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Based on observation, record review, and interviews, the hospital failed to ensure:1) the contracted registered dietitian provided services to the hospital as required by her contract for 1 of 1 registered dietitian's contract reviewed (S43) 2) the contracted pharmacist provided services to the hospital as required by his contract for 1 of 1 contracted pharmacist's contract reviewed (S44). Findings:

1) Contracted Registered Dietitian:
Observation of the Post Surgical Unit's (PSU) freezer used for patient nourishments revealed the following: 4 popsicles in a tray labeled 04/04/11; 9 sugar-free popsicles in a tray labeled 04/12/11; 4 four ounce cartons of ice cream in trays with dates of 04/04/11 and 05/02/11; and 2 sugar-free cartons of ice cream in a tray dated 04/14/11. These observations were confirmed by Dietary Tech S42.

Review of Registered Dietitian (RD) S43's contract, signed 04/01/02, revealed her continuing services included quarterly assessment of the food provider, monthly visits to the hospital to observe meal service and to discuss any problems with meal service or patient assessments with staff, and to serve as a member and attend the quarterly Performance Improvement meeting.

Review of the Performance Improvement Committee meeting minutes for all meetings held in 2011 and 02/12/12 (the only meeting conducted in 2012) revealed no documented evidence that RD S43 had attended any of the meetings.

Review of the "Dietetic Consultation Report" dated January 2012, February 2012, and March 2012 revealed no documented evidence of the dates that RD S43 visited the hospital. Further review revealed each report had a check mark in the blank for the following areas: menus followed "(nursing home)"; refrigerators/freezers at proper temperatures; proper storage procedures; functions: patient meal service, patient visitation, patient assessment. Further review revealed no documented evidence of documentation in the sections titled "progress made since last report" and "recommendations". There was no documented evidence of which patients were visited, which patients were assessed, and that any patient charts were reviewed for accurate nutritional assessments.

Review of the "Temperature Record With Freezer" for the PSU for March 2012 revealed the refrigerator temperature was to be between 35 degrees and 45 degrees Fahrenheit (hospital policy revealed temperature should be between 35 and 41 degrees). Further review revealed the refrigerator temperature was out of range on 03/01/12 (33 degrees), 03/02/12 (32 degrees), 03/03/12 (32 degrees), and 03/04/12 (34 degrees). Further review revealed no documented evidence that action was taken to correct the temperature that were out of range.

Review of the "Temperature Record With Freezer" for the PSU for April 2012 revealed the refrigerator temperature was out of range on 04/01/12 (34 degrees), 04/02/12 (34 degrees), 04/05/12 (34 degrees), 04/07/12 (34 degrees), and 04/09/12 (34 degrees). Further review revealed no documented evidence that action was taken to correct the temperature that were out of range.

Review of Patient #2's "Nutritional Assessment" performed on 03/31/12 by Dietary Tech S12 revealed the plan to "discuss food/drug interactions" had "NKDA" (no known drug allergies) documented by S12. Review of Patient #2's "Admit History" dated 03/30/12 revealed she was allergic to Codeine, Aspirin, and Ibuprofen.

Review of Patient #4's "Nutritional Assessment" performed on 02/29/12 by Dietary Tech S42 revealed no documented evidence that Patient #4's "appetite" had been assessed as evidenced by the absence of a check mark in the boxes labeled "excellent (90-100%) Good (75-90%) Fair (50-75%) Poor (<50%)" (less than 50 per cent).

In a face-to-face interview on 04/12/12 at 11:03am, Administrator S1 indicated she did not have written evaluations of the hospital's food provider performed quarterly by RD S43 as required by S43's contract.

In a face-to-face interview on 04/12/12 at 11:20am, Dietary Tech S42 confirmed Patient #2's nutritional assessment had NKDA when Patient #2 was actually allergic to Codeine, Aspirin, and Ibuprofen. S42 indicated she did not document Patient #4's appetite when she did the initial assessment, because she waited to see what the patient ate during her hospital stay. S42 could offer no explanation for how she would determine in a change in the patient's appetite from the time of admission if she didn't assess the appetite on the initial nutritional assessment. S42 further indicated "I don't know why we do those anyway" (referring to the nutritional assessment). S42 provided RD S43's "Dietetic Consultation Report" for January 2012, February 2012, and March 2012. S42 indicated she did not know what day RD S43 actually visited the hospital. She further indicated RD S43 did not perform patient chart reviews during her visits.

Review of the hospital policy titled "Food Storage", policy number DTY-12, reviewed 01/16/12, and contained in a binder presented by Administrator S1 as current policies, revealed, in part, "...1. All stock must be rotated with each new order. ... Labels should be dated with the date item is received, with new items placed behind supply in stock of the same item. ... 6. Refrigerator temperatures: a. Temperatures for refrigerators should be between 35-41 degrees Fahrenheit and must be recorded daily...". Further review revealed no documented evidence of the action to be taken when the temperature was out of the acceptable range.

2) Contracted Registered Pharmacist:
Review of Registered Pharmacist S44 contract signed 04/10/2000 revealed the following services were to be provided: direct and serve as a resource person to the hospital's employees and physicians regarding the actions, interactions, compatability, dosage, indications, and possible adverse reactions of all pharmaceutical products; develop and evaluate on an annual basis appropriate policies and procedures directing the pharmacy-related activities and services of the hospital including medication procurement, dispensing, and administration; responsible for performance improvement in the pharmacy and attend and participate in the quarterly Pharmacy and Therapeutics Committee meetings; maintain the hospital's drug distribution system; perform chart reviews to ensure proper documentation of drug usage; and monitor all IV (intravenous) admixture usage.

In a face to face interview on 04/12/12 at 3:45pm Pharmacist S44 indicated his role in the facility was that of consultant and felt he was not responsible for the adminsitration of medication in the hospital. Further S44 confirmed he does not perform chart audits or participate in performance improvement.

Based on record review and interview the hospital failed to develop a process to ensure contracted services for Anesthesia and Pharmacy were provided in a safe and effective manner. This resulted in the following: 1) for 5 of 14 patients receiving anesthesia (#1, #13, #17,#19, #20) out of a total sample of 21 medical records failing to have a pre-anesthesia evaluation performed within 48 hours prior to administration of anesthesia by a person qualified to administer anesthesia; 2) 4 of 17 sampled patients who received anesthesia services (#1, #4, #8, #21) out of a total of 21 sampled medical records failing to have a post-anesthesia evaluation completed no later than 48 hours after surgery or a procedure requiring anesthesia services; and 3) IV (intravenous) medications were admixed by the nursing staff without supervision of the pharmacist, medication orders failing to be reviewed with the patient record for known allergies, therapy contraindications, dose and route of administration, directions for use, duplication of therapy, interactions, and optimum therapeutic outcomes prior to dispensing the first dose of medication, physician orders for ranges in dose and frequency being accepted with the nurse making the decision regarding the specific strength/dose and frequency for 9 of 21 sampled patients (#1, #2, #4, #5, #7, #8, #9, #12, #21). Findings:


1) for 5 of 14 patients receiving anesthesia (#1, #13, #17,#19, #20) out of a total sample of 21 medical records failing to have a pre-anesthesia evaluation performed within 48 hours prior to administration of anesthesia by a person qualified to administer anesthesia (See findings at Tag A1003).

2) 4 of 17 sampled patients who received anesthesia services (#1, #4, #8, #21) out of a total of 21 sampled medical records failing to have a post-anesthesia evaluation completed no later than 48 hours after surgery or a procedure requiring anesthesia services; (See findings at Tag A1005)

3) IV (intravenous) medications were admixed by the nursing staff without supervision of the pharmacist, medication orders failing to be reviewed with the patient record for known allergies, therapy contraindications, dose and route of administration, directions for use, duplication of therapy, interactions, and optimum therapeutic outcomes prior to dispensing the first dose of medication, physician orders for ranges in dose and frequency being accepted with the nurse making the decision regarding the specific strength/dose and frequency for 9 of 21 sampled patients (#1, #2, #4, #5, #7, #8, #9, #12, #21); (See findings at Tag A0501).

Review of the evaluations for Anesthesia and Pharmacy completed for the year 2011 and submitted to the Medical Director for signature and to the Governing Body for approval at the next scheduled meeting revealed no problems were noted in the performance of their contracts and both were approved by RN S1 Administrator for approval.

In a face to face interview on 04/11/12 at 2:00pm RN S1 Administrator when asked about the process used to evaluation the performance of the contracts, S1 responded the contracts were approved if she was not informed of any problems.

Based on record review and interview the hospital failed to develop, measure, track and analyze indicators related to the quality of patient care. This resulted in the following: 1) 3 of 3 patients failing to receive blood (#1, #3, #4) per policy and procedure with two of the patients (#1 and #4) having documented temperatures of >100 degrees Fahrenheit during the transfusions; 2) 6 of 21 sampled patients (#1, #2, #4, #7, #9, #14) failing to receive medications as ordered by his/her physician for which no medication variances had been completed; and 3) 5 of 5 physician failing to have TB testing performed annually and the process used by the hospital for documenting TB testing of employees failing to ensure results were read within the 48 to 72 hours according to CDC guidelines for 14 out of 14 personnel records reviewed. Findings:


1) 3 of 3 patients failing to receive blood (#1, #3, #4) per policy and procedure (See findings at Tag A0409).

2) 6 of 21 sampled patients (#1, #2, #4, #7, #9, #14) failing to receive medications as ordered by his/her physician (See findings at Tag A0405).

3) 5 of 5 physician failing to have TB testing performed annually and the process used by the hospital for documenting TB testing of employees failing to ensure results were read within the 48 to 72 hours according to CDC guidelines for 14 out of 14 personnel records reviewed; (See findings at Tag 0749).

Based on record review and interview the hospital failed to develop and implement indicators for the process of blood administration. This resulted in failure of the nursing staff to follow hospital policy and procedure for obtaining a consent for transfusion, clarification of orders and monitoring of vital signs for 3 of 3 patients (#1, #3, #4) receiving blood out of a total sample of 21 patients. Findings:

Patient #1
Review of the medical record for Patient #1 revealed a 70 year old woman admitted to the hospital for a Right Total Knee Arthroplasty on 02/28/12 and discharged on 03/03/12. Review of the Physicians Orders dated 03/01/12 (no time documented when ordered) revealed... "Type + (and) cross + transfuse 2u (units) PRB (packed red blood)".

Review of the "Transfusion Record" for Patient #1 revealed Unit# W1384 12 000793 was started on 03/01/12 at 5:00pm and completed at 7:40pm (2 hours 40 minutes) and Unit# W1384 12 000805 was started at 8:30pm and completed at 11:45pm (3 hours 15 minutes).

Review of the Blood Administration Record for Patient #1 revealed baseline vitals were obtained at 5:00pm at which time the IV site was assessed as red with edema, infiltrated and had to be discontinued and the IV restarted (cite not documented). Further review revealed Unit# W1384 12 000793 was started on 03/01/12 at 5:26pm with vital signs recorded at 5:41pm, 5:56pm and 6:15pm and Unit# W1384 12 000805 was started at 8:30pm with vital signs recorded at 8:38pm, 8:50pm, 9:05pm, 9:20pm and 10:20pm. According to the Blood Administration Record vital signs are recorded at baseline, 5 minutes after the infusion is started, then every 15 minutes times 4, then every hour until complete or more frequently if patient's condition warrants. Vital signs should have been recorded on Patient #1 at 5:31pm, 5:46pm, 6:01pm, 6:16pm, 6:31pm and 7:41pm, for Unit #1 and 8:35pm, 8:45pm, 9:00pm, 9:15pm, 9:45pm, 10:45pm and 11:45pm for Unit #2.

Patient #3
Review of the medical record revealed Patient #3 was a 78 year old female admitted to the hospital on 12/23/11 and discharged on 12/24/11 for administration of 2 Units of PRBCs (Packed Red Blood Cells) due to her diagnosis of anemia. Review of the physician's order, which was a copy of an order on the doctor prescription pad placed in the medical record, revealed Type and Match, Transfuse 2 units PRBC dx (diagnosis) anemia. There was no rate ordered by the physician for the rate of administration of the PRBCs.

Review of the Blood Administration Record revealed the Vital Signs should be taken as follows: baseline, 5 minutes after infusion started, then every 15 minutes x 4, then every hour unit complete or more frequent if patient's condition warrants.

Review of the vital signs for the 1st unit of PRBCs revealed a baseline set of vital signs were taken at 7:35 p.m., the blood was started at 7:40 p.m. and at 7:45 p.m. the 5 minutes vital signs were taken. The every 15 minutes vital signs x 4 were taken at 8 p.m., 8:15 p.m., and 8:30 p.m. Another set of vital signs should have be taken at 8:45 p.m. for the last q 15 minute vital signs x 4, but the next set of vital signs were not taken until 9:30 p.m.

Review of the vital signs for the 2nd unit of PRBCs revealed a baseline set of vital signs were taken at 11:25 p.m., the blood was documented as being started at 11:35 p.m. The every 5 minutes vital signs were taken at 11:40 p.m. then the vital signs should have been taken every 15 minutes for 4 times, but they were not taken at the correct time interval. A set of vital signs were taken at 11:55 p.m., which was correct, but then the next sets of vital signs were taken at 12:25 a.m.,12:55 a.m., and 1:25 a.m., which were 30 minutes apart instead of 15 minutes apart per the hospital's policy.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of the "Physicians Orders" dated 02/29/12 at 8:00am revealed an order to type and match for 2 units of packed cells and transfuse "today". There was no documented evidence of an order for the rate at which the blood was to be transfused, and there was no clarification order documented by the nurse.

Review of Patient #4's "Blood Administration Record" dated 02/29, with no documented evidence of the year, revealed the blood was initiated at 1:15pm, the same time that the baseline vital signs were taken. Review of the "Transfusion Record" revealed the unit of packed cells was started on 02/29/12 at 1:15pm . Further review of the "Blood Administration Record" revealed the vital signs were reassessed 5 minutes after the baseline vital signs were taken, which was also the time that the blood was started. Further review revealed Patient #4 had a temperature of 100.5 degrees Fahrenheit, no documented evidence whether the temperature was taken orally or axillary (baseline temperature was 98.7 axillary and some of the later temperatures were taken orally), and the RN (registered nurse) documented "no s/s (signs and symptoms) noted". Further review revealed the transfusion was complete at 4:00pm with no documented evidence of the vital signs at the conclusion of the blood transfusion.

Review of Patient #4's "Nurses Notes" dated 02/29/12 at 4:20pm revealed her temperature orally was 102.8 degrees Fahrenheit. Further review revealed an order on 04/29/12 at 4:30pm to cancel the second unit of packed red blood cells and to administer Benadryl 25 mg (milligrams) and Tylenol 650 mg orally.

Review of Patient #4's "Consent and Disclosure for Transfusion of Blood and Blood Components", signed by Patient #4 on 02/29/12 at 12:30pm and by LPN (licensed practical nurse) S20 on 02/29/12 at 12:30pm, revealed no documented evidence of the physician's signature as evidenced by the line for signature being blank and having the record flagged for the signature.

In a face-to-face interview on 04/12/12 at 4:45pm, Director of Nursing (DON) S2 indicated blood usage was monitored for compliance in meeting the criteria for administration; however the actual monitoring of the blood administration process was not being done.

Review of the hospital's policy on Blood Administration revealed in part, "...Assessment 1. Verify physician's or health care provider's order for blood component transfusion with date, time of transfusion, duration, and any pre-transfusion or post-transfusion medication you will administer...4. Check that the patient has properly completed and signed transfusion consent before retrieving blood...h. Remain with patient during the first 15 minutes of a transfusion...Monitor patient's vital signs at 5 minutes, then q (every) 15 min (minutes) x 4, then q 1 hr (hour) until complete. Most transfusion reaction occur within the first 15 minutes of a transfusion...".

Review of the hospital's "Blood Administration Record" revealed the pre-infusion check off was to include the following: physician order for transfusion verified (did not require the nurse to check for an order for the rate of infusion); consent signed (did not specify who had to sign, such as patient, witness, physician); patient/family/significant other instructed to call nurse for symptoms of rash, itching, chills, fever, flank pain, chest pain or shortness of breath. Further review revealed the patient's vital signs were to include a baseline vital signs and to be checked 5 minutes after the infusion was started, then every 15 minutes times 4, then every hour until complete or more frequently if the patient's condition warranted it.

Based on interview the hospital failed to implement a performance improvement project for the present year. Findings:

In a face to face interview on 04/12/12 at 4:45pm RN S2, Director of Nursing, verified a performance improvement project for 2012 was not implemented. S2 went on to explain the hospital had made changes in personnel and decided to wait for the person hired to perform Compliance to choose and implement the project.

Based on record review and interview, the hospital failed to ensure each patient had a medical history and physical examination (H&P) completed and documented no more than 30 days before or 24 hours after admission but prior to surgery for 2 of 17 patients (#4, #19) who had a surgical procedure and 1 of 3 patients admitted for medical treatment (#2) from a total of 21 sampled patients. Findings:

Patient #2
Review of Patient #2's medical record revealed she was a 56 year old female who was admitted on 03/30/12 with diagnoses of influenza, asthma, and bronchitis. Review of her "History and Physical" revealed it was signed by her physician with no documented evidence of the date and time the physical examination was performed. There as no way to determine that the examination was performed within 24 hours of admission.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of her history and physical examination revealed it was performed on 02/27/12 at 1:50pm with no documented evidence of the signature of the physician who performed and documented the examination.

Patient #19
Review of Patient #19's medical record revealed he was a 77 year old male who had a left phaco cataract extraction with intraocular lens implant on 04/11/12. Review of the "History and Physical" revealed the surgeon documented on 04/11/12 at 6:52am that the H&P exceeded 7 days prior to admission, and the current exam had not changed. Review of the H&P from the previous procedure of 03/14/12 revealed a hand-written note under the section titled "Physical Examination" to see the cardiologist's notes. Review of the cardiologist's notes revealed the H&P was performed on 02/13/12, 58 days prior to the procedure. There was no documented evidence that a H&P was performed within 30 of the procedure.

In a face-to-face interview on 04/12/12 at 11:03am, Administrator S1 could offer no explanation for the H&Ps not being dated and timed when signed or not having a signature of the physician. When informed that observation revealed a physician did not ask the patient about changes in his/her condition and one physician did not come to the bedside in pre-op prior to the patient being taken to the surgery suite, S2 indicated she would have to bring this to the attention of the medical director.

In a face-to-face interview on 04/12/12 at 1:30pm, Director of Nursing (DON) S2 indicated she may have to re-educate staff about reviewing the cardiologist's documentation as part of the H&P. S2 further indicated the staff was aware that the H&P needed to be done within 30 days. She could offer no explanation for patients being sent to surgery without an accurate and timely H&P on the medical record.

Review of the hospital policy titled "Accurate and Timely Record Completion", policy number MR-02, approved 04/02/12, and included in the manuals presented by Administrator S1 as current, revealed, in part, "...A medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services. The H&P must be in place in the patient's medical records within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia. There must be a complete H&P, and an update in the medical record of every patient prior to surgery, or a procedure requiring anesthesia services, except in emergencies...".

Review of the hospital's Medical Staff By-laws revealed in part, "A Medical History and Physical examination of the patient must be completed within 30 days before admission or registration. When the medical history and physical examination are completed within 30 days before admission, an updated examination of the patient, including any changed in the patient's condition, must be completed and documented within 24 hours after admission, but prior to surgery or procedure requiring anesthesia services... If upon examination, the physician finds no change in the patient's condition since the H&P was completed, he/she may indicate in the patient's medical record that the H&P was reviewed. The patient was examined, and that "no change" has occurred in the patient's condition since the H&P was completed. Any changes in the patient's condition must be documented by the physician in the update note and placed in the patient's medical record within 24 hours of admission, but prior to surgery or a procedure requiring anesthesia services."





26351

Based on observation, record review, and interview the hospital failed to ensure all patients who had a History and Physical (H&P) prior to 24 hours before surgery or a procedure requiring anesthesia services were reassessed by a physician for any changes in the patient's condition prior to the surgical procedure for 5 of 17 patients having a surgical procedure performed (#9, #13, #14, #15, and #20) from a total of 21 sampled patients. Findings:

Observation on 04/12/12 at 8:38 am in the Pre-Operative Unit revealed Physician S27 speaking with Random Patient R1 before eye surgery. Further observation revealed MD S27 did not ask patient if there had been any changes in his condition within the last 24 hours.

Observation on 04/12/12 at 9:00am in the Pre-Operative unit revealed the circulating nurse indicating the History and Physical (H&P) had not been signed by MD S49. RN S35 Supervisor of the OR (Operating Room) took the H&P to the OR suite where S49 was located and returned a few minutes later with the signed H&P.

Patient #9
Review of Patient #9's medical record revealed she was a 67 year old female who had a left total knee arthroplasty on 04/09/12. Further review revealed her H&P was performed on 03/23/12 at 11:41am with no documented evidence of the signature of the physician who performed the H&P. Further review revealed the surgeon signed the H&P (performed on 03/23/12) on 04/09/12 at 10:30am with no documented evidence whether there was a change in Patient #9's medical condition since 03/23/12.

Patient #13
Review of the medical record for Patient #13 revealed a 60 year old female to the hospital on 01/04/12 for an inguinal hernia repair. Review of the History and Physical (H&P) found in the medical record revealed it was performed on 11/22/11 and an evaluation by a cardiologist on 12/06/11. Further review revealed no documented evidence Patient #13 was evaluated for any changes in her condition occurring after the last evaluation before the scheduled procedure on 01/04/12 was performed.

Patient #14
Review of Patient #14's medical record revealed she was an 82 year old female who had a right phaco cataract extraction with intraocular lens implant on 02/24/12. Further review revealed the H&P was performed and documented on 02/08/12. Further review revealed the H&P was updated to revealed no change in Patient #14's medical condition on 02/24/12 at 8:41am, after the procedure had been performed. Review of the anesthesia record revealed surgery ended at 8:07am, anesthesia ended at 8:10am, and the H&P was updated 31 minutes after anesthesia was completed.

Patient #15
Review of Patient #15's medical record revealed he was a 14 year old male admitted to the hospital on 2/10/12 for a meatotomy. Further review revealed an H&P was performed and documented on 2/6/12. There was no documented evidence Patient #15 was evaluated for changes in his condition after 2/6/12 evaluation and prior to his 2/10/12 surgery was performed.

Patient #20
Review of Patient #20's medical record revealed he was a 89 year old male admitted to the hospital for a possible transurethral resection of a bladder tumor on 4/11/12. Review of his medical record revealed an undated and not timed male physical examination form from the physician's office and no documentation of an evaluation for a change in his condition occurring after the last evaluation before the scheduled surgery on 4/11/12.

In a face-to-face interview on 04/12/12 at 11:03am, Administrator S1 could offer no explanation for the H&Ps not being updated when informed that observation revealed a physician did not ask the patient about changes in his/her condition and one physician did not come to the bedside in pre-op prior to the patient being taken to the surgery suite. S2 indicated she would have to bring this to the attention of the medical director.

Review of the hospital policy titled "Accurate and Timely Record Completion", policy number MR-02, approved 04/02/12, and included in the manuals presented by Administrator S1 as current, revealed, in part, "...A medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services. The H&P must be in place in the patient's medical records within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia. There must be a complete H&P, and an update in the medical record of every patient prior to surgery, or a procedure requiring anesthesia services, except in emergencies...".

Review of the hospital's Medical Staff By-laws revealed in part, "A Medical History and Physical examination of the patient must be completed within 30 days before admission or registration. When the medical history and physical examination are completed within 30 days before admission, an updated examination of the patient, including any changed in the patient's condition, must be completed and documented within 24 hours after admission, but prior to surgery or procedure requiring anesthesia services... If upon examination, the physician finds no change in the patient's condition since the H&P was completed, he/she may indicate in the patient's medical record that the H&P was reviewed. The patient was examined, and that "no change" has occurred in the patient's condition since the H&P was completed. Any changes in the patient's condition must be documented by the physician in the update note and placed in the patient's medical record within 24 hours of admission, but prior to surgery or a procedure requiring anesthesia services."


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26351

Based on observation, record review, and interviews, the hospital failed to ensure the registered nurse (RN) supervised and evaluated the nursing care for each patient for 7 of 21 sampled patients (#1, #2, #4, #5, #7, #9, #17). 1) The RN failed to assess and report a change in a patient's condition to the physician related to a 10 cc (cubic centimeters) urinary output in 8 hours (#9) and elevated blood pressure (#2). 2) The RN failed to ensure patients met the Aldrete score of 9 prior to being discharged from PACU (post anesthesia care unit) for 3 of 14 patients who had surgery from a total of 21 sampled patients (#4, #9, #17). 3) The RN failed to assess a diabetic patient's blood sugar prior to administration of insulin (#1). Findings:

1) The RN failed to assess and report a change in the patient's condition to the physician related to urinary output (#9) and elevated blood pressure (#2):
Patient #9
Review of Patient #9's medical record revealed she was admitted on 04/09/12 and had a left total knee replacement. Review of the "Patient Care Flow Sheet" dated 04/09/12 revealed Patient #9 was admitted to the PSU at 1:55pm. Further review revealed she had a 16 French foley catheter in place draining cloudy urine by gravity to the GU (genitourinary) bag. Further review revealed the following documentation:
4:00pm - clear yellow urine present;
8:20pm - 150 cc (cubic centimeters) urine in foley; physician paged - documented by LPN (licensed practical nurse) S22;
8:25pm - spoke with physician, reported urinary output along with vital signs, no new orders - documented by LPN S22;
11:30pm - assessment done by RN S39; "u/o (arrow down)" (meaning urinary output decreased; foley catheter repositioned with approximately 30 cc in GU bag;
1:30am - "still min.u/o < 50 cc (minimal urinary output less than) in foley catheter - by RN S39;
2:30am - "u/o minimal... will continue to monitor u/o" - by RN S39;
4:00am - "still scant u/o. (Physician) notified of pt. (patient) status including I&O (intake and output), u/o, v/s's (vital signs)... irrigated foley catheter (with) 50 cc sterile 0.9 sodium chloride x 2 (times 2) obtaining only irrigant back..." - by RN S39;
5:30am - "10 cc amber urine emptied from GU bag" - by RN S39;
7:00am - "report given - transfer care - oncoming shift" - by RN S39.
Review of the "Patient Care Flow Sheet" and the nurse's narrative notes revealed no documented evidence that RN S39 notified the physician when only the ordered urinary irrigant was returned and when only 10 cc urinary output for the 8 hour shift was obtained.

Review of Patient #9's "Patient Care Flow Sheet" and nurse's notes dated 04/10/12 revealed RN S10 documented "16 Fr (french) foley in place-no urine in tubing or foley bag @ (at) present time; continue to monitor urine output. Further review revealed RN S10 reported to the physician at 8:10am the patient's status including labs, urinary output, and infusion rate. Further review revealed an order was obtained at 8:10am to increase fluids to 150 ml (milliliters) per hour and consult Patient #9's primary care physician for medical management. A telephone call was placed at 8:15am to the primary care physician by RN S10 who documented "(physician) on call & (and) will be notified of consult via answering service". Further review revealed entries written by RN S10 at 9:10am, 10:00am, late entry for 8:30am (no documented evidence of the time the late entry was written), 11:00am, and 11:20am with no documented evidence of an assessment of urinary output. Further review revealed a late entry was documented by RN S10 for 9:30am, with no documented evidence of the time the entry was written, that included "small amount of dark amber urine noted to foley bag... will continue to monitor urinary output".

Observation on 04/10/12 at 11:55am revealed Patient #9 was sitting in bed with a meal tray present. Further observation revealed the urine bag contained a scant amount of dark amber urine.

In a face-to-face interview on 04/10/12 at 11:55am, RN S10 indicated the urine in the GU bag was the entire amount collected since the start of her shift. S10 was asked to empty and measure the amount of urine in the GU bag.

In a face-to-face interview on 04/10/12 at 12:08pm, RN S10 indicated she emptied 40 ml urine that was collected from the start of the 7:00am shift to present. She further indicated she was aware that 10 cc had been emptied for the entire previous shift. S10 further indicated she had not heard from the on call primary care physician since she left a message with the answering service. She confirmed that she had not called back since not hearing from her since the call was placed at 8:15am (almost 4 hours since the call was placed).

Review of Patient #9's nurse's notes for 04/10/12 entries by RN S10 as follows:
12:25pm - called physician's office and informed she was not in the office;
1:30pm - on phone with physician giving update on patient status - phone disconnected - calling back;
2:00pm - on hold with office for 30 minutes; new orders received.

In a face-to-face interview on 04/10/12 at 1:50pm, Director of Nursing (DON) S2 indicated she received a report on Patient #9 from PSU Coordinator S14 earlier today. S2 further indicated the report included that Patient #9 had decreased urinary output last night, the nurse irrigated the foley, the nursing staff was monitoring the output, and they were waiting for the physician to come this morning. S2 indicated she was not told that only the irrigant was obtained when Patient #9's catheter was irrigated twice. S2 confirmed that the inability to reach the consulted physician should have been reported to her, and that was not done.

In a face-to-face interview on 04/10/12 at 3:40pm, DON S2 indicated she spoke with RN S39 who confirmed that the urinary output for the night shift (8 hours) was 10 cc, and the physician was not notified of the change in condition.

Patient #2
Review of Patient #2's medical record revealed she was a 56 year old female who was admitted on 03/30/12 with diagnoses of influenza, asthma, and bronchitis. Review of the "Patient Care Flow Sheet" dated 04/01/12 revealed Patient #2's blood pressure in the right arm was 148/72 and in the left arm was 130/103 at 3:20pm. There was no documented evidence of documentation of the abnormal blood pressure in the nurse's notes. Further review of the flow sheet and the nurse's notes revealed no documented evidence that Patient #2's blood pressure was reassessed until the next scheduled time at 7:00pm to be 130/88, with no documented evidence of which arm the reading was taken to determine if the elevated blood pressure assessed from the left arm remained elevated.

In a face-to-face interview on 04/12/12 at 1:30pm, DON S2 indicated she didn't know if the nurse would have notified the physician for a blood pressure of 130/103. She further indicated if the patient was not symptomatic, she would not have expected the nurse to notify the physician. When asked if the nurse should have reassessed the blood pressure sooner than 3 and 1/2 hours later, S2 indicated she would have to review Patient #2's entire medical record to answer the question.

Review of the hospital policy titled "PSU Flowsheet", policy number PSU-007, reviewed 02/29/12, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...12. Head to toe assessment Q (every) shift elaborating on abnormal assessments in nurses' notes...".

2) The RN failed to ensure patients met the Aldrete score of 9 prior to being discharged from PACU:
Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of her "PACU Flow Sheet" dated 02/28/12 revealed she arrived to PACU at 8:51am and had an Aldrete score of 4 upon admission (activity 0, respiration 1, circulation 2, consciousness 0, and oxygen saturation 1. Further review revealed her Aldrete score increased to 7 at 9:06am. Further review revealed her Aldrete score at 9:10am was 8 (activity 2, respiration 2, circulation 2, consciousness 1, and oxygen saturation 1). She remained in PACU until her transfer to PSU at 12:29pm. Further review revealed Patient #4's Aldrete score remained 8 at 9:25am, 9:40am, 9:55am, 10:10am, 10:25am, 10:40am, 10:55am, 11:25am, and 11:55am (last documented Aldrete score prior to transfer). Further review of the nurse's narrative notes revealed no documented evidence why Patient #4 was discharged from PACU prior to meeting criteria according to hospital policy and procedure.

Patient #9
Review of Patient #9's medical record revealed she was admitted on 04/09/12 and had a left total knee replacement. Review of her "PACU Flow Sheet" dated 04/09/12 revealed she arrived to PACU at 12:40pm and had an Aldrete score of 8 upon admission (activity 2, respiration 2, circulation 2, consciousness 1 (arousable on call), and oxygen saturation 1 (oxygen maintained greater than 90 per cent). Further review revealed she remained in PACU until her transfer to PSU at 1:50pm. Further review revealed Patient #9's Aldrete score remained 8 at 12:55pm, 1:10pm, 1:25pm, and 1:40pm (last documented score prior to transfer to PSU). Further review of the nurse's narrative notes revealed no documented evidence why Patient #9 was discharged from PACU prior to meeting criteria according to hospital policy and procedure.

Patient #17
Review of the medical record for Patient #17 revealed a 71 year old female admitted to the hospital on 04/10/12 for Right Total Knee Replacement under general anesthesia. Further review of the medical record revealed Patient #17 had a history of anemia, HTN (hypertension) and NIDDM (non-insulin dependent diabetes mellitus) and was classified as an ASA II for anesthesia.

Review of the PACU (post-anesthesia care unit) Flow Sheet dated 04/10/12 revealed Patient #17 was received in PACU at 9:15am with 3 liters of oxygen per nasal cannula and assessed as a "7" according to the Aldrete Score (2- moving all extremities, 2- able to take deep breaths and cough, 1- blood pressure +/- 20-50mm pre-anesthesia assessment, 1- arousable on call, and 1- O2 (oxygen) maintain > 92%). Further review of the medical record revealed Patient #17's Aldrete Score had not changed throughout her one hour stay in PACU. Review of the nurse's narrative notes revealed no evidence as to why Patient #17 was discharged before meeting criteria according to hospital policy and procedure.

In a face-to-face interview on 04/12/12 at 2:45pm, Anesthesiologist S45 could offer no explanation for patients being discharged from PACU prior to meeting the discharge criteria of an Aldrete score of at least 9.

Review of the hospital policy titled "Scoring System in PACU", policy number PAC-005, reviewed 02/29/12, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...Aldrete Scoring System: Optimum score is 10 ...Procedure: 2. Patients scoring a 9 or greater will be transferred to PSU... PADSS Score (Postanesthetic Discharge Scoring System): Optimum score is 10 ... Procedure: 1. Score will be done prior to discharge from the facility 2. Patients scoring equal or greater to 9 may be discharged".

3) The RN failed to assess a diabetic patient's blood sugar prior to start of the surgical procedure:
Review of the medical record for Patient #1 revealed a 70 year old woman admitted to the hospital for a Right Total Knee Arthroplasty on 02/28/12. Further review of Patient #1's medical record revealed a history of NIDDM (Non-Insulin Dependent Diabetes Mellitus) and was on Glyb/Metform 5/500mg i po (by mouth) BID (twice a day) and Januvia 100mg i po q day. Review of the MAR (medication administration record) revealed Patient #1 had not taken
Glyb/Metform and Januvia the morning of surgery.

Review of the medical record for Patient #1 revealed a Chem-8 was performed on 02/28/12 at 0756 (7:56am) prior to the start of the surgical procedure. Review of the medical record, including the form used to document labs and the MAR, revealed no documented evidence accuchecks were performed on Patient #1.

Review of the Physicians' Orders dated 02/29/12 (no time documented) revealed.... "Lantus 50u bs (blood sugar). Review of the MAR for Patient #1 revealed Lantus 50units was administered to Patient #1 on 03/01/12 and 03/02/12 at 9:00pm.

In a face to face interview on 04/11/12 at 1:00am RN S2 Director of Nursing indicated she would expect the nurse to perform an accucheck before administering insulin to a diabetic patient. Further she verified the for used for documentation of the glucometer results for Patient #1 was blank.

Review of the hospital policy titled "Standards of Care-Preop", policy number Pre-004, reviewed 02/29/12, and presented in the manual provide by Administrator S1 as the current policies, revealed no documented evidence that the blood glucose assessment of the diabetic patient was addressed in the assessment and management components of the pre-op patient assessment.






25065

Based on record review and interview, the hospital failed to ensure medications were administered as ordered by the physician for 6 of 21 sampled patients (#1, #2, #4, #7, #9, #14). Findings:

Patient #1
Review of the medical record for Patient #1 revealed a 70 year old woman admitted to the hospital for a Right Total Knee Arthroplasty on 02/28/12. Further review of Patient #1's medical record revealed a history of NIDDM (Non-Insulin Dependent Diabetes Mellitus) and was on Glyb/Metform 5/500mg i po (by mouth) BID (twice a day) and Januvia 100mg i po q day.

Review of the Physicians' Orders dated 02/29/12 (no time documented) revealed.... "Lantus 50u bs (blood sugar). Further review of the medical record revealed no documented evidence the nurse clarified the order with the physician for route and frequency.

Review of the MAR (medication administration record) revealed Patient #1 received Lantus 50 units on 02/28/12, 02/29/12 and 03/01/12.

In a face to face interview on 04/12/12 at 1:30pm RN S2 Director of Nursing indicated all medication orders which do not contain the route and dosage should be clarified with the physician before administration of the drug.


Patient #2
Review of Patient #2's medical record revealed she was a 56 year old female who was admitted on 03/30/12 with diagnoses of influenza, asthma, and bronchitis. Review of the "Physician Orders" revealed an order dated 04/03/12, with no documented evidence of the time the order was written, to initiate Advair 250/50 one puff twice a day prior to discharge to instruct on the use of the mechanism.

Review of Patient #2's nurse's notes and medication administration record revealed no documented evidence that Patient #2 received Advair prior to discharge as ordered or that Patient #2 was instructed on the use of the mechanism. Review of the "Patient Medication List" revealed Advair was listed as new medications with a hand-written note of "take as directed", with no documented evidence of the author of this documentation.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of the "Physician Orders" dated 02/28/12, with no documented evidence of the time the order was written, revealed an order to restart Lisinopril 20/25 orally every day. There was no documented evidence of an order for specific blood pressure parameters for which the medication should be held.

Review of Patient #4's medication administration record revealed no Lisinopril was held on 02/29/12 as evidenced by LPN (licensed practical nurse) S20's initials being circled (which means per policy that the medication was held). Review of the nurse's notes revealed no documented evidence of the reason the medication was held or that the physician and RN (registered nurse) was notified that the medication was being held.

Patient #7
Review of Patient #7's medical record revealed she was a 21 year old female who had a bilateral breast augmentation with saline on 04/09/12. Review of the admit physician orders dated 04/05/12 at 10:30am and noted by the pre-op nurse on 04/09/12 at 7:30am revealed an order for Ancef 1 gram to be administered IVPB (intravenous piggyback) on call to OR (operating room).

Review of Patient #7's "Anesthetic Record" dated 04/09/12 revealed Ancef 1 gram was administered IVPB at the start of anesthesia in the OR at 7:58am, rather than on call in pre-op as ordered by the physician.

Patient #9
Review of Patient #9's medical record revealed she was a 67 year old female who had a left total knee replacement on 04/09/12. Review of the "Physician Orders" revealed a clarification order written on 04/09/12 at 4:00pm by LPN S22 for Lisinopril and Hydrochlorothiazide 20 mg (milligrams) / 12. 5 mg orally every night. There was no documented evidence of an order for specific blood pressure parameters for which the medication should be held.

Review of Patient #9's medication administration record revealed Lisinopril was held at 9:00pm on 04/09/12 as evidenced by LPN S22's initials being circled with a note of "see notes". Review of the nurse's notes dated 04/09/12 revealed an entry by LPN S22 of "Lisinopril held for B/P (blood pressure) 104/82". There was no documented evidence that LPN S22 informed the RN or the physician of the decision to hold the medication.

Patient #14
Review of Patient #14's medical record revealed she was an 82 year old female who had a right phaco cataract extraction with intraocular lens implant on 02/24/12. Review of the post-op orders, with no documented evidence of the date and time the pre-printed orders were initiated, revealed an order for Zymaxid or Zymar, or Vigamox, or Ciprofloxacin drops one right eye every 5 minutes times 2 in the post-op area.

Review of Patient #14's "PACU (post anesthesia care unit) Flow Sheet" dated 02/24/12 revealed a note in the medication section of "Zymaxid gtts (drops) instilled per OR RN", with no documented evidence of the signature or initials of the nurse who completed this documentation. Review of the "OR Nursing Record-Eye" and the "Anesthetic Record" dated 02/24/12 revealed no documented evidence that Zymaxid eye drops were administered in OR.

In a face-to-face interview on 04/12/12 at 1:30pm, Director of Nursing (DON) S2 confirmed there was no documented evidence that a RN performed an assessment when Lisinopril was held by the LPN for Patients #4 and #9.

In a face-to-face interview on 04/12/12 at 5:05pm, DON S2 indicated the clinical coordinators perform patient chart audits, and if medication errors were found during the audit, the coordinator would complete a medication variance.

Review of the hospital policy titled "PSU (post surgical unit) Medication Administration Record (MAR)", policy number PSU-009, reviewed 02/23/12, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...In the event a medication is withheld, the nurse will circle their initials and then document the reason in the nurse's notes. The MD is to be notified as deemed appropriate...".

Review of the hospital policy titled "Pre-Operative Admission", policy number PRE-002, approved 02/29/12, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...Administer medications as per physician's order, record on Preoperative Record...".

Based on record review and interview, the hospital failed to ensure a physician's order was documented for medications administered for 1 of 21 sampled patients (#4). The hospital failed to ensure all physician orders for medications included the exact strength or concentration, dose, route, and frequency for 8 of 21 sampled patients (#1, #4, #5, #7, #8, #9, #12, #21). Findings:

1) Physician's order documented for medications administered:
Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of the "PACU (post anesthesia care unit) Flow Sheet" dated 02/28/12 revealed Albuterol mechanical aerosol 2.5 mg in 3 ml (milliliters) was administered at 10:30am.

Review of Patient #4's physician orders revealed no documented evidence of an order to administer Albuterol in PACU.

2) Medication orders included exact strength, dose, and frequency:
Patient #1
Review of the medical record for Patient #1 revealed a 70 year old female admitted to the hospital on 02/28/12 for a Right Total Knee Replacement. Review of the Physicians' Orders dated 02/28/12 at 11:40am revealed an order for Ativan 1-2mg IVP in PACU (post anesthesia care unit). Review of the Physicians' Orders dated 02/29/12 (no time documented) revealed.... "Lantus 50u bs (blood sugar). Further review of the medical record revealed no documented evidence the nurse clarified the order with the physician for route and frequency.

Review of the MAR (medication administration record) revealed Patient #1 received Lantus 50 units on 02/28/12, 02/29/12 and 03/01/12.

Patient #2
Review of Patient #2's medical record revealed she was a 56 year old female who was admitted on 03/30/12 with diagnoses of influenza, asthma, and bronchitis. Review of Patient #2's admit orders dated 03/30/12 revealed an order for Ultram 50 mg 1 - 2 orally every 4 hours as needed for pain or body aches. Further review revealed no documented evidence of the specific dose to be administered, which required the nurse to decide what strength/dose to administer. There was no documented evidence of a clarification order by the nurse for the specific dose of Ultram to be administered.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of Patient #4's "Anesthesia Order Sheet - PACU" revealed no documented evidence of the date and time the standing order was initiated. Further review revealed an order to titrate morphine 1 mg to 4 mg IV within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. There was no documented evidence of an order for the specific dose and frequency between administration of each dose of Morphine. Further review revealed no clarification order received by the nurse for the specific dose and frequency for Morphine administration.

Review of Patient #4's "Anesthesia Order Sheet - PACU" revealed a verbal order was received on 02/28/12 at 9:25am for Dilaudid 0.5 mg - 2 mg IV titrated prn (as needed) pain. Further review revealed no documented evidence that the order for Dilaudid included the exact dose and frequency (time interval) for which it was to be administered.

Patient #5
Review of the medical record for Patient #5 revealed she was admitted to the hospital on 3/30/12 for laparoscopic cholecystectomy related to her diagnosis of biliary dyskinesia. Review of her physician order to transfer to PACU(Post Anesthesia Care Unit) then admit to Post Surgical Unit as an outpatient, dated 3/30/12, revealed an order for Percocet 5 mg(milligram) i-ii (1 to 2) po (by mouth) q (every) 4 hrs(hours) prn ( as needed) pain or Vicodin 5 mg i-ii po q 4hrs prn pain. Phenergan 12.5-25 mg IVP(intravenous)q 4hrs prn nausea. Review of the Anesthesia Order Sheet for dated 3/30/12 at 11:20 a.m. revealed an order for pain medication. The order read, Pain: Unless contraindicated, titrate morphine 1 mg to 4 mg IV (intravenous) within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. If no relief notify Anesthesiologist. 2. Unless contraindicated, give cholecystectomy patients Demerol 12.5 mg IV every 5 minutes until pain is relieved. Do not exceed 50 mg total. If no relief notify Anesthesiologist.

Patient #7
Review of Patient #7's medical record revealed she was a 21 year old female who had a bilateral breast augmentation with saline on 04/09/12. Review of Patient #7's post-op orders dated 04/09/12 revealed the following medications were ordered with a range rather a specific dose, route, and frequency:
Morphine 2 - 4 mg IV every 15 minutes prn maximum 10 mg every 2 hours;
Lortab 7.5 mg orally 1 -2 every 3-4 hours prn pain;
Phenergan 12.5 mg - 25 mg orally/IV every 6 hours prn nausea.

Review of Patient #7's "Anesthesia Order Sheet - PACU" dated 04/09/12 revealed an order to titrate morphine 1 mg to 4 mg IV within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. There was no documented evidence of an order for the specific dose and frequency between administration of each dose of Morphine.

Patient #8
Review of the medical record for Patient #8 revealed Patient #8 was admitted to the hospital on 4/09/12 for a total left knee arthroplasty. Review of the Physician Orders dated 4/9/12 on the Anesthesia Order Sheet for PACU (Post Anesthesia Care Unit) revealed the order, Unless contraindicated, titrate morphine 1 mg to 4 mg IV (intravenous) within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. If no relief notify Anesthesiologist. 2. Unless contraindicated, give cholecystectomy patients Demerol 12.5 mg IV every 5 minutes until pain is relieved. Do not exceed 50 mg total. If no relief notify Anesthesiologist.

Patient #9
Review of Patient #9's medical record revealed she was a 67 year old female who had a left total knee replacement on 04/09/12. Review of Patient #9's "Anesthesia Order Sheet - PACU" revealed an order to titrate morphine 1 mg to 4 mg IV within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. There was no documented evidence of an order for the specific dose and frequency between administration of each dose of Morphine.

Review of Patient #9's "Anesthesia Order Sheet - PACU" revealed a verbal order, with no documented evidence of the date and time the order was received, for Dilaudid 0.5 mg - 2 mg IV in PACU for pain. Further review revealed no documented evidence of the a clarification order that included the specific dose and frequency at which Dilaudid was to be administered.

Patient #12
Review of the medical record for Patient #12 revealed she was admitted on 3/30/12 for a
laparoscopic cholecystectomy for biliary dysfunction. Review of her PSU Cholecystectomy Admit Orders revealed an order for Percocet 5 mg (milligrams) i-ii (1 to 2) po (by mouth) q (every) 4 hrs(hours) prn ( as needed) pain or Vicodin 5 mg i-ii po q 4hrs prn pain. Phenergan 12.5-25 mg IVP (intravenous) q 4hrs prn nausea. Review of the Anesthesia Order Sheet dated 3/30/12 at 11:20 a.m,. revealed an order for pain medication. The order read, Pain: Unless contraindicated, titrate morphine 1 mg to 4 mg IV (intravenous) within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. If no relief notify Anesthesiologist. 2. Unless contraindicated, give cholecystectomy patients Demerol 12.5 mg IV every 5 minutes until pain is relieved. Do not exceed 50 mg total. If no relief notify Anesthesiologist.

Patient #21
Review of the medical record for Patient #21 revealed a 45 year old female admitted to the hospital on 07/16/11 for nausea and vomiting after having gastric sleeve surgery on 07/11/11.
Review of the Physicians' Orders revealed the following range orders: 07/26/11 at 10:18pm Morphine 3-5mg prn for pain; and 07/21/11 at 1:01pm Zofran 4-8mg IVP every 4-6 hours prn for nausea.

In a face-to-face interview on 04/12/12 at 1:30pm, Director of Nursing S2 indicated they would have to revise the standing orders to address the range orders. She further indicated that she had been "a nurse for 30 years and we always used ranges".

In a face-to-face interview on 04/12/12 at 2:45pm, Anesthesiologist S45 indicated she had always used range orders for medications and was not aware that she could not use ranges according to federal regulations.

Review of the hospital policy titled "Routine Scheduled Medications", policy number PHM-041, reviewed 02/25/11, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...All pertinent information required for safe administration of medications shall be obtained, including drug, dose and strength, route, date, and time schedule...".

Based on record review and interview the hospital failed to ensure the policy and procedure was followed for verbal orders as evidenced by failure of the nursing staff to readback the order to the physician for verification for 4 of 21 sampled medical records (#1, #4, #9, #21). Findings:

Patient #1
Review of the medical record for Patient #1 revealed a 70 year old woman admitted to the hospital for a Right Total Knee Arthroplasty on 02/28/12. Review of the Physicians' Orders revealed the following orders were received by the nursing staff without any documented evidence the order was verified with the physician:
02/28/12 11:04am Ativan 1-2mg IVP (intravenous push) in PACU (post anesthesia care unit);
02/28/12 6:10pm Zofran 4mg IVP q (every) 4 hours prn (as needed) n/v (nausea/vomiting);
02/28/12 8:50pm Phenergan 25mg IV q 4 hours prn N/V; 02/28/12 8:55pm Resume home meds 1. Nexium 40mg i po (by mouth) q day, 2. Januvia 100mg i po q day, 3. Pramipexole 0.5mg i po q day, 5. Nifedipine 90 mg i po q day, 6. Triam/HCTZ 37.5/25mg i po q AM, 7. Avapro 300mg q day, 8. Tricor 145mg i po q day, 9. Glyg/Metform 5/500mg i po BID; and Restoril 30mg po q hs (hour of sleep) prn insomnia.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of the "Physician Orders" revealed the telephone order received on 02/29/12 at 4:30pm had no documented evidence of read-back verification by the nurse.

Patient #9
Review of Patient #9's medical record revealed she was a 67 year old female who had a left total knee replacement on 04/09/12. Review of the "Physician Orders" revealed the following orders had no documented evidence of read-back verification by the nurse:
verbal order for Dilaudid, not dated and timed by the nurse who received the order;
2 separate verbal orders written on 04/10/12 at 5:00pm; and
04/10/12 at 9:25pm verbal order.

Patient #21
Review of the medical record for Patient #21 revealed a 45 year old female admitted to the hospital on 07/16/11 for nausea and vomiting after having gastric sleeve surgery on 07/11/11.
Review of the Physicians' Orders revealed the the following orders were received by the nursing staff without any documented evidence the order was verified with the physician:
07/18/11 Hurricane Spray, Versed 10mg IVP, Demerol 100mg IVP, Labetolol 5mg;
07/21/11 at 1325 (1:25pm) Give remainder of 1 liter of IV fluids;
07/26/11 at 10:18pm Morphine 2-5mg prn for pain
07/27/11 at 8am Swallow Study today;
07/21/11 Catapres patch .3 q week.

In a face-to-face interview on 04/12/12 at 1:30pm, Director of Nursing S2 offered no explanation for the nurses not documenting a read-back verification for physician orders received by telephone or verbally.

Review of the hospital policy titled "Physician's Orders", policy number MR-05, no documented evidence of the date of approval or review, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...2. Telephone/Verbal Orders ... B. Promptly document the order on an Order Sheet to include date, time, treatment or medication, route, dose, frequency, priority. C. Restate the order back to the ordering physician D. Document Telephone Order Read Back (TORB) or Verbal Order Read Back (VORB), ordering physician name, co-sign by nurse...".

Based on record review and interview, the hospital failed to: 1) ensure all nursing staff assigned to administer IV (intravenous) medications and blood transfusions were provided training which included content of physicians' orders, demonstration of assessment of vital signs, accurate documentation of the blood administration in the patient record; 2) ensure blood was administered according to the hospital's policy and procedure resulting in in patients not having a completed informed consent, vital signs according to policy, and a patient's elevated temperature not documented as an abnormal finding for 3 of 3 patients receiving blood from a total of 21 sampled patients (#1, #3, #4); and 3) ensure all physician orders for IV medications included an order for the rate at which the IV was to be infused for 5 of 8 patients' records reviewed who received IV medications from a total sample of 21 patients (#2, #4, #7, #9, #13). Findings:

1) Staff training for IV medications and blood transfusions:
Review of the "Nursing Skills Checklist" for Pre-Op/PACU (post anesthesia care unit) / PSU (post surgical unit) revealed competency in blood administration included review of the policy and procedure; administration of blood, plasma, platelets; check blood and charting; and signs and symptoms of reactions.

Review of the "Annual Equipment Day" revealed blood administration competency was assessed by verbalization by the nurse of the process.

Review of the Performance Appraisal used by the hospital to evaluate the nursing staff revealed .... "16. Skill level- Performs procedures safely, correctly, effectively and in accordance with applicable guidelines".

In a face to face interview on 04/12/12 at 11:00am RN S2 Director of Nursing indicated when blood utilization was performed, the process for administration was not reviewed.

2) Failed to follow the hospital's policy for the administration of blood products:
Review of the hospital's "Blood Administration Record" revealed the pre-infusion check off was to include the following: physician order for transfusion verified (did not require the nurse to check for an order for the rate of infusion); consent signed (did not specify who had to sign, such as patient, witness, physician); patient/family/significant other instructed to call nurse for symptoms of rash, itching, chills, fever, flank pain, chest pain or shortness of breath. Further review revealed the patient's vital signs were to include a baseline vital signs and to be checked 5 minutes after the infusion was started, then every 15 minutes times 4, then every hour until complete or more frequently if the patient's condition warranted it.

Patient #1
Review of the medical record for Patient #1 revealed a 70 year old woman admitted to the hospital for a Right Total Knee Arthroplasty on 02/28/12 and discharged on 03/03/12. Review of the Physicians Orders dated 03/01/12 (no time documented when ordered) revealed... "Type + (and) cross + transfuse 2u (units) PRB (packed red blood)".

Review of the "Transfusion Record" for Patient #1 revealed Unit# W1384 12 000793 was started on 03/01/12 at 5:00pm and completed at 7:40pm (2 hours 40 minutes) and Unit# W1384 12 000805 was started at 8:30pm and completed at 11:45pm (3 hours 15 minutes).

Review of the Blood Administration Record for Patient #1 revealed baseline vitals were obtained at 5:00pm at which time the IV site was assessed as red with edema, infiltrated and had to be discontinued and the IV restarted (cite not documented). Further review revealed Unit# W1384 12 000793 was started on 03/01/12 at 5:26pm with vital signs recorded at 5:41pm, 5:56pm and 6:15pm and Unit# W1384 12 000805 was started at 8:30pm with vital signs recorded at 8:38pm, 8:50pm, 9:05pm, 9:20pm and 10:20pm. According to the Blood Administration Record vital signs are recorded at baseline, 5 minutes after the infusion is started, then every 15 minutes times 4, then every hour until complete or more frequently if patient's condition warrants. Vital signs should have been recorded on Patient #1 at 5:31pm, 5:46pm, 6:01pm, 6:16pm, 6:31pm and 7:41pm, for Unit #1 and 8:35pm, 8:45pm, 9:00pm, 9:15pm, 9:45pm, 10:45pm and 11:45pm for Unit #2. There was no documented evidence vital signs were assessed on Patient #1 at the completion of either unit.

Patient #3
Review of the medical record revealed Patient #3 was a 78 year old female admitted to the hospital on 12/23/11 and discharged on 12/24/11 for administration of 2 Units of PRBCs (Packed Red Blood Cells) due to her diagnosis of anemia. Review of the physician's order, which was a copy of an order on the doctor prescription pad placed in the medical record, revealed Type and Match, Transfuse 2 units PRBC dx (diagnosis) anemia. There was no rate ordered by the physician for the rate of administration of the PRBCs.

Review of the Blood Administration Record revealed the Vital Signs should be taken as follows: baseline, 5 minutes after infusion started, then every 15 minutes x 4, then every hour unit complete or more frequent if patient's condition warrants.

Review of the vital signs for the 1st unit of PRBCs revealed a baseline set of vital signs were taken at 7:35 p.m., the blood was started at 7:40 p.m. and at 7:45 p.m. the 5 minutes vital signs were taken. The every 15 minutes vital signs x 4 were taken at 8 p.m., 8:15 p.m., and 8:30 p.m. Another set of vital signs should have be taken at 8:45 p.m. for the last q 15 minute vital signs x 4, but the next set of vital signs were not taken until 9:30 p.m.

Review of the vital signs for the 2 rd unit of PRBCs revealed a baseline set of vital signs were taken at 11:25 p.m., the blood was documented as being started at 11:35 p.m. The every 5 minutes vital signs were taken at 7:40 p.m. then the vital signs should have been taken every 15 minutes for 4 times, but they were not taken at the correct time interval. A set of vital signs were taken at 11:55 p.m., which was correct, but then the next sets of vital signs were taken at 12:25 a.m.,12:55 a.m., and 1:25 a.m., which were 30 minutes apart instead of 15 minutes apart per the hospital's policy.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of the "Physicians Orders" dated 02/29/12 at 8:00am revealed an order to type and match for 2 units of packed cells and transfuse "today". There was no documented evidence of an order for the rate at which the blood was to be transfused, and there was no clarification order documented by the nurse.

Review of Patient #4's "Blood Administration Record" dated 02/29, with no documented evidence of the year, revealed the blood was initiated at 1:15pm, the same time that the baseline vital signs were taken. Review of the "Transfusion Record" revealed the unit of packed cells was started on 02/29/12 at 1:15pm . Further review of the "Blood Administration Record" revealed the vital signs were reassessed 5 minutes after the baseline vital signs were taken, which was also the time that the blood was started. Further review revealed Patient #4 had a temperature of 100.5 degrees Fahrenheit, no documented evidence whether the temperature was taken orally or axillary (baseline temperature was 98.7 axillary and some of the later temperatures were taken orally), and the RN (registered nurse) documented "no s/s (signs and symptoms) noted". Further review revealed the transfusion was complete at 4:00pm with no documented evidence of the vital signs at the conclusion of the blood transfusion.

Review of Patient #4's "Nurses Notes" dated 02/29/12 at 4:20pm revealed her temperature orally was 102.8 degrees Fahrenheit. Further review revealed an order on 04/29/12 at 4:30pm to cancel the second unit of packed red blood cells and to administer Benadryl 25 mg (milligrams) and Tylenol 650 mg orally.

Review of Patient #4's "Consent and Disclosure for Transfusion of Blood and Blood Components", signed by Patient #4 on 02/29/12 at 12:30pm and by LPN (licensed practical nurse) S20 on 02/29/12 at 12:30pm, revealed no documented evidence of the physician's signature as evidenced by the line for signature being blank and having the record flagged for the signature.

In a face-to-face interview on 04/12/12 at 1:30pm, Director of Nursing (DON) S2 indicated the physician was supposed to sign the patient's blood consent prior to the blood being administered. She could offer no explanation for the baseline vital signs taken at the same time that the blood was initiated and for not having vital signs assessed at the completion of the blood transfusion.

Review of the hospital's policy on Blood Administration revealed in part, "...Assessment 1. Verify physician's or health care provider's order for blood component transfusion with date, time of transfusion, duration, and any pretransfusion or postransfusion medication you will administer...4. Check that the patient has properly completed and signed transfusion consent before retrieving blood...h. Remain with patient during the first 15 minutes of a transfusion...Monitor patient's vital signs at 5 minutes, then q (every) 15 min (minutes) x 4, then q 1 hr (hour) until complete. Most transfusion reaction occur within the first 15 minutes of a transfusion...".

3) Failed to ensure physician's orders for IV medications included the rate to be infused:
Patient #2
Review of Patient #2's medical record revealed she was a 56 year old female who was admitted on 03/30/12 with diagnoses of influenza, asthma, and bronchitis. Review of the "Physician's Orders" dated 03/30/12, with no documented evidence of the time the order was written, revealed orders for Rocephin 1 gram IV every day, Zithromax 500 mg (milligrams) IV daily, and Solumedrol 125 IV one time dose. Further review revealed no documented evidence that the order included the rate at which the medications were to be infused, and there was no clarification order requested by the nurse.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of the "Total Knee Replacement Clinical Progression Management" (physician orders), with no documented evidence of the date and time the pre-printed standing orders were implemented, revealed an order for Cefazolin 1 gram IVPB (intravenous piggyback) in OR (operating room). Further review revealed no documented evidence that the order included the rate at which the medication was to be infused, and there was no clarification order requested by the nurse.

Review of the "Post-Op Total Knee Replacement" orders, with no documented evidence of the date and time the pre-printed standing orders were implemented, revealed an order for Cefazolin 1 gram IVPB every 8 hours times 3 doses. Further review revealed no documented evidence that the order included the rate at which the medication was to be infused, and there was no clarification order requested by the nurse.

Review of Patient #4's "Anesthesia Order Sheet - PACU" (post anesthesia care unit) revealed a verbal order received on 02/28/12 at 9:25am for Ofirmev 1000 mg IVPB with no documented evidence of the rate at which the medication was to be infused.

Patient #7
Review of Patient #7's medical record revealed she was a 21 year old female who had a bilateral breast augmentation with saline on 04/09/12. Review of the "Breast Augmentation" physician orders dated 04/05/12 at 10:30am revealed an order for Ancef 1 gram IVPB on call to OR. Further review revealed no documented evidence that the order included the rate at which the medication was to be infused, and there was no clarification order requested by the nurse.

Review of Patient #7's "Post Op Orders" dated 04/09/12 at 9:30am revealed an order for Ancef 1 gram IVPB times one dose. Further review revealed no documented evidence that the order included the rate at which the medication was to be infused, and there was no clarification order requested by the nurse.

Patient #9
Review of Patient #9's medical record revealed she was a 67 year old female who had a left total knee replacement on 04/09/12. Review of the admission orders dated 04/09/12 at 8:49am revealed an order for Cefazolin 1 gram IVPB in OR. Further review revealed no documented evidence that the order included the rate at which the medication was to be infused, and there was no clarification order requested by the nurse.

Review of Patient #9's "Post-Op Total Knee Replacement" physician orders dated 04/09/12 at 2:00pm revealed an order for Cefazolin 1 gram IVPB every 8 hours times 3 doses. Further review revealed no documented evidence that the order included the rate at which the medication was to be infused, and there was no clarification order requested by the nurse.

Patient #13
Review of the medical record for Patient #13 revealed a 60 year old female to the hospital on 01/04/12 for an inguinal hernia repair. Review of the Admit Orders for Patient #13 (no date or time documented when ordered) revealed an order for Ancef 2gm IVPB (intravenous piggyback) in holding.

Review of the Pre-Operative Report for Patient #13 revealed no documented evidence Ancef 2gm had been started in the pre-operative (holding area) prior to the start of the surgical procedure. Review of the Anesthetic Record for Patient #13 revealed she was taken to the operating room at 9:24am at which time the Ancef 2gm was administered (no rate of administration documented). Surgery began16 minutes later.

In a face-to-face interview on 04/12/12 at 1:30pm, DON S2 could offer no explanation for the IV medication orders not having the rate of infusion order by the physician.

In a face-to-face interview on 04/12/12 at 5:05pm, DON S2 indicated the clinical coordinators did chart audits, and if any medication errors were noted, the coordinator would complete a variance report.

Review of the hospital policy titled "Routine Scheduled Medications", policy number PHM-041, reviewed 02/25/11, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...All pertinent information required for safe administration of medications shall be obtained, including drug, dose and strength, route, date, and time schedule...". There was no documented evidence that the rate of infusion had been addressed in the policy.

Review of the hospital policy titled "Questionable Drug Orders", policy number PHM-037, reviewed 03/14/12, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...Any questionable drug order will be clarified prior to the administration of the medication...".

Review of the hospital policy titled "Physician's Orders", policy number MR-05, no documented evidence of the date of approval or review, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...2. Telephone/Verbal Orders The Nurse accepting the telephone/verbal order will: ... B. Promptly document the order on an Order Sheet to include date, time, treatment or medication, route, dose, frequency, priority. C. Restate the order back to the ordering physician...".




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26351

Based on record review and interview, the hospital failed to ensure each patient's record was accurately written (#2, #4, #7, #14) for 4 of 21 sampled medical records and completed no later than 30 days after discharge for 1 of 21 sampled patients (#4). Findings:

Patient #2
Review of Patient #2's medical record revealed she was a 56 year old female who was admitted on 03/30/12 with diagnoses of influenza, asthma, and bronchitis. Review of Patient #2's "Nutritional Assessment" performed on 03/31/12 by Dietary Tech S12 revealed the plan to "discuss food/drug interactions" had "NKDA" (no known drug allergies) documented by S12. Review of Patient #2's "Admit History" dated 03/30/12 revealed she was allergic to Codeine, Aspirin, and Ibuprofen.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12 and was discharged on 03/02/12. Review of the "Discharge Summary / Short Stay Report" revealed the course of hospital stay was not documented, and the physician did not date and time when he signed the discharge summary. Further review revealed the "Operative Progress Note" dated 02/28/12 was hand-written, did not have the clinical findings documented, and the physician did not sign the note. Further review revealed no documented evidence that an operative note was dictated within 30 days of the procedure as required by hospital policy.

In a face-to-face interview on 04/12/12 at 11:03am, Administrator S1 could offer no explanation for the patient's medical record not being completed within 30 days after discharge and for the written operative notes being incomplete and not being dictated as required by hospital policy.

Review of Patient #4's "Nutritional Assessment" performed on 02/29/12 by Dietary Tech S42 revealed no documented evidence that Patient #4's "appetite" had been assessed as evidenced by the absence of a check mark in the boxes labeled "excellent (90-100%) Good (75-90%) Fair (50-75%) Poor (<50%)" (less than 50 per cent).

In a face-to-face interview on 04/12/12 at 11:20am, Dietary Tech S42 confirmed Patient #2's nutritional assessment had NKDA when Patient #2 was actually allergic to Codeine, Aspirin, and Ibuprofen. S42 indicated she did not document Patient #4's appetite when she did the initial assessment, because she waited to see what the patient ate during her hospital stay. S42 could offer no explanation for how she would determine in a change in the patient's appetite from the time of admission if she didn't assess the appetite on the initial nutritional assessment. S42 further indicated "I don't know why we do those anyway" (referring to the nutritional assessment).

Patient #7
Review of Patient #7's medical record (reviewed after Patient #7 was discharged on 04/10/12) revealed she was a 21 year old female who had a bilateral breast augmentation with saline on 04/09/12 and was discharged on 04/10/12. Review of the "Discharge Summary / Short Stay Report" revealed no documented evidence of the discharge date, medications, and the signature of the physician with the date and time.

Patient #14
Review of Patient #14's medical record revealed she was an 82 year old female who had a right phaco cataract extraction with intraocular lens implant 0n 02/24/12. Review of her "Admit History" revealed the operation was listed as a left phaco cataract extraction with intraocular lens implant. Further review revealed the "admit History" from the previous procedure performed on 02/08/12 was used, and the nurse failed to update Patient #14's surgical procedure.

In a face-to-face interview on 04/12/12 at 1:30pm, DON (Director of Nursing) S2 indicated the nurse can update a patient's admit history from a previous procedure if it's for the same procedure/eye, but a new admit history should have been completed for Patient #14, since a different eye was being done.

Review of the hospital policy titled "Accurate and Timely Record Completion", policy number MR-02, approved 04/02/12, and included in the manuals presented by Administrator S1 as current, revealed, in part, "...To satisfy the requirement of providing an operative note immediately following a procedure; in the event the surgeon does not dictate after a procedure. A written operative progress note describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon. ...An operative report should be dictated within 30 days describing in detail the procedure performed. An operative report should include a description of the specific significant surgical tasks performed by that practitioner...".

Review of the hospital policy titled "Physician Notification Process", policy number MR-10, reviewed 02/11/11, and included in the manuals presented by Administrator S1 as current, revealed, in part, "...It is the policy of this hospital to monitor the status of incomplete medical records for each staff physician and maintain a listing of staff physicians who are deficient in timely completion of these records. Medical records shall be completed within 30 days of patient's discharge...".

Review of the hospital policy titled "Medical Record Content Documentation", policy number MR-13, reviewed 02/11/11, and included in the manuals presented by Administrator S1 as current, revealed, in part, "...Purpose: To ensure that the hospital has a complete and accurate medical record for every individual assessed or treated. ... 1. Accurate, legible, concise, correctly spelled phrases and entries should be made. ...3. All entries must be signed with initials. ... 4. All entries must be dated and times...".

Based on record review and interview the hospital failed to ensure all patients' medical record entries were complete, dated, timed, and authenticated as evidenced by the hospital failing to: 1) ensure all patients receiving blood products had a consent signed by the physician for 2 of 3 patients receiving blood from a total sample of 21 patients (#1, #4); 2) ensure all patients had admit orders for 2 of 21 sampled patients (#3, #6); and 3) ensure all medical record entries were dated, timed, and authenticated for 6 of 21 sampled patients (#2, #3, #4, #9, #12, #19). Findings:

1) ensure all patient receiving blood products had a consent signed by the physician:
Patient #1
Review of the medical record for Patient #1 revealed a 70 year old woman admitted to the hospital for a Right Total Knee Arthroplasty on 02/28/12 and discharged on 03/03/12. Further review revealed the consent for Transfusion of Blood and Blood Products dated 03/01/12 at 2:50pm and 03/01/12 at 5:00pm had not been signed by the ordering physicians as required by the hospital.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of the "Physicians Orders" dated 02/29/12 at 8:00am revealed an order to type and match for 2 units of packed cells and transfuse "today".

Review of Patient #4's "Consent and Disclosure for Transfusion of Blood and Blood Components", signed by Patient #4 on 02/29/12 at 12:30pm and by LPN (licensed practical nurse) S20 on 02/29/12 at 12:30pm, revealed no documented evidence of the physician's signature as evidenced by the line for signature being blank and having the record flagged for the signature.

In a face-to-face interview on 04/12/12 at 1:30pm, Director of Nursing (DON) S2 indicated the physician was supposed to sign the patient's blood consent prior to the blood being administered.

Review of the hospital's policy on Blood Administration revealed in part, "...Assessment 1. Verify physician's or health care provider's order for blood component transfusion with date, time of transfusion, duration, and any pre-transfusion or post-transfusion medication you will administer...4. Check that the patient has properly completed and signed transfusion consent before retrieving blood...".

2) ensure all patients had admit orders for 2 of 21 sampled patients:
Patient #3
Review of the medical record for Patient #3 revealed a 76 year old women admitted on 12/23/11 to the hospital for a transfusion of 2 units of PRBCs (Packed Red Blood Cells) due to the diagnosis of anemia and discharge on 12/24/11. Further review revealed there were no orders to admit the patient to the hospital for the transfusion of the PRBCs.

Patient # 6
Review of the medical record for Patient #6 revealed a 92 year old women admitted on 1/24/12 for intravenous antibiotics for 10 days. Further review revealed no admission orders to admit the patient to the hospital for the infusion of antibiotics.

An interview was conducted with S2DON on 04/12/12 at 1:30 p.m. She reported Patient #3 and Patient #6 should have had admission orders to the hospital and both medical charts were incomplete.

Review of the hospital Medical Staff by-laws revealed, " The attending physician shall be responsible for the preparation of a complete medical record for each patient he/she admits... No medical record shall be filed until it is complete except on order of the Medical Review Committee...

3) ensure all medical record entries were dated, timed, and authenticated:
Patient #2
Review of Patient #2's medical record revealed she was a 56 year old female who was admitted on 03/30/12 with diagnoses of influenza, asthma, and bronchitis. Review of the "History and Physical" (H&P) revealed no documented evidence of the date and time the physician documented the H&P.

Review of Patient #2's physician orders revealed the admit orders dated 03/30/12 had no documented evidence of the time the physician wrote the orders.

Patient #3
Review of the medical record of Patient #3 revealed she was a 78 year old female admitted to the hospital to receive 2 units of PRBCs (Packed Red Blood Cells). Review of the physician order to Type and Match and Transfuse 2 units of PRBC revealed the physician did not date or time the order.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of the "Discharge Summary/Short Stay Report" revealed no documented evidence of the date and time it was documented by the physician. Review of Patient #4's "Operative Progress Note" revealed no documented evidence of the surgeon's signature.

Review of Patient #4's pre-printed admit, post-op, post-op day 1, post-op day 2, and post-op day 3 orders of the surgeon revealed no documented evidence of the date and time the orders were initiated. Further review revealed an order written by the physician on 03/02/12 had no documented evidence of the time the order was written.

Patient #9
Review of Patient #9's medical record revealed she was a 67 year old female who had a left total knee replacement on 04/09/12. Review of the surgeon's pre-printed post-op day 1 orders revealed no documented evidence of the time the orders were initiated. Review of Patient #9's "Progress Notes" revealed no documented evidence of the time the note was written on 04/10/12 (2 entries) and 04/11/12.

Patient #12
Review of the medical record of Patient #12 revealed she was a 28 year old female admitted to the hospital on 03/30/12 for a Lap Cholecystectomy. Review of the Admission orders revealed the orders were dated 03/30/12, but the order was not timed.

Patient #19
Review of Patient #19's medical record revealed he was a 77 year old male who had a left phaco cataract extraction with intraocular lens implant on 04/11/12. Review of the surgeon's pre-printed admit and intra-op orders and anesthesia's pre-printed pre-op orders revealed no documented evidence of the time any of the orders were initiated.
Review of the hospital's Medical Staff By-laws revealed in part, "...5. All medical records/order entries shall be properly authenticated by the physician's signature along with the date and time of the signature...".

In a face-to-face interview on 04/12/12 at 11:03am, Administrator S1 offered no explanation for the physicians not dating, timing, and authenticating their medical record entries.

Review of the hospital policy titled "Physician's Orders", policy number MR-05, no documented evidence of the date of approval or review, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...1. Pre-printed standing orders may be instituted by a physician for use on specific groups of patients. ... C. Pre-printed orders are subject to review and change as necessary, and will be presented to each physician for approval and signature. ...4. Standing Orders ... B. Each order will be written on an order sheet and signed by writing S.O. (standing order), the physician's name, the nurse, date and time. The Standing Order will be authenticated by the physician within 48 hours as a verbal order is. It will include the physician's signature, date and time".

Review of the hospital policy titled "Medical Record Content Documentation", policy number MR-13, no documented evidence of the date of approval or review, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...1. Accurate, legible, concise, correctly spelled phrases and entries should be made. ... 4. All entries must be dated and times...".



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26351

25065


Based on record review and interview, the hospital failed to ensure all verbal orders were authenticated within 48 hours and included read-back verification by the nurse as required by hospital policy for 7 of 21 sampled patients (#1, #2, #3, #4, #6, #9, #21). Findings:

Patient #1
Review of the medical record for Patient #1 revealed a 70 year old woman admitted to the hospital for a Right Total Knee Arthroplasty on 02/28/12. Review of the Physicians' Orders revealed the physician did not date and time the order when he authenticated the order: 02/28/12 8:50pm Phenergan 25mg IV q 4 hours prn N/V; 02/28/12 8:55pm Resume home meds 1. Nexium 40mg i po (by mouth) q day, 2. Januvia 100mg i po q day, 3. Pramipexole 0.5mg i po q day, 5. Nifedipine 90 mg i po q day, 6. Triam/HCTZ 37.5/25mg i po q AM, 7. Avapro 300mg q day, 8. Tricor 145mg i po q day, 9. Glyg/Metform 5/500mg i po BID; and Restoril 30mg po q hs (hour of sleep) prn insomnia; and 03/01/12 @ 4:10pm Insert urethral catheter to closed drainage.

Patient #2
Review of Patient #2's medical record revealed she was a 56 year old female who was admitted on 03/30/12 with diagnoses of influenza, asthma, and bronchitis. Review of the "Physician Orders" revealed the following orders had not been authenticated within 48 hours or timed and dated when the physician signed the standing order:
03/30/12 at 2:30pm - no documented evidence the telephone order was authenticated by the physician as of 04/09/12, 10 days since it was given;
03/30/12 at 4:45pm - standing order was not dated and timed when signed by the physician;
03/31/12 - standing order, with no documented evidence of the time the order was initiated, was not dated and timed when signed by the physician.

Patient #3
Review of the medical record of Patient #3 revealed she was a 78 year old female admitted to the hospital to receive 2 units of PRBCs (Packed Red Blood Cells). Review of the verbal physician orders for Lasix 40 mg IV after 1st unit of PRBCs on 12/23/11 revealed the physician did not date and time the order when he authenticated the order.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of the "Physician Orders" revealed the following orders had not been authenticated within 48 hours, timed and dated when the physician signed the standing order, or included read-back verification by the nurse:
standing order for anesthesia, with no documented evidence of the date and time the order was initiated, was not dated and timed when signed by the physician;
02/28/12 at 9:25am - verbal order was signed by the physician on 03/08/12 at 10:00am, 9 days after it was given rather than within 48 hours as required by hospital policy;
02/29/12 at 2:00pm - telephone order was not dated and timed when signed by the physician;
02/29/12 at 4:30pm - telephone order with no documented evidence of read-back verification by the nurse and no documented evidence of the date and time the physician signed the order.

Patient #6
Review of the medical record of Patient #6 revealed she was a 92 year old female admitted to the hospital for intravenous antibiotics for a recurrent urinary tract infection. Review of the physician order for Rocephin 2 grams IVPB (intravenous piggy back) q (every) day x (times) 10 days revealed the physician did not date or time the verbal order when he authenticated the order.

Patient #9
Review of Patient #9's medical record revealed she was a 67 year old female who had a left total knee replacement on 04/09/12. Review of the "Physician Orders" revealed the following orders had not been authenticated within 48 hours, timed and dated when the physician signed the standing order, or included read-back verification by the nurse:
verbal order for Dilaudid was not dated and timed by the nurse who received the order, did not include a read-back verification, and there was no documented evidence of the date and time when the physician signed the order;
2 separate verbal orders written on 04/10/12 at 5:00pm had no documented evidence of a read-back verification by the nurse who received the order;
04/10/12 at 9:25pm - verbal order had no documented evidence of a read-back verification by the nurse who received the order.

Patient #21
Review of the medical record for Patient #21 revealed a 45 year old female admitted to the hospital on 07/16/11 for nausea and vomiting after having gastric sleeve surgery on 07/11/11.
Review of the Physicians' Orders revealed revealed the physician did not date and time the order when he authenticated the orders for the following: 07/16/11 Admit orders; 07/17/11 at 9am for Clonidine Patch 0.3 mg every week; and 07/22/11 at 10:15am Swallow Study now.

In a face-to-face interview on 04/12/12 at 11:03am, Administrator S1 offered no explanation for the physicians not dating and timing when they sign verbal/telephone orders. She confirmed that without a date and time of the signature, there was no way to determine that the order was signed within 48 hours as required by hospital policy.

Review of the hospital's Medical Staff By-laws revealed, " All routine physician orders shall be in writing. An order shall be considered in writing if dictated to a licensed nurse and signed by the attending physician. The attending physician must sign all verbal or telephone orders as soon as possible and not later than 48 hours."

Review of the hospital policy titled "Physician's Orders", policy number MR-05, no documented evidence of the date of approval or review, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...2. Telephone/Verbal Orders ... B. Promptly document the order on an Order Sheet to include date, time, treatment or medication, route, dose, frequency, priority. C. Restate the order back to the ordering physician D. Document Telephone Order Read Back (TORB) or Verbal Order Read Back (VORB), ordering physician name, co-sign by nurse...".





26351

Based on record review and interview the hospital failed to ensure all medical records contained a completed discharge summary (#1, #4) and death summary (#21) for 3 of 10 inpatients out of 21 sampled medical records. Findings:

Review of the "Discharge Summary/Short Stay Report" form submitted by the hospital as the one currently in use revealed the following required information: Discharge Date; Admit Date; Reason for Admit; Procedure(s) Performed; Course of Hospital Stay; Condition at Discharge; Medication; Diet; Activity; Follow Up; Physician Signature; and Date/Time.

Patient #1
Review of the medical record for Patient #1 revealed a 70 year old woman admitted to the hospital for a Right Total Knee Arthroplasty on 02/28/12 and discharged on 03/03/12.

Review of the Discharge Summary/Short Stay Report for Patient #1 revealed the course of the hospital stay and activity was not completed. Further review revealed no documented evidence the form was authenticated by the physician as evidenced by a blank in the space provided for the signature of the physician and the date/time signed.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12 and was discharged on 03/02/12.

Review of the Discharge Summary/Short Stay Report for Patient #4 revealed the course of hospital stay was not completed. Further review revealed the physician did not date and time when he documented the discharge summary.

Patient #21
Review of the medical record for Patient #21 revealed a 45 year old female admitted to the hospital on 07/16/11 for nausea and vomiting after having gastric sleeve surgery on 07/11/11.
Further review of the medical record revealed Patient #21 was found unresponsive on 02729/11 at 4:20am and after unsuccessful attempts to revive her, Patient #21 was pronounced dead at 0540 (5:40am). Review of the death record found in the medical record revealed no documented evidence of the cause of death and no death summary was documented.

In a face to face interview on 04/11/12 at 11:00am RN S2 Director of Nursing indicated the reason the chart on Patient #21 had not been completed was due to the family's decision to obtain a private autopsy and refused to share the information found with the hospital or the attending physician.

Review of the hospital's Medical Staff By-laws revealed in part, "....6. The attending physician shall be responsible for the preparation of a complete medical record for each patient he/she admits. The record shall include...final diagnosis and discharge summary. No medical record shall be filed until it is complete except on order of the Medical Review Committee...11. Patients shall be discharged only on order of the physician. At the time of discharge, the attending physician shall complete the record, state his final diagnosis, and sign the record...".

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

1) Failing to have pharmacy policies and procedures developed, implemented, and periodically reviewed and revised by the contracted pharmacist as required by the professional service agreement; failing 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; failing to ensure that only pharmacists or pharmacy-supervised personnel compounded drugs by having medication admixtures prepared by the RNs (registered nurse); and failing 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 5 of 21 sampled patients (#1, #4, #8, #17, #21) (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 pharmacy failed to comply with his responsibilities agreed upon in the professional services agreement with the hospital related to pharmacy policies and procedures, the Pharmacy and Therapeutics Committee (P&T), performance improvement related to pharmacy, and chart reviews (see findings in tag A0492); and

3) Failing to ensure the compounding, packaging, and dispensing of drugs was performed under the supervision of the pharmacist (see findings in tag A0501).

25065

Based on observation, record review, and interviews, the hospital failed to ensure the pharmacy was administered according to accepted professional principles 1) The hospital failed to have pharmacy policies and procedures developed, implemented, and periodically reviewed and revised by the contracted pharmacist as required by the professional service agreement. 2) 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. This resulted in physician orders for ranges in dose and frequency being accepted with the nurse making the decision regarding the specific strength/dose and frequency for 9 of 21 sampled patients (#1, #2, #4, #5, #7, #8, #9, #12, #21). 4) The hospital failed to ensure that only pharmacists or pharmacy-supervised personnel compounded drugs by having medication admixtures prepared by the RNs (registered nurse). 5) 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 5 of 21 sampled patients (#1, #4, #8, #17, #21). Findings:

1) The hospital failed to have pharmacy policies and procedures developed, implemented, and periodically reviewed and revised by the contracted pharmacist as required by the professional service agreement:

Review of the "Professional Services Agreement" between the hospital and Contract Pharmacist S44 signed 04/10/11, revealed, in part, "...3. Responsibilities: The Consultant ... agrees to provide the following services for the Hospital: ...Develop and evaluate, on an annual basis, appropriate policies and procedures directing the pharmacy-related activities and services of the hospital. These policies and procedures include, but are not limited to medication procurement, dispensing, and administration...".

Review of the pharmacy policy manual presented by Administrator S1 as the current policies revealed the following policies, the signature of the person who approved the policy, and the date it was approved:
"Routine Scheduled Medications" approved by Director of Nursing (DON) S2 on 03/15/10;
"PSU (post surgical unit) Medication Administration Record" approved by DON S2 on 07/22/11;
"Questionable Drug Orders" approved by DON S2 on 03/30/09;
"Automatic Stop Orders" approved by DON S2 on 03/30/09;
"Medications Brought From Home" approved by DON S2 on 03/30/09;
"Medication Removal" approved by DON S2 on 03/15/10;
"Medication Errors" approved by DON S2 on 03/30/09'
"Acquisition And Management Of Medications" approved by DON S2 on 03/01/11;
"Consultant Pharmacist, Aspects Of Care" approved by DON S2 on 03/15/10;
"Intravenous Admixtures" approved by DON S2 on 03/14/12;
"Drug Storage Security Measures: Keyless Entry-Electronic Tracking" approved by DON S2 on 03/15/10;
"Administration Of Medication" approved by DON S2 on 03/15/10; and
"Regulatory Standards And Quality In-House Service" approved by DON S2 on 03/14/12.
Further review revealed no documented evidence the policies and procedures were developed, implemented, and periodically reviewed and revised by Contract Pharmacist S44.

In a face-to-face interview on 04/12/12 at 3:45pm, Contract Pharmacist S44 indicated he was not a "policy maker". If the hospital had questions related to pharmacy, he would make recommendations only. S44 further indicated his "role is not to oversee the pharmacy". He offered no explanation for the discrepancy in his perceived role versus what's stated in his professional service agreement.

2) 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. This resulted in physician orders for ranges in dose and frequency being accepted with the nurse making the decision regarding the specific strength/dose and frequency:
In a face-to-face interview on 04/12/12 at 9:50am, Pharmacy RN S41 indicated Contract Pharmacist S44 did not review each patient's medication ordered by the physician prior to administration of the first dose. She further indicated the PSU nurse would fax the physician orders to her so she can assure the availability of the medication. S41 further indicated the ordered medications were not reviewed for known allergies, therapy contraindications, dose and route of administration, directions for use, duplication of therapy, interactions, and optimum therapeutic outcomes.

In a face-to-face interview on 04/12/12 at 3:45pm, Contract Pharmacist S44 confirmed that he did not review each patient's ordered medications for known allergies, therapy contraindications, dose and route of administration, directions for use, duplication of therapy, interactions, and optimum therapeutic outcomes.

Patient #1
Review of the medical record for Patient #1 revealed a 70 year old female admitted to the hospital on 02/28/12 for a Right Total Knee Replacement. Review of the Physicians' Orders dated 02/28/12 at 11:40am revealed an order for Ativan 1-2mg IVP in PACU (post anesthesia care unit). Review of the Physicians' Orders dated 02/29/12 (no time documented) revealed.... "Lantus 50u bs (blood sugar). Further review of the medical record revealed no documented evidence the nurse clarified the order with the physician for route and frequency.

Review of the MAR (medication administration record) revealed Patient #1 received Lantus 50 units on 02/28/12, 02/29/12 and 03/01/12.

Patient #2
Review of Patient #2's medical record revealed she was a 56 year old female who was admitted on 03/30/12 with diagnoses of influenza, asthma, and bronchitis. Review of Patient #2's admit orders dated 03/30/12 revealed an order for Ultram 50 mg 1 - 2 orally every 4 hours as needed for pain or body aches. Further review revealed no documented evidence of the specific dose to be administered, which required the nurse to decide what strength/dose to administer. There was no documented evidence of a clarification order by the nurse for the specific dose of Ultram to be administered.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of Patient #4's "Anesthesia Order Sheet - PACU" revealed no documented evidence of the date and time the standing order was initiated. Further review revealed an order to titrate Morphine 1 mg to 4 mg IV within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. There was no documented evidence of an order for the specific dose and frequency between administration of each dose of Morphine. Further review revealed no clarification order received by the nurse for the specific dose and frequency for Morphine administration.

Review of Patient #4's "Anesthesia Order Sheet - PACU" revealed a verbal order was received on 02/28/12 at 9:25am for Dilaudid 0.5 mg - 2 mg IV titrated prn (as needed) pain. Further review revealed no documented evidence that the order for Dilaudid included the exact dose and frequency (time interval) for which it was to be administered.

Patient #5
Review of the medical record for Patient #5 revealed she was admitted to the hospital on 3/30/12 for laparoscopic cholecystectomy related to her diagnosis of biliary dyskinesia. Review of her physician order to transfer to PACU(Post Anesthesia Care Unit) then admit to Post Surgical Unit as an outpatient, dated 3/30/12, revealed an order for Percocet 5 mg(milligram) i-ii (1 to 2) po (by mouth) q (every) 4 hrs(hours) prn ( as needed) pain or Vicodin 5 mg i-ii po q 4hrs prn pain. Phenergan 12.5-25 mg IVP(intravenous)q 4hrs prn nausea. Review of the Anesthesia Order Sheet for dated 3/30/12 at 11:20 a.m. revealed an order for pain medication. The order read, Pain: Unless contraindicated, titrate Morphine 1 mg to 4 mg IV (intravenous) within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. If no relief notify Anesthesiologist. 2. Unless contraindicated, give cholecystectomy patients Demerol 12.5 mg IV every 5 minutes until pain is relieved. Do not exceed 50 mg total. If no relief notify Anesthesiologist.

Patient #7
Review of Patient #7's medical record revealed she was a 21 year old female who had a bilateral breast augmentation with saline on 04/09/12. Review of Patient #7's post-op orders dated 04/09/12 revealed the following medications were ordered with a range rather a specific dose, route, and frequency:
Morphine 2 - 4 mg IV every 15 minutes prn maximum 10 mg every 2 hours;
Lortab 7.5 mg orally 1 -2 every 3-4 hours prn pain;
Phenergan 12.5 mg - 25 mg orally/IV every 6 hours prn nausea.

Review of Patient #7's "Anesthesia Order Sheet - PACU" dated 04/09/12 revealed an order to titrate Morphine 1 mg to 4 mg IV within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. There was no documented evidence of an order for the specific dose and frequency between administration of each dose of Morphine.

Patient #8
Review of the medical record for Patient #8 revealed Patient #8 was admitted to the hospital on 4/09/12 for a total left knee arthroplasty. Review of the Physician Orders dated 4/9/12 on the Anesthesia Order Sheet for PACU (Post Anesthesia Care Unit) revealed the order, Unless contraindicated, titrate morphine 1 mg to 4 mg IV (intravenous) within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. If no relief notify Anesthesiologist. 2. Unless contraindicated, give cholecystectomy patients Demerol 12.5 mg IV every 5 minutes until pain is relieved. Do not exceed 50 mg total. If no relief notify Anesthesiologist.

Patient #9
Review of Patient #9's medical record revealed she was a 67 year old female who had a left total knee replacement on 04/09/12. Review of Patient #9's "Anesthesia Order Sheet - PACU" revealed an order to titrate Morphine 1 mg to 4 mg IV within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. There was no documented evidence of an order for the specific dose and frequency between administration of each dose of Morphine.

Review of Patient #9's "Anesthesia Order Sheet - PACU" revealed a verbal order, with no documented evidence of the date and time the order was received, for Dilaudid 0.5 mg - 2 mg IV in PACU for pain. Further review revealed no documented evidence of a clarification order that included the specific dose and frequency at which Dilaudid was to be administered.

Patient #12
Review of the medical record for Patient #12 revealed she was admitted on 3/30/12 for a
laparoscopic cholecystectomy for biliary dysfunction. Review of her PSU Cholecystectomy Admit Orders revealed an order for Percocet 5 mg (milligrams) i-ii (1 to 2) po (by mouth) q (every) 4 hrs(hours) prn ( as needed) pain or Vicodin 5 mg i-ii po q 4hrs prn pain. Phenergan 12.5-25 mg IVP (intravenous) q 4hrs prn nausea. Review of the Anesthesia Order Sheet dated 3/30/12 at 11:20 a.m,. revealed an order for pain medication. The order read, Pain: Unless contraindicated, titrate Morphine 1 mg to 4 mg IV (intravenous) within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. If no relief notify Anesthesiologist. 2. Unless contraindicated, give cholecystectomy patients Demerol 12.5 mg IV every 5 minutes until pain is relieved. Do not exceed 50 mg total. If no relief notify Anesthesiologist.

Patient #21
Review of the medical record for Patient #21 revealed a 45 year old female admitted to the hospital on 07/16/11 for nausea and vomiting after having gastric sleeve surgery on 07/11/11.
Review of the Physicians' Orders revealed the following range orders: 07/26/11 at 10:18pm Morphine 3-5mg prn for pain; and 07/21/11 at 1:01pm Zofran 4-8mg IVP every 4-6 hours prn for nausea.

Review of the hospital policy titled "Routine Scheduled Medications", policy number PHM-041, reviewed 02/25/11, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...All pertinent information required for safe administration of medications shall be obtained, including drug, dose and strength, route, date, and time schedule...".

Review of the hospital policy titled "Administration Of Medication", policy number PHM-024, reviewed 03/14/12, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...Policy: Standards of safe practice will be adopted and followed at Physicians Medical Center to ensure the safe administration of medication to patients. Procedure: A. The nurse preparing the medication for administration must be familiar with that particular medication, its possible side effects, and its contraindications. The nurse must know that the route of administration is correct for the particular medication being administered. Reference books are available, including the PDR (physician desk reference). The pharmacy nurse will help to obtain the necessary information needed for the particular medication question. He/she will contact the Consultant Pharmacist if necessary...".

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...".

3) The hospital failed to ensure that only pharmacists or pharmacy-supervised personnel compounded drugs by having medication admixtures prepared by the RNs:
In a face-to-face interview on 04/12/12 at 9:05am, RN Pre-op Coordinator S37 indicated the nurse would be required to admix Ampicillin, Unasyn, Vancomycin, Zosyn, Cleocin, Gentamicin (other than 80 mg), and Doxycycline if ordered by the physician. She further indicated the nurse would reconstitute the medication according to the drug book directions, add the reconstituted solution to the appropriate amount fluids, and label the bag. S37 indicated the IV preparation would be done in the medication room of pre-op, and there is no laminar flow hood available in the hospital.

In a face-to-face interview on 04/12/12 at 9:20am, RN PACU Coordinator S36 indicated the medications requiring admixing by the nurse were the same medications as used in pre-op. She further indicated the nurse would prepare the IV medication in the medication room of PACU.

In a face-to-face interview on 04/12/12 at 9:30am, LPN (licensed practical nurse) Clinical Coordinator S40 indicated the PSU nurses do their own admixing of medications in the PSU medication room.

In a face-to-face interview on 04/12/12 at 3:45pm, Contract Pharmacist S44 indicated admixing of antibiotics does not require that it be done by a pharmacist, and a laminar flow hood was not required.

Review of the hospital policy titled "Intravenous Admixtures", policy number PHM-015, approved 03/14/12 by DON S2, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...Policy: Intravenous admixtures may be prepared by licensed nursing staff for use in patient care as ordered by the physician. Medications may be reconstituted and added to the appropriate basic solution... per manufacturer's recommendations...". There was no documented evidence that admixing medications were to be performed by the RN and that it would be done by the RN only when the drug was ordered stat or when the drug would deteriorate upon standing as required by the Louisiana State Board of Registered Nurses.

Review of the Louisiana State Board of Registered Nurses Declaratory Statement On The Role And Scope Of Practice Of Registered Nurses Delegating Intravenous Therapy Interventions", revealed, in part, "...Administration refers to preparation of the drug, gathering the necessary equipment, administering the medication, and monitoring (evaluating) the patient's response to the therapy. Note. The functions of administration may not be delegated when indicated as a nondelegatable nursing intervention within the context of this statement. In selected situations preparation of IV admixtures may be performed by an RN when the drug is prescribed as "stat" or when the drug would deteriorate upon standing. "Gathering the necessary equipment" refers to the RN actually assembling the IV equipment and medication...".

Review of the "Louisiana Administrative Code Title 46 - Professional and Occupational Standards Part LIII: Pharmacists Chapter 15. Hospital Pharmacy", revealed, in part, "...1513. Labeling A. All drugs dispensed by a hospital pharmacy, intended for use within the facility, shall be dispensed in appropriate containers and adequately labeled as to identify patient name and location, drug name(s) and strength, and medication dose(s). Additionally, compounded preparations and sterile preparations shall be labeled with the expiration or beyond-use date, initials of the preparer, and the pharmacist performing the final check. ...(5) "Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or device
by a pharmacist for his patient as the result of a practitioner's prescription drug order...".

4) 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:
Observation of the PSU medication room on 04/12/12 at 9:30am revealed the home prescription bottles were in the patient bins for Patient #8 and #17. This observation was confirmed by LPN Clinical Coordinator S40.

Review of the physician orders for Patients #1, #4, #8, #17, and #21 revealed orders for home medications to be resumed with the names of the medications listed. There was no documented evidence of a specific order by the physician to administer the patient's home medications while in the hospital as required by hospital policy.

Patient #4
Review of Patient #4's "Physicians Orders" dated 02/28/12, with no documented evidence of the time the order was written, revealed an order to "restart: Crestor 20 mg po QD (every day), Trilipix 135 mg po QD, Lisinopril 20/25 po QD".

Patient #8
Review of Patient #8's "Physicians Orders" dated 04/09/12 at 1:30pm revealed an order to "restart home meds. Hold for BP (blood pressure) < (less than) 100/60 Clonidine 0.3 mg i po BID (one by mouth twice a day) Lisinopril 40 mg i po BID Diovan 80 mg i po a AM (every morning) HCTZ (hydrochlorothiazide) 25 mg i po q AM".

Patient #17
Review of Patient #17's "Physicians Orders" dated 04/10/12 at 7:35pm revealed an order to "resume home meds (medications): Diovan HCT 160-25 mg q AM po, Glucovance 5-500 mg q AM & PM (and night) po, Glimepiride 2 mg po 1/2 tab (tablet) q AM, Bystolic 10 mg po q PM".

In a face-to-face interview on 04/12/12 at 9:50am, RN Pharmacy Nurse S41 indicated the PSU nurses receive the patients' home medications and places them in the patient's respective drug bin in the PSU pharmacy room. She further indicated the PSU nurse dispensed the home medication as ordered by the physician, and the home medications were not sent to the pharmacy to be identified by the contract pharmacist.

In a face-to-face interview on 04/12/12, Contract Pharmacist S44 indicated he did not identify the patient's home medications when they were ordered by the physician, because the medication was in a labeled bottle that was dispensed by another pharmacist.

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...".



26351

Based on observation, 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 pharmacy policies and procedures, the Pharmacy and Therapeutics Committee (P&T), performance improvement related to pharmacy, and chart reviews. Findings:

Review of the "Professional Services Agreement" between Physician Medical Center and Contract Pharmacist S44, effective 04/10/2000, revealed, in part, "...3. Responsibilities. The Consultant ... agrees to provide the follosing services for the Hospital: A. Maintain current Pharmacy Registration in the State of Louisiana ... D. Direct and serve as a resource person to the facility's employees and physicians regarding the actions, interactions, compatibility, dosage, indications, and possible adverse reactions of all pharmaceutical products. ... E. Develop and evaluate, on an annual basis, appropriate policies and procedures directing the pharmacy-related activities and services of the hospital. These policies and procedures include, but are not limited to medication procurement, dispensing, and administration. ... K. Responsible for Performance Improvement in pharmacy - related procedures and attends and participates on the quarterly Pharmacy and Therapeutics Committee meetings. ... R. Performs chart reviews to ensure proper documentation of drug usage. ... V. Monitor all IV (intravenous) admixture usage...".

1) Direct and serve as a resource person to the facility's employees and physicians regarding the actions, interactions, compatibility, dosage, indications, and possible adverse reactions of all pharmaceutical products:
In a face-to-face interview on 04/12/12 at 9:50am, Pharmacy RN S41 indicated Contract Pharmacist S44 did not review each patient's medication ordered by the physician prior to administration of the first dose. She further indicated the PSU nurse would fax the physician orders to her so she can assure the availability of the medication. S41 further indicated the ordered medications were not reviewed for known allergies, therapy contraindications, dose and route of administration, directions for use, duplication of therapy, interactions, and optimum therapeutic outcomes.

In a face-to-face interview on 04/12/12 at 3:45pm, Contract Pharmacist S44 confirmed that he did not review each patient's ordered medications for known allergies, therapy contraindications, dose and route of administration, directions for use, duplication of therapy, interactions, and optimum therapeutic outcomes.

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) Develop and evaluate, on an annual basis, appropriate policies and procedures directing the pharmacy-related activities and services of the hospital:
Review of the pharmacy policy manual presented by Administrator S1 as the current policies revealed the following policies, the signature of the person who approved the policy, and the date it was approved:
"Routine Scheduled Medications" approved by Director of Nursing (DON) S2 on 03/15/10;
"PSU (post surgical unit) Medication Administration Record" approved by DON S2 on 07/22/11;
"Questionable Drug Orders" approved by DON S2 on 03/30/09;
"Automatic Stop Orders" approved by DON S2 on 03/30/09;
"Medications Brought From Home" approved by DON S2 on 03/30/09;
"Medication Removal" approved by DON S2 on 03/15/10;
"Medication Errors" approved by DON S2 on 03/30/09'
"Acquisition And Management Of Medications" approved by DON S2 on 03/01/11;
"Consultant Pharmacist, Aspects Of Care" approved by DON S2 on 03/15/10;
"Intravenous Admixtures" approved by DON S2 on 03/14/12;
"Drug Storage Security Measures: Keyless Entry-Electronic Tracking" approved by DON S2 on 03/15/10;
"Administration Of Medication" approved by DON S2 on 03/15/10; and
"Regulatory Standards And Quality In-House Service" approved by DON S2 on 03/14/12.
Further review revealed no documented evidence the policies and procedures were developed, implemented, and periodically reviewed and revised by Contract Pharmacist S44.

In a face-to-face interview on 04/12/12 at 3:45pm, Contract Pharmacist S44 indicated he was not a "policy maker". If the hospital had questions related to pharmacy, he would make recommendations only. S44 further indicated his "role is not to oversee the pharmacy". He offered no explanation for the discrepancy in his perceived role versus what's stated in his professional service agreement.

3) Responsible for Performance Improvement in pharmacy - related procedures and attends and participates on the quarterly Pharmacy and Therapeutics Committee meetings:
In a face-to-face interview on 04/12/12 at 3:45pm, Contract Pharmacist S44 indicated his role in the facility was that of consultant and felt he was not responsible for the administration of medication in the hospital. Further S44 confirmed he does not participate in performance improvement. He further indicated he does not attend P&T Committee meetings.

Review of the hospital policy titled "Regulatory Standards And Quality In-House Service", policy number PHM-021, approved 03/14/12 by DON S2, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "Purpose: To ensure pharmacy compliance with regulatory standards and to provide quality in-house pharmacy service to patients. ... Procedure: A. The function of the Pharmacy and Therapeutics Committee will be fulfilled by the Medical Review Committee (Medical Executive. The Consultant Pharmacist and pharmacy nurse will collaborate with the Medical review Committee on issues involving pharmacy. ... C. The Consultant Pharmacist and/or pharmacy nurse will be present at the Committee Meeting that involves pharmacy issues". Review of Contract Pharmacist S44's "Professional Service Agreement" revealed no documented evidence that attendance at the P&T committee meetings could be delegated to the pharmacy nurse.

4) Performs chart reviews to ensure proper documentation of drug usage:
In a face-to-face interview on 04/12/12 at 3:45pm, Contract Pharmacist S44 indicated his role in the facility was that of consultant and felt he was not responsible for the administration of medication in the hospital. Further S44 confirmed he does not perform chart audits.

5) Monitor all IV admixture usage:
In a face-to-face interview on 04/12/12 at 9:05am, RN Pre-op Coordinator S37 indicated the nurse would be required to admix Ampicillin, Unasyn, Vancomycin, Zosyn, Cleocin, Gentamicin (other than 80 mg), and Doxycycline if ordered by the physician. She further indicated the nurse would reconstitute the medication according to the drug book directions, add the reconstituted solution to the appropriate amount fluids, and label the bag. S37 indicated the IV preparation would be done in the medication room of pre-op, and there is no laminar flow hood available in the hospital.

In a face-to-face interview on 04/12/12 at 9:20am, RN PACU Coordinator S36 indicated the medications requiring admixing by the nurse were the same medications as used in pre-op. She further indicated the nurse would prepare the IV medication in the medication room of PACU.

In a face-to-face interview on 04/12/12 at 9:30am, LPN (licensed practical nurse) Clinical Coordinator S40 indicated the PSU nurses do their own admixing of medications in the PSU medication room.

In a face-to-face interview on 04/12/12 at 3:45pm, Contract Pharmacist S44 indicated admixing of antibiotics does not require that it be done by a pharmacist, and a laminar flow hood was not required. He further indicated he does not supervise/monitor the admixture of IV medications performed by the nurses.

Review of the Louisiana State Board of Registered Nurses Declaratory Statement On The Role And Scope Of Practice Of Registered Nurses Delegating Intravenous Therapy Interventions", revealed, in part, "...Administration refers to preparation of the drug, gathering the necessary equipment, administering the medication, and monitoring (evaluating) the patient's response to the therapy. Note. The functions of administration may not be delegated when indicated as a nondelegatable nursing intervention within the context of this statement. In selected situations preparation of IV admixtures may be performed by an RN when the drug is prescribed as "stat" or when the drug would deteriorate upon standing. "Gathering the necessary equipment" refers to the RN actually assembling the IV equipment and medication...".

Review of the "Louisiana Administrative Code Title 46 - Professional and Occupational Standards Part LIII: Pharmacists Chapter 15. Hospital Pharmacy", revealed, in part, "...1513. Labeling A. All drugs dispensed by a hospital pharmacy, intended for use within the facility, shall be dispensed in appropriate containers and adequately labeled as to identify patient name and location, drug name(s) and strength, and medication dose(s). Additionally, compounded preparations and sterile preparations shall be labeled with the expiration or beyond-use date, initials of the preparer, and the pharmacist performing the final check. ...(5) "Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or device
by a pharmacist for his patient as the result of a practitioner's prescription drug order...".

Based on record review and interviews, the hospital failed to ensure the compounding, packaging, and dispensing of drugs was performed under the supervision of the pharmacist. IV (intravenous) medications were admixed by the nursing staff as evidenced by hospital policy and staff interviews. 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. This resulted in physician orders for ranges in dose and frequency being accepted with the nurse making the decision regarding the specific strength/dose and frequency for 9 of 21 sampled patients (#1, #2, #4, #5, #7, #8, #9, #12, #21). Findings:

1) IV medications were admixed by the nursing staff:
In a face-to-face interview on 04/12/12 at 9:05am, RN Pre-op Coordinator S37 indicated the nurse would be required to admix Ampicillin, Unasyn, Vancomycin, Zosyn, Cleocin, Gentamicin (other than 80 mg), and Doxycycline if ordered by the physician. She further indicated the nurse would reconstitute the medication according to the drug book directions, add the reconstituted solution to the appropriate amount fluids, and label the bag. S37 indicated the IV preparation would be done in the medication room of pre-op, and there is no laminar flow hood available in the hospital.

In a face-to-face interview on 04/12/12 at 9:20am, RN PACU Coordinator S36 indicated the medications requiring admixing by the nurse were the same medications as used in pre-op. She further indicated the nurse would prepare the IV medication in the medication room of PACU.

In a face-to-face interview on 04/12/12 at 9:30am, LPN (licensed practical nurse) Clinical Coordinator S40 indicated the PSU nurses do their own admixing of medications in the PSU medication room.

In a face-to-face interview on 04/12/12 at 3:45pm, Contract Pharmacist S44 indicated admixing of antibiotics does not require that it be done by a pharmacist, and a laminar flow hood was not required.

Review of the hospital policy titled "Intravenous Admixtures", policy number PHM-015, approved 03/14/12 by DON S2, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...Policy: Intravenous admixtures may be prepared by licensed nursing staff for use in patient care as ordered by the physician. Medications may be reconstituted and added to the appropriate basic solution... per manufacturer's recommendations...". There was no documented evidence that admixing medications were to be performed by the RN and that it would be done by the RN only when the drug was ordered stat or when the drug would deteriorate upon standing as required by the Louisiana State Board of Registered Nurses.

Review of the Louisiana State Board of Registered Nurses Declaratory Statement On The Role And Scope Of Practice Of Registered Nurses Delegating Intravenous Therapy Interventions", revealed, in part, "...Administration refers to preparation of the drug, gathering the necessary equipment, administering the medication, and monitoring (evaluating) the patient's response to the therapy. Note. The functions of administration may not be delegated when indicated as a nondelegatable nursing intervention within the context of this statement. In selected situations preparation of IV admixtures may be performed by an RN when the drug is prescribed as "stat" or when the drug would deteriorate upon standing. "Gathering the necessary equipment" refers to the RN actually assembling the IV equipment and medication...".

Review of the "Louisiana Administrative Code Title 46 - Professional and Occupational Standards Part LIII: Pharmacists Chapter 15. Hospital Pharmacy", revealed, in part, "...1513. Labeling A. All drugs dispensed by a hospital pharmacy, intended for use within the facility, shall be dispensed in appropriate containers and adequately labeled as to identify patient name and location, drug name(s) and strength, and medication dose(s). Additionally, compounded preparations and sterile preparations shall be labeled with the expiration or beyond-use date, initials of the preparer, and the pharmacist performing the final check. ...(5) "Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or device
by a pharmacist for his patient as the result of a practitioner's prescription drug order...".

2) 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. This resulted in physician orders for ranges in dose and frequency being accepted with the nurse making the decision regarding the specific strength/dose and frequency:
In a face-to-face interview on 04/12/12 at 9:50am, Pharmacy RN S41 indicated Contract Pharmacist S44 did not review each patient's medication ordered by the physician prior to administration of the first dose. She further indicated the PSU nurse would fax the physician orders to her so she can assure the availability of the medication. S41 further indicated the ordered medications were not reviewed for known allergies, therapy contraindications, dose and route of administration, directions for use, duplication of therapy, interactions, and optimum therapeutic outcomes.

In a face-to-face interview on 04/12/12 at 3:45pm, Contract Pharmacist S44 confirmed that he did not review each patient's ordered medications for known allergies, therapy contraindications, dose and route of administration, directions for use, duplication of therapy, interactions, and optimum therapeutic outcomes.

Patient #1
Review of the medical record for Patient #1 revealed a 70 year old female admitted to the hospital on 02/28/12 for a Right Total Knee Replacement. Review of the Physicians' Orders dated 02/28/12 at 11:40am revealed an order for Ativan 1-2mg IVP in PACU (post anesthesia care unit). Review of the Physicians' Orders dated 02/29/12 (no time documented) revealed.... "Lantus 50u bs (blood sugar). Further review of the medical record revealed no documented evidence the nurse clarified the order with the physician for route and frequency.

Review of the MAR (medication administration record) revealed Patient #1 received Lantus 50 units on 02/28/12, 02/29/12 and 03/01/12.

Patient #2
Review of Patient #2's medical record revealed she was a 56 year old female who was admitted on 03/30/12 with diagnoses of influenza, asthma, and bronchitis. Review of Patient #2's admit orders dated 03/30/12 revealed an order for Ultram 50 mg 1 - 2 orally every 4 hours as needed for pain or body aches. Further review revealed no documented evidence of the specific dose to be administered, which required the nurse to decide what strength/dose to administer. There was no documented evidence of a clarification order by the nurse for the specific dose of Ultram to be administered.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of Patient #4's "Anesthesia Order Sheet - PACU" revealed no documented evidence of the date and time the standing order was initiated. Further review revealed an order to titrate Morphine 1 mg to 4 mg IV within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. There was no documented evidence of an order for the specific dose and frequency between administration of each dose of Morphine. Further review revealed no clarification order received by the nurse for the specific dose and frequency for Morphine administration.

Review of Patient #4's "Anesthesia Order Sheet - PACU" revealed a verbal order was received on 02/28/12 at 9:25am for Dilaudid 0.5 mg - 2 mg IV titrated prn (as needed) pain. Further review revealed no documented evidence that the order for Dilaudid included the exact dose and frequency (time interval) for which it was to be administered.

Patient #5
Review of the medical record for Patient #5 revealed she was admitted to the hospital on 3/30/12 for laparoscopic cholecystectomy related to her diagnosis of biliary dyskinesia. Review of her physician order to transfer to PACU(Post Anesthesia Care Unit) then admit to Post Surgical Unit as an outpatient, dated 3/30/12, revealed an order for Percocet 5 mg(milligram) i-ii (1 to 2) po (by mouth) q (every) 4 hrs(hours) prn ( as needed) pain or Vicodin 5 mg i-ii po q 4hrs prn pain. Phenergan 12.5-25 mg IVP(intravenous)q 4hrs prn nausea. Review of the Anesthesia Order Sheet for dated 3/30/12 at 11:20 a.m. revealed an order for pain medication. The order read, Pain: Unless contraindicated, titrate Morphine 1 mg to 4 mg IV (intravenous) within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. If no relief notify Anesthesiologist. 2. Unless contraindicated, give cholecystectomy patients Demerol 12.5 mg IV every 5 minutes until pain is relieved. Do not exceed 50 mg total. If no relief notify Anesthesiologist.

Patient #7
Review of Patient #7's medical record revealed she was a 21 year old female who had a bilateral breast augmentation with saline on 04/09/12. Review of Patient #7's post-op orders dated 04/09/12 revealed the following medications were ordered with a range rather a specific dose, route, and frequency:
Morphine 2 - 4 mg IV every 15 minutes prn maximum 10 mg every 2 hours;
Lortab 7.5 mg orally 1 -2 every 3-4 hours prn pain;
Phenergan 12.5 mg - 25 mg orally/IV every 6 hours prn nausea.

Review of Patient #7's "Anesthesia Order Sheet - PACU" dated 04/09/12 revealed an order to titrate Morphine 1 mg to 4 mg IV within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. There was no documented evidence of an order for the specific dose and frequency between administration of each dose of Morphine.

Patient #8
Review of the medical record for Patient #8 revealed Patient #8 was admitted to the hospital on 4/09/12 for a total left knee arthroplasty. Review of the Physician Orders dated 4/9/12 on the Anesthesia Order Sheet for PACU (Post Anesthesia Care Unit) revealed the order, Unless contraindicated, titrate morphine 1 mg to 4 mg IV (intravenous) within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. If no relief notify Anesthesiologist. 2. Unless contraindicated, give cholecystectomy patients Demerol 12.5 mg IV every 5 minutes until pain is relieved. Do not exceed 50 mg total. If no relief notify Anesthesiologist.

Patient #9
Review of Patient #9's medical record revealed she was a 67 year old female who had a left total knee replacement on 04/09/12. Review of Patient #9's "Anesthesia Order Sheet - PACU" revealed an order to titrate Morphine 1 mg to 4 mg IV within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. There was no documented evidence of an order for the specific dose and frequency between administration of each dose of Morphine.

Review of Patient #9's "Anesthesia Order Sheet - PACU" revealed a verbal order, with no documented evidence of the date and time the order was received, for Dilaudid 0.5 mg - 2 mg IV in PACU for pain. Further review revealed no documented evidence of a clarification order that included the specific dose and frequency at which Dilaudid was to be administered.

Patient #12
Review of the medical record for Patient #12 revealed she was admitted on 3/30/12 for a
laparoscopic cholecystectomy for biliary dysfunction. Review of her PSU Cholecystectomy Admit Orders revealed an order for Percocet 5 mg (milligrams) i-ii (1 to 2) po (by mouth) q (every) 4 hrs(hours) prn ( as needed) pain or Vicodin 5 mg i-ii po q 4hrs prn pain. Phenergan 12.5-25 mg IVP (intravenous) q 4hrs prn nausea. Review of the Anesthesia Order Sheet dated 3/30/12 at 11:20 a.m,. revealed an order for pain medication. The order read, Pain: Unless contraindicated, titrate Morphine 1 mg to 4 mg IV (intravenous) within the first 5 minutes then 2 mg every 5 minutes for a total of 10 mg or until pain is relieved. If no relief notify Anesthesiologist. 2. Unless contraindicated, give cholecystectomy patients Demerol 12.5 mg IV every 5 minutes until pain is relieved. Do not exceed 50 mg total. If no relief notify Anesthesiologist.

Patient #21
Review of the medical record for Patient #21 revealed a 45 year old female admitted to the hospital on 07/16/11 for nausea and vomiting after having gastric sleeve surgery on 07/11/11.
Review of the Physicians' Orders revealed the following range orders: 07/26/11 at 10:18pm Morphine 3-5mg prn for pain; and 07/21/11 at 1:01pm Zofran 4-8mg IVP every 4-6 hours prn for nausea.

Review of the hospital policy titled "Routine Scheduled Medications", policy number PHM-041, reviewed 02/25/11, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...All pertinent information required for safe administration of medications shall be obtained, including drug, dose and strength, route, date, and time schedule...".

Review of the hospital policy titled "Administration Of Medication", policy number PHM-024, reviewed 03/14/12, and presented in the manual provide by Administrator S1 as the current policies, revealed, in part, "...Policy: Standards of safe practice will be adopted and followed at Physicians Medical Center to ensure the safe administration of medication to patients. Procedure: A. The nurse preparing the medication for administration must be familiar with that particular medication, its possible side effects, and its contraindications. The nurse must know that the route of administration is correct for the particular medication being administered. Reference books are available, including the PDR (physician desk reference). The pharmacy nurse will help to obtain the necessary information needed for the particular medication question. He/she will contact the Consultant Pharmacist if necessary...".

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...".

Based on record review and interviews, the hospital failed to ensure access to the hospital pharmacy was limited to specific staff according to hospital policy. Findings:

Review of the hospital policy titled "Drug Storage Security Measures: Keyless Entry-Electronic Tracking", policy number PHM-035, reviewed on 03/14/12, and contained in the pharmacy policy manual presented by Administrator S1 as the current policies, revealed, in part, "Purpose: To ensure controlled access to drug inventory and to help prevent diversion of drugs. ... Procedure: ... I. Only the Director of Nursing, Pharmacist, Clinical Coordinators-PSU (post surgical unit) and PACU (post anesthesia care unit), pharmacy nurse, pharmacy nurse alternates, and weekend charge nurse will have access cards for the main pharmacy...".

In a face-to-face interview on 04/12/12 at 9:50am, RN (registered nurse) Pharmacy Nurse S41 indicated she leaves the hospital usually at 4:00pm. She further indicated the PSU nursing staff have access to the main pharmacy after she's (S41) gone for the day.

In a face-to-face interview on 04/12/12 at 4:35pm with Director of Nursing (DON) S2 and PSU Coordinator S14 present, both S2 and S14 confirmed that all PSU nursing staff have access to the main pharmacy.

Based on record review and interview, the hospital failed to ensure the policy for personnel radiation monitoring badges included the directions for the maintenance of and proper storage of the badges when not in use. Findings:

Review of documentation presented by Imaging Coordinator S15 of the investigation that was conducted by Nuclear Med Tech S16 of the abnormal radiation reading from 08/02/11 revealed the following: "...it was noted that badge # (number) 89 RN (registered nurse) S46 read above ALARA level II for the quarter. S46 was notified of the reading and presented possible reasons for the higher exposure level, most of which occurred in one month of the quarter. S46 believes that a slightly increased patient load in fluoroscopy as well as accidentally leaving her film badge in a hot vehicle would explain her increased reading. ALARA principles were re-covered and her future readings will be monitored closely".

In a face-to-face interview on 04/11/12 at 10:30am, Imaging Coordinator S15 indicated the hospital policy did not direct how personnel radiation monitoring badges were to be stored when not in use. He further indicated he takes his badge home at the end of the day, and some employees keep their badge in their desk drawer. S15 further indicated the OR (operating room) staff's badges were kept in the OR.

Review of the hospital policy titled "Personnel Monitoring", policy number IM-007, reviewed by Imaging Coordinator S15 on 02/15/12, and presented by S15 as the current policy, revealed, in part, "...All individuals who are occupationally exposed to ionizing photon radiation on a regular basis will be issued a film whole body monitor that will be processed by a contract service on a monthly basis...". Further review of the policy revealed no documented evidence that the maintenance of and proper storage of the badges when not in use were addressed in the policy.

Based on record review and interview, the hospital failed to comply with its policy for ALARA (as low as reasonably achievable) when an employee's radiation monitoring badge tested above Investigational Level I. Findings:

Review of the "Minutes of the Radiation Safety Committee" dated 08/02/11 at 11:40am revealed new business included that "one reading was above Level II for the quarter. A cause will be investigated and written notification given". Review of the "Minutes of the Radiation Safety Committee" dated 11/01/11 at 11:20am and 01/31/12 at 11:45am revealed there was no old business. There was no documented evidence that a report of the investigation of the reading above Level II that was discussed in the meeting on 08/02/11 had been reported during the subsequent radiation safety meeting.

Review of documentation presented by Imaging Coordinator S15 of the investigation that was conducted by Nuclear Med Tech S16 of the abnormal radiation reading from 08/02/11 revealed the following: "...it was noted that badge # (number) 89 RN (registered nurse) S46 read above ALARA level II for the quarter. S46 was notified of the reading and presented possible reasons for the higher exposure level, most of which occurred in one month of the quarter. S46 believes that a slightly increased patient load in fluoroscopy as well as accidentally leaving her film badge in a hot vehicle would explain her increased reading. ALARA principles were re-covered and her future readings will be monitored closely". Further review revealed no documented evidence Radiation Safety Officer (RSO) S47 was informed of the findings of the investigation.

In a face-to-face interview on 04/11/11 at 1:55pm, Imaging Coordinator S15 confirmed there was no documentation that the results of the investigation of the abnormal reading of the radiation badge from 08/02/11 had been been discussed at the radiation safety committee meetings held on 11/01/11 as required by hospital policy.

Review of the hospital policy titled "Radiation Safety Committee", policy number IM-002, reviewed by Imaging Coordinator S15 on 02/15/12, and presented by S15 as the current policy, revealed that the hospital's Radiation Safety Officer was S47.

Review of the hospital policy titled "ALARA Program", policy number IM-001, reviewed by Imaging Coordinator S15 on 02/15/12, and presented by S15 as the current policy, revealed, in part, "Purpose: To establish an ALARA program for the purpose of keeping exposure to radiation As Low As Reasonable Achievable... Radiation Safety Committee: ... c. Review of the ALARA program ... 2. The RSO will perform a quarterly review of occupational radiation exposure with particular attention to instances in which the investigational levels in Table 1 are exceeded. The principal purpose of this review is to assess trends in occupational exposure as an index of the ALARA program quality and to decide if action is warranted when investigational levels are exceeded. ...The following actions will be taken at the investigational levels as stated in Table 1: ... c. Personnel dose equal to or greater than Investigational Level II. The RSO will investigate in a timely manner the causes of all personnel doses equaling or exceeding Investigational Level II, and, if warranted, will take action. A report of the investigation, any actions taken, and a copy of the individual's Form DRC-5. or its equivalent will be presented to the RSC (radiation safety committee) at its first meeting following completion of the investigation. The details of these reports will be included in the RSC minutes...".

Based on record review and interview, the hospital failed to ensure the radiology personnel met the certification requirements of their job descriptions for 2 of 2 ultrasound techs (S17, S18). Findings:

Review of the job description of the Diagnostic Medical Sonographer (ultrasound tech) revealed certification by the American Registry of Diagnostic Sonographers in OB/GYN (obstetrics/gynecology), abdomen, and vascular was required for employment.

Review of Ultrasound Tech (UST) S17's personnel file revealed she was registered by the ARDMS (American Registry of Diagnostic Medical Sonographers) in abdomen. There was no documented evidence that UST S17 was registered in OB/GYN and vascular as required by her job description.

Review of UST S18's personnel file revealed no documented evidence that she was registered in OB/GYN and abdomen as required by her job description.

In a face-to-face interview on 04/11/12 at 10:30am, Imaging Coordinator S15 indicated UST S17 was working on getting her certification, but she was not currently registered in OB/GYN, abdomen, and vascular. He further indicated UST S18 was registered in breast ultrasound and vascular and worked at the breast center. S15 indicated he would have to change the job descriptions for the ultrasound techs. He further indicated he was not aware that the UST job description required registry in OB/GYN, abdomen, and vascular.

Based on observation, record review, and interview, the hospital failed to ensure the dietary manager implemented the hospital's policies for the safe practice for food handling. Findings:

Observation of the Post Surgical Unit's (PSU) freezer used for patient nourishments revealed the following: 4 popsicles in a tray labeled 04/04/11; 9 sugar-free popsicles in a tray labeled 04/12/11; 4 four ounce cartons of ice cream in trays with dates of 04/04/11 and 05/02/11; and 2 sugar-free cartons of ice cream in a tray dated 04/14/11. These observations were confirmed by Dietary Tech S42.

Review of the "Temperature Record With Freezer" for the PSU for March 2012 revealed the refrigerator temperature was to be between 35 degrees and 45 degrees Fahrenheit (hospital policy revealed temperature should be between 35 and 41 degrees). Further review revealed the refrigerator temperature was out of range on 03/01/12 (33 degrees), 03/02/12 (32 degrees), 03/03/12 (32 degrees), and 03/04/12 (34 degrees). Further review revealed no documented evidence that action was taken to correct the temperature that were out of range.

Review of the "Temperature Record With Freezer" for the PSU for April 2012 revealed the refrigerator temperature was out of range on 04/01/12 (34 degrees), 04/02/12 (34 degrees), 04/05/12 (34 degrees), 04/07/12 (34 degrees), and 04/09/12 (34 degrees). Further review revealed no documented evidence that action was taken to correct the temperature that were out of range.

In a face-to-face interview on 04/12/12 at 11:20am, Dietary Tech S42 confirmed the items in the patient nourishment freezer in the PSU were not dated when they were placed in the freezer. S42 indicated the labels were old labels and had not been replaced with current labels when the food items were placed in the freezer. She confirmed that the refrigerator temperature log did not indicate that action was taken when the refrigerator temperatures were out of acceptable range.

Review of the hospital policy titled "Food Storage", policy number DTY-12, reviewed 01/16/12, and contained in a binder presented by Administrator S1 as current policies, revealed, in part, "...1. All stock must be rotated with each new order. ... Labels should be dated with the date item is received, with new items placed behind supply in stock of the same item. ... 6. Refrigerator temperatures: a. Temperatures for refrigerators should be between 35-41 degrees Fahrenheit and must be recorded daily...". Further review revealed no documented evidence of the action to be taken when the temperature was out of the acceptable range.

Based on record review and review of the Center for Disease Control's (CDC) Guidelines for Preventing the Transmission of Mycobacterium tuberculosis (TB) in a Health Care setting and interviews, the hospital failed to: 1) ensure all physicians' were free of tuberculosis (TB) annually for 5 of 5 physician files reviewed for TB screening annually and 2) to ensure all staff who were tested by the hospital for annual TB surveillance had his/her results read within the 48 to 72 hours according to CDC guidelines for 14 out of 14 personnel records reviewed. Findings:

1) ensure all physicians' were free of tuberculosis (TB)
Review of the Physician Credentialing file for MD S23 revealed the date of his last TB skin test was 11-15-10.

Review of the Physician Credentialing file for MD S24 revealed the date of his last TB skin test was "not known."

Review of the Physician Credentialing file for MDS25 revealed no documentation of a TB skin test.

Review of the Physician Credentialing file for MD S26 revealed no documentation of a TB skin test.

Review of the Physician Credentialing file for MDS27 revealed a notation on his Health Status Report as the date of his last TB skin test as within the last 5 years, negative. Further review of his personnel file revealed no documented evidence of a TB skin test within the last year.


2) to ensure all staff who were tested by the hospital for annual TB surveillance had his/her results read within the 48 to 72 hours according to CDC guidelines
Review of the hospital Tuberculin Testing form used for documentation of all staff's Tuberculin (Mantoux) testing revealed no documentation of the time the test was performed and no documentation of when the test was read. Due to the hospital having no documentation of the time of the performance of the test and/or the reading of the skin test, there is no documentation the CDC guidelines were met to read the TB skin test within the allotted 48 to 72 hours.

An interview was conducted with RN S3, Infection Control Officer, on 04/12/12 at 3:40 p.m. She reported there was no timing documented on the staff TB skin test form and the physician had not received their TB tests annually.

Review of Centers for Disease Control Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005 revealed in part, HCWs (Health Care Workers) refer to all paid and unpaid persons working in health-care settings who have the potential for exposure to M. tuberculosis through air space shared with persons with infectious TB disease. Part time, temporary, contract, and full-time HCWs should be included in TB screening programs. All HCWs who have duties that involve face to-face contact with patients with suspected or confirmed TB disease (including transport staff) should be included in a TB screening program. The following are HCWs who should be included in a TB screening program: ... Dental staff ... Physicians (assistant, attending, fellow, resident, or intern), including anesthesiologists, pathologists, psychiatrists, psychologists.

Based on record review and interview the hospital failed to ensure all patients had a pre-anesthesia evaluation performed within 48 hours prior to administration of anesthesia by a person qualified to administer anesthesia for 5 of 14 patients receiving anesthesia (#1, #13, #17,#19, #20) out of a total sample of 21 medical records. Findings:


Patient #1
Review of the medical record for Patient #1 revealed a 70 year old female admitted to the hospital for a Right Total Knee Arthroplasty on 02/28/12. Review of the Pre-Anesthesia Form for Patient #13 revealed the evaluation was performed on 02/24/12 which was 96 hours prior to surgery. Further review revealed no documented evidence the evaluation was up-dated on the date of surgery.

Patient #13
Review of the medical record for Patient #13 revealed a 60 year old female admitted to the hospital on 01/04/12 for an inguinal hernia repair. Review of the Pre-Anesthesia Form for Patient #13 revealed the evaluation was performed on 12/30/11 which was 120 hours prior to surgery. Further review revealed no documented evidence the evaluation was up-dated on the date of surgery.

Patient #17
Review of the medical record for Patient #17 revealed a 71 year old female admitted to the hospital on 04/10/12 for a Right Total Knee Replacement. Review of the Pre-Anesthesia Form for Patient #17 revealed the evaluation was performed on 04/04/12 which was 144 hours prior to surgery. Further review revealed no documented evidence the evaluation was up-dated on the date of surgery.

Patient #19
Review of Patient #19's medical record revealed he was a 77 year old male who had a left Phaco Cataract Extraction with Intraocular Lens Implant on 04/11/12. Review of the "Pre-Anesthetic Evaluation" revealed it was signed by the anesthesiologist on 03/07/12 at 11:40am, 34 days prior to the day of the procedure. There was no documented evidence of a pre-anesthesia evaluation within 48 hours prior to the procedure.

Patient #20
Review of the medical record for Patient #20 revealed a 89 year old man admitted to the hospital for a possible transurethral resection of a bladder tumor on 04/11/12. Review of the Pre-Anesthesia Form for Patient #20 revealed the evaluation was performed on 04/04/12, which was 168 hours prior to the surgery. Further review revealed no documented evidence the evaluation was updated on the day of surgery.

In a face-to-face interview on 04/12/12 at 2:45pm, Anesthesiologist S45 indicated she reviews all patient charts the day before the procedure but doesn't document, sign, date, and time the review.

Review of the hospital policy titled "Accurate and Timely Record Completion", policy number MR-02, approved 04/02/12, and included in the manuals presented by Administrator S1 as current, revealed, in part, "...A pre-anesthesia evaluation must be completed and documented by an individual qualified to administer anesthesia it must be completed within 48 hours prior to surgery for both inpatient and outpatient surgery or a procedure requiring anesthesia services...".


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Based on record review and interview, the hospital failed to ensure a post-anesthesia evaluation was completed no later than 48 hours after surgery or a procedure requiring anesthesia services for 4 of 17 sampled patients who received anesthesia services (#1, #4, #8, #21) out of a total of 21 sampled medical records. Findings:

Patient #1
Review of the medical record for Patient #1 revealed a 70 year old female admitted to the hospital on 02/28/12 for a Right Total Knee Replacement. Review of the "PACU (post anesthesia care unit) Flow Sheet" dated 02/28/12 revealed the anesthesiologist signed the post anesthesia note on 02/28/12 with no documented evidence of the time the post-anesthesia evaluation was performed. There was no means of determining that the post-anesthesia evaluation was performed prior to Patient #1 being released from PACU.

Patient #4
Review of Patient #4's medical record revealed she was a 61 year old female who had a right total knee arthroplasty on 02/28/12. Review of the "PACU (post anesthesia care unit) Flow Sheet" dated 02/28/12 revealed the anesthesiologist signed the post anesthesia note on 02/28/12 with no documented evidence of the time the post-anesthesia evaluation was performed. There was no means of determining that the post-anesthesia evaluation was performed prior to Patient #4 being released from PACU.

Patient #8
Review of Patient #8's medical record revealed a 66 year old male admitted to the hospital for a left total knee arthroplasty on 04/09/12. Review of the PACU Flow Sheet dated 04/09/12 revealed the anesthesiologist signed the post anesthesia note on 04/09/12 with no documented evidence of the time the post-anesthesia evaluation was performed. There was no means of determining that the post-anesthesia evaluation was performed prior to Patient #8 being transferred out of the PACU.

Patient #21
Review of the medical record for Patient #21 revealed a 45 year old female admitted to the hospital on 07/16/11 for nausea and vomiting after having gastric sleeve surgery on 07/11/11.
Further review of the medical record revealed Patient #21 had a history of diabetes and hypertension and was assessed as an ASA III for anesthesia.

Review of the PACU (post-anesthesia care unit) Flow Sheet dated 07/27/11 revealed Patient #21 had a Sleeve Revision and EGD and was admitted to PACU at 5:30pm and transferred to the Post-Surgery Unit at 6:30pm. Further review revealed no documented evidence a post anesthesia evaluation was performed on Patient #21 before being discharged from PACU. Review of the Physicians' Progress Notes revealed no documented evidence a post-evaluation was completed by anesthesia within 48 hours after the surgical procedure.

In a face-to-face interview on 04/12/12 at 2:45pm, Anesthesiologist S45 indicated she performed a post-anesthesia evaluation of the patient in PACU if she was not needed in the OR (operating room). She further indicated her evaluation was based on the vital signs obtained by the PACU RN (registered nurse) and looking at the cardiac monitor. S45 indicated if she was busy in the OR, the PACU RN would report the patient's vital signs and whether the patient was tolerating fluids, and she'd give approval to release the patient from PACU over the telephone. S45 indicated she was not knowledgeable of the federal regulations for anesthesia services in the acute care hospital.

Review of the hospital policy titled "Accurate and Timely Record Completion", policy number MR-02, approved 04/02/12, and included in the manuals presented by Administrator S1 as current, revealed, in part, "...A post-anesthesia evaluation must be completed and documented by an individual qualified to administer anesthesia within 48 hours after surgery or a procedure requiring anesthesia services...".


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