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Based on the interviews, the review of medical records and hospital policies and procedures, the Governing Body did not ensure that every patient receives care that meets generally acceptable standards of professional practice.

Findings Include:

At interview with the Director of pharmacy on 10/28/11, it was determined that Pharmaceutical Services did not have adequate oversight of all patient care areas in the hospital. Hospital policies and procedures regarding pediatric dosing have not been consistently implemented and audits of the Emergency Department, Operating Room and Labor & Delivery are not adequate to monitor the safe delivery of drugs which resulted in patient harm.

See citations under 482.25 and 482.55.
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Based on medical record review it was determined that the medical staff did not provide care consistent with accepted standard of medical practice. This finding was noted in 1 of 17 applicable medical record reviewed.

Findings include:

Review of MR #13 on 10/31/11 noted that on 4/19/11, the patient, a 66 year-old was admitted for complaints of pain on swallowing, facial swelling and earache. On examination the physician noted submandibular infection and salivary gland stones. The patient was noted to be allergic to Penicillin; however, the physician ordered Unasyn 1.5 MG Q6H IVPB. The facility investigation report indicated that the medication was not provided by pharmacy as the patient was allergic to penicillin. Nursing documentation indicated that the resident was paged and made aware of the patient's allergy. There was no documentation that the resident followed up and ordered an alternate medication.

Based on medical record review it was determined that not all drugs were administered under supervision of nursing or other personnel in accordance with federal and state laws and regulations and with approved medical staff policies and procedures. This finding was noted in 1 of 17 applicable medical records reviewed.

Findings include:
Review of MR #13 on 10/31/11 noted that on 4/19/11 at 8:30pm, the physician ordered Losartan 100MG PO daily, HCTZ 12.5MG once daily, and Amlodipine 5MG once daily. Nursing staff noted the orders at 2110; however there was no documentation on the Medication Administration Record (MAR) to indicate that these medications were transcribed by the nurse as per facility's policy.

On 4/20/11 at 11:30am, nursing documentation indicated that "the patient refused blood pressure medication stating that " I already took my meds" . The patient was educated about not taking home meds while hospitalized. The patient verbalized understanding of instructions. However, there was no indication that nursing staff communicated with the medical staff and pharmacy regarding the patient's home medications. The staff failed to implement the facility's policy and procedure regarding "medications brought from home" . The policy notes that all medications for use in the hospital shall be supplied by the Department of Pharmacy Services. In addition, patient may not use or administer any medications brought from home unless the medication is non-formulary and/ or the medication is temporarily out -of-stock. If that situation exists, the nurse may administer the medication from the patient's own supply after the pharmacist has positively identified and dispensed the medication.
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Based on interviews, review of medical record and other documents, it was determined that pharmaceutical services lacked adequate oversight that promotes consistent application of pharmaceutical services and care throughout the hospital.

Findings include:

The review of policy titled "Medication Administration During Urgent Situations" notes that urgent situation is defined as a situation which the patient's clinical condition deems that the urgent administration of medications is necessary because any delay in the medication administration process e.g., pharmacist's review prior to administration may cause harm to the patient. The policy further states that in institutional settings all medication orders should be reviewed by a pharmacist prior to the administration of the medication to the patient, unless in a patient care area where the medication use process is continuously supervised by a physician such as the ER, OR and L&D.

Pharmacy Services did not implement a system that optimizes patient safety in the ER, OR and L&D. At interview with the Director of Pharmacy on 10/28/11, he stated that physician orders from the Emergency Department, Operating Room and Labor& Delivery are exempt from pharmacy review because the areas are continuously supervised by physicians. The VP of Patient Services and the Director of Pharmacy both stated that any pharmacy attempts to review physician orders in these areas will do more harm than good. In addition, pharmacy is not equipped to conduct adequate oversight of these clinical areas. The Emergency Department system "Empower", the Operating Room system "Pices" and the Labor & Delivery system "ENC" do not interface with the pharmacy system "Worx" .

Based on interview with Associate Director of Pharmacy, audits are done retroactively and manually and are limited to tracking of controlled drugs that are taken out in close proximity; excessive dosing and medication taken on override. Pharmacy is unable to quickly reconcile physician orders with records of drug administration without manually reviewing each patient's medical record. Pharmacy has no access to the three different systems used in the ED, OR and L&D. Pharmacy has not conducted periodic audits of physician orders to assure that medications are ordered in accordance with the hospital policy and that problems are identified and corrected. The residents' as well as the attending physicians ' non compliance to hospital standing policy for pediatric orders was not identified by pharmacy. Audits of physician orders only began the week of October 24, 2011 after a medication incident in the ED, where a 6 month old patient received an overdose of Azithromycin 500mg IVPB. The medication was not ordered in accordance with the hospital policy that requires all pediatric and neonatal physician orders to be weight based. This finding regarding lack of compliance with weight based orders was noted in three other pediatric records.
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Based on record review it was determined that the facility's surgical policy was not consistently implemented in order to ensure that surgical information is accurately documented. This deficiency was noted in one (1) of twelve (12) applicable medical record reviewed.

Findings include:

Review of MR #12 on 10/31/11 noted that this 43 year old patient had a dental surgical procedure on 9/6/11; diagnosis - Dental Caries. It was documented that the procedure started on 9/6/11 at 15:50 and ended on 9/6/11 at 15:45. The duration of the procedure was noted as 1434. The end time and the duration of the procedure were not correctly documented.
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Based on interviews, unit tours, the review of medical records and hospital's policy, it was determined the facility did not consistently ensure that informed consents are properly executed before surgical procedures. This deficiency was noted in four (4) of twelve (12) applicable medical records reviewed.

Findings include:
During the tour of the ambulatory surgical unit, on 10/28/11 at approximately 11:00 AM, it was observed that the patient in MR #9 was waiting for a surgical procedure. The patient reported that the proposed surgical intervention was "for hemorrhoids". The patient was unable to state the risks, benefits and alternatives to this proposed intervention.
Review of the MR#9 noted the surgical procedure was repair of fistula in anus. Review of the consent form noted that the patient had signed the consent form for the procedure but the name of the surgeon or medical provider who explained the risks and benefits to the patient was not on the form.
The Director of Operating Room was interviewed on 10/28/11 at approximately 11:30 AM; the staff stated that the surgeon will discuss the nature, purpose, benefits, risks and alternatives to the procedure and signed the section on the form. It was noted that the patient had already signed the consent form without being fully informed of the proposed procedure.

Review of MR #10 (closed record), on 10/31/11 at approximately 12:20 PM, noted that the patient was unable to consent for procedures. It was noted that several telephone consent forms were obtained from the patient's daughter. Review of one of the consent form dated 4/12/11 at 5:00 PM noted two signatures in the section of the form designated for the physician. One of the signatories was not identified.

During the tour of the surgical unit (5th floor), on 11/1/11 at approximately 1:00 PM, MR #5 and 6 were reviewed.
Review of MR # 5 noted that this 58 year old male was admitted to the facility on 10/20/2011. The patient consented to a surgical procedure (left profound femoral bypass) on 10/30/11. The generalized statement on the form indicated that the physician explained the nature, purposes of the procedure and the patient was informed of expected benefits and complications and the risks that may arise as well as possible alternative methods of diagnosis. However, the possible risks, alternative and benefits to this proposed intervention was not listed on the informed consent form or in the medical record, as per hospital policy.

Similar findings noted for MR # 6 a 46 year old female who under went Laparoscopy cholecystectomy on 10/31/11. The patient in MR # 5 was interviewed on 11/1/11 at approximately 2:00 PM. The patient could not recall if the physician had explained the risk, benefits or alternative to the procedure for the diagnosis.
The patient in MR #6 reported that the physician discussed the procedure but the potential risks or alternatives were not discussed with her.
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Based on medical record review and staff interviews, it was determined that the facility did not consistently ensure that operative report requirements were met. This deficiency was noted in five (5) of twelve (12) applicable medical records reviewed.

Findings include:
1. Review of MR # 5 noted that the patient underwent a left profunda femoral bypass on 10/31/11. The post-operative notes dated 10/31/11 was incomplete as it did not include the description of techniques, findings and tissues removed during the procedure. The Medical Record Department was contacted regarding operating report dictation # 414901 listed in the medical record. The Medical Record Department staff reported that the Operative Report was dictated but has not been transcribed and therefore was unavailable for review.

In MR# 6, the post-operative notes dated 10/31/11 included the surgical procedure and the findings. However, the complete Operative Report was not available for review. The Medical Record Department had no record of operative report -dictation # 41492 listed in the medical record.

Review of MR # 7 on 10/31/11 noted that this 54 year had an ERCP on 7/29/2011. The surgeon's post -op notes were not in the record. In addition, a copy of the operative report which described technique and findings was not located in the medical record.

Similar findings regarding lack of documentation of operative report was noted in MR #8, a 59 year-old, who underwent Hydrocelectomy on 9/23/11. There were no post-operative notes or operative report in the medical record.

2. Review of MR #11, a 67 year-old patient underwent a left video assisted thoracotomy, blebectomy with talc pleurodesis on 5/2/11. The post-operative notes the second assistant is not recorded but left blank. On the Operative Report the second assistant is noted only as Medical Student; the name of the student was not identified.
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A) Based on interviews, the review of medical records and other documents, it was determined that the care of patients in the Emergency Department was not supervised by a qualified member of medical staff to assure safe delivery of care. Specific reference is made to patient in MR #1.

Findings include:

MR #1 is a 6 month old male child that presented to the Emergency Department on 10/21/11 with complaints of coughing, fever and vomiting. The patient arrived at 10:00 and was triaged ESI level 2 at 10:07. The lack of attending supervision of a PGY 1 resident was evident in the care of the patient. There was no evidence that the resident upon obtaining the patient's history and physical discussed the plan of care with the attending physician. Although, the attending physician notes at 10:07 prior to the H/P at 10:47 that the patient was alert and oriented with mild respiratory distress and cough, there was no attending involvement until 15:41, when she noted the patient was receiving an excessive dose Azithromycin and advised the IV infusion to be discontinued immediately.
There was lack of attending involvement in the assessment and diagnosis of the patient. At 14:43, the resident determined the patient will need inpatient hospital care for 24 hours or more because of likely pneumonia. The preliminary x-ray reading that supports the diagnosis of pneumonia was not documented either by the resident or the attending physician. The official report of the chest x-ray done at about 13:00, revealed the lungs are clear with no definite infiltrates or effusions; the impression was a negative chest x-ray.

Two orders for antibiotics were entered into the computer system by the resident at 15:01, Ceftriaxone 50mg/kg IVPB-400mg and Azithromycin 500mg IVPB. The facility policy titled " Medication Administration During Urgent Situation " notes that pharmacy will not review medication orders in patient care areas where the medication use process is continuously supervised by a physician. The emergency Room, Operating Room and Labor & Delivery have been designated by the hospital as areas that are continuously supervised by physicians. The attending physician did not continuously supervise medication use during the care of this patient as there was no indication that she reviewed the patient ' s medication orders before they were implemented. The order for Azithromycin was not written in accordance with the facility policy titled " Medication Orders " that requires weight based dosing (such as mg/kg/day) be written along with the medication dose for those medications with information available in the dosing reference. The orders for Ceftriaxone and Azithromycin did not include the amount of intravenous admixture and the duration of therapy.

The resident documented that Azithromycin drip was stopped at 15:41. At the same time, the attending notes that the child was active and alert with stable vital signs. The EKG ordered stat at 15:41 was just commencing when the patient initially coded at 16:03. The patient was admitted to the Pediatric Intensive Care Unit with diagnoses of cardiogenic shock and pulmonary edema. The patient expired on 10/24/11.

Similar findings related to the lack implementation of the hospital policy that requires pediatric dose be written in kilogram of body weight were noted in MR #s 2, 3 and 4.

MR #2
This 7 year-old was evaluated in the ED on 9/25/11 with a chief complaint of wheezing. Chest x-ray showed infiltrate in the right mid zone. The patient was admitted for treatment with IV antibiotics. The medications received in the ED included Prednisone 60mg PO; Ceftriaxone 1gm IVPB. Both medications were not written in mgs/kg/dose as required. The nurse implemented both orders.

MR#3
This 4 year-old presented to the ED on 9/29/11 with complaints of non productive cough, fever, shortness of breath and wheezing. Physician orders included Magnesium Sulfate 1gm IVPB; Prednisone 28mg PO and Solumedrol 30mg IVPB. The medication orders were not written in mgs/kg/dose in accordance with the facility ' s policy on medication orders for pediatric patients.

MR #4
The patient in MR #4 is a 3 year-old female that was evaluated in the ED on 8/1/11 for complaints of fever and vomiting. The order for Tylenol 100mg was not written in mg/kg/dose.

B) Based on interviews, the review of medical record and other documents, nursing staff in the Emergency Department failed to ensure that drugs were administered in accordance with the hospital policy and accepted standards of practice.

Findings include:

Nursing staff did not consistently implement the facility ' s policies and guidelines for administration of medications to the pediatric patient. Four (4) out of eight (8) applicable records revealed that nurses implemented orders for pediatric patients that were not written in mgs/kg/dose as specified by nursing guideline titled " Guidelines For Administering Medications To The Pediatric Patient. " In addition, the policy requires that nurses use available resources such as the ED physician, Pediatric Drug Handbook or Harriet as well as pharmacy to verify accuracy of dose prescribed. The nurse on 10/21/11 administered Azithromycin 500mg IVPB to a 6 month old patient. The nurse did not use available resources to verify the dose. Based on interview with the Director of Pharmacy on 10/28/11, Azithromycin is not stock in the pediatric Omnicell because the medication is not usually given to pediatric patients. The nurse obtained the medication from the adult Omnicell. The patient coded twice in the ED following the administration Azithromycin overdose; he developed cardiogenic shock and pulmonary edema. The patient expired on 10/24/11.

Both antibiotics Ceftriaxone 400mg and Azithromycin 500mg were administered rapidly; Ceftriaxone in 17 minutes and Azithromycin in 16 minutes. The medication Guideline notes that when administering IV medications, it is the responsibility of the nurse to check specific drug for suggested duration of infusion and make sure that medication has infused in the proper amount of time (usually 30 minutes to 1 hour). The nurse did not administer the medication with an IV pump as mandated for pediatric patients less than two years old. Based on interview with the VP of Patient Services each antibiotic should have been administered over 1 hour with an IV pump.
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