HospitalInspections.org

Based on observation, label review, and interview, the provider failed to supply adequate ventilation in a room (soiled utility room of the operating room [OR] suite) where Cidex OPA was used. Findings include:

1. Observation at 11:10 a.m. on 3/2/10 in the soiled utility room of the OR suite revealed:
*The vent for the room was closed.
*The room was not mechanically ventilated.
*Cidex OPA solution was used in that room.

Label review of Cidex OPA revealed it should have been used in well ventilated areas. Review of a Material Safety Data Sheet revealed "Rooms where CIDEX Solution is used should be large enough to ensure adequate dilution of vapor and should have a minimum air exchange rate of 10 air exchanges per hour."

Interview at 1:00 p.m. with the director of nursing revealed she was not aware the vent in the room was not open. She did not know the air exchange rate of that soiled utility room.

A. Based on review of medical staff and allied health professional's files and interview, the provider failed to maintain current and updated reappointment information for eight of eight credentialing files (1, 2, 3, 4, 5, 6, 7, and 8) reviewed. Findings include:

1. Review of medical staff 1's credentialing file revealed:
*Information in the credentialing file revealed the initial application was dated 6/20/07.
*There was no documentation for a current application, professional and clinical performance review, professional references, professional liability insurance, health status stability, privileges, continuing education, completion of medical records, or the National Practitioner Data Bank (NPDB.)

2. Review of allied health professional 2's credentialing file revealed:
*The initial application was dated by the allied health professional 6/22/07.
*That initial application was approved and dated by the medical staff member on 7/10/07 and the governing body member on 7/17/07.
*Professional references for technical skills, professional judgement, and ethical character were completed in October 2007 after the medical staff member and governing body member had recommended approval.
*No current professional and clinical performance review, professional references, health status, clinical privileges, continuing education, meeting or committee attendance if applicable, completion of medical records, and NPDB or comparable resource.
*A current Re-Appointment Application to Medical Staff dated 2/19/10 and signed by the allied health profession was in the credentialing file. That one page application revealed the following information was required:
-The applicant was requesting active staff privileges as currently on file.
-The amount of continuing education completed since the last credentialing.
-The applicant's licensure information.
-No information for liability insurance.
-Medical information regarding last physical exam and immunization status.
*There was no further information attached or included with the application for the required documentation according the medical staff bylaws.

3. Review of allied health professional 3's credentialing file revealed:
*A Physician Assistant Practice Agreement dated 11/1/07 that listed the services the allied health professional was permitted to perform.
*The signature page for the initial application to medical staff indicated signatures were obtained from a member of the hospital medical staff on 10/9/07 and the hospital board member on 10/16/07.
*There was a handwritten note that stated for appointment recommended "Contingent on receipt of the South Dakota Physician Assistant license."
*No South Dakota Physician Assistant license for 2007 was located in the credentialing file.
*A current Re-Appointment Application to Medical Staff dated 11/9/09 and signed by the allied health profession was in the credentialing file. The application was signed by the chief of medical staff on 12/10/09 and the president of the board of directors on 12/15/09. That one page application revealed the following information was required and documented by the applicant:
-A request for active staff privileges as currently on file.
-The amount of continuing education completed since the last credentialing.
-The licensure information.
-The information for liability insurance and no judgements or settlements in the prior three years.
-The medical information regarding last physical exam and immunization status.
*There was a NPDB inquiry dated 12/8/09, however there was no further information attached or included with the application dated 2/19/10 for the required documentation according the medical staff bylaws.

4. Review of allied health professional 4's credentialing file revealed:
*The initial application was dated by the allied health professional on 3/19/07.
*This initial application was approved and dated by the medical staff member on 3/13/07. That was prior to when the application was submitted by the allied health professional. There was a second signature by a member of the governing body recommended appointment on 3/20/07.
*There was no current license on file.
*There was no current proof of liability insurance.
*No documentation for current professional and clinical performance review, professional references, health status, clinical privileges, continuing education, completion of medical records, and NPDB or comparable resource.

5. Review of allied health professional 5's credentialing file revealed:
*A current Re-Appointment Application to Medical Staff dated 11/14/09 and signed by the allied health profession was in the credentialing file. The application was signed by the chief of medical staff on 12/10/09 and the president of the board of directors on 12/15/09. That one page application revealed the following information was required and documented by the applicant:
-A request for active staff privileges as currently on file.
-The amount of continuing education completed since the last credentialing.
-The licensure information.
-The information for liability insurance and no judgements or settlements in the prior three years.
-The medical information regarding last physical exam and immunization status.
*There was no documentation for current professional and clinical performance review, professional references, health status, clinical privileges, continuing education, completion of medical records, and NPDB or comparable resource.

6. Review of medical staff 6's credentialing file revealed:
*A most recent Re-Appointment Application to Medical Staff was signed by the applicant on 12/19/08.
*There was no recommendation, approval, or signatures from the chief of medical staff or the board of directors.
*There was no documentation for current professional and clinical performance review, professional references, health status, clinical privileges, continuing education, completion of medical records, and NPDB.

7. Review of medical staff 7's credentialing file revealed:
*A current Re-Appointment Application to Medical Staff dated 7/15/09 and signed by the allied health profession was in the credentialing file. The application was signed by the chief of medical staff on 7/16/09 and the president of the board of directors on 8/18/09. That one page application revealed the following information was required and documented by the applicant:
-A request for active staff privileges as currently on file.
-The amount of continuing education completed since the last credentialing.
-The licensure information.
-The information for liability insurance and no judgements or settlements in the prior three years.
-The medical information regarding last physical exam and immunization status.
*No documentation for a current application, professional and clinical performance review, professional references, professional liability insurance, health status stability, privileges, continuing education, or completion of medical records.

8. Review of medical staff 8's credentialing file revealed:
*A current Re-Appointment Application to Medical Staff dated 12/11/07 and signed by the allied health profession was in the credentialing file. That application was signed by the chief of medical staff on 12/11/07 and the president of the board of directors on 1/15/08. That one page application revealed the following information was required and documented by the applicant:
-A request for active staff privileges as currently on file with a list of request privileges attached.
-No information regarding the amount of continuing education completed since the last credentialing.
-The licensure information.
-No information for liability insurance and if any judgements or settlements had occurred in the prior three years.
-The medical information regarding last physical examination and immunization status.
*The last two pages of the privilege list form had signature sheets for the chairman of the medical staff to sign and the chairman and the secretary of the governing board. One sheet had been signed by the chairman of the medical staff on 2/19/09. There was no signatures for the chairman and the secretary of the governing board.
*There was no documentation for a current professional and clinical performance review, professional references, health status stability, continuing education, completion of medical records, or the NPDB.

9. Review of the provider's Credentialing and Discipline policy dated February 15, 1994 revealed each member of the medical staff would be reviewed for reappointment every year. In addition the following factors would be considered with each member seeking reappointment:
*Professional and clinical performance including relevant technical skills and the exercise of professional judgement.
*Professional and clinical performance generated as part of the hospital's quality assurance and utilization review program.
*References from physicians who were knowledgeable with respect to the applicants competence and ethical character.
*Evidence the applicant maintained a current license.
*Status of professional liability and malpractice insurance including limits and deductibles.
*Health status including mental and emotional stability.
*Current privileges and the basis for any requested modification.
*Participation in continuing education programs.
*Attendance at medical staff, committee, department, and service meetings.
*Service on medical staff and hospital committee.
*Timely completion of medical records in compliance with the policies of the hospital, the bylaws, and the rules and regulations of the medical staff.
*Material provided by the NPDB in response to the proper query by an authorized representative of the hospital.
*The appointment and reappointment process with respect to each applicant or member of the medical staff shall be documented, and complete and accurate records shall be maintained.
*Allied health professionals would be reviewed for renewal of his or her privileges on an annual basis according to the same procedure as the medical staff.


Interview and credentialing file review on 3/2/10 at 9:00 a.m. with the administrator and the quality/patient safety coordinator confirmed all of the above credentialing files had not been completed, reviewed, and documented according the medical staff bylaws. Further interview revealed there had not been a consistent individual assigned to complete the credentialing process according to the bylaws.

Review of http://www.e-verifile.com/risk_assessment/medical_credentialing.html revealed "The National Practitioner Databank (NPDB) is primarily an alert or flagging system intended to facilitate a comprehensive review of health care practitioners' professional credentials. The information contained in the NPDB is intended to direct discrete inquiry into, and scrutiny of, specific areas of a practitioner's licensure, professional society memberships, medical malpractice payment history, and a record of clinical privileges. The information obtained in the NPDB should be considered together with other relevant data in evaluating a practitioner's credentials; it is intended to augment, not replace, traditional forms of credentials review."

Review of http://bhpr.hrsa.gov/dqa/ indicated the intent of the NPDB was to keep unprofessional or incompetent practitioners moving from state to state. The NPDB contained information on the following actions against physicians:
*Adverse licensure actions.
*Clinical privileges actions.
*Professional society membership actions.
*Paid medical malpractice judgements and settlements.
*Exclusions from participation in Medicare/Medicaid programs.
*Registration actions taken by the United States Drug Enforcement Administration.



15036

B. Based on interview and record review, the provider failed to ensure physicians' privilege lists were current for 11 of 11 sampled physicians (1, 7, 8, 28, 29, 30, 31, 32, 33, 34, and 35) performing surgery procedures in the operating room (OR). Findings include:

1. Review of the OR credentialing binder revealed the following forms:
*A Delineation of Privileges Desired form. Physicians requested privileges in the areas of medical, anesthesia, surgical, gynecological, obstetrical, pediatric, radiological, orthopedic, and dental.
*An Applicant's Acknowledgment form where the physician signed and dated attesting to his/her knowledge of the application process.
*An approval form for the medical staff to recommend an applicant for appointment and the board of directors to approve that appointment.

2. Review of the privileging forms maintained in the OR credentialing binder revealed the forms were not current, the medical staff and board of directors did not consistently indicate on the forms their recommendation or approval, and the privilege lists did not have the signature or date of the staff member responsible for verifying the applicant's requested privileges. Review of the privileging forms for the following physicians revealed:

a. Physician 1:
-The Delineation of Privileges Desired list did not have the reviewer's name or a date for review on it.
-The Applicant's Acknowledgment form was signed by the physician on 6/20/07.
-The board of directors recommended an appointment on 2/14/08, approximately 7? months after the applicant's acknowledgment.
-The board of directors signed the approval page on 2/19/08. It was unclear if the board of director approved the appointment, that block on the form was completely blacked out.

b. Physician 7:
-The Applicant's Acknowledgment form was signed by the physician on 5/25/07.
-Emergency privileges were granted by the administrator on 5/30/07.
-The medical staff recommended privileges on 6/12/07.
-The board of directors signed the form on 6/19/07.
-The Delineation of Privileges Desired list for gynecological privileges was signed by the reviewer on 6/19/07. Other sections of the list requesting surgical, medical, obstetrical, pediatric, newborn and infant, and orthopedic privileges were not signed or dated by a reviewer.

c. Physician 8:
-The Applicant's Acknowledgment form was signed by the physician on 9/28/87.
-There was no recommendation or approval from from the medical staff or board of director with the file.

d. Physician 28:
-The Delineation of Privileges Desired list did not have the reviewer's name or a date for review on it.
-The Applicant's Acknowledgment form was signed by the physician on 6/16/03.
-The medical staff signed an approval form on 6/16/03 but did not date the signature. The box titled appointment recommended had not been checked.
-The board of directors signed for appointment approval on 6/17/03. The box titled appointed had not been checked.

e. Physician 29:
-The Delineation of Privileges Desired list did not have the reviewer's name or a date for review on it.
-The Applicant's Acknowledgment form was signed by the physician on 9/19/08.
-There was no recommendation or approval form from the medical staff or board of director with the file.

f. Physician 30:
-The Delineation of Privileges Desired list did not have the reviewer's name or a date for review on it.
-The Applicant's Acknowledgment form was signed by the physician on 11/7/03.
-The medical staff recommended the appointment on 1/20/04 and the board of directors approved the appointment on that same day.
-The appointment was approved approximately 55 days after the applicant's acknowledgment form.

g. Physician 31:
-The Delineation of Privileges Desired list did not have the reviewer's name or a date for review on it.
-The Applicant's Acknowledgment form was signed by the physician on 10/3/08.
-There was no recommendation or approval from from the medical staff or board of director with the file.

h. . Physician 32:
-The Delineation of Privileges Desired list did not have the reviewer's name or a date for review on it.
-The Applicant's Acknowledgment form was signed by the physician on 9/17/08.
-There was no recommendation or approval form from the medical staff or board of director with the file.

i. Physician 33:
-The Delineation of Privileges Desired list did not have the reviewer's name or a date for review on it.
-The Applicant's Acknowledgment form was signed by the physician on 11/7/97.
-The medical staff recommended the appointment on 4/20/98, approximately 5 months after the applicant's acknowledgment form.
-The board of directors signed the approval form but that signature was not dated. The board of directors did not place a checkmark in the box titled appointed.

j. Physician 34:
-The Delineation of Privileges Desired list did not have the reviewer's name or a date for review on it.
- There was no Applicant's Acknowledgment form with the file.
-There was no recommendation or approval form from the medical staff or board of director with the file.

k. Physician 35:
-The Delineation of Privileges Desired list did not have the reviewer's name or a date for review on it.
-The Applicant's Acknowledgment form was signed by the physician on 12/22/06.
The medical staff recommended privileges on 2/13/07.
-The board of directors approved the appointment on 2/20/07, approximately two months after the Applicant's Acknowledgment form.

3. Interview on 3/2/10 at 9:45 a.m. with the OR manager revealed she was responsible for ensuring the privilege list binder was updated. The OR manager revealed human resource (HR) was in the process of updating the physicians' credentials. She needed to check with HR for the current credentialing information.

A. Based on record review and interview, the provider failed to ensure the infection control program incorporated a system for monitoring, reporting, and investigating potential communicable diseases for all employees. Findings include:

1. Interview on 3/3/10 at 3:20 p.m. with the infection control coordinator (ICC) revealed:
*She was not aware the infection control program should have included employees at risk for infections and communicable diseases.
*An infection control log was maintained to track and review patients at risk for infections and communicable diseases.
*There was no log or program that tracked employees at risk for infections and communicable diseases after they were hired. If an employee called in sick that was handled by each department head. Any information regarding that illness was placed in the employee's personnel file. The ICC was not informed of an employee illness or received information regarding that employee's illness.
*She would only be involved in an employee illness if that employee approached her.
*Employees were not allowed to work if they were coughing and had a temperature.
*Employees that were out of work for three consecutive days were required to have a physician's medical clearance before returning to duty.
*The provider's infection control program included employee immunization screening and a health evaluation upon hire.

Review of the provider's infection control manual revised December 2009 revealed written permission from the physician was required if an employee was out sick three consecutive days.




25107

B. Based on testing, label review, and interview, the provider was not using an adequate amount of disinfectant to ensure disinfection in areas cleaned by one randomly observed housekeeping cart. Findings include:

1. Interview at 10:50 a.m. on 3/2/10 with the housekeeping supervisor revealed:
*The housekeeping staff were responsible for cleaning all areas of the hospital except some of the operating room.
*The disinfectant used in the facility was Virex water.
*Virex water was used to disinfect all surfaces.
*The solution was to be mixed at one ounce per gallon of water.

Testing of the Virex water at the time of the interview revealed the solution tested 300 parts per million (ppm) quaternary ammonia (quat).

Review of the label for Virex water revealed the solution was to be mixed at one ounce per gallon of water. One ounce per gallon of water would provide a solution of 660 ppm quat disinfectant.

Further interview with the housekeeping supervisor revealed she did not know why the solution was not strong enough. They were mixing the solution according to the directions on the label but they did not test the solution for strength.

C. Based on interview, the provider failed to implement an infection control policy for the proper cleaning of any room used for the isolation of Clostridium difficile (C.diff). Findings include:

1. Interview with a housekeeping staff person at 10:25 a.m. on 3/2/10 revealed:
*The housekeeping staff were responsible for cleaning all isolation rooms.
*The housekeeping staff were not notified by the nursing staff as to what infectious agent the room was isolated for.
*All rooms were disinfected with a quaternary ammonia product.
*She was aware quaternary ammonia products were not acceptable to disinfect against C. diff.
*The facility had not had a case of C. diff in months.

Interview with the nursing staff at 11:00 a.m. confirmed housekeeping staff were not notified of the infectious agent.

Interview with the director of nursing at the 3:00 p.m. exit interview revealed the provider had a system to notify housekeeping of the infections agent. She was not aware if the staff were using the system.

A. Based on record review and interview, the provider failed to document the medical condition for three of three sampled emergency room patients (1, 2, and 3) regarding if they were stable or if their condition had not been stabilized prior to the transfers. Findings include:

1. Review of patients 1, 2, and 3's Release of Responsibility Authorization/Certification for Transfer form revealed the statement that was to be checked to indicate the condition of the patient was not marked. Those statements were:
*The patient had been examined and stabilized such that within reasonable medical probability and based upon information available at the time of examination, no medical deterioration of the patient condition was likely to result from the transfer.
*The patient's condition had not been stabilized.

Further review of patient 3's physician orders indicated the patient was very seriously ill. The emergency room record form indicated patient 3's condition on discharge was very poor.

Interview on 3/2/10 at 10:30 a.m. with the registered nurse confirmed the statements were to be completed by the physician prior to discharge.

Interview on 3/2/10 at 12:05 p.m. with the director of nursing confirmed the above statements regarding patients 1, 2, and 3's medical condition should have been checked by the physician prior to the transfer.



18560

B. Based on medical record review and interview, the provider failed to document the time the consent for treatment forms had been completed for 35 of 35 sampled records reviewed. Findings include:

1. Review of 35 medical records that included swing bed patients, emergency department patients, medical patients, and surgical patients revealed the consent for treatment forms were signed and dated. Further review revealed none of the consent for treatment forms were timed when completed.

Interview on 3/3/10 at 4:15 p.m. with an admission department staff member confirmed they had not documented the time the consent for treatments were signed when patients were admitted.

Based on record review and interview, the provider failed to assess vital signs (VS) for eight of ten sampled emergency room patients (1, 2, 4, 5, 6, 7, 8, and 9) prior to their discharge. Findings include:

1. Review of patient 1's emergency room (ER) record revealed:
*On 2/26/10 at 5:35 a.m. he was admitted to the ER by ambulance following a motor vehicle accident, and he had not been wearing a seatbelt.
*Diagnoses were a left scapular pain and neck pain with a history of diabetes, hypertension, and massive obesity.
*His admission VS and a blood pressure (BP) was obtained at 5:40 a.m. His BP was 230/70 millimeters per mercury (mm/Hg).
*His BP at 7:15 a.m. was 154/90 mm/Hg.
*No other VS were documented.
*He was transferred at 8:12 a.m. to another health care provider.

2. Review of patient 2's ER record revealed:
*On 2/27/10 at 5:43 p.m. the 21 month old child was brought to the ER after she had been attacked by a dog.
*She had dog bites through her upper lip and nose, by the right ear, and on right check located below her eye.
*The physician's documentation revealed the child had extensive lacerations to the upper lip and face.
*VS obtained were at the time of admission.
*No VS were obtained prior to the child's transfer at 6:15 p.m. to another health care provider

3. Review of patient 4's ER record revealed:
*On 1/23/10 at 8:58 p.m. he was admitted to the ER.
*Diagnoses were chest pain and abdominal pain with the cause unknown.
*VS were obtained on admission with a BP of 176/93 mm/Hg and a pulse (P) of 97 beats per minutes (bpm).
*A second set of VS were obtained at 9:10 p.m., and the BP was 188/90 mm/Hg and the P was 94 bpm.
*No other VS were documented.
*The patient was discharged to home at 10:12 p.m.

4. Review of patient 5's ER record revealed:
*On 1/13/10 at 12:44 a.m. he was admitted to the ER.
*The patient had taken 18 to 19 sleeping pills.
*VS were documented at the time of admission and at 5:00 a.m.
*No other VS were documented.
*The patient was discharged to home at 6:30 a.m.

5. Review of patient 6's ER record revealed:
*On 1/13/10 at 7:12 p.m. he was admitted to the ER.
*The patient had been assaulted by five men who had hit him on the head multiple times with beer bottles.
*The patient had two hematomas and abrasions to his forehead, and swelling was present around his right eye.
*VS were documented at the time of admission.
*No other VS were documented.
*The patient was discharged to home at 7:55 p.m.

6. Review of patient 7's ER record revealed:
*On 12/28/09 at 8:11 a.m. he was admitted to the ER.
*The patient had chest pain and felt a flutter like sensation in his chest. Afterwards he felt faint and had been dizzy.
*VS were documented at the time of admission and at 9:00 a.m.
*No other VS were documented.
*The patient was placed on telemetry to monitor his cardiac rhythm.
*The patient was discharged to home at 12:17 p.m. with instructions to wear a Holter monitor to monitor his heart status for the next month.

7. Review of patient 8's ER record revealed:
*On 12/15/09 at 4:16 p.m. the four year old was brought to the ER by ambulance from a house fire.
*Black soot was visible in the child's nose.
*The child had "coarse breath sounds" in the right lung when ausculted with a stethoscope.
*VS were documented at the time of admission.
*A nebulizer inhalation treatment was administered at 4:30 p.m. and completed at 4:40 p.m.
*No other VS were documented in relationship to the nebulizer inhalation treatment or prior to discharge.
*The patient was discharged to home at 5:50 p.m.

8. Review of patient 9's ER record revealed:
*On 12/5/09 at 12:13 p.m. he was admitted to the ER following a motor vehicle accident.
*The patient complained of chest discomfort and revealed he had hit his head on the windshield.
*VS were documented at the time of admission with the BP 146/97 mm/Hg.
*Vital signs were repeated with the BP readings of:
-149/57 mm/Hg at 12:50 p.m.
-152/94 mm/Hg at 1:25 p.m.
-156/94 mm/Hg at 2:35 p.m.
*No other VS were documented prior to discharge at 3:55 p.m.

9. Interview on 3/2/10 at 10:30 a.m. with the registered nurse confirmed:
*No additional VS had been documented in patient 1, 2, 4, 5, 6, 7, and 9's written or electronic medical records (EMR) to re-evaluate elevated BPs or the patients' BP prior to discharge.
*No assessment for patient 8's respiratory status was documented in the written or EMR.
*The reassessment of the VS should have been assessed and documented in the written or EMR.

Interview on 3/2/10 at 12:05 p.m. with the director of nursing revealed:
*She would have expected the VS to have been obtained prior to each of the patient's discharges from the ER or for any abnormal VS obtained.
*She would have expected patient 8's respiratory status to have been assessed after the nebulizer inhalation treatment and prior to the patient's discharge.

Review of the provider's Admission to the Emergency Department Nursing Interventions policy dated December 2004 revealed under the heading Reassessment As Appropriate for Nature & Severity of Condition to:
*Recheck abnormal VS.
*Evaluate for response to treatments/medications and interventions for pain control.

Further review of the policy indicated to check the patient's VS at discharge if length of stay was longer then four hours.

Review of Patricia A. Potter and Ann Griffin Perry, Fundamentals of Nursing, 6th edition, Mosby, St. Louis, Mo, 2005, revealed:
*Page (p) 261:
-Nurses were responsible for making accurate and appropriate clinical decisions.
-The nurse would take immediate action when a client's clinical condition deteriorated, and who decided if a client was experiencing complications that warranted notification of the physician.
*P. 279:
-"The nurse follows the nursing process to organize and deliver nursing care. Use of the process allows the nurse to integrate elements of critical thinking to make judgements and take actions based on reason. The nursing process is used to identify, diagnose, and treat human response to health and illness. The process includes five steps: assessment, nursing diagnosis, planning, implementation, and evaluation."
*P. 293:
-Data documentation was the last part of a complete assessment. A thorough, concise, and accurate documentation of facts was necessary when recording patient data. Observation and recording of patient status was a legal and professional responsibility. The nurse practice acts in all states and the American Nurses Association Policy Statement (2003) and Standards of Clinical Nursing Practice (1998) mandate accurate data collection and recording as independent functions essential to the role of the professional nurse.

A. Based on interview, record review, and policy review, the provider failed to ensure: *Laryngoscopes used by anesthesia staff during patient intubations received high-level disinfection for one of one sampled patient (44).
*Anesthesia policy for disinfection of reusable items reflected the provider's current policy for high-level disinfection for one of one operating room (OR).
Findings include:

1. Observation on 3/2/10 at 10:00 a.m. revealed at the end of the case the anesthesia provider wiped down his anesthesia machine and accessory equipment with a CaviWipe XL towelette.

Interview on 3/3/10 at 10:50 a.m. with the primary certified registered nurse anesthetist (CRNA 5) for the provider revealed laryngoscopes (blade and handles) were not high-level disinfected between each patient use. A CaviWipe was used to disinfect laryngoscopes between each patient use. That had been a long standing practice for him at that facility. CRNA 5 revealed Cidex could have been used to provide high-level disinfection for laryngoscopes. He revealed that might be the best practice, and would develop a policy for disinfecting laryngoscopes using Cidex.

Review of the provider's OR register from 1/5/10 through 3/2/10 revealed 24 surgical procedures had been performed that required administration of general anesthesia, patient intubation, and the use of a laryngoscope.

Review of the provider's Infection Control - Anesthesia policy revised 12/19/08 revealed:
*"Laryngoscope blades will be wiped with an approved germicide at the beginning of the day."
*"Reusable items (face masks, nasal airways) will be cleaned after use and soaked in Cidex for 10 minutes. The disinfected equipment will be thoroughly rinsed and dried prior to reuse."
*"Reusable items will be sterilized using the appropriate methods prior to reuse."

Review of the provider's Policy on the use of Cidex OPA revised 12/19/08 revealed high-level disinfection of instruments required a 12 minute soak in the Cidex OPA solution.

Review of the manufacturer's product information on the CaviWipe XL container revealed:
*"This product is not to be used as a terminal sterilant/high level disinfectant on any surface or instrument that (1) is introduced directly into the human body, either into or in contact with the blood stream or normally sterile areas of the body, or (2) contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body."
*"This product may be used to preclean or decontaminate critical or semi-critical medical devices prior to sterilization/high level disinfection."
*"Harmful if absorbed through the skin."

Review of the Association of periOperative Registered Nurses, 2009 Standards and Recommended Practices, Denver, Co., p. 580, revealed:
*The Spaulding Classification System listed laryngoscope handles and blades as semi-critical instruments that required high-level disinfection.
*Instruments were classified as semi-critical that came in contact with mucous membranes or non-intact skin.
*High-level disinfection could be used when sterilization of semi-critical instruments was not possible.
*High-level disinfection killed all microorganisms but not necessarily a large number of bacterial spores.

B. Based on observation, interview, and record review, the provider failed to ensure soda lime cannisters were not used beyond the manufacturer's expiration date for one of one anesthesia machine. Findings include:

1. Observation on 3/1/10 at 2:50 p.m. in the OR revealed the soda lime canister on the anesthesia machine had expired August 2009. Review of the three spare soda lime canisters revealed they had expired August 2009.

Interview on 3/1/10 at 2:50 p.m. with the OR manager revealed she was not aware soda lime canisters had expiration dates. The OR manager revealed the last procedure done with general anesthesia had been performed on 2/25/10.

Interview on 3/2/10 at 10:05 a.m. with CRNA 5 revealed he was not aware soda lime canisters had expiration dates. He had checked other facilities he practiced at and found canisters that were also expired. Further interview with CRNA 5 revealed no harm would come to the patient with an expired soda lime canister.

Review of the Anesthesia Safety Requirements policy dated December 2009 revealed daily check of the quality of the soda lime was performed and changed if needed. There was no indication the expiration date on the canister should have been checked.

Review of Michael P. Dosch, The Anesthesia Gas Machine, revised June 2009, www.udmercy.edu/crna/agm/07.htm revealed the function for soda lime was to "make rebreathing possible, thus conserving gases and volatile agents, decreasing OR pollution, and avoiding hazards of carbon dioxide rebreathing" during surgical procedures.

C. Based on interview, record review, and policy review, the provider failed to ensure:
*After high-level disinfection endoscopes were not recontaminated by the use of contaminated plastic containers for the final rinse prior to the patient's colonoscopy procedure in one of one scope room.
*Enzymatic detergent used to preclean endoscopes prior to high-level disinfection was not beyond the manufacturer's expiration date for one of two patient care areas (scope room).
*Alcohol used during the terminal disinfection process for endoscopes was not beyond the manufacturer's expiration date for one of two patient care areas (scope room).
Findings include:

1. Observation on 3/1/10 at 3:45 p.m. in the scope room revealed a container of Cidex solution.

Interview on 3/1/10 at 3:45 p.m. with staff members 24 and 27 revealed there were no colonoscopies scheduled for 3/1/10 and 3/2/10. The surveyor requested staff members 24 and 27 describe the process used for disinfecting scopes used for colonoscopy procedures. Staff members 24 and 27 revealed:
*The endoscopes were cleaned with an enzymatic detergent, rinsed, and then placed in Cidex for high-level disinfection.
*The endoscope would then be removed from the Cidex and placed in a plastic container for final rinsing prior to the colonoscopy procedure.
*That plastic container used during the final rinse was cleansed with an enzymatic detergent. The plastic container was not sterilized or high-level disinfected prior to use. At the time of the interview one of the two plastic containers used during the process was being stored on the soiled utility room floor adjacent to the scope room.
*Staff members 24 and 27 agreed the high-level disinfected endoscopes were being placed in contaminated containers during the final rinse that occurred prior to patient use.
*That was how the scopes had been disinfected for at least a year or more.

Review of the provider's Policy on use of Cidex OPA revised 12/19/08 and reviewed December 2009 revealed:
*The Cidex OPA solution came premixed.
*The scope was cleaned with an enzymatic cleaner, rinsed with tap water, and dried before placing in the Cidex solution.
*The scope was soaked for 12 minutes, rinsed three times, and flushed with 30 milliliters of alcohol.

Review of the manufacturer's date on two of the opened containers of enzymatic detergent and two unopened gallon containers revealed the product had expired March 2007. The enzymatic detergent was used to preclean surgical instruments and endoscopes prior to high-level disinfection.

Review of the manufacturer's expiration date on the bottle of alcohol used to flush the endoscopes revealed the product expired October 2007. The alcohol was used at the end of the day to assist with internal drying of the endoscopes prior to storage.

Interview on 3/2/10 at 3:45 p.m. with staff members 24 and 27 revealed the enzymatic detergent and alcohol were expired. Continued interview revealed supplies were checked monthly for outdates. The staff members stated the placement of the expiration date on the enzymatic detergent made it difficult to read. The expiration date could not be clearly seen until at least ? of the contents had been used.

D. Based on interview, record review, and policy review, the provider failed to ensure:
*Cidex OPA (high-level disinfectant) activation was documented according to the provider's policy for two of two patient care area (OR and the scope room).
*Cidex OPA was tested for proper concentration level between each patient use for two of two patient care areas (OR and the scope room).
*Cidex test strips used to test proper concentration levels were not beyond the manufacturer's expiration date for one of two patient care areas (OR and the scope room).
Findings include:

1. Observation on 3/1/10 at 3:20 p.m. in the OR soiled utility room revealed a tub containing a greenish colored solution. There was no label on that tub identifying the solution, date when that solution had been mixed, or name of the staff member who had mixed that solution. Interview at that time with the OR manager revealed the liquid was activated Cidex OPA. Cidex OPA was a high-level disinfectant utilized to disinfect scopes used during colonoscopy procedures. She was not sure when the Cidex OPA solution had been activated or the staff member responsible. The last documented activation date on the log sheet for Cidex OPA was 12/16/09. Once activated Cidex was only good for 14 days.

Interview on 3/1/10 at 3:20 p.m. with the OR manager confirmed:
*Each time staff activated Cidex that information should have been documented on the log sheet.
*She was not aware Cidex should have been tested prior to each patient use.
*She was not sure when the last time the Cidex solution had been used for high-level disinfection.

Review of the OR register revealed on 12/16/10 two colonoscopy procedures had been performed. Review of the Cidex log sheet revealed on 12/16/09 the solution had been activated, tested, and had been found safe to use. Review of the log sheet revealed testing the concentration of the Cidex solution had not occurred when the endoscope had been high-level disinfected for the second patient's colonoscopy procedure. Review of the Cidex log sheet from December 2009 through 3/1/10 revealed temperature monitoring did not occur on any date the Cidex solution concentration had been monitored.

Review of the provider's Policy on use of Cidex OPA reviewed December 2009 revealed the solution was used for 14 days and discarded. The date and expiration date should have been written on the top of the Cidex container. The policy did not indicate the concentration and temperature of the Cidex should have been monitored prior to each patient use.

Review of the manufacturer's instructions revealed once activated Cidex OPA was reused for a maximum of 14 days provided the required concentration and temperature (77 degrees Fahrenheit) existed based upon monitoring parameters. Continued review revealed the Cidex OPA solution should have been tested prior to each use to determine the concentration was above the minimum effective concentration as determined by the test strips.

2. Review of the manufacturer's expiration date on the bottle for the Cidex test strips maintained in the OR soiled utility room revealed the strips had expired February 2010. Review of the manufacturer's information on the test strip bottle revealed once the bottle had been opened the date of opening and a new expiration date should have been documented on the side of the bottle. Review of the manufacturer's storage instructions for the test strips revealed "Do not use after 90 days of opening the bottle." There was no date of opening or a new expiration date documented in the space provided on that bottle of test strips.

Interview on 3/1/10 at 3:20 p.m. with the OR manager revealed she was not aware a new expiration date should have been established once the Cidex test strips were opened.

E. Based on interview and record review, the provider failed to develop and implement policies and procedures for outpatient discharge criteria for four of four sampled surgical outpatients (26, 27, 28, and 29). Findings include:

1. Review of the following patients' medical records revealed colonoscopy procedures were performed on the dates listed. The patients were discharged home later on that same day:
*Patient 26 - admitted on 2/16/10.
*Patient 27 - admitted on 2/16/10.
*Patient 28 - admitted on 12/10/09.
*Patient 29 - admitted on 9/1/09.

Review of the physician's Standing Order Colonoscopy/Gastroscopy form revealed there was no order for patient discharge, standing order for discharge, or what criteria should have been met before the patient was discharged home. The standing order provided information on the type of consent that should have been signed, intravenous fluids, vital signs, diet, medications, and enemas that were administered.

Review of patients 26, 27, 28, and 29's outpatient medical records revealed there were no physicians' orders for discharges.

Review of the provider's policies and procedures revealed there were no policies or protocol guidelines for the staff to determine when a patient was stable for discharge.

Interview on 3/5/10 at 3:00 p.m. with the director of nursing (DON) confirmed patients 26, 27, 28, and 29 did not have orders to discharge them from the facility. The DON revealed the Standing Order Colonoscopy/Gastroscopy orders did not include a discharge order or criteria that should have been met prior to discharging the patient. Continued interview with the DON revealed the provider did not have a policy, protocol, or procedure criteria for patients that came in for outpatient procedures.

F. Based on interview and record review, the provider failed to ensure physicians' privilege lists were current for 11 of 11 sampled physicians (1, 7, 8, 28, 29, 30, 31, 32, 33, 34, and 35) performing surgery procedures in the OR. Findings include:

1. Review of the privileging forms maintained in the OR credentialing binder revealed the forms were not current, the medical staff and board of directors had not consistently indicated on the forms their recommendation or approval, and the privilege lists did not have the signature or date of the staff member responsible for verifying the applicant's requested privileges.

Refer to C240, findings A and B.

G. Based on observation and interview, the provider failed to ensure the physical environment was maintained in a clean and sanitary manner for three of three patient care areas (operating room, post-anesthesia recovery, and the procedure room). Findings include:

1. Random observation between 3/1/10 and 3/3/10 of the following patient care areas revealed:
*Operating room:
-The interior door to the OR was severely gouged in two areas. Approximately four inches of wood had been gouged creating an uncleanable surface.
-Several dead bugs were observed in four of six ceiling lights.
-Four bags of sterile water used for irrigation during surgical procedures were stored on a shelf in the soiled utility room.
-The varnish was missing exposing the wood on the edges of two wooden standing platforms used by the staff during surgical procedures creating uncleanable surfaces.
-The paint on wooden crates used to store surgical gases had several medium size gouges exposing the wood. Those wooden crates were stored next to the hopper in the soiled utility room exposing the gas tanks to potential contamination from the hopper water spray.
*Post-anesthesia recovery (PAR) area:
-The interior wood door to PAR was severely gouged on the edges creating uncleanable surfaces.
-The paint on the radiator was severely chipped in numerous areas.
-One side of the base on an obstetric supply cabinet had the varnish and wood severely gouged.
-A cardboard box setting on the floor was used to store sheets, gowns, and pillow cases for patient use.
*Procedure room: Stored on the soiled utility room floor were two plastic bins used during the process of instrument disinfection and one cardboard box of sterile water used for irrigation during surgical procedures.

H. Based on observation and interview, the provider failed to ensure outside shipping containers were not used to store medical supplies in one of two central store rooms (CSR). Findings include:

1. Observation on 3/2/10 at 8:30 a.m. in the CSR revealed several cardboard boxes of medical supplies stored in the respiratory therapy equipment room and the supply room for OR supplies. Review of those cardboard boxes revealed they were the original outside shipping containers and contained medical supplies. Continued review in the operating room storage room revealed other medical supplies that would have been taken into the operating room were commingled with those outside shipping container boxes.

Review of the Association of periOperative Registered Nurses, 2009 Standards and Recommended Practices, Denver, CO., p. 329 revealed "Supplies and equipment should be removed from external shipping containers and web-edged or corrugated cardboard boxes in the unrestricted area before transfer into the surgical suite. External shipping containers and web-edged cardboard boxes may collect dust, debris, and insects during shipment and may carry contaminants into the surgical suite."

Interview on 3/2/10 at 8:30 a.m. with a staff member working in CSR revealed she was not aware outside shipping containers should not have been stored with operating room supplies.

Interview on 3/3/10 at 2:15 p.m. with the director of nursing revealed outside shipping containers should not have been used to stored medical supplies in CSR.