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1500 LINE AVENUE

SHREVEPORT, LA 71101

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on record review and interview the hospital failed to ensure medications were administered with an accurate order as provided by physicians. This deficient practice was evidenced by conscious sedation administered by RNs without documenting the verbal orders as provided by a physician for 4(#14, #16, #17, #18) of 6 (#14, #15, #16, #17, #18, #19, #20) patients reviewed for RN administered conscious sedation from a total sample of 30.
Findings:

Review of a hospital policy titled, "Safe and Effective Drug Administration", last reviewed January 2018, and provided by S35PharmTech as current, revealed in part that verbal orders would be obtained and verified. The nurse obtaining the verbal order would read back to the physician and document. Orders would include the dose, route, and frequency and notes as verbal/telephone order. Further review revealed medications should be administered according to the order.

Review of a hospital policy titled, "Managing the Patient Receiving IV Conscious Sedation/Analgesia", provided by S2DON as current revealed no reference to what discipline the policy applied (RN, Anesthesia staff) or to orders for the IV Conscious Sedation. Further review revealed documentation would include the dosage, route, time of all medications used, and the Level of Consciousness.

Patient #14
Review of the medical record for Patient #14 revealed she received a Left C4 Transforaminal epidural steroid injection per S29MD in the outpatient pain unit on 05/03/18. Further review revealed she received IV Sedation by S8RN during her procedure. The record documented Patient #14 received 2 mg. of Versed IVP at 1:25 p.m., 2 mg. Versed IVP at 1:28 p.m., and 2 mg. Versed IVP at 1:30 p.m. Review of the physician orders revealed a preprinted order for Versed IVP for anxiety, with a blank space for milligrams filled in with "6" filled in by hand. No other orders for Versed were noted. Review of the Intraoperative record revealed no documentation of the patient's level of conscious during the procedure or at the time of each administration of Versed.

Patient #16
Review of the medical record for Patient #16 revealed he received a Left sacroiliac joint injection nerve block, L5-S1 medial branch, and S2, S3, and S4 lateral branch under fluoroscopic interpretation per S26MD in the outpatient pain unit on 07/27/18. Further review revealed he received IV Sedation administered by S9RN during his procedure. The record documented Patient #16 received 2 mg. of Versed IVP at 9:45 a.m. and 2 mg. Versed IVP at 9:48 a.m. Review of the physician orders revealed a a preprinted order for Versed IVP for anxiety, with a blank space for milligrams filled in, by hand, with "4". No other orders for Versed were noted. Review of the Intraoperative record revealed no documentation of the patient's level of conscious during the procedure or at the time of each administration of Versed.

Patient #17
Review of the medical record for Patient #17 revealed she received an epidural steroid injection per S27MD in the outpatient pain unit on 08/14/18. Further review revealed she received IV Sedation administered by S10RN during her procedure. The record documented Patient #17 received 2 mg. of Versed IVP at 9:53 a.m., 2 mg. Versed IVP at 9:55 a.m., and 2 mg of Versed IVP at 9:58 a.m. Review of the physician orders revealed a a preprinted order for Versed IVP for anxiety, with a blank space for milligrams filled in, by hand, with "6". No other orders for Versed were noted. Review of the Intraoperative record revealed no documentation of the patient's level of conscious during the procedure or at the time of each administration of Versed.

Patient #18
Review of the medical record for Patient #18 revealed he received a Left C6 and Left C7 nerve root block per S28MD in the outpatient pain unit on 08/10/18. Further review revealed he received IV Sedation administered by S36RN during his procedure. The record documented Patient #18 received 2 mg. of Versed IVP at 8:05 a.m., and 2 mg. Versed IVP at 8:06 a.m. Review of the physician orders revealed a a preprinted order for Versed IVP for anxiety, with a blank space for milligrams filled in, by hand, with "4". No other orders for Versed were noted. Review of the Intraoperative record revealed no documentation of the patient's level of conscious during the procedure or at the time of each administration of Versed.

In an interview 8/22/18 at 1:43 p.m. S8RN reported she is responsible for administering IV conscious sedation to patients undergoing pain procedures in the outpatient pain unit. S8RN reported that she takes Versed into the procedure room, and administers Versed upon the verbal order(s) of the physician. She reported that the physician would tell her the amount to administer and each time he or she wanted an additional amount given. She reported she would fill in the physicians orders AFTER the procedure for the total amount given. S8RN verified that she received a verbal order each time the medication was administered to the patient, but did not document a verbal order with the time, and amount ordered for each administration. S8RN confirmed she did not have a physician's written order prior to administering the medication. S8RN confirmed the order on the patients' charts was not the way the medication was administered.

In an interview 8/22/18 at 1:55 p.m. S2DON and S4RN Manager Intervention Rad agreed that the orders for IV Conscious sedation were not documented as verbal orders. S2DON agreed that nurses were supposed to document verbal orders when received and should include the time received, the medication, amount, route ordered.

PHARMACY: REPORTING ADVERSE EVENTS

Tag No.: A0508

Based on record review and interview, the hospital failed to: 1) report medication errors to the physician for 1 patient (#9); and 2) failed to document medication errors in the medical record for 2 patients (#7, #8) in a total sample of 5 patients who were reviewed for medication errors. Findings:

1. Patient #9
Review of the hospital's incident reports for medication errors revealed patient #9 failed to receive a scheduled dose of Ancef (IV antibiotic), which was discovered by the nurse on 01/22/18 at 11:42 p.m. Review of the medical record revealed no documented evidence that the physician was notified of the missed dose of Ancef.
On 08/21/18 at 3:30 p.m., an interview with S7RN CQI confirmed there was no evidence that the physician was notified of the missed dose of medication.

2. Patient #7
Review of the hospital's incident reports for medication errors revealed patient #7 received a dose of Cipro (IV antibiotic) instead of the ordered antibiotic Ancef on 04/06/18 at 3:10 p.m. Review of the medical record revealed no documented evidence that the error was recorded in the patient's records.
On 08/21/18 at 3:30 p.m., an interview with S7RN CQI confirmed that the medication error was not documented in the medical record for patient #7.

Patient #8
Review of the hospital's incident reports for medication errors revealed patient #8 failed to receive a scheduled dose of Clindamycin (IV antibiotic), which was discontinued in error by the nurse and discovered on 07/27/18 at 10:37 a.m. Review of the medical record revealed no documented evidence that the error was recorded in the patient's records.
On 08/21/18 at 3:30 p.m., an interview with S7RN CQI confirmed that the medication error was not documented in the medical record for patient #7.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observations, record reviews and interviews, the hospital failed to ensure the Infection Control Program was implemented to prevent and control infections and communicable diseases as evidenced by:
1) Failing to ensure patient care equipment was sanitized between patient use
2) Failing to ensure syringes containing medications for patient use were labeled and capped.

Findings:

1. Observations during initial tour on 5/20/18 at 9:55 a.m. revealed walkers with green duct tape wrapped around the center bars in rooms #'s a, b, c, d, e, f, g, h, i, and j. The rooms were listed as being clean and ready for patient's use.

During an interview on 8/20/18 at 11:15 a.m., S3RN stated the green duct tape is used to tag the equipment as being owed by the hospital and the tape is usually changed once a month.

2. Observation during the initial tour of the Interventional Radiology building on 8/20/18 at 10:35 a.m. revealed four unlabeled and uncapped syringes on the sterile field/tray set-up in room #k. S4RN Interventional RadiologyUnit Manager was present during the tour and acknowledged the syringes were not labeled or capped.

Review of Hospital Policy "Procedure for Epidural Steroid Injection" revealed, in part, the following:
Procedure: Sterile Procedure. Care should be taken not to contaminate the sterile field.

Review of Hospital Policy "Medications on Sterile Field" revealed, in part, the following:
Procedure 4. All medications on the field are labeled with the name and strength.

Review of Hospital Policy "Infection Control Aseptic Technique" revealed, in part, the following:
Policy: The operating room staff will utilize aseptic technique.
Procedures: 3. Items within a sterile field are sterile. c. Syringes placed in the sterile filed are to remain closed until use.

During an interview on 8/20/18 at 10:40 a.m., S5Radiology Technician stated drawing up the medications and leaving them uncapped on the sterile tray is the way we do it.

During an interview on 8/21/18 at 1:00 p.m., S6RN COO acknowledged the syringes should have been labeled and capped.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observations, interviews, and record reviews the hospital failed to ensure the Surgical Services Department followed acceptable professional standards of practice, acceptable infection control practices and/or hospital policy as evidenced by:

1) failing to ensure that surgical equipment/batteries for surgical tools were available in a quantity that was commensurate with the hospital's expected daily procedure volume, as evidenced by the hospital's frequent use of IUSS of surgical equipment (batteries for surgical drills and saws) (provided by the hospital and/or by contract) for patient's surgical procedures,

2) failing to ensure that staff in the perioperative surgical suite's restricted and semi-restricted areas followed acceptable professional standards of practice, acceptable infection control practices and/or hospital policy as evidenced by: a) observations of surgical staff wearing skull caps (surgeon caps) that did not completely cover all their hair (head and facial beard hair), b) observations of surgical staff wearing home laundered cloth hats that were not completely covered by a disposable surgical bouffant hat, c) observations of surgical staff wearing surgical masks around their necks, and d) reports by staff that not all physicians wore a surgical mask during epidural/spinal injections.
3) Failing to have a policy and procedure in place related to IV fluids and Irrigation fluids stored in warmers without labeling or temperature logs.
Findings:

1) Failure to ensure that surgical equipment/batteries for surgical tools were available in a quantity that was commensurate with the hospital's expected daily procedure volume, as evidenced by the hospital's frequent use of IUSS of surgical equipment (batteries for surgical drills and saws) (provided by the hospital and/or by contract) for patient's surgical procedures.

Review of hospital policy titled, "Instrument cleaning, Packaging, and sterilization" provided by S11RNAsstMgr as current revealed, in part that "Flash sterilization [IUSS] should not be used as a substitute for sufficient instrument inventory." Further review revealed the following documentation would be kept for both steam and flash [IUSS] sterilized items: Sterilizer identification number, sterilization date, cycle number, contents of each load, duration, temperature of exposure, identification of operators, results of biological tests, and time and temperature recordings.

A review of AORN Guidelines for Perioperative Practice, 2018 edition - Sterilization: Recommendation VII revealed in part; Immediate Use Steam Sterilization should be kept to a minimum and should only be used in selected clinical situations. Further review revealed IUSS should not be used as a substitute for sufficient inventory.
Review of the Daily Operating Room IUSS log from 06/12/18 through
June 2018- 78 loads of batteries processed
July 2018- 105 loads of batteries processed
August 1-21, 2018 -76 loads of batteries processed
Further review revealed loads with no documentation as to what was processed or why IUSS processing was necessary. Other documentation as to what and/or why IUSS was used included: Rep instruments/Loaner, holes in wrapper (without documentation what instrument was processed), only part of the loads had a documentation as to what patient the processed instruments were used on, cycle counts were missing on some loads. Review of the logs and the above noted documentation or lack of documentation was verified by S11RNAsstMgr.
In an interview 8/21/18 at 4:20 p.m. S11RNAsstMgr reported that most of the IUSS items were batteries used for the Orthopedic Surgical drills and saws. He reported the batteries were processed using IUSS because the hospital did not have a sufficient number for the number of surgical cases scheduled. S11RNAsstMgr agreed that insufficient surgical inventory was not an acceptable reason to use IUSS. S11RNAsstMgr verified that the IUSS logs did not have consistent documentation for each load as per the hospital's policy and procedure.


2) Failure to ensure that staff in the perioperative surgical suite's restricted and semi-restricted areas followed acceptable professional standards of practice, acceptable infection control practices and/or hospital policy as evidenced by: a) observations of surgical staff wearing skull caps (surgeon caps) that did not completely cover all their hair (head and facial beard hair), b) observations of surgical staff wearing home laundered cloth hats that were not completely covered by a disposable surgical bouffant hat, c) observations of surgical staff wearing surgical masks around their necks, and d) staff reports that not all physicians wore a surgical mask during epidural/spinal injections.

Review of the hospital policy titled "Infection Control" last updated June 2016, provided by S11RNAsstMgr as current, revealed in part that all individuals who enter the semi-restricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite. The policy outlined some suggestions for home laundering. Further review revealed the following, " ...B. Head coverings are considered part of the surgical attire and should be disposable or laundered daily. Head coverings should cover all the hair, scalp skin, ears, sideburns and the nape of the neck. If head covering does not cover all these areas a disposable bouffant cap should be donned over the reusable head covering. Head coverings should be donned upon arrival to the operating room and not removed until the scrubs are removed. C. Shoe covers and masks should be removed immediately upon exit from the restricted areas. Masks should not be worn hanging around the neck. Resource: AORN, "Standards and Recommended Practices," 2015. 2015 AORN stance: 'Surgical attire should be laundered in a healthcare accredited laundry facility.' Specialists Hospital Shreveport stand with the above policy and allows home laundered scrubs present in the OR suite."

Review of "AORN 2018 Edition Guidelines for Perioperative Practice" revealed in part: Surgical Attire, Recommendation I- Clean surgical attire should be worn in the semi-restricted and restricted areas of the perioperative setting. The collective body of evidence supports wearing clean surgical attire in the perioperative setting to reduce the number of microorganisms in the environment and the patient's risk for developing an SSI. Clean scrub attire has been laundered in a health care-accredited laundry facility and has not been previously worn. Recommendation II: All individuals who enter the semi-restricted and restricted areas should wear scrub attire that has been laundered at a health care-accredited laundry facility or disposable scrub attire provided by the facility and intended for use within the perioperative setting. Recommendation III: Personnel entering the semi-restricted and restricted areas should cover the head, hair, ears and facial hair.

Review of CDC Safe Injection Practices to Prevent Transmission of Infections to Patients revealed the following: IV.I. Infection control practices for special lumbar puncture procedures: Wear a surgical mask when placing a catheter or injecting material into the spinal canal or subdural space.

Observations made 08/21/18 from 3:00 p.m. to 4:20 p.m., with S11RNAsstMgr, revealed the following:
-in OR "g" S33MD was wearing a skull cap with hair exposed at the sides and back of his head, S20ST was wearing a cloth skull cap with sideburns, hair on sides and back of head exposed, S16RN was wearing a fabric head cover, and S18CRNA was wearing a skull cap with hair exposed at sides and back of his head. A surgical procedure was in progress.
-In sterile corridor S21HK was observed to wear a skull cap with his hair exposed from under his skullcap on the sides and back of his head.
-In OR "b" S22ManfRep was observed with part of his beard and his sideburns exposed outside of the coverage of his surgical mask, S17RN ,circulating a surgical case in progress was wearing a cloth head cover, S23CRNA was observed to have a skull cap on with hair exposed on sides and back of head.
-OR "e", S15RN, circulating a surgical case in progress was noted to have a cloth head cover.
-OR "d", S37ORTech, observed cleaning the room between cases, wore a skull cap with hair exposed at sides and back of his head. S24ORTech was observed to enter the OR wearing a mask around his neck.
-S16RN was observed to exit OR "g", with anesthesia and take the patient to a PACU bay, give report, then exit into the PACU unit with her mask still on. S11RNAsstMgr, present for the observations reported it is a common practice for staff to not remove their masks when they exit the ORs, and it is the practice of some staff to wear their masks around their necks. S11RNAsstMgr verified that this was not the hospital's policy.

-In OR "e" S12ST was observed to be wearing a cloth head covering. S32MD was observed to have facial hair exposed around the sides of his mask, S14PA was observed to wear a paper skull cap, with hair exposed at the sides and back of his head.

In an interview 8/22/18 S2DON verified the surgical attire policy was used hospital wide in both the inpatient and outpatient surgical and procedural units. She reported that the hospital's policy was to allow surgical staff to home launder their surgical attire. When asked how the hospital could ensure surgical attire was being laundered according to standards and quality parameters, she acknowledged that it couldn't. She reported neither the surgical services manager or she, the Infection Control Officer were aware of the current guidelines that surgical attire be laundered in a health care- accredited laundry facility. She verified that it was not policy for staff to have hair, ears, facial hair exposed in the restricted areas of the surgery department. She also acknowledged that surgical masks should not be worn around staffs' necks and should be removed on exiting the OR.

In an interview 8/22/18 at 1:43 p.m. S8RN reported she worked with patients undergoing pain procedures in the outpatient pain unit. S8RN reported that there were a few physicians that did not wear surgical masks during epidural/spinal injection procedures.

In an interview 8/22/18 at 1:55 p.m. S2DON and S4RN Interventional RadiologyUnit Manager both reported that there were some physicians that did not wear surgical masks during epidural/spinal injection procedures. S4RN Interventional RadiologyUnit Manager reported she was not aware that the CDC recommended that surgical masks be worn for procedures involving injecting the epidural/spinal space.


3) Failure to have a policy and procedure in place related to IV fluids and Irrigation fluids stored in warmers without labeling or temperature logs.
Review of AORN 2018 Guidelines for Perioperative Practice revealed in the Environment of Care, Recommendation V, "Precautions should be taken to avoid thermal injuries related to warming solutions, blankets, and patient linens in bland and solution-warming cabinets, V.f. Solution manufacturers' instructions for use should be followed regarding the maximum temperature and length of time solutions should remain in the warming cabinet or compartment and for usability after removal. Solution manufacturers' recommendations for maximum temperature setting, time limit that solutions may remain in the warming device, and for solution use after removal vary. Manufacturers'' setting may be determined by the stability of the container and the solutions. V.f.1. When solutions are placed in warming cabinets, they should be labeled with the date of insertion or date of removal. Labeling helps determine when the solution has reached its maximum shelf life and prevents overheating related to being left in the warmer too long."

Observations made 08/21/18 from 3:00 p.m. to 4:20 p.m., with S11RNAsstMgr, revealed the following:
Pre-Operative area: Warmer cabinet with 1 liter bags of IV fluids (Lactated Ringers) that exceeded 25 bags. Further observation revealed no labels with date/time the fluids were placed in the warmer or 'use by" date/time.

In an interview 08/21/18 at 3:05 p.m. S25RN reported that she was not aware that the fluids should be labeled or of a hospital policy related to IV fluids stored in the warmers. She reported that pharmacy was responsible for stocking the IV fluids in the warmers.
In an interview 8/21/18 at 3:05 p.m. S34RNMgr for the Pre and Post-Operative units reported she did not know how long the IV fluids were acceptable for use when store in the warming cabinets.
In an interview S11RNAsstMgr, present for the observations reported the hospital did not have a policy regarding IV fluids, Irrigation fluids, or linen stored in warming cabinets. He reported that the surgical department did not keep a log of the temperatures of the warming cabinets used in the perioperative areas.