HospitalInspections.org

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 4 of 7 surgical patients (S1, S2, S3 and S4) in the sample who utilized an alcohol based prep for surgery.

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, preferably as part of a systemic approach by the CAH to preventing surgery related fires.

S1 was observed at 9:09 a.m. on 8/24/10 while in the operating room for a surgical procedure. At 9:13 and 47 seconds a.m., the operating room surgical technician (ST)-A started cleaning the surgical area (left breast, neck, and axilla area) with ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol). ST-A cleansed the area until 9:14 and 54 seconds a.m., and there was no pooling of the ChloraPrep observed. At 9:15 and 20 seconds a.m., it was noted that ST-A, and the surgeon started draping the patient. At that point they had waited only 26 seconds for the alcohol based skin cleanser to dry.

Review of the ChloraPrep manufacturer's instructions for use noted the following: "To Reduced Risk of Fire, PREP CAREFULLY: do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)...drying time for dry surgical sites (such as abdomen or arm) is approximately three (3) minutes."

Review of the CAH's nursing services procedure titled, "Draping Procedure General," dated as revised 8/17/10, identified the following: "1. Begin draping only after alcohol-based prep is confirmed dry, and no pooling has occurred, by two OR (Operating Room) team members. This must be documented on the OR nursing record."

The Surgical Nurse Manager was interviewed at 9:30 a.m. on 8/24/10, and she stated the surgical team should wait at least 3 minutes for the alcohol based skin prep to dry prior to draping the patient in surgery. She confirmed that ST-A and the surgeon had not waited 3 minutes for the alcohol based skin prep to dry prior to draping S1 for surgery.

Review of closed surgical patient records for S2, S3 and S4, revealed the following:

S2 had surgery (cesarean section with elective tubal ligation) on 8/17/10 at 5:28 a.m. DuraPrep had been used as the skin prep. The nursing OR record did not identify that the DuraPrep was dry with no pooling prior to having draped the patient.

S3 had surgery (right total knee arthroplasty) on 7/12/10 at 7:54 a.m. DuraPrep had been used as the skin prep. The nursing OR record did not identify that the DuraPrep was dry with no pooling prior to draping the patient.

S4 had surgery (laparoscopic cholecystectomy) on 7/31/10 at 8:15 a.m. DuraPrep had been used as the skin prep. The nursing OR record did not identify that the DuraPrep was dry with no pooling prior to draping the patient.

The Surgical Nurse Manager was interviewed at 9:30 a.m. on 8/24/10, she stated that the surgical team should wait at least 3 minutes for the alcohol based skin prep to dry prior to draping the patient in surgery. She confirmed this practice should be documented on the Nursing OR Record. The Surgery Nurse Manager was again interviewed at 10:55 a.m. on 8/25/10, during which she confirmed that the Nursing OR Records had not identified that the alcohol based skin prep had been dry with no pooling for the closed record reviews of surgical patients S2, S3 and S4.

Based on record review and staff interview, the Critical Access Hospital (CAH) failed to ensure that each medical entry was properly authenticated with a timed and dated signature for 6 of 8 emergency records reviewed (E1, E3, E4, E5, E6 and E7); 11 of 14 inpatient records reviewed (P1, P2, P3, P4, P5, P8, P9, P10, P11, P12 and P13); and 5 of 8 surgical records reviewed (S1, S2, S3, S7 and S8 ).

Findings include: Authentication of records by physicians lacked dated and timed signatures for 11 of 14 (P1, P2, P3, P4, P5, P8, P9, P10, P11, P12, and P13) inpatient records reviewed. Examples included: Dated and timed physician signatures were lacking on Discharge Summaries, Progress Notes, Standing Orders and/or History and Physical examinations in records P1, P2, P3, P4, P5, P8, P9, P10, P11, P12 and P13.

Five of eight surgical records (S1, S2, S3, S7 and S8 ) reviewed lacked proper authentication of entries by the physician and/or surgeon. Entries lacking proper authentication included: pre and post operative orders, and standing surgical physician orders. For example, records S7 (with cholecystectomy performed 8/19/10) and S8 (with appendectomy performed on 8/1/10) lacked timed and dated physician signatures on the medication standing orders and on the pre and post operative general surgery orders.

Physician authentication of Emergency Room records lacked dated and timed signatures on records for patients E1, seen in the emergency department (ED) 8/22/10; E3, seen in ED on 8/11/10; E4, seen in the ED on 8/7/10; E5, seen in the ED on 8/3/10; E6 seen in ED on 8/1/10; and for E7 seen in ED on 6/15/10. Emergency room documents lacking proper authentication included physician handwritten notes and medication orders, patient transfer forms, and dictated emergency room notes.

Interviews were conducted with the Administrator and Chief Nursing Officer at 11:30 a.m. on 8/26/10. They verified that entries in the medical records reviewed lacked consistent authentication of the time and/or date the entries had been made by the author. It was further indicated that although this had been addressed by the CAH's PI (performance improvement) program, it remained an ongoing problem.

Based on interview and record review, the Critical Access Hospital (CAH) failed to ensure that a qualified practitioner evaluated risks of pre and post anesthesia for 3 of 6 surgical patients (S3, S5, and S6) reviewed who had received anesthesia services. Findings include:

S3 had surgery (right total knee arthroplasty) at 7:54 a.m. on 7/12/10. The "PRE ANESTHESIA EVALUATION" had not been completed. The following areas were left blank: Family History of Anesthesia Complications; Allergies, Hepato/Gastrointestinal, Renal/Endocrine. Additionally, the "POST ANESTHESIA NOTE" was not legible and did not address the patient's cardiopulmonary status; level of consciousness; or any follow-up care and/or observations.

S5 had surgery (left eye cataract removal) at 10:31 a.m. on 6/17/10. The "PRE ANESTHESIA EVALUATION" had not been completed. The following areas were left blank: Family History of Anesthesia Complications; Allergies, Respiratory, and Problem List/ Diagnoses. Additionally, the "POST ANESTHESIA NOTE" was not legible and did not address the patient's cardiopulmonary status; level of consciousness; or any follow-up care and/or observations.

S6 had surgery (right testicle hydrocele repair) at 8:57 a.m. on 8/11/10. The "PRE ANESTHESIA EVALUATION" had not been completed. The following areas were left blank: Allergies and Problem List/ Diagnoses. Additionally, the "POST ANESTHESIA NOTE" was not legible and did not address the patient's cardiopulmonary status; level of consciousness; or any follow-up care and/or observations.

The Director of Nursing Services was interviewed at 11:20 a.m. on 8/25/10. She confirmed during interview that the "PRE ANESTHESIA EVALUATIONs" were not fully completed, and the "POST ANESTHESIA NOTEs" were not legible and failed to address the patients' cardiopulmonary status; level of consciousness; or any follow-up care and/or observations for S3, S5 and S6.

Based on review of quality assurance information and staff interview, the CAH (Critical Access Hospital) failed to evaluate all hospital services including anesthesia, organ/tissue donation, and physical environment as part of the overall quality improvement program.

The findings include: the CAH did not evaluate all patient care services as part of the overall quality improvement (QI) program.

During review of the QI information it was noted the services of anesthesia and physical environment had not reported quality data to the QI Committee during the past year nor did the QI minutes reflect evaluation of those services. It was also noted that organ/tissue donation services had not been incorporated into the overall QI plan for 2010.

Interview was conducted with the Quality Coordinator at 9:30 a.m. on 8/26/10. The Quality Coordinator confirmed the services provided by anesthesia and physical environment had not been formally evaluated by the CAH's QI process as there had been no reporting of quality data from those areas during the past year. It was also confirmed that organ/tissue donation services had not been incorporated into the 2010 QI plan to be evaluated as part of the CAH's QI process.