HospitalInspections.org

Based on observation, interview, and record review, the governing body failed to effectively govern the conduct of the hospital's infection control program, quality assurance program, and outpatient services. Findings include:

1. Review of the quality assurance program revealed a lack of proper oversight, implementation, and integration of urology clinic services. Refer to A263, findings 1-3 and A285, finding 1.

2. Review of the infection control program revealed a lack of proper oversight, implementation, and integration of:
*Disinfection of instruments in the urology clinic. Refer to A747, findings 1-5.
*Infection control procedures in the urology clinic, surgical areas, catheterization laboratory, gastrointestinal laboratory, and pediatrics floor. Refer to A749 findings 1-10.

3. Review of the outpatient services program revealed a lack of proper oversight, implementation, and integration of the services provided by the urology clinic. Refer to A1076, findings A.1-3 and B.1.

Based on interview and admission packet review, the provider failed to inform behavioral health unit (Worthmore Addiction Services) outpatients how to contact the state agency to file a grievance for one of one outpatient (54) reviewed. Findings include:

1. Review of outpatient 54's medical record revealed no documentation he had received information on how to file a grievance with the state agency.

Review of the Worthmore Addiction Services admission packet patient rights information revealed patients had the right to voice grievances in relation to policies and services offered by the facility. Oral and written complaints could be registered at the unit's office between 8:00 a.m. and 4:30 p.m. Monday through Friday. There was no information on how to contact the state agency to file a grievance.

Interview on 2/14/12 at 2:00 p.m. with the behavioral health unit manager confirmed outpatients of Worthmore Addiction Services had not received the above required information.

Based on observation, policy review, and interview, the provider failed to store medical records in two of twelve reviewed outpatient clinic areas (orthopedic and neurology) in a way that ensured confidentiality. Findings include:

1. Observation on 2/15/12 at 10:45 a.m. of a storage room in the outpatient orthopedic clinic revealed:
*The storage room held exposed x-ray films.
*The room was located off a short hallway connecting the inside corridor and an outside door.
*The location of the room and a closed door from the inside corridor prevented clinic personnel from observing the room.
*The door to the room was not locked and did not have a locking device.
*A person would have been able to exit the building by using the outside door without returning to the inside corridor of the clinic.

Interview on 2/15/12 at 4:55 p.m. with health information manager (HIM) H revealed the door to the room should have been locked when not attended.



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2. Observation on 2/15/12 at 2:35 p.m. in the neurology clinic revealed:
*The clinic's reception office was also where patient medical records were stored.
*Storage cabinets were used to store most of the records in folders.
*Not all of the cabinets had locks.
*There were numerous patient documents/forms not in folders placed on tables, counters, and desks.
*The entry to the reception area had a sliding wooden door with no lock.

Interview during the above observation with patient services representative B and registered nurse C revealed:
*Not all file cabinets had locks.
*The file cabinets that had locks were not locked after clinic hours.
*There was only a sliding, unlockable, wooden door to the reception/file area.
*The cleaning crew came after the clinic had closed for the day.
*The cleaning crew would have had access to all patient medical and personal information found in the files and on the counters.

Interview on 2/16/12 at 8:40 a.m. with environmental supervisor D revealed no business associates agreement for the Health Insurance Portability and Acountability Act (HIPAA) had been signed with the contracted cleaning service. The contracted cleaning service employees were not employed by the hospital.

Interview on 2/16/12 at 11:20 a.m. with the director of Quality/Patient Services and HIM H revealed an Outside Vendor/Contractor Agreement Form covered patient confidentiality. There had been no agreement form signed by the contracted cleaning service.

Review of the provider's Outside Vendor/Contractor Safety Policy & Procedure Notification revised November 2007 revealed:
*Section 10 was noted as patient confidentiality.
*"All Outside Vendor/Contractors under contract with ... have a responsibility to respect and protect the patient's right to privacy. Patient confidentiality is a conscious effort by every worker to keep private any information relating to a patient's presence in the healthcare center. If you see patients or overhear confidential information, do not share or report this information to others."
*An agreement form was included in the above policy. It stated "By signing below the official representative of the company named below verifies that he/she has received the ... Outside Vendor/Contractor Safety Policy & Procedure Notification. The undersigned also verifies that he/she has read and understands the content of this document and will ensure that his/her company, its employees, and any/all subcontractors hired by the general contractor will comply with all provisions contained herein."

Review of the provider's policy #K-19 revised March 2003 for Safeguarding Protected Health Information (HIPAA) stated "... shall have in place appropriate administrative, technical and physical safeguards to protect the privacy of protected health information (PHI) from any intentional or unintentional use or disclosure that is in violation of the privacy standards, and make a reasonable attempt to safeguard against incidental uses or disclosures associated with any other permitted or required use for disclosure. There shall be a functioning mechanism designed to safeguard PHI against loss, destruction, tampering and unauthorized access or use."

Based on record review, interview, and policy review, the provider failed to properly document ongoing restraint assessments that ensured the least restrictive restraint measures were being used for one of one sampled surgical patient (34) in restraints. Findings include:

1. Nursing restraint documentation review and interview on 2/15/12 at 2:15 p.m. with the surgical floor nurse manager regarding the use of restraints on patient 34 revealed:
*The patient had brain surgery on 2/6/12.
*Soft wrist restraints had been applied and removed on several occasions from 2/7/12 through 2/12/12 to prevent interference with medical care.
*She confirmed the nursing staff had not documented the every two hour restraint assessment required by the provider's restraint and seclusion policy on 2/9/12 at 8:00 a.m., 4:00 p.m., and 6:00 p.m. She further stated due to the lack of the above assessments she was unable to show this surveyor the least restrictive restraint measures were taken for the patient at those times.
*She confirmed the patient's physician had also not written an order for the restraints used on 2/9/12. Refer to A168, finding 1.

Review of the provider's revised August 2010 restraint and seclusion policy revealed:
*Nursing personnel were to monitor patients in restraints at least every two hours and document the results of those assessments. The every two hour assessment documentation was to contain:
"-Patient observed and Centers for Medicare and Medicaid Services of restrained limbs is checked.
-Toileting offered.
-Fluids and nutrition offered.
-Restraints released, extremities massaged, range of motion, position change.
-Document behavior."
*Restraints were to have been removed at the earliest opportunity.
*"A reassessment of the patients behavior and need for the continuation of restraint will be documented by the Registered Nurse at least every four hours."

Based on record review, interview, and policy review, the provider failed to ensure three of three restrained patients (17, 34, and 42) had physician orders for the restraints. Findings include:

1. Physician order review and interview on 2/15/12 at 2:15 p.m. with the surgical floor nurse manager regarding the use of restraints on patient 34 revealed:
*The patient had brain surgery on 2/6/12.
*Soft wrist restraints had been applied and removed on several occasions from 2/7/12 through 2/12/12 to prevent interference with medical care.
*She confirmed no physician orders for the soft wrist restraints used on the patient on 2/8/12 and 2/9/12 existed.
*She confirmed proper nursing documentation of restraint use had not occurred on 2/9/12. Refer to A165, finding 1.
*She confirmed nursing staff should have verified daily the patient had orders for the restraints.
*She confirmed the physician should have written daily restraint orders for the patient when restraints were used.

Review of the provider's revised August 2010 restraint and seclusion policy revealed:
*A physician's order should have been obtained to restrain a patient.
*Patients should not have been restrained without a physician's order unless the patient's life was endangered. In the case when a patient's life was endangered the restraint could have been applied by the nurse without a physician's order. However a telephone order for the restraint would have been obtained as soon as possible following the application. The telephone order would have been required to be signed within twenty-four hours by the ordering physician.



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2. Review of patient 17's medical record revealed he was admitted to the behavioral health unit (BHU) on 2/10/12 for aggressive behaviors.

Further review of patient 17's medical record revealed:
*On 2/11/12 he was in seclusion from 8:00 a.m. to 12:00 p.m.
*Mental health unit assessment completed on 2/11/12 at 1:30 p.m. revealed he was returned to seclusion at that time.
*The restraint and seclusion documentation flowsheet was reinitiated at 1:30 p.m.
*Fifteen minute checks were initiated at 1:30 p.m.
*Physician's order for seclusion stated start date 2/11/12 and start time 2:01 p.m.

Further review of patient 17's medical record revealed:
*Physician's order for chair table/tray restraint stated start date 2/12/12, start time 12:00, stop date 2/13/12, and stop time 12:00. Additional comment noted "or side rails."
*Physician's order for chair table/tray restraint stated start date 2/13/12, start time 12:00, stop date 2/14/12, and stop time 12:00. No additional comment was noted.
*Nursing documentation dated 2/13/12 at 11:59 p.m., 2/14/12 at 2:00 a.m., 2/14/12 at 4:00 a.m., and 2/14/12 at 6:00 a.m. revealed four side rails were up on patient 17's bed.

3. Review of patient 42's medical record revealed:
*Physician's orders daily for chair table/tray restraint from 1/4/12 through 1/12/12.
*Nursing documentation from 1/4/12 through 1/12/12 revealed four side rails were up on patient 42's bed.

4. Interview on 2/14/12 at 10:40 a.m. with the BHU manager confirmed:
*Four side rails on a patient's bed was a restraint.
*Physician's orders should have addressed the use of full side rails.

5. Review of the provider's Restraint and Seclusion policy revised August 2010 revealed:
*Order for restraints must be obtained from a licensed independent practitioner.
*A physician's order should have been obtained prior to the application of restraints.

Based on record review, interview, and policy review, the provider failed to ensure an effective, ongoing, data driven, hospital-wide quality assessment and performance improvement (QAPI) program was implemented and maintained. Findings include:

1. Interview on 2/15/12 at 3:30 p.m. with the vice president of clinics, clinic director, clinic manager, quality assurance director, and director of infection control at the urology clinic confirmed:
*They had not identified high-level disinfection as a high-risk problem prone area for the urology clinic.
*The staff process for high-level disinfection of urology instruments was not in accordance with the disinfectant manufacturer's recommendations.
*The high-level disinfection practices in the urology clinic had not conformed to the hospital's policy or standards of practice.
*The clinic director had participated in development of the high-level disinfection policy, had not ensured that policy was implemented accordingly in the urology clinic, and had not conducted assessments of the staff use of high-level disinfectants.
*The infection control director revealed clinic rounding had not been conducted at the urology clinic but they were in the process of getting that implemented.

Interview on 2/16/12 at 3:05 p.m. with the quality assurance director confirmed she had not received any QAPI reporting from the urology clinic since 2009, which was prior to the clinic becoming provider based.

Refer A747, finding 1.

2. Numerous areas for breaches in infection control were identified throughout the survey process. Certified infection control (CIC) specialist S revealed bi-annual safety rounding was completed by committee members or designated staff. Staff conducting the roundings were guided by a checklist, but there were no documented observations of staff performing patient cares.

Refer to A701, findings A1 and B1; A724, findings 1-6; and A747, findings 1-5.

3. Review of the provider's May 2011 policy Performance Improvement Plan Fiscal Year 2012 revealed:
*Department managers' responsibility included collecting and reporting data on departmental quality indicators and communicate quality activities to the staff and to the performance improvement (PI) council.
*The PI specialist's responsibility included but not limited to: coordinating hospital PI activities, provide staff training on quality tools and principles, and assist department managers in identifying quality monitors.
*The PI council was responsible for the general oversight of the organization's departmental and interdepartmental performance monitoring and improvement activities.
*The quality of care committee's (QOC) responsibilities included but not limited to providing structure for accountability, developing goals and objectives of the organization, and recommending action when prioritized improvement projects were not achieved or sustained.
*The QOC was responsible for reviewing reports from infection/transfusion committee, operative/invasive review committee, cancer committee, critical care committee, medical, surgical and pediatric/obstetric-family medical sections.

Based on observation, interview, and policy review, the provider failed to identify the high- risk and problem prone areas of one of one provider based urology clinics. Findings include:

Review on 2/15/12 and 2/16/12 of the high-level disinfection processes of the urology clinic revealed the clinic was not processing any instruments, equipment, or devices in a hygenic and safe manner. Refer to A747, findings 1-5.

Interview on 2/15/12 at 3:30 p.m. with the vice president of clinics, clinic director, clinic manager, quality assurance director, and director of infection control at the urology clinic revealed:
*None of them had identified high-level disinfection as a high-risk problem prone area in the urology clinic that they had oversight of.
*They thought the urology clinic had been a provider based clinic and part of the hospital since sometime in 2010.

Interview on 2/16/12 at 10:00 a.m. with the director of infection control revealed she agreed the urology clinic should have been identified as a high-risk problem prone area due to the complex procedures and processes performed in that clinic.

Based on record review, interview, and policy review, the provider failed to ensure:
*All admission, medication, and discharge orders were written and authenticated by a physician in a timely manner for one of two rehabilitation (rehab) patients (19) reviewed.
*Inpatient admission orders were obtained for two of four behavioral health unit (BHU)
patients (17 and 18) reviewed.
*BHU patients' legal status was documented for two of four BHU patients (18 and 42) reviewed.
Findings include:

1. Review of patient 19's rehab record revealed:
*He had been discharged from the swing bed unit and readmitted to rehab on 1/31/12.
*There was no written or electronically authenticated physician's order for discharge from swing bed or for the admission to rehab on 1/31/12.
*There was a written verbal order read back (VORB) on the medication reconciliation form signed and noted by a registered nurse (RN). It was dated 1/31/12. That VORB was not yet electronically authenticated by the physician at the time of the record review.

Interview on 2/14/12 at 2:30 p.m. with RN E confirmed:
*Patient 19's medication reconciliation form in the record was a VORB dated 1/31/12. It had been noted by an RN that day but it had not been signed by the physician.
*The 1/31/12 medication orders had not been electronically authenticated by the physician as of 2/14/12.
*The physician had been gone from 1/31/12, the day of patient 19's admission, and was still out of town.
*Those medication orders had been used by nursing to administer medication to patient 19 during his stay in rehab from 1/31/12 through 2/14/12.
*Physicians were supposed to sign VORB within 48 hours after they had been entered into the computer.
*The provider had just started electronic physician's orders in October 2011 and the system was "new to them."
*She was not sure what the process was to ensure physician's orders had been authenticated electronically within 48 hours.
*She thought the patient care system team or health information management had addressed the issues with the physician order entries.

Interview on 2/14/12 at 2:45 p.m. with RN E and RN/director of rehabilitation services G confirmed:
*Patient 19's physician had left on 1/31/12, the day of admission, and was still out of town. He was not due to return until later in the month.
*When the acute care nurses entered the physician's orders electronically they would sometimes use the order source code status "05" which meant the orders had not required a physician's signature.
*Patient 19's medication orders had been entered by an RN as order source "05". The correct code had not been used to enter the patient's physician orders.

Interview with health information management (HIM) director H on 2/14/12 at 2:40 p.m. and again at 4:40 p.m. confirmed:
*If an electronic physician's order had not been signed by the physician it would automatically go to the physician's sign que to make them aware of the incomplete record.
*Patient 19's VORB had not been electronically signed by the physician.
*The "05" code had been used by the nurse entering the medication orders. That code meant the orders had not needed a signature. The correct code should have been "03."
*The acute care nurses sometimes used the "05" order entry code to enter physician's orders.
*The nursing staff had been provided extensive education on the physician order entry by the patient care system team.
*The "05" code should not have been used by nurses to enter any physician orders.
*The provider's bylaws stated all physician's orders should have been signed.
*The provider had been in the process of changing the order source entry codes.
*She thought the "05" order source code should have been eliminated because all physician's orders needed to be signed unless they were a copied order from a patient's previous facility chart.
*Patient 19 had no signed physician's orders for discharge from swing bed or the admission to rehab on 1/31/12.
*Patient 19 had no signed physician's orders for any of his medications from 1/31/12 through 2/14/12.

Interview on 2/15/12 at 12:00 p.m. with director of rehab G confirmed the provider needed to correct their physician order process to ensure orders were signed by the physician.

Review of the transfer of patients to and from the swing bed program reviewed January 2008 revealed:
*For reimbursement purposes the swing bed unit was considered a separate institution.
*Those patients should have been discharged from one unit and admitted to the unit to which they were transferred.

Review of the transfer of patients to and from the rehabilitation center reviewed January 2008 revealed:
*For reimbursement purposes the rehabilitation center was considered a separate institution.
*Those patients should have been discharged from one unit and admitted to the unit to which they were transferred.

Review of the admission criteria and pre-screening policy and procedure reviewed December 2011 revealed all admissions to rehab required a written physician's order.

Review of the physician's orders policy revised December 2011 revealed:
*Verbal communication of orders should be limited to urgent situations where immediate electronic communication was not feasible.
*Verbal orders may be accepted from the physician or the physician designated agent, but must be electronically signed by the ordering physician within 48 hours.

2. Further review of resident 19's record on 2/15/12 at 2:55 p.m. with HIM director H revealed patient 19 had been discharged to his home on 2/14/12. There was no physician's order for the patient's discharge in the record.

Interview with director of rehab G on 2/15/12 at 5:15 p.m. confirmed:
*The interdisciplinary team had known to discharge the patient on 2/14/12 after the team had met with the family.
*The provider should have had a physician's order for discharge.



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2. Review of patient 18's medical record revealed she was a patient in the BHU on 2/13/12. There was no physician's order to admit her as an inpatient to the BHU.

3. Review of patient 17's medical record revealed he was a patient in the BHU on 2/10/12. There was a physician's order dated 2/10/12 for patient 17 status as observation.

Interview on 2/14/12 at 9:50 a.m. with the BHU manager confirmed a physician's order to admit patients as inpatients to the BHU should have been documented in the above patients' medical records. She further stated patients were not admitted to the BHU on an observation status.

5. Review of patient 18's medical record revealed she was a patient in the BHU on 2/13/12. There was no documentation of her legal status in her medical record.

6. Review of patient 42's medical record revealed she was a patient in the BHU from 1/3/12 to 1/13/12. Her documented legal status was noted as "not applicable."

Interview on 2/14/12 at 9:55 a.m. with the BHU manager revealed a patient's legal status would either be documented as involuntary commitment or court/legal hold. She stated if there was no documentation of a patient's legal status the patient was assumed to be a voluntary commitment. She did not know why patient 42's legal status was documented as "not applicable." She further confirmed the patient's legal status (voluntary, involuntary, or court/legal hold) should have been documented in their medical record.

Based on observation, policy review, and interview, the provider failed to ensure outdated and otherwise unusable medications were not available for patient use in:
*Three of three observed surgical intravenous (IV) kits on the surgical unit.
*Four of twelve observed clinic areas (orthopedic, podiatry, internal medicine, and urology) for medication storage.
Findings include:

1. Observation on 2/14/12 at 11:20 a.m. of IV start kits located in the surgical unit revealed each of the kits contained an opened 50 milliliter (ml) multiple-dose vial lidocaine injection. The vials were not marked with a date of opening to determine how long they could have been used.

Interview at the above time with the director of pharmacy revealed the vials had been placed in the kits by the pharmacy on 2/9/12. The pharmacy director stated the vials should have been marked with a date of opening when first used.

2. Observation on 2/15/12 at 10:45 a.m. at the podiatry clinic revealed one opened multiple-dose vial of Sensorcaine 0.5 percent (%) dated as opened on 8/3/11 and one opened multiple-dose vial of Sensorcaine 2% dated as opened on 8/4/11.

Interview at the above time with registered nurse (RN) I revealed:
*The clinic did not use the Sensorcaine on a regular basis.
*The opened vials of Sensorcaine should have been removed from use because they were past their beyond-use date.

3. Observation on 2/15/12 at 11:00 a.m. at the orthopedic clinic revealed two opened multiple-dose vials of lidocaine 1% not marked with a date when they were opened.

Interview at the above time with RN J revealed:
*The clinic had not used the lidocaine on a regular basis.
*The opened vials of lidocaine should have been removed from use.

Review of the provider's policy for the pharmacy department revealed multiple-dose vials should have been marked with an opening date when first used.



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4. Observation on 2/15/12 at 1:15 p.m. of suite 104 at the physicians plaza building revealed a 50 ml vial of 2% lidocaine was found opened and half used in the medication storage cabinet. That vial had no labeling as to when it had been opened.

5. Observation on 2/15/12 at 1:30 p.m. of suite 140 at the physicians plaza building revealed a 50 ml vial of 1% lidocaine and a 50 ml vial of 1% lidocaine with 1% epinephrine were found opened and partially used in the medication storage cabinet. Those vials had no labeling as to when they had been opened.

6. Observation on 2/15/12 at 1:40 p.m. of suite 105 at the physicians plaza building revealed a sample box of the medication Vesicare with an expiration date of May 2010 was found in a cabinet next to the sink in examination (exam) room five.

Interview on 2/15/12 at 1:50 p.m. with the director of quality assurance related to findings 4-6 revealed:
*It was the provider's policy to label all multi-dose vials of medication with the date it was opened.
*All multi-dose vials were to have been disposed of after they had been opened for twenty- eight days.
*No expired medications should have been left in circulation.
*None of the medications found in findings 4-6 were acceptable for patient use and they all should have been disposed of.

Based on observation, interview, and regulation review, the provider failed to ensure operating room staff who were exposed to radiation:
*Were periodically monitored per exposure meters/badge tests.
*Were trained on radiation exposure.
Findings include:

1. Observation on 2/14/12 from 10:30 a.m. through 11:05 a.m. of patient 11's surgery revealed:
*Fluoroscopy was used throughout the case.
*All staff exposed to that radiation had frontal lead aprons only. The only person in the room who had additional shielding from the fluoroscopic tube head was the physician who had a lead shield in front of him.
*The circulating nurse was noted on several occasions to have her unprotected back to the fluoroscopic tube head when the physician had it activated. Her distance to the tube head was three to five feet on those occasions.
*Anesthesia staff were noted to have been within three feet of the fluoroscopic tube head on several occasions when the tube head was activated.
*The physician never alerted staff as to when he was actively using fluoroscopy during the above observation period.
*None of the staff in that room had radiation exposure badges on except the physician.

Interview on 2/14/12 at 10:55 a.m. with certified registered nurse anesthetists (CRNA) K and L and circulating nurse M revealed:
*None of them could remember any training provided to them related to radiation safety by the provider.
*They had not been offered or instructed to wear radiation badges by any managerial staff.

Interview, employee training record review, and regulation review, on 2/14/12 at 2:02 p.m. with the director of peri-operative services, director of radiology, and the quality assurance director revealed:
*They had not offered or required operating room staff exposed to radiation to wear exposure meters/badges for five years.
*They all concurred operating room staff were exposed to radiation in multiple different types of surgical cases.
*The training records for CRNA K and L confirmed they had not received any training in radiation exposure.
*The director of peri-operative services and the director of radiology confirmed operating room staff exposed to radiation had not received regular radiation training.
*They agreed circulating nurse M was directly exposed to radiation according to this surveyor's observations.
*They agreed the provider had not met the Centers for Medicare and Medicaid Regulations for radiation metering/badging and training.

Review of the provider's reviewed August 2004 personnel radiation monitoring policy revealed:
*All persons exposed to ionizing radiation would have been furnished a "Film badge" (radiation monitoring badge).
*The total of the radiation exposure from each persons film badge would have been completed monthly.

Review of the provider's reviewed April 2011 general rules of radiation safety policy revealed staff members exposed to radiation should have been trained upon hire and annually.

A. Based on observation and interview, the provider failed to maintain the following areas in a sanitary manner.
*One of two walk-in freezers had dirty walls and fan grates.
*Three of three fans located by the dish machine were not clean.
*One observed supply air register in the kitchen ceiling was not clean.
Findings include:

1. Observation on 2/14/12 from 8:30 a.m. to 9:30 a.m. in the kitchen revealed:
*One of two walk-in freezers had dirty walls and fan grates. The walls and fan grates were covered with lint and dust (photos 4 and 5).
*Three of three fans located by the dish machine were not clean. Each fan was covered with lint. Two of the fans were blowing on the clean dishes when they came out of the dish machine and towards the back side of the dish machine. The pipes on the back side of the dish machine were covered with lint (photos 1, 2, and 3).
*One observed supply air register in the kitchen ceiling was not clean. The register was covered with lint (photo 6).

Interview on 2/14/12 at 9:30 a.m. with certified dietary manager F revealed:
*She was not aware of the condition of the walk-in freezer. She agreed it needed to be cleaned. She was not sure how often the walls and fan grates of the freezers were cleaned. She did not know when it was last cleaned.
*She was aware the kitchen fans were dirty and had started a work order to have them cleaned. Those fans were on a preventative maintenance list and were cleaned by the maintenance department. She was not sure how often they were cleaned but thought it was every six weeks.
*She was not aware of the condition of the supply air register. She agreed it needed to be cleaned. Cleaning of the supply air register would be done by the maintenance department. She did not know when it was last cleaned.

Interview on 2/16/12 at 8:30 a.m. with the plant operations manager revealed:
*The kitchen area had a dedicated maintenance person who was responsible for cleaning and repairs.
*The freezers were on a semi-annual cleaning schedule and were last cleaned 10/11/11.
*The fans by the dish machine were on a bi-monthly cleaning schedule and were last cleaned 2/2/12.
*He had not found a preventative maintenance record for the cleaning of the air supply register.



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B. Based on observation and interview the provider failed to install a ceiling in the following areas where clean supplies were being stored. Building ductwork, plumbing, wiring, and sprayed steel I beams were exposed to clean supplies in the following rooms 4-SE-32, 3-SE-02, 3-SE-07, and 3-SE-56.
Findings include:

1. Observation on 2/14/12 between 8:40 a.m. and 9:30 a.m revealed:
*Two environmental services rooms 4-SE-32 and 3-SE-02 did not have enclosed ceilings.
*Clean linen closet 3-SE-07 did not have an enclosed ceiling.
*Room 3-SE-56 labeled as "storage" did not have an enclosed ceiling and had many clean supplies, hospital equipment, and monitors stored inside.

Interview with the environmental services manager at the above time revealed he was not sure why the rooms mentioned above were without ceilings.

Based on observation, interview, and manufacturer's manual review, the provider failed to:
*Properly label/identify the number of uses of three of seven reprocessed Dornier laser probes.
*Ensure expiration dates of supplies were properly monitored to ensure safety and quality in 3 of 13 provider based physician clinics located in the physician's plaza building.
*Maintain supplies in a safe and hygenic manner for 3 of 13 provider based physician clinics located in the physician's plaza building.
Findings include:

1. Observation on 2/14/12 at 8:10 a.m. of the operating suite equipment supply area revealed:
*The provider had Dornier laser probes they were re-using. Four of those laser probes had reprocessing dates and the number of times the instrument had been used on them. Three of them did not have those marking.

Interview and manufacturer's manual review on 2/14/12 at 9:40 a.m. with the director of peri-operative services and sterile processing technician O revealed:
*The manufacturer stated the Dornier laser probe was to only have been reused a total of five times.
*Sterilization services had not developed a written policy on how the Dornier laser probes usage would be tracked.
*Sterile processing technician O stated all the Dornier laser probes not in their factory packaging should have had a number on them indicating the number of times they had been used. That was the unwritten process they had been following to ensure they were not used more than five times.
*They agreed of the seven Dornier laser probes found not in their original packing, three of them had not been marked with the number of times used.
*They both agreed they were not able to tell this surveyor for sure how many times the three unmarked Dornier laser probes had been used.
*They both agreed a written protocol for the Dornier laser probes would ensure both sterile processing staff and operating room staff knew the process and ensured the Dornier laser probes were used per the manufacturer's instructions.

2. Observation and interview on 2/15/12 at 1:15 p.m. of suite 104 at the physician's plaza building revealed:
*A pap smear container with patient information on it had been placed back into the main supply cabinet in the examination (exam) room next to the physician's office.
*Registered nurse (RN) A had placed that labeled container back into circulation because she and the physician had not used it on a previous patient's visit. After discussion she agreed placing labeled sample containers back into circulation could potentially cause a laboratory error. She further agreed that pap smear container should have been discarded once it was labeled and un-used during a patient visit to ensure patient safety.

3. Observation and interview on 2/15/12 at 1:25 p.m. of suite 140 at the physician's plaza building revealed:
*Four expired bottles of hemoccult developer were in the storage area by the physician's office. Three of those bottles had expired in September 2011 and one bottle had expired in June 2011.
*Two used 50 milliliter (ml) syringes were also in the above clean storage room cabinets.
*The unidentified clinic nurse agreed the bottles of hemoccult developer had expired and should have been removed from circulation. She further agreed that hemoccult developer could have potentially caused an inaccurate hemoccult test reading if used.
*She had used the above mentioned 50 ml syringes to irrigate patients ears. When asked by this surveyor if she had cleaned them she stated no. When asked by this surveyor why they had not been cleaned and why they were returned to a clean supply area she stated she should have discarded the syringes after each use.

4. Observation and interview on 2/15/12 at 1:35 p.m. of suite 105 at the physician's plaza building revealed:
*The storage areas throughout that clinic had multiple expired supplies. The following expired supplies were found:
-Four containers of Iodoform packing strips. Two expired in July 2010, one expired in May 2010, and one expired in February 2010.
-Two 5-0 chromic gut sutures expired in July 2011.
-One container of expired Bilevel urine dip stix test strips expired on 11/10/09.
-One box of thirty six inch sterile female urinary catheters expired in April 2010.
-Ten self-cath urinary catheters expired May 2006.
-One 14 french urinary catheter kit expired on 8/26/05.
-One closed urinary drainage bag expired in January 2003.
-Fifteen urinary urethral catheter trays. Three expired in July 2002, four expired in April 2003, and eight expired in February 2007.
*RN N had no scheduled processes or clinic policy for checking for expired supplies. She stated the supply expiration dates were checked when staff had time. She was unable to explain why so many supplies found by this surveyor had been expired for greater than a year if the supplies had been periodically checked for expiration.
*Clean supplies were stored on the floor of an empty exam room. That exam room also contained a biohazardous waste barrel (photos 8 and 9).
*RN N was not aware there was a problem with storing clean supplies on the floor. She also was not aware clean supplies should not have been stored with dirty/biohazardous equipment and waste.

Interview on 2/15/12 at 2:55 p.m. with the infection control nurse and the director of quality assurance regarding findings 2-4 revealed they confirmed:
*The expired supplies found in findings 2-4 should not have been in circulation.
*Supplies had not been maintained in a safe and hygenic manner in suites 104, 105, and 140 of the physician's plaza.
*Having multiple expired supplies in circulation did not meet professional standards.



27953

Preceptor - 20880

5. Observation on 2/15/12 at 1:30 p.m. at the internal medicine clinic suite 104 revealed the following medical supplies were expired:
*Three blue and five purple vacutainers (blood draw vials) expired August 2011.
*Three yellow vacutainers expired January 2012.
*Six Ethilon 4-0 sutures expired January 2012.
*Two skin staple extractors had sterile packaging that was faded and discolored showing packaging breakdown.

Interview during the above observation with registered nurse A revealed she:
*Had gone through the medical supplies once a month for expiration dates.
*Stated the above expired supplies had been an oversight.



15036

6. Observation on 2/15/12 at 3:00 p.m. at the urology clinic in examination room 3 revealed:
*One urology tray was opened and had expired February 2002.
*Three catherization trays had expired November 2006.
*One box with numerous electrosurgical unit disposal cautery handpieces had expired on 12/12/10.

Interview on 2/15/12 at the time of the above observation with RN N confirmed those medical supplies were expired. RN N revealed she was not aware those supplies had expired, they were no longer used at the clinic, and should have been disposed of.

25107

Based on observation, interview, label review, and record review, the provider failed to:
*Maintain the equipment used to monitor the humidity in one of seven operating rooms (2).
*Supply adequate ventilation in one of one urology clinics where Metricide (glutaraldehyde) was used.
Findings include:

1. Review of the humidity log and interview on 2/13/12 at 3:30 p.m. with the plant operations manager revealed:
*The humidity in the hospital was monitored and controlled by a computer. The computer would alarm if the humidity in the operating rooms dropped below 30 percent (%) or climbed above 60%.
*Operating room (OR) 2's humidity level was 15%.
*The computer was showing a yellow alarm in regards to the humidity level in OR 2. The computer showed the initial alarm for the humidity level in OR 2 was triggered on 2/2/12. Random review of the humidity log revealed the humidity in OR 2 was below 30% as far back as 10/26/11 when it was recorded as 28.24%.
*The zone in the building where OR 2 was located had a history of high humidity and alarms associated with high humidity. He was not aware OR 2 was indicating a low humidity alarm.

Interview and observation on 2/15/12 starting at 9:00 a.m. in the OR suite with surgery control desk coordinator P revealed:
*OR 2 was one of the busiest operating rooms and was in use.
*Humidity in the ORs was computer controlled. Plant operations was responsible for maintaining the humidity in the ORs.
*Plant operations would send temperature and humidity reports to the OR suite. The reports were kept in a binder in the OR suite.
*He was not aware the report was indicating the humidity in OR 2 was 15%. He relied completely on the plant operations staff to maintain the humidity in the ORs.
*There was a separate hygrometer in all of the ORs. He was not aware of the humidity level in OR 2. He went into OR 2 and retrieved the hygrometer which indicated the humidity was 41%.

Interview on 2/15/12 at 4:25 p.m. with the director of plant operations and plant operations manager revealed:
*That zone in the building had a history of high humidity alarms.
*The computer was set up to classify alarms as red (high priority) and yellow (low priority).
*The high humidity alarms would trigger a red alarm.
*The current low humidity alarm was triggering a yellow alarm or low priority. The computer should have been set up to flag the low humidity as a red or high priority alarm.
*The plant operations staff had identified and documented the alarm. Nothing was documented about what had been done to resolve the alarm.
*They believed the staff had been desensitized to the alarm due to the history of high humidity alarms in that area. They also agreed more should have been done and documented to resolve the alarm issue.
*The current alarm was caused by a faulty humidity sensor in OR 2.

2. Observation, interview, and label review on 2/15/12 starting at 2:30 p.m. in the urology clinic with registered nurse (RN) N revealed:
*Metricide (glutaraldehyde) was used in multiple areas of the clinic including patient care areas.
*None of the areas where Metricide was used were ventilated by any method other then the building's air handling system.
*Some of the containers that Metricide was stored in did not have lids (photos 7 and 10).
*The Metricide label stated "Use in a well-ventilated area in closed containers."

Based on observation, interview, record review, and policy review, the provider failed to ensure:
*Procedures performed in one of one observed urology clinic were done with properly disinfected instruments.
*Infection control procedures in the urology clinic, surgical areas, heart catheterization laboratory, gastrointestinal laboratory, and pediatrics floor were properly implemented. Refer to A749 findings 1-10.
*Quality assurance and improvement monitoring was completed for high-risk activities in the urology clinic. Refer to A263 findings 1-3.

NOTICE OF IMMEDIATE JEOPARDY (IJ):
On 2/15/12 at 3:00 p.m. observation of the urology clinic revealed practices to disinfect and use instruments for urological procedures created immediate jeopardy for patients of the clinic. The identified conditions included:
*The high-level disinfectant used for instruments was not properly monitored, tested for concentration, and the manufacturer's recommendations were not followed.
*Instruments that were reused for multiple patients were not properly disinfected because they were not completely submerged in disinfectant or rinsed prior to patient use.
*Containers used to soak certain instruments were not designed so the entire instrument could have been disinfected.
*Instruments were soaking in containers that were not accurately labeled to identify the disinfectant being used.
*Expired and opened sterile supplies were available for use and not removed from stock.
*Clinic staff had no formal policy to follow when performing high-level disinfection.
*Clinic staff members and physician R were not aware of the Centers for Disease Control (CDC) standards for disinfection of urological instruments.
*Two cystoscopy procedures and one stent placement had been done using clinic instruments on 2/15/12.

Interview at the above time with the provider's director of quality/patient services, the infection control officer, and physician R confirmed significant risk to patient safety had been identified. The provider's personnel stated procedures in the urology clinic would be suspended until the identified issues were resolved.

On 2/15/12 at 4:45 p.m. the survey team met and discussed the above findings. The team determined the significant risk created a potential IJ to patients of the urology clinic.

On 2/15/12 at 5:05 p.m. the survey team telephoned the state agency administrator for formal approval of the IJ. The findings were explained to the administrator and assistant administrator. It was explained that the provider's personnel had verbally stated procedures in the urology clinic had been suspended until the provider presented a plan of correction (POC) to the state agency. It was also explained the physician performing the procedures was scheduled to have been on vacation for several days beginning on 2/16/12. The state administrator informed the survey team he would telephone the regional office for review of the IJ determination.

On 2/15/12 at 5:40 p.m. the survey team received a telephone call from the state administrator. The administrator stated personnel from the regional office would not be available for consultation until the morning of 2/16/12. The administrator asked for additional written information to have been e-mailed to him. The administrator also stated because of the assurances from the provider's personnel to suspend procedures and the physician's vacation, no additional notifications needed to have been given to the provider's personnel on 2/15/12.

On 2/16/12 at 9:05 a.m. the survey team leader received a telephone call from the state agency assistant administrator confirming approval had been received from the regional office to proceed with the IJ.

On 2/16/12 at 9:35 a.m. notice of IJ was given verbally to the vice president of the hospital division. He was asked to prepare an immediate POC to ensure patient safety related to disinfection and use of equipment in the urology clinic.

On 2/16/12 at 11:10 a.m. the provider presented a draft immediate POC to the survey team. The information on the draft POC was discussed by telephone with the state agency administrator and assistant administrator.

On 2/16/12 at 11:55 a.m. the requested changes to the draft immediate POC were presented to the vice president of the hospital division. The requested changes were agreed to.

On 2/16/12 at 12:45 p.m. the provider presented an immediate POC with the requested changes and signed by the provider's chief executive officer (CEO) to the survey team. The POC was also faxed to the state agency.

On 2/16/12 at 1:45 p.m. the state agency assistant administrator telephoned the survey team and stated the submitted immediate POC signed by the CEO was acceptable to the state agency. The survey team then approved the immediate POC to correct the IJ determination.

IMMEDIATE POC:
The immediate POC dated 2/16/12, signed by the provider's CEO, and approved by the survey team included:
"1. All procedures scheduled in the urology clinic will no longer be performed in the clinic setting. Needed procedures will be performed in the hospital setting.
2. Upon receipt of the notice of deficiencies for the recertification survey from the state agency a POC will be developed and returned to the state agency within ten calendar days from receipt of statement of deficiencies.
3. Procedures in the clinic will not be scheduled or resumed until the provider has received permission from the state agency to do so by acceptance of the POC for the recent recertification survey.
4. Outreach equipment from the urology clinic will no longer be allowed to accompany the physician on outreach visits.
5. As is being done now in the hospital setting, procedures are reviewed by the operative/invasive committee as part of the provider's quality assurance program. Any urological procedures performed by the urologist are and will continue to be part of that program."

Findings include:


27457

1. Observations and interviews on 2/15/12 from 1:35 p.m. through 3:15 p.m. at suite 105 of the physician's office plaza revealed:
*Registered nurse (RN) N was the nurse in charge of the clinic. She had been the registered nurse in that clinic for several years.
*Medical assistant/surgical technician P also worked in the clinic.
*Services offered in the clinic were urological.
*Invasive procedures such as cystoscopy, transrectal ultrasound with biopsy, and urethral dilation were some of those mentioned.
*The only physician that worked out of that clinic was physician R.
*High-level disinfection was performed in the clinic. That high-level disinfection was performed both in the laboratory area as well as in three patient examination (exam) rooms. The high-level disinfectant used throughout the clinic was 2% glutaraldehyde.
*The laboratory had a pan with an urethral dilatator in it next to the sink. That dilatator was not fully submerged in the green liquid in that pan (photo 7 and 13). RN N confirmed the liquid in that pan was 2% glutaraldehyde. When RN N was asked how the instrument was disinfected she stated she first washed the instrument with Dawn dish washing liquid in the laboratory's hand sink. She then rinsed it and placed it in the 2% glutaraldehyde for twenty minutes or so. After that she again rinsed it with water from the laboratories hand sink and then it was ready for insertion into the patient. RN N had also earlier informed this surveyor she and medical assistant P always dumped the urine samples from patients into the other side of the above mentioned hand sink after completing microscopic studies of that urine.
*The exam room where ultrasound procedures were performed had an open stainless steel cylinder with a forceps hanging out of the top of it. That cylinder was on top of the ultrasound machine and half full of a green liquid (photo 10). RN N confirmed the liquid inside that cylinder was 2% glutaraldehyde. She stated staff used that cylinder to partially submerge the ultrasound probe after it had been used in a transrectal ultrasound with biopsy. The forceps that were in the 2% glutaraldehyde were used for multiple purposes. She confirmed those instruments were cleaned in the manner noted above in that rooms hand sink.
*RN N confirmed exam room 5 also had urology instruments that were being processed in that room in the same manner as described above.
*When RN N was asked how she had come about disinfecting instruments in that manner she stated a former nurse and physician assistant that worked at the clinic showed her how to do it.
*The 2% glutaraldehyde used in all the areas was changed every two weeks. No staff ever tested the 2% glutaraldehyde to ensure its strength and ability for it to disinfect during those two weeks. RN N did not know there were test strips available for testing it.
*RN N was not aware special ventilation was required in areas where glutaraldehyde was used. Refer to A726, finding 2.
*Multiple patients were seen throughout a normal day and most of the high-level disinfected instruments were used several times during the course of those days.
*RN N had no written policy to guide her and the other staff on how to perform high-level disinfection.
*Several instruments in the clinic were taken to other facilities served by that physician.

2. Interview on 2/15/12 at 3:30 p.m. with the vice-president of clinics, the clinic director, the clinic manager, the director of quality, the director of infection control, physician R, and surveyor 15036 revealed:
*Physician R was not aware of the Centers for Disease Control Standards for high-level disinfection. He based the clinics current high-level disinfection practices on what he had read on different physician sites on the Internet. He believed that he and his staff were properly performing high-level disinfection.
*The director of infection control confirmed none of the current high-level disinfection practices in the urology clinic conformed to hospital policy or standards of practice.
*The clinic director had been part of a team put together to address high-level disinfection in the clinics. However he had never addressed the high-level disinfection processes in the urology clinic.
*They believed the urology clinic had been a provider based clinic since sometime in 2010.
*None of them had conducted rounds in the urology clinic and identified the significant lack of proper high-level disinfection.
*They all agreed it was in the best interest of the patients that all procedures in the urology clinic that required the use of high-level disinfected instruments and devices would cease until which time the identified issues were fully corrected.

3. Observation, interview, and manufacturer's instruction review on 2/16/12 at 9:09 a.m. with the director of infection control, the clinic manager, and RN N in suite 105 of the physician's plaza (urology clinic) revealed:
*They had no manufacturer's cleaning instructions for the urethral dilatator.
*They agreed the manufacturer's instructions for cleaning and disinfecting the ultrasound probe, the cystoscope, and biopsy forceps had not been followed.
*They agreed the manufacturer's instructions for the use of glutaraldehyde had not been followed.
*None of them had ever reviewed the manufacturer's instructions for cleaning and disinfecting the equipment and devices used in that clinic prior to the time of that interview.
*No clinic staff had ever received any formal training or completed competencies on high- level disinfection.
*RN N had not received any instruction from physician R or clinic management related to high-level disinfection.
*They agreed the cystoscopes and associated equipment had not been properly stored.
*They agreed nursing standards and disinfecting standards had not been adhered to.




15036

4. Observation on 2/15/12 at 3:00 p.m. in the Urology Clinic examination room 3 revealed:
*Two tall standing pipe apparatus constructed of polyvinyl chloride (PVC) piping contained disinfecting solution. Soaking in an upright position in one of those pipes were one endoscope, one cautery device, and two grasping forceps (photo 11).
*On the counter top two clamps were soaking in a small silver cylinder filled with a disinfecting solution (photo 12).
*On the countertop was a small square silver container filled with a disinfecting solution. In that solution was two clamps, two stopcocks, one cautery tip, and two rubber stoppers. The label on the container indicated the solution was 2% glutaraldehyde (photo 12).

Interview at the time of the above observation with RN N confirmed:
*The solution in all containers listed above was the disinfecting solution Metricide.
*Instruments soaked for a period of 20 minutes.
*There was no method in place for monitoring the efficacy of the high-level disinfection solution.
*She did not have testing strips in the clinic to monitor the disinfectant.
*She did not follow the manufacturer's instructions for testing efficacy or temperature of the high-level disinfectant.

Observation and interview with RN N in examination room 3 confirmed the following medical supplies had expired:
*One urology tray expired February 2002 and the sterile packaging had been opened.
*Three catheter trays had expired November 2006.
*One box of disposable hand held cautery pencils had expired 12/14/10.

Observation and interview with CIC specialist S and the director of outpatient clinics confirmed:
*The urology clinic current process and procedure used for high-level disinfection of instruments and equipment was not in accordance with current acceptable standards of practice.
*The process used for high-level disinfection did not disinfect the entire piece of equipment or instrument when placed in the disinfectant (photo 11).
*Equipment and instruments were not completely immersed in the disinfection. The end portion of the scopes, graspers, and cautery devices used with urology procedure were not disinfected.
*The hospital had the capability to use peracetic acid for sterilizing urology endoscopes.
*Two cystoscopy and one stent placement case had been done on that day 2/15/12.



25107

5. Observation and interview on 2/15/12 at 3:00 p.m. with medical assistant P revealed:
*He was the person responsible for cleaning and disinfecting the cystoscopes.
*The physician traveled to outreach sites with a scope to perform procedures.
*They had prepared a traveling kit to take with them to clean the scopes. The kit contained two PVC containers for soaking and rinsing scopes.
*When they traveled to outreach clinics they would take Metricide (glutaraldehyde) with them to disinfect the scope. The Metricide was activated the day of use and poured into smaller containers for transport. When they reached the outreach site the Metricide would be poured from the smaller container into the PVC container to soak the scope in.
*The scope would be washed with soapy water using a brush to clean the bore. The scope would be rinsed and then placed into a PVC container of Metricide and left to soak for a minimum of thirty minutes but on average an hour. He did not use a timer to track the soak time of the scope. He would set up the room and wait for lab results while the scope was soaking. When he was done with all of the prep work between cases the scope would be ready to rinse.
*The scope was then removed from the Metricide and placed into a PVC tube of sterile water and rinsed one time. After the scope was rinsed once in sterile water it was ready to be used.
*The Metricide was never tested in between uses. It could be used up to four times a day to disinfect the scope between patients.
*The scopes were only processed by this method and were never sent to the hospital sterile processing department for cleaning, disinfecting, or sterilizing.

Review of the label for Metricide revealed:
*"Metricide solution is a high-level disinfectant when used or reused, according to directions for use, at full strength for a maximum of 14 days at 25 degrees Celsius with an immersion time of at least 45 minutes."*"Metricide solution can be reused for a period not to exceed 14 days provided the required conditions or glutaraldehyde concentration, pH, and temperature exist based upon monitoring described in directions for use. DO NOT rely solely on days in use. Efficacy of this product during its use-life must be verified by a 1.5% glutaraldehyde concentration indicator to determine that at least the minimum effective concentration (MEC) of 1.5% glutaraldehyde is present."
*"Metricide, Metricide 28, and Metricide plus 30 solutions are compatible with enzymatic detergents which are mild in pH, low foaming, and easily rinsed from equipment. Detergents that are either highly acidic or alkaline are contraindicated as precleaning agents since improper rinsing could affect the efficacy of the Metricide, Metricide 28 and Metricide Plus 30 solutions by altering the pH."
*"Use in a well-ventilated area in closed containers."
*"Contaminated, reusable devices MUST BE THOROUGHLY CLEANED prior to disinfection, or sterilization, because residual contamination will decrease effectiveness of the germicide."
*"The user MUST adhere to the directions of use, because any modification will affect the safety and effectiveness of the germicide."
*"Metricide solution is intended for use in manual (bucket and tray) systems made from polypropylene, ABS, polyethylene, glass-filled polypropylene or special molded polycarbonate plastics."
*"Blood and other bodily fluids must be thoroughly cleaned from surfaces, lumens, and objects before application of the disinfectant or sterilant."
*"For complete disinfection or sterilization of medical instruments and equipment, thoroughly clean, rinse and rough dry objects before immersing in Metricide, Metricide 28, or Metricide Plus 30 solution. Cleanse and rinse the lumens of hollow instruments before filling with Metricide."
*"High-Level Disinfection (Bucket/tray manual system). Immerse medical equipment/device completely in Metricide solution for a minimum of 45 minutes at 25 degrees Celsius to destroy all pathogenic microorganisms, except for large numbers of bacterial endospores, but including Mycobacterium tuberculosis. Remove devices and equipment from the solution and rinse thoroughly following rinsing instructions below."
*"Rinsing instructions. Following immersion in Metricide solution, thoroughly rinse the equipment or medical device by immersing it completely in three separate copious volumes of water. Each rinse should be a minimum of one minute in duration unless otherwise noted by the device or equipment manufacturer. Use fresh portions of water for each rinse. Discard the water following each rinse. Do not reuse the water for rinsing or any other purpose, as it will be contaminated with glutaraldehyde."
*"Refer to the reusable device/equipment manufacturer's labeling for additional rinsing instructions."
*"Metricide solution has also demonstrated efficacy in the presence of 2% organic soil contamination and a simulated amount of microbiological burden during reuse. This solution may be used and reused within the limitations indicated above for up to 14 days after activation. Do not use activated solution beyond 14 days. Efficacy of this product during its use-life must be verified by a 1.5% glutaraldehyde concentration indicator to determine that the minimum effective concentration of 1.5% is present."
*"During the usage of Metricide solution, as a high-level disinfectant and/or sterilant, it is recommended that a thermometer and timer be utilized to ensure that the optimum usage conditions are met. In addition, it is recommended that the Metricide solution be tested with a 1.5% glutaraldehyde concentration indicator prior to each usage. this is to ensure that the appropriate concentration of glutaraldehyde is present and to guard against a dilution which may lower the effectiveness of the solution below its MEC. The pH of the activated solution may also be periodically checked to verify that the pH of the solution is between 6.5 and 8.5."
*"Once Metricide, Metricide 28 or Metricide Plus 30 solution has been activated, it should be stored in the original container until transferred to the containers in which the immersion for disinfection or sterilization is to take place. Containers should be stored in a well-ventilated, low traffic area at room temperature."

Review of the provider's September 2010 cleaning, disinfection, sterilization and reuse of patient care equipment in the clinic setting policy revealed:
*Semi-critical or critical items (i.e. endoscopy equipment and instruments, etc) shall receive thorough mechanical cleaning to remove organic debris prior to any high-level disinfection or sterilization. See attached sterilization/disinfection table (Source: APIC principles and Practices)
*"Use of high level disinfectants (i.e. 2% glutaraldehydes, 6% H 2 O 2 or .2 % peracetic acid) requires routine testing and logging of solution effectiveness, according to disinfectant guidelines, as well as staff monitoring, as indicated by product literature."
*"Appropriate "soak time" for high level disinfection is 20 minutes. All cleaned equipment must be submerged entirely to achieve effective results."

Based on observation, interview, policy review, and manufacturer's instructions review, the provider failed to:
*Conform to aseptic/sterile surgical technique for one of two observed surgical cases.
*Ensure un-cleanable single-use items were not re-used from surgical patient to surgical patient.
*Maintain the clean environment of the clean supply room of the urology clinic.
*Label and date one observed spray bottle in the clean supply room of the urology clinic.
Findings include:

1. Observations on 2/14/12 from 10:30 a.m. through 11:35 a.m. of patient 11's surgical procedure revealed:
*Surgical technician P was noted inserting bare foam padding under the buttocks and legs of the patient. Anesthesia staff were also noted using that same type of bare foam padding to pad the patients elbows and head.
*Surgical technician P who prepared and sterile draped the patient for his surgical procedure had not worn a surgical gown during that process. During that time it was noted surgical technician P contaminated the sterile draping multiple times with his bare arms as he only had sterile gloves on.
*Once patient 11 was draped surgical technician P was noted preparing the surgical table still un-gowned. During that table preparation it was noted surgical technician P cross-contaminated the perimeter of the surgical table on multiple occasions with his uncovered non-sterile scrub shirt and pants.
*Once patient 11's procedure was set to begin surgical technician P again came to the surgical table un-gowned. He remained un-gowned for the entire course of the procedure.
*When physician R entered the operating room his surgical mask was positioned below his nose exposing both of his nostrils. The mask stayed in that position throughout the procedure.
*Once physician R was gowned and gloved he took his position on a chair between the patient's sterile draped legs and then began to position an undraped non-sterile radiation shield with his sterile gloved hands. After that initial breach in sterile technique the physician did not re-glove nor was he asked to by the circulating nurse or surgical technician. As the procedure progressed physician R was noted on multiple occasions going from unsterile items to sterile items. At that same time surgical technician P who was assisting the doctor was noted to have been cross-contaminating with his bare arms the wires and catheters that were being introduced into the patient's bladder and ureters.

Interview on 2/14/12 at 10:50 a.m. with circulating nurse M revealed:
*Surgical technician P always attended those types of cases un-gowned and had been doing that for years.
*Surgical technician P always assisted physician R with his cases.
*She saw nothing out of the normal that day from the way physician R and surgical technician P normally conducted those types of surgical cases.
*At 10:58 a.m. this surveyor requested that circulating nurse contact the director of peri-operative services and have him come to the operating room.

Interview on 2/14/12 at 11:00 a.m. with the director of peri-operative services in the semi-sterile hallway revealed:
*He was not aware surgical technician P had not been wearing a surgical gown for the pre or intraoperative phases of some urological surgeries.
*He was informed of this surveyor's observations to that point. He confirmed the observations of this surveyor were significant breaches in sterile surgical technique.
*This surveyor requested he contact the director of infection control immediately.

Continued observation and interview on 2/14/12 at 11:08 a.m. of patient 11's surgery revealed:
*The surgery was close to concluding.
*Physician R addressed this surveyor and stated he decided it was not necessary to have surgical technician P gowned during those types of procedures. His rationale for that decision was to prevent surgical technician P's sterile gown from getting cross-contaminated by his back. This surveyor then proceeded to inform the physician he would need to take a close look at his and surgical technician P's sterile technique and maintenance of a sterile field.

Interview and policy review on 2/14/12 at 11:14 a.m. with the director of infection control and the director of per-operative services regarding this surveyor's observations in patient 11's surgery revealed:
*They both confirmed based on the above observations physician R and surgical technician P had completely cross-contaminated the surgical field.
*They both confirmed the above observations had not conformed to the standards of practice for maintaining and ensuring a sterile field.
*According to the provider's policy on surgical attire those scrubbed into a case should always have been gowned and had surgical masks on appropriately.
*The director of peri-operative services agreed it was the responsibility of every person in that operating room to ensure proper operative standards were maintained at all times.

Continued observation and interview on 2/14/12 at 11:35 a.m. of operating room one with the director of infection control revealed:
*The surgical case had concluded and the operating room was being prepared for the next case.
*The same foam pads noted earlier were now observed to have been placed on the clean/disinfected surgical table that was prepared for the next patient. Those pads were confirmed to have been used in patient 11's case by an unidentified surgical staff member.
*The director of infection control confirmed that type of padding was not cleanable and should not have been re-used. She also stated that she was not aware surgical staff were re-using that foam padding. This surveyor requested at that time that the foam padding be disposed of and the table and any other surfaces that the foam padding was in contact with be re-disinfected.



25107

2. Observation and interview on 2/15/12 at 2:45 p.m. with RN N in the clean supply room of the urology clinic revealed:
*Two unwrapped forceps lying on the counter where other clean supplies were stored.
*The forceps were dirty and were used to clamp catheters and should not have been stored in the clean supply room.
*One clear plastic spray bottle with a brown liquid that was unlabeled and not dated. RN N believed the bottle contained betadine but did not know for sure. She agreed the bottle should have been labeled with the contents and dated.



15036

3. Observation on 2/13/12 at 3:50 p.m. of the pediatric evacuation room/clean utility room revealed:
*A washer and dryer was located in that room and was used to wash patient clothing.
*On open shelving clean patient care supplies were stored. Supplies ranged from infant formula to dressings.
*The washer had accumulated dried laundry detergent residue in the dispensing basket, the washer and dryer were dusty, and the lint trap of the dryer had not been cleaned.
*Stored on the floor were two cardboard boxes with wall files and a DVD/CD changer.
*The evacuation stretcher hung on one wall.

Interview with certified infection control (CIC) specialist S at the time of the above observation confirmed the findings and stated the washer and dryer should not be located in a clean utility room. Bringing soiled and potentially contaminated patient clothing into the clean utility was a breach in infection control practices.

4. Observation on 2/14/12 at 9:37 a.m. in operating room (OR) 4 of anesthesiologist V assisting with patient 16's intubation and intravenous (IV) restart revealed:
*Anesthesiologist V removed his contaminated gloves, did not perform hand hygiene, and exited the room.
*This surveyor observed anesthesiologist V enter OR 5, did not perform hand hygiene, and put on clean gloves to assist with that patient's care.

Interview with CIC specialist S at the time of the above observation confirmed anesthesiologist V should have performed hand hygiene after removal of his contaminated gloves and prior to exiting OR 4.

Review of the provider's January 2010 hand hygiene policy revealed:
*Hand hygiene was the removal of transient microbial contamination acquired by recent patient, environmental, or other source/contact.
*Hands should have been washed with plain soap when visibly dirty.
*Alcohol handrubs were used any time hands were not visibly dirty, before direct patient contact, and after removing gloves.

5. Observation on 2/14/12 at 10:01 a.m. of the cleaning process for room turn-over between surgical procedures in OR 4 revealed:
*Prior to the patient being extubated the staff entered the room and began disinfecting equipment used during the surgical procedure.
*At the end of the procedure the staff disinfected the OR table, put on clean linen, and reused the contaminated uncleanable pink foam armrest pads.
*After the anesthesia provider had left the room, a staff member removed the towel covering the top of the anesthesia cart. That towel had a small noticeable blood stain on it. Without disinfecting the top of the cart a clean towel was placed back on top of the anesthesia cart.

Interview on 2/14/12 at 10:13 a.m. with director of surgical services X and CIC specialist S confirmed to prevent potential cross-contamination:
*Staff should not begin room turn-over and equipment disinfection when the patient was still in the room.
*The pink armrests used during surgical procedures were not cleanable and should not have been saved to reuse on other patients.
*The staff should have disinfected the top of the anesthesia cart prior to covering the top with a clean towel.

Review of the Association of periOperative Registered Nurses, Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Settings, 2010 Edition, Denver, CO, revealed: "Mattresses and padded positioning device surfaces (eg, OR beds, arm boards, patient transport carts) should be moisture-resistant and intact."

6. Observation on 2/14/12 at 10:30 a.m. in the OR decontamination room revealed certified surgical technician (CST) W while wearing incomplete personal protective equipment (PPE) prepared contaminated surgical instruments for the washer sterilizer. CST W PPE consisted of a pair of examination gloves. She did not wear appropriate eye protection or a protective cover gown/apron over her surgical scrubs. Continued observation of CST W revealed:
*The inner surface of the sink she was working at had been marked with a fill line. The water level was below that line.
*Prior to placing the contaminated instruments in an enzymatic cleaning solution, she added additional water to the solution already in the sink.

Interview with CST W at the time of the above observation revealed:
*The solution in the sink was a combination of water and an enzymatic cleaner.
*She should not have added additional water to that solution but mixed a new batch to clean the instruments with.
*Mixing of the enzymatic cleaner included filling the sink to the fill line with water and adding one squirt of enzymatic cleaner from the dispenser.

7. Observation on 2/14/12 at 10:40 a.m. in the post-anesthesia care unit soiled utility room revealed clean PPE chemotherapy supplies were stored in cabinets. Interview at the time of the observation with CIC specialist S confirmed clean supplies should not have been stored in the soiled utility room.

Review of the provider's undated policy mixing enzymatic cleaners revealed:
* "There is no written policy for mixing of enzymatic cleaners. In order to ensure consistency, the equipment is set up by the manufacturer representative at installation. No modifications of the amounts are done by staff."
*The policy did not address how much water was mixed with the dispensed enzymatic cleaner or the amount of enzymatic cleaning solution that was automatically dispensed.

8. Observation on 2/14/12 at 11:48 a.m. in the OR decontamination room revealed CST W working at the decontamination sink with inappropriate PPE coverage. The CST wore a face shield, an apron without sleeves, and long plastic gloves that stopped at the end of her short sleeved scrub top.

Observation and interview with director of surgical services X at the time of the 11:48 a.m. observation revealed CST W was not wearing the correct PPE to work with contaminated equipment. The sleeveless apron and the long plastic gloves did not cover her entire scrub uniform. There was a potential for her uniform to become contaminated.

Review of the provider's October 2011 cleaning of instruments policy revealed in the workroom gloves, aprons and protective eyewear were used.

Review of the provider's October 2011 sterile processing department policy revealed in the decontamination area a cover gown made of non-permeable material was worn to prevent clothing from becoming wet. Goggles or a mask with eye shield should have been worn during instrument decontamination.

Review of IAHCSMM Central Service Technical Manual, 7th Edition, Chicago, IL, 2007, revealed:
*Page 101- Staff working in the decontamination area must wear:
-General purpose utility gloves should have been worn. The thickness and durability of the gloves prevented them from being easily torn when performing normal duties.
-A fluid-resistant covering with sleeves should have been worn to prevent contamination of clothing and prevent the CST skin from exposure to blood and body fluids. Arms should should have been covered completely.
-A full-length face shield or a combination of mask and eye goggles should have been worn to protect mucous membranes from exposure to splashes, sprays, and/or aerosolized contaminated fluids.
-Shoe covers should have been worn to protect shoes from becoming wet and contaminated during the cleaning process.

9. Observation in the cauterization lab (cath lab) revealed:
*On 2/14/12 at 1:42 p.m. in cath lab number 2:
-The backtable of sterile instruments and supplies had been covered with a sterile drape cloth. The edges of that cover extended below the level of the backtable.
*After the procedure the staff placed the blood pressure cuff on the contaminated cath bed, cleansed the cuff with a disinfectant wipe, and stored the blood pressure cuff for later use.
*After the procedure the staff disinfected equipment wearing gloves and with those contaminated gloves put supplies away in the clean supply storage area.
*On 2/15/12 at 9:10 a.m.:
-A staff member exited cath lab number 1 carrying a wash basin which contained a reddish color liquid and entered the soiled utility room across the hallway.
-In the soiled utility room there were no trash or linen bins. The trash bag and linen bag were stored on the floor for pickup.

Interview on 2/14/12 during the above observation with CIC specialist S revealed:
*She was not aware the backtable should not have been covered after set-up, and sterile equipment once set-up should have been continuously observed by the staff.
*The blood pressure cuff would not be considered disinfected since it had been wiped down on an unclean surface.
*The staff should have removed their contaminated gloves prior to putting away clean supplies.
*The reddish color liquid was irrigation fluid. Contaminated liquid should not have been carried in an uncovered container.
*Soiled trash and linen bags should have been stored in bins for pickup, not on the floor in the soiled utility room.
*Staff were not following appropriate infection control practices in the examples cited above.

10. Observation on 2/15/12 at 12:50 p.m. in the gastrointestinal lab, suite 202, room 18 of patient 55's esophagogastroduodenoscopy (EGD) and colonoscopy procedure revealed:
*Physician U entered the procedure room wearing a lab coat over his scrub attire.
*Physician U completed the EGD procedure wearing the lab coat over his scrub attire.
*The physician removed his lab coat, sat in a chair, put a towel over his lap, and proceeded with the patient's colonoscopy procedure.
*Parts of the scope rested on the mattress of the bed and the physician's lap during the procedure.
*At the end of the procedure the physician charted at the computer, put his lab coat on, and exited the room.
*During the colonoscopy procedure RN T assisted the physician by advancing the colonoscopy scope and applying pressure to the patient's abdomen as directed by the physician. She did not wear PPE to protect her uniform or eyewear to protect against potential contamination during the procedure.

Interview on 2/15/12 immediately after the procedure with physician U and RN T revealed:
*The physician did not wear PPE during colonoscopy cases because they were considered contaminated procedures. If the patient had an infection then he would have worn PPE.
*The physician agreed you would not always be able to determine if a patient had an infection.
*The nurse did not wear PPE other than clean gloves. There were cover aprons available for the staff but they were not worn.

Interview on 2/15/12 immediately after the procedure with CIC specialist S confirmed staff should have worn appropriate PPE during colonoscopy cases to protect against potential contamination.

Observation on 2/15/12 at 12:50 p.m. in the gastrointestinal lab, suite 202, room 18 revealed:
*A metal three-tiered cart was used during colonoscopy procedures for clean supplies. The second and third tier of that cart were used to store towels in a closed bin.
*At the end of the colonoscopy procedure for patient 55, only the top of the three tiered cart was disinfected. The second, third tiers, and the plastic bins were not cleansed with a disinfectant wipe.

Interview on 2/15/12 immediately after patient 18's colonoscopy procedure with CIC specialist S and RN T confirmed:
*The towels in the bins located on the three tier cart were placed under patients prior to positioning them for their colonoscopy procedure. The towels were used by the staff to grasp and guide the colonoscopy scope during the procedure.
*The entire cart and all items on that cart should have been disinfected, it was located adjacent to the patient bed during the procedure, and there was a potential for cross-contamination of items on that cart.

Based on observation, interview, and policy review, the provider failed to ensure inpatients receiving conscious sedation during surgical procedures performed in the hospital's gastrointestinal room, suite 202, room 18 were continuously monitored by a registered nurse for one of one observed patient's (55)
surgical procedure. Findings include:

1. Observation on 2/15/12 at 2:45 p.m. of patient 55's esophagogastroduodenoscopy (EGD) and colonoscopy procedure revealed registered nurse (RN) T:
*Connected the patient to machines for heart rate, blood pressure, and oxygen saturation monitoring.
*Administered Demerol and Versed to facilitate conscious sedation prior to the start of the EGD procedure and again at the beginning of the colonoscopy procedure.
*During the colonoscopy she assisted the physician throughout the procedure by advancing the scope and providing pressure to the patient's abdomen when instructed by the physician.
*Had the student nurse observing the procedure push the reset button when the blood pressure cuff alarm sounded. The RN was assisting the physician by advancing the colonoscopy scope.
*Did not engage the patient with verbal stimuli unless the patient responded to painful stimulation felt from the physician manipulation of the colonoscopy scope.

Interview on 2/15/12 with RN T at the conclusion of the procedure revealed:
*Normally only the physician and RN participated in colonoscopy procedures in suite 202, room 18.
*The RN was responsible for monitoring the patient and assisting the physician in completing all procedures.
*She assisted the physician with patient 55's colonoscopy by guiding the scope and applying abdominal pressure throughout the entire procedure.
*She completed written documentation after the procedure. The blood pressure, heart rate, and oxygen saturation information was obtained from the monitors.

Interview and review of the provider's moderate sedation policy on 2/15/12 in the afternoon with director of surgical services X and director of emergency services Y revealed:
*Moderate sedation was used for all patient procedures performed in suite 202, room 18.
*They agreed patients receiving moderate sedation should have been continuously monitored by the RN.
*The RN assisting the physician throughout the procedure was not available to continuously monitor the patients.
*Monitoring the patient was the RN's responsibility but she could do small tasks that did not distract her attention long-term from the patient.

Review of the South Dakota Board of Nursing position statement on Management of Adult Clients Receiving IV Moderate Sedation for Short-Term Therapeutic, Diagnostic, or Surgical Procedures by RNs revealed:
*"The RN managing the care of the adult client receiving IV moderate sedation shall have no other responsibilities that would leave the client unattended or compromise continuous monitoring."
*The RN managing the care of adult clients receiving IV moderate sedation should be able to:
-Assess total client care requirements during the administration of and recovery from moderate sedation.
-Monitoring included but was not limited to respiratory rate, oxygen saturation, blood pressure, cardiac rate and rhythm, and level of consciousness.
-Anticipate and recognize potential complications of moderate sedation in relation to the type of medication being administered.
-Intervene in the event of complications or unexpected outcomes in compliance with physician orders, standing orders, or medical protocols/guidelines.

Review of the provider's February 2005 moderate sedation policy revealed:
*"Moderate Sedation (conscious sedation, sedation/analgesia) is a drug induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or with light tactile stimulation. No interventions are required to maintain a patent airway and spontaneous ventilation is adequate. Cardiovascular function is usually maintained."
*"Because sedation to anesthesia is a continuum, it is not always possible to predict how an individual patient receiving moderate sedation will respond."
*"Vital sign monitoring will include: heart rate, respiratory rate, blood pressure and oxygenation. Heart rate and oxygenation should be continuously monitored by use of a pulse oximeter. Respiratory rate and adequacy of pulmonary ventilation should be continually monitored by observation."
*"The patient's response to care provided throughout the sedation-supported procedure must be documented in the patient's record."
*During the intra-procedure the RN was responsible for monitoring and documenting the patient's vital signs every five minutes or more frequently as necessary.

Based on observation, interview, policy review, manufacturer's instruction review and record review the provider failed to ensure outpatient procedure services rendered in one of one off-site urology clinic was in accordance with acceptable standards of practice. Findings include:

1. Observations and interviews on 2/15/12 from 1:35 p.m. through 3:15 p.m. at suite 105 of the physician's office plaza revealed:
*Registered nurse (RN) N was the nurse in charge of the clinic. She had been the registered nurse in that clinic for several years.
*Medical assistant/surgical technician P also worked in the clinic.
*Services offered in the clinic were urological.
*Invasive procedures such as cystoscopy, transrectal ultrasound with biopsy, and urethral dilation were some of those mentioned.
*The only physician that worked out of that clinic was physician R.
*High-level disinfection was performed in the clinic. That high-level disinfection was performed both in the laboratory area as well as in three patient examination (exam) rooms. The high-level disinfectant used throughout the clinic was 2% glutaraldehyde.
*The laboratory had a pan with an urethral dilatator in it next to the sink. That dilatator was not fully submerged in the green liquid in that pan (photo 7 and 13). RN N confirmed the liquid in that pan was 2% glutaraldehyde. When RN N was asked how the instrument was disinfected she stated she first washed the instrument with Dawn dish washing liquid in the laboratory's hand sink. She then rinsed it and placed it in the 2% glutaraldehyde for twenty minutes or so. After that she again rinsed it with water from the laboratory's hand sink and then it was ready for insertion into the patient. RN N had also earlier informed this surveyor she and medical assistant P always dumped the urine samples from patients into the other side of the above mentioned hand sink after completing microscopic studies of that urine.
*The exam room where ultrasound procedures were performed had an open stainless steel cylinder with a forceps hanging out of the top of it. That cylinder was on top of the ultrasound machine and half full of a green liquid (photo 10). RN N confirmed the liquid inside that cylinder was 2% glutaraldehyde. She stated staff used that cylinder to partially submerge the ultrasound probe after it had been used in a transrectal ultrasound with biopsy. The forceps that were in the 2% glutaraldehyde were used for multiple purposes. She confirmed those instruments were cleaned in the manner noted above in that rooms hand sink.
*RN N confirmed exam room 5 also had urology instruments that were being processed in that room in the same manner as described above.
*When RN N was asked how she had come about disinfecting instruments in that manner she stated a former nurse and physician assistant that worked at the clinic showed her how to do it.
*The 2% glutaraldehyde used in all the areas was changed every two weeks. No staff ever tested the 2% glutaraldehyde to ensure its strength and ability for it to disinfect during those two weeks. RN N did not know there were test strips available for testing it.
*RN N was not aware special ventilation was required in areas where glutaraldehyde was used. Refer to A726, finding 2.
*Multiple patients were seen throughout a normal day and most of the high-level disinfected instruments were used several times during the course of those days.
*RN N had no written policy to guide her and the other staff on how to perform high-level disinfection.
*Several instruments in the clinic were taken to other facilities served by that physician.

2. Interview on 2/15/12 at 3:30 p.m. with the vice-president of clinics, the clinic director, the clinic manager, the director of quality, the director of infection control, physician R, and surveyor 15036 revealed:
*Physician R was not aware of the Centers for Disease Control Standards for high-level disinfection. He based the clinics current high-level disinfection practices on what he had read on different physician sites on the Internet. He believed he and his staff were properly performing high-level disinfection.
*The director of infection control confirmed none of the current high-level disinfection practices in the urology clinic conformed to hospital policy or standards of practice.
*The clinic director had been part of a team put together to address high-level disinfection in the clinics. However he had never addressed the high-level disinfection processes in the urology clinic.
*They believed the urology clinic had been a provider based clinic since sometime in 2010.
*None of them had conducted rounds in the urology clinic and identified the significant lack of proper high-level disinfection.
*They all agreed it was in the best interest of the patients that all procedures in the urology clinic that required the use of high-level disinfected instruments and devices would cease until which time the identified issues were fully corrected.

3. Observation, interview, and manufacturer's instruction review on 2/16/12 at 9:09 a.m. with the director of infection control, the clinic manager, and RN N in suite 105 of the physician's plaza (urology clinic) revealed:
*They had no manufacturer's cleaning instructions for the urethral dilatator.
*They agreed the manufacturer's instructions for cleaning and disinfecting the ultrasound probe, the cystoscope, and biopsy forceps had not been followed.
*They agreed the manufacturer's instructions for the use of glutaraldehyde had not been followed.
*None of them had ever reviewed the manufacturer's instructions for cleaning and disinfecting the equipment and devices used in that clinic prior to the time of that interview.
*No clinic staff had ever received any formal training or completed competencies on high level disinfection.
*RN N had not received any instruction from physician R or clinic management related to high-level disinfection.
*They agreed the cystoscopes and associated equipment had not been properly stored.
*They agreed nursing standards and disinfecting standards had not been adhered to.

4. Review of the quality assurance program revealed a lack of proper oversight, implementation, and integration of urology clinic services. Refer to A285, finding 1.

5. Review of how supplies were monitored for expiration and stored in the urology clinic revealed lack of oversight and adherence to professional practices. Refer to A724, finding 4.



15036

6. Observation on 2/15/12 at 3:00 p.m. in the urology clinic examination room 3 revealed:
*Two tall standing pipe apparatus constructed of polyvinyl chloride (PVC) piping containing disinfecting solution. Soaking in an upright position in one of those pipes were one endoscope, one cautery device, and two grasping forceps (photo 11).
*On the counter top two clamps were soaking in a small silver cylinder filled with a disinfecting solution (photo 12).
*On the countertop was a small square silver container filled with a disinfecting solution. In that solution was two clamps, two stopcocks, one cautery tip, and two rubber stoppers. The label on the container indicated the solution was 2% glutaraldehyde (photo 12).

Interview at the time of the above observation with RN N confirmed:
*The solution in all containers listed above was the disinfecting solution Metricide.
*Instruments soaked for a period of 20 minutes.
*There was no method in place for monitoring the efficacy of the high-level disinfection solution.
*She did not have testing strips in the clinic to monitor the disinfectant.
*She did not follow the manufacturer's instructions for testing efficacy or temperature of the high-level disinfectant.

Observation and interview with RN N in examination room 3 confirmed the following medical supplies had expired:
*One urology tray expired February 2002 and the sterile packaging had been opened.
*Three catheter trays had expired November 2006.
*One box of disposable hand held cautery pencils had expired on 12/14/10.

Observation and interview with CIC specialist S and the director of outpatient clinics confirmed:
*The urology clinic current process and procedure used for high-level disinfection of instruments and equipment was not in accordance with current acceptable standards of practice.
*The process used for high-level disinfection did not disinfect the entire piece of equipment or instrument when placed in the disinfectant (photo 11).
*Equipment and instruments were not completely immersed in the disinfection. The end portion of the scopes, graspers, and cautery devices used with urology procedure were not disinfected.
*The hospital had the capability to use peracetic acid for sterilizing urology endoscopes.
*Two cystoscopy and one stent placement case had been done on that day 2/15/12.





25107

7. Observation and interview on 2/15/12 at 3:00 p.m. with medical assistant P revealed:
*He was the person responsible for cleaning and disinfecting the cystoscopes.
*The physician traveled to outreach sites with a scope to perform procedures.
*They had prepared a traveling kit to take with them to clean the scopes. The kit contained two PVC containers for soaking and rinsing scopes.
*When they traveled to outreach clinics they would take Metricide (glutaraldehyde) with them to disinfect the scope. The Metricide was activated the day of use and poured into smaller containers for transport. When they reached the outreach site the Metricide would be poured from the smaller container into the PVC container to soak the scope in.
*The scope would be washed with soapy water using a brush to clean the bore. The scope would be rinsed and then placed into a PVC container of Metricide and left to soak for a minimum of thirty minutes but on average an hour. He did not use a timer to track the soak time of the scope. He would set up the room and wait for lab results while the scope was soaking. When he was done with all of the prep work between cases the scope would be ready to rinse.
*The scope was then removed from the Metricide and placed into a PVC tube of sterile water and rinsed one time. After the scope was rinsed once in sterile water it was ready to be used.
*The Metricide was never tested in between uses. It could be used up to four times a day to disinfect the scope between patients.
*The scopes were only processed by this method and were never sent to the hospital sterile processing department for cleaning, disinfecting, or sterilizing.

Review of the label for Metricide revealed:
*"Metricide solution is a high-level disinfectant when used or reused, according to directions for use, at full strength for a maximum of 14 days at 25 degrees Celsius with an immersion time of at least 45 minutes."*"Metricide solution can be reused for a period not to exceed 14 days provided the required conditions or glutaraldehyde concentration, pH, and temperature exist based upon monitoring described in directions for use. DO NOT rely solely on days in use. Efficacy of this product during its use-life must be verified by a 1.5% glutaraldehyde concentration indicator to determine that at least the minimum effective concentration (MEC) of 1.5% glutaraldehyde is present."
*"Metricide, Metricide 28, and Metricide plus 30 solutions are compatible with enzymatic detergents which are mild in pH, low foaming, and easily rinsed from equipment. Detergents that are either highly acidic or alkaline are contraindicated as precleaning agents since improper rinsing could affect the efficacy of the Metricide, Metricide 28 and Metricide Plus 30 solutions by altering the pH."
*"Use in a well-ventilated area in closed containers."
*"Contaminated, reusable devices MUST BE THOROUGHLY CLEANED prior to disinfection, or sterilization, because residual contamination will decrease effectiveness of the germicide."
*"The user MUST adhere to the directions of use, because any modification will affect the safety and effectiveness of the germicide."
*"Metricide solution is intended for use in manual (bucket and tray) systems made from polypropylene, ABS, polyethylene, glass-filled polypropylene or special molded polycarbonate plastics."
*"Blood and other bodily fluids must be thoroughly cleaned from surfaces, lumens, and objects before application of the disinfectant or sterilant."
*"For complete disinfection or sterilization of medical instruments and equipment, thoroughly clean, rinse and rough dry objects before immersing in Metricide, Metricide 28, or Metricide Plus 30 solution. Cleanse and rinse the lumens of hollow instruments before filling with Metricide."
*"High-Level Disinfection (Bucket/tray manual system). Immerse medical equipment/device completely in Metricide solution for a minimum of 45 minutes at 25 degrees Celsius to destroy all pathogenic microorganisms, except for large numbers of bacterial endospores, but including Mycobacterium tuberculosis. Remove devices and equipment from the solution and rinse thoroughly following rinsing instructions below."
*"Rinsing instructions. Following immersion in Metricide solution, thoroughly rinse the equipment or medical device by immersing it completely in three separate copious volumes of water. Each rinse should be a minimum of one minute in duration unless otherwise noted by the device or equipment manufacturer. Use fresh portions of water for each rinse. Discard the water following each rinse. Do not reuse the water for rinsing or any other purpose, as it will be contaminated with glutaraldehyde."
*"Refer to the reusable device/equipment manufacturer's labeling for additional rinsing instructions."
*"Metricide solution has also demonstrated efficacy in the presence of 2% organic soil contamination and a simulated amount of microbiological burden during reuse. This solution may be used and reused within the limitations indicated above for up to 14 days after activation. Do not use activated solution beyond 14 days. Efficacy of this product during its use-life must be verified by a 1.5% glutaraldehyde concentration indicator to determine that the minimum effective concentration of 1.5% is present."
*"During the usage of Metricide solution, as a high-level disinfectant and/or sterilant, it is recommended that a thermometer and timer be utilized to ensure that the optimum usage conditions are met. In addition, it is recommended that the Metricide solution be tested with a 1.5% glutaraldehyde concentration indicator prior to each usage. this is to ensure that the appropriate concentration of glutaraldehyde is present and to guard against a dilution which may lower the effectiveness of the solution below its MEC. The pH of the activated solution may also be periodically checked to verify that the pH of the solution is between 6.5 and 8.5."
*"Once Metricide, Metricide 28 or Metricide Plus 30 solution has been activated, it should be stored in the original container until transferred to the containers in which the immersion for disinfection or sterilization is to take place. Containers should be stored in a well-ventilated, low traffic area at room temperature."

Review of the provider's September 2010 cleaning, disinfection, sterilization and reuse of patient care equipment in the clinic setting policy revealed:
*Semi-critical or critical items (i.e. endoscopy equipment and instruments, etc) shall receive thorough mechanical cleaning to remove organic debris prior to any high-level disinfection or sterilization. See attached sterilization/disinfection table (Source: APIC principles and Practices)
*"Use of high level disinfectants (i.e. 2% glutaraldehydes, 6% H 2 O 2 or .2 % peracetic acid) requires routine testing and logging of solution effectiveness, according to disinfectant guidelines, as well as staff monitoring, as indicated by product literature."
*"Appropriate "soak time" for high level disinfection is 20 minutes. All cleaned equipment must be submerged entirely to achieve effective results."