HospitalInspections.org

Based on record review and interview the hospital failed to follow their policy and procedure to ensure the patient's (or his/her representative's) rights included the right to be able to request or refuse treatment as evidenced by no signed consent for treatment in the medical record of 2 (#22, #24) of 2 newborns admitted at delivery reviewed out of a total sample of 35.
Findings:

Review of a Policy titled Consent Forms (issued May 1985, last revised June 2012), provided by S25 Director of Women and Children Services as current revealed , in part,...
Procedure: Steps: Consent Forms-Types- 1. Admission Consent Form: Consent to treatment
A. The Admission Consent Form should be signed when the patient is admitted to the hospital. Key points: A. This record signifies the patient's consent to routine hospital services, diagnostic procedures, medical treatment, and hospital rules. This record is only for routine activities.

Review of the Rules and Regulations of the Medical Staff, review date of 11/13/12, and provided as current by S13 Medical Services Director, revealed in part the following:....C. Delinquent Medical Records: Article III - General Conduct of Care. 1. A general consent form, signed by or on behalf of every patient admitted to the hospital, must be obtained at the time of admission....

Patient #22
Review of the medical record for Patient #22 revealed she was a female neonate (newborn) born 04/01/13 at 9:26 a.m., and was admitted to the hospital as a separate patient with her own medical record number 04/01/13 at 9:26 a.m. Further review revealed a Summary Sheet Medical Records (Page 1 of 1), also know as a face sheet. The face sheet contained documented patient, guarantor, and insurance information as well as "Newborn Delivery" under comments. Review of an Authorization for Medical Treatment section on the face sheet revealed, in part, the following:
" I, the undersigned, am presenting myself for admission to (name of hospital), and I voluntarily consent to the rendering of such care, including diagnostic procedures and medical treatment, by (name of patient's physician) and by the authorized agents and employees of the hospital and by its medical staff, or their designees, as may in their professional judgment be deemed necessary or beneficial..." Further review revealed the patient signature, the "or nearest relative signature", relationship to patient, and witness lines were blank. At the bottom of the page were the following words in all capital letters and bold print: Authorization must by signed by the patient, or by the nearest relative.

Review of Patient #22's mother's (Patient #21) medical record revealed no consent that referenced treatment of her newborn child.


Patient #24
Review of the medical record for Patient #24 revealed she was a female neonate born 04/01/13 at 10:23 a.m., and was admitted to the hospital as a separate patient with her own medical record number 04/01/13 at 10:23 a.m. Further review revealed a Summary Sheet Medical Records (Page 1 of 1). The document contained patient, guarantor, and insurance information as well as "Newborn Delivery" under comments. Review of an Authorization for Medical Treatment section on the face sheet revealed, in part, the following:
" I, the undersigned, am presenting myself for admission to (name of hospital), and I voluntarily consent to the rendering of such care, including diagnostic procedures and medical treatment, by (name of patient's physician) and by the authorized agents and employees of the hospital and by its medical staff, or their designees, as may in their professional judgment be deemed necessary or beneficial..." Further review revealed the patient signature, "or nearest relative signature, relationship to patient, and witness lines were blank. At the bottom of the page were the following words in all capital letters and bold print: Authorization must by signed by the patient, or by the nearest relative.

Review of Patient #24's mother's (Patient #23) medical record revealed no consent that referenced treatment of her newborn child.

In an interview 4/2/13 at 12:45 p.m. S1 CNO (Chief Nursing Officer) and S25 Director of Women and Children Services verified that there were no signed consents for treatment on the medical records of Patients #22 and #24. S25 Director of Women and Children Services reported that the hospital did not obtain a consent for treatment for a newborn. Both S1 CNO and S25 Director of Women and Children Services confirmed that the hospital was not following the policy and procedure for consents. They further verified that this practice was not in line with the Medical Staff Bylaws.

Based on record review and interviews, the hospital failed to ensure the registered nurse (RN) supervised and evaluated the nursing care of each patient. The RN failed to clarify the physician's orders for the specific dose of the medication and the parameters for titration for a continuous infusion of an anesthetic agent (Propofol) and, the RN failed to follow the hospital policy and procedure for initiation of a continuous infusion of an anesthetic agent (Propofol) for 1 (#12) of 3 current patients (#12, #R1, #R2) reviewed for the use of Propofol infusions out of a total sample of 35. Findings:

Review of the hospital policy titled, "Diprivan (Propofol), no policy number, revised date of March 2013, provided as current by S6 Director of ICU (Intensive Care Unit) revealed in part the following: Policy:..Requires physician's orders...Procedure: Note the physician's order....10. Initiate infusion as per Physician's order, if no order is given, initiate infusion at 5 ug/kg/min (micrograms/kilograms/minute) (=2 cc/hr for 70 kg. patient). Increase infusion rate in increments of 5 to 10 ug/kg/min over 5 to 10 minute intervals until desired level of sedation is achieved...13. Utilize Riker Sedation/Agitation Scale to assess level of sedation.


Review of the Pharmacy Department Policy and Procedure titled Medication Management-Ordering and Transcribing, Policy No. 10-02, Revised 3/2009, revealed in part:
Contents of Medication Orders:
Each medication order shall include:
-patient name and location
-Time and date of order
-Drug name, strength (and dosage form, if necessary).
-Directions for use (including route of administration).
-Prescriber's signature or that of his or her authorized agent.

Patient #12
Review of the clinical record for Patient #12 revealed the patient was a 64 year old female admitted to the hospital on 03/25/13 as a transfer from another area hospital. The patient's diagnoses included Septic Shock secondary to Pneumonia, Respiratory Failure, Spontaneous Pneumothorax, Azotemia, Thrombocytopenia, Atrial Fibrillation and Delirium.

Review of the physician's orders dated 03/30/13 (no time documented) revealed the following order: "Propofol PRN (as needed) vent (ventilator) sedation - titrate for comfort." There was no documented evidence that the RN clarified the physician's order to include the starting dose, route, desired level of sedation, or the rate of titration.

Review of the MAR (Medication Administration Record), the 12-hour ICU flow sheets and the electronic nursing documentation for 03/30/13 with S7RN on 04/01/13 at 2:55 p.m. revealed the Propofol infusion was started on 03/30/13 at 11:00 a.m. at 10 mcg/kg/min. with the patient's Riker score of 6. S7RN confirmed the above findings.

In a face-to-face interview on 04/01/13 at 4:15 p.m., S6 Director of ICU reviewed the record for Patient #12 and verified there were no clarification orders obtained for the administration of the Propofol infusion. S6 Director of ICU verified in the hospital policy dictated the starting dose of the Propofol infusion should have been 5 mcg/kg/min and the RN did not follow the policy.

Based on record review and staff interview, the hospital failed to ensure the registered nurse (RN) assigned the nursing care of ICU (Intensive Care Unit) patients to nursing personnel who had received education/training and had been evaluated for competency in the administration of a continuous infusion of an anesthetic agent (Propofol) for 2 of 2 (S7RN, S8RN) ICU nursing personnel records reviewed for education/competency in Propofol administration. Findings:

Review of the Policy and Procedure titled, "Moderate Sedation", revised date of March 2013, revealed in part the following: It is the intent of this policy to provide nursing staff with guidelines to safely and appropriately care for the patient receiving moderate sedation to facilitate the performance of diagnostic or therapeutic procedures....Note: This policy does not apply in the following situations: Administration or titration of anesthetic agents by registered nurse to intubated patients in critical care settings.


Review of the personnel records for S7RN and S8RN revealed both nurses were employed as ICU nurses. Review of the education and competency records for S7RN and S8RN revealed an annual competency for Moderate Sedation. Review of the competency evaluation for Moderate Sedation revealed no documentation Propofol infusion was included in the competency. There was no documented evidence of a competency for the administration of Propofol infusions.

In a face-to-face interview on 04/04/13 at 10:00 a.m., S6 ICU Director provided the training material for "Moderate Sedation" as the competency evaluation for Propofol infusions. Review of the "Moderate Sedation Self Study Module" revealed the only reference to Propofol in the module was regarding IVP (Intravenous push) administration. There was no documented evidence of any guidance/instruction related to Propofol infusions. S6 ICU Director verified there was nothing specific to Propofol infusions in the competency evaluation or in the self-study module. S6 ICU Director verified the self-study module did not include how to initiate, titrate or monitor Propofol infusions. S6 ICU Director verified the post-test for the self-study module did not include administration of Propofol infusions.

Based on record review and interview the hospital failed to have a system in place to identify and complete incomplete patient medical records promptly for 2 (#32, #33) of 4 (#32, #33, #34, #35) closed medical records reviewed out of a total sample of 35 medical records.
Findings:

Review of the Rules and Regulations of the Medical Staff, review date of 11/13/12, and provided as current by S13 Medical Services Director, revealed in part the following:....C. Delinquent Medical Records: 1. A record is considered incomplete for fourteen (14) days from the date filed in the physician's box. A record is considered delinquent after it has been in the physician's box for fifteen (15) days or more. A record is considered automatically delinquent after discharge if there is no dictated or written (complete) history and physical and/or operative report. A physician will be notified by regular U.S. Mail when a record becomes delinquent....

Patient #32
Review of the clinical record for Patient #32 revealed the patient was a 53 year old female admitted to the hospital on 12/11/12 with diagnoses of Altered Mental Status and Urinary Tract Infection. The record revealed the patient expired on 12/25/12.
Review of the physician's orders revealed the following incomplete orders:
12/13/12 - Verbal order for Lopressor 25 mg by mouth twice a day and order for consult. Order signed by physician but failed to include date and time of authentication.
12/14/12 - Order written by physician for analysis of spinal fluid, plus medication orders. Order signed by physician but failed to include the time.
12/17/12 - Verbal order to change tube feeding. Order signed by physician but failed to include date and time of authentication.
12/18/12 - Verbal order for portable liver ultrasound at bedside. No documented evidence the order was dated/timed/signed by the physician.
12/19/12 - Verbal order for Ativan, then another Ativan clarification order. Both verbal orders signed by the physician, but failed to include date and time of authentication.
12/19/12 - Verbal order for puree diet and aspiration precautions. No documented evidence the order was dated/timed/signed by the physician.
12/20/12 - Verbal order for Wound Vac Orders. No documented evidence the order was dated/timed/signed by the physician.
12/20/12 - Anesthesia Adult Post Operative Orders, signed by the physician, but failed to include the date and time of the order.
12/20/12 - Non-violent restraint orders signed by physician, but failed to date or time order.
12/22/12 - Verbal order for Posey Bed restraint, not dated/timed/signed by the physician.
12/24/12 - Verbal Order for enclosed bed restraint, not dated/timed/signed by the physician.
In a face-to-face interview on 04/03/13 at 2:30 p.m., S2 Director of Quality verified the above physician orders were incomplete.

Patient #33
Review of the medical record for Patient #33 revealed she was a 61 year old admitted 10/08/12 for a heart catherization. Review of Physician's orders revealed, in part, five handwritten order entries dated 10/9/12 by an RN (Registered Nurse) as verbal orders received from a physician. Further review revealed all five order entries were authenticated with a physician's signature, but without a time or date for the entries.


In an interview 4/4/13 at 10:30 a.m. with S15 RHIT (Registered Health Information Technician), Director of Medical Records, S2 Director of Quality, and S1 CNO (Chief Nursing Officer), S15 RHIT reported that a medical record was considered incomplete only if a history and physical, a discharge summary, a transfer note, and operative or procedural note were omitted or not signed and dated. When the physician's orders for Patient #32 were reviewed, S15 RHIT verified that the physician's authenticating signature was not timed and dated. S15 RHIT verified that the medical record was not included in the delinquent records. When asked if a medical record with physician's orders not signed was considered incomplete, S15 RHIT responded that she would not consider it incomplete because the orders were not signed within the required 10 day window. The Medical Record department would not make an attempt to obtain the required signatures with a date and time of authentication and the closed chart would remain without the required signatures. When asked if the incomplete signatures, dates, times, etc. were reported to anyone, she confirmed that they were only included in the Quality reports as a percentage or number, not specifically identified. S15 RHIT reported that there were no policies and procedures for the Medical Record department; only the Medical Staff Bylaws were used as reference for delinquent records. S15 RHIT, S1 CNO, and S2 Director of Quality reported that until the time of this discussion the accurate identification of incomplete medical records had not occurred. They verified that there was not a system in place to accurately identify and correct this practice.

Based on interview and record review, the hospital failed to ensure all medical record entries were dated, timed and authenticated by the practitioner responsible for providing or evaluating the service provided for 8 (#9, #10, #12, #13, #14, #18, #32, #33) of 35 patients sampled. Findings:
Review of the hospital's Rules and Regulations of the Medical Staff, review date of 11/13/12, and provided as current by S13 Medical Services Manager revealed in part the following: Article II Medical Records. A. Completion of Medical Records....2. All clinical entries in the patient's medical record shall be accurately dated and authenticated.....7. A practitioner's routine orders, when applicable to a given patient, shall be reproduced in detail on the order sheet of the patient's record, dated, timed and signed by the practitioner. Progress Notes: Pertinent progress notes shall be recorded at the time of observation, sufficient to permit continuity of care and transferability....
Patient #9
Review of the medical record for Patient #9 revealed she had been admitted to the hospital on 3/25/13 at 11:14 a.m. with diagnosis which included violent behavior.
A review was made of documents for Patient #9 titled Behavior Management Seclusion-Restraint (Violent) Assessments and Documentation. The restraint incidents for the following dates and times had a signature by a physician, but no time or date the document had been authenticated: 3/26/13 at 7:50 p.m., 3/28/13 at 5:30 p.m., 3/28/13 at 10:00 p.m., 3/29/13 at 10:30 a.m., 3/31/13 at 09:45 a.m., 3/31/30 at 6:45 p.m.
Patient #10
Review of the medical record for Patient #10 revealed she had been admitted to the hospital on 3/31/13 at 6:50 a.m. with diagnosis which included depression and suicidal thoughts.
Review of the document in Patient #10's medical record titled Subcutaneous Sliding Scale Insulin Physician Orders revealed an order for low dose Human Regular Insulin twice per day with the scale listed. The order was signed by the physician, but not dated or timed.
Review of the Physician's Order for Patient #10 revealed an order dated 3/29/13 for Haldol 5 mg (milligrams) q (every) 2 p.m. The order had been signed by a physician, but no time for the order had been written.

Patient #12
Review of the clinical record for Patient #12 revealed the patient was a 64 year old female admitted to the hospital's ICU (Intensive Care Unit) on 03/25/13 as a transfer from another area hospital. The patient's diagnoses included Septic Shock secondary to Pneumonia, Respiratory Failure, Spontaneous Pneumothorax, Azotemia, Thrombocytopenia, Atrial Fibrillation and Delirium.

Review of the physician's orders revealed the following orders were dated and signed by the physician, but failed to include the time of the order:
03/30/13 (no time documented) revealed orders for ventilator settings, Propofol infusion and x-rays, blood gases, and lab tests.
03/27/13 (no time documented) revealed orders for ventilator settings and x-rays, blood gases, and lab tests.
Further review of the physician's orders revealed an order for wrist restraints dated 04/01/13. The order was signed by the physician, but there was no documented evidence of a date or a time on the order.

Review of the physician's progress notes documented by S29 Physician (Patient's Admitting Physician) revealed the following progress notes failed to include the time of the note: 04/01/13, 03/29/13, 03/28/13, 03/25/13, and 03/26/13.

Review of the physician's progress notes documented by S30 Physician (Patient's Pulmonologist) revealed the following progress notes failed to include the time of the note: 03/31/13, 03/30/13, and 03/27/13.

In a face-to-face interview on 04/01/13 at 4:15 p.m., S6 Director of ICU reviewed the record for Patient #12 and verified the above physician's orders were not timed by the physician and the order on 04/01/13 had not been dated or timed by the physician. S6 Director of ICU verified the above physician's progress note entries had not been timed by the physician.

Patient #13
Review of the patient's record revealed the patient was a 9 year old female admitted to the PICU (Pediatric Intensive Care Unit) on 03/29/13 with a diagnosis of DKA (Diabetic Ketoacidosis). Review of the physician's orders revealed a signed order dated 03/31/13 to increase the patient's insulin dose. There was no documented evidence of the time the order was written by the physician. Review of the physician's admit notes revealed the note was dated and signed on 03/29/13, but there was no documented evidence of the time of the entry.
In a face-to-face interview on 04/02/13 at 10:20 a.m., S9RN reviewed the clinical record for Patient #13 and verified the above orders and progress notes were not timed by the physician.

Patient #14
Review of the patient's record revealed the patient was a 3 month old female admitted to the Pediatric Unit on 04/01/13 with a diagnosis of Intractable Nausea and Vomiting. Review of the physician's orders revealed a signed order dated 04/02/13 for X-rays and lab tests. There was no documented evidence of the time the order was written by the physician. Further review of the physician's orders revealed the order was signed off by the RN at 9:55 a.m.
In a face-to-face interview on 04/02/13 at 10:30 a.m., S2 Director of Quality verified the physician had failed to include the time of the written order.

Patient #18
Review of the patient's record revealed the patient was a 49 year old female admitted to the hospital on 03/19/13. The patient was observed to be a current patient on the medical surgical unit where she was in isolation for C-diff (Clostridium Difficile). The patient's diagnoses also included Intractable Nausea and Vomiting, Renal Failure with dialysis, and Chronic Obstructive Pulmonary Disease.
Review of the physician's progress notes revealed the following physician entries were not timed: 04/01/13, 03/31/13, 03/30/13, 03/29/13, 03/28/13, and 03/27/13.
In a face-to-face interview on 04/02/13 at 3:30 a.m., S2 Director of Quality verified the physician had failed to include the time in the above progress notes.

Patient #32
Review of the clinical record for Patient #32 revealed the patient was a 53 year old female admitted to the hospital on 12/11/12 with diagnoses of Altered Mental Status and Urinary Tract Infection. The record revealed the patient expired on 12/25/12.
Review of the physician's orders revealed the following incomplete orders:
12/13/12 - Verbal order for Lopressor 25 mg. by mouth twice a day and order for consult. Order signed by physician but failed to include date and time of authentication.
12/14/12 - Order written by physician for analysis of spinal fluid, plus medication orders. Order signed by physician but failed to include the time.
12/17/12 - Verbal order to change tube feeding. Order signed by physician but failed to include date and time of authentication.
12/18/12 - Verbal order for portable liver ultrasound at bedside. No documented evidence the order was dated/timed/signed by the physician.
12/19/12 - Verbal order for Ativan, then another Ativan clarification order. Both verbal orders signed by the physician, but failed to include date and time of authentication.
12/19/12 - Verbal order for puree diet and aspiration precautions. No documented evidence the order was dated/timed/signed by the physician.
12/20/12 - Verbal order for Wound Vac Orders. No documented evidence the order was dated/timed/signed by the physician.
12/20/12 - Anesthesia Adult Post Operative Orders, signed by the physician, but failed to include the date and time of the order.
12/20/12 - Non-violent restraint orders signed by physician, but failed to date or time order.
12/22/12 - Verbal order for Posey Bed restraint, not dated/timed/signed by the physician.
12/24/12 - Verbal Order for enclosed bed restraint, not dated/timed/signed by the physician.
In a face-to-face interview on 04/03/13 at 2:30 p.m., S2 Director of Quality verified the above physician orders were incomplete.

Patient #33
Review of the medical record for Patient #33 revealed he was a 71 year old admitted for a heart catheterization. Further review of the medical record revealed the following telephone orders without a date or time of the physician's authenticating signature:
10/9/12 at 10:00 p.m. - Verbal order for: 1. Mag Sulfate (Magnesium Sulfate) 1 gram in 50 cc (cubic centimeters) NS (Normal Saline) over 1 hour. 2. 60 mcg (micrograms) KCl (Potassium Chloride) in 150 cc SW (Saline Water) over 3 hours. 3. Ca (Calcium Gluconate) 1 amp (ampule) stat (now) IV (intravenously).
10/9/12 at 10:50 p.m. - 2 amps Ca Chloride IV stat.
10/9/12 at 11:15 p.m.-Insulin gtt (drops) per protocol.
10/9/12 at 8:30 p.m. - Transfuse 3 units PRBC (packed red blood cells) stat.
10/0/12 at 11:00 p.m.-Transfuse 2 units PRBC stat, transfuse for Hgb (hemoglobin) less than 8.
10/9/12 at 6:15 p.m. - Albumin 5 % 500 cc IV now.
10/9/12 at 7:00 p.m.-Albumin 5% 500 cc IV now.
10/9/12 at 7:00 p.m.-(Obtain) Hemoglobin and Hematocrit at 7:00 p.m.
10/9/12 at 7:13 p.m. - Increase PEEP (Positive End Expiratory Pressure) to 10. - 3 units PRBC now. - 500 cc Albumin q (every) 6 hours. -Vasopressin: titrate (to achieve) SBP (Systolic Blood Pressure) greater than or equal to 60.
10/9/12 at 9:20 p.m.-1. Increase IMV (Inspired Mechanical Ventilation) 2. 40 mg Lasix IV stat. 3. 2 amps Bicarb (Potassium Bicarbonate).
10/9/12 at 9:50 p.m. - Decrease PEEP to 5.

In a face-to-face interview on 04/03/13 at 2:30 p.m., S2 Director of Quality verified the above physician orders were incomplete.









17091








30420

Based on interview and record review, the hospital failed to keep current and accurate records of the receipt and disposition of scheduled drugs as evidenced by discrepancies in the wastage of scheduled drugs not being reconciled promptly for 5 of 6 monthly narcotic reports.
Findings:
Review of the Pharmacy Policy titled Controlled Drugs: Distribution and Accountability (General), Policy No. 15-01, revealed in part:
Controlled drugs shall be distributed, administered, and accounted for in accordance with federal laws, rules, and regulations and the laws rules, and regulations of this state, and other applicable law.
The Director of Pharmacy, acting as the facility's agent, shall ensure that the distribution and administration of controlled drugs are documented adequately by pharmacy, nursing service, and other involved services ...

Review of the Policy titled Medication Administration, revised 7/12, revealed in part:
1. Accountability of all controlled substances is required by law, therefore accurate documentation of narcotics is mandatory.

Review of the Pharmacy Policy titled Controlled Drugs: Administration, Policy No. 15-10, revealed in part:
The disposition of a portion of a controlled drug remaining in an ampule, vial, syringe, or patch must be documented.

Review of the monthly Narcotic Audit dated 1/10/13 revealed the following discrepancies that had not been reconciled:
Hydromorphone 2 mg tablet-pulled 4 mg, wasted 2 mg, but documented given 3 mg.
Alprazolam 0.25 mg tablet- did not document given, not returned either.
Hydromorphone 4 mg/ml 4 mg vial-pulled 4 mg, document 2 mg given, no waste, not returned.

Review of the monthly Narcotic Audit dated 3/4/13 revealed the following discrepancies that had not been reconciled:
Morphine 5 mg, ordered 3 mg-no waste.
Lorazepam 2 mg/ml 1 ml- dispensed 2 mg, ordered 1 mg- no waste.

Review of the monthly Narcotic Audit for 1/13 from the offsite campus revealed the following discrepancies that had not been reconciled:
1/29/13: Butorphanol 2 mg/ml- 1 mg not wasted.
1/30/13: Butorphanol 2 mg/ml- 1 mg not wasted.
1/29/13: Morphine 2 mg/ml- 0.9 ml not wasted.
1/30/13: Phenobarbital 65 mg/ml- 63 mg not wasted.

Review of the monthly Narcotic Audit for 2/13 from the offsite campus revealed the following discrepancies that had not been reconciled:
2/10/13: Chloral Hydrate 500 mg/5 ml- 4.5 ml not wasted.
2/11/13: Butorphanol 2 mg/ml- 1 mg not wasted.

Review of the monthly Narcotic Audit for 3/13 from the offsite campus revealed the following discrepancies that had not been reconciled:
3/4/13: Butorphanol 2 mg/ml inj- 1 mg not wasted.
3/5/13: Butorphanol 2 mg/ml inj- 1 mg not wasted.
3/1/13: Phenobarbital 20 mg/5 ml-18 mg not wasted.

In an interview on 4/2/13 at 10:15 a.m. with S26PharmacyManager at the offsite campus, she stated a list of narcotic waste discrepancies from the automated medication dispensing system was printed every month. She stated the unit managers of surgery, labor and delivery, or neonatal intensive care were notified when a nurse had not properly wasted narcotic medications. S26PharmacyManager at the offsite campus said the pharmacy did not fill out an incident report or any other documentation of an investigation. S26PharmacyManager at the offsite campus also stated the pharmacy department did not follow up on if an investigation by the unit manager had been completed or if the narcotic discrepancy had been resolved.

In an interview on 4/2/13 at 10:45 a.m. with S25DirectorWomensServices, she stated she was the nursing director at the offsite campus. S25DirectorWomensServices stated she had never seen the Narcotic Audit sheet or been made aware of any discrepancies with waste of narcotics by the nursing staff. S25DirectorWomensServices said if the director of women's services should have been notified about narcotic discrepancies it would have been her.

In an interview on 4/2/13 at 10:50 a.m. with S1CNO, she stated she had never seen the Narcotic Audit Form presented by the pharmacy or been made aware of any discrepancies with narcotic waste by the nursing staff.

In an interview on 4/2/13 at 3:30 p.m. with S24PharmacyDirector, he stated a random sample of narcotic administration and wastage was generated by the pharmacy monthly from the automated medication distribution system to assess for accurate administration and wastage at both campuses. S24PharmacyDirector stated the generated document was titled Narcotic Audit. He stated the pharmacist at the offsite campus was supposed to notify the nurse manager of the unit when there was a narcotic wastage discrepancy identified from that unit, but the offsite pharmacy did not get the memo and had not been reporting the discrepancies. S24PharmacyDirector also said the offsite pharmacy had not done investigations to resolve the narcotic waste that was unaccounted for on the Narcotic Audit form. At the main campus, S24PharmacyDirector said the random monthly narcotic audits were done in real time and the individual hospital units were notified of a discrepancy with wastage on the day it was discovered. He said once the discrepancies were resolved, they were removed from the Narcotic Audit list. If there was no resolution, S24PharmacyDirector said the discrepancy remained on the list. After reviewing the last three months of Narcotic Audits at the main campus, S24PharmacyDirector verified there were 3 unresolved narcotic discrepancies in 1/13 and 2 unresolved narcotic discrepancies in 3/13. He verified the unresolved discrepancies of the wasted narcotics meant scheduled medications were missing. S24PharmacyDirector also verified the offsite campus had 4 unresolved discrepancies from 1/13, 2 unresolved narcotic discrepancies from 2/13 and 3 unresolved narcotic discrepancies from 3/13. S24PharmacyDirector verified no investigation had been initiated by the pharmacy or nursing staff about the missing scheduled medications. On 4/3/13 at 9:35 a.m., S24PharmacyDirector verified there had been no incident reports filed about the unaccounted for narcotics and the CEO had not been notified.

Based on interview and record review, the hospital failed to ensure drugs and biologicals were distributed safely by not clarifying physician's orders for the correct route of administration as per hospital policy for 2 (#10, #11) of 3 (#9, #10, #11) psychiatric charts reviewed out of a total of 35 (#1- #35) sampled patients.
Findings:
Review of the Pharmacy Department Policy and Procedure titled Medication Management-Ordering and Transcribing, Policy No. 10-02, Revised 3/2009, revealed in part:
Contents of Medication Orders:
Each medication order shall include:
-patient name and location
-Time and date of order
-Drug name, strength (and dosage form, if necessary).
-Directions for use (including route of administration).
-Prescriber's signature or that of his or her authorized agent.

Patient #10
Review of the medical record for Patient #10 revealed she had been admitted to the hospital on 3/31/13 at 6:50 a.m. with diagnosis which included depression and suicidal thoughts.
Review of the Physician's Order for Patient #10 revealed an order dated 3/29/13 (no time) for Haldol 5 mg (milligrams) q (every) 2 p.m. No route of administration had been written.
Review of the MAR (medication administration record) for Patient#10 revealed the Haldol order from 3/29/13 was written: Haloperidol (5 mg) tablet oral every day 2 p.m. dose.
Further review of the medical record for Patient #10 revealed no nursing or pharmacy documentation that the incomplete order for Haldol dated 3/29/13 had been clarified by a nurse or the pharmacist with the physician before placing a route for the Haldol on the MAR.
In an interview on 4/1/13 at 4:30 p.m.. with S24PharmacyDirector, he stated the pharmacy did not clarify the route on the Haldol order for Patient #10 dated 3/29/13. He said the order for the Haldol should have been clarified before the medication was written on the MAR and was administered to Patient #10.
Patient # 11
Review of the medical record for Patient #11 revealed he had been admitted to the hospital on 3/25/13 at 1:21 p.m. for a psychiatric evaluation.
Review of the Physician's Order for Patient #11 dated 3/21/13 (no time) revealed the following order: change Depakote 500 mg BID (twice per day). No route was indicated.
Review of the MAR for Patient #11 revealed the following order: Divalproex (Depakote) 500 mg Sustained release 24 hr (hour) Oral Daily at Bedtime.
Further review of the medical record for Patient #11 revealed no nursing or pharmacy documentation that the incomplete order dated 3/21/13 for Depakote had been clarified by a nurse or the pharmacist with the physician before placing a route for the Depakote on the MAR.
In an interview on 4/1/13 at 4:30 p.m.. with S24PharmacyDirector, he stated the pharmacy did not clarify the route on the Depakote order for Patient #11 dated 3/21/13. He said the order should have been clarified before the medication was written on the MAR and administered to Patient #11.

30364


Based on observation, interview and record review, the hospital failed to ensure scheduled medications were stored in a secure area to prevent unmonitored access by unauthorized individuals as evidenced by partially empty vials of narcotics being disposed of in sharps containers which were stored in unmonitored utility rooms with access by hospital employees.

Findings:

Review of the Pharmacy Policy titled Controlled Drugs: Distribution and Accountability (General), Policy No. 15-01, revealed in part:
Storage and Security: The Director of Pharmacy, acting as the facility's agent, shall ensure adequate storage and security for controlled drugs in accordance with federal laws and the laws of the state.

Review of the Pharmacy Policy titled Controlled Drugs: Disposition/Destruction, Policy No. 15-06, revealed in part:
If controlled medications are not a candidate to be returned through the reverse distributor process (e.g. drug wasting), then they will be disposed of through the sewer system with appropriate witness documentation.

Review of the Policy titled Medication Administration, revised 7/12, revealed in part:
I. Licensed witness must visualize the actual wasting of medications down the drain. Do not throw wasted pills, capsules, etc. in sharps containers.

In an interview on 4/1/13 at 12:15 p.m. with S21NurseManager, she stated when narcotics remained in vials after the dose was withdrawn, the remaining amount of the narcotic and the vial were disposed of in the sharps container. S21NurseManager said the narcotic waste was not withdrawn from the vial and discarded into the sink or trash.

In an interview on 4/1/13 at 3:35 p.m. with S23RN, she stated if a narcotic was given, the waste that remained in the vial was thrown into the sharps container. S23RN verified she did not remove the waste from the vial and dispose of it into the sink or other container.

An interview on 04/02/13 at 10:30 a.m. was conducted with S20CRNA. S20CRNA was asked about the proper disposal of unused narcotics/controlled substances. S20CRNA indicated that all unused narcotic/controlled substances are to be wasted with another nurse as a witness. He further indicated that the unused narcotic/controlled vial or bottle with the remaining narcotic/controlled substance in it can be thrown in a red sharps box.

In an interview on 4/1/13 at 4:15 with S1CNO, she stated the sharps containers were locked while on the units. She said once the containers were removed from the units by housekeeping, they were placed in unlocked grey containers in the dirty utility rooms. She said the grey bins were emptied once per day by biomedical staff. She said the dirty utility rooms in certain areas were locked and inaccessible by patients, but verified housekeeping, technicians, nurses, and other staff members had unsupervised access to the rooms and sharps containers.

Observation of the dirty utility room on the psychiatric unit on 4/1/13 at 11:55 a.m. revealed an unlocked grey container where sharps containers were stored. The utility room had no windows or cameras to allow observation within the room.

Based on interviews, observations and record reviews the hospital failed to ensure the surgical care of patients was performed in a manner designed to assure the achievement and maintenance of a high standard of medical practice and patient care as required by the AORN (Association of peri-Operative Registered Nurses) Standards and Recommended Practices. This failed practice was evidenced by the hospital failing to have the means to ensure the temperature of warmed fluids was not above 98.6 degrees F (Fahrenheit) when used for patients as evidenced by the temperature of the warmers that contain irrigating fluids and IV (intravenous) fluids being set at 104 degrees F and having no means to check the temperature of these fluids before patient use other than by touch.
Findings:
A review of the hospital policy titled "Warming of Flexible IV and Irrigation Solution Containers" and provided by S16RN Director of peri-Operative Services as the most current policy revealed the warmers containing solutions for patient use would not exceed 104 degrees F, and the temperature of the warmers would be monitored daily.
Review of the AORN "Peri-Operative Standards and Recommended Practices" 2013 Edition revealed a section titled "Equipment and Product Safety". This section revealed Recommendation VII indicated that fluids used for patients should not exceed 98.6 degrees F and should be monitored for appropriate temperature before use. The recommendation further revealed that fluids that are too warm can cause burns and fluids that are too cool can increase the risk of heat loss and hypothermia during surgical procedures. The recommendation also stated that equipment was commercially available to monitor patient fluids as it is administered.
An observation was made on 04/02/13 while touring the surgical suites in the presence of S16RN Director of peri-Operative Services, S17RN Assistant Director of peri-Operative Services and S18 Pharmacist of patient fluid warmers containing irrigation fluids and IV fluids set at 104 degrees F.
An interview on 04/02/13 at 10:00 a.m. was conducted with S17RN Assistant Director of peri-Operative Services in the presence of S16RN Director of peri-Operative Services and S18 Pharmacist. S17RN Assistant Director of peri-Operative Services was asked how staff monitored the temperature of the irrigating fluids used for patients during procedures. She indicated the warmers containing the irrigating fluids were set no higher than 104 degrees F. She was asked if staff checked the irrigating fluid temperature before the irrigating fluids were used on a patient. S17RN Assistant Director of peri-Operative Services indicated staff do not have anything available on the sterile field to monitor the irrigating fluids and would test the fluids by touch alone. She was asked if she was aware of the AORN Recommended Practice that stated fluids used for patient irrigation should not exceed 98.6 degrees F and she indicated "No".
An interview on 04/02/13 at 10:15a.m. was conducted with S18 Pharmacist in the presence of S16RN Director of peri-Operative Services and S17RN Assistant Director of peri-Operative Services. S18 Pharmacist indicated she was responsible for monitoring the warmers containing the IV fluids used for patient use and further indicated they were set no higher than 104 degrees F.
An interview on 04/02/13 at 10:30 a.m. was conducted with S20CRNA (Certified Registered Nurse Anesthetist). He was asked how he monitored the temperature of the warmed IV fluids used for patients during procedures. S20CRNA indicated he did not have any equipment available to monitor the IV fluids before given intravenously to patients except by touch alone.

Based on interviews and record reviews the hospital failed to ensure that informed surgical consents were properly executed for patients prior to surgical interventions. This failed practice was evidenced by 2 of 5 patient's surgical consents ( #4, #5) reviewed out of 35 sampled medical records, with no documented evidence on the informed surgical consent that listed reasonable therapeutic alternatives with their associated risks/benefits or the associated risks/benefits of no treatment.

Findings:

A review of the hospital policy titled "Informed Consent" provided by S1CNO as the most current policy revealed an informed surgical consent was complete when the physician who would perform the surgical procedure had also clearly explained to the patient and documented the risks/benefits of any reasonable therapeutic alternatives and the possible results of non-treatment.

A review of the form titled "Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information" revealed section 6), the physician was to document reasonable therapeutic alternatives and risks/benefits associated therewith, risks of no treatment.

Patient #4
The patient was admitted to the hospital on 04/01/13 for a scheduled left inguinal hernia repair with mesh. A review of Patient #4's Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information form, revealed section 6) was left blank.

Patient #5
The patient was admitted to the hospital on 04/01/13 for a scheduled insertion of a subclavian venous access port. A review of Patient #5's Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information form, revealed section 6) was left blank.

An interview on 04/01/13 at 9:30 a.m. was conducted with S16RN Director of Peri-Operative Services. The Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information forms for Patient #4 and Patient #5 was reviewed with S16RN Director of peri-Operative Services. He indicated the physician should have documented in section 6) the therapeutic risks/benefits and the risks/benefits of no treatment according to hospital policy.

Based on interviews and record reviews the hospital failed to ensure that anesthesia consents were properly executed for patients prior to surgical interventions that required anesthesia. This failed practice was evidenced by 5 of 5 patient anesthesia consents ( #4, #5, #6, #7, #8) reviewed out of 35 sampled medical records, with no documented evidence on the anesthesia consents that indicated why the type of anesthesia chosen for the patient was indicated and recommended according to the patient's condition.

Findings:

A review of the hospital policy titled "Informed Consent" provided by S1 CNO as the most current policy revealed an anesthesia consent should document appropriate documentation on the anesthesia consent of the discussions of the contemplated administration of anesthesia with the patient in relation to the patient's condition.

A review of the form titled "Anesthesia Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information" revealed section 2) Treatment Procedure: the anesthesiologist was to indicate the type of anesthesia (General, Epidural, Spinal, Regional or Monitored Anesthesia Care) that the patient was being consented. In section 3) Patient's Condition: the anesthesiologist was to document the reason why the type of anesthesia indicated in section 2) was indicated and recommended in regard to the patient's diagnoses, medical condition and the surgical procedure to be performed.

Patient #4
The patient was admitted to the hospital on 04/01/13 for a scheduled left inguinal hernia repair with mesh. A review of Patient #4's Anesthesia Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information form, revealed section 3) Patient's Condition was left blank.

Patient #5
The patient was admitted to the hospital on 04/01/13 for a scheduled insertion of a subclavian venous access port. A review of Patient #5's Anesthesia Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information form, revealed section 3) Patient's Condition was left blank.

Patient #6
The patient was admitted to the hospital on 04/01/13 for a scheduled Pterygium excision. A review of Patient #6's Anesthesia Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information form, revealed section 3) Patient's Condition was left blank.

Patient #7
The patient was admitted to the hospital on 04/01/13 for a scheduled Pterygium excision. A review of Patient #5's Anesthesia Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information form, revealed section 3) Patient's Condition was left blank.

Patient #8
The patient was admitted to the hospital on 04/01/13 for a scheduled Pterygium excision. A review of Patient #5's Anesthesia Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information form, revealed section 3) Patient's Condition was left blank.

An interview on 04/01/13 at 10:45 a.m. was conducted with S27Anesthesiologist. The Anesthesia Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information form was reviewed with S27Anesthesiologist. S27Anesthesiologist was made aware that section 3) Patient's Condition was left blank on 5 of 5 Anesthesia Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information forms. He indicated he was not aware he was supposed to fill out that section.