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Based on observation, record and document review, the hospital failed to provide correct contact information for external grievance resolution on their Patient Rights and Responsibilities form for one (Patient 33) of 35 sampled patients; and failed to provide written proof that the Patient Rights and Responsibilities had been provided to one (Patient 61) of 35 sampled patients; and failed to publicly post the correct contact name and address for the State Agency; and failed to update their policy and procedure for patient rights and responsibilities with the correct contact information for the State Agency.

Findings:

1. Review of both the paper and electronic record on 4/12/11 showed Patient 61's record did not contain documented acknowledgement by Patient 61 that she had received a written copy of patient rights. The MOS/PL (Manager of Orthopedic Services/Physician Liaison) present during the review, said the documentation was missing.

2. Record review, on 4/13/11 at 10:25 a.m., showed the "Patient Rights" form for Patient 33 listed the patients' rights while a patient at the hospital. The section on how to file a complaint with the Department of Public Health had the old address and the old title for the department.

3. Review of the hospital policy and procedure for "Patient Rights and Responsibilities", last reviewed on 8/10, identified as one of the rights to file a complaint with the "...Department of Health Services...". The policy had an attachment, "Patient Advocacy List", which included the "Department of Heath Services" with a telephone number. The telephone number was dialed on 4/13/11 at 3:30 p.m. but the caller heard only a recording, stating the number was no longer in service.


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4. On 4/12/11 at 1:00 p.m., the general hospital postings behind framed glass located by the hospital admissions department was observed. Among the postings was a copy of Patients' Rights and Responsibilities that included a contact name and address for the State Agency. Review showed neither the name of the Agency or the address for the agency were correct. The address had been changed more than five years ago from the Berkeley site to Richmond and the State Agency was renamed more than four years ago to the Department of Public Health from the Department of Health Services.

Based on interview, record and document review, the hospital failed to ensure that nursing staff followed hospital policies and procedures for pain management and monitoring after opiate administration and to follow physician orders; failed to follow updated alcohol withdrawal policies; and failed to follow hospital policy for nutrition screening.

The failures affected 7 (Patients 3,4,5,22,31,33,64) of 35 sampled patients as follows:

For patient 31, nursing staff failed to reassess 15 minutes after an intravenous opiate pain medication was given and failed to reassess him every 15 minutes for a total of one hour when the opiate dose had been increased, which had the potential that the medication may not have been effective in relieving pain and that opiate related side effects, such as respiratory depression, would not be detected in a timely manner.

For Patient 33, nursing staff failed to follow the physician's post-operative orders for vital sign monitoring (temperature, blood pressure, pluses and respiratory rate) in a fresh postoperative patient, which put Patient 33 at risk that potential postoperative complications, such as respiratory depression, bleeding from the surgery site, equipment/tubes not working properly, skin changes, etc., would not be detected early.

For Patient 31 and 33, who were on PCA opiate pain medication, nursing staff failed to follow physician's orders for monitoring every two hours, respirations, pain rate, level of consciousness, and level of sedation. In addition, for Patient 33, oxygen saturation levels were not monitored as required. These failures increased the risk that potential oversedation and respiratory depression would not be recognized in a timely manner.

For Patient 22, nursing staff administered an IV opiate ordered for severe pain only for a patient reporting moderate pain, nor monitored for sedation after administration of IV opiates, increasing the risk that oversedation would not be recognized in a timely manner.

For Patients 3, 4, and 5, nursing staff failed to treat, evaluate, and assess for alcohol withdrawal symptoms and sedation by hospital policy and physician orders, potentially exposing Patient 3,4, and 5 to ineffective or excessive treatment.

For Patient 64, nursing staff failed to assess a patient with increased nutrition needs for prompt nutritional consultation upon admission, potentially delaying nutrition interventions.

Definitions:

PCA - A computerized pump which allows a patient to self administer a set dose of medication via lV (intravenous) by pushing a button at the end of a cord connected to the PCA pump. The pump can also be set to give an initial loading dose of the pain medication when the PCA is first started. The time interval in minutes between doses is set per physician orders as well as the total limit on dosage per hour.

Dilaudid is a opioid-synthetic narcotic pain medication that has a high risk of respiratory depression and slowing of the heart rate. The Institute for Safe Medication Practices (ISMP) in their 2/07 Newsletter identified morphine and Dilaudid as the most frequent high-alert medications. (High-alert as defined by ISMP are medications that have a heightened risk of causing significant patient harm when they are used in error and the consequences of an error are clearly more devastating to patients.)

Pulse Oximetry - Uses a probe, on the finger or earlobe to indirectly measure blood oxygen saturation levels; or how much oxygen is carried by hemoglobin in the blood. Continuous pulse oximetry is more useful to show trends of oxygenation than occasional checks. Pulse oximetry is one way to measure how well the patient is breathing

Pain Scale - Numerical pain rating using 0-10; 0 being no pain, 1-3 mild pain, 4-6 moderate pain, and 7-10 severe pain.

Findings:

1. Record review on 4/11/11 showed that Patient 31 had delivered a healthy baby boy, via caesarean section, on 4/7/11.

The "Patient Controlled Analgesia (PCA)" pain medication physician order, dated 4/7/11 at 3 p.m., showed Patient 31 could self administer a dose of 0.1 mg (milligram) of Dilaudid (a potent narcotic mediation, five to eight times stronger than morphine) through the IV (intravenous) site every six minutes.

During an interview, on 4/11/11 at 10:55 a.m., Patient 31 stated the PCA Dilaudid only made her sleepy and did not help with pain control.

Review of the "Physician Orders", dated 4/7/11 at 7:55 p.m., showed an order to discontinue the PCA and instead give Dilaudid 0.5 mg as need for pain. Review of the electronic "MAR" (Medication Administration Record), dated 4/7/11, showed Patient 31 had received Dilaudid 0.5 mg IV dose at 8:45 p.m.

Review of the "Postpartum-Flowsheet", dated 4/7/11, showed, entries at 9:10 p.m., 9:15 p.m., 9:20 p.m., and 9:25 p.m., only had pulse and the oxygen saturation assessments. The first entry for pain assessment, after the initial 0.5 mg Dilaudid dose, was at 9:30 p.m., when Patient 1 had received a second dose of Dilaudid. Further review of that entry for "Result Details" showed that the actual time of pain score assessment was at 9:15 p.m., thirty minutes after the initial increased dose of Dilaudid had been given. There was no assessment of sedation level, respiratory assessment rate, depth/effort, or blood pressure with the entries.

During an interview on 4/13/11 at 7:31 a.m. RN U (Registered Nurse) stated Patient 31's pain level had been 6 out of 10 on the pain scale and that Patient 31 had informed her the pain medication made her sleepy. Patient 31's pain level had gone from 6 to 4 after the initial IV Dilaudid 0.5 mg dose. RN U acknowledge she had not monitored all of Patient 31's vital signs or assess Patient 31's pain level within 15 minutes of giving the Dilaudid. RN U had not reassessed Patient 31's pain level, blood pressure and respiratory rate every 15 minutes for one hour after an increased in the Dilaudid dosage. RN U was asked if she considered Dilaudid 0.5 mg IV an appropriate dose for Patient 31, she stated she did not know and that this was the first time she had ever physically given Dilaudid IV push. RN U was asked if Patient 31 was opiate tolerant, she stated no. When asked what her understanding was of a patient who was opiate tolerant, RN U stated a patient who had opiate pain medication on prior surgeries.

Review of the hospital's policy and procedure, "Opiates-Monitoring and Administration for the Management of Pain", last revised 1/11, showed procedures for patient reassessment. Nurses were to reassess and monitor the patient for the presence of pain and for opiate related adverse side effects. Patients were to be reassessed within 15 minutes after an IV opiate was administered and if that IV opiate dosage had been increased then the patient was to be reassess every 15 minutes for one hour. The patient reassessment would include sedation level, respiratory - rate, dept/effort, oxygen saturation level, blood pressure and pulse.

The Pharm 1 (Pharmacist) on 4/12/11 at 8:32 a.m. was shown the Dilaudid order for Patient 31, which did not have route of administration in the order. Pharm 1 stated route would be clarified, and for this order, taken by a nurse, the pharmacist would first call and speak to the nurse. Pharm 1 checked the omni-cell
pharmacy link, but no record of order being clarified was found. There were no further physician orders to show that the order had been clarified but the electronic MAR had Dilaudid per IV route.

On continued interview, on 4/13/11 at 7:31 a.m., RN U stated the pharmacy department will not enter medication orders in the MAR if there is no route of administration included in the order. She stated she was surprised that a pharmacist had not called the nursing unit to clarify the order.

2. Record review on 4/13/11 showed Patient 33 had abdominal hernia repair surgery on 4/11/11. The "Postoperative Orders-Ventral Hernia", dated 4/11/11 at 10 a.m., showed vital signs were to be done every hour for two hours, then every two hours for two hours, then every four hours. For pain control Patient 33 had Dilaudid PCA ordered. The "Patient Controlled Analgesia (PCA)" dated 4/11/11 at 10:20 a.m., showed respirations, pain rate, level of consciousness, level of sedation, and oxygen saturation level were to monitored every two hours.

Patient 33 had arrived on the medical-surgical nursing unit on 4/11/11 at 11:45, patient assessment , vital signs and oxygen saturation level were done. The next assessment/vital signs and oxygenation levels were done at 12:45 p.m., 3:07 p.m., 8:10 p.m., and on 4/12/11 at midnight. The vital signs/oxygenation saturation levels should have been done, as per physician's order, at 12:45 p.m., 1:45 p.m., 3:45 p.m., and then every four hours starting at 7:45 p.m.

Record review showed that Patient 33 had a pain assessment done on arrival to the medical-surgical unit at 11:45 a.m., but the next pain assessment was at 8:10 p.m., almost eight hours after the initial assessment. The next monitoring of the respiratory rate, oxygen saturation level, level of consciousness, level of sedation and pain rating was at 4/12/11 at midnight, then at 8 a.m.,11:55 a.m., 2:59 p.m., which were not every two hours.

The MOS/PL (Manger of Orthopedic Services/Physician Liaison) assisted in electronic record review for Patients 31 and 33.


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3. Record review on 4/11/11 showed Patient 22 was admitted to the hospital on 4/7/11 for chicken pox and viral pneumonia. Review of physician orders dated 4/8/11 indicated for pain management, Patient 22 was to receive: "Acetaminophen (Tylenol) 650 mg PO (by mouth) q (every) 6 h(ours) prn (as needed) mild pain"; "Hydrocodone-Acetaminophen (Norco) 5/325 mg 1 tablet PO q4h prn moderate pain"; "Hydromorphone (Dilaudid) 1 mg IV (intravenous) q3h prn severe pain."

Review of the electronic Medication Administered Report (MAR) for prn medications on 4/13/11 showed on 4/9/11 at 10:40 a.m., RN A administered Dilaudid 1 mg IV for Patient 22's report of pain at 7, severe pain. Review showed at 10:55 a.m.,15 minutes later, RN A reassessed Patient 22's pain level at 4, now moderate. No other assessment was seen to determine if Patient 22 were experiencing adverse effects like respiratory depression or increased sedation from the IV opiate medication . On 4/9/11 at 3:03 p.m., RN A administered Dilaudid 1 mg IV for Patient 22's report of pain at 5, moderate pain. Fifteen minutes later, at 3:18 p.m., RN A assessed Patient 22's pain level at 0, meaning no pain. There was no further assessment documented to determine if Patient 22 were experiencing adverse effects from the IV opiate medication.

On 4/13/11 at 12:55 p.m., RN A was asked if she recently received education about opiate medications and monitoring for sedation. She stated "We did a lot of talking in the staff meeting about monitoring sedation. RN A stated she knew to reassess a patient 15 minutes after administering an IV opiate if it were new or an increased dose. RN A stated that documenting sedation level would be in the pain assessment but "I don't know if I necessarily charted it. I did the re-eval in 15 minutes. Each time he was appropriate." RN A stated she knew a patient with a PCA (patient-controlled analgesia) had a form "where you chart sedation" but for other IV narcotics it as "chart by exception, so you don't chart if they're not sedated. RN A was asked why she administered Dilaudid 1 mg. for Patient 22's reported pain level of 5, moderate pain. RN A acknowledged a pain level of 5 did not warrant a medication for severe pain, but stated "I'm sure it was because he was nauseated and I didn't want to give him PO (For moderate pain, Patient 22 was to receive one Norco tablet). I had been talking to him about his pain management and what would be the right choice."

Review of the policy "Monitoring and Administration of Opiates for the Management of Pain" indicated "Reassessment after opiate administration will include: a. Sedation assessment: Oversedation precedes respiratory depression. Utilize the level of consciousness and level of sedation tools in the computerized patient record with each reassessment. Document assessment and reassessment data in the patient medical record."

Review of the hospital's "Self Study Module for Nursing Cerner Documentation" required of nursing staff to complete by 2/14/11, indicated nursing staff should "Use a step-wise approach for selection of analgesics to match intensity of pain: Mild (1-3 on Numerical scale); Moderate (4-6 on Numerical scale); Severe (7-10 on Numerical scale). Give medication that the MD has ordered for the pain scale indicated by the patient's report. For example, if the patient reports a pain of 4, you must five what is ordered for Moderate pain (and not severe)." "A patient who just received an injectable opiate must be monitored for adverse effects for at least 1 hour." Nursing staff was to monitor for "Opiate adverse side effects" by knowing "The most common adverse effects of opioids are nausea, vomiting, pruritus (itching), constipation, respiratory depression, and sedation. Sedation is a sensitive indicator of respiratory depression. Therefore, in conjunction with regular respiratory assessments, routine and systematic assessment of the degree of patient sedation is vital."

Review of employee records showed RN A completed training for opiate administration and monitoring on 2/5/11


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4. The hospital's policy titled, "Nursing Assessment for Patients at Risk for Alcohol Withdrawal", revised and reviewed on 3/11, indicated that for patients with a history of heavy drinking, defined as consuming an average of more than 2 drinks per day, the nurse is to assess the severity of withdrawal symptoms using the CIWA scale minimally every 6 hours for 72 hours. CIWA is the Clinical Institute Withdrawal Assessment of Alcohol Scale and is designed specifically to assess for symptoms of alcohol withdrawal such as, tremors, hallucinations and agitation.

Patient 4's record review on 4/12/11 in the company of the nurse lead for the computer project (RN T) showed that the hospital had admitted Patient 4 on 3/22/11 for abnormal cardiac changes. Patient 4 was 56 years old and had a known history of chronic alcoholism. According to the admissions history and physical, Patient 4 was consuming 3-4 glasses of vodka daily, with the last drink consumed on the night prior to admission.

Patient 4 did not receive CIWA assessments every 6 hours for 72 hours as required by hospital policy. Patient 4's CIWA assessments were conducted, as follows:
3/22/11 5 p.m. CIWA score 2 (mild withdrawal symptoms if less than 10)
3/23/11 12:45 p.m. CIWA score 7
3/24/11 10:16 a.m. CIWA score 2
3/24/11 4: 29 p.m. CIWA score 1
3/24/11 8 p.m. CIWA score 0
3/25/11 8:37 a.m. CIWA score 2
Patient 4's record did not contain any additional CIWA assessments.

According to the same policy, Patient 4 had minimal alcohol withdrawal symptoms based on CIWA scores between (0-10). For patients with minimal symptoms, the policy directed nursing staff to assess CIWA every 6 hours for 72 hours and 15 minutes after benzodiazepine administration.

Patient 4 had physician's orders for two benzodiazepines for the management of alcohol withdrawal symptoms, dated 3/22/11 at 2 p.m.,
Librium 25 milligrams (mg) by mouth three times daily
Ativan 2mg intravenously (IV) push every two hours as needed for anxiety

Additionally, Patient 4 had active orders for intravenous Dilaudid for pain and Ambien (a benzodiazepine used for sleep).

Benzodiazepines are centrally acting depressant. They can cause respiratory depression, apnea, hypotension and sedation. Combining benzodiazepines with opiates (Dilaudid) may increase the likelihood of these adverse events. ()

Patient 4 received medications as follows:
3/22/11 4:23 p.m. Librium 25mg CIWA at 5 p.m.
3/22/11 8:36 p.m. Librium 25mg No CIWA reassessment
3/23/11 12:55 a.m. Ativan 2mg No CIWA reassessment
3/23/11 5:05 a.m. Ativan 2mg No CIWA reassessment
3/23/11 9:27 a.m. Librium 25mg No CIWA reassessment
3/23/11 9:28 a.m. Ativan 2mg No CIWA reassessment
3/23/11 12:42 p.m. Ativan 2mg CIWA at 12:45 p.m.
3/23/11 1:21 p.m. Librium 25mg No CIWA reassessment
3/23/11 2:49 p.m. Ativan 2mg No CIWA reassessment
3/23/11 9:02 p.m. Librium 25mg No CIWA reassessment
3/23/11 11:45 p.m. Ativan 2mg No CIWA reassessment
3/24/11 8:54 a.m. Librium 25mg CIWA at 10:16 a.m.
3/24/11 2:13 p.m. Librium 25mg No CIWA reassessment
3/24/11 3:55 p.m. Ativan 2mg CIWA at 4:29 p.m.
3/24/11 8:10 p.m. Librium 25mg No CIWA reassessment
3/25/11 8:56 a.m. Librium 25mg No CIWA reassessment

Patient 4's alcohol withdrawal symptoms were not reassessed 15 minutes after benzodiazepines administration, as required by hospital policy.

The same policy indicated the following,
"Utilize the Riker scale to assess level of sedation after benzodiazepines for alcohol withdrawal treatment. Goal is for Riker scale score of 4. If Ryker score is less than 4, do not administer benzodiazepines. Notify physician if Riker score is 3 or less..."

Patient 4's only Ryker score was documented only once on 3/23/11 at 8 a.m. There was no other documented evidence that Patient 4's level of sedation after benzodiazepine administration was assessed, as required by hospital policy.

During interview, on 4/12/11 at 4 p.m., the director of education (DE) said Patient 4 should have been assessed using CIWA and Ryker as required by hospital policy.

During record review and interview, on 4/13/11 at 9:44 p.m., the Director of Intensive Care Unit & Definitive Observation Unit (DICU/DOU) and the DOU day shift supervisor (RN I) could not provide any additional documentation regarding Patient 4's alcohol withdrawal symptoms and post benzodiazepine administration assessments. DICU/DOU and RN I could not provide any explanation for the lack of assessments and said they were working on educating nursing staff.

5. Patient 3's record review on 4/13/11, in the company of DICU/DOU and RN I, showed that the hospital had admitted Patient 3 on 4/11/11 for the treatment and management of acute alcohol intoxication. Patient 3 was started on the alcohol withdrawal prophylaxis and treatment protocol on 4/11/11 at 3:45 p.m.

On 4/11/11 at 4 p.m. and 5:15 p.m., Patient 3 received Ativan 2 mg IV, in accordance with the protocol.

On 4/12/11 at 11:52 a.m. and 4:42 p.m., Patient 3 received Ativan 2 mg IV, in accordance with the protocol

Patient 3's record did not contain any evidence that a nurse had evaluated Patient 3's level of sedation (Ryker Score) after benzodiazepine administration on 4/11/11 at 4 p.m. and 5:15 p.m. or 4/12 at 11:52 a.m. and 4:42 p.m., as required by hospital policy and the protocol. During interview on 4/13/11 at 12:32 p.m., DICU/DOU and RN I could not provide an explanation for the lack of the lack of Ryker scores after administration of benzodiazepines.

The alcohol withdrawal prophylaxis and treatment protocol required nursing staff to, "Assess Riker, CIWA, RR (respiratory rate), sp02 (oxygen saturation), P (pulse), BP (blood pressure) 15 minutes after every dose and document in the medical record." Additionally, the alcohol withdrawal prophylaxis and treatment protocol instructed staff to hold benzodiazepines if the Riker score was less than 4 or the respiratory rate less than 12.

Patient 3's respiratory rates were as follows
4/13/11 3 p.m. 10
4/13/11 3:30 p.m. 15
4/13/11 4 p.m. 11
4/13/11 4:15 p.m. 20

Patient 3 received an Ativan dose on 4/13/11 at 4:05 p.m.

During interview on 4/13/11 at 12:32 p.m., DICU/DOU said that the protocol was not clear and did not specify for how long the respiratory rate had to be below 12 prior to withholding benzodiazepines.

During the same interview, when asked about additional patients treated or managed for alcohol withdrawal, DICU/DOU said the hospital treated one other patient (Patient 5) since the approval of the " Nursing Assessment for Patients at Risk for Alcohol Withdrawal ", on 3/11. DICU/DOU said the hospital staff had not followed the intent of the alcohol withdrawal prophylaxis and treatment protocol of completing treatment at the more severe level, once a patient's CIWA score reaches that level. When Patient 5's alcohol withdrawal symptoms (lower CIWA score) improved, the staff began treatment for a less severe level.

6. Review of Patient 5's record showed that the hospital had admitted the patient on 3/28/11 for a lung mass and persistent cough. The admission history and physical showed that Patient 5 consumed two to three glasses of vodka every night. Patient 5 had orders for the initiation of the alcohol withdrawal prophylaxis and treatment protocol. On 3/31/11 at 9:30 a.m., Patient 5's CIWA score was 16, which was mild to moderate withdrawal symptoms "Level II". On 3/31/11 at 11:30 a.m., Patient 5's CIWA score was 29, indicating severe withdrawal symptoms and requiring more aggressive treatment and monitoring "Level III". On 4/2/11 at 12:05 a.m., when Patient 5's CIWA score decreased to 20 (mild to moderate withdrawal), new alcohol withdrawal prophylaxis and treatment protocol orders were obtained to treat Patient 5 for mild to moderate withdrawal "Level II". Several hours later, on 4/2/11 at 3:30 a.m., Patient 5's symptoms worsened and his CIWA score was 28, and new orders were obtained to treat Patient 5 for severe withdrawal "Level III".

During the same interview, DICU/DOU said the hospital updated the alcohol withdrawal prophylaxis and treatment protocol to include the following statements, "The alcohol protocol is a 'one-way street'. You can go from level 1 to level II to level III; but not the reverse; refer to the tapering orders when tapering is appropriate." DICU/DOU said the hospital was continuing to provide education and training to the physicians, nurses and pharmacists regarding the alcohol withdrawal and prophylaxis protocol.


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7. On 4/12/11, review showed Patient 64 was admitted with diagnoses including a worsening sacral wound. The patients' history and physical dated 4/4/11 noted that the patient was admitted from home with a sacral wound that would not heal. A comprehensive nursing admission assessment dated 4/4/11 failed to note any nutritional risk factors despite the admission diagnosis. In a concurrent interview with the chief nursing office (CNO) she acknowledged that the nursing admission assessment was not accurate.

Hospital document titled "Multidisciplinary Patient Assessment and Reassessment" dated 5/10 noted that the initial assessment will be performed by a Registered Nurse. It also noted that the RN would be doing the initial nutritional status assessment. It also noted that patients who are admitted with a pressure sore or wound would be at nutritional risk and would be referred to the RD.

Based on interview, observation, and record and document review, the hospital failed to ensure that medication was administered as ordered for one (Patient 61) of 35 sampled patients. For Patient 61, whose potassium level (K+) continued to drop as her kidney function improved, nursing staff did not administer potassium chloride in a timely manner as ordered, which delayed the onset of action of the medication.

Findings:

Record review on 4/12/11 showed Patient 61 was 90 years and had been admitted to the intensive care unit on 4/7/11 with multiple medical diagnoses, which included acute kidney failure. Patient 61 had been transferred to the medical-surgical nursing unit on 4/10/11. On admission Patient 61's serum potassium (K+) level was 6.2 (normal range 3.5-5.0), creatinine level was 4.46 (normal range 0.5-1.4), and blood urea nitrogen (BUN) was 100 (normal range 7-21). Both creatinine and BUN are indicators of kidney function. Further laboratory review of this values showed while kidney function improved (BUN and creatinine levels began to drop) the K+ blood level also dropped:

K+ Creatinine BUN

4/8/11 - 4:25 a.m. 4.4 2.98 77
4/8/11 - 3:10 p.m. 3.8 2.20 60
4/9/11 - 4:04 a.m. 3.5 1.42 43

Review of the "Physician Orders", dated 4/9/11 at 4:35 p.m., showed an order for potassium chloride 10 meq (milliequivalent) by mouth "now". The Medication Administration Record (MAR) showed Patient 61 had received the potassium chloride 10 meq on 4/9/11 at 6:51 p.m., over two and one-quarter hours after the medication had been ordered.

During an observation and interview in the intensive care unit on 4/12/11 at 11:21 a.m., RN V (intensive care nurse) was asked to check the omnicell (medication dispensing unit) to see if potassium chloride 10 meq was part of the regular stock; it was. The ADICU (Assistant Director of Intensive Care Unit), who was also present, stated a "now" order could be given up to two hours after ordered.

Review of the hospital policy and procedure "Administration of Medications", last revised 12/10, showed the administration of urgent doses. "STAT or NOW medication orders will be of highest priority and will be administered immediately, up to 30 minutes from time the order is received if dispensed from Pharmacy..."

Based on record and document review, the hospital failed to ensure physician orders for administering packed red blood cell transfusions were followed for one (Patient 61) of 35 sampled patients. For Patient 61 the hospital failed to administer/transfused packed red blood cells over four hours as ordered by the physician, which put Patient 61 at risk for fluid overload complications, such as labored breathing, peripheral swelling, and a rapid increase in the blood pressure.

Findings:

Record review on 4/12/11 showed Patient 61 was 90 years and had been admitted to the intensive care unit on 4/7/11 with multiple medical diagnoses, which included acute kidney failure. Laboratory review showed on 4/9/11 Patient 61's hemoglobin level was 8.3 (normal range for females, 12-15.2) and on 4/10 the level was 8.8.

Review of the "Physician Orders", dated 4/9/11 at 10:37 a.m. and 4/10/11 at 10:12 a.m., showed for each date an order for transfusing one unit of packed red blood cells and each unit of packed cells was to be infused over four hours. Review of the "Physician Order Form" for blood products dated 4/9/11 at 11 a.m. and 4/10/11 at 10:15 showed that Patient 61 had "Heart Disease" as a coexisting disease state.

One of the complications from blood/packed cell transfusion is circulatory fluid overload, where the increase blood volume causes a rapid increase in blood pressure, labored breathing, and generalized swelling. The extra volume stresses the heart. Patient 61 was at an increase risk for fluid overload; she was elderly, had acute renal failure, and had been identified with "heart disease".

Record review of the "Crossmatch Transfusion Record", dated 4/9/11, showed that the transfusion of packed red blood cells was started at 4:30 p.m. and had been completed at 7:35 p.m.; total of three hours and five minutes infusion time. The transfusion record for 4/10/11 showed the transfusion of packed red blood cells was started at 1:05 p.m. and completed at 3:30 p.m.; total of two hours and 25 minutes infusion time.

Review of the hospital policy and procedure "Blood Product Administration outside of the Operating Room", last revised 3/09, showed transfusions were to be administered over the appropriate recommended times intervals unless a specific time was ordered by the physician. The policy recommended time interval for packed red blood cells was over two-three hours, not to exceed four hours.

Based on interview, record and document review the hospital failed to follow their policy and procedure "General Documentation Guidelines" for one (Patient 33) of 35 sampled patients. For Patient 33 a order entry for a pain medication was written over a prior order, which resulted in an illegible entry that may have been misread or misinterpreted and which had the potential to result in a medical error.

Definitions:

PCA - A computerized pump which allows a patient to self administers a set dose of medication via lV (intravenous) by pushing a button at the end of a cord that was connected to that PCA pump; this would be the PCA mode. The pump can also be set to give an initial loading dose of the pain medication when the PCA is first started. The interval between doses is set per minutes and a total limit on dosage per hour is also set. A continuous mode, where the pump is set to give a continuous small amount of pain medication per hour, can be set in addition to the PCA mode.

Findings:

Record review on 4/13/11 at 10:25 a.m. of the "Patient Controlled Analgesia (PCA), dated 4/11/11 at 10:20 a.m., for Patient 33 showed that the loading dose and the as needed (prn) dose orders had been written over prior entries, which made it unclear what the actual doses were. The MOS/PL (Manager of Orthopedic Services/Physician Liaison), who had assisted with the electronic and paper chart access, stated that a line should have been drawn through the error entry and a new entry made instead of writing over the first/error entry.

Review of the "General Documentation Guidelines", last revised 10/10, showed the procedure for incorrect or error entries in the medical record, "When an incorrect entry or error is made in charting, do NOT erase or obliterate the information." Corrective action was to draw a single line through the inaccurate documentation, sign or initial and date and time the entry.

Based on staff interview and document review, the facility failed to ensure that
"Medical Staff Rules and Regulations" were in compliance with the above-referenced regulation.

Findings:

On April 12, 2011 at 1:30 p.m., review of the "Medical Staff Rules and Regulations" approved August, 2010 revealed the following: on Page 7, it stipulates: "Orders-#2- A verbal medication or biological order shall be considered to be in writing, if dictated to a duly authorized individual and authenticated as soon as possible, but not later than forty-eight (48) hours..."

On a subsequent interview with the Assistant Director of the Health Information Management Department, she stated that the incomplete records are analyzed for completion of all medication orders within 48 hours. However, the Health Information Management Department follows the 'Policy and Procedure-Orders-Reviewed-11-10-II-Policy which states "All medication orders must be authenticated, dated and timed by the responsible practitioner as soon as possible and, in any case, within 48 hours' rather than all orders authenticated within 48 hours by Federal regulation.

Based on interview and record review, the hospital failed to ensure one (Patient 25) of 35 sampled patients had complete medical records. Patient 25 was a surgical patient transferred from the recovery room to the DOU for observation after experiencing rapid respiratory rate and uncontrolled hypertension (high blood pressure). Documentation of times and doses of antihypertensive medication were not recorded.

Findings:

During record review with the assistant director for quality assurance on 4/12/11 at approximately 10 a.m., review showed Patient 25 underwent a surgical procedure on 4/11/11 and was transferred to the DOU (definitive observation unit) for observation after experiencing rapid respiratory rate and uncontrolled hypertension in the recovery room (PACU or post anesthesia care unit). Review showed two anesthesiologist orders for IV (intravenous, or through the vein) Labetalol (an antihypertensive medication used in IV form for hypertensive emergencies); "Labetalol 10 mg. IV q (every) 5 min prn (as needed) SysBP (systolic blood pressure) >(greater than) 190, to 60 mg. total" written when Patient 25 arrived in the PACU at 3 p.m. and "Labetalol 30 mg. IV q 10 min prn SysBP >200 to 120 mg. total" written at 4:06 p.m. while Patient 25 was in the PACU.

Review of the Nursing Note Form documented by RN F on 4/11/11 at 11:08 p.m. showed at 3:10 p.m. "Pt. BP continues to increase. (Anesthesiologist) at bedside orders Labetalol. See medication admin. record (MAR) for doses."

At 3:20 p.m., "Labetalol continues to be repeated for HTN."
At 4 p.m. "Continues to be hypertensive."

Review of the record with the DOU charge nurse showed no documentation of Labetalol or any other medication given by RN F.

On 4/12/11 at 1:10 p.m. the PACU supervisor stated through an audit they discovered no medications were documented and called RN F to complete the MAR.

On 4/13/11 at 11:14 a.m. RN F stated Patient 25 was so busy, she did not have time to chart each dose of medication as she administered it. She stated "I entered all the meds after the fact. Then I must have missed the "check" button or the computer logged me out."

On 4/13/11 at 11:19 a.m., the Director of Perioperative Services stated "This problem has happened before. Yes, we tell them to save it (date inputted), keep saving it every so often so it's not lost."

Based on record reviews and staff interviews, the hospital failed to ensure three (Patients 1, 2, 4) of 35 sampled patients were provided safe and effective use of medications as evidenced by:

1. The failure to ensure that Patient 2 met the criteria for opiate tolerance prior to approving and dispensing a Fentanyl Patch, in accordance with manufacturer's instructions and the hospital's policy and procedures. This failure had the potential to expose Patient 2 to adverse events such as respiratory depression.

2. The failure to ensure that Patient 4 did not have multiple active orders for benzodiazepines and did not receive two benzodiazepines at the same time. This failure had the potential to expose Patient 4 to serious adverse reactions related to the duplicate use of benzodiazepines, such as excessive sedation and respiratory depression.

3. The failure to clarify Patient 1's as needed pain medication orders. This failure had the potential to expose Patient 1 to inconsistent use of pain medications which could lead to ineffective or excessive use of pain medications.

Findings:
1. The Fentanyl Patch is a narcotic (opioid) pain medicine applied to the skin. It contains Fentanyl, a very potent narcotic pain medicine. Fentanyl Patches are only intended for treating persistent, moderate to severe pain in patients who are opioid-tolerant, meaning those patients who take a regular, daily, around-the-clock narcotic pain medicine. Patients who are opioid-tolerant are more resistant to the dangerous side effects of narcotic pain medicines than patients who only occasionally take these medicines. For patients who are not opioid-tolerant, the amount of Fentanyl in one Fentanyl patch of the lowest strength is large enough to cause dangerous side effects, such as respiratory depression (severe trouble breathing or very slow or shallow breathing) and death.
Due to numerous reports of adverse events with Fentanyl Patches, including fatalities, caused by inappropriate prescribing, dispensing, and administration of the drug, The Food and Drug Administration (FDA) issued a public advisory, "Deaths and overdoses have occurred, and the directions for the use of this medication must be followed exactly to prevent death or serious side effects."
Additionally, the FDA required pharmaceutical companies who manufacture Fentanyl Patches to place a boxed warning (black box warning) on the labeling. A boxed warning is the strongest warning that the FDA requires. When a medication's labeling includes a boxed warning it means that medical studies indicate that the medication carries a significant risk of serious or even life-threatening adverse effects. The Fentanyl Patches' boxed warning includes the following:
"Fentanyl should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to Fentanyl Patch 25 (microgram per hour) mcg/hr. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 milligrams (mg) of oral morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid. Because serious or life-threatening hypoventilation could occur, Fentanyl Patch is contraindicated: In patients who are not opioid-tolerant "
Review of the hospital's policy titled, "Fentanyl IV and Transdermal Use", revised on 4/11, showed the following,
"Transdermal Fentanyl should not be used in patients who are opiate naive."
"Transdermal Fentanyl should not be used for the management of intermittent pain."
"If Fentanyl patch is started for chronic pain, then the patient should demonstrate opiate tolerance and who require a total daily dose at least equivalent to Fentanyl patch 25 mcg/hr."
"Opioid tolerance is defined as someone who have been on another opioid for at least 7 days at least 60 mg/day of oral morphine ....or an equivalent analgesic dose of another opioid."
Record review showed that the hospital had admitted Patient 2 on 3/27/11 to treat urosepsis (infection in the urinary tract). Patient 2 was 87 years old with multiple diagnoses including chronic pain, diabetes and heart failure. Patient 2's pre admit medication list did not include any opiate pain medications.
On 4/5/11, Patient 2 had orders for and received a Fentanyl 25 mcg/hr patch every 72 hours. Review of the Pharmacist's Fentanyl Patch Dispensing Form, dated 4/5/11, showed that a pharmacist had indicated that Patient 2 had received the following opiates,
"Average Dilaudid intravenous (IV) 2.8 mg/24 hrs"
"Average Lortab Elixir 45 mg Hydrocodone/24 hours"
The pharmacist indicated that Patient 2's opiate use, for the past seven days, had met the minimum required to convert to Fentanyl Patch 25 mcg/hr, as per Black Box warning and hospital policy.
On 4/11/11 at 2:52 p.m., review of Patient 2's electronic medication administration records for the seven days prior to the initiation of the Fentanyl Patch on 4/5/11, showed the following opiate medication use:
3/29/11: Dilaudid IV 3 mg
3/30/11: Dilaudid IV 2 mg
3/31/11: Dilaudid IV 2.5 mg and Hydrocodone oral 15 mg
4/1/11: Hydrocodone 37.5 mg
4/2/11: Hydrocodone 22.5 mg
4/3/11: Hydrocodone 7.5 mg
4/4/11: Dilaudid IV 2.5 mg and Hydrocodone 15 mg
Patient 2's opiate use did not meet the minimum criteria for opiate tolerance to qualify for Fentanyl Patch 25 mcg/hr. Patient 2 did not use a minimum of oral morphine 60 mg (or the equivalent) for seven days. Additionally, according to the package insert, Fentanyl patches are indicated for management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time, and cannot be managed by other means such as nonsteroidal analgesics, opioid combination products, or immediate-release opioids.

During interview, on 4/12/11 at 4:27 p.m., the lead clinical pharmacist (Pharm 1) said that Patient 2 did not meet the minimum criteria for opiate tolerance based on his history of opiate use during the seven days prior to initiation of the Fentanyl Patch 25 mcg/hr. Pharm 1 said the pharmacist who approved and dispensed the Fentanyl Patch needed additional training.
According to the Institute for Safe Medication Practice (WWW.ISMP.ORG), "Despite warnings from the FDA, manufacturers, and various patient safety agencies, fentanyl transdermal patches continue to be prescribed inappropriately to treat acute pain in opiate-naive patients... Unfortunately, pharmacists have often filled these prescriptions without question, and nurses caring for patients have applied the patches without recognizing the prescribing error."
ISMP's Fentanyl Patch safe practice recommendations include the following:

"Creating specific prescribing and dispensing guidelines"

"Determining the indication: Pharmacists should determine the indication and ensure that the patient is opiate-tolerant and suffering from chronic pain before dispensing the medication ...Verification of the indication and any conversations with the prescriber regarding the patient and the prescribed medication should be documented in a consistent place."

2. Record review on 4/12/11 in the company of the nurse lead for the computer project (RN T) showed that the hospital had admitted Patient 4 on 3/22/11 for abnormal cardiac changes. Patient 4 was 56 years old and had a known history of chronic alcoholism. According to the admissions history and physical, Patient 4 was consuming 3-4 glasses of vodka daily, with the last drink consumed on the night prior to admission.

Patient 4's admission orders, dated 3/22/11, included the following for the management of alcohol withdrawal symptoms:
Librium 25 mg by mouth three times daily
Ativan 2 mg IV push every two hours as needed for anxiety

Additionally, the electronic medication administration record showed that Patient 4 had active orders for Dilaudid IV for pain, starting 3/22/11 and Ambien daily for sleep, starting 3/24/11.

Librium, Ativan and Ambien are benzodiazepines and sedative hypnotics. They are centrally acting depressant. They can cause respiratory depression, apnea, hypotension and sedation. Combining benzodiazepines with opiates (Dilaudid) may increase the likelihood of these adverse events. (Online.Lexi.com )

On 3/23/11 at 9:27 a.m., Patient 4 received Librium 25 mg orally
On 3/23/11 at 9:28 a.m., Patient 4 received Ativan 2 mg intravenously

RN T could not find any documented explanation for the administration of both oral and intravenous benzodiazepines at the same time to Patient 4. There was no documented assessment of Patient 4's alcohol withdrawal symptoms on 3/23/11 prior to the administration of Librium and Ativan at 9:27 a.m. and 9:28 a.m.

During interview on 4/12/11 at 4 p.m., a DOU charge nurse (RN H) said that she would not administer oral and intravenous benzodiazepines at the same time. RN H said this was contrary to hospital policy.

During interview on 4/13/11 at 9:44 a.m., the director of education (DE), the Director of Intensive Care Unit & Definitive Observation Unit (DICU/DOU) and the DOU day shift supervisor (RN I) said patients treated for alcohol withdrawal should not have two active orders for benzodiazepine or receive two benzodiazepines at the same time.

During interview on 4/13/11 at 10 a.m., the pharmacy supervisor (Pharm 2) said that patients treated for alcohol withdrawal should not have two active benzodiazepine orders and should not receive two benzodiazepines at the same time. A pharmacist's note dated 3/22/11 at 4:26 p.m. indicated that the prescriber was aware of the Ativan and Librium combination.

DICU/DOU said DOU nursing staff had contacted the ordering physician regarding the duplicate benzodiazepine orders for Patient 4. Several nurse's notes indicated that the prescriber was aware of the duplicate benzodiazepine orders. DICU/DOU could not say whether the physician had wanted Patient 4 to receive both IV and oral benzodiazepines at the same time.

The hospital's policy and procedures titled, "Nursing Assessment for Patients at Risk for Alcohol Withdrawal", approved on 3/11, indicated the following, "Patients receiving benzodiazepines for treatment of alcohol withdrawal who are not on the alcohol withdrawal protocol will have the physician contacted to discontinue all other benzodiazepines on patient profile. No other benzodiazepine orders will be processed while the patient is being treated for alcohol withdrawal."

During the same interview DICU/DOU and DE explained that physicians do not have to use the alcohol withdrawal protocol order set, however, patients treated for alcohol withdrawal should not be on two benzodiazepines at the same time. DICU/DOU and DE said the hospital is working with physicians, nurses and pharmacists to educate.

3. Record review in the company of RN H, Pharm 2 and the consultant pharmacist showed that Patient 1 had the following active pain medications orders on 4/11/11:

Hydromorphone 0.5 mg IV every 2 hours as needed for breakthrough pain, originally ordered on 3/28/11
Lortab Elixir 10 ml (a combination analgesic that contains 5 mg hydrocodone per 10 ml) NGT (nasogastric tube) every 4 hours as needed for pain, originally ordered on 4/8/11

Hydromorphone 0.5 mg IV is not equianalgesic to Lortab elixir 10 ml. It is approximately equivalent to 10 mg oral hydrocodone, twice as potent as the prescribed Lortab dose.

Review of the hospital's policy and procedures titled, "Pain Assessment and Management " , reviewed on 3/11, indicated that nursing staff will assess patients' pain levels using a numerical rating scale, where "0" is no pain and "10" is the worst pain ever experienced. Additionally, the policy stated that orders for pain medications will specify the dose for mild, moderate or severe pain and frequency and route of administration; range orders are to be avoided.

During group interview on 4/11/11 at 1:47 p.m., RN H, Pharm 2 and the consultant pharmacist said Patient 1's pain medication orders were not clear. Pharm 2 and RN H explained that the term breakthrough pain is used when patients are on a scheduled pain medication regimen. Patient 2 did not have any other active pain medication orders. Pharm 2 and RN H said Patient 1's pain medication orders should have been clarified in order to ensure consistent use of pain medications for Patient 1.

Based on medical record review, Registered Dietitian and Pharmacy interview the hospital failed to ensure an effective system for 1 of 5 patients in a sample size of 35 patients identified at nutritional risk (Patient 1) for physician review nutrition interventions. Failure to ensure an effective system for physician review of nutritional interventions may result in further compromise of nutritional and clinical status.

Findings:

Patient 1 was admitted with a long standing history of reflux disease that included food impaction. An admission nursing screening dated 4/8/11 noted that the patient "failed dysphasia screening. Admission diet order dated 3/25/11 was NPO (nothing by mouth) while the patient was on a ventilator (a mechanical breathing machine). A follow up physician order dated 4/1/11 initiated total parenteral nutrition (TPN-feeding through a vein in the arm), premix at a rate of 75 cc's/hour. A physicians diet order dated 4/7/11 implemented tube feeding of Osmolite at a rate of 20 cc's/hour in addition to the TPN). Hospital document titled "Routine Chemistry" from 4/1-4/4/11 revealed that 7 of 7 blood glucose values were elevated ranging from 127-166 mg/ml (reference range (82-115 mg/ml). Hospital document titled "Point of Care Testing" from 4/3-4/10/11 noted that 28 of 35 finger stick tests were elevated with abnormal results ranging from 127-177 mg/dl (reference range 80-120 mg/dl).

A comprehensive nutrition assessment dated 4/2/11 noted that the patient was currently on a solution that offered 25% dextrose and 4.25% amino acids at a rate of 75 cc'/hr. The RD recommended decreasing the dextrose to 15% in an effort to better control blood glucose levels. A follow up assessment dated 4/5/11 noted that the dextrose solution remained at 25%. It was also noted that Patient 1 was being overfed. The RD recommended a decrease the dextrose to an 18% solution. An reassessment dated 4/7/11 again noted a nutrition diagnosis of excessive intake from enteral nutrition with a recommendation to modify the rate, composition of schedule of the feeding. In an interview on 4/10/11 at 10:30 am, with RD 3 she stated that the RD's charted the recommendations in the electronic medical record which should have been reviewed by the pharmacist who was the person responsible for formulating the parenteral feeding formula. She also stated she would expect the physician reviewed recommendations for nutrition interventions. In an interview with Pharmacist 1 on 4/13/11 at 3 p.m., she stated that it was the responsibility of the pharmacist to inform the physician of nutrition recommendations; however was unable to provide documentation that the physician was notified of the recommended nutritional interventions. There was no documentation that the hospital developed an effective system to ensure review of nutritional recommendations by those persons responsible for the care of the patient.

The hospital failed to ensure the approved Diet Manual provided detailed guidance on how to prepare and serve the therapeutic diets ordered by the physician. Failure to provide therapeutic diets ordered by the physician does not ensure the nutritional needs of all patients are met.

Findings:

Patient 61 was admitted with diagnoses including urosepsis. Physician prescribed 1800 Calorie diet. During an interview on 4/4/12/11 at 2:30 p.m., RD 2 stated the hospital did not provide calorie levels diets, and provided the hospital approved Diet Manual, the "on-line" American Dietetic Association Nutrition Care Manual. The hospital specific diet list attached to the on-line manual narrative revealed no detailed guidance describing the how to prepare the 1800 Calorie diet.

Similarly, Patient 1 had physician ordered diet: Nissan Diet, for which there was no detailed description of how to serve the diet in the diet manual.

Based on observation, interview and document review the hospital failed to ensure the disaster menu had been approved by the registered dietitian and that it was comprehensive to include all therapeutic diet types would be available during a disaster, and that it was incorporated into the hospital Emergency Operations Plan. Failure to ensure a planned, comprehensive disaster menu would put medically frail patients at risk in the event of a disaster that required the hospital to shelter in place.
On 4/11/11 at 12:30 p.m. and on 4/12/11 at 1:30 p.m. the hospital disaster menu was reviewed with Dietary Management Staff 1 and Registered Dietitian 2. RD 2 stated although she had reviewed the menu, she had not approved it. The menu was based on dehydrated foods, however did not provide guidance for foods to be served to patients on therapeutic diets including those with diabetes and renal (kidney) disease and tube feedings. Review of the hospital Emergency Operations Plan and Documents revealed the menu plan had not been incorporated into the comprehensive overall hospital plan. DMS 1 and RD 2 acknowledged the plan needed further work and was not complete.

Based on observation, interview and record review, the hospital failed to implement policies and procedures to control infections and communicable diseases of patients and personnel.

Patient 21 was diagnosed with an infectious disease requiring all visitors and staff follow contact isolation precautions, but contact precautions were not observed by a visitor and a housekeeper, increasing the risk of spreading the disease.

Surveillance of hospital staff for contagious diseases did not include proof of annual tuberculosis screening for four of 19 staff and annual influenza vaccination for two of 19 staff, increasing the risk for spreading contagious diseases.

Food was stored, prepared, and served by personnel not following infection control precautions, increasing potential for food-borne illness and spreading of infection through cross-contamination.

Findings:

1. On 4/11/11 at 9:00 a.m. during initial kitchen observations with Registered Dietitian 3 and Dietary Staff 4, a 2-inch deep full steam table pan containing raw chicken in a marinade, dated 4/5/11 was observed in Refrigerator 7. During a concurrent interview, DS 4 stated the chicken had been put in the refrigerator on 4/5/11 and would be cooked for the evening dinner meal. Review of facility policy "Expiration Date Guide" directed the raw chicken be cooked within five days of preparation from the frozen. On 4/12/11 at 2:00 p.m. Dietary Management Staff 1 acknowledged the chicken should have been thrown away on 4/10/11 when it was not.

2. During general food production observation on 4/11/11 beginning at 9:40 am, it was noted that a dietary staff member was cutting vegetables using a knife. It was also noted that upon completion of the task he placed the knife in a red bucket in the sink along with other knives and scoops. In a concurrent interview with DS 6 he stated that he was responsible for cold food production activities and after using utensils he placed them in the red bucket which contained sanitizer.

In an interview with DMS A on 4/12/11 at 11:30 am, he stated that on a recent inspection from an outside vendor he was guided to place the items in sanitizer solution and that they could be reused as long as the sanitizer was effective. Review of dietary services policy titled "Equipment Care and Cleaning" dated 8/10 guided staff that for "Miscellaneous Equipment ...will be maintained in an appropriate sanitary manner ..." The standard of practice would be to ensure
that all utensils are effectively cleaned, rinsed and sanitized after each use (Food Code, 2009).

3. On 4/11/11 beginning at 12:25 p.m., patient meal delivery observed. During the observation it was noted that CNA 5 was delivering the noon meal to a random patient. She was observed to place the meal tray on the over bed table then proceed to position the patient by physically touching him and adjusting his legs. Upon completion of this task she proceeded to begin uncovering the meal tray and beverages without the benefit of washing her hands. In an interview on 4/11/11 at 12:20 with LN M the surveyor asked her to describe her expectation for handwashing during meal delivery. She stated that she would expect that CNA staff washed her hands anytime after patient contact.

Hospital document titled "Hand Hygiene Policy" dated 8/07 guided staff that the "Indications for hand washing and hand antisepsis include: ...Before and after direct contact with patients, ...Before handling ...food."


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4. On 4/11/11 at 10:20 a.m., observation showed Patient 21 wearing a breathing mask and lying in bed in the intensive care unit (ICU). A visitor wearing regular street attire stood by the bedside, gripping the bed rails. Review of the clinical record showed Patient 21 was originally admitted to the hospital intensive care unit (ICU) on 4/5/11 for gastrointestinal bleeding. She was transferred to the DOU (definitive observation unit, a step down unit) as her condition improved, but transferred back to the ICU on 4/11/11 for new onset seizure activity. Review of the electronic medical record showed "Order Entry Details", dated 4/11/11 to reflect Patient 21's recent transfer back to the ICU showed "Contact Precautions" under "Isolation Precautions" indicating Patient 21 required more than standard precautions (gloves and hand washing to protect from contact with body fluids/substances) to keep an infectious disease from spreading to staff and other patients.

Review of Patient 21's plan of care dated 4/6/11, showed nursing staff identified Patient 21 had several infections, including "c-diff" or clostridium difficile, an easily transmitted infection. Nursing staff was to "notify Infection Control practitioner" and monitor by following lab work.

On 4/11/11 at 11:40 a.m., the ICU assistant manager confirmed Patient 21 was on contact precautions and pointed to a sign posted next to the doorway of Patient 21's room. However, observation showed much of the sign was blocked from easy viewing by a portable computer station parked next to the doorway as well. The sign, bordered in bright orange, contained at the top, images of a stop sign in English and Spanish on either side of the words "Contact Precautions" The rest of the sign instructed "To prevent the spread of infection Anyone* (the asterisk referenced "Check with the Patient's Nurse for assistance") Entering This Room Must" perform Hand Hygiene before entering room and wash hands with soap and water before leaving room; (put on) gloves; and (put on cover) gown." "Applies whether or not contact with the patient or the patient's environment is anticipated." Observation showed the visitor was again in the room. He was not attired in a protective cover gown and not wearing gloves, although he held onto the bed rails, considered part of the patient's environment. The assistant ICU manager stated "Anyone visiting should check with us." RN B stated (visitor) was instructed several times. RN B was informed the visitor was noticed several times entering Patient 21's room without wearing protective clothing. The chief nursing officer stated "Exactly, we should have caught him."

On 4/12/11 at 8:50 a.m., Housekeeper A was observed inside Patient 21's room, wearing gloves but no protective gown while removing a trash bag from its holder. The privacy curtain was pulled closed to less than two feet of the doorway. Housekeeper A pushed the curtain away in order to leave the room, wearing the same contaminated gloves. He then walked down the hallway, wearing the same contaminated gloves. The assistant ICU manager stated they had moved the sign up but also saw the housekeeper in the room without a protective cover gown. She confirmed as well the contamination occurring from using the same gloves to remove trash bags and open the privacy curtain.

Review of the hospital policy "Standard Precautions & Transmission-Based Precautions" showed "In addition to Standard Precautions, use Contact Precautions for patients known or suspected to have serious illnesses easily transmitted by direct patient contact or by contact with items in the patient's environment." According to the policy, Standard Precautions represented first tier infection prevention by

Review of the hospital policy "Clostridium difficile infection (CDI) Management in the Healthcare Setting" indicated "Appropriate signage is the orange-colored contact Precautions sign specific to enteric precautions which requires all staff and visitors to use appropriate PPE (personal protective equipment such as gloves and cover gown) when in contact with the patient and the patient's environment."

The housekeeping supervisor was interviewed on 4/12/11 at 2:50 p.m. He stated "They know they're supposed to follow protocols." He stated further "They should follow the placard (contact precaution sign)." The housekeeping supervisor stated the service was not notified of patients with special precautions. "We have to rely on nursing."

The Director of Infection Prevention was interviewed by telephone on 4/13/11 at 1:45 p.m. She stated "I always make a point for nursing to be on the look out for staff (other than patient care providers)." She stated "We've had issues with him; hel'll be good for awhile, and then he'll revert." The Director added "They get tired of hearing it from me and from (Housekeeping Supervisor)" Now they can hear it from you."




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5. Review of 19 employee health files showed that the hospital failed to document annual TB (tuberculosis) testing for four employees (RN D, RN E, RN G, SPD A) and annual Flu vaccine or declination for two employees (Housekeeper A, RN G) which was in direct violation of the hospital's Infection control policy "Exposure Control Plan".

Review on 4/13/11 of the hospital's Infection Control Policy "Exposure Control Plan" dated October 2003 and revised 3/2011 showed that the policy instructed the Employee Health Coordinator to screen all employees, physicians and volunteers for TB prior to starting work, upon hire and annually thereafter, who had contact with patients.

Review on 4/13/11 of the hospitals Clinical Safety Policy "Preventive Immunization and Screening of Healthcare Personnel to Reduce the Risk of Transmission of Infectious Diseases" dated 9/1/10 showed that the policy instructed the Employee Health Nurse to obtain one of the following for each healthcare personnel (HCP- all paid or unpaid persons working in the healthcare setting who have the potential for exposure to patients): 1. documentation that the vaccination was given; 2. a completed attestation statement that the HCP has received the vaccination from a different source; or 3. a signed document that states the HCP declined the vaccination after educational counseling.

During an interview on 4/13/11 at 2:05 p.m., the Employee Health Coordinator stated that all HCP are required to have an annual TB screening but that she was unaware of any enforcement used to encourage employees to have it done, such as not being scheduled to work until they have complied. The Employee Health Coordinator further stated that the influenza vaccine was offered to all HCP but that she was unsure of any enforcement for not signing the declination if the vaccine was refused by an HCP.

Based on observation, interview and record review the hospital failed to ensure the safe delivery of patient care while in the operating room by failing to develop and implement a policy and procedure related to surgical counts that included blades (disposable surgical knife blades that attach to reusable handles) resulting in the potential for injury of patients and/or staff by misplaced blades or retention of a misplaced blade in the patient's surgical wound.

Findings:

On 4/13/11, prior to a patient entering the operating room for a procedure, the scrub tech (ST A) was observed counting the surgical sponges and suture/needles with the OR Nursing Educator who then wrote the total on the white board above the circulators desk. ST A also handed off a tray that had three blades in it. No notation was made on the white board regarding the number of blades on the surgical field. When asked, RN C, the circulating nurse stated "we never have counted blades, it's not part of our policy." At this point ST A stated that she only had one blade and RN C replied, "You should have two." There was no documentation to trace how many blades there were when the procedure was set up.

On 4/13/11 when asked about the policy for surgical counts the OR Nursing Educator stated that "We do not count blades here, we never have. I guess we should be aware of how many blades we started with and how many and where they are after the case ends."

Review on 4/13/11 of the Patient Safety Policy "Prevention of Retained Surgical /Invasive Procedure Items" showed that the policy stated that they follow the 2008 AORN recommended practice for sponge, sharp, and instrument counts. The policy instructed staff that sharps and miscellaneous items should be counted on all procedures, before the procedure has begun to establish a baseline count, before the closure of a cavity within a cavity, before wound closure begins, at skin closure or end of procedure, and at the time of permanent relief of either the scrub person or the circulating nurse. The policy further instructed staff that an initial sharp count should be preformed and recorded on all procedures and that the scrub person should be able to account for all sharps on the sterile field. The Policy failed to define sharps and did not specifically state that blades would be counted.

According to the AORN (Association of Operating Room Nurses) Journal August 2010 News, unintended retention of a foreign body is among the top ten sentinel events reported to The Joint Commission. It ' s estimated that 1,500 to 2,000 retained surgical item cases occur each year in the United States The AORN Recommended Practices for Prevention of Retained Surgical Items, provides recommendations for key practices to prevent the retention of sponges, towels, needles, instruments, fragments and other surgical items that could be left inside a patient after a surgical or invasive procedure is completed. AORN recommends that all sponges, sharps, needles, towels, instruments, fragments, and other surgical items be counted prior to start of the surgical procedure, on beginning of closure of any body cavity, and on closure of skin.