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510 E 8TH ST POST OFFICE BOX 370

FREEMAN, SD 57029

No Description Available

Tag No.: C0276

Based on observation, interview, and policy review, the provider failed to:
*Date multi-dose vials of medication with the opened date or expiration date in one of one attached provider based clinic (Rural Health Clinic).
*Maintain inventory and security of sample drugs in one of one attached provider based clinic (Rural Health Clinic).
Findings include:

1. Observation and interview on 8/26/13 at 3:45 p.m. with the clinic manager and licensed practical nurse F in procedure room B of the Rural Health Clinic revealed:
*Twelve opened multi-dose vials of medication.
*There were no dates written on any of the opened multi-dose vials.
*They could not tell when or how long the medications had been opened.
*The clinic staff did not date any medications or multi-dose vials when they were opened. They were not aware of any policies that would have required them to date the multi-dose vials when opened.

Interview on 8/27/13 at 2:17 p.m. with the infection control nurse revealed:
*She was not aware the clinic staff were not dating the multi-dose vials when they were opened.
*She had been working with the clinic to incorporate them into the hospital standards of practice but had not addressed medications yet.

Review of the provider's undated Multi-dose vials policy revealed:
*"All multi dose vials will be dated with the expiration date of 28 days and initialed with person who broke the seal."
*"All open vials will be discarded after 28 days from the date of seal broken."



18560

2. Observation and interview on 8/28/13 at 9:10 a.m. with licensed practical nurse (LPN) C revealed:
*Drug samples were kept in locked cupboards in the clinic breakroom.
*The keys were kept in the drawer directly below the cupboards.
*Drug samples had been documented on a log sheet in a three ring binder when received and dispensed.
*There was not a system in place to validate how many of each drug had been stored in the cupboards.
*The samples had included the controlled drug Lyrica.

Interview on 8/29/13 at 11:30 a.m. with the clinic manager and LPN C confirmed the clinic breakroom had been used by staff other than the nurses and physicians. They agreed a system should have been in place to count the drugs and further secure the controlled drugs.

PATIENT CARE POLICIES

Tag No.: C0278

Based on record review, interview, and policy review, the provider failed to ensure:
*Medical supplies beyond the manufacturer's use date were not available for patient use in two of two storage areas (stress testing room and clean supply room).
*Instrument pre-cleaning detergent was mixed in accordance with the manufacturer's directions for use (DFU) for one of one operating room suite.
*Metricide high-level disinfectant (HLD) was used in accordance with the manufacturer's DFU for two of two sampled patients' (39 and 41) cystoscopy procedures.
*The urethral scope after being high-level disinfected was not recontaminated prior to patient use for two of two patients' (39 and 41) cystoscopy procedures.
*A single-use medical device was not reprocessed for one of one patient's (41) cystoscopy procedure.
*Staff disinfected the rubber septum of medication vials prior to withdrawing medications for one of one patient's (40) colonoscopy procedure.
*The procedure room door and the operative suite was unaccessible to unauthorized individuals.
Findings include:

1. Observation on 8/27/13 at 9:13 a.m. of patient 39's cystoscopy procedure revealed registered nurse (RN) D:
*Wore sterile gloves, a protective cover gown, but did not wear appropriate eye protection when he removed a urethral scope and a stopcock from a bin that contained Metricide high-level disinfectant (HLD).
*Rinsed the urethral scope and stopcock in one water bath instead of three water baths and placed that equipment on the procedure table.
*Had previously hung an intravenous (IV) bag of fluid on an IV pole to use for irrigation during the procedure.
*Had contaminated his sterile gloves when he removed the pull tab from the IV irrigation bag.
*Had worn the contaminated gloves to spike the IV irrigation bag with the sterile cystoscopy tubing, and he connected the stopcock and cystoscopy tubing to the endoscope.
*Had used a clean blue towel and covered the urethral scope and cystoscopy tubing prior to leaving the room.
*Did not wear appropriate eye protection while assisting the physician with the cystoscopy procedure.

Observation on 8/27/13 at 10:03 a.m. at the conclusion of patient 39's procedure revealed RN D had not completely stripped and disinfected the procedure bed. RN D removed the contaminated blanket and cloth incontinent pad and discarded them into the dirty linen bag. The contaminated disposable Chux pad was thrown in the trash. RN D had left the bedspread on, covered it with a clean blanket, and put a clean cloth incontinent pad and a clean disposable Chux pad on top of that blanket. RN D had not disinfected the procedure bed with a disinfectant prior to remaking it. At 10:40 a.m. patient 41 was taken into the cystoscopy room and positioned on that bed for his procedure.

2. Observation on 8/27/13 at 10:08 a.m. in the decontamination room revealed RN G was pre-cleaning a urethral scope without appropriate eye protection or an impermeable cover gown/apron over her uniform. Interview with RN G at the time of the observation revealed:
*One squirt of Asepti-Zyme cleaning detergent was used in one gallon of water for pre-cleaning.
*She did not know how much water she had added to the sink.
*She had estimated how much water equaled one gallon instead of measuring it.

3. Observation on 8/27/13 at 10:20 a.m. of patient 41's cystoscopy procedure revealed RN D:
*Wore sterile gloves but did not wear a protective cover gown over his uniform, or eye protection while working with the Metricide HLD solution.
*Had removed the urethral scope, a stopcock, and a plastic penile clamp from the bin of Metricide solution.
*Had performed one water rinse of the urethral scope, stopcock, and penile clamp in the same rinse water used to rinse patient 39's cystoscopy instruments.
*Had contaminated his sterile gloves when he had removed the pull tab from an IV irrigation bag.
*Had worn the contaminated gloves to spike the IV irrigation bag with the sterile cystoscopy tubing, and he connected the stopcock and cystoscopy tubing to the urethral scope.
*Had used a clean blue towel and covered the endoscope, cystoscopy tubing, and penile clamp prior to leaving the room.
*At 10:40 a.m. he escorted the patient into the cystoscopy room and positioned him in bed. The bed had not been appropriately stripped and disinfected after patient 39's cystoscopy procedure.

4. Review of the manufacturer's DFU revealed "Following immersion in Metricide, Metricide 28, or Metricide Plus 30 solution, thoroughly rinse the equipment or medical device by immersing it completely in three separate copious volumes of water. Each rinse should be a minimum of one minute in duration unless otherwise noted by the device or equipment manufacturer. Use fresh portions of water for each rinse. Discard the water following each rinse. Do not reuse the water for rinsing or any other purpose, as it will be contaminated with glutaraldehyde."

Interview on 8/27/13 at 8:45 a.m. and again at 12:40 p.m. with RN D and the operating room (OR) director revealed:
*They were not aware the manufacturer required three separate water rinses for equipment disinfected with Metricide. They confirmed:
-RN D's sterile gloves had been contaminated after handling the IV irrigation bag. He had taken the overpouch off the IV irrigation bag earlier and had hung it on the IV pole.
-He had contaminated the urethral scope and sterile cystoscopy tubing by handling those items with his contaminated gloves.
*The bed used for cystoscopy procedures should have been completely stripped of linen, disinfected between patient procedures, and remade with clean linen.
*They were not aware the penile clamp was a single-use item and should not have been high-level disinfected or reused for other patients.

5. Observation on 8/28/13 at 8:20 a.m. in the procedure room prior to, during, and after patient 40's colonoscopy procedure revealed:
*The procedure room door was accessible directly from the restricted corridor of the OR suite.
*The staff kept the door to the restricted area of the OR suite open as they prepared equipment and supplies for the case. The restricted area was accessible directly from the hospital corridor used by the public.
*The certified registered nurse anesthetist opened several medication vials and withdrew mediation without disinfecting the vial septum.
*Surgical technician I contaminated her clean gloves when she:
-Assisted the physician to put on his gown.
-Put on protective eyewear.
-Opened a tube of lubricant, picked up the outer wrapper of a glove packet, and put a small amount of lubricant on the inside of that wrapper.
-At the end of the colonoscopy procedure she removed her protective OR gown and began pre-cleaning the contaminated colonoscope. Several small wet spots were observed on the front of her uniform during the pre-cleaning process.
*At the end of the colonoscopy procedure the staff reopened the door while disinfecting the room.

Review of the provider's Standard Precautions policy dated 7/21/05 and reviewed on 1/3/13 revealed:
*Work practice controls that were a part of the facility's blood-borne pathogen compliance program included but was not limited to employees selecting and wearing appropriate personal protective equipment (gloves, gowns, masks, etc.).
*A mask and eye protection/face shield were worn to protect mucous membranes of the eyes, nose, and mouth during procedures that were likely to generate splashes or sprays of blood, body fluids, secretions, and excretions.
*A gown was worn to protect the skin and to prevent soiling of clothing during procedures that were likely to generate splashes or sprays of blood, body fluids, secretions, and excretions.
*Equipment used for patient care should have been handled in a manner to prevent contaminations of clothing and transfer of microorganisms to other environments.



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6. Observation at 3:10 p.m. on 8/26/13 revealed the following outdated supplies were stored in a bin in the stress laboratory (lab):
*Two Veni-guard IV dressings expired March 2010.
*One small bore extended IV set expired June 2010.
*Three Tegaderm dressings expired August 2010.
*Two Tegaderm dressings expired July 2011.
*Two 18 gauge IV catheters expired November 2012.
*Two small bore extended IV sets expired December 2012.

Observation at 3:30 p.m. on 8/26/13 of the clean supply room revealed:
*One Viasys enteral feeding tube expired August 2008.
*Two Vacuum Assisted Closure sets expired August 2010.
*Six top-fill enteral nutrition bags expired October 2010.
*One Champion enteral pump set expired January 2011.

Interview at 1:00 p.m. on 8/27/13 with the director of nursing revealed she was responsible for checking the stress lab for outdated supplies. She stated since only two stress tests had been conducted in that lab over the past year she had overlooked checking those supplies. She stated nursing staff were responsible for checking all supplies for outdates monthly. She confirmed the above supplies had been missed during those reviews.

Review of the provider's undated Shelf Life policy revealed supplies sterilized by manufacturers would be outdated as specified on the package.



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8. Observation and interview on 8/26/13 at 3:50 p.m. with the clinic manager in the attached provider based clinic revealed:*The paper towel supply for the hand sinks located in procedure rooms A and B and in the laboratory were unprotected rolls of paper towels.
*She had only been the clinic manager since January 2013. The paper towel supplies had been that way before she had started working there.
*She was not aware the paper towel supply should have been in a protected dispenser.

Interview on 8/27/13 at 2:17 p.m. with the infection control nurse revealed:
*She had been working with the clinic to incorporate them into the hospital standards of practice.
*She had addressed the multiple use of cloth towels for hand drying, but she had missed the unprotected paper towel rolls at the hand sinks at the above listed locations.
*She agreed the paper towel supply should have been stored protected in a dispenser.

No Description Available

Tag No.: C0298

Based on record review, interview, and policy review, the provider failed to ensure care plans were individualized to address the needs and physician-directed care for three of ten sampled acute care patients (25, 28, and 29). Findings include:

1. Review of patient 25's 6/26/13 physician's admission orders revealed she was not to have had anything by mouth except small sips of water with her medications.

Review of patient 25's 6/16/13 care plan revealed small frequent meals were to have been offered per physician's orders. Nothing was noted to indicate the patient was not to have been taking any food by mouth.

2. Review of patient 28's physician's orders revealed orders on:
*5/4/13 to provide oxygen (O2) for O2 saturation rates (level of oxygen in the blood) to have been maintained at 94 percent (%).
*5/4/13 to provide thigh-high Ace wraps.
*5/4/13 to be up with assistance.
*5/5/13 to restrict oral fluids to 1,000 cubic centimeters (cc) maximum.
*5/5/13 to use an incentive spirometer (breathing treatment) every one hour while awake.
*5/6/13 to wear a 24 hour Holter monitor (to check for abnormalities in heart rhythm and rate).
*5/6/13 to walk with the assistance of a walker.
*5/6//13 to assist with medication management for a new diagnosis of congestive heart failure (CHF), atrial flutter with bradycardia (irregular, slow heart rate), and coronary artery disease.
*5/8/13 to discontinue the O2 and Ace wraps.
*5/10/13 to restrict fluid intake to 2,000 cc per 24 hours.

Review of patient 28's 5/4/13 nurse's notes revealed he had:
*Been up to the bathroom with the assistance of one person by his side.
*Utilized a cane for walking.
*Pitting edema (extreme swelling) of both lower legs.
*Ace wraps applied to both legs.

Review of patient 28's care plan initiated 5/4/13 and dated as ongoing revealed nothing to address:
*The need for assistance when up.
*The use of a cane or walker for walking.
*The need for the use of Ace wraps due to edema.
*The need for fluid restrictions.
*The need for a Holter monitor due to heart irregularities.
*The need for the use of an incentive spirometer.

3. Review of patient 29's 4/22/13 through 4/24/13 physician's orders revealed:
*O2 was to have been provided at 2 liters per nasal cannula.
*Assistance was to have been provided to move from the bed to the chair.
*Diet was to have been nectar thickened liquids without the use of a straw.
*Comfort care measures were to have been provided.
*Medications were to have been provided for seizure activity and "twitching."
*Medications were to have been provided to address pain concerns.

Review of patient 29's 4/22/13 nurse's notes revealed she had to be repositioned in bed. She had been incontinent of urine. She had multiple episodes of twitching and tremors. She had been medicated frequently for complaints of pain.

Review of patient 29's 4/22/13 care plan revealed nothing to address:
*The need for O2.
*The need for frequent repositioning and incontinence care.
*The need for the use of nectar-thickened liquids without the use of a straw.
*The need to provide care for seizure activity.
*The need to provide care to ensure comfort.

4. Review of the provider's 9/2/04 Care Plan for the Patient policy revealed the purpose of the care plan was to:
*Give direction and establish continuity of patient care.
*Provide a means for communication between nursing personnel and other health team members on all shifts.
*Indicate goals to be achieved and processes used to achieve them.
*Assign priorities to the problems that were the most urgent based on nursing diagnoses.
*Establish outcome criteria.
*Be maintained and kept current to reflect the changing problems and needs of the patient.
*Utilize pre-printed care plans but individualize them to meet current patient needs.

Interview on 8/27/13 at 11:10 a.m. with the director of nursing revealed pre-printed care plans had been used for patients based on their diagnoses. She confirmed those care plans had not been individualized to meet each patient's needs. She also confirmed the care plans had not been updated to reflect changes in physician's orders.

No Description Available

Tag No.: C0307

23059

Based on record review and interview, the provider failed to ensure all sampled medical record entries from different patient service areas were validated with signatures, dates, or times. A sample of 243 medical record entries revealed 118 instances where either the signature, date, or time of the entry was not recorded. Findings include:

1. Review of seventy-nine written physicians' orders during review of medical records on all patient care areas revealed two were not dated and nine were not timed.

2. Review of eighty-three physicians' progress notes during review of medical records on all patient care areas revealed ten were not dated and twenty-eight were not timed.

3. Review of fifty-two miscellaneous forms regarding nursing assessments of the patient during review of medical records on all patient care areas revealed seven were not signed, seventeen were not dated, and forty-one were not timed.

4. Review of ten discharge summaries of acute care patients revealed two of ten were not timed.

5. Review of ten history and physicals of acute care patients revealed one was not dated and two were not timed.

6. Interview with the director of nursing at 11:10 a.m. on 8/27/13 revealed she was aware all entries should have been signed, dated, and timed. Further interview revealed the provider did not have a policy regarding dating and timing of the above entries within the medical record.

No Description Available

Tag No.: C0388

Based on record review, interview, and policy review, the provider failed to ensure one of seven swing bed patients (8) had a comprehensive assessment completed. Findings include:

1. Review of patient 8's physician's orders revealed she had been admitted on 4/12/13 into swing bed for end of life care.

Review of patient 8's admission nursing assessment revealed:
*There were multiple unanswered questions on the form including:
-Height and weight.
-Other chronic illnesses or recent hospitalizations.
-Skin assessment had not identified location of bruises that had been checked.
-Orientation (awareness of date and time).
-If she had any valuables on her.
-How information had been obtained.
-Medication information.
-Risk Factor screen.
-Pain assessment.

Interview on 8/28/13 at 9:40 a.m. with the director of nursing revealed:
*Patient 8's assessment had not been completed thoroughly.
*It was her expectation all questions on that assessment would have been answered.

Review of the provider's swing bed policy manual revealed it had not addressed the completion of nursing assessments when patients were admitted.

No Description Available

Tag No.: C0395

Based on record review, interview, and policy review, the provider failed to ensure one of one swing bed patient (8) admitted for end of life care had a comprehensive care plan. Findings include:

1. Review of patient 8's entire medical record revealed:
*She had been admitted on 4/12/13.
*The 4/12/13 physician's admission order read "End of Life care."
*She had passed away on 4/16/13.
*There was not a comprehensive care plan in the record.
*There was not a plan that addressed end of life care.

Interview on 8/28/13 at 9:40 a.m. with the director of nursing regarding patient 8 revealed:
*There was not a care plan in her record.
*There should have been a care plan completed.

Review of the provider's undated care and discharge planning for swing bed patients policy revealed "The care plan will be developed within 48 hours of admission to the swing-bed program."