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Based on record reviews of facility documentation and staff interviews, the facility failed to ensure specific patient rights were protected and promoted; and implement their written policy and procedures that protect and promote each patient's rights for 5 of 15 patients (Patient's #4, #5, #6, #7, and #9) reviewed with a patient rights violation after the implementation of restraints used for medical reasons, and the management of behaviors.

Specifically, the facility failed to ensure:

1.) The use of restraint was in accordance with an order of a physician or other licensed independent practitioner, and authorized to order restraint or seclusion by hospital policy in accordance with State law for Patient's #5 and #7,

2.) That Patient #4 was monitored during restraint with documentation and assessment by a physician, other licensed independent practitioner or appropriate trained staff, and

3.) A physician or other licensed independent practitioner sees the patient; face-to-face within 1-hour after initiation of a restraint used for the management of violent or self-destructive behavior for Patient's #4, #6, and #9.

The regulatory restraint requirements were not met to include; physician orders, monitoring, assessments, and documentation which affected Patient's #4, #5, #6, #7, and #9.

Refer to A0168, A0175, and A0178 for evidence of specific findings.

The cumulative effect of these deficient practices resulted in the facility's inability to meet the Condition of Participation for Patient Rights.

Based on record review of documentation and interview, the facility failed to ensure the use of restraint was in accordance with an order of a physician or other licensed independent practitioner who was responsible for the care of the patient as specified under §482.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law for 2 of 15 Patient's reviewed, (Patient #5 and #7) who had restraints implemented.

This deficient practice affected Patient #5 and #7's rights.

Findings included:

Review of the facility's policy regarding Restraint and Seclusion, effective 12/02/2014, indicated in part; for General Provisions in the area of; Orders, that a "restraint shall be ordered by a physician member of the medical staff." A restraint was defined as any manual method, physical, or mechanical device, material, or equipment that immobilized or reduces the ability of a patient to move his or her arms, legs, body, or head freely.

In the area for Behavioral Restraints; a registered nurse may initiate restraint in advance of the physician's order; and as soon as possible, but no longer than one hour after the initiation of restraint, the registered nurse shall consult with a responsible physician about the patient's physical and psychological status and obtain an order (verbal or written).

In the area of Medical Restraints revealed the indications for medical restraint may be used for the following indications when less restrictive means would not be effective in protecting the patient; i. the patient is pulling at tubes, lines, or dressings. Orders: a. If an attending physician is not available, a registered nurse may initiate restraint in advance of physician's order. i. In some emergency situations, the need for a restraint intervention may occur so quickly that an appropriate order cannot be obtained before the application of restraints. In these emergency situations, the order must be obtained either during the emergency application or immediately after the restraint has been applied. ii. The ordering physician shall authenticate the telephone order for restraints within 24 hours.

Record review of Patient #5's emergency department records and the restraint daily log revealed a medical restraint implemented for a 4-point (both wrists and both ankles), and a vest on 02/13/17 at 16:40 PM. The medical restraint was implemented for interfering with medical interventional devices.

Further review of Patient #5's medical records including all physician orders for 02/13/17 revealed there was not a physician's order obtained for the use and implementation of the medical restraint for Patient #5 on 2/13/17.

Record review of Patient #7's behavioral health inpatient records and the restraint daily log revealed on 2/18/17 he was agitated, combative, and tried attacking staff and attempting to bite the mental health techs. Staff implemented a 3-minute physical hold on Patient #7 according to the flow sheet and restraint daily log; and then placed him in seclusion from 11:10 to 13:30.

Further review of Patient #7's inpatient medical records including all physician orders revealed there was not a physician's order obtained for the implementation of the 3 minute physical hold initiated by staff on 2/18/17. There only was a physician's order obtained for the use of seclusion.

During an interview on 4/26/17 at 12:50 PM with the Quality Director of Nursing (Q-DON) confirmed the above findings for Patient's #5 and #7 after review of the records. Further interview with the Q-DON on 4/27/17 at 09:30 AM confirmed the facility's policy and procedures for restraint were not followed for Patient's #5 and #7 to ensure a physician's order was obtained for the implementation of restraint, as required.

Based on record review of documentation and interviews, the facility failed to ensure that 1 of 15 patients reviewed (Patient #4) who were restrained; were monitored by a physician, other licensed independent practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. Patient #4 was restrained for an undetermined amount of time due to lack of monitoring documentation and assessments by the appropriate staff.

This deficient practice affected Patient #4's rights.

Findings included:

Review of the facility's policy regarding Restraint and Seclusion, effective 12/02/2014, indicated in part, that for behavioral restraints included the requirements for all settings; e. Continuous, in-person observations: i. A competent staff member of the same gender of the patient will monitor patients in behavioral restraint through continuous in-person observation, unless contraindicated by the patient's history. In the area of Monitoring Restraints; i. An appropriately trained staff member shall monitor the patient every 15 minutes thereafter. ii. The monitoring shall include the following, unless it is inappropriate for the type of restraint or seclusion employed: 1. Signs of any injury associated with applying restraint, 2. Nutrition and hydration, 3. Circulation and respirations, 4 hourly range of motion, 5. Vital signs, 6. Hygiene and elimination, 7. Physical and psychological status and comfort, and 8. Readiness for discontinuation of restraint.

Review of Patient #4's emergency department records and restraint daily log revealed he had a behavioral restraint; 4 point (both wrists and both ankles) implemented on 3/10/17 at 21:53 for violent behavior, intended to cause harm to self or others. Patient #4 was noted with altered mental status.

There was no documentation in Patient #4's medical records that he had been monitored following the implementation of the 4 point behavioral restraint on 3/10/17. Patient #4's record did not have documentation of when this restraint was released and there was not any documentation of a physician face to face assessment completed within one hour of restraint application.

During an interview on 4/26/17 at 12:10 PM with the Quality Director of Nursing (Q-DON) confirmed the above findings for Patient #4 after review of the records; which revealed no monitoring following the implementation of restraints on 3/10/17, and it was unknown when Patient #4 was released from restraints since it was not in the nursing flowchart. The Q-DON further stated that it appeared Patient #4's electronic medical record had the "paper records missing from his chart" and were not scanned in.

Based on record review of facility documentation and staff interviews, the facility failed to have a physician or other licensed independent practitioner see the patient; face-to-face within 1-hour after initiation of a restraint used for the management of violent or self-destructive behavior, and according to facility policy for 3 of 12 patients reviewed (Patient #4, #6, and #9) with restraints due to behaviors.

This deficient practice affected the rights for Patient's #4, #6, and #9.

Findings included:

Review of the facility's policy regarding Restraint and Seclusion, effective 12/02/2014, indicated in part, that for behavioral restraints included the requirements for all settings; b. One-hour face-to-face assessment: A physician or a registered nurse who is trained to assess medical and psychiatric stability with demonstrated competence, other than the registered nurse who initiated the use of restraint or seclusion shall conduct a face-to-face evaluation of the patient within one hour following the initiation of restraint or seclusion to personally verify the need for restraint or seclusion.

Record review of Patient #4's emergency department records and restraint daily log revealed he had a behavioral restraint; 4 point (both wrists and both ankles) implemented on 3/10/17 at 21:53 for violent behavior, intended to cause harm to self or others. Patient #4 was noted with altered mental status.

There was no documentation in Patient #4's medical records that a physician face to face assessment was completed for Patient #4 within one hour of restraint application on 3/10/17.

Record review of Patient #6's emergency department records and restraint daily log revealed he had a behavioral 4 point restraint implemented on 3/21/17 from 02:00 to 04:30 for violent behavior, intended to cause harm to self or others.

There was no documentation in Patient #6's medical records that a physician face to face assessment was completed for Patient #6 within one hour of restraint application on 3/21/17.

Record review of Patient #9's behavioral health inpatient records and restraint daily log revealed the physician ordered seclusion for Patient #9 on 3/2/17 for "aggressive and combative behavior; banging head on wall." The seclusion records revealed Patient #9 was in seclusion from 06:15 to 06:30.

There was no documentation in Patient #9's medical records that a physician face to face assessment was completed for Patient #9 within one hour of seclusion implemented on 3/2/17.

During an interview on 4/26/17 at 12:50 PM with the Quality Director of Nursing (Q-DON) confirmed the above findings for Patient's #4, #6, and #9 after review of the records. Further interview with the Q-DON on 4/27/17 at 09:30 AM confirmed the facility's policy and procedures for restraint were not followed for Patient's #4, #6, and #9; and she consulted with the emergency department physician's to explore techniques to ensure the one-hour face-to-face assessments were completed, as required.

Based on review of documentation and interview, it was determined that the hospital failed to develop, implement, and maintain an effective, ongoing, hospital wide, data driven quality assessment and performance improvement program.

1. The facility administrative officials failed to ensure pharmacy staff had a system to track, monitor, and collect date for the medication physical counts and kept accurate records of the disposition of expired drugs.

2. The governing body and administrative officials failed to ensure an effective Quality Program. The administrative officials did not provide quality oversite and monitoring of pharmacy staff not having a way to track expired controlled/narcotic medications once they were removed from circulation. There were no controlled substance medication log for expired controlled/narcotic medications.


Refer to A273 and A309

Based on observations, record reviews and interview, the facility administrative officials failed to ensure pharmacy staff had a system to track, monitor, and collect date for the medication physical counts and kept accurate records of the disposition of expired drugs listed in schedules II, III, IV and V of the Comprehensive Drug Abuse Prevention and Control Act. The facility failed to measure, analyze, and track quality indicators that assess processes of caree, hopsital service and operations.


Findings include:


Observations conducted at the facility's downtown campus on 4/24/17 from 3:00 pm to 3:45 pm, in the pharmacy, revealed the following:

Expired scheduled controlled drugs, which had been removed from patient circulation, were being stored in the omnicell machine in the same area as active medication. The expired narcotics/ controlled drugs were being stored in a small plastic tray on the very bottom shelf of the omnicell machine. Pharmacy staffs were observed frequently going in and out of the omnicell cabinet that contained the expired controlled medications.

In an interview conducted on 4/24/17 at 3:10 pm, the Director of Pharmacy and the on duty Pharmacist were asked by the surveyor how expired controlled drugs were reconciled, accounted for, to include the disposition of the drugs. The Director of pharmacy stated that the expired controlled/ narcotic medications were not counted/ reconciled once they were removed from circulation. When asked if they knew what the current count was for the expired controlled drugs, the director of pharmacy stated he did not know, and was unable to pull the count up in the computer system.

On 4/24/17 at 3:25 pm, The Director of pharmacy was asked to conduct a current count of the expired controlled medications. When pharmacy staff pulled the small plastic tray containing the expired controlled medications out of the omnicell, another small plastic bag containing 3 vials of Ativan (benzodiazepine) 2 mg/ml (milligrams/milliliter) were found underneath the wire grate of the omnicell, at the very back of the machine. At the time of discovery, the Director of pharmacy was asked if he knew how long the Ativan vials had been in the omnicell system. He stated that he did not have any way of knowing how long they had been there.

During an interview conducted on 4/25/17 at 10:50 am, the Director of pharmacy was asked to print out the controlled substance logs for the expired controlled substances for the previous 12 month period (April 2016- April 2017). The director stated that he did not have any controlled substance logs for the expired drugs. He further revealed that he did not have any controlled logs for the expired drugs because, once the medications are removed from circulation, the count balance is zeroed out in the computer system. The surveyor then asked if the facility tracked employee access to the expired controlled medications and how unauthorized personnel were prevented from accessing them. The Director stated that anyone of the pharmacy staffs (16 Technicians) could access the expired controlled medications and that he had no way of knowing who was accessing them because the expired controlled drugs were not being reconciled/ accounted for in the computer system.

Further interview with the Director of Pharmacy, revealed he is not asked to attend a facility QAPI meeting. The Director of Pharmacy revealed the Pharmacy "heads" will conduct their own quality meeting amongst themselves, but only is invited to a QAPI meeting if there is a specific pharmacy issue they need to address..


Interview on 4/25/17 at 2:30 p.m. with the facility Vice President of Quality Performance Management(VP of QPM) revealed each hospital/facility had their own QAPI meetings that the facility directors attend. After those meetings, the Director of Pharmacy should share that information with the Vice President of Pharmacy where he shares that information for the hopsital wide QAPI meeting. The VP of QPM stated she was aware of the pharmacy heads meeting amongst themselves, but was not aware of them not attending their own hopsital QAPI meetings.


Record review of the facility policy and procedure entitled Management of Controlled Substances, Effective date 09/14 revealed in part the following:

Section III, Subsection 1:
-a.) The facility pharmacy has overall responsibility for controlled drugs.
-b) The director of pharmacy, acting as the facility's agent, must ensure that the purchasing, receiving, dispensing, distributing, and administration of controlled drugs are documented adequately by facility staffs.
-c) The director of pharmacy, acting as the facility's agent, must ensure adequate storage and security for controlled drugs in accordance with federal laws and laws of the state.

Section III, Subsection 2:
-Perpetual inventories are maintained by all individuals involved in the distribution and/or administration of controlled substances. A complete and accurate inventory of all controlled substances will be taken as required by the state and Drug Enforcement Agency (DEA).
- a.) Perpetual Inventory Maintenance: Main Pharmacy Vault:
A perpetual inventory will be maintained for all controlled substances and Butorphanol, Carisprodal, Tramadol, Nalbuphine, and Epinephrine. Withdrawls, returns, and receipts will be entered and maintained on the NarcStation.


Record review of the governing body and QAPI meeting minutes from Aril 2016 through April 2017 revealed there was no mention nor documentation of pharmacy not having a way to track and trend expired controll/narcotic medications that were pulled from circulation.

Based on document review the governing body and administrative officials failed to ensure an effective Quality Program. The administrative officials did not provide quality oversite and monitoring of pharmacy staff not having a way to track expired controlled/narcotic medications once they were removed from circulation. There were no controlled substance medication log for expired controlled/narcotic medications.


The findings were:



Observations conducted at the facility's downtown campus on 4/24/17 from 3:00 pm to 3:45 pm, in the pharmacy, revealed the following:

Expired scheduled controlled drugs, which had been removed from patient circulation, were being stored in the omnicell machine in the same area as active medication. The expired narcotics/ controlled drugs were being stored in a small plastic tray on the very bottom shelf of the omnicell machine. Pharmacy staffs were observed frequently going in and out of the omnicell cabinet that contained the expired controlled medications.

In an interview conducted on 4/24/17 at 3:10 pm, the Director of Pharmacy and the on duty Pharmacist were asked by the surveyor how expired controlled drugs were reconciled, accounted for, to include the disposition of the drugs. The Director of pharmacy stated that the expired controlled/ narcotic medications were not counted/ reconciled once they were removed from circulation. When asked if they knew what the current count was for the expired controlled drugs, the director of pharmacy stated he did not know, and was unable to pull the count up in the computer system.

On 4/24/17 at 3:25 pm, The Director of pharmacy was asked to conduct a current count of the expired controlled medications. When pharmacy staff pulled the small plastic tray containing the expired controlled medications out of the omnicell, another small plastic bag containing 3 vials of Ativan (benzodiazepine) 2 mg/ml (milligrams/milliliter) were found underneath the wire grate of the omnicell, at the very back of the machine. At the time of discovery, the Director of pharmacy was asked if he knew how long the Ativan vials had been in the omnicell system. He stated that he did not have any way of knowing how long they had been there.

During an interview conducted on 4/25/17 at 10:50 am, the Director of pharmacy was asked to print out the controlled substance logs for the expired controlled substances for the previous 12 month period (April 2016- April 2017). The director stated that he did not have any controlled substance logs for the expired drugs. He further revealed that he did not have any controlled logs for the expired drugs because, once the medications are removed from circulation, the count balance is zeroed out in the computer system. The surveyor then asked if the facility tracked employee access to the expired controlled medications and how unauthorized personnel were prevented from accessing them. The Director stated that anyone of the pharmacy staffs (16 Technicians) could access the expired controlled medications and that he had no way of knowing who was accessing them because the expired controlled drugs were not being reconciled/ accounted for in the computer system.

Further interview with the Director of Pharmacy, revealed he is not asked to attend a facility QAPI meeting. The Director of Pharmacy revealed the Pharmacy "heads" will conduct their own quality meeting amongst themselves, but only is invited to a QAPI meeting if there is a specific pharmacy issue they need to address..


Interview on 4/25/17 at 2:30 p.m. with the facility Vice President of Quality Performance Management(VP of QPM) revealed each hospital/facility had their own QAPI meetings that the facility directors attend. After those meetings, the Director of Pharmacy should share that information with the Vice President of Pharmacy where he shares that information for the hopsital wide QAPI meeting. The VP of QPM stated she was aware of the pharmacy heads meeting amongst themselves, but was not aware of them not attending their own hopsital QAPI meetings.


Record review of the facility policy and procedure entitled Management of Controlled Substances, Effective date 09/14 revealed in part the following:

Section III, Subsection 1:
-a.) The facility pharmacy has overall responsibility for controlled drugs.
-b) The director of pharmacy, acting as the facility's agent, must ensure that the purchasing, receiving, dispensing, distributing, and administration of controlled drugs are documented adequately by facility staffs.
-c) The director of pharmacy, acting as the facility's agent, must ensure adequate storage and security for controlled drugs in accordance with federal laws and laws of the state.

Section III, Subsection 2:
-Perpetual inventories are maintained by all individuals involved in the distribution and/or administration of controlled substances. A complete and accurate inventory of all controlled substances will be taken as required by the state and Drug Enforcement Agency (DEA).
- a.) Perpetual Inventory Maintenance: Main Pharmacy Vault:
A perpetual inventory will be maintained for all controlled substances and Butorphanol, Carisprodal, Tramadol, Nalbuphine, and Epinephrine. Withdrawls, returns, and receipts will be entered and maintained on the NarcStation.


Record review of the governing body and QAPI meeting minutes from Aril 2016 through April 2017 revealed there was no mention nor documentation of pharmacy not having a way to track and trend expired controll/narcotic medications that were pulled from circulation.

Based on observations, record reviews and interview, the facility's pharmaceutical services failed to:

1.) Ensure pharmacy staff conducted physical counts and kept accurate records of the receipt and disposition of expired drugs listed in schedules II, III, IV and V of the Comprehensive Drug Abuse Prevention and Control Act; and

2.) Ensure expired drugs listed in schedules II, III, IV and V of the Comprehensive Drug Abuse Prevention and Control Act were kept under proper security to minimize unauthorized access.

This deficient practice placed the facility at increased risk of experiencing serious drug diversions and/or adverse patient outcomes.

The cumulative effect of these deficient practices resulted in the facility's inability to meet the Condition of Participation for Pharmaceutical Services.

Refer to TAGS A0494 and A0504

Based on observations, record reviews and interview, the facility failed to ensure pharmacy staff conducted physical counts and kept accurate records of the disposition of expired drugs listed in schedules II, III, IV and V of the Comprehensive Drug Abuse Prevention and Control Act.

This deficient practice placed the facility at increased risk of experiencing drug diversions.

Findings include:

Observations conducted at the facility's downtown campus on 4/24/17 from 3:00 pm to 3:45 pm, in the pharmacy, revealed the following:

Expired scheduled controlled drugs, which had been removed from patient circulation, were being stored in the omnicell machine in the same area as active medication. The expired narcotics/ controlled drugs were being stored in a small plastic tray on the very bottom shelf of the omnicell machine. Pharmacy staffs were observed frequently going in and out of the omnicell cabinet that contained the expired controlled medications.

In an interview conducted on 4/24/17 at 3:10 pm, the Director of Pharmacy and the on duty Pharmacist were asked by the surveyor how expired controlled drugs were reconciled, accounted for, to include the disposition of the drugs. The Director of pharmacy stated that the expired controlled/ narcotic medications were not counted/ reconciled once they were removed from circulation. When asked if they knew what the current count was for the expired controlled drugs, the director of pharmacy stated he did not know, and was unable to pull the count up in the computer system.

On 4/24/17 at 3:25 pm, The Director of pharmacy was asked to conduct a current count of the expired controlled medications. When pharmacy staff pulled the small plastic tray containing the expired controlled medications out of the omnicell, another small plastic bag containing 3 vials of Ativan (benzodiazepine) 2 mg/ml (milligrams/milliliter) were found underneath the wire grate of the omnicell, at the very back of the machine. At the time of discovery, the Director of pharmacy was asked if he knew how long the Ativan vials had been in the omnicell system. He stated that he did not have any way of knowing how long they had been there.

During an interview conducted on 4/25/17 at 10:50 am, the Director of pharmacy was asked to print out the controlled substance logs for the expired controlled substances for the previous 12 month period (April 2016- April 2017). The director stated that he did not have any controlled substance logs for the expired drugs. He further revealed that he did not have any controlled logs for the expired drugs because, once the medications are removed from circulation, the count balance is zeroed out in the computer system. The surveyor then asked if the facility tracked employee access to the expired controlled medications and how unauthorized personnel were prevented from accessing them. The Director stated that anyone of the pharmacy staffs (16 Technicians) could access the expired controlled medications and that he had no way of knowing who was accessing them because the expired controlled drugs were not being reconciled/ accounted for in the computer system.

Record review of the facility policy and procedure entitled Management of Controlled Substances, Effective date 09/14 revealed in part the following:

Section III, Subsection 1:
-a.) The facility pharmacy has overall responsibility for controlled drugs.
-b) The director of pharmacy, acting as the facility's agent, must ensure that the purchasing, receiving, dispensing, distributing, and administration of controlled drugs are documented adequately by facility staffs.
-c) The director of pharmacy, acting as the facility's agent, must ensure adequate storage and security for controlled drugs in accordance with federal laws and laws of the state.

Section III, Subsection 2:
-Perpetual inventories are maintained by all individuals involved in the distribution and/or administration of controlled substances. A complete and accurate inventory of all controlled substances will be taken as required by the state and Drug Enforcement Agency (DEA).
- a.) Perpetual Inventory Maintenance: Main Pharmacy Vault:
A perpetual inventory will be maintained for all controlled substances and Butorphanol, Carisprodal, Tramadol, Nalbuphine, and Epinephrine. Withdrawls, returns, and receipts will be entered and maintained on the NarcStation.

Based on observation, interview, and record review, the facility failed to ensure expired drugs listed in schedules II, III, IV and V of the Comprehensive Drug Abuse Prevention and Control Act were kept under proper security to minimize unauthorized access.

This deficient practice placed the facility at increased risk of experiencing serious drug diversions and/or adverse patient outcomes.

Findings include:

Observations conducted at the facility's downtown campus on 4/24/17 from 3:00 pm to 3:45 pm, in the pharmacy, revealed the following:

Expired scheduled controlled drugs, which had been removed from patient circulation, were being stored in the omnicell machine in the same area as active medication. The expired narcotics/ controlled drugs were being stored in a small plastic tray on the very bottom shelf of the omnicell machine. Pharmacy staffs were observed frequently going in and out of the omnicell cabinet that contained the expired controlled medications.

During an interview conducted on 4/25/17 at 10:50 am, the Director of pharmacy was asked if the facility tracked employee access to the expired controlled medications and how unauthorized personnel were prevented from accessing them. The Director stated that anyone of the pharmacy staffs (16 Technicians) could access the expired controlled medications and that he had no way of knowing who was accessing them because the expired controlled drugs were not being reconciled/ accounted for in the computer system.

Record review of the facility policy and procedure entitled Management of Controlled Substances, Effective date 09/14 revealed in part the following:

- Section III:
-a.) The facility pharmacy has overall responsibility for controlled drugs.
-b) The director of pharmacy, acting as the facility's agent, must ensure that the purchasing, receiving, dispensing, distributing, and administration of controlled drugs are documented adequately by facility staffs.
-c) The director of pharmacy, acting as the facility's agent, must ensure adequate storage and security for controlled drugs in accordance with federal laws and laws of the state.

Based on observation, interview and hospital policy review, the North Central Baptist Hospital failed to meet the requirement because it did not follow hospital policy on sterile processing in that a pair of Jameson scissors was available for use that did not have a load control identification label that indicated the sterilizer used, cycle or load number, date of sterilization and identification of the staff member that packaged them. Instruments with unprotected sharp tips had been packaged in peel pouches such that the integrity of the packaging could be breached, a towel clip had been processed in a closed position such that it could not be determined that the entire instrument had been exposed to the sterilization process and were not labeled with the initials of the staff member that packaged them.

Findings Included:

During a tour of the sterile instrument room at North Central Baptist Hospital, on 04/25/17 at 12:30 p.m. accompanied by S#25, observation revealed the following instruments were available for patient use:

A pair of Jameson scissors that did not have a load control identification label that indicated the sterilizer used, the cycle or load number, date of sterilization and did not identify the staff that packaged them.

A pair of S retractors, a pair of Ragnell retractors, a Pituitary Ronguer, and an Ortho Caliper in peel pouches that did not include the initials of the staff member that packaged them.

A skin hook, a gelpi retractor and a pair of Jameson scissors with unprotected sharp tips had been packaged in peel pouches.

A towel clip that had been packaged in a closed position in a peel pouch.

In an interview on 04/25/17 at 12:30 p.m. in the sterile instrument room, S#25 confirmed the above findings.

Review of a hospital policy entitled, Infection Control in Sterile Processing, document #NURS-SS-SP-05 with an effective date of 05/16 revealed it stated the following in part on page 3 on 04/25/17 at 3:20 p.m.:

F. Packages to be sterilized should be labeled before sterilization. The label information should include, but not limited to:

Appropriate identification of package contents clearly marked with the sterilization date on the outside of the wrapper or container.

Sterilizer load/lot number. The corresponding load/lot number is documented on the Sterilization Log (NURS-SS-SP-6) record to assist with recall procedures as necessary.

A method to identify the package assembler.