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25065

Based on record review and interview, the hospital failed to ensure an updated examination of the patient was completed and documented prior to surgery when the medical history and physical examination are completed within 30 days before admission for 2 of 11 sampled patients (#F1, #F6). Findings:

Patient #F1
Review of Patient #F1's medical record revealed she had a left thyroid lobectomy with frozen section on 05/31/12. Review of her "History and Physical" (H&P) revealed it was performed on 05/24/12. Further review revealed no documented evidence that the H&P was updated by the physician prior to the surgical procedure on 05/31/12.

Patient #F6
Review of Patient #F6's medical record revealed he had a laparoscopic cholecystectomy and laparoscopic Nissen Fundoplication on 06/01/12. Review of his H&P revealed it was completed on 05/09/12. Further review revealed the H&P was updated on 06/01/12 with no documented evidence of the time that the H&P update was performed. There was no means of determining that the H&P was updated prior to the procedure.

In a face-to-face interview on 06/01/12 at 11:15am, SF1 Administrator indicated she had sent a certified letter to all credentialed physicians to notify them that the H&P had to be updated prior to the procedure and that all medical records had to be properly authenticated with the physician's signature that was dated and timed.

Review of a copy of the letter presented by SF1 Administrator that she sent to the credentialed physicians on 04/16/12 revealed, in part, "...Sent Via Certified Mail ... All medical records / orders shall be properly authenticated; to include the attending physicians signature, date and time of the signature ... All H and P's must be completed within 30 days before admission or registration, but prior to surgery Updated patient examinations, including any changes in the patient's condition, must be completed and documented within 24 hours after admission, but prior to surgery or procedure...".


26351

Based on record review and interviews, the hospital failed to ensure drugs were administered according to accepted standards of practice and hospital policy for 3 of 9 inpatients' records reviewed who received medications from a total sample of 11 patients (#F2, #F4, #F7). Findings:

Patient #F2
Review of Patient #F2's medical record revealed he had a Lumbar L5-S1 Transforaminal Interbody Fusion on 05/29/12.

Review of Patient #F2's "Physicians Orders" revealed a verbal clarification order on 05/29/12 with no documented evidence of the time the verbal order was received for Lortab 7.5 mg 1 tablet by mouth every 4-6 hours as needed for breakthrough pain scale of 1 to 4, Lortab 7.5 mg 2 tablets by mouth every 4-6 hours as needed for breakthrough pain scale of 5-10, Percocet 7.5 mg one tablet every 4-6 hours as needed for breakthrough pain scale of 1 to 4, and Percocet 7.5 mg 2 tablets by mouth every 4-6 hours as needed for pain scale 5-10. Further review revealed no documented evidence of a clarification order with specific time intervals that the Lortab and Percocet could be repeated. There was also no documented evidence of how the nurse was to determine whether to give Lortab or Percocet.

Patient #F4
Review of Patient #F4's medical record revealed she had a Left L2-5 Lumbar Laminectomy Decompression on 05/29/12.

Review of Patient #F4's "Physicians Orders" revealed a verbal order received on 05/29/12 at 10:55am for Dilaudid 0.5 mg SIVP (slow intravenous push) every 5 to 10 minutes up to 2 mg total for severe pain. Further review revealed no documented evidence of a clarification order with the specific time interval that Dilaudid could be repeated.

Patient #F7
Review of Patient #F7's medical record revealed she had a Right Total Knee Replacement on 05/29/12.

Review of Patient #F7's "Anesthesia PACU (post anesthesia care unit) Orders" revealed a verbal order received on 05/29/12 at 9:41am for Dilaudid 0.5 mg SIVP every 5 to 10 minutes up to 2 mg total for severe pain. Further review revealed no documented evidence of a clarification order with the specific time interval that Dilaudid could be repeated. Further review revealed a verbal order was received on 05/30/12 at 8:15am for Zofran 4 mg IVP (intravenous push) every 4-6 hours as needed for nausea. There was no documented evidence of a clarification order with the specific time interval that Zofran could be repeated.

In a face-to-face interval on 06/01/12 at 4:10pm, Director of Nursing SF2 offered no explanation when informed that record review revealed ranges were used for time intervals when medication doses could be repeated.

Review of the hospital policy titled "Routine Scheduled Medications", number PHM-041, reviewed 02/25/11, and presented by Director of Nursing SF2 as the current policy, revealed, in part, "...B. All pertinent information required for safe administration of medications shall be obtained, including drug, dose and strength, route, date, and time schedule...".

25065

Based on record review and interview, the hospital failed to ensure that all medical record entries were dated, timed, and authenticated for 3 of 11 sampled patients (#F3, #F8, #F11). Findings:

Patient #F3
Review of Patient #F3's medical record revealed she had a Laparoscopic Cholecystectomy on 05/31/12.

Review of Patient #F3's "Operative Progress Note" written 05/31/12 revealed no documented evidence of the time the note was written by the physician.

Patient #F8
Review of Patient #F8's medical record revealed he had a Laparoscopic Cholecystectomy on 05/17/12. Review of the "PACU (post anesthesia care unit) Flow Sheet" dated 05/17/12 revealed the post anesthesia note was signed by the anesthesiologist on 05/17/12 with no documented evidence of the time the note was signed.

Patient #F11
Review of Patient #F11's medical record revealed she had a Left Total Knee Replacement on 05/21/12. Review of the Medical Management Consult revealed no documented evidence of the date and time the examination was performed and documented.

In a face-to-face interview on 06/01/12 at 11:15am, SF1 Administrator indicated she had sent a certified letter to all credentialed physicians to notify them that all medical record entries had to be properly authenticated to include the physician's signature with the date and time.

Review of a copy of the letter presented by SF1 Administrator that she sent to the credentialed physicians on 04/16/12 revealed, in part, "...Sent Via Certified Mail ... All medical records / orders shall be properly authenticated; to include the attending physicians signature, date and time of the signature ...".




26351

25065

Based on record review and interview, the hospital failed to ensure all verbal orders were authenticated, dated, and timed by the physician within 48 hours for 8 of 11 sampled patients (#F2, #F3, #F4, #F5, #F6, #F7, #F9, #F11). Findings:

Patient #F2
Review of Patient #F2's medical record revealed he had a Lumbar L5-S1 Transforaminal Interbody Fusion on 05/29/12.

Review of Patient #F2's "Physician Orders" revealed telephone and verbal orders received on 05/29/12 at 5:45pm (2 separate orders) and 05/30/12 at 9:00am had not been signed within 48 hours. Further review revealed a verbal order given on 05/29/12 at 6:40pm was signed with no documented evidence of the date and time the physician signed the order. Further review revealed a verbal clarification order received on 05/29/12, with no documented evidence of the time the order was received by the nurse, had not been signed by the physician within 48 hours.

Patient #F3
Review of Patient #F3's medical record revealed she had a Laparoscopic Cholecystectomy on 05/31/12.

Review of Patient #F3's "Anesthesia PCA (patient controlled analgesia) Orders" no documented evidence of the time the anesthesiologist signed the standing order on 05/31/12.

Patient #F4
Review of Patient #F4's medical record revealed she had a Left L2-5 Lumbar Laminectomy Decompression on 05/29/12.

Review of Patient #F4's "Anesthesia PACU (post anesthesia care unit) Orders" revealed no documented evidence of the time the anesthesiologist signed the standing order on 05/29/12. Further review revealed a verbal order received on 05/29/12 at 10:55am with no documented evidence of the time the anesthesiologist signed the verbal order.

Patient #F5
Review of Patient #F5's medical record revealed she had a Laproscopic Banding on 05/31/12.

Review of Patient #F5's "Anesthesia Order Sheet" revealed no documented evidence of the time the anesthesiologist signed the verbal order on 05/31/12.

Patient #F6
Review of Patient #F6's medical record revealed he had a Laparoscopic Cholecystectomy and Nissen Fundoplication on 06/01/12.

Review of Patient #F6's "Anesthesia PACU Orders" revealed no documented evidence of the time the anesthesiologist signed the standing order on 06/01/12.

Patient #F7
Review of Patient #F7's medical record revealed she had a Right Total Knee Replacement on 05/29/12.

Review of Patient #F7's "Physicians Orders" revealed no documented evidence of the date and time the physician signed the verbal orders given on 05/29/12 at 12:00pm, 05/29/12 at 1:15pm, 05/29/12 at 1:30pm, and 05/30/12 at 8:15am. Further review revealed no documented evidence of the date and time the physician signed a standing order written by the nurse on 05/30/12 at 12:30am.

Patient #F9
Review of Patient #F9's medical record revealed he had a Laparoscopic Cholecystectomy on 05/17/12. Review of Patient #F9's orders revealed a verbal order given on 05/18/12 at 8:00am had no documented evidence of the date and time the physician signed the verbal order.

Patient #F11
Review of Patient #F11's medical record revealed she had a Left Total Knee Replacement on 05/21/12. Review of Patient #F11's "Anesthesia Order Sheet - PACU" revealed no documented evidence that the verbal order received on 05/21/12 at 11:14am had been signed within 48 hours by the physician. Review of the "Physicians Orders" revealed that telephone/verbal orders received on 05/2112 at 12:10pm, 05/21/12 at 12:55pm, 05/23/12 at 5:10pm, 05/24/12 at 9:41am, and 05/24/12 at 12:23pm had no documented evidence that they were signed within 48 hours. Further review revealed verbal orders received 05/21/12 at 8:55pm, 05/23/12 at 8:00am, and 05/24/12 at 7:30am had no documented evidence of the date and time the physician signed the verbal orders.

In a face-to-face interview on 06/01/12 at 11:15am, SF1 Administrator indicated she had sent a certified letter to all credentialed physicians to notify them that verbal orders had to be properly authenticated with the physician's signature that was dated and timed within 48 hours of the order being given.

Review of a copy of the letter presented by SF1 Administrator that she sent to the credentialed physicians on 04/16/12 revealed, in part, "...Sent Via Certified Mail ... All medical records / orders shall be properly authenticated; to include the attending physicians signature, date and time of the signature All verbal or telephone orders must be signed by the attending physician within 48 hours...".



26351

Based on record review and interviews, the hospital failed to meet the requirements for the Condition of Participation for Pharmaceutical Services as evidenced by:

1) Failing to ensure the pharmacy services was administered according to accepted professional principles. The pharmacist failed to review all medication orders prior to dispensing the first dose of medication and review the physician's medication order and patient record for known allergies, therapy contraindications, dose and route of administration, directions for use, duplication of therapy, interactions, and optimum therapeutic outcomes as required by the Louisiana Board of Pharmacy for 6 of 9 inpatients' charts reviewed who received medications from a sample of 11 patients (#F2, #F3, #F4, #F5, #F7, #F11). This resulted in physician orders with ranges in time interval being accepted with the nurse making the decision regarding the specific time interval for 3 of 9 inpatients' charts reviewed who received medications from a sample of 11 patients (#F2, #F4, #F7). The pharmacist failed to ensure patients' home medications ordered by the physician to be resumed and used while in the hospital were identified by the pharmacist prior to the nurse administering the home medications for 3 of 9 inpatients' charts reviewed who received home medications from a sample of 11 patients (#F2, #F3, #F11) (see findings in tag A0491).

2) Failing to ensure the consulting pharmacist was responsible for developing, supervising, and coordinating all the activities of the pharmacy services. The consulting pharmacist failed to comply with his responsibilities agreed upon in the professional services agreement with the hospital and as required by the Louisiana Board of Pharmacy related to review of medication orders prior to the first dose being administered ( #F2, #F3, #F4, #F5, #F7, #F11) and to identification of patients' home medications prior to the medications being administered (#F2, #F3, #F11) for 6 of 9 inpatients' charts reviewed who received medications from a sample of 11 patients (see findings in tag A0492).

Based on record review and interviews, the hospital failed to ensure the pharmacy was administered according to accepted professional principles. 1) The hospital failed to ensure the pharmacist reviewed all medication orders prior to dispensing the first dose of medication and reviewed the physician's medication order and patient record for known allergies, therapy contraindications, dose and route of administration, directions for use, duplication of therapy, interactions, and optimum therapeutic outcomes as required by the Louisiana Board of Pharmacy for 6 of 9 inpatients' charts reviewed who received medications from a sample of 11 patients (#F2, #F3, #F4, #F5, #F7, #F11). This resulted in physician orders with ranges in time interval being accepted with the nurse making the decision regarding the specific time interval for 3 of 9 inpatients' charts reviewed who received medications from a sample of 11 patients (#F2, #F4, #F7). 2) The hospital failed to ensure patients' home medications ordered by the physician to be resumed and used while in the hospital were identified by the pharmacist prior to the nurse administering the home medications for 3 of 9 inpatients' charts reviewed who received home medications from a sample of 11 patients (#F2, #F3, #F11). Findings:

1) The hospital failed to ensure the pharmacist reviewed all medication orders prior to dispensing the first dose of medication and reviewed the physician's medication order and patient record for known allergies, therapy contraindications, dose and route of administration, directions for use, duplication of therapy, interactions, and optimum therapeutic outcomes:
Patient #F2
Review of Patient #F2's medical record revealed he had a Lumbar L5-S1 Transforaminal Interbody Fusion on 05/29/12.

Review of Patient #F2's "Physicians Orders" revealed a verbal clarification order on 05/29/12 with no documented evidence of the time the verbal order was received for Lortab 7.5 mg 1 tablet by mouth every 4-6 hours as needed for breakthrough pain scale of 1 to 4, Lortab 7.5 mg 2 tablets by mouth every 4-6 hours as needed for breakthrough pain scale of 5-10, Percocet 7.5 mg one tablet every 4-6 hours as needed for breakthrough pain scale of 1 to 4, and Percocet 7.5 mg 2 tablets by mouth every 4-6 hours as needed for pain scale 5-10. Further review revealed no documented evidence of a clarification order with specific time intervals that the Lortab and Percocet could be repeated. There was also no documented evidence of how the nurse was to determine whether to give Lortab or Percocet.

Review of Patient #F2's "Physicians Orders" revealed a telephone order received on 05/29/12 at 5:45pm to apply a thin layer of Bactroban ointment to the affected area under the right eye three times a day. Review of the MAR revealed Bactroban was applied at 9:00pm on 05/29/12, and the pharmacist reviewed the medication order on 05/30/12 at 8:30am, 11 hours and 30 minutes after the medication was applied. Further review revealed a verbal order received 05/29/12 at 6:40pm for Lyrica 100 mg by mouth in the morning and at night and Niaspan ER 500 mg by mouth every night. Review of the MAR (medication administration record) revealed Lyrica and Niaspan were administered on 05/29/12 at 9:00pm, and the pharmacist reviewed the medication order on 05/30/12 at 8:30am, 9 hours 50 minutes after the first dose was administered. Further review revealed a telephone order was received on 05/30/12 at 4:40pm for Fioricet 50 mg by mouth every 4 hours as needed for headache. Review of the MAR revealed Patient #F2 received Fioricet on 05/30/12 at 5:00pm and 9:00pm, and the pharmacist reviewed the medication order on 05/31/12 at 10:00am, 17 hours after the first dose was administered and 13 hours after the second dose was administered.

Patient #F3
Review of Patient #F3's medical record revealed she had a Laparoscopic Cholecystectomy on 05/31/12.

Review of Patient #F3's "PSU Cholecystectomy Admit Orders" dated 05/31/12 at 11:40am revealed an order for Vicodin 5 mg one tablet by mouth every 4 hours as needed for pain for pain level of 104, if no relief in 30 minutes may administer additional Vicodin 5 mg one tablet by mouth and Vicodin 5 mg 2 tablets by mouth every 4 hours as needed for pain level of 5-10. Review of the MAR revealed Patient #F3 received Vicodin 5 mg 2 tablets on 05/31/12 at 1:10pm, and the pharmacist reviewed the medication order on 05/31/12 at 1:30pm, 1hour 50 minutes after the order was received and 20 minutes after the medication was administered.

Patient #F4
Review of Patient #F4's medical record revealed she had a Left L2-5 Lumbar Laminectomy Decompression on 05/29/12.

Review of Patient #F4's "Physicians Orders" revealed a verbal order received on 05/29/12 at 10:55am for Dilaudid 0.5 mg SIVP (slow intravenous push) every 5 to 10 minutes up to 2 mg total for severe pain. Further review revealed no documented evidence of a clarification order with the specific time interval that Dilaudid could be repeated.

Review of Patient #F4's "Physicians Orders" revealed a telephone order received on 05/31/12 at 8:10am for Flexeril 10 mg one tablet by mouth every 8 hours as needed for muscle spasms. Further review revealed an order on 05/31/12 at 9:30am for Lyrica 75 mg by mouth twice a day. Review of the MAR revealed Patient #F4 received Flexeril on 05/31/12 at 8:15am, and the pharmacist reviewed the medication order on 05/31/12 at 4:10pm, 7 hours 55 minutes after the first dose was administered. Further review revealed she received Lyrica on 05/31/12 at 10:00am, and the pharmacist reviewed the medication order on 05/31/12 at 4:10pm, 6 hours and 10 minutes after the first dose was administered.

Patient #F5
Review of Patient #F5's medical record revealed she had a Laproscopic Banding on 05/31/12.

Review of Patient #F5's "Laparoscopic Gastric Banding Post-Op Orders" dated 05/31/12 at 11:00am revealed an order for Protonix 40 mg IV (intravenous) every day. Review of the MAR revealed Protonix was administered on 05/31/12 at 1:00pm, and the pharmacist reviewed the medication order on 05/31/12 at 2:20pm, 1 hour 20 minutes after the first dose was administered and 3 hours 20 minutes after the order was received.

Review of Patient #F5's "Physicians Orders" revealed a telephone order received on 05/31/12 at 12:50pm for Lortab Elixir 2 teaspoons by mouth every 4 hours as needed for pain level of 1 to 5. Review of the MAR revealed Lortab Elixir was administered on 05/31/12 at 1:00pm, and the pharmacist reviewed the medication order on 05/31/12 at 2:20pm, 1 hour and 20 minutes after the first dose was administered.

Patient #F7
Review of Patient #F7's medical record revealed she had a Right Total Knee Replacement on 05/29/12.

Review of Patient #F7's "Anesthesia PACU (post anesthesia care unit) Orders" revealed a verbal order received on 05/29/12 at 9:41am for Dilaudid 0.5 mg SIVP every 5 to 10 minutes up to 2 mg total for severe pain. Further review revealed no documented evidence of a clarification order with the specific time interval that Dilaudid could be repeated.

Review of Patient #F7's "Physicians Orders" revealed a standing order written on 05/30/12 at 12:30am for Benadryl 25 mg by mouth every 6 hours as needed for itching. Review of the MAR revealed Benadryl was administered on 05/30/12 at 12:30am, and the pharmacist reviewed the medication order on 05/30/12 at 8:30am, 8 hours after the medication was administered. Further review revealed a verbal order was received on 05/30/12 at 8:15am for Zofran 4 mg IVP (intravenous push) every 4-6 hours as needed for nausea. Review of the MAR revealed Zofran was administered on 05/30/12 at 8:15am, and the pharmacist reviewed the medication order on 05/30/12 at 8:30am, 15 minutes after the medication was administered.

Patient #F11
Review of Patient #F11's medical record revealed she had a Left Total Knee Replacement on 05/21/12.

Review of Patient #F11's MAR revealed the following medications were administered during her hospital stay with no documented evidence that the medication orders were reviewed prior to the first dose being administered:
PCA Morphine 20 mg every 2 hours initiated on 05/21/12 at 12:30pm and 05/22/12 at 11:10pm;
Percocet 5 mg 2 tablets by mouth on 05/23/12 at 8:15am;
Ultram 50 mg 2 tablets by mouth on 05/23/12 at 8:25pm and 05/24/12 at 9:00am;
Benadryl 25 mg by mouth on 05/23/12 at 12:45pm;
Tylenol 650 mg by mouth on 05/23/12 at 12:45pm; Lasix 20 mg IV on 05/23/12 at 4:05pm and 05/23/12 at 8:15pm;
Lovenox 30 mg subcutaneously at 6:00am and 6:00pm on 05/22/12 and 05/23/12 and at 6:00am on 05/24/12;
Ramipril 5 mg by mouth at 9:00pm on 05/21/12 and at 3:00pm and 9:00pm on 05/22/12 and 05/23/12;
Ramipril 10 mg by mouth at 9:00am on 05/22/12, 05/23/12, and 05/24/12;
Trazadone 50 mg by mouth at 9:00pm on 05/21/12, 05/22/12, and 05/23/12;
Alphagan P Ophthalmic Solution at 9:00pm on 05/21/12 and at 9:00am, 12:00pm, and 9:00pm on 05/22/12 and 05/23/12;
Latanoprost Ophthalmic Solution at 9:00pm on 05/21/12, 05/22/12, and 05/23/12;
Hydrochlorothiazide 12.5 mg by mouth at 9:00am on 05/22/12, 05/23/12, and 05/24/12;
Omeprazole 20 mg by mouth at 9:00am on 05/22/12, 05/23/12, and 05/24/12;
Norvasc 5 mg by mouth at 9:00pm on 05/22/12 and 05/23/12; and
Metoprolol 25 mg by mouth at 5:10pm on 05/23/12.

Review of Contract Pharmacist SF5's and SF6's "Professional Services Agreement" dated 05/01/12 revealed, in part, "...3. Responsibilities. The Consultant is responsible for the overall administration of the Hospital's pharmaceutical services and is responsible for developing, implementing, supervising, and coordinating all activities of Hospital's pharmaceutical services in order to ensure compliance with local, state, and federal rules. ... Consultant must: ...c. Direct and serve as a resource person to the Hospital's employees and physicians regarding the actions, interactions, compatibility, dosage, indications, and possible adverse reactions of all pharmaceutical products. ... k. Review all physician's medication orders and patient record for known allergies, therapy contraindications, dose and route administration, directions for use, duplication of therapy, interactions, and optimum therapeutic outcomes in accordance with prescribed guidelines...".

In a telephone interview on 06/01/12 at 2:25pm, Contract Pharmacist SF5 indicated that PSU had been faxing physicians' orders to Company A, and he or Contract Pharmacist SF6 would review the order, make a notation of the date and time of their review, and fax the order back to the hospital. SF5 further indicated that he usually came to the hospital about 3:30pm to review orders, and whatever was written after that time was reviewed the next morning at whatever time the pharmacist came to the hospital. He further indicated that the pharmacist did not review patients' medication orders after 3:30pm or 4:30pm, unless the nurse called the pharmacist after hours.

In a face-to-face interview on 06/01/12 at 4:10pm, Director of Nursing SF2 indicated the policy for the first dose review by the pharmacist was in development. When asked why the policy had not been revised to address the identified problems from the last survey, SF2 indicated she didn't know how to formulate a policy when they were trying to work out the kinks in the system. She further indicated that the process of faxing that was described by the pharmacist had not started until this week.

In a face-to-face interview on 06/01/12 at 4:33pm, SF3 Compliance Officer indicated that Contract Pharmacist SF6 had said that pain and nausea medications did not have to have a pharmacist's review before the first dose was administered.

Review of the "Louisiana Administrative Code Title 46 - Professional and Occupational Standards Part LIII: Pharmacists Chapter 15. Hospital Pharmacy", revealed, in part, "...1511. Prescription Drug Orders A. The pharmacist shall review the practitioner's medical order prior to dispensing the initial dose of medication, except in cases of emergency...". Further review of definitions listed revealed, in part, "...(13) "Drug regimen review" means and includes, but is not limited to, the following activities: (a) Review of the prescription drug order and patient record for [i] known allergies, [ii] therapy contraindications, [iii] dose and route of administration, and [iv] directions for use, (b) Review of the prescription drug order and patient record for duplication of therapy, (c) Review of the prescription drug order and patient record for interactions, and (d) Review of the prescription drug order and patient record for proper utilization including over- or under-utilization, and optimum therapeutic outcomes...".

2) The hospital failed to ensure patients' home medications ordered by the physician to be resumed and used while in the hospital were identified by the pharmacist prior to the nurse administering the home medications:
Patient #F2
Review of Patient #F2's medical record revealed he had a Lumbar L5-S1 Transforaminal Interbody Fusion on 05/29/12.

Review of Patient #F2's "Physicians Orders" revealed a verbal order received 05/29/12 at 6:40pm to resume his home medications which included Lipitor 20 mg one by mouth every morning, Cymbalta 40 mg one by mouth every day at noon, Lyrica 100 mg by mouth in the morning and at night, Bystolic 5 mg one by mouth every day at noon, Niaspan ER 500 mg one by mouth every night, and Nexium DR 40 mg one by mouth every morning. Review of the MAR and the progress notes revealed no documented evidence that the medications were identified by the pharmacist.

In a face-to-face interview on 06/01/12 at 10:40am, PSU (post surgical unit) Coordinator RN SF4 confirmed there was no documentation that the pharmacist had identified Patient #F2's home medications.

Patient #F3
Review of Patient #F3's medical record revealed she had a Laparoscopic Cholecystectomy on 05/31/12.

Review of Patient #F3's "Physicians Orders" revealed a telephone clarification order on 05/31/12 at 1:30pm to resume her home medications which included Atenolol 25 mg by mouth daily, Metformin 500 mg by mouth daily, Isosorbide Dinatrate 20 mg by mouth twice a day, Lovaza 1 gram by mouth twice a day, Dexilant 60 mg by mouth daily, Lovastatin 20 mg by mouth at bedtime, Exforge HCT 5-160-25 mg one by mouth daily, Aspirin 81 mg by mouth daily to begin 06/01/12, and Plavix 75 mg by mouth daily to begin 06/01/12. Review of the MAR and the progress notes revealed no documented evidence that the medications were identified by the pharmacist.

In a face-to-face interview on 06/01/12 at 11:00am, PSU Coordinator RN SF4 indicated that it was not clear if the pharmacist had inspected and identified Patient #F3's home medications or just reviewed the medication order.

Patient #F11
Review of Patient #F11's medical record revealed she had a Left Total Knee Replacement on 05/21/12.

Review of Patient #F11's "Physicians Orders" revealed a verbal clarification order on 05/21/12 at 8:55pm to resume her home medications which included Ramipril 5 mg by mouth at 3:00pm and at bedtime, Ramipril 10 mg by mouth every morning, Trazodone 50 mg by mouth every night, Alphagan P Ophthalmic Solution 0.1 % (per cent) 5 ml (milliliters) one drop in the left eye three times a day, Latanoprost Ophthalmic Solution 0.005 % 2.5 ml one drop in both eyes every night, Hydrochlorothiazide 12.5 mg by mouth every morning, and Omeprazole 20 mg by mouth every morning. Review of the MAR and the progress notes revealed no documented evidence that the medications were identified by the pharmacist.

Review of Contract Pharmacist SF5's and SF6's "Professional Services Agreement" dated 05/01/12 revealed, in part, "...3. Responsibilities. The Consultant is responsible for the overall administration of the Hospital's pharmaceutical services and is responsible for developing, implementing, supervising, and coordinating all activities of Hospital's pharmaceutical services in order to ensure compliance with local, state, and federal rules. ... Consultant must: ...c. Direct and serve as a resource person to the Hospital's employees and physicians regarding the actions, interactions, compatibility, dosage, indications, and possible adverse reactions of all pharmaceutical products. ... k. Review all physician's medication orders and patient record for known allergies, therapy contraindications, dose and route administration, directions for use, duplication of therapy, interactions, and optimum therapeutic outcomes in accordance with prescribed guidelines. l. Ensure that all physician-ordered patient home medications that are to be resumed and/or used while in the Hospital are identified prior to administration...".

In a telephone interview on 06/01/12 at 2:25pm, Contract Pharmacist SF5 indicated that PSU had been faxing physicians' orders to Company A, and he or Contract Pharmacist SF6 would review the order, make a notation of the date and time of their review, and fax the order back to the hospital. He further indicated that he did not visually identify the patients' home medications. SF5 indicated that SF6 had said that he felt that a retail pharmacist had filled the patients' home medications and they were being brought to the hospital in the pharmacy container. SF5 indicated he usually came to the hospital about 3:30pm to review orders, and whatever was written after that time was reviewed the next morning at whatever time the pharmacist came to the hospital. He further indicated that the pharmacist did not review patients' medication orders after 3:30pm or 4:30pm, unless the nurse called the pharmacist after hours.

In a face-to-face interview on 06/01/12 at 4:10pm, Director of Nursing SF2 indicated the policy for the first dose review by the pharmacist was in development. When asked why the policy had not been revised to address the identified problems from the last survey, SF2 indicated she didn't know how to formulate a policy when they were trying to work out the kinks in the system. She further indicated that the process of faxing that was described by the pharmacist had not started until this week.

In a face-to-face interview on 06/01/12 at 4:10pm (same interview held with Director of Nursing SF2), SF1 Administrator indicated the nurses were told to use the hospital's medications if the patients' home medications had not been reviewed by the pharmacist, but this had not been added to the hospital policy yet.

In a face-to-face interview on 06/01/12 at 4:33pm, SF3 Compliance Officer indicated that Contract Pharmacist SF6 had said that pain and nausea medications did not have to have a pharmacist's review before the first dose was administered.

Review of the hospital policy titled "Medications Brought From Home", policy number PHM-014, reviewed 03/14/12, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...Policy: Patient's home medications will be brought from home only at the discretion of the physician or attending anesthesiologist. Prescription medications must be properly labeled. Procedure: ... C. An order will be written on the patient's chart and signed by the attending physician or anesthesiologist ordering use of home medication. This order will give the nursing personnel permission to administer the private drug to the patient as ordered by the attending physician or anesthesiologist. ... E. Home medication orders for patients remaining in the hospital's Post Surgical Unit will require that home prescriptions be brought in by the patient/family and turned over to the hospital nursing staff for dispensing...".

Review of the "Louisiana Administrative Code Title 46 - Professional and Occupational Standards Part LIII: Pharmacists Chapter 15. Hospital Pharmacy", revealed, in part, "...1511. Prescription Drug Orders A. The pharmacist shall review the practitioner's medical order prior to dispensing the initial dose of medication, except in cases of emergency...". Further review of definitions listed revealed, in part, "...(13) "Drug regimen review" means and includes, but is not limited to, the following activities: (a) Review of the prescription drug order and patient record for [i] known allergies, [ii] therapy contraindications, [iii] dose and route of administration, and [iv] directions for use, (b) Review of the prescription drug order and patient record for duplication of therapy, (c) Review of the prescription drug order and patient record for interactions, and (d) Review of the prescription drug order and patient record for proper utilization including over- or under-utilization, and optimum therapeutic outcomes...".






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26351

Based on record review and interviews, the hospital failed to ensure the consulting pharmacist was responsible for developing, supervising, and coordinating all the activities of the pharmacy services. The consulting pharmacy failed to comply with his responsibilities agreed upon in the professional services agreement with the hospital related to review of medication orders prior to the first dose being administered and as required by the Louisiana Board of Pharmacy ( #F2, #F3, #F4, #F5, #F7, #F11) and to identification of patients' home medications prior to the medications being administered (#F2, #F3, #F11) for 6 of 9 inpatients' charts reviewed who received medications from a sample of 11 patients. Findings:

Review of Contract Pharmacist SF5's and SF6's "Professional Services Agreement" dated 05/01/12 revealed, in part, "...3. Responsibilities. The Consultant is responsible for the overall administration of the Hospital's pharmaceutical services and is responsible for developing, implementing, supervising, and coordinating all activities of Hospital's pharmaceutical services in order to ensure compliance with local, state, and federal rules. ... Consultant must: ...c. Direct and serve as a resource person to the Hospital's employees and physicians regarding the actions, interactions, compatibility, dosage, indications, and possible adverse reactions of all pharmaceutical products. ... k. Review all physician's medication orders and patient record for known allergies, therapy contraindications, dose and route administration, directions for use, duplication of therapy, interactions, and optimum therapeutic outcomes in accordance with prescribed guidelines. l. Ensure that all physician-ordered patient home medications that are to be resumed and/or used while in the Hospital are identified prior to administration...".

Patient #F2
Review of Patient #F2's medical record revealed he had a Lumbar L5-S1 Transforaminal Interbody Fusion on 05/29/12.

Review of Patient #F2's "Physicians Orders" revealed a verbal clarification order on 05/29/12 with no documented evidence of the time the verbal order was received for Lortab 7.5 mg 1 tablet by mouth every 4-6 hours as needed for breakthrough pain scale of 1 to 4, Lortab 7.5 mg 2 tablets by mouth every 4-6 hours as needed for breakthrough pain scale of 5-10, Percocet 7.5 mg one tablet every 4-6 hours as needed for breakthrough pain scale of 1 to 4, and Percocet 7.5 mg 2 tablets by mouth every 4-6 hours as needed for pain scale 5-10. Further review revealed no documented evidence of a clarification order with specific time intervals that the Lortab and Percocet could be repeated. There was also no documented evidence of how the nurse was to determine whether to give Lortab or Percocet.

Review of Patient #F2's "Physicians Orders" revealed a telephone order received on 05/29/12 at 5:45pm to apply a thin layer of Bactroban ointment to the affected area under the right eye three times a day. Review of the MAR revealed Bactroban was applied at 9:00pm on 05/29/12, and the pharmacist reviewed the medication order on 05/30/12 at 8:30am, 11 hours and 30 minutes after the medication was applied. Further review revealed a verbal order received 05/29/12 at 6:40pm for Lyrica 100 mg by mouth in the morning and at night and Niaspan ER 500 mg by mouth every night. Review of the MAR (medication administration record) revealed Lyrica and Niaspan were administered on 05/29/12 at 9:00pm, and the pharmacist reviewed the medication order on 05/30/12 at 8:30am, 9 hours 50 minutes after the first dose was administered. Further review revealed a telephone order was received on 05/30/12 at 4:40pm for Fioricet 50 mg by mouth every 4 hours as needed for headache. Review of the MAR revealed Patient #F2 received Fioricet on 05/30/12 at 5:00pm and 9:00pm, and the pharmacist reviewed the medication order on 05/31/12 at 10:00am, 17 hours after the first dose was administered and 13 hours after the second dose was administered.

Review of Patient #F2's "Physicians Orders" revealed a verbal order received 05/29/12 at 6:40pm to resume his home medications which included Lipitor 20 mg one by mouth every morning, Cymbalta 40 mg one by mouth every day at noon, Lyrica 100 mg by mouth in the morning and at night, Bystolic 5 mg one by mouth every day at noon, Niaspan ER 500 mg one by mouth every night, and Nexium DR 40 mg one by mouth every morning. Review of the MAR and the progress notes revealed no documented evidence that the medications were identified by the pharmacist.

In a face-to-face interview on 06/01/12 at 10:40am, PSU (post surgical unit) Coordinator RN SF4 confirmed there was no documentation that the pharmacist had identified Patient #F2's home medications.

Patient #F3
Review of Patient #F3's medical record revealed she had a Laparoscopic Cholecystectomy on 05/31/12.

Review of Patient #F3's "PSU Cholecystectomy Admit Orders" dated 05/31/12 at 11:40am revealed an order for Vicodin 5 mg one tablet by mouth every 4 hours as needed for pain for pain level of 104, if no relief in 30 minutes may administer additional Vicodin 5 mg one tablet by mouth and Vicodin 5 mg 2 tablets by mouth every 4 hours as needed for pain level of 5-10. Review of the MAR revealed Patient #F3 received Vicodin 5 mg 2 tablets on 05/31/12 at 1:10pm, and the pharmacist reviewed the medication order on 05/31/12 at 1:30pm, 1hour 50 minutes after the order was received and 20 minutes after the medication was administered.

Review of Patient #F3's "Physicians Orders" revealed a telephone clarification order on 05/31/12 at 1:30pm to resume her home medications which included Atenolol 25 mg by mouth daily, Metformin 500 mg by mouth daily, Isosorbide Dinatrate 20 mg by mouth twice a day, Lovaza 1 gram by mouth twice a day, Dexilant 60 mg by mouth daily, Lovastatin 20 mg by mouth at bedtime, Exforge HCT 5-160-25 mg one by mouth daily, Aspirin 81 mg by mouth daily to begin 06/01/12, and Plavix 75 mg by mouth daily to begin 06/01/12. Review of the MAR and the progress notes revealed no documented evidence that the medications were identified by the pharmacist.

In a face-to-face interview on 06/01/12 at 11:00am, PSU Coordinator RN SF4 indicated that it was not clear if the pharmacist had inspected and identified Patient #F3's home medications or just reviewed the medication order.

Patient #F4
Review of Patient #F4's medical record revealed she had a Left L2-5 Lumbar Laminectomy Decompression on 05/29/12.

Review of Patient #F4's "Physicians Orders" revealed a verbal order received on 05/29/12 at 10:55am for Dilaudid 0.5 mg SIVP (slow intravenous push) every 5 to 10 minutes up to 2 mg total for severe pain. Further review revealed no documented evidence of a clarification order with the specific time interval that Dilaudid could be repeated.

Review of Patient #F4's "Physicians Orders" revealed a telephone order received on 05/31/12 at 8:10am for Flexeril 10 mg one tablet by mouth every 8 hours as needed for muscle spasms. Further review revealed an order on 05/31/12 at 9:30am for Lyrica 75 mg by mouth twice a day. Review of the MAR revealed Patient #F4 received Flexeril on 05/31/12 at 8:15am, and the pharmacist reviewed the medication order on 05/31/12 at 4:10pm, 7 hours 55 minutes after the first dose was administered. Further review revealed she received Lyrica on 05/31/12 at 10:00am, and the pharmacist reviewed the medication order on 05/31/12 at 4:10pm, 6 hours and 10 minutes after the first dose was administered.

Patient #F5
Review of Patient #F5's medical record revealed she had a Laproscopic Banding on 05/31/12.

Review of Patient #F5's "Laparoscopic Gastric Banding Post-Op Orders" dated 05/31/12 at 11:00am revealed an order for Protonix 40 mg IV (intravenous) every day. Review of the MAR revealed Protonix was administered on 05/31/12 at 1:00pm, and the pharmacist reviewed the medication order on 05/31/12 at 2:20pm, 1 hour 20 minutes after the first dose was administered and 3 hours 20 minutes after the order was received.

Review of Patient #F5's "Physicians Orders" revealed a telephone order received on 05/31/12 at 12:50pm for Lortab Elixir 2 teaspoons by mouth every 4 hours as needed for pain level of 1 to 5. Review of the MAR revealed Lortab Elixir was administered on 05/31/12 at 1:00pm, and the pharmacist reviewed the medication order on 05/31/12 at 2:20pm, 1 hour and 20 minutes after the first dose was administered.

Patient #F7
Review of Patient #F7's medical record revealed she had a Right Total Knee Replacement on 05/29/12.

Review of Patient #F7's "Anesthesia PACU (post anesthesia care unit) Orders" revealed a verbal order received on 05/29/12 at 9:41am for Dilaudid 0.5 mg SIVP every 5 to 10 minutes up to 2 mg total for severe pain. Further review revealed no documented evidence of a clarification order with the specific time interval that Dilaudid could be repeated.

Review of Patient #F7's "Physicians Orders" revealed a standing order written on 05/30/12 at 12:30am for Benadryl 25 mg by mouth every 6 hours as needed for itching. Review of the MAR revealed Benadryl was administered on 05/30/12 at 12:30am, and the pharmacist reviewed the medication order on 05/30/12 at 8:30am, 8 hours after the medication was administered. Further review revealed a verbal order was received on 05/30/12 at 8:15am for Zofran 4 mg IVP (intravenous push) every 4-6 hours as needed for nausea. Review of the MAR revealed Zofran was administered on 05/30/12 at 8:15am, and the pharmacist reviewed the medication order on 05/30/12 at 8:30am, 15 minutes after the medication was administered.

Patient #F11
Review of Patient #F11's medical record revealed she had a Left Total Knee Replacement on 05/21/12.

Review of Patient #F11's "Physicians Orders" revealed a verbal clarification order on 05/21/12 at 8:55pm to resume her home medications which included Ramipril 5 mg by mouth at 3:00pm and at bedtime, Ramipril 10 mg by mouth every morning, Trazodone 50 mg by mouth every night, Alphagan P Ophthalmic Solution 0.1 % (per cent) 5 ml (milliliters) one drop in the left eye three times a day, Latanoprost Ophthalmic Solution 0.005 % 2.5 ml one drop in both eyes every night, Hydrochlorothiazide 12.5 mg by mouth every morning, and Omeprazole 20 mg by mouth every morning. Review of the MAR and the progress notes revealed no documented evidence that the medications were identified by the pharmacist.

Review of Patient #F11's MAR revealed the following medications were administered during her hospital stay with no documented evidence that the medication orders were reviewed prior to the first dose being administered:
PCA Morphine 20 mg every 2 hours initiated on 05/21/12 at 12:30pm and 05/22/12 at 11:10pm;
Percocet 5 mg 2 tablets by mouth on 05/23/12 at 8:15am;
Ultram 50 mg 2 tablets by mouth on 05/23/12 at 8:25pm and 05/24/12 at 9:00am;
Benadryl 25 mg by mouth on 05/23/12 at 12:45pm;
Tylenol 650 mg by mouth on 05/23/12 at 12:45pm; Lasix 20 mg IV on 05/23/12 at 4:05pm and 05/23/12 at 8:15pm;
Lovenox 30 mg subcutaneously at 6:00am and 6:00pm on 05/22/12 and 05/23/12 and at 6:00am on 05/24/12;
Ramipril 5 mg by mouth at 9:00pm on 05/21/12 and at 3:00pm and 9:00pm on 05/22/12 and 05/23/12;
Ramipril 10 mg by mouth at 9:00am on 05/22/12, 05/23/12, and 05/24/12;
Trazadone 50 mg by mouth at 9:00pm on 05/21/12, 05/22/12, and 05/23/12;
Alphagan P Ophthalmic Solution at 9:00pm on 05/21/12 and at 9:00am, 12:00pm, and 9:00pm on 05/22/12 and 05/23/12;
Latanoprost Ophthalmic Solution at 9:00pm on 05/21/12, 05/22/12, and 05/23/12;
Hydrochlorothiazide 12.5 mg by mouth at 9:00am on 05/22/12, 05/23/12, and 05/24/12;
Omeprazole 20 mg by mouth at 9:00am on 05/22/12, 05/23/12, and 05/24/12;
Norvasc 5 mg by mouth at 9:00pm on 05/22/12 and 05/23/12; and
Metoprolol 25 mg by mouth at 5:10pm on 05/23/12.

In a telephone interview on 06/01/12 at 2:25pm, Contract Pharmacist SF5 indicated that PSU had been faxing physicians' orders to Company A, and he or Contract Pharmacist SF6 would review the order, make a notation of the date and time of their review, and fax the order back to the hospital. He further indicated that he did not visually identify the patients' home medications. SF5 indicated that SF6 had said that he felt that a retail pharmacist had filled the patients' home medications and they were being brought to the hospital in the pharmacy container. SF5 indicated he usually came to the hospital about 3:30pm to review orders, and whatever was written after that time was reviewed the next morning at whatever time the pharmacist came to the hospital. He further indicated that the pharmacist did not review patients' medication orders after 3:30pm or 4:30pm, unless the nurse called the pharmacist after hours.

In a face-to-face interview on 06/01/12 at 4:10pm, Director of Nursing SF2 indicated the policy for the first dose review by the pharmacist was in development. When asked why the policy had not been revised to address the identified problems from the last survey, SF2 indicated she didn't know how to formulate a policy when they were trying to work out the kinks in the system. She further indicated that the process of faxing that was described by the pharmacist had not started until this week.

In a face-to-face interview on 06/01/12 at 4:10pm (same interview held with Director of Nursing SF2), SF1 Administrator indicated the nurses were told to use the hospital's medications if the patients' home medications had not been reviewed by the pharmacist, but this had not been added to the hospital policy yet.

In a face-to-face interview on 06/01/12 at 4:33pm, SF3 Compliance Officer indicated that Contract Pharmacist SF6 had said that pain and nausea medications did not have to have a pharmacist's review before the first dose was administered.

Review of the hospital policy titled "Medications Brought From Home", policy number PHM-014, reviewed 03/14/12, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...Policy: Patient's home medications will be brought from home only at the discretion of the physician or attending anesthesiologist. Prescription medications must be properly labeled. Procedure: ... C. An order will be written on the patient's chart and signed by the attending physician or anesthesiologist ordering use of home medication. This order will give the nursing personnel permission to administer the private drug to the patient as ordered by the attending physician or anesthesiologist. ... E. Home medication orders for patients remaining in the hospital's Post Surgical Unit will require that home prescriptions be brought in by the patient/family and turned over to the hospital nursing staff for dispensing...".

Review of the "Louisiana Administrative Code Title 46 - Professional and Occupational Standards Part LIII: Pharmacists Chapter 15. Hospital Pharmacy", revealed, in part, "...1511. Prescription Drug Orders A. The pharmacist shall review the practitioner's medical order prior to dispensing the initial dose of medication, except in cases of emergency...". Further review of definitions listed revealed, in part, "...(13) "Drug regimen review" means and includes, but is not limited to, the following activities: (a) Review of the prescription drug order and patient record for [i] known allergies, [ii] therapy contraindications, [iii] dose and route of administration, and [iv] directions for use, (b) Review of the prescription drug order and patient record for duplication of therapy, (c) Review of the prescription drug order and patient record for interactions, and (d) Review of the prescription drug order and patient record for proper utilization including over- or under-utilization, and optimum therapeutic outcomes...".