, to determined if there were any changes in the patient's condition, be completed and documented within 24 hours for three of three sampled procedural patients. (Patients 141, 142, and 143)

Patients 141, 142, and 143 had H & Ps that were greater than 30 days old and had short form H & Ps and/or interval updates that did not include a physical exam.

Patient 142 had an incomplete and inaccurate interval update examination which included Mallampati Scale (a standardized classification tool to predict ease of intubation (breathing tube used in the case of emergency) based on a visual assessment by the physician of the anatomy of the oral (mouth) cavity that was not performed.

MSMs 61, 62, 63, 64, 65, 66, 67, 68, 69, and 70 routinely conduct their updated examinations in the cardiac cath lab while the patient is under sterile drapes where a full physical examination cannot be performed.

These patients did not have a complete history and physical conducted within 30 days, prior to the procedure, and updated interval examinations were incomplete. This failure had the potential for patient harm because of undetected patient condition changes.

Findings:

1. According to the facility's Medical Staff Rules and Regulations, dated 8/12, "A-3 A medical history and physical examination is to be completed no more than 30 days prior to or within 24 hours after inpatient admission. For a medical history and physical examination that was completed within 30 days prior to in patient admission, an update documenting any changes in the patient's condition is completed within 24 hours after inpatient admission or prior to surgery... A-4 A history and physical is required for all patients with the exception of outpatients presenting for treatment or procedures covered by the Conditions of Admission form which do not require a separate consent. The history and physical must contain: 1) history of present illness; 2) medical and surgical history, medications, and allergies; 3) physical exam ; 4) impression; 5) plan. Chief complaint, review of systems, family history, and social history should be included when pertinent but not necessarily under separate headings."

The facility's policy titled, "Procedural Anesthesia/Analgesia-Hospitalwide," dated 9/24/12 , read, "Verify that H&P is on the chart...Assure all of the following have been documented prior to the start of the procedure or (Underlined) before the patient is moved to the procedure area ... Mallampati Scale...Interval update to the History and Physical per hospital policy and medical staff rules and regulations."

On 4/22/13 at 9:40 am, during an observation of a cardiac catheterization (to view the vessels of the heart), Patient 142 was observed lying face up on a table in the center of the Cardiac Cath Suite. A heart monitor was on the patient monitoring his heart rhythm and rate, blood pressure, and oxygen saturation level (assessment tool for oxygen level in blood). A sterile prep (disinfection of entry site) was observed to the expected entry sites by Nurse Manager (NM) 18 and then sterile drapes were placed from neck to feet.

Patient 142's record was reviewed concurrently and contained a surgical checklist (list of required documentation and third review by nursing) signed off as completed by Registered Nurse (RN) 68. The checklist indicated the H & P and the interval update were present. Patient 142's record contained a H & P, dated 3/22/13 (31 days), and no evidence of an interval update. When the 31 day H & P was brought to RN 68's attention by the surveyor, RN 68 stated that she had calculated the date from 3/23/13, when Medical Staff Member (MSM) 61 signed off the H & P with the understanding that was acceptable, but confirmed the H & P occurred on 3/22/13.

At 10:05 am, MSM 61 entered the Cardiac Cath Suite. MSM 61 was informed he needed to do another H & P, since the current one was over 30 days. MSM 61 was observed reviewing Patient 142's record. MSM 61 did not speak to the patient nor conduct a physical examination. The "Time Out" procedure (to confirm the correct patient, procedure, and pertain information) was discussed with the team members at 10:13 am, immediately prior to starting the procedure.

A review of Patient 142's record, after the procedure, provided documentation that MSM 61 conducted a H & P at 10:10 am (while Patient 142 was in Cardiac Cath Suite prepped for the procedure) and an interval update to the H & P was documented at the same time. A Mallampati Scale, a visual clinical instrument used to assess the ease of obtaining an airway by direct observation, was documented as Class II by MSM 61 at 10:10 am. A Mallampati Scale cannot be obtained without the patient opening his mouth and sticking his tongue out as far as he can, and observing the airway. From the time when MSM 61 entered the procedure room to the beginning of the procedure, no physical exam, including a visualization of Patient 142's airway was observed as conducted by MSM 61 for Patient 142, as required by facility policy and nationally recognized standards of practice. Patient 142's record did not contain any other evidence of an assessment of the Mallampati Scale.

In an interview on 4/22/13 at 2:10 pm, MSM 61 stated that it was very rare to have a H & P occur greater than 30 days prior to the procedure. He stated that because he had not been notified ahead of time, he conducted the H & P while Patient 142 was lying under sterile drapes on the Cath Suite table. MSM 61 stated that he did the best he could, but was limited in conducting the physical exam due to the position of the patient and sterile drapes prevented him from doing a complete history and physical. MSM 61 stated he did not talk to the patient, but was able to get the necessary information from his record. During the interview, MSM 61 was notified via telephone that he had to conduct another H & P for another patient (Patient 143).

MSM 61 had three (Patients 141, 142, and 143) scheduled procedures for 4/22/13. All three patients had documented H & P's greater than 30 days.

On 4/24 and 4/25/13, two confidential interviews were conducted. These interviews confirmed that all the cardiologists privileged to perform cardiac catheterizations (MSMs 61, 62, 63, 64, 65, 66, 67, 68, 69, and 70) routinely conducted their interval updates while the patients were on the procedure tables, draped, and ready for procedure. Both interviewees stated that it would be impossible to conduct an updated examination of the patient while they were positioned on the table and draped with sterile drapes. They further stated that in all other outpatient procedures, the interval update examination was conducted in the preoperative area before the patient was taken into the procedure room.

On 4/24/13 at 2:40 pm, NM 23 confirmed Patients 141, 142, and 143 had H & Ps that were greater than 30 days old and had short form H & Ps that were performed in the cath suite immediately prior to the procedure start and were incomplete with current physical examination information, including the Mallampati Scale.

In an interview on 4/25/13 at 9:30 am, MSM 62 stated he thought the "new regulation," update examination prior to patients entering the Cardiac Cath Suite, was not practical for the doctors and that other health facilities were not requiring the interval update examination, prior to patients entering the procedure room.

The "new regulation" had been in effect since 10/17/08.

In an interview on 4/25/13 at 3:45 pm, Director of Quality Management stated that the expectation would be that the physician would do a physical examination, which would include having the patient open their mouth to evaluate Mallampati Scale as part of their interval update.

2. On 4/22/13 at 1:10 pm, MSM 61 was observed at Patient 143's bedside in the preoperative area. Patient 143 was scheduled to follow Patient 142. Patient 143 had a H & P, dated 2/15/13 (66 days) and signed by MSM 61 on 4/1/13. MSM 61 signed the interval update to H & P in Patient 143's record at 1:05 pm.

MSM 61 had received a call at 2:10 pm that a H & P needed to be done.

A review of the record, after the procedure, provided documentation that a H & P was conducted at 2:15 pm on 4/22/13, prior to the procedure.

In a interview on 4/24/13 at 2:40 pm, NM 19 stated that everyone, three nurses and procedure doctor, had reviewed Patient 143's record and signed off as completed at 1:05 pm although the H&P was greater than 30 days old. NM 19 stated that due to the surveyor's discussion regarding previous case (Patient 142), Patient 143's record was reviewed an additional time (normally not done) which revealed that the H & P was not within 30 days of the scheduled procedure. NM 19 confirmed that the cardiac cath staff were not in the routine of observing this regulation.