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Based on observation, interview, record review and policy review, the Critical Access Hospital (CAH) was found not to be in compliance with the Conditions of Participation for Physical Environment (CFR 485.623) due to failure to ensure proper procedures were followed related to use of alcohol based skin preparation in anesthetizing locations to prevent the risk of surgical fires. This practice was evident for 3 of 3 outpatients (OP1, OP2 and OP3) and 3 of 4 inpatients (IS1, IS2 and IS3) in the sample who required this type of surgical prep.

Findings include: The CAH 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. CMS (Centers for Medicare and Medicaid Services) had issued a Survey and Certification Memo dated 1/12/2007, addressing risk reduction techniques to permit safe use of alcohol based skin preparations in inpatient anesthetizing locations in CAHs. The use of an alcohol based skin preparations in inpatient or outpatient anesthetizing locations is not considered safe, unless appropriate fire risk reduction measures are taken, preferable as part of a systemic approach by the CAH to preventing surgery related fires.

On 6/11/2010, at 1:00 p.m. an interview was conducted with the operating room (OR)manager regarding policy/procedure for use of alcohol based skin preparation. It was verified the CAH had been using alcohol based skin preps as preferred by the surgeon. Although the OR manager indicated they routinely checked to assure the alcohol had completely dried, the CAH staff had not documented in the patient record verifying that appropriate procedures were followed ensuring the proper use of the alcohol based skin preparation prior to the surgical procedure.

During record review it was noted that alcohol based skin preparation (Chloraprep) had been utilized during three (3) outpatient laparoscopic cholecystectomies on the following dates: (OP1) 4/30/10, (OP2) 6/11/10, and (OP3) 12/31/09; and three (3) inpatient surgical (IS1) Hernia repair on 1/28/10; (IS2) C-section on 12/17/09 and (IS3) hemicolectomy on 1/22/10. Review of the Perioperative Record for all six (6) records confirmed that alcohol based skin preparation had been utilized as indicated by the surgical staff. No documentation was evident to indicate the alcohol based skin prep had been dried and/or the appropriate procedure implemented. When queried as to the method of alcohol skin prep application, interview with the operating room manager on 6/17/2010 at 12:00 p.m. revealed the pre-packaged Chloraprep application had been routinely used by two of the surgeons.

The Johnson Memorial Health Services (JMHS) CAH policy 32145 "Skin Preparation in the Operating Room" indicated the following procedure (#7 thru #8):
(7.) Allow sufficient contact time of antiseptic agents with the skin before applying sterile drapes to achieve maximum effectiveness of the agent; and
(8.) Allow sufficient time for complete evaporation of any flammable antiseptic agent (e.g., alcohol, alcohol-based preparations) to reduce the possibility of fire.

The Director of Nursing (DON) was interviewed at 3:15 p.m. on 6/17/2010. The DON confirmed there was no documentation evident in the patient records regarding drying of the prep prior to draping.

Based on policy review, committee meeting minute review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the Pharmacy and Therapeutics Committee (P & T) convened and implemented drug utilization review as directed by the current CAH policy and failed to develop policies that defined emergent, urgent and routine medication usage to assure quality pharmaceutical services were provided.

Findings include: The P&T committee did not meet quarterly as required by the CAH policy. Pharmacy policies lacked definitions of emergent, urgent and routine medication usage. Review of the CAH's pharmacy policies on 6/17/10 revealed the CAH had not defined medications in categories of emergent, urgent, or routine in order to assure quality of pharmacy services. Review of the P & T committee minutes for the past year revealed this committee had met in conjunction with the Professional Activities Committee on 6/10/09 and not again until 3/10/10 (9 months later). Review of the pharmacy policies revealed policy
#25165 included, "the pharmacy services of the hospital shall have an active and continuing Pharmacy and Therapeutics Committee; this committee shall meet quarterly and include the following personnel: Hospital Administrator, Director of Nurses (DON), Pharmacist and Medical Staff Physicians & Practitioners". "Meetings are held at least once every 3 months in conjunction with the Medical Staff meetings". Interview with the DON at 2:30 p.m. on 6/17/10, confirmed the P & T committee had not met as defined in policy.

Further pharmacy policy review indicated that policy # 25190 "Drug Utilization Review", included the following:
(1.) antibiotic usage evaluations are an ongoing integral part of the hospital's quality assurance program for auditing patient's medications;
(2) the actual review of antibiotic usage will be performed by the Pharmacy and Therapeutics Committee.
(3) The antibiotic audit system will be comprehensive program integrating pharmacy, infection control, laboratory, the medical staff, concurrent medication reviews and retrospective review on a quarterly time table. It will be criteria based, problem focused and results oriented.
(4) Retrospective or Concurrent Audits- Based on a quarterly time table, the following review categories will be audited: specific reviews, antibiotic or antibiotic group review, empirical antibiotic therapy and prophylaxis
(5) The P &T will be responsible for assuring that assessment includes clinical review as well as statistical/prevalence studies of antibiotic usage.
The procedures included: "the P &T committee will establish at its designated quarterly meetings, the criteria and objectives of the next quarter's antibiotic audit".

Review of P & T committee meetings lacked discussion of any antibiotic usage and/or evaluation. The formulary had been discussed and approved but no further drug utilization reviews were evident. Interview with the DON on 6/17/10 at 12:00 p.m. confirmed that antibiotic tracking had not been discussed at the P & T meetings and indicated she had no further information for review. She also verified the lack of quarterly P & T committee meetings.

Based on record review and staff interview, the Critical Access Hospital (CAH) failed to assure that the Registered Nurse (RN) evaluated each patient and documented clinical assessments for 3 of 20 discharged patient records reviewed (P11, P12 and P13).

Findings include: Initial and/or follow-up nursing assessments had not always been evident in the records of P11, P12 and P13 so that patient progress could be accurately assessed.

During review of the discharged record for P11, the discharge summary documented, "84 year old patient had been admitted on 12/28/2009 with the diagnoses that included recurrent cellulitis and impetigo of the left lower leg. The patient had satellite lesions developed due to increasing left leg swelling, edema, redness and cellulitis. The patient had intravenous antibiotic therapy (Vancomycin)." During review of a physician progress note dated 12/29/09 it was documented the patient had a "fairly large buttocks ulceration, the ulcer is approximately 3 cm x 3 cm and appears to be a stage III." The physician's assessment indicated, "Stage III buttocks ulcer". Physician dictation dated 12/30/09 revealed, "after he had a bowel movement yesterday it was noted that he had an ulcer in the pilonidal area; it appears to be the very same area where he had pilonidal cyst removal about two years ago".

During review of nursing documentation it was noted the 84 year old patient had been admitted on 12/28/09 at 10:15 a.m.. The RN had documented at 10:20 a.m. on 12/28/09, " Integumentary Findings: abnormals: lips cracked, skin dry, skin itching, skin pale, skin red (bilateral upper and lower extremities and peri ares), skin rough, skin scaly, skin tear (left upper extremity), skin turgor poor, other (Peri area is bright red, patient states "it has been that way for a long time" denies any pain in this area). Interventions: area left to open air, dressing applies (OpSite applied to skin tear on left upper extremity) Skin care given. " The RN had also documented the patient had edema +3 moderate indent (left lower extremity). There had been no further documentation regarding the condition and/or assessment of the patient's buttock until 12/29/09 at 6:07 p.m. (32 hours after admission). The following nursing note had been entered into the electronic record at that time, "had an incontinent extra large formed BM (bowel movement) light brown in color. Noted to have a Stage III pressure ulcer on the coccyx. No signs or symptoms of infection noted. MD (medical doctor) notified and was in to assess wound". During review of the "System assessment related to the skin" with the Director of Nursing (DON) on 6/16/10 at 2:30 p.m. it was noted the facility's document titled, initial 'Nurse Database' included the following areas to assess: mobility, motion, gait, alignment, joint function/skin color, texture, turgor and integrity. The record lacked evidence that a visual inspection had occurred regarding the condition of the buttock and/or peri-area until documented on 12/30/10. Subsequent nursing documentation indicated a wound present on the buttock but a description related to size had not been evident. Further interview with the DON on 6/17/10 at 3:00 p.m. confirmed the CAH had not implemented any type of pressure ulcer assessment tool to identify high risk pressure ulcer patients upon admission.

The discharge summary dated 3/15/10 for P12 indicated the 95 year old patient had been admitted with acute bowel obstruction which had resolved after several days, however, the patient had then developed a fever and had been found to have had a urinary tract infection.

Nursing documentation dated 3/10/10 at 2:30 p.m. indicated the patient had been admitted for acute bowel obstruction from the adjacent Care Center. The initial 'Nurse Database' findings indicated "Gastrointestinal: abnormals: abdomen distended, abdomen tender to touch, nausea and ostomy present. Interventions included: monitored bowel sounds, monitored bowel pattern, monitored electrolytes, monitored I & O, NG tube to be placed, on low intermittent suction, Positioned for comfort". The only initial assessment documented regarding the patient's genitourinary findings indicated on 3/10/10 at 9:00 p.m. "abnormals: dribbling urine, incontinent of urine." Interventions included: "use of incontinence product". Subsequent entries dated 3/11/10 at 7:10 a.m. and 3/11/10 at 11:00 p.m. indicated "foul odor urine, incontinent of urine" and "Interventions: use of incontinence product". Nursing documentation dated 3/12/10 at 4:39 a.m. revealed "foul odor urine, incontinent of urine, open wounds in peri area (folds very reddened, moist) urine not clear. In addition, the patient's record lacked evidence that a skin inspection (e.g. peri-area) had occurred during the initial nursing database assessment so that a baseline could be established. The facility's system assessment related to the genitourinary included the following areas to assess: urine frequency, control, color, consistency, odor, comfort. During interview with the DON at 3:00 p.m. on 6/17/10, she confirmed the record lacked any evidence that preventive skin measures had been implemented for this incontinent patient other than "incontinence product" and confirmed the CAH had not implemented any further assessments related to urinary incontinence.

The discharge summary for P13 indicated the 57 year old patient had been admitted with "...increased symptoms of leg swelling and increased SOB (shortness of breath)" on 3/30/10. The patient had been placed on a course of Heparin anticoagulation and Coumadinization for left lower leg DVT (deep vein thrombosis) and associated pulmonary embolism. The physician's progress note dated 4/1/10 indicated, "legs show significant decrease of the edema; the left leg is almost the size of the right today".

Initial nursing documentation indicated the patient had been admitted with a DVT of left inner thigh on 3/30/10 at 11:45 a.m. Further nursing documentation revealed on 3/30/10 at 8:31 p.m. "generalized edema (left leg)". No further description and/or assessment of the left leg was evident until 3/31/10 at 8:41 a.m. (12 hours and 10 minutes later), "edema +1, no indent left leg noted DVT" and at 8:48 a.m. "continues to be red and warm and swollen". Nursing documentation dated 3/31/10 at 9:47 p.m. indicated "no redness noted in left leg; swelling is decreased to minimal". The condition of the leg was again noted on 4/1/10 at 10:00 p.m. "left leg slightly swollen, ankles visible; behind left knee appears to be a horizontal skin scrape/bruise; affected leg is slightly warmer than other leg". An initial assessment upon admission related to color, skin temperature, degree of swelling and extent of swelling of the left leg was lacking in description in nursing documentation. Interview with the DON at 3:00 p.m. on 6/17/10, confirmed the record lacked consistent documentation related to the condition of the left leg so that a consistent comparison could be assessed between nursing staff in order to ensure that accurate progress could be determined.

Based on review of surgical privileges and staff interview, the Critical Access Hospital (CAH) failed to assure the current roster listing each practitioner's surgical privileges had been updated and made available in the surgical suite.

Findings include: An updated and current surgical privilege roster was not available to surgical staff in the surgical suite. During a tour of the surgical suite with the OR (operating room) supervisor at 10:00 a.m. on 6/17/10, it was noted the roster delineating each practitioner's surgical privileges was not current. For example, the delineation of privileges for surgeon-A, who performed most of the surgical procedures in the CAH, was dated 12/06. It was confirmed by the OR supervisor the roster in the OR area lacked the most recent delineation of surgical privileges for the providers listed. It was also indicated that some of the practitioners listed in the roster no longer provided services for the CAH.

Review of medical staff credentials provided by the CAH administration revealed surgeon-A had current surgical privileges granted by the governing body on 11/24/08. However, this information had not been provided in written form to be available to the OR staff.

Based on review of surgical patient records and staff interview the Critical Access Hospital
(CAH) failed to ensure that a post anesthesia evaluation was documented in 1 of 1 records (IS1) reviewed in which anesthesia was provided by certified registered nurse anesthetist- B (CRNA), in a sample of 8 surgical patient records.

The findings include: the record for surgical patient IS1 lacked documented evidence of the required post anesthesia evaluation. (The record for IS1 was the only record reviewed in the sample of 8 surgical records in which CRNA-B had administered anesthesia.) Patient IS1, 83 years old, had been admitted for an out patient laparoscopic hernia repair on 1/28/10. The surgical procedure had been converted to an open repair due to extensive adhesions and IS1 remained in the CAH as inpatient status. IS1 had been discharged on 1/31/10. Review of the "Anesthesia Record" authored by CRNA-B revealed the Pre-Anesthesia evaluation had been conducted at 1245 on 1/28/10. The area on the form designated for the Post Anesthesia Comment had been left blank. The record lacked further evidence that a proper post anesthesia evaluation, including documentation of cardiopulmonary status, consciousness level, follow-up care/observations, or any post anesthesia complications had been completed by CRNA-B.

Interview and review of the record for IS1 with Medical Records staff- K on 6/17/10 at 10:45 A.M. confirmed documentation of the required post anesthesia evaluation was lacking.

Review of the current CAH policies related to Anesthesia Standards of Care was conducted. It was revealed the policy had not specifically required the documentation of the post anesthesia evaluation by the provider qualified to administer anesthesia, nor had the policy required the post anesthesia evaluation to include at a minimum, documentation of cardiopulmonary status, level of consciousness, follow-up care/observations, and any complications which may have occurred in the post anesthesia recovery period.

Interview with the Director of Nurses (DON) on 6/17/10 at 3:00 P.M. indicated the routine practice in the CAH had been documentation by the CRNA of a post anesthesia evaluation recorded on the Anesthesia Record. It was confirmed by the DON the current policy lacked description of the required components of the post anesthesia evaluation.