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Based on interview and record review, the hospital failed to enforce its policy that patients admitted by a podiatrist would also be cared for by doctor of medicine (MD) or a doctor of osteopathy (DO) for two sampled patient records (Patients 16 and 17). The deficient practice had the potential to create situations in which the podiatrist was providing care beyond his expertise.

Findings:

Review of the hospital's medical staff rules and regulations dated 10/21/10 indicated, "When a patient is admitted to the hospital by a dentist or podiatrist, an M.D. or D.O. Medical Staff member shall assume responsibility for the overall aspect of the patient's medical care."

Review of Patient 16's medical record indicated he was admitted to the hospital by a podiatrist on 9/9/10 and discharged 9/11/10. The medical history and physical examination (H&P) and interval update had both been completed by the podiatrist. No consultation or progress note by an MD or DO was found in Patient 16's record for the admission in question.

In an interview on 11/4/10 at 9:46 a.m., Staff A stated there was no consultation in the record for the admission in question, "just one progress note by [the podiatrist]".

Review of Patient 17's medical record indicated she was admitted to the hospital by a podiatrist on 6/1/10 and discharged 6/2/10. The medical history and physical examination (H&P) and interval update had both been completed by the podiatrist. No consultation by an MD or DO was found in Patient 16's record for the admission in question. A poorly legible progress note by the anesthesiologist dated 6/2/10 was present.

In an interview on 11/4/10 at 9:54 a.m., Staff A stated all the orders had been written by the podiatrist and that one of the progress notes was written by an anesthesiologist, but that there was no consultation in the record for the admission in question.

In an interview on 11/4/10 at 11:02 a.m., Staff B stated that Patient 17 had not technically been admitted since she was on 23-hour observation status. Staff B stated that for Patient 16, the podiatrist "didn't do what he was supposed to and we didn't catch it."

Comparison of Staff B's statement to Patient 17's medical record indicated she had two admission orders on the same sheet dated 6/1/10, one stating "Admit to Inpatient Status" and another stating "Admit to PACU pt will be 23 hr stay". Patient 17's facesheet indicated she was admitted 6/1/10 at 1015 and discharged 6/2/10 at 1410, greater than 24 hours after her admission.

Based on interview and record review, the hospital failed to include details regarding anticipated capital expenses in its prospective capital plan. The deficient practice limited the clarity of the plan.

Findings:

Review of the hospital's "STATEMENT OF JUSTIFICATION" for fiscal year 2010-2011 indicated that it included the hospital's five-year capital plan. The section labeled "Uses of funds" contained non-specific descriptions such as "Sleep Lab", "AOB", and "Marina Land". No information was present regarding the objectives of these three projects.

In an interview on 11/5/10 at 12:06 p.m., Staff C stated that the details regarding the capital projects could be found in the strategic planning committee minutes at the time each project was discussed but that there was no single summary which included specifics of all the projects.

Based on interview and record review, the hospital failed to document its evaluation of the quality of service for 1 of 2 sampled contracts (Corporation A). The deficient practice had the potential to allow perfunctory evaluation of the quality of the service.

Findings:

Review of the hospital's list of contracts indicated it had a maintenance agreement with Corporation A.

In an interview and record review on 11/5/10 at 12:47 p.m., Staff D stated the hospital monitored the timeliness of Corporation A's preventive maintenance and stated the documentation was contained in the preventive maintenance records. Review of the hospital's computerized preventive maintenance records indicated that they included documentation of each visit for each machine covered by the contract, but no aggregate statistics regarding the contractor's overall performance. Staff D stated he made notations on the cover of the folder for each vendor regarding the positive and negative aspects of the hospital's experience with the vendor. The folder for Corporation A, however, contained no such notations.

Review of the hospital's computerized profile for one employee of Corporation A indicated the hospital had completed background checks with federal and state government agencies, had agreements with the vendor's employee to adhere to various hospital policies, and had documentation of the employee's immunizations. No information was present regarding the employee's competence to perform the contracted service or the quality of his work.

Based on interview and record review, the hospital failed to determine the number of distinct performance improvement projects it was conducting. The deficient practice had the potential to diminish the hospital leadership's awareness of the scope of its quality assessment and performance improvement (QAPI) program.

Findings:

Review of the hospital's 2009 Quality and Safety Annual Report indicated that the nursing department had been piloting a structured report for transfer of information at the change of shift in the "Ortho/Neuro/Spine Unit" in 2009 and that the new structured report would be rolled out to all nursing units in 2010. The annual report also indicated that a fall reduction program would be an area of focus for 2009-2010 and the hospital would work to ensure all nursing units incorporate fall reduction strategies into practice, to educate staff about fall management, and to improve documentation related to falls.

Review of the hospital's dashboard for "Performance Improvement Initiatives 2nd Quarter 2010, Part 1" indicated the hospital was working to increase the percentage of lost patient property returned by means of "new visitor control procedures."

Review of the hospital's listing of "PERFORMANCE IMPROVEMENT MONITORING/INITIATIVES - 2010" indicated that it included "Environment of Care", "Communicating Medications To Next Provider", and "Patient Flow Initiatives" but did not specifically list structured nursing reports, fall reduction, or return of lost patient property as current projects. The listing also did not specify the number of specific projects occurring under each of its listed categories of projects or the number of projects overall.

Review of the hospital's listing of "DEPARTMENT SPECIFIC PERFORMANCE IMPROVEMENT INITIATIVES" indicated that the projects for Ortho/Neuro/Spine did not include a structured nursing report. The two page document made no mention of structured nursing reports, fall reduction, return of lost patient property, or new visitor control procedures. There was no project regarding "Environment of Care" as there had been on the initial listing presented to the surveyor. The listing also did not indicate the number of projects being conducted.

In an interview on 11/5/10 at 9:37 a.m., Staff E stated the second list was "kind of an expansion" of the first list. She stated the projects regarding the environment of care would be found in a binder rather than on the second list. She stated there were also instances of performance improvement projects not reported to the governing body.

Based on interview and record review, the hospital failed to obtain details regarding all prior malpractice cases in 1 of 9 sampled credentials files (Practitioner 3). The deficient practice had the potential to reduce the hospital's ability to discern the qualifications of applicants to its medical staff.
Findings:

Review of Practitioner 3's credentials file indicated that he was newly appointed to the hospital's medical staff on 9/21/10. Practitioner 3 had three previous malpractice cases and the hospital had obtained statements from Practitioner 3 regarding two of the three malpractice cases.

Review of the hospital's medical staff bylaws indicated medical staff applications were to include details regarding malpractice cases.

In an interview on 11/3/10 at 10:54 a.m., Staff F stated there were no statements from Practitioner 3 regarding his malpractice case from 1996.

Based on interviews and record reviews the hospital nursing staff failed to develop a nursing care plan for one of 50 patients in the sample who had failed to take his medication as prescribed by his physician to prevent blood clots.

Findings:

On 8/23/10, Patient 12 was admitted to the hospital via the emergency room with chest pain. The patient had a history of a previous heart attack, high blood pressure, coronary artery disease and was status post a previous stent (a device inserted to open a clogged blood vessel) placement.

The emergency room physician, the cardiac catheterization report and the admission medication history indicated the patient had run out of his prescription of Plavix, a medication used to prevent blood clots. The medication history reviewed by the registered nurse also indicated the patient brought in empty medication containers and on 8/23/10 also had not taken metoprolol ER 25 milligrams (mg) (blood pressure lowering medication), Coreg 12.5 mg (used to treat high blood pressure), and Simvastatin 20 mg (a cholesterol lowering medication).

There was no assessment or other documentation in the record to explain why the patient had not refilled his prescriptions. There was no care plan initiated on admission to address the problem of missed medications.

On 8/27/10, Patient 12 was discharged. There was no evidence in the record the nurse discussed the importance of taking prescribed medications consistently and any attempt to determine if the patient had any other related needs.

The nurse manager for the heart center was interviewed on 11/5/10 at 11 a.m. and stated the nursing notes and care plans did not assess or address the patient's knowledge regarding his medications.

Based on interviews and record reviews, the hospital failed to ensure that medications were administered in accordance with the physicians' orders and accepted standards of practice for four of six sampled patients (Patients 1, 2, 11, and 13) as evidenced by:

1. The failure to implement hypoglycemia physician's orders. This failure delayed the treatment of Patient 13's hypoglycemia.

2. The failure to ensure the safe use of medications when hospital nursing staff did not administer adult insulin infusion orders in accordance with the physicians' orders for Patients 1 and 2.

3. The failure to ensure the safe use medications when hospital staff did not administer warfarin (blood thinner) as prescribed by the physician for Patient 11.

Findings:

1. Hypoglycemia is a condition that occurs when blood glucose (sugar) is too low. There are various degrees of hypoglycemia. If left untreated, hypoglycemia can get worse and cause confusion, clumsiness, or fainting. Severe hypoglycemia can lead to seizures, coma, and even death. When the blood glucose drops below 55 milligrams per deciliter (mg/dL), the brain becomes deprived of glucose and can no longer function normally.

Record review on 11/4/10, at the critical care unit (CCU), showed that Patient 13 was 59 years old with an extensive past medical history that included multiple hospitalizations and chronic infections. Patient 13 was on a mechanical ventilator for respiratory failure. The hospital admitted Patient 13 on 10/14/10 for respiratory failure and possible aspiration pneumonia and sepsis.

Patient 13's hospitalization course included antibiotic treatment for aspiration pneumonia and nutritional support with intravenous nutrition (TPN) and tube feeds (a medical device). Both TPN and tube feeds provide patients with dextrose (a form of sugar), carbohydrates, proteins and fats, to patients who have difficulty swallowing or are unable to eat for medical reasons. Patient 13's medications included insulin (sliding scale dosing) as needed to lower blood glucose. Patient 13's insulin orders included monitoring and treatment parameters for hypoglycemia.

On 11/2/10 at 1:23 a.m., at the Level II unit (step down/telemetry unit), Patient 13 suffered from a respiratory arrest and code blue was activated. During treatment, the code blue team discontinued Patient 13's TPN and tube feeds. The TPN was discontinued in order to access the intravenous catheter to administer medications to restore cardiopulmonary status. The tube feeds were discontinued in order to minimize the risk for aspiration pneumonia. On 11/2/10 at 3:30 a.m., the hospital transferred Patient 13 to the Critical Care Unit (CCU) on a ventilator and intravenous medications used to maintain cardiopulmonary status.

During interview on 11/5/10 at 9:30 a.m., the assistant director of pharmacy (ADOP) explained that medications used in cardiopulmonary resuscitation and discontinuing TPN may contribute to hypoglycemia.

Patient 13's blood glucose, after transfer to CCU, were as follows on 11/2/10:

4:58 a.m.
Blood glucose 37 mg/dL; Dextrose 12.5 grams (gm) administered

6:08 a.m.
Blood glucose 76 mg/dL

6:57 a.m.
Blood glucose 74 mg/dL

8:28 a.m.
Blood glucose 57 mg/dL; Dextrose 12.5 gm administered

11:17 a.m.
Blood glucose 56 mg/dL; Dextrose 12.5 gm administered

12:34 p.m.
Blood glucose 73 mg/dL

Review of Patient 13's insulin sliding scale/hypoglycemia treatment orders, dated 10/26/10 and active for 11/2/10, showed the following,

"For blood sugar less than 75 mg/dl Call Physician "

"For symptomatic hypoglycemia: monitored blood sugar less than 75 milligrams/deciliter and symptomatic: call physician, monitor blood glucose every 15 minutes and repeat hypoglycemia treatment until BG (blood glucose) is greater than 100 mg/dl "

"For patients who can not take PO (by mouth): Dextrose 50% in water: 25 milliliter (12.5 gm) intravenous push "

Review of Patient 13's record on 11/4/10 at 10:47 a.m. in the company of the director of clinical informatics (RN 1), a staff pharmacist (Pharm 2), the director of ICU/CCU (DIR 3) and the assistant director of ICU/CCU (ADIR 2), showed the following:

No documented evidence of notifying the physician when Patient 13's BG was 37 on 11/12/10 at 4:58 a.m., as required by physician's orders.

During interview on 11/4/10 at 10:47 a.m., DIR 3 said the expectation was for the nurse to notify the physician promptly and to document physician notification.

No documented evidence that blood glucose was measured every 15 minutes until the blood glucose became greater than 100 mg/dL, as required by physician's orders.

During the same interview, DIR 3 and ADIR 2 said the physician's orders were not followed. DIR 3 and ADIR 2 said blood glucose should have been checked every 15 minutes after interventions until it reached 100 mg/dL. This was to ensure that the blood glucose was increasing, to determine the need for additional interventions, and to avoid complications of prolonged hypoglycemia.

On 11/4/10 at 4 p.m., RN 1 provided a nursing note completed on 11/2/10 at 10:46 p.m. by the CCU staff nurse (RN 4), who cared for Patient 13 upon transfer to CCU. The note showed that the physician was notified on 11/2/10 at 6:30 a.m. of the discontinued TPN and the low blood glucose, 1.5 hours after Patient 13's BG was 37.

During a telephone interview on 11/5/10 at 9:30 a.m., in the company of DIR 3, RN 1 and ADOP, RN 4 said she had spoken with the physician at about 6:30 a.m. to notify him of the low blood sugar and the discontinued TPN.

During the same interview, RN 4 said Patient 13 was lethargic but somewhat responsive. RN 4 said she only administered one dose of dextrose 12.5 gm on 11/2/10 at approximately 5 a.m. for the blood sugar of 37. RN 4 said she did not check blood sugars every 15 minutes, but said she checked them as often as she could, as documented.

During the same interview, RN 4 said she had restarted Patient 13's tube feedings. RN 4 explained the TPN had been discontinued on Level II during the code and was not restarted on CCU because another TPN bag was not available. RN 4 did not obtain orders for dextrose 10% infusion (used to provide dextrose until the TPN becomes available).

During the same interview, DIR 3 and RN 4 said the CCU was unusually busy on 11/2/10 early morning, with multiple code blues and admissions.

A nursing note completed on 11/2/10 12:19 p.m. by the day nurse, showed that Patient 13's blood glucose was frequently dropping requiring treatment with Dextrose boluses. The note indicated the physician was at the bedside. The note indicated the new orders for Dextrose 10% infusion were obtained until the TPN arrived.

Patient 13's record did not show that blood sugars were monitored every 15 minutes until blood sugar was greater than 100 mg/dL, as required by physician's orders.

Patient 13 did not receive repeat hypoglycemia treatment until blood glucose was greater than 100 mg/dL, as required by physician's orders.

Patient 13's blood glucose remained below 100 mg/dL in the critical unit for more than seven hours.



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2. On 11/2/10 at 10 a.m., a review of Patient 1's medical record with the charge nurse (RN 5) at the CCU was conducted. It reflected that, on 11/1/10, Patient 1 had a physician order for an insulin drip per "ADULT INSULIN INFUSION ORDERS Target Blood Glucose (BG) 100 - 139 mg/dL (unit of measurement)." This protocol was to be utilized in adult patients in the ICU/CCU and to initiate when BG was above or equal to 140 mg/dL.

On 11/2/10 at 11 a.m., Patient 1's critical care flowsheet reflected the following insulin rates on 11/1/10: (Note that the insulin rate is determined by the rate of change from prior BG level and the current rate. If the previous rate is calculated incorrectly, the subsequent rates would be based on that incorrect rate).

4:30 a.m. BG: 502 Documented rate: 5 units/hr
(correct, according to protocol)

7 a.m. BG: 454 Rate: 8 units/hr
(incorrect. The order called for an increase by 1 unit/hr; 5 +1= 6 units total)

8 a.m. BG: 406 Rate: 8 units/hr
(no change = correct, but based on the previous incorrect calculation)

10 a.m. BG: 366 Rate: 8 units/hr
(incorrect, order called for an increase by 1.5 units/hr, therefore, rate should have been 8+1.5 = 9.5 units/hr )

4 p.m. BG: 256 Rate: 9.5 units/hr
(Correct, protocol called for an increase in 1.5 unit/hr from 8 unit/hr, but based on previous incorrect calculation)

6 p.m. BG: 241 Rate:11 units/hr
(correct; increase in 1.5 units/hr from 9.5 units/hr)

10:30 p.m. BG: 174 Rate: 9 units/hr
(incorrect, the order called for no change; rate should have been 11 units/hr if following protocol)

11 p.m. BG: 145 Rate: 9 units (no change, correct)

1:30 a.m. (11/2/10) BG: 91 Rate:7 units/hr
(incorrect, order called for a decrease by 1.5 units; rate should have been 9 - 1.5 = 7.5 units/hr)

The above calculations were reviewed and verified with RN 5. She confirmed that the nursing staff did not adhere to the insulin protocol, as ordered, when some of the insulin rates were not administered according to the administration parameters on the protocol. She reasoned because the BG was trending down, the nursing staff must have adjusted the rates based on their "clinical judgment".

On 11/2/10 at 11:05 a.m. the director of ICU/CCU (DIR 3) was interviewed. She said the nursing staff were expected to implement orders based on the established protocol, and any deviations from the protocol required additional physician's order.

At about 11:15 a.m., RN 5 said there was no documentation in Patient 1's medical record indicating the physician was called, and there was no physician order to deviate from the insulin infusion protocol.

3. On 11/2/10 starting at 11:30 a.m., a concurrent interview and record review of Patient 2's medical record was conducted with RN 5 and DIR 3 at the ICU. The review reflected, on 10/21/10, the patient had a physician order for an "insulin drip goal BG 140-180 mg/dL".

During the interview, both RN 5 and DIR 3 said there was only one approved insulin infusion protocol for the ICU/CCU, which was the "ADULT INSULIN INFUSION ORDERS Target Blood Glucose 100-139 mg/dL" protocol.

On 11/2/10 at 11:50 a.m., the staff nurse (RN 6), who had cared for Patient 2 on 10/21/10, said she understood the order as to start an insulin drip and carried out the order by using the "adult insulin infusion orders target blood glucose 100 -139 mg/dL" protocol (although the target BG parameters indicated on the physician's order was different, 140-180 mg/dL, instead of 100-139 mg/dL). RN 6 said she did not clarify the order with the physician. There was no insulin infusion protocol in the patient's chart.

On 11/2/10 at 12 p.m., DIR 3 said that it was a requirement to have the insulin infusion protocol signed by the physician before it was carried out.

Review of the critical care flowsheet for Patient 2 indicated some of the insulin rates on 10/21/10 were not carried out in accordance with the administration parameters on the protocol. For example, on 10/21/10 at 6 p.m., the BG was 171, the protocol called for 3 units/hr rate; at 8 p.m., the BG 109, the protocol called for a decrease by 1 unit/hr (3 -1 = 2 units/hr) but 2.5 units/hr rate was documented on the flowsheet. RN 5 verified the incorrect administration rates. The questionable protocol was used, and nursing staff did not adhere to the parameters for administration on the protocol.

4. On 11/5/10 at 9:30 a.m., a concurrent interview and record review of Patient 11's medical record was conducted at the MSCV (Medical Surgical Cardiovascular) unit with the director of pharmacy (DOP), a staff pharmacist (Pharm 3), and a MSCV staff nurse (RN 7).

The record indicated on 10/25/10, Patient 11 had an order for Coumadin 4 milligrams at each bedtime for atrial fibrillation (irregular heart rhythm); there was no hold parameters. On the same day, his INR (international normalized ratio - a blood test to monitor the therapeutic range of Coumadin therapy) was 3.43 (normal INR is 2 - 3).

Review of the patient's electronic medication administration record (eMAR) reflected the Coumadin was held (not given) on 10/25/10 with documented reason: "Coumadin held tonight INR =3.43". There was no order to hold Coumadin on 10/25/10, and, there was no documented evidence the physician was informed for the held Coumadin dose in the record.

During the same interview and record review, Pharm 3 provided the pharmacist's "Anticoagulation Monitoring worksheet" for Patient 11. It documented the INR of 3.43 and a comment of "OK to give per MD" and a pharmacist's initials on 10/25/10. Pharm 3 said the document indicated the pharmacist had been informed by the physician that it was okay to give the Coumadin although the patient's INR was high.

Based on interview and record review, the hospital failed to ensure that verbal orders were timed and authenticated within 48 hours by the ordering practitioner for one patient (Patient 14) out of one sampled patient, in accordance with hospital policy and procedures.

Findings:

Patient 14's record review on 11/4/10 at the Level II Unit (step down/telemetry unit) showed medication orders dated 10/25/10 for, "1. No Coumadin today; 2. Vit. K 5 mg Sub Q now". The orders were a telephone order from a physician. The time the orders were received was not recorded.

During interview on 11/4/10 at 11:10 a.m., the director of nursing at Level II (DIR 1) said that a registered nurse had received the orders for a physician. DIR 1 said the nurse should have recorded the time the telephone orders were received. Further review of the order with DIR 1 showed that the ordering physician signed and dated the orders on 11/1/10 at 1:25 p.m. DIR 1 said the hospital's policy is for prescribers to authenticate telephone orders within 48 hours.

Review of the hospital's policy and procedures "Medication Use" indicated the following:

"The date, time, signature and title of person taking the telephone order must be recorded with the telephone order."

"Verbal/telephone medication orders must be authenticated by the physician within 48 hours."

Based on observations, staff interviews, and record review, the hospital failed to store and administer medications in accordance with accepted professional standards and hospital policies and procedures as evidenced by:

1. The failure to ensure that pharmacy staff implement the Pyxis (automated
medication dispensing cabinet) overrides in accordance with the hospital's policy
and procedures. The pharmacy staff failed to conduct the retrospective review of
the Pyxis overrides daily for two months. Also, there was a lack of a system to ensure the override medication reconciliation reports were followed-up appropriately.

2. The failure to develop an approved override list in the Pyxis System
Management P&P in accordance with accepted professional principles (see
ASHP and ISMP guidelines).

3. The failure to implement a system to identify medication storage issues (out of
range temperatures) in the Pharmacy Pass-through refrigerator and the 5-Tower
medication refrigerator. The hospital also failed to develop policy and procedures
to address the timeframe to inform the pharmacy and to transfer medications out
if the medication refrigerator(s) went out of the established range.

4. The failure to ensure that frozen vaccines, antibiotics and medications were
stored at the appropriate temperature range, in accordance with manufacturer's
instructions in order to maintain medication integrity and stability and the failure to
ensure that the hospital had a policy to ensure that frozen medications were
stored in accordance with manufacturer's storage instructions at the appropriate
temperature ranges. This failure had potential to expose patients to ineffective vaccinations, medications and treatments.

Findings:

1. Pyxis override is a function by which an authorized user obtains the medication before the the pharmacist has entered the medication into the Pyxis profile for the patient. Pyxis override bypasses the pharmacist verification for order appropriateness and accuracy.

An interview with the pharmacy technician (Tech 1), who had responsibility to review Pyxis overrides, was conducted on 11/1/10 at 10:40 a.m. She stated she was supposed to review the Pyxis overrides daily (retrospectively, for overrides occurring the day prior) but had not been doing so for the last two months.

On 11/1/10, the hospital's 8/07 policy and procedure on "Pyxis System Management" stipulated that "pharmacy will be monitoring override use daily to ensure that every override is coupled with a valid patient order."

During the same interview above, when asked to describe the override reviewing process, Tech 1 said she checked to make sure there was an order to match each override. If an order could not be found, an override medication reconciliation report would be sent out to the appropriate unit manager, who had 24 hours to investigate and report back to the pharmacy. Tech 1, however, said that she did not have a system to ensure all override medication reconciliation reports were investigated and returned to the pharmacy.

On 11/1/10, review of the hospital-wide override activity report for the previous day (10/31/10) revealed the overrides included controlled substance medications such as fentanyl, morphine, hydromorphone, oxycodone, and other dangerous medications.

In the Medication Safety Alert of July 2000, the Institute for Safe Medication Practices (ISMP) identified the following regarding automated dispensing cabinet overrides: "Administering a drug before a pharmacist has reviewed the order and screened it for safety increases the risk of a medication error, most notably administering a drug to which patients are allergic, at unsafe doses, or with unrecognized food or drug interactions." As a safe practice safeguard, the institute recommended, "The order should be reviewed before subsequent doses are administered (or immediately after the pharmacy reopens)."

2. The ISMP Alert above also recommended, "Establish a restricted list of urgent or emergent drugs that may be available via the 'override' feature."

On 11/1/10, the hospital's P&P on "Pyxis System Management", dated 8/07, did not have an established list of override medications. The DOP confirmed that there was no approved list of override medications and said there should be one in the P&P.

In the "Guidelines on the Safe Use of Automated Dispensing Devices" 2010, the American Society of Health-System Pharmacists (ASHP- a nationally recognized organization) wrote the following in regards to overrides: "Override access to medications should be limited to cases in which the drug product has been approved by a multidisciplinary committee of physicians, pharmacists, and nurses as having a clinically urgent need for the medication that outweighs the potential risk of medication error."

3. During a visit to the engineering department on 11/1/10 at 1:30 p.m., an engineering staff (ENG 1) said the engineering department monitored all patient-care refrigerators, including those storing medications. He said engineering staff monitored CheckPoint System twice per shift for each of three shifts every 24 hours. (CheckPoint is a computerized remote temperature monitoring system.) The medication refrigerator temperatures were set from 36 to 46 degrees Fahrenheit (?F).

A 14-day history of temperature readings for the Pharmacy Pass-Through refrigerator was requested during this visit. Review of the data with ENG 1 and DOP indicated the refrigerator was out of range periodically for extended periods of time from 10/14/10 to 10/30/10 including the following:

Date Out of range period/lowest temp
10/14/10 4 hours/33.8?F
10/17/10 6 hours/34.88?F
10/18/10 2 hours/34.16?F
10/19/10 2 hours/34.3?F
10/20/10 3.75 hours/33.6?F
10/30/10 5 hours/33.6?F

During the same visit at 2:20 p.m., ENG 1 said, "For temperature that's out of range for 5 hours is too long!" He said he was not aware the pharmacy pass-through refrigerator was out of range. He added, "I know I've got issues. We need to be aware of it [out of range temperature] and inform the pharmacy."

On the same day at 2:30 p.m., the Pass-through refrigerator in the inpatient pharmacy contained many medications including Epogen (for treating anemia), many intravenous (IV) antibiotic bags (clindamycin, penicillin, vancomycin, cefazolin- antibiotics to treat various infections), neonatal TPN (nutrition given through the vein), and other refrigerated medications. At this time, the DOP started taking out medications that were prepared on or before 10/30/10.

Interviews with the DOP and a pharmacy staff during this visit reflected the pharmacy had never been informed of the out of range temperatures in the Pass-through refrigerator, therefore, no corrective action had been taken.

4. On 11/3/10 at 2:50 p.m., review of the temperature reading history for the 5-Tower medication refrigerator with the DOP and ENG 1 was conducted. The graphical data showed that the temperatures were constantly moving in and out of the established parameters (36 to 46?F) from 10/21/10 to 10/25/10. The numeric data showed the temperatures were out of range for 2 to 4 hours at a time, and temperatures went down as low as 24.6?F (below freezing, freezing is 32?F) at times.

Again, ENG 1 said he was not aware of the out of range temperatures in the 5-Tower medication refrigerator, and said the temperature monitoring was an issue. At 3 p.m., after checking with the pharmacy staff, the DOP said the pharmacy department had no awareness that the 5-Tower medication refrigerator was problematic on said dates. He said there were no records indicating the pharmacy was informed, therefore, no corrective actions were taken, i.e., transferring medications to a functioning refrigerator.

Per the document provided by the DOP on 11/4/10, the 5-Tower medication refrigerator contained medications including many intravenous antibiotic solutions (vancomycin, azithromycin, doxycycline, Zosyn) and intravenous potassium replacement solutions during 10/21/10 to 10/25/10.

5. On 11/5/10, review of the hospital's latest P&P on "PATIENT FOOD/DRUG REFRIGERATOR TEMPERATURE CONTROL AND MONITORING" revealed it did not address how soon after the temperature was out of range to inform the pharmacy and when to transfer the medications to a functioning refrigerator.

The American Journal of Health System Pharmacist, 2007, Volume 64, had the following regarding storage of refrigerated medications: "Failure to follow storage recommendations of pharmaceutical products can result in subpotent products and potentially, therapeutic failure."

On 11/5/10 at 11:30 a.m., during a group interview, the DOP agreed that the hospital's policy and procedure on refrigerated medication storage needed to address the timeframe as to when the pharmacy would be informed and when to transfer medications out of the problematic refrigerator(s).



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6. During medication storage inspection at the pharmacy on 11/5/10 at 10:37 a.m., in the company of the assistant director of pharmacy (ADOP), the pharmacy's medication freezer digital temperature display indicated that the temperature was -12 .2 degrees Celsius (?C). The freezer contained the following:

Vaccine:
3 vials of Varivax (Varicella virus live vaccine), used for the prevention of chicken pox, a highly contagious disease. The storage instructions on the box indicated the following, "Store Frozen at an average temperature of -15 ?C or colder "

Antibiotics:
1044 doses of Baxter's frozen premixed Zosyn Injection Solution in single dose plastic containers.

240 doses of Baxter's frozen premixed Azactam Injection Solution in single dose plastic containers.

Zosyn and Azactam are potent antibiotics used to treat potentially life-threatening infections. Review of the manufacturer's storage instructions on the antibiotics' manufacturer labels indicated to store at -20 degrees Celsius (?C ) or -4 Fahrenheit (-4?F) or below.

Other medications:
Ten Prostin E 2 suppositories used in labor and delivery procedures. The storage instructions on the box indicated the following, "Suppositories must be kept frozen; store in freezer not above -20?C (-4?F)."

Two large zip lock bags containing, Prostin vaginal gel syringes for external use, used for labor and delivery procedures.

The hospital pharmacy compounded the suppositories and the only storage instructions on the syringes were to store in freezer and not refreeze.

During interview on 11/5/10 at 10:40 a.m., the ADOP could not provide any documentation for the freezer temperature storage requirements for the Prostin vaginal gel syringes.

There was one vial of Botox injectable, used in various medical and surgical procedures. The storage instructions on the box indicated the following, "unopened vials of Botox should be stored in a refrigerator (2-8 ?C)."

During the same interview, the ADOP could not provide an explanation for the storage of Botox in the freezer.

During the same interview, the ADOP explained that an automated wireless system continuously recorded the freezer temperatures. The ADOP could not say at what temperatures the hospital had set freezer temperatures. The ADOP provided a report of the freezer temperatures from 10/6/10 to 11/5/10. The report indicated that the freezer temperature range was -20 ?F (coldest/minimum) to 10.4? F (warmest/maximum). The medications in the freezer required maximum storage temperatures of -4?F. Review of the provided report showed that temperatures reached temperatures above the maximum storage temperatures daily between 10/6/10 and 11//5/10. The ADOP could not say for how long the freezer temperatures had been set between -20 ?F to 10.4?F or how the hospital had determined to set the temperature range.

Review of the hospital's current policy regarding medication storage titled, "Patient Food/Drug Refrigerator Temperature Control and Monitoring", formulated in 4/08, indicated, that the purpose of the policy was to assure that medications are stored in accordance with proper medication storage guidelines. Additionally, the policy indicated that medication freezers temperatures will be between "-4 ?F and -32?F or -20?C to 0?C." Storing frozen medications at temperatures from -20?C to 0?C is not consistent with the manufacturer's storage requirements.

During medication storage inspection in the company of the clinical nurse specialist for obstetrics and labor and delivery (RN 3) on 11/3/10 at 12:10 p.m., the OB PACU had a dorm style refrigerator (approximately 2.5 feet x 3 feet) with a freezer compartment. The freezer compartment did not have a separate door. The freezer compartment had a metal box, which contained 15 Prostin 3 mg/3 ml vaginal syringes for external use. The hospital pharmacy had compounded the syringes. The suppositories had a sticker indicating to store frozen. RN 3 said the refrigerator temperature was recorded and monitored wirelessly by the engineering department. RN 3 could not say whether the freezer temperatures were recorded or monitored to ensure that the suppositories were stored properly.

During an interview on 11/4/10 at 4 p.m., the clinical informatics director (RN 1) said the engineering department was not recording or monitoring the freezer temperature for the OB PACU refrigerator/freezer. During an interview on 11/5/10 at 10:40 a.m., The ADOP could not provide any documentation regarding the stability and storage requirements for the hospital compounded Prostin 3 mg/3 ml vaginal syringes. The ADOP said the hospital used the Prostin E 2 suppositories to compound the syringes. The storage instructions on the Prostin E 2 suppositories box indicated the following, "Suppositories must be kept frozen; store in freezer not above -20?C (-4?F)."

According to the American Society of Health System Pharmacists, 1980, Technical Assistance Bulletin on Hospital Drug Distribution and Control, "Drug storage is an important aspect of the total drug control system. Proper environmental controls (i.e., proper temperature, light, humidity, conditions of sanitation, ventilation, and segregation) must be maintained wherever drugs and supplies are stored in the institution ...The effectiveness of the drug control system depends on adherence to policies (broad, general statements of philosophy) and procedures (detailed guidelines for implementing policy). The importance of an up-to-date policy and procedure manual for drug control cannot be overestimated ....All pharmacy staff must be familiar with the manual; it is an important part of orientation for new staff and crucial to the pharmacy's internal communication mechanism. In addition, preparing written policies and procedures requires a thorough analysis of control operations; this review might go undone otherwise."

According to a CDPH, All Facilities Letter (AFL 09-56), issued on 12/10/09, regarding Medication Safety: Storage of Medications Requiring Refrigeration, the principles of proper medication storage include the following:

"Development and implementation of policies and procedures to ensure safe storage of medications under proper conditions (e.g., temperature, humidity, protection from light and security).

Development and implementation of policies and procedures to identify, remove, and properly dispose of outdated, contaminated, recalled, or otherwise unusable drug products throughout the health care organization. Additionally, development and implementation of policies and procedures to ensure that any patients who may have received a contaminated, recalled or otherwise unusable drug product are quickly identified, notified and evaluated for potential untoward outcome.

Storage equipment (e.g., refrigerators, thermometers, carts and cabinets) is maintained in accordance with standards of practice and/or manufacturer recommendations to ensure proper functioning.

Adherence to pharmaceutical manufacturer requirements for product storage.

An alerting system to quickly identify situations where high and low refrigerator temperature limits are exceeded. (This would also be applicable to medical devices used for warming intravenous and irrigating solutions.)

All medication storage areas must be periodically inspected by qualified staff in accordance with facility policy, standards of practice and/or regulatory requirements to ensure that medications are safely and properly stored.

For refrigerators used to store vaccines, the temperature should be monitored and recorded twice a day."

Based on observations, interviews and record reviews, the hospital failed to provide patient safety and to distribute, control and use drugs in accordance with hospital policies and applicable standards of practice, as evidenced by:

1. The lack of availability of the required medications and solutions in the
hospital's Malignant Hyperthermia (a life threatening medical emergency)
emergency carts.

2. The lack of pharmacy and therapeutics committee approved written policies and procedures to determine the contents, use and process for maintaining all emergency medication kits used in the hospital, in accordance with state laws (California Code of Regulations, Title 22, Section 70263 f-f(3)) and standards of care.

3. The failure to ensure that pharmacist unit inspections were completed, monthly for all units in the hospital, in accordance with hospital policy and procedures. The hospital also failed to ensure that the pharmacist monthly inspections were performed by pharmacists (instead of pharmacy technicians) in accordance with the California Code of Regulations, Title 22, Section 70263(q)(10).

4. The failure to ensure pharmacy staff documented the pharmacist assessment and verification for fentanyl patch usage in the Clinical Intervention Documentation in accordance with the hospital policy and procedure for one of three patients (Patient 9).

Findings

1. On 11/3/10 at 11:10 a.m., in the operating room hallway, inspection of the Malignant Hyperthermia kit emergency supply (MH or malignant hyperthermia is a rare but potentially fatal reaction to certain medications used in anesthesiology) showed it did not contain any insulin. Insulin is used to treat high potassium levels, which can occur during an MH emergency. High levels of potassium can cause irregular heart rhythms and must be treated promptly. The Malignant Hyperthermia Association of the United States (MHAUS) is a nationally recognized organization that sets standards of care for the treatment of this disorder. MHAUS has documented that an MH Cart or Kit containing medications, equipment, and supplies it has designated should be immediately available to operating room personnel. It has documented that one of the medications be insulin. During an interview on 11/13/10 at 11:10 a.m., the operating room educator nurse (RN 2) said the hospital followed MHAUS guidelines and the MH kit insulin should have been available in the designated refrigerator.

On 11/3/10 at 12:10 p.m., in the obstetrics/labor and delivery post anesthesia care unit, inspection of the MH kit emergency supply showed that it did not contain refrigerated sodium chloride for irrigation. During an MH crisis, the cold sodium chloride for irrigation would be used to cool the patient. The clinical nurse specialist for obstetrics/labor and delivery (RN 3) provided a list of supplies for the MH Cart. Review of the list showed that ten sodium chloride, one liter, irrigation bottles should be stored in the refrigerator. During an interview on 11/3/10 at 12:10 p.m., RN 3 said the refrigerator was too small to store ten bottles of sodium chloride for irrigation.

2. The California Code of Regulations, Title 22, requires the following, with regards, to emergency medication supplies:

70263(f) Supplies of drugs for use in medical emergencies only shall be immediately available at each nursing unit or service area as required.
(1) Written policies and procedures establishing the contents of the supply, procedures for use, restocking and sealing of the emergency drug supply shall be developed.
(2) The emergency drug supply shall be stored in a clearly marked portable container, which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within.
(3) The supply shall be inspected by a pharmacist at periodic intervals specified in written policies. Such inspections shall occur no less frequently than every 30 days. Records of such inspections shall be kept for at least three years.

During unit inspection on 11/13/10 at 11:10 a.m., in the operating room hallway, in the company of RN 2, a staff pharmacist (Pharm 2), the assistant director of surgical services (ADIR 2) and the interim director of surgical services (DIR 2), the emergency drug supply in the malignant hyperthermia (MH) cart was not sealed by a pharmacist. During interview on 11/13/10 at 11:10 a.m., Pharm 2 and RN 2 could not say whether a pharmacist had inspected and sealed the supply of drugs stored in the MH cart.

When asked, RN 2, Pharm 2, DIR 1 and ADIR 2 could not say if the hospital's pharmacy and therapeutics had approved policies establishing the contents, management and use of the MH cart emergency drugs and supplies. RN 2 provided a list of medications and supplies for the MH cart and showed training and competency materials for the staff. RN 2 said she had developed the training materials and competencies and educated staff. The list of medications and supplies for the MH cart was not consistent with MHAUS guidelines or the training material. The list did not contain insulin, whereas MHAUS and the training material required insulin.

During unit inspection on 11/3/10 at 12:10 p.m., in the obstetrics/labor and delivery post anesthesia care unit, in the company of RN 3, the surveyor identified an acrylic box, labeled Lipid Rescue Kit, on top of the adult crash cart. The kit contained 20% intravenous fat emulsion along with supplies and was not sealed. RN 3 explained that the Lipid Rescue Kit was an emergency kit used in the treatment of local anesthetic induced cardiac arrest.

During pharmacy inspection on 11/5/10 at 10:00 a.m., in the company of the assistant director of pharmacy, the surveyor identified emergency kits labeled RSI (Rapid Sequence Intubation Kits), used for the expedient placement of a tube to enable breathing during emergencies.

Review of the hospital's policy and procedures titled, "Crash Cart Equipment Check Procedure", last reviewed on 9/09, showed that the policy did not include or address the Malignant Hyperthermia Cart, the Lipid Rescue Kit or the RSI Kit.

During interview on 11/5/10 at 11:00 a.m., the director of pharmacy (DOP) said the hospital did not have a pharmacy and therapeutics approved policy and procedures establishing the contents of the supply, procedures for use, restocking and sealing of the malignant hyperthermia cart. Additionally, the DOP said the hospital did not have P&T approved policies and procedures for the Lipid Rescue and RSI kits.

The American Society of Hospital Systems Pharmacists, 1980, Technical Assistance Bulletin on Hospital Drug Distribution and Control, concerning the Emergency Medication Supplies section, indicated the following, "A policy to supply emergency drugs when the pharmacist is off the premises or when there is insufficient time to get to the pharmacy should exist. Emergency drugs should be limited in number to include only those whose prompt use and immediate availability are generally regarded by physicians as essential in the proper treatment of sudden and unforeseen patient emergencies. The emergency drug supply should not be a source for normal "stat" or "p.r.n." drug orders. The medications included should be primarily for the treatment of cardiac arrest, circulatory collapse, allergic reactions, convulsions, and bronchospasm. The P&T committee should specify the drugs and supplies to be included in emergency stocks. Emergency drug supplies should be inspected by pharmacy personnel on a routine basis to determine if contents have become outdated and are maintained at adequate levels. Emergency kits should have a seal which visually indicates when they have been opened. The expiration date of the kit should be clearly indicated."



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3. On 11/3/10 at 2:40 p.m., review of the pharmacy nursing unit inspection log with the DOP reflected the pharmacist unit inspections were not consistently done monthly for all units of the hospital. The log indicated the inspection did not occur at the OR (operating room) in May, August, September, and October 2010. The inspections also did not occur from January to April 2010 and June to September 2010 at the Ryan Ranch facility. Other units, where inspections were not conducted monthly, included the CathLab, Diagnostic Imaging, the Wound Care Center, and the pharmacy CII Safe. The log also indicated only 3 units (out of 31) were inspected by the pharmacy staff in October 2010.

On the same day at 2:50 p.m., the DOP said the unit inspection should be done monthly. He acknowledged the monthly unit inspections had not been done consistently for all units.

The hospital's 3/08 "Unit Inspection" policy and procedure indicated, "All drug storage areas within this hospital will be inspected at least monthly under the direction of the Pharmacy Manager. The purpose is to ensure proper storage of medications."

4. On 11/5/10 at 9:20 a.m., the DOP said the unit inspections were conducted by pharmacy technicians (instead of pharmacists).

To date, the California Code of Regulations, Title 22, Section 70263(q)(10) indicates, "Drugs maintained on the nursing unit shall be inspected at least monthly by a pharmacist."

5. On 11/1/10 at 11:50 a.m., an interview was conducted with the assistant pharmacy manager (Pharm 1) regarding the pharmacy intervention related to the fentanyl patch use. Fentanyl transdermal patch is a potent narcotic (opioid) pain medicine applied to the skin, which 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. 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. The FDA required pharmaceutical companies who manufacture fentanyl patches to place a boxed warning (black box warning- BBW) on the labeling. A boxed warning provides a brief, concise summary of the information that is critical for a prescriber to be aware of, including any restriction on distribution or use.

During the above interview, Pharm 1 said all orders for fentanyl patches were evaluated by pharmacists to ensure appropriate indication for use and meeting the prescribing criteria as indicated by the FDA's BBW.

The hospital's policy and procedure on "Transdermal Fentanyl Patch Prescribing and Dispensing Requirements" indicated, "Pharmacist must verify the indication prior to dispensing the medication... Verification of the indication and opiate history as well as any conversation with the nurse, family or prescriber regarding the medication or patient must be documented in the Pharmacy Information System (Clinical Intervention Documentation)."

On 11/4/10 at 10:15 a.m., an interview and record review of Patient 9's medical record was conducted with the DOP and Pharm 1. The record review indicated the patient had a physician order for Fentanyl 25 mcg patch on 10/17/10. The pharmacist intervention in the Clinical Intervention Documentation on 10/17/10 indicated: "Must meet all criteria: Management of persistent, moderate to severe chronic pain...No contraindications including sudden, occasional,or mild pain...." The intervention documentation did not indicate how the assessment was done, what record was reviewed, and with whom the pharmacist spoke to verify opiate use history, etc.

During the same interview and record review above, the DOP said his expectation of the pharmacists was to clearly indicate in the Clinical Intervention Documentation what assessment was done, what document(s) were reviewed, and with whom the pharmacist verified the information, specific to name and place, e.g., spoke with nurse (nurse's name), at the Med/surg unit, etc.

Based on observation, the hospital failed to maintain the radiological service department in a manner that was free of hazards. The failure could affect the safety of patients and staff. Findings:

During a tour of the hospital radiology department conducted on 11/3/10 the following hazards were noted:

1. A fan enclosed in a wall cabinet with an attached filtration system was used for cooling an X-ray machine. The fan and filter had no record of being serviced thus the efficiency and safety of unit could not be verified.

2. Multiple pieces of mobile X-ray equipment were stored in a working imaging room (fluoroscopy room). When the room was in use, staff moved the excess equipment into the hall blocking a fire exit door.

3. A corridor that connected the catheterization laboratory (a procedure room used to evaluate the function of blood vessels in the heart) and imaging department was cluttered with equipment such as a laser machine, mobile X-ray machine units, supply carts, etc., that blocked a fire exit door. The storage of equipment also blocked the emergency gas shut off panel and patient handrails.

Based on observation, staff failed to maintain the intensive care unit in a safe manner by allowing the unit to be cluttered with equipment that compromised its cleanliness.

Findings:

On 11/1/10 a tour of the hospital's intensive care unit was conducted. During the tour, it was noted that adjacent to the nurses station was a counter cluttered with equipment. On the counter were gurney pads stacked one on top of the other. Next to the pads was patient care equipment (IV infusion pumps) and on top of the equipment were a number of personal protection respirators. Although staff stated everything was clean there could be no assurance to this claim, as all the articles were randomly placed on the counter.

In addition, it was noted that a privacy curtain was used to visually block the entrance into the unit. This privacy curtain blocked view of the emergency exit sign over the entrance door and fully blocked the door (exit) itself.

Based on observation and interview, the laboratory service failed to develop a procedure for the sterilizing of glass containers used for tissue storage.

Findings:

On 11/2/10 a tour of the hospital laboratory service was conducted. During this visit it was noted that in the microbiology section of the lab, staff used a sterilizer for glass tubing. According to the staff member (technician) assigned to sterilize the tubing, she did not have any procedure to follow when using the sterilizer and was taught by her predecessor.

Two staff members from the hospital central sterile processing department, who were present during the visit stated the technician was not following the acceptable standards of practice of the hospital for sterilizing. According to the staff members, the technician failed to put an internal heat indicator strip in the sterile packs to assure the internal heat of the packs met the required temperature. The sterile packs did not have a lot/load number to aid in a recall in the event the sterilizer had been compromised and a daily test was not done to assure the sterilizer was working properly.

Based on observation, the hospital failed to develop a system of identifying a new process for dirty linen storage and its implications regarding infection control.

Findings:

During a tour of the hospital conducted between 11/1/10 to 11/3/10 it was noted the dirty linen containers were only large enough for one set of linen change. According to administrative staff, the change was made from a larger linen storage container to a smaller one for staff convenience (not as heavy to lift). While touring the hospital it was noted that many of the smaller containers were overfilled exposing the dirty linen. This problem was found in the critical care unit, nuclear medicine, medical surgical unit, etc.

There was no evidence the hospital infection control officer had monitored this new process of storing dirty linen.

Based on interview and record review, the hospital failed to delineate specific surgical privileges in 1 of 9 sampled credentials files (Practitioner 2), and failed to ensure the surgical privileges were in accordance with the current competencies of the practitioner in 1 of 9 sampled credentials files (Practitioner 3). The deficient practices reduced the hospital's ability to ensure that its medical staff and allied health professionals only performed those surgical procedures in which they had current competence.

Findings:

Review of Practitioner 2's credentials file indicated he was a physician assistant (PA) in emergency medicine. His core privileges in emergency medicine included, "Surgical Procedures: Evaluate and treat within the physician assistant's scope of training and experience (examples: I&D of abscess, foreign body removal)." Practitioner 2's credentials file contained no further delineation of which surgical procedures, if any, were in the scope of his training and experience.

In an interview on 11/3/10 at 10:24 a.m., Staff F stated, "The surgical privileges for PA's are not further broken out."

Review of the hospital's Allied Health Professional Rules and Regulations indicated that dependent practitioners could only render services under 1) a diagnosis specific protocol, 2) a delegation "of specific cognitive and procedural clinical services", or 3) a physician order.

Review of Practitioner 3's credentials file indicated he was newly appointed to the hospital's medical staff on 9/21/10 and was granted core privileges in general surgery. The procedures list for the general surgery core privilege included adrenalectomy. Review of Practitioner 3's activity reports from another hospital and billing reports from his practice indicated he had not recently performed an adrenalectomy.

Review of the Surgical Council on Resident Education's General Surgery Residency Curriculum Outline (accessed at http://www.surgicalcore.org/patientcareoutline.html) indicated that a consortium of professional associations including the American Board of Surgery and the American College of Surgeons had determined that adrenalectomies were complex operations of the endocrine system which were not consistently performed by general surgeons in training and not typically performed in general surgery practice. The outline further indicated that competency in specific procedures categorized as complex was not required of physicians completing general surgery residencies.

In an interview on 11/3/10 at 11:35 a.m., Staff F stated the hospital did not check case volumes on core privileges. She agreed that no instances of adrenalectomies could be found in Practitioner 3's activity reports. She stated the hospital also considered verification from the residency program that each practitioner could perform the privileges requested.

Review of the residency verification in Practitioner 3's credentials file indicated that the non-physician program manager of a vascular surgery fellowship Practitioner 3 had completed in 1992 had certified that Practitioner 3 was competent to perform the privileges he had requested after she had reviewed Practitioner 3's evaluations.

No clarification was present in the credentials file or offered by Staff F explaining how the performance evaluations from a vascular surgery fellowship could be used by a non-physician to determine that Practitioner 3 was competent to perform complex endocrine surgeries 18 years later.

Based on observation, interview, and record review, the hospital failed to require a complete medical history and physical examination (H&P) prior to surgery for two sampled patients (Patients 18 and 19). The deficient practice had the potential to prevent discovery of health issues impacting the risk of performing surgery.

Findings:

In an observation on 11/1/10 at 12:01 p.m., Patient 18 was recovering from surgery in the recovery room.

Review of Patient 18's medical record indicated that the pre-operative H&P did not include a review of systems.

In an interview on 11/1/10 at 2:51 p.m., Staff G stated that Patient 19 had undergone a caesarean section earlier in the day.

Review of Patient 19's medical record indicated that the pre-operative H&P did not include a family history; review of systems; examination of the head, eyes, ears, nose, throat, neck, cardiovascular and respiratory systems, extremities, neurologic system, or a notation regarding the patient's mental status.

Review of the hospital's medical staff rules and regulations indicated that the pre-operative H&P was a separate requirement from the pre-anesthesia assessment and the missing components from the H&P's for Patients 18 and 19 were all required under the hospital's definition of a complete H&P.