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400 PARK STREET POST OFFICE BOX 408

GREGORY, SD 57533

No Description Available

Tag No.: C0276

Based on observation, interview, and policy review, the provider failed to ensure:*Aseptic technique was used by one of one certified registered nurse anesthetist (CRNA) (A) for the administration of intravenous (IV) medications.
*Multiple dose vials were labeled when opened in three of four satellite clinics (Avera Gregory, Avera Colome, and Avera Winner).
*Multiple dose vials were discarded within 28 days in one of one anesthesia carts.
*Outdated medications and biologicals were discarded in one of one anesthesia cart and three of four satellite clinics (Avera Gregory, Avera Colome, and Avera Winner).
*Unauthorized persons did not have access to supplies stored in one of one supply room in the hospital.
*Sample medications were secured in one of four satellite clinics (Avera Gregory).
Findings include:

1. Observation on 3/29/11 from 10:15 a.m. through 10:50 a.m. revealed CRNA A:
*Administered IV medications to patient 12 during a surgical procedure in the operating room.
*CRNA A did not cleanse the port of the IV tubing with alcohol prior to injecting medications that included propofol.
*The IV tubing had been under a blanket.
*CRNA A did not cleanse the vial top of IV medications that included propofol.

Review of Charles F. Lacy, et al., Lexi-Comp Drug Information Handbook,18th Ed., 2009, pp. 1255 and 1256, revealed:
*Propofol vials have the potential to support the growth of various microorganisms despite product additives.
*To limit the potential for contamination, recommendations should be strictly adhered to.
*Strict aseptic technique must be maintained in handling.

2. Observation on 3/29/11 at 11:00 a.m. revealed the anesthesia cart had medications that were past the assigned beyond-use date. Those medications were ondansetron with a 2/15/11 date on the multiple use vial and Trandate with a 1/4/11 date on the multiple use vial. That same anesthesia cart also had two 500 milliliter (ml) IV bags of dextrose 5 percent (%) with 33% normal saline that had expired January 2011.

Interview on 3/29/11 at 11:10 a.m. with CRNA A revealed:
*He was not aware how long multiple use vials were good for once the vial had been accessed.
*The CRNAs were responsible for ensuring the anesthesia cart did not contain outdated medications.

Review of the provider's 2/15/10 medication administration policy revealed:
*All multiple dose vials should be discarded within 28 days of opening.
*The vial would have been marked with the expiration date.

3. Observation on 3/30/11 from 12:45 p.m. through 1:15 p.m. of the satellite Avera Colome Medical Clinic revealed:
*One bottle of ProSpray surface disinfection, expired December 2009.
*One can of saline wound wash, expired September 2010.
*One vial of 0.9% sodium chloride, expired September 2010.
*One package 3-0 coated Vicryl sutures, expired January 2000.
*Two packages 4-0 Ethilon sutures, expired July 2006.
*Four packages 4-0 Ethilon sutures, expired July 2010.
*Five packages 5-0 Ethilon sutures, expired January 2011.
*One biopsy punch, expired October 2010.
*Two 10 ml vials of Depo-testosterone 240 milligrams (mg)/ml, expired July 2010.
*One 5 ml vial of Dexamethasone sodium phosphate 4 mg/ml, expired August 2010.
*One 5 ml vial of Dexamethasone sodium phosphate 4 mg/ml, expired May 2009.
*One 1000 ml IV bag of 0.9 percent (%) sodium chloride, expired March 2009.
*One bottle of aspirin 81 mg, expired August 2010.
*One package of dextrose 50 mg/ml, expired February 2009.
*One vial of diphenhydramine 50 mg/ml, expired September 2009.
*One vial of Solu-Cortef 250 mg, expired January 2010.
*Two vials of epinephrine 1:1000, expired August 2009.
*One bottle of Nitro-Quick 0.4 mg, expired Mary 2009.
*Two vials of Kenalog 40 mg without an open date.
*One vial of DepoMedrol 80 mg without an open date.

4. Observation on 3/30/11 from 1:25 p.m. through 1:45 p.m. of the satellite Avera Winner Medical Clinic revealed:
*Two bottles of ProSpray surface disinfection, expired October 2009.
*One can of saline wound wash, expired March 2009.
*Four bottles of povidone-iodine, expired September 2008.
*One 10 ml vial of Depo-testosterone 200 mg/ml without an open date.
*Two 30 ml vials of cyanocobalamin 1000 micrograms/ml without an open date.
*One 50 ml vial of Sensorcaine 0.5%, without an open date.
*One 20 ml vial of lidocaine 1% without an open date.
*One 30 ml vial of 0.9% sodium chloride without an open date.
*Two 5 ml vials of Depo-medrol 80 mg/ml without an open date.
*One 5 ml vial of Kenalog 40 mg/ml without an open date.
*One 30 ml vial of Dexamethasone 4 mg/ml without an open date.




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5. Observation at the satellite Avera Gregory Medical Clinic at 1:15 p.m. on 3/30/11 revealed:
*Three opened multi-dose vials of 0.25% Sensorcaine without an opening date.
*Two opened multi-dose vials of 2% Lidocaine without an opening date.
*One bottle of 0.7% Candarthin with the expiration date of August 2010.

Interview with RN F at that time revealed the nurses were responsible for monitoring outdates on medications. She also stated multi-dose vials were to have been dated when opened, and they expired after 28 days of use.




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6. Observation on 3/30/11 from 1:20 p.m. to 2:00 p.m. at the satellite Avera Gregory Medical Clinic revealed the following items were expired:
*Examination room five had two boxes (12 packages each) of 6-0 Ethilon sutures expiration date January 2011 and seven packages 5-0 Ethilon sutures expiration date January 2009.
*Examination room four had six expired BD vacutainers:
- Two red/black top expired October 2010 and one other expired March 2010.
- One purple top expired February 2011.
- Two green top expired September 2010.
*Examination room twelve had:
- Five packages of 6-0 Ethilon sutures expired July 2007.
- Four packages of 6-0 Vicryl sutures expired 2010.
- Two packages of 3-0 Vicryl sutures expired January 2002.
*Supply room had:
- One 250 ml bag of normal saline expired January 2011.
- One 500 ml bag of normal saline expired September 2010.
- Four 1000 ml bags of half normal saline expired August 2010.
- Two 1000 ml bags of half normal saline expired January 2009.
- Two bottles of Redi Cat 2 berry smoothie expired November 2009.

Review of the provider's medication guidelines for satellite clinics approved June 2005 revealed a designated staff member at each clinic was to complete a monthly inspection of the medications stored in the clinic to identify outdated or unusable drugs. The outdated or unusable drugs were to be disposed of according to established policy.




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7. Observation on 3/29/11 from 2:40 p.m. to 2:50 p.m. revealed a storage room off the rear garage containing boxes of IV solutions, IV administration supplies, and many other patient care items. The door between the supply room and the garage was unlocked and open. The door to enter the garage from the emergency room was unlocked. The door to enter the garage from the outside entrance area was unlocked. During the time of observation there were no personnel present to monitor the supply room, garage, or emergency room.

Observation on 3/30/11 at 9:45 a.m. of the above area revealed the same condition. At 9:50 a.m. billing manager E entered the garage to unpack supplies. Interview at the above time revealed the door to enter the garage from the outside entrance area was to have been locked.

8. Observation on 3/30/11 from 1:20 p.m. to 2:30 p.m. at the Avera Gregory Medical Clinic revealed an unlocked sample medication cabinet in the hall directly outside the break room and approximately 25 feet from a side entrance door to the clinic. The break room was used by all staff members of the clinic. During the time of observation there were periods where the cabinet was not under the direct observation of authorized personnel.

Interview on 3/30/11 at 2:30 p.m. with RN F revealed the only clinic staff authorized to access the sample medication cabinet were nurses and physicians. The RN also stated the side door was not a main door to the clinic. She stated there were times when it was used by patients or visitors to enter or exit the building.

Review of the provider's medication guidelines for clinics approved June 2005 revealed sample medications were to be stored in either a reasonably secured area or maintained under direct supervision during clinic business hours.

No Description Available

Tag No.: C0307

Based on record review, interview, and policy review, the provider failed to ensure all sampled medical record entries from different patient service areas were authenticated with signatures, dates, and/or times. A sample of 257 medical record entries revealed 167 instances where either the signature, date, or time of the entry was not recorded. Findings include:

1. Review of 108 written physicians' orders during review of medical records on all patient care areas revealed 2 were not dated and 17 were not timed.

2. Review of 38 telephone or verbal physicians' orders during review of medical records on all patient care areas revealed 1 was not timed.

3. Review of 62 physicians' progress notes during review of medical records on all patient care areas revealed 8 were not signed, 32 were not dated, and 46 were not timed.

4. Review of 49 miscellaneous forms regarding physician or staff contact with the patient during review of medical records on all patient care areas revealed 5 were not signed, 21 were not dated, and 35 were not timed.

Interview on 3/30/11 at 9:35 a.m. with the health information manager revealed:
*She was aware that all entries in a patient's medical record must be signed, dated, and timed.
*All charts were audited after discharge, and the physician responsible was notified.
*She had presented information on that regulation to the medical staff in October 2010 and in January 2011.
*She had a performance improvement plan in place.
*There had been no improvement with the signing, dating, and timing of the medical record.

Review of the provider's revised May 2010 charting procedures policy revealed all entries must be signed, dated, and timed.

Review of the January 20, 2011 quarterly quality assurance meeting minutes revealed "Date/time/signature saw very small improvement; timely signing was all over the board."