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Based upon interview and document review, the governing body did not ensure that 5 of 20 contracted services had a quality assurance performance improvement (QAPI) plan (Organ Procurement Program, Nuclear Medicine, Orthopedic and Fracture Clinic, Consulting Radiologist, Golden Tongue Consultants).

Findings include:

The Organ, Tissue, and Eye Procurement Program, a contracted service with Life Source and the Minnesota Lions Eye Bank, did not have a QAPI program. Although Life Source and the Lions Eye Bank provided data which included the number of referrals, timeliness of referral, and a donation summary, the organ procurement program did not evaluate the data. The organ procurement program did not measure, analyze and track quality indicators, identify opportunities for improvement, implement preventative actions and track performance. The Chief Nursing Officer was interviewed at 3:45 p.m. on 1/5/12, and verified the only QAPI program was the data which was supplied by Life Source and the Minnesota Lions Eye Bank.

The Nuclear Medicine Department, a contracted service, did not have a QAPI program. The Clinical Services Director was interviewed at 9:45 a.m. on 1/6/12. He stated a review of the contracted service for nuclear medicine was conducted annually to ensure all elements of the contract were current, had been maintained over the past year and remained current. The information gathered for the annual contract review was from five sources, physicians and other departments which interfaced with the Nuclear Medicine Department. Although data was gathered, there was no quality indicators identified related to patient satisfaction nor any opportunities identified for improvement or changes which would lead to improvement. The Clinical Services Director stated the annual contract review was the only QAPI program conducted by the Nuclear Medicine Department.



12831

The orthopedic and fracture clinic, a contracted service with the hospital, did not have a comprehensive QAPI program. The hospital provided data which included a review of contract agency certification and a yearly questionnaire. The yearly questionnaire did not monitor the contracted service on an ongoing basis. The hospital did not use that information received through the questionnaire to develop projects which could improve patient's care and safety. The comments section on that form noted some concerns which included, "How the person was assigned, call taking for nights and weekends could be confusing, once the on call person was not available; trying to call the clinic was frustrating." They had received negative feedback regarding clinic staff from patients. The last comment indicated the form was hard to use by covering a year of interactions. There was no follow up to monitor these concerns and no performance improvement project initiated for the orthopedic and fracture clinic contracted services.


The consulting radiologist contracted service with the hospital did not have a comprehensive QAPI program. The hospital provided data which included a review of contract agency certification and a yearly questionnaire. The yearly questionnaire did not monitor the contracted service on an ongoing basis. The hospital did not use the information received through the questionnaire to develop projects which could improve patient's care and safety. The comments section indicated the questions on the radiologist form did not necessarily apply to radiologists. Some concerns about the telemedicine readings were also noted. There was no follow up to monitor these concerns and no performance improvement project initiated for the radiologist contracted services.


The consulting Golden Tongue contracted service with the hospital, did not have a comprehensive QAPI program. The hospital provided data which included a review of contract agency certification and a yearly questionnaire. The yearly questionnaire did not monitor the contracted service on an ongoing basis. The hospital did not use the information received through the questionnaire to develop projects which could improve patient's care and safety. The printed questions were to be answered with the use of Excellent, Good, Fair or Poor. The question as to whether the patient's care and services provided were relevant to the patients' clinical needs was answered, "Poor." The question of efficiency of the service provided was also answered as "Poor." Some concerns about the interpreter's coming late or not showing up at all was also noted. However, there was no follow up to monitor or measure these concerns and no performance improvement project initiated for the interpreter's contracted services by the hospital.

The Chief Executive Officer was interviewed at 2:45 p.m. on 1/5/12, confirmed they did not do QAPI projects for all their contracted services. He indicated they did not gather measurable information throughout the year for contracted services.

The hospital's Patient Safety and Performance Improvement Plan, policy last revised 4/26/11, indicated it was expected all departments and services participate in at least one organizational and one department or service performance improvement project or initiative annually.

Based on observation, document review, and interview, the facility failed to ensure the security of stored patient medical records located in the hospital and an outpatient area. This had the potential to affect most patients in the hospital.

Findings include:

Pharmacy records and patient medical records were stored in three unsecured areas of the hospital.

During a tour of the medical records storage areas at 9:45 a.m. on 1/4/12, the 100 wing storage, noted 245 cardboard boxes of pharmacy's information were not secure. That storage area could be accessed by 274 people using badges. A sample of titles with badges to enter that storage area included seven outside contractors, an exterminator company, hospital vendors, painters, junior volunteers, housekeeping, maintenance staff, nurse's assistants, licensed practical nurses, registered nurses, a nearby clinic, and other people not authorized to have access to patients' pharmacy information or patients' medical records.

The pharmacy medical records were stored in unlocked cardboard boxes with the dates of patients stay on the outside of the boxes. The boxes were approximately 11 by 19 by 12 inches in size, most boxes contained hundreds of patient names, medical record number, admission number, the patient's physician's name, the medications with dose and amount ordered for each patient. Some of the boxes contained hundreds of physician's prescriptions which included the physician's federal identification (ID) number, drug enforcement agency (DEA) number, the physician's signature, patient's name, date of birth, medical record number and the name and dose of the medication. There were boxes of invoices for medications from different drug companies which included the hospital's narcotic customer number, DEA number and federal ID number.

In the same above storage area, there was a seven foot fenced off area where patients' medical records were stored in boxes. Inside that locked fence area (called, "the cage") there were at least 200 boxes of patient's complete, medical records per estimate from the health information services (HIS) operations manager. There was enough other items stored in that area to easily step on a stored item and then step over the fence on to a stored items on the other side of the fence. The ceiling height varied, however, was at least two feet above the fence.

A cook, a maintenance person and the grounds keeper entered that area while the boxes were being counted. Interview with the HIS Operations Manager at approximately 11:20 a.m. on 1/4/12, indicated that area was considered a "staff" storage area. She further indicated medical records were not involved with the storage of pharmacy's information.

The HIS Operations Manager indicated every one coming into that area needed to do so through the use of a badge and they would not have the key to get into the cage. That would be the same 274 people as listed above. Most of the people with a badge to access that area would not be authorized to look at any of the patient's records; however, access to thousands of patients record would be easy, if anyone wanted to access them.

Interview with pharmacist-A at 9:15 a.m. on 1/5/12, verified the pharmacy records were not being stored in a confidential manner in the 100 wing storage area.

A second medical record storage area was within another larger general storage area. That storage area had a six foot fenced off area where patients' medical records were stored in boxes. Inside that locked fence area there were at least 200 boxes of patients' complete, paper, medical records per estimate from the facility service administrative assistant. There were enough other items stored in that area to easily step on a stored item and then step over the fence on to a stored items on the other side of the fence. The ceiling height varied, however, was at least three feet above the fence.

Interview with the facility service administrative assistant at approximately 10:10 a.m. on 1/6/12, indicated these were patient records that had already been scanned electronically. The boxes observed had patients records dated from 2009 to 2011. Most of the people using that general storage area would not be authorized to look at any patients' records, however, access to the patients' records admitted from 2009 to 2011, could be easily accessed.

There were also more recent medical records files stored in 14 rolling files behind the medical record offices. Each rolling file was approximately 20 feet long. Medical record staff did not have a view of these stored patient files. These files were not locked and anyone with access to the medical record office would have access to these files. Interview with medical record personnel-A at 10:00 a.m. on 1/6/12, regarding who else worked in that area that should not have access to these patients files she indicated: seven accountants, patient accountants representatives, the billing staff, 13 administrative assistants, data entry staff, four people taking phone calls regarding billing, six temporary staff, and a claim person. These people had badges they used daily to come and go out of that work place. She also indicated a junior volunteer had day time access only. A list of 145 people was later provided who had access to these patients medical record.

An interview at approximately 2:00 p.m. on 1/6/12, with the HIS Operations Manager indicated they would not know if a patient medical record was missing from any of these three areas. They use to find patient medical records missing or misfiled when they had a request to have the patient record pulled, however, that does not happen as often since the use of electronic records. She further indicated they have not destroyed any of their medical records.



15508

The Outpatient Behavioral Health Services had paper medical files stored in an unsecured area.

During a tour of the Outpatient Behavioral Health office at 11:10 a.m. on 1/4/12, it was observed there were several hundred paper medical records stored in unlocked filing cabinets. These cabinets were located in the medical records area of the outpatient clinic. These paper medical records were prior to the implementation of the current electronic record system.

In an interview at 11:15 a.m. on 1/4/12, with the office manager she stated the housekeeping staff clean that area before office hours and therefore would have access to these paper medical records.

The facility's policy of Protection of Patient Privacy Physical Safeguards last reviewed 4/1/03, specified, "Patient charts, records, reports, images and other documents or media containing protected health information must be stored securely. The means for securing such information must be appropriate to the location and the risk of unauthorized access."

The Pharmacy Security Policy last reviewed on 8/23/11, indicated all personnel on duty shall protect pharmaceuticals and records and guard against the theft or diversion of drugs.

Based upon interview and record review, the hospital did not ensure physician orders were complete, dated, timed, and authenticated for 12 of 31 (P11, P10, P15, P19, P12, P3, P4, P5, P31, P20, P13 and P9) medical records reviewed.

Findings include:

P11's medical record contained verbal orders which were signed by the physician (MD)-A but did not include a date or time of when they were signed.

P11's medical record contained verbal admission orders dated 12/29/11. Although each of the five pages of the order had a MD signature on the bottom, there was no date and time indicating when MD-A reviewed and approved the verbal orders.
During interview on 1/5/12, with registered nurse (RN)-B she verified the MD did not sign or date the admission orders for the patient. She stated, "We are working on that."

P10's medical record contained a telephone order by MD-B which ws received at 6:35 on 12/23/11, for Aldactone (blood pressure medication) 25 milligrams (mg) to be given daily to P10. The MD signed the order on 12/27/11, but did not specify a time of the signature.





15508


P15's medical record contained admission orders which were not signed by a MD.
P15 had telephone admission orders regarding medications which included Ativan (antianxiety) were obtained on 12/29/11. The medical record was reviewed on 1/5/12, and there was no physician signature verifying the verbal orders.
During interview at 9:15 a.m. on 1/5/12, RN-C verified P15's verbal orders were not signed off by a physician.

P19's medical record contained a telephone order for medication admission orders which included Celexa (antidepressant) and Geodon (antipsychotic) dated 12/28/11. That order was signed by Physician-B but did not contain a date or time verifying when that was signed.
During interview at 9:50 a.m.on 1/5/12, RN-C verified P19's verbal orders were signed off by a physician but not dated or timed.

P12's medical record contained several telephone orders which were not dated or timed. In addition, the medical record contained two verbal orders which were not signed by a physician.
P12's medical record contained verbal orders dated 12/22/11, for Clonidine (anti-hypertensive) and that order was signed by physician-B; however, there was no date or time indicating when the physician signed these verbal orders. On 12/14/11, a verbal order was obtained for a restraint and Haldol (antipsychotic) for out of control behavior that had not been signed by the physician when reviewed on 1/5/12. On 12 21/11, a verbal order was obtained for a restraint for out of control behavior; that had not been signed by the physician when reviewed on 1/5/12.
During interview at 2:40 p.m. on 1/4/12, RN-B verified P12's verbal orders were signed by a physician but not dated or timed. She also stated that the verbal orders from 12/14/11 and 12/21/11, were not signed by a physician



18622


P3's medical record contained telephone orders which were not signed by the MD and did not include a date or time of when they were signed.
P3's medical record contained telephone orders for Ativan intravenous (IV) and to titrate per Clinical Institute Withdrawal Assessment (CIWA) at 2150 (9:50 p.m.) dated 1/1/12, and Ativan IV and to titrate per CIWA at 10:14 p.m. Additional telephone orders were received at 3:15 p.m. on 1/2/12, for Tylenol (mild analgesic) regular strength two tabs every four hours as need for a headache. Zofran (antiemetic) 4-8 mg every six hours as needed. Hydrocortisone (topical steroid) 1 % cream apply to rash twice a day as needed. Another telephone order was given at 3:30 p.m. to clarify Zofran order per above was to be administered IV route. At 8:12 p.m. on 1/2/12, a telephone order was received to increase Ativan to max of 24 IV per hour and to titrate. None of the telephone orders had a MD and there was no date and time indicating when the MD reviewed and approved the verbal orders.

P4's medical record contained a verbal order which was signed by the MD but did not include a date or time of when they were signed.
P4's medical record contained verbal clarification order for Omeprazole (used for gastroesophageal reflux disease) dated 1/2/29/12. The order had a MD signature, but there was no date and time which indicated when the MD reviewed and approved the verbal orders.
P4's medial record contained a telephone order for Code Status: Full code at 1610 (4:10 p.m.) on 1/3/12, and it had not been signed, timed and dated.

P5's medical record contained a verbal orders which were signed by the MD but did not include a date or time of when they were signed.
P5's medical record contained a verbal order to discontinue orthostatic blood pressures dated 12/31/11. P5's medical record had a verbal order to collect a urine for urinalysis dated 12/28/11. The orders had a MD signature on the bottom, but there was no date and time indicating when the MD reviewed and approved the verbal orders.
P5's medical record contained a telephone order at 5:20 p.m. on 12/21/11, for 20 mg of Lasix (a diuretic) IV one dose only at 5:35 p.m. P5's medical record indicated a telephone order for Saline (salt water) lock IV. The orders had a MD signature, but there was no date and time indicating when the MD reviewed and approved the verbal orders.

P31's medical record contained verbal orders which were signed by the MD but did not include a date or time of when they were signed.
P31's medical record contained a verbal order for a regular diet, to change intravenous fluids to keep vein open and if tolerating liquids may discontinue dated 8/20/11. The orders had a MD signature, but there was no date and time indicating when the MD reviewed and approved the verbal orders. P31's was a discharged medical record greater than 30 days.
P31's medial record contained two telephone orders. The first order on 8/19/11, was for Versed (a medication used to induce sleepiness or drowsiness and relieve apprehension) 1 mg IV immediately (STAT) and Morphine (a narcotic) 4 mg IV STAT. The orders were signed but not dated or timed.

The Director of Quality Assurance (QA) was interviewed at 2:45 p.m. on 1/5/12, and confirmed the facility had problems on getting the practitioners who gave the verbal order to authenticate with signature within 24 hours, including date and time for telephone and verbal orders. The Director of QA confirmed medical records for P3, P4, P5, and P31 had verbal and telephone orders that had not been signed off according to the facility's policy. The Director of QA confirmed that practitioners were not following the facility's policies on completing medical records.



29249


P20's medical record contained verbal orders that were not signed within 48 hours.
P20's medical record contained 20 verbal orders dated 12/27/11, one verbal order dated 12/28/11, three verbal orders dated 12/29/11, four verbal orders dated 12/30/11, six verbal orders dated 12/31/11, and two verbal orders dated 1/1/12. All 36 of these verbal orders were signed off on 1/4/12, not within the 48 hours required.
During interview at 10:00 a.m. on 1/5/12, with RN-C he verified none of the orders were signed within 48 orders. He stated, "They are signed late; it must have been over the holidays."
No further information was provided


29440


P13's medical record contained telephone orders which were not signed by MD-D and also telephone orders that did have a physician signature, but did not include a date or time of when the physician reviewed and approved the telephone order.
P13's medical record contained telephone orders dated 1/3/12, to start Pitocin augmentation orders (medication orders to induce labor), "Birthcare Orders" (order set related to pre-delivery orders), and for "Outpatient Evaluation 37 Weeks or More Gestation" orders (order set for obstetrical patient). Physician-D initialed the telephone orders but did not include a time or date for when the review and approval occurred. Additionally on 1/13/12, a telephone order was given by MD-D for the order set "Foley Catheter Orders" (orders related to urinary drainage). These orders lacked physician signature, date, and time to indicate the orders had been reviewed and approved by the physician.

P9's medical record contained written care area orders that were not signed by the MD-C.
P9's medical record included a written care area order for the order set "Foley Catheter Order" (for urinary drainage) written 1/3/12. The order lacked any physician signature, date and time to indicate review and approval of the order.

At 9:30 a.m. on 1/6/12, Clinical Nurse Lead-A verified the physicians had not signed these telephone orders and written care area orders for P13 and P9. Clinical Nurse Lead-A verified the facility policy was for the MD to sign the order with the date and time included. The Clinical Nurse Lead-A stated the facility policy was for that to be done within 24 hours of the initial order being taken.

A review of the facility's police from The Rules and Regulations of the Medical Staff Bylaws of Hutchinson Area Health Care approved by the Governing Body on 5/17/11, indicated, "Verbal orders, including telephone orders, shall be considered to be in writing if given to a duly authorized person and signed, dated, timed, and authenticated as soon as possible by the practitioner ordering such treatment, and within twenty-four (24) hours."

The facility had a policy, Rules and Regulations, approved by the Governing Body 5/17/11, page 11, under incomplete charts indicated, "Within thirty (30) days after discharge, the medical record of a discharged patient must be fully completed by all Physicians and ancillary personnel involved in the care of the patient."

Based upon observation, interview and policy review, the hospital did not ensure 12 of 12 emergency carts which stored medications were kept in a secure area.

Findings include:

Emergency carts were not kept in a secure area in the operating room suite and the post anesthesia care unit (PACU).

During a tour of the operating rooms and the PACU at approximately 2:30 p.m. on 1/4/12, an adult and a pediatric Code Blue cart, which contained emergency medications, were observed in the PACU. A newborn resuscitation cart, which contained emergency medications, was located in operating room 3. The carts were secured with red and blue tags, which did not have any other identifying information on them. Although staff checked the integrity of the tags on the carts daily, there was no way to determine who had applied the security tags, which tag had been applied, nor who had removed the tag or the reason for removal of the security tag. A certified registered nurse anesthetist (CRNA)-A was interviewed at 2:15 p.m. on 1/4/12. He stated the newborn resuscitation cart was kept in operating room #3 in the event an emergency caesarean section was performed.

In addition, the Surgery Supervisor was interviewed at approximately 3:15 p.m. on 1/4/12, and stated housekeeping personnel cleaned the operating rooms and the PACU from 4:00 p.m. until 10:00 p.m. daily, as needed. The Supervisor stated operating room personnel were not always present while housekeeping personnel cleaned the surgical suite.


18622


Adult and pediatric emergency medication carts/Code Blue carts were not kept in a secure area on the medical - surgical unit, Cardiac Rehab Suite, Birth Care Adult and Neonatal during observations throughout the survey.

The Birth Care Adult and Neonatal unit emergency medication carts which contained emergency medications were observed at approximately 7:30 a.m. on 1/5/12, in a back hall between patient room number 208 and 209. There was an obstructed view of the emergency medication carts and only one of the two carts could be observed from the nurse's station. The carts were secured with red and blue tags, which did not have any other identifying information on them. Although staff checked the integrity of the tags on the carts daily, there was no way to determine who had applied the security tags, which tag had been applied, nor who had removed the tag or the reason for removal of the security tag. An interview with RN-D at 7:45 a.m. on 1/5/12, confirmed that both of the emergency medication carts were not visible from the nurses station.

The medical - surgical emergency medication cart was observed in an alcove across from the nurse's station at 8:05 a.m. on 1/5/12. There was a nurse sitting at the desk. The medical - surgical emergency medication cart had a red plastic tab which secured the medications in the emergency cart. The cart was secured with red tag, which did not have any other identifying information on them. Although staff checked the integrity of the tags on the carts daily, there was no way to determine who had applied the security tags, which tag had been applied, nor who had removed the tag or the reason for removal of the security tag.

The cardiac rehab emergency medication cart was observed at 10:00 a.m. on 1/5/12, on the lower level of the hospital in the rehab area in the cardiac rehab suite. The emergency medication cart had a red plastic tab securing the cardiac rehab emergency medication cart. The cardiac emergency medication cart was not visible from the nurse's station. During the tour of the rehab unit there was no staff in the area who could observe the cardiac emergency medication cart. The cart was secured with blue tags, which did not have any other identifying information on them. Although staff checked the integrity of the tags on the carts daily, there was no way to determine who had applied the security tags, which tag had been applied, nor who had removed the tag or the reason for removal of the security tag. The Rehab Manager was interviewed during the tour and confirmed the cardiac rehab emergency medication cart had emergency cardiac drugs and was secured by a plastic blue or red tab.

The Clinical Division Director, a Registered Pharmacist, was interviewed at approximately 9:00 a.m. on 1/5/12, and confirmed the emergency medication carts had blue tabs on the carts to secure the carts. The blue tabs are applied by pharmacy after pharmacy checks the emergency medication carts. The blue tabs are removed when a nurse needs to access the emergency carts and then would replace the red tabs after the nurse restocked the items taken from the emergency medication cart. The red tabs did not have identifiers on them and therefore the number of times the emergency cart had been accessed could not able to be determined. The Clinical Division Director confirmed the number of emergency medication carts were 12 and that all 12 carts were secured with the blue/red plastic tabs which could easily be removed and replaced. The red tabs were kept in the top drawer of the emergency medication cart or on the nurses station. The Clinical Division Director confirmed that there were eight adult emergency carts in the following locations that were secured with red tabs: PACU, Medical - Surgical Unit, Emergency Department (ED), Intensive Care Unit (ICU) / Cardiac Care Unit (CCU), Cardiac Rehab Suite, Respiratory Therapy/Stress Lab, Birth Care Adult and Neonatal, and Same Day Surgery. There were an additional four Broselow pediatric (child) emergency carts that use the red tab to secure the carts in the following areas: ED CCU, operating room, and obstetrics. The Clinical Division Director confirmed that 12 of 12 emergency carts were compromised because the red tabs had no identifying information and it could not be determined how often the carts could have been entered and security of the carts was lacking. Staff were not always present at the nurse's station and the hallway was traversable by patients, visitors, and non-nursing staff.

The facility's policy on Code Blue and Procedure (no date) indicated the following procedure was to be followed for security checks and restocking of medications and supplies:

1. Security Locks and Replacement:
a. Pharmacy uses a colored lock (usually BLUE, just not red) on all crash carts to secure the medication, equipment and supply integrity. When resupply of medications is needed, authorized staff break lock integrity and restock medications. The Crash Cart Charge Sheet is filled out and returned to pharmacy.
b. After crash cart use nursing staff will replace medications and supplies. Medications for replacement are stocked in CCU and ER Omnicells. The replacement medications are signed out to the patient "Crash Cart". A RED lock is placed pharmacy is notified. Pharmacy will do a second check to verify medications and place a pharmacy lock, these locks are stored in pharmacy.
c. The colored - drawers on the pediatric Broselow carts are red - locked after they are checked and restocked. These drawers are not re-locked with a pharmacy lock.

2. Security Checks
a. Crash carts are checked for lock security minimally every 24 hours. Security checks are documented on a calendar and initialed when complete
b. If a red lock is the only lock noted notify pharmacy immediately. A pharmacy staff person will recheck the medication contents and apply a pharmacy lock.
c. If a cart is found unlocked at any time, an RN will take responsibility to check contents of the cart and replace the red lock.

Based on observation and interview, the facility was found not in compliance with Life Safety from Fire found at CFR 482.41 (b).

Refer to Life Safety Code deficiencies-K0043, K0052, K0056, K0062, K0078, and K0130, for additional information.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure safety from fire therefore they were unable to meet this condition.

Based on observation, document review, and interview, the facility failed to secure biohazard wastes. Biohazard wastes were observed to be stored in an unsecured storage room for 1 of 1 storage rooms utilized to store waste.


Findings include:


During the physical environmental tour conducted at 2:50 p.m. on 1/5/12, a storage room on the main floor of the hospital, which had been designated and labeled for biohazard waste was observed to be opened and unsecured without staff present in the room. In a follow-up observation made at 8:40 a.m. on 1/6/12, the same door was found opened, unsecured and no staff present in the room.

The contents of the room included six sharps containers; one gallon barrel of laboratory wastes; one and one half 30 gallon barrels of chemotherapy wastes; one eight gallon container of surgical wastes and 18 eight gallon containers of nursing wastes.

In an interview at 10:35 a.m. on 1/6/12, with the Patient Safety Officer (PSO), she stated the room was to be locked at all times. The PSO indicated the self-closing door hinge was broken.

The facility's policy Hazardous Materials and Wastes Management Plan last reviewed 2/23/11, specified that (hazardous materials and waste), "Storage areas will be secured and labeled appropriate with the hazards stored there."

Based upon interview, record review and policy review, the hospital was found not to be in compliance with the Conditions of Participation for Surgical Services (CFR 482.51) due to failure to follow acceptable standards of practice related to surgical instrument counts, the use of alcohol based surgical skin preparations, and the use of electrocautery devices. The hospital lacked a policy/procedure to ensure surgical instruments were counted at specified time frames when the possibility existed that an instrument could be unintentionally retained. In addition, the hospital did not ensure that a policy had been developed related to the use of alcohol based skin preparations in anesthetizing locations nor were staff documenting in the medical record that appropriate policies had been followed related to the use of alcohol based skin preparations. The hospital also did not have a policy related to the use of electrosurgical instruments (cautery instruments).

Findings include:

Refer to findings at A-0951 regarding lack of surgical instruments counts, documentation of use of alcohol based skin preparations, and the use of electrocautery equipment in the surgical suite.

SURGICAL INSTRUMENTS

The surgical services supervisor was interviewed at 10:50 a.m. on 1/4/12. She stated the hospital performed counts on sponges, needles and blades prior to the start and upon completion of every surgical procedure. She verified that surgical instruments were not a part of the surgical count, even in cases where an instrument could be unintentionally retained. She stated the hospital was "moving toward the process of counting surgical instruments within the next year" but a policy had not been developed nor implemented.

The Association of Operating Room Nurses (AORN) is a nationally recognized professional organization who recommends standards of practice governing surgical services. AORN's current recommendation regarding surgical instrument counts indicates instruments should be counted on all procedures in which there was a likelihood that an instrument could be retained. Instrument counts protect the patient and are a proactive injury-prevention strategy.

ALCOHOL BASED SKIN PREPARATIONS

The hospital did not implement policies and procedures to ensure compliance with applicable federal regulations and guidelines related to the use of alcohol based skin preparations in the surgical department. The Centers for Medicare and Medicaid Services (CMS) issued a Survey and Certification Memo on 1/12/07, which addressed risk reduction techniques to permit safe use of alcohol based skin preparation in inpatient anesthetizing locations in hospitals. The use of alcohol based skin preparations in inpatient or outpatient anesthetizing locations is not considered safe, unless appropriate fire risk reduction measures are taken, preferably as part of a systemic approach by the hospital to prevent surgery related fires.

The surgical services supervisor was interviewed at 2:15 p.m. on 1/5/12. She stated that all surgical staff had been inserviced in the safe use of alcohol based skin preparations in the surgical suite. She verified a policy had not been developed related to the safe use of alcohol based skin preparations nor did hospital staff document in the patient medical record verifying that appropriate procedures were followed ensuring the proper use of the alcohol based skin preparations prior to the surgical procedure.

ELECTROSURGICAL INSTRUMENTS (CAUTERY)

The surgical services supervisor was interviewed at 10:50 a.m. on 1/4/12, She stated the hospital did not have a policy related to the use of electrosurgical (cautery) devices. The service manual, revised 5/2011, for Valley Lab, the manufacturer of cautery units used within the surgical suite, was reviewed. The service manual recommended that "an active cautery instrument should not be placed near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical instruments that are activated or hot from use can cause a fire. When not in use, place electrosurgical instruments in a safety holster or safely away from patients, the surgical team, and flammable materials."

Based upon observation, interview and record review, the hospital did not ensure safe surgical practices were followed in accordance with acceptable standards of practice related to instrument counts when the possibility existed than an instrument could be unintentionally retained. In addition, the hospital did not ensure proper procedures were followed related to the use of alcohol based skin preparations in anesthetizing locations to prevent the risk of fire for 1 of 1 (P32) surgical procedures observed where alcohol based skin prep was used. The hospital also did not ensure the safe use of electrocautery equipment in the surgical suite for 2 of 3 (P44, P45) surgical procedures observed in which electrocautery equipment was used. This had the potential to affect most of the patients undergoing surgery at the hospital.

Findings include:

INSTRUMENT COUNTS:
The surgical services supervisor was interviewed at 10:50 a.m. on 1/4/12, and stated the surgical counts only included knife blades/sharps, suture and sponges. She verified no other surgical instruments were counted even in surgical procedures where there was a possibility a surgical instrument could be unintentionally retained. She stated the hospital was "moving toward the process of counting surgical instruments within the next year" but a policy had not been developed nor implemented.

The Association of Operating Room Nurses (AORN) is a nationally recognized professional organization who recommends standards of practice governing surgical services. AORN's current recommendation regarding surgical instrument counts indicates instruments should be counted on all procedures in which there was a likelihood that an instrument could be retained. Instrument counts protect the patient and are a proactive injury-prevention strategy.

ALCOHOL BASED SKIN PREPARATIONS:
The hospital did not implement policies and procedures to ensure compliance with applicable federal regulations and guidelines related to the use of alcohol based skin preparations in the surgical department. The Centers for Medicare and Medicaid Services (CMS) issued a Survey and Certification Memo on 1/12/2007, which addressed risk reduction techniques to permit safe use of alcohol based skin preparation in inpatient anesthetizing locations in hospitals. The use of alcohol based skin preparations in inpatient or outpatient anesthetizing locations is not considered safe, unless appropriate fire risk reduction measures are taken, preferably as part of a systemic approach by the hospital to prevent surgery related fires.

At 9:22 a.m. on 1/4/12, surgical staff was observed to use Chloraprep skin prep (alcohol-based surgical skin cleansing preparation) for pre-operative skin preparation for P32. Surgical staff were observed to watch the clock in the operating room with operative area untouched for three minutes.

By review of the "Surgical Services Perioperative Record Form" dated 1/4/12, the "Prep" section of the form indicated that Chloraprep was selected as skin preparation used but contained no documentation of dry time being observed or verification that the prepped site was dry before continuing with the procedure.

At 9:48 a.m. on 1/6/12, the operating room manager stated the facility did not have a policy on the use of alcohol-based skin preparations and observing dry times. The operating room manager verified that P32 had received an alcohol-based skin preparation as part of the surgical procedure but that the record indicated no observation of dry time or verification that the site was dry before proceeding with the procedure.

The surgical services supervisor was interviewed at 2:15 p.m. on 1/5/12. She stated that all surgical staff had been inserviced in the safe use of alcohol based skin preparations in the surgical suite. She verified a policy had not been developed related to the safe use of alcohol based skin preparations nor did hospital staff document in the patient medical record verifying that appropriate procedures were followed ensuring the proper use of the alcohol based skin preparations prior to the surgical procedure.

USE OF ELECTROSURGICAL EQUIPMENT (ELECTROCAUTERY):
Physician (MD)-A did not utilize a holster device to place the electrocautery device following use for 2 of 3 surgical procedures observed.

P44 was observed at 7:55 a.m. on 1/4/12, undergoing a ganglion cyst removal from the right wrist. MD-A utilized an electrocautery device at 7:58 a.m. and at 8:00 a.m. Immediately following the use of the electrocautery device, MD-A placed the device on the paper surgical drape. There was no cautery holster on the surgical field nor did the registered nurse (RN)-A or the surgical technologist-A remind the surgeon to utilize a holster for the cautery device.

P45 was observed at 9:20 a.m. on 1/4/12, undergoing an umbilical hernia repair. Physician-A used an electrocautery device at 9:22 a.m., 9:25 a.m, and 9:27 a.m. and immediately after use, placed the device on the paper surgical drapes covering the patient's lower abdomen. Physician-A again used the electrocautery device at 9:30 a.m. and immediately placed the device on the paper surgical drapes covering the patient's upper abdomen. RN-F in the operating room did not remind the surgeon to place the cautery device in the holster nor was there a holster within the surgical field.

The RN-A in the operating room was interviewed at 10:45 a.m. on 1/4/12. She stated she had the cautery holster available for the physician but did not request he use the holster.

The surgical services supervisor was interviewed at 10:50 a.m. on 1/4/12. She stated MD-A does not prefer to utilize a holster to place the active electrocautery device. She stated the hospital did not have a policy related to the use of electrosurgical (cautery) devices.

The service manual revised 5/2011, for Valley Lab, the manufacturer of cautery units used within the surgical suite, was reviewed. The service manual recommended that "an active cautery instrument should not be placed near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical instruments that are activated or hot from use can cause a fire. When not in use, place electrosurgical instruments in a safety holster or safely away from patients, the surgical team, and flammable materials."



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