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Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.25, PHARMACEUTICAL SERVICES was out of compliance.

A-494 - Standard: Current and accurate records must be kept of the receipt and disposition of all scheduled drugs. The facility failed to maintain accurate drug records which showed disposition of controlled medications and reconciliation of any variances which occurred. Additionally, the facility failed to have a standard process to investigate improper practices regarding controlled medication which would minimize the time frame between detection and determination of the extent of loss or diversion. This failure created the potential for drug diversion and had the potential to affect all patients within the facility.

A-505 - Standard: Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use. The facility failed to ensure outdated medications were removed from stock according to the manufacture's expiration date. This failure created the potential for patients to receive expired medications.

Based on interviews and document review, the facility failed to maintain accurate drug records which showed disposition of controlled medications and reconciliation of any variances, which occurred during transfer from the pharmacy's Automatic Dispensing Cabinet (ADC) to the patient care units. Additionally, the facility failed to have a standard process to investigate improper practices regarding controlled medications, which would minimize the time frame between detection and determination of the extent of loss or diversion.

This failure created the potential for drug diversion and had the potential to affect all patients within the facility.

FINDINGS:

POLICY

According to the policy, Medication Diversion Prevention Policy (Section V-Preparing and Dispensing), for Automatic Dispensing Cabinets (ADC), the authorized staff member would stock the ADC and verify the inventory count. The verification could occur electronically (e.g. Pyxis CII Safe Compare Report) or the authorized staff member would print a proof of deliver report. This would be reconciled and signed by the Pharmacist, Administrator or Practice Manger, filed and stored.

Further, the policy noted any remaining controlled medication packaged in an amount larger than the dose being administered must be wasted immediately.

The CEO, Administrator, or Practice Manager, along with the Director of Pharmacy is responsible for controlled medication oversight, including tracking and reporting of inappropriate controlled medication usage.

Each facility should form a multidisciplinary team that is charged with developing a coordinated and systematic approach to prevention and detection of medication diversion.

1. Pharmacy staff did not reconcile Pyxis CII Safe Compare Reports (Compare Reports) to ensure controlled medications (a drug for which control and regulation has been declared due to the danger of addiction, abuse, physical and mental harm, trafficking by illegal means and the dangers from actions of those who have used the substances) removed from the pharmacy's ADC were delivered to the intended patient care unit. Additionally, the facility did not have a process in place to ensure the Compare Reports were printed and reconciled.

a) On 02/11/16 at 11:31 a.m., an interview was conducted with a Pharmacy Technician (PT #19) who stated the Compare Report would show controlled medications removed from the main pharmacy ADC not yet stocked at the intended unit's ADC. S/he further stated, at the end of each PT shift the Compare Report should have been printed and if there was a variance on the report, the PT should have noted the reason for the variance. PT #19 stated the report verified what medications were removed from the main pharmacy safe and sent to the patient care units. S/he further stated the report ensured everything removed from the pharmacy safe was delivered to the intended destination. PT #19 stated the report needed to be reconciled in order for variances to be investigated as soon as possible. PT #19 stated all PTs had been trained on the Compare Report process.

b) Review of the Compare Report, printed 12/10/15 at 4:00 p.m., revealed 20 Pregabalin 100 milligram (MG) capsules (a medication used to treat epilepsy, neuropathic pain, fibromyalgia and generalized anxiety disorder) were sent from the main pharmacy ADC with the intent to be stocked in the 6th floor ADC at 6:55 a.m. There was no evidence the controlled medication was stocked on the 6th floor at the time the report was printed. The variance listed on the report was not reconciled and lacked evidence of an investigation. Approximately 4 1/2 hours later a second Compare Report was printed at 8:27 p.m. The 20 Pregabalin 100 mg capsules remained listed on this report. The second report showed no evidence pharmacy staff investigated the variance. Four days lapsed without any evidence showing the 20 Pregabalin capsules were stocked in the 6th floor ADC.

c) The Compare Reports were not printed for 16 of 31 days for the month of December 2015. Out of the 15 days the reports were printed, only 3 of those days had a report for each shift (2 shifts per day). Furthermore, the reports lacked evidence pharmacy staff investigated and reconciled the variances listed on the reports.

Review of January 2016 Compare Reports revealed 9 of 31 days did not have Compare Reports printed. Out of the 22 days the reports were printed, only 6 of those days had a report for each shift (2 shifts per day).

d) Review of the Compare Report, printed on 02/04/16 at 4:33 p.m., revealed a variance for 10 Oxycodone CR 10 mg tablets (an opioid pain medication used to treat moderate to severe pain) which were sent from the main pharmacy's ADC to the Surgical Orthopedic Center (SOC) medication station at 4:24 p.m. There was no evidence pharmacy staff reviewed the Compare Report or printed follow up reports showing the medication was stocked in the SOC's ADC. The next Compare Report printed was dated 02/09/16 at 3:09 p.m. Four days lapsed without any evidence showing the controlled medication was received at the intended location.

e) On 02/10/16 at 1:08 p.m., an interview was conducted with the Director of Pharmacy (Pharmacist #14) who stated the Compare Reports were used to track the movement of controlled medications from the main pharmacy ADC to the patient care unit's ADCs. Pharmacist #14 stated if the controlled medication was not loaded into the unit's ADC, it would show on the Compare Report as a variance.

All pharmacy staff present for the interview confirmed a lapse of Compare Reports from 02/05/16 through 02/08/16. All agreed this was too long of a time frame to wait for a variance to be found.

f) On 02/12/16 at 11:15 a.m., an interview was conducted with Pharmacist #14 who stated the variance report was printed each shift so PTs could track the controlled medication transferred from the pharmacy ADC to the patient care unit ADC locations. Pharmacist #14 stated PTs were responsible for reviewing and reconciling the report each shift. S/he further stated the investigation process for the variances listed on the Compare Reports could use more detail.

Pharmacist #14 stated s/he was now aware of the missing Compare Reports, and stated the lack of reports and variance reconciliation could lead to a drug diversion being overlooked.

2. The facility failed to complete monthly Compare Report audits to ensure variances listed on the audits were reconciled.

a) On 02/10/16 at 1:08 p.m., the surveyor requested the monthly variance report audits for the prior 6 months.

At 5:07 p.m., (4 hours later), Pharmacist #14 provided the monthly Compare Report audits. Pharmacist #14 stated there may be "gaps" in the audits provided by him/her and the Pharmacy Clinical/Operations Specialist (Pharmacist #20) was still looking for the missing audits.

b) On 02/11/16 at 12:46 p.m., an interview was conducted with Pharmacist #20 who stated s/he was responsible for the monthly audits of the Compare Reports printed by the pharmacy technicians. Pharmacist #20 stated s/he was responsible for monitoring and reconciling the Compare Reports for variances.

Audits were requested for December 2015 and January 2016. Review of the audits, provided by Pharmacist #20, revealed the audits were not conducted until after the meeting with the surveyor on 02/10/16 at 12:30 p.m. (1 day prior). The Compare Reports attached to the audit sheets had a print date of 02/10/16 at 4:39 p.m. Pharmacist #20 was asked if audits were completed prior to the survey, and s/he stated "no." Pharmacist #20 then stated his/her priority was nursing diversion audits, and when s/he had time, the other pharmacy department audits would be done.

c) On 02/12/16 at 11:15 a.m., an interview was conducted with Pharmacist #14 who stated Pharmacist #20 audited the Compare Reports once a month to ensure the facility was tracking controlled medications dispensed from the pharmacy safe to the nursing units. Pharmacist #14 stated s/he was now aware of the missing audits and reports, and confirmed this failure could lead to a drug diversion being overlooked.



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3. The facility failed to have a standard process to investigate improper practices regarding controlled medications which would minimize the time frame between detection and determination of the extent of loss or diversion.

a) An interview with Pharmacist #14, on 02/10/16 at 10:06 a.m., revealed the facility had a Diversion Management Committee which met monthly to review individuals who did not meet the facility's expectations for managing controlled medications or were at risk for drug diversion.

Meeting minutes were requested from the Diversion Management Committee meetings. Pharmacist #14 stated there were no formal meeting minutes from the committee.

The Pharmacist stated pharmacy staff would monitor the RxAuditor reports, a report that identified staff who were statistically significant above peers in accessing, administering and wasting controlled medications, monthly to help identify outliers. The Pharmacist would bring those findings to the committee meetings to discuss. If Pharmacist #14 had a concern or the committee wanted to do a "deeper dive" on an identified staff member s/he would create an individual tracking folder to bring to the committee.

Pharmacist #14 provided a tracking folder for Registered Nurse #15 (RN). The folder revealed the facility had a concern in October 2014 regarding RN #15's practices with controlled medications. Inside the front cover it was noted the committee met regarding RN #15 on 10/20/14. The committee noted RN #15 was a contracted employee who would be counseled and repeat audits would be conducted. Pharmacist #14 confirmed the information during an interview on 02/12/16 beginning at 11:16 a.m.

There was no additional information in the tracking folder on what was discussed with RN #15 or if the RN was counseled. Additionally, there was no documentation to show if drug diversion had been investigated and ruled out.

During an interview with Pharmacist #14 and the Chief Nursing Officer (CNO #16), on 02/12/16 at 11:16 a.m., CNO #16 stated the facility would have met with RN #15 but it would have been up to the contracting agency to complete the counseling. CNO #16 stated the contracting agency would maintain documentation of the counseling and s/he was not sure if the facility had a copy.

As of the survey exit, on 02/12/16 at 4:00 p.m., no documentation of counseling for RN #15 had been provided.

b) Review of RN #15's tracking folder showed the facility identified subsequent concerns and began auditing RN #15's controlled medication practices again in September 2015.

According to the Controlled Substance Audit Summary for September 2015, 17 patients cared for by RN #15 were reviewed with 3 discrepancies noted.

- On 09/02/15, RN #15 withdrew Fentanyl 100 mcg/2ml amp (a powerful synthetic opiate analgesic similar to but more potent than morphine). RN #15 administered 50 mcg. There was "missing documentation of waste for remaining 50 mcg."

- On 09/12/15, RN #15 withdrew Hydromorphone 1 mg/ml syringe (an opioid pain medication) and administer 0.5 mg. There was no documentation of waste or administration for remaining 0.5 mg.

- On 09/22/15, the RN withdrew Fentanyl 100 mcg/2ml amp and administered 50 mcg. There was no documentation of waste or administration for the remaining 50 mcg.

The Controlled Substance Audit Summary for October 2015, showed RN #15 had 9 patients reviewed which resulted in 9 discrepancies. As example:

- On 10/21/15 RN #15 removed Fentanyl 100 mcg from the Pyxis at 10:04 a.m. At 1:48 p.m. (over 3 3/4 hours later) the RN had a late restock of the entire dose.

- On 10/13/15 RN #15 removed Fentanyl 100 mcg and administered 50 mcg. Additionally the RN removed Hydromorphone 1 mg and administered only .75 mg. The excess Fentanyl 50 mcg and Hydromorphone .25 mg were not wasted until 3 hours after they had been removed from the Pyxis.

Review of the November 2015 Controlled Substance Audit Summary, showed the facility reviewed 29 patients cared for by RN #15 and identified 5 discrepancies. As example:

- On 11/11/15 RN #15 removed Fentanyl 100 mcg at 10:41 a.m. S/he did not administer and waste the excess medication until 1:40 p.m., 3 hours after it had been removed from the Pyxis.

- On 11/12/15 the RN removed Fentanyl 100 mcg. There was no documentation of administration, waste or return associated with the removal.

c) Review of an undated log sheet, provided by Pharmacist #14 and used to track individuals the Diversion Management Committee met on, showed the committee once again met to discuss RN #15 on 12/02/15. The log noted the committee reviewed 15 patients who RN #15 cared for and had an "issue" with late wasting and late restocking with controlled medications. The action identified on the log was to have the "director" meet with the employee and according to the log an email was sent to the Assistant Vice President of Surgical Services (AVP #2) on 12/07/15.

On 02/11/16, the surveyor requested any emails AVP #2 had received regarding RN #15. AVP #2 presented an email, dated 11/26/13 (over 2 years earlier), which showed the facility had a concern with RN #15's wasting of controlled substances. AVP #2 had no additional documentation regarding RN #15.

There was no documentation the facility met with RN #15 to discuss identified concerns and determine if drug diversion had occurred.

Subsequent to the committee's meeting on 12/02/15, RN #15 continued to have discrepancies noted on the Controlled Substance Audit Summary. According to the December 2015 report, 15 patients were reviewed and 5 discrepancies were noted. As example:

- On 12/29/15 RN #15 removed Fentanyl 100 mcg at 10:00 a.m. S/he administered 50 mcg and did not waste the remaining 50 mcg until 1:04 p.m., more than 3 hours after removal and administration.

- On 12/30/15 the RN removed Fentanyl 100 mcg at 9:17 a.m. and administered 50 mcg. There was no documentation of administration or waste for the remaining Fentanyl 50 mcg.

During an interview, on 02/11/16 at 3:49 p.m., AVP #2 stated s/he had not had any conversations regarding controlled medication discrepancy concerns with RN #15 until the day before. AVP #2 stated Pharmacist #14 stopped him/her in the hall on 02/10/16 (after the Pharmacist's interview with the surveyors) and told him/her RN #15 was holding on to controlled medications for too long. AVP #2 stated the expectation was for PACU (post-anesthesia care unit) staff to administer the controlled medication within 5-10 minutes. S/he noted holding on to controlled medications for 60 minutes or more was not acceptable.

AVP #2 stated s/he had a conversation with RN #15 about medication practices but it was informal and not documented.

Review of documents provided showed the facility had intermittently monitored and identified concerns with RN #15's practices for management of controlled medications for over 2 years.

As of the survey exit there was no documentation the facility and contracting agency met with RN #15 after identified concerns regarding controlled medication practices for each of the previous 5 months, to determine if drug diversion had occurred.

Based on observation, interviews, and document review, the facility failed to ensure outdated medications were removed from stock according to the manufacturer's expiration date.
This failure created the potential for patients to receive expired medications.

FINDINGS:

POLICY

According to policy, Outdated Drugs/Drug Disposal, all medication stock will be inspected to insure the prompt removal of outdated drugs from stock and subsequent storage and disposition.

1. The facility failed to ensure outdated medications were removed from patient care units and not available for patient use.

a) On 02/10/16 at 8:51 a.m., a tour of the 7th floor Neuro/Spine unit was conducted with Director #27 and Charge Nurse #28. During the tour, 6 outdated multi-dose vials of 0.9% Sodium Chloride (30 milliliter vials) were found in the patient supply room. The vials had a manufacturer expiration date of November 2015. Charge #28 stated the Central Supply Department was responsible for monitoring outdated supplies. S/he further stated the outdated vials should have been discarded.

b) On 02/10/16 at 9:30 a.m., an interview was conducted with Pharmacist #30 who stated 0.9 % Sodium Chloride vials were used when intravenous antibiotics needed to be diluted prior to being administered to patients. Pharmacist #30 stated outdated medication vials should have been discarded per the manufacture's date on the vial.

c) On 02/11/16 at 11:31 a.m., an interview was conducted with Pharmacy Technician #19 who stated medications should have been discarded by the manufacturer recommendations printed on the vial.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.42, INFECTION CONTROL, was out of compliance.

A-0749 - Standard: The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. The facility failed to maintain appropriate infection control processes in the areas of humidity levels in the surgical department, integrity of patient care supplies, and cleaning/disinfection of surgical supplies, equipment and operating rooms. These failures created the potential for transmission of health care acquired infections to patients receiving care in the facility.

Based on observation, interviews and document review, the facility failed to maintain appropriate infection control processes in the areas of humidity levels in the surgical department, integrity of patient care supplies, and cleaning/disinfection of surgical supplies, equipment and operating rooms. Additionally, the facility failed to ensure staff followed infection control processes when performing patient care tests at the bedside in 1 of 1 observations conducted (Patient P).

These failures created the potential for transmission of health care acquired infections to patients receiving care in the facility.

FINDINGS:

POLICY

According to Temperature & Humidity Control in the Operating Room (OR), The current requirements per Association of periOperative Registered Nurses (AORN) and National Fire Protection Association are 20-60% humidity. If the temperature and humidity ranges fall out of the recommended levels, the OR staff will notify facilities management as soon as possible.

According to Reprocessing of Flexible Endoscopes, Hang the endoscope vertically with the distal tip hanging freely in a clean, well-ventilated, dust free area.

According to Surgery/Delivery In-Between Case Cleaning, Equipment and Supplies included a lobby dust pan and broom.

According to Terminal Cleaning Sterile & Delivery Areas, Equipment and Supplies included a lobby dust pan and broom.

According to Clinical Guidance: Blanket/Fluid/Solution Warming - Refrigeration Guidelines, For IV fluids in Fluid Warmers, remove on or before 14 days.

According to Temperature Control of Surgical Patients, The manufacturer's guidelines will be followed when bagged fluids are warmed through a fluid warming device.

According to Re-Use of Disposable Medical Supplies and Equipment, Single-use or disposable medical supplies and equipment shall not be re-used or resterilized. If a single-use sterile item is opened and not used, it shall be discarded.

According to Nova Bedside Glucose Policy, Standard precautions will be observed for the collection and handling of all blood specimens. Only the meter and the test strip to be used should go into a patient's room. For a finger puncture, cleanse the fingertip with soap and water and wipe dry with cotton ball or allow to air dry.

REFERENCE

According to the Association of periOperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2015:

Recommendation IVe.1. (page 276), The relative humidity in a restricted area should be maintained within a range of 20% to 60%.

Recommendation IX.a. (page 594), Flexible endoscopes should be stored in a closed cabinet and hanging in a secure vertical position. When flexible endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential development of an environment conductive to microbial growth in the endoscope.

Recommendation II.d. (page 13), Floors should be mopped with damp or wet mops. Dry methods of environmental cleaning (i.e., dusting, sweeping) should not be used in semi-restricted and restricted areas.

Recommendation II.b. (page 12), All horizontal surfaces in the OR (e.g., furniture, surgical lights, booms, equipment) should be damp dusted before the first scheduled surgical or other invasive procedure of the day.

Recommendation II.b.1 (page 530), Fluids kept in a warming cabinet should be labeled with an expiration date based on the manufacturer's recommendation for storage above room temperature.

According to the Manufacturer's Instructions for the Olympus Evis Exera II Ultrasound Gastrovideoscope, Hang the endoscope in the storage cabinet with the distal end hanging freely. Make sure that the insertion section hangs vertically and as straight as possible.

1. The facility used dry dusting brooms to clean OR suites.

a) On 02/11/16 at 10:55 a.m., a tour of the Main OR Department revealed the following brooms located in the restricted areas of the department:

- One broom was observed on a janitor's cart located in a hallway outside of OR #5, OR #6, OR #7, and OR #8.

- One broom was observed on a janitor's cart located in a hallway outside of the sub-sterile room located between OR #1 and OR #2.

- One broom was observed in the janitor's closet located in the restricted area of the surgical department.

b) On 02/09/16 at 12:45 p.m., an interview with two Environmental Service Staff Members (Employee #3 and Employee #4) was conducted. Employee #3 stated s/he would use brooms to sweep the OR suites. Employee #4 explained s/he would begin cleaning OR suites by using a black broom to sweep the floor followed by using a wet mop.

c) On 02/09/16 at 11:00 a.m., an interview was conducted with the Director of the OR (Director #1) who stated s/he was unaware that Environmental Staff were using brooms to sweep the floors in the OR suites. Director #1 further stated the expectation was for staff to first dry mop the floors and then use a wet mop. This was in contrast with AORN guidelines which stated damp or wet mops should have been used to mop floors.

d) On 02/11/16 at 3:39 p.m., an interview was conducted with the Infection Prevention Manager (IP #13) who confirmed the facility followed AORN guidelines for infection control practices in the surgical department. IP #13 stated s/he was unaware of brooms being used to sweep the OR suites and they should not have been used because of the possibility of aerosolizing infectious particles in the air.

An additional interview with IP #13 was conducted on 02/12/16 at 2:44 p.m. During this interview, IP #13 explained s/he would spend approximately 10-15% of his/her time focusing on infection control in the Surgical Department. IP #13 stated s/he would try to conduct monitoring rounds in one of the surgical units monthly which would involve looking for anything that would draw his/her attention to a breech in infection control. IP #13 then stated s/he did not document the rounds being done or if any findings were communicated to staff in the surgical department.

2. The facility did not store reprocessed endoscopes in a manner to avoid contamination or growth of microorganisms.

a) On 02/09/16 at 1:30 p.m., the Main OR department's endoscope storage cabinet was observed with a Surgical Technician (ST #5). Inside the storage cabinet an endoscope was observed hanging from a hook with the distal tip wrapped around the hook, which created a complete coil in the endoscope.

During the observation, ST #5 stated there probably was not ample space available when the scope was placed in the closet and that was the reason why it was looped around the hook. ST #5 then proceeded to readjust the endoscope to hang in a vertical position.

b) On 02/11/16 at 9:37 a.m., an interview was conducted with Director #1 who confirmed the expectation was for scopes to be stored in a vertical position after reprocessing in order to be able to dry completely.

c) On 02/11/16 at 3:39 p.m., an interview was conducted with IP #13 who stated the expectation was for endoscopes to be stored in a vertical position in order to decrease the risk of bacterial growth by allowing any residual water from reprocessing the endoscope to drain.

3. The facility did not clean OR suites in accordance with national standards of care before the first scheduled procedure of the day.

a) On 02/08/16 at 9:12 a.m., an interview was conducted with an OR Registered Nurse (RN #6) who stated s/he would not routinely clean the OR suite s/he was assigned to before the first scheduled procedure of the day unless s/he noticed something in the room that needed to be cleaned.

On 02/08/16 at 9:17 a.m., an interview was conducted with Surgical Technicians (ST #11 and ST #12). ST #11 revealed s/he was precepting ST #12 who was on orientation. ST #11 stated s/he would not wipe down horizontal surfaces in OR suites before the first case of the day because they had been terminally cleaned the night before.

On 02/10/16 at 1:44 p.m., an interview was conducted with an OR RN (RN #7) who stated since OR suites were terminally cleaned overnight staff did not clean them before the first procedure of the day unless they were visibly soiled. RN #7 further stated s/he felt there would not be enough time to clean OR suites before the first case of the day.

b) On 02/11/16 at 9:37 a.m., an interview was conducted with Director #1 who revealed OR suites were terminally cleaned each night between 7:00 p.m. and 4:00 a.m. Director #1 stated s/he did not think it was necessary to clean the OR suites in the morning before the first case of the day since they had been terminally cleaned the night before. This was in contrast to the AORN recommendation which stated all horizontal surfaces in the OR should be damp dusted before the first scheduled surgical or other invasive procedure of the day.

c) On 02/11/16 at 3:39 p.m., an interview was conducted with IP #13 who explained since OR suites were terminally cleaned during the night it was not expected for staff to clean the suites before the first case of the day. IP #13 stated s/he was not aware of the AORN recommendation which stated all horizontal surfaces in the OR should be damp dusted before the first scheduled surgical or other invasive procedure of the day. IP #13 then stated the facility should have been cleaning the OR suites before the first case of the day in accordance with AORN guidelines.

4. The facility did not ensure intravenous (IV) fluids stored in warming cabinets were safe for patient use.

a) On 02/09/16 at 10:55 a.m., a tour of the Main OR department revealed the following IV fluid bags stored in fluid warming cabinets past the expected discard date:

- In the sub-sterile room located between OR #7 and OR #8, one 1000 ml bag of Lactated Ringer's IV fluid was observed in a fluid warming cabinet with the date of 2/8 written on the bag.

- In the sub-sterile room located between OR #9 and OR #10, two 3000 ml bags of 0.9% Normal Saline IV fluid were observed in a fluid warming cabinet with the date of 2/5 written on the bag.

b) On 02/11/16 at 9:37 a.m., an interview was conducted with Director #1 who confirmed the date written on the IV fluid bags indicated the date the fluid should have been discarded. Director #1 explained the facility followed AORN guidelines and facility policies when storing IV fluids in the warming cabinets, which instructed to discard IV fluids in warming cabinets after 14 days.

c) On 02/11/16 at 3:39 p.m., an interview was conducted with IP #13 who confirmed the facility's expectation was for IV fluids to be removed and discarded from the fluid warming cabinet when they were expired in order to decrease the risk of bacterial growth in the fluid.

5. Staff in the Pre-Operative Unit did not ensure single use patient care supplies were stored in their protective packaging and safe for patient use.

a) On 02/09/16 at 9:45 a.m., a tour of the Main Preop (pre-operative) Unit and the Main PACU (post-anesthesia care unit) was conducted. Observations during the tour revealed the following patient care supplies:

- In the Preop Unit Medication Room, two sets of IV tubing without the manufacturer's protective packaging were observed on a shelf.

- In Bay #5 of the PACU, one oxygen mask with the manufacturer's protective packaging ripped open was observed in the third drawer of a storage cart.

b) On 02/09/16 at 10:08 a.m., an interview was conducted with the Director of the Preop Unit and PACU (Director #8), who stated any patient care supplies found out of their packaging should not have been used and should have been discarded.

c) On 02/11/16 at 3:39 p.m., an interview was conducted with IP #13 who confirmed the expectation was for staff to discard opened supplies in order to decrease the risk of patients receiving potentially contaminated items.

6. The facility did not maintain humidity levels in the Main OR suites at levels required by policies and national standards of care.

a) A tour of OR #7 was conducted on 02/09/16 at 12:15 p.m. with Director #1. Director #1 explained the facility followed AORN guidelines for determining the acceptable humidity levels in the OR, which were between 20-60%. Observation of the thermostat in OR #7 revealed the humidity level was 16.5%. Director #1 stated s/he would not be concerned if the humidity level fell below the accepted range. This was not in accordance with the policy which instructed staff to contact facilities management as soon as possible if temperatures and humidity ranges fell out of the required level.

Further observations from the same tour revealed the following OR suites' humidity levels:

- OR #8's humidity level was 16%.

- OR #2's humidity level was 15.9%.

b) Review of the Main OR Humidity Log from 01/01/16 to 02/09/16 (40 days total) revealed the following examples of humidity levels falling below the acceptable range:

- OR #1's humidity levels fell below the acceptable range 25 of 40 days reviewed. The lowest humidity level during the reviewed time frame was 6.3% on 02/04/16.

- OR #2's humidity levels fell below the acceptable range 26 of 40 days reviewed. The lowest humidity level during the reviewed time frame was 7.3% on 02/04/16.

- OR #3's humidity levels fell below the acceptable range 18 of 40 days reviewed. The lowest humidity level during the reviewed time frame was 6.9% on 02/04/16.

d) On 02/11/16 at 3:39 p.m., an interview was conducted with IP #13 who confirmed the humidity level range in the OR suites was expected to be between 20-60% in accordance with AORN guidelines. IP #13 stated s/he was unaware humidity levels fell below 20% in the OR suites. IP #13 further stated this would be a concern due to an increased risk of fire in the OR suites.



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7. The facility did not ensure patient care supplies stored in nurse servers in patient rooms were discarded between each patient. Additionally, the facility failed to ensure nursing staff performed hand hygiene prior to removing supplies from the nurse servers; therefore, the facility could not ensure the supplies were not contaminated.

a) On 02/09/16 at 9:36 a.m., a tour of the Critical Care Units (CCU) was conducted with Employee #21 and the CCU Director (Director #22). At 10:03 a.m., an observation of a medication pass was conducted with RN #23 in room 3133. A nurse server was found stocked with syringes, saline flushes, and additional patient care supplies. RN #23 obtained a disinfectant wipe and saline flush from the top drawer and then administered the intravenous (IV) medication Digoxin (used to treat congestive heart failure and to slow the heart rate in patients with atrial fibrillation) through Patient O's IV catheter. During the medication observation, RN #23 did not perform hand hygiene when entering the patient's room, prior to administering the IV medication through the patient's IV catheter, and after exiting the room.

b) On 02/10/16 at 10:00 a.m., an interview was conducted with Director #22 who stated the supplies kept in the nurse servers were only disposed of, if the patient was on contact precautions. Director #22 stated nursing staff hands should not have been contaminated when removing supplies from the nurse servers. S/he further stated hand hygiene should have been done to prevent contamination of the supplies. Director #22 then stated if the supplies were contaminated, they should have been discarded.

c) On 02/11/16 at 2:17 p.m., an interview was conducted with IP #13 who stated if the facility could not ensure sterility had been maintained after a patient was discharged, the supplies in the nurse servers should have been discarded. S/he further stated if the facility could not ensure hand hygiene had been done every time the drawers of the nurse servers were accessed, staff should have discarded those supplies.

d) On 02/12/16 at 10:29 a.m., an interview was conducted with RN #25 who stated items were left in the nurse servers in patient rooms if the patient was not an isolation patient. RN #25 stated the carts should have been accessed with clean gloves or clean hands.

e) On 02/12/16 at 10:37 a.m., an interview was conducted with RN #26 who stated the nurse servers should have been accessed with gloves and hand hygiene should have been done before accessing the supplies in the cart. S/he further stated, after patients were transferred, the nurse or tech would restock the nurse server; however, any supplies wrapped would remain in the nurse server.

8. The facility did not ensure patient care supplies used to conduct blood glucose tests were uncontaminated and safe for patient use.

a) On 02/09/16 at 11:43 a.m., Patient Care Technician (PCT) #24 performed a blood glucose test on Patient P in room 6126 (6th floor). PCT #24 carried a clear plastic bio-hazard bag containing multiple lancets and cotton balls into the patient's room, along with the container of test strips. PCT #24 used multiple lancets during the test. After the first unsuccessful attempt at collecting blood, PCT #24 removed his/her gloves and used his/her bare hands to obtain another lancet and cotton ball from the bag. PCT#24 did not perform hand hygiene prior to placing his/her hands into the bag. PCT #24 carried the same bag of supplies to patient room 6111 and left the bag of supplies on the side rail connected to the wall outside of the room. PCT #24 did not disinfect the plastic bag when s/he exited room 6126.

b) On 02/10/16 at 9:30 a.m., a tour of the 7th floor Neuro/Spine Unit was conducted with Director #27 and Charge Nurse #28. During the tour, a clear plastic bag filled with lancets and cotton balls was observed next to the glucometer dock station. Charge Nurse #28 stated the bag should not have been taken into patient rooms.

c) On 02/10/16 at 9:32 a.m., an interview was conducted with PCT #24 who stated the bag containing the lancets and cotton balls could be taken into patient rooms. PCT #24 stated s/he changed the bag every shift. PCT #24 stated s/he would clean the bag of supplies after exiting an isolation room but would not disinfect the bag before or after taking care of other patients.

d) On 02/10/16 at 9:34 a.m., an interview was conducted with the 6th floor unit Manager (Employee #29), who stated staff were expected to take lancets and cotton balls out of the clear plastic bag when performing glucose tests on patients. However, Employee #29 then stated it was okay for the bags to be brought into the room, unless the patient was on isolation precautions. S/he stated the bags should have been disinfected with the glucometer.

e) On 02/11/16 at 2:17 p.m., an interview was conducted with IP #13 who stated the expectation was one lancet and one cotton ball was to be brought to one patient room at a time. S/he further stated re-education needed to be done with staff that performed blood glucose tests.

9. The facility failed to ensure patient's hands were washed with soap prior to glucose testing.

a) On 02/09/16 at 11:43 a.m., PCT #24 performed a blood glucose test on Patient P in room 6126 (6th floor). PCT #24 did not clean or disinfect the patient's fingertips prior to piercing the patient's fingertip with the lancet. PCT #24 pierced the patient's finger 3 times before s/he was able to collect a sufficient amount of blood for the test. After the observation, PCT #24 stated per protocol, staff should check patient's hands to see if they were visibly soiled, then staff would need to wash the patient's hand with soap and water. PCT #24's statement was in contrast to facility policy.

b) On 02/11/16 at 3:39 p.m., an interview was conducted with IP #13 who stated s/he was not aware of the updated policy which stated for a finger puncture, staff should cleanse the fingertip with soap and water and wipe dry with cotton ball or allow to air dry.
Neither PCT #24 and IP #13 were aware of facility policy.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.51, SURGICAL SERVICES, was out of compliance.

A-0951 - Standard: Delivery of Service - Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. The facility failed to ensure duties performed in the surgical department were conducted in accordance with established high standards of care and facility policies. This failure resulted in the potential for transmission of health care acquired infections to patients receiving care in the facility. In addition, this failure created the potential for unauthorized staff, patients, and visitors to divert or tamper with accessible medications and supplies. Furthermore, this failure created an increased risk of fire in the surgical department.

Based on observations, interviews, and document review the facility failed to ensure duties performed in the surgical department were conducted in accordance with established high standards of care and facility policies to ensure positive patient outcomes.

This failure resulted in the potential for transmission of health care acquired infections to patients receiving care in the facility. In addition, this failure created the potential for unauthorized staff, patients, and visitors to divert or tamper with accessible medications and supplies. Furthermore, this failure caused an increased risk of fire in the surgical department.

FINDINGS:

POLICY

According to Purchasing-Receiving/Medication Availability, Products will be stored under appropriate conditions to preserve integrity.

According to Temperature & Humidity Control in the Operating Room (OR), The current requirements per Association of periOperative Registered Nurses (AORN) and National Fire Protection Association are 20-60% humidity. If the temperature and humidity ranges fall out of the recommended levels, the OR staff will notify facilities management as soon as possible.

According to Reprocessing of Flexible Endoscopes, Hang the endoscope vertically with the distal tip hanging freely in a clean, well-ventilated, dust free area.

According to Surgery/Delivery In-Between Case Cleaning, Equipment and Supplies included a lobby dust pan and broom.

According to Terminal Cleaning Sterile & Delivery Areas, Equipment and Supplies included a lobby dust pan and broom.

According to Clinical Guidance: Blanket/Fluid/Solution Warming - Refrigeration Guidelines, For IV fluids in Fluid Warmers, remove on or before 14 days.

According to Temperature Control of Surgical Patients, The manufacturer's guidelines will be followed when bagged fluids are warmed through a fluid warming device.

According to Intravenous Therapy and Central Lines - Adult, IV solution bags/bottles will be timed and dated when hung.

According to Re-Use of Disposable Medical Supplies and Equipment, Single-use or disposable medical supplies and equipment shall not be re-used or resterilized. If a single-use sterile item is opened and not used, it shall be discarded.

REFERENCE

According to the Association of periOperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2015:

Recommendation IVe.1. (page 276), The relative humidity in a restricted area should be maintained within a range of 20% to 60%.

Recommendation IX.a. (page 594), Flexible endoscopes should be stored in a closed cabinet and hanging in a secure vertical position. When flexible endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential development of an environment conductive to microbial growth in the endoscope.
Recommendation II.d. (page 13), Floors should be mopped with damp or wet mops. Dry methods of environmental cleaning (i.e., dusting, sweeping) should not be used in semi-restricted and restricted areas.

Recommendation II.b. (page 12), All horizontal surfaces in the OR (e.g., furniture, surgical lights, booms, equipment) should be damp dusted before the first scheduled surgical or other invasive procedure of the day.

Recommendation II.b.1 (page 530), Fluids kept in a warming cabinet should be labeled with an expiration date based on the manufacturer's recommendation for storage above room temperature.

According to the Manufacturer's Instructions for the Olympus Evis Exera II Ultrasound Gastrovideoscope, Hang the endoscope in the storage cabinet with the distal end hanging freely. Make sure that the insertion section hangs vertically and as straight as possible.

1. The facility did not ensure medications and supplies used for the administration of medications were secured in a manner to avoid diversion or tampering.

a) On 02/09/16 at 9:45 a.m., a tour of the Main Preoperative (Preop) Unit and the Main Post Anesthesia Care Unit (PACU) was conducted with the Director of the Operating Room (Director #1) and a Registered Nurse in the Preop Unit (RN #9). Observations revealed the following unsecured medications and supplies:

- In Bay #9 of the Main Preop Unit, the top drawer of a storage cabinet was unlocked and revealed one 10 milliliter (ml) manufactured saline syringe out of its packaging and with no cap on the end of the syringe. The syringe was filled with an unknown clear liquid. The storage cabinet was accessible to patients, visitors, and staff. Upon finding the syringe, RN #9 stated the syringe should have been discarded and proceeded to empty the syringe of unknown liquid in a sink located at the nurses' station.

- In the "Difficult Intubation Cart" located adjacent to the Main PACU, the top drawer was unlocked and revealed one 50 ml bottle of topical 4% Lidocaine solution. The bottle was approximately 1/4th full of an unknown liquid. Upon finding the bottle, Director #1 stated medications should not have been stored in the "Difficult Intubation Cart" and proceeded to remove the bottle from the cart.

b) On 02/10/16 at 9:32 a.m., a tour of the Gynecological (GYN) OR was conducted with the Clinical Nurse Coordinator (CNC #10) of the Preop Unit and the PACU. Observation of GYN Preop Bay #5 revealed a storage cart with the top drawer unlocked which was filled with packaged prefilled saline syringes, needles, and syringes. The cart was accessible to patients, visitors, and staff. CNC #10 stated the drawer should have been locked at all times and proceeded to lock the drawer.

c) On 02/11/16 at 10:25 a.m., an interview was conducted with the Assistant Vice President of Surgical Services (AVP #2) who confirmed the expectation was for all medications to be secured from unauthorized use. AVP #2 stated the facility considered manufactured prefilled saline syringes to be medications that needed to be secured in the same way all medications were secured. AVP #2 further stated s/he had been conducting random monitoring checks throughout the surgical department; however, s/he was not documenting the performance of the monitoring checks or if any corrective actions or education were necessary as a result of the checks.

2. The facility did not maintain humidity levels in the Main OR suites at levels required by policies and national standards of care.

a) A tour of OR #7 was conducted on 02/09/16 at 12:15 p.m. with Director #1. Director #1 explained the facility followed AORN guidelines for determining the acceptable humidity levels in the OR, which were between 20-60%. Observation of the thermostat in OR #7 revealed the humidity level was 16.5%. Director #1 stated s/he would not be concerned if the humidity level fell below the accepted range. This was not in accordance with the policy which instructed staff to contact facilities management as soon as possible if temperatures and humidity ranges fell out of the required level.

Further observations from the same tour revealed the following OR suites' humidity levels:

- OR #8's humidity level was 16%.

- OR #2's humidity level was 15.9%.

b) Review of the Main OR Humidity Log from 01/01/16 to 02/09/16 (40 days total) revealed the following examples of humidity levels falling below the acceptable range:

- OR #1's humidity levels fell below the acceptable range 25 of 40 days reviewed. The lowest humidity level during the reviewed time frame was 6.3% on 02/04/16.

- OR #2's humidity levels fell below the acceptable range 26 of 40 days reviewed. The lowest humidity level during the reviewed time frame was 7.3% on 02/04/16.

- OR #3's humidity levels fell below the acceptable range 18 of 40 days reviewed. The lowest humidity level during the reviewed time frame was 6.9% on 02/04/16.

c) On 02/11/16 at 10:25 a.m., an interview was conducted with AVP #2 who confirmed the expected humidity range in the OR suites was between 20-60%. AVP #2 stated the reason it was important to keep humidity levels above 20% was to reduce the risk of fire or spark hazards in the OR.

3. The facility did not store reprocessed endoscopes in a manner to avoid contamination or growth of microorganisms.

a) On 02/09/16 at 1:30 p.m., the Main OR department's endoscope storage cabinet was observed with a Surgical Technician (ST #5). Inside the storage cabinet an endoscope was observed hanging from a hook with the distal tip wrapped around the hook, which created a complete coil in the endoscope.

During the observation, ST #5 stated there probably was not ample space available when the scope was placed in the closet and that was the reason why it was looped around the hook. ST #5 then proceeded to readjust the endoscope to hang in a vertical position.

b) On 02/11/16 at 9:37 a.m., an interview was conducted with Director #1 who confirmed the expectation was for scopes to be stored in a vertical position after reprocessing in order to be able to dry completely.

c) On 02/11/16 at 10:25 a.m., an interview was conducted with AVP #2 who stated reprocessed endoscopes should have been stored vertically for any residual water to be able to drain out of the end. AVP #2 further stated there should have been staff members checking to ensure endoscopes were hung vertically.

4. The facility used dry dusting brooms to clean OR suites.

a) On 02/11/16 at 10:55 a.m., a tour of the Main OR Department revealed the following brooms located in the restricted areas of the department:

- One broom was observed on a janitor's cart located in a hallway outside of OR #5, OR #6, OR #7, and OR #8.

- One broom was observed on a janitor's cart located in a hallway outside of the sub-sterile room located between OR #1 and OR #2.

- One broom was observed in the janitor's closet located in the restricted area of the surgical department.

b) On 02/09/16 at 12:45 p.m., an interview with two Environmental Service Staff Members (Employee #3 and Employee #4) was conducted. Employee #3 stated s/he would use brooms to sweep the OR suites. Employee #4 explained s/he would begin cleaning OR suites by using a black broom to sweep the floor followed by using a wet mop.

c) On 02/09/16 at 11:00 a.m., an interview was conducted with Director #1 who stated s/he was unaware that Environmental Staff were using brooms to sweep the floors in the OR suites. Director #1 further stated the expectation was for staff to first dry mop the floors and then use a wet mop. This was in contrast with AORN guidelines which stated damp or wet mops should have been used to mop floors.

d) On 02/11/16 at 10:25 a.m., an interview was conducted with AVP #2 who explained the facility followed AORN standards for guidance with cleaning the surgical department. AVP #2 stated sweeping the floors of the OR suites was a common practice done at the facility. AVP #2 then stated s/he was not aware of the AORN guideline instructing against the use of dry dusting or sweeping in semi-restricted and restricted areas of the surgical department because of the possibility of aerosolizing infectious particles in the air.

5. The facility did not clean OR suites in accordance with national standards of care before the first scheduled procedure of the day.

a) On 02/08/16 at 9:12 a.m., an interview was conducted with an OR Registered Nurse (RN #6) who stated s/he would not routinely clean the OR suite s/he was assigned to before the first scheduled procedure of the day unless s/he noticed something in the room that needed to be cleaned.

On 02/08/16 at 9:17 a.m., an interview was conducted with Surgical Technicians (ST #11 and ST #12). ST #11 revealed s/he was precepting ST #12 who was on orientation. ST #11 stated s/he would not wipe down horizontal surfaces in OR suites before the first case of the day because they had been terminally cleaned the night before.

On 02/10/16 at 1:44 p.m., an interview was conducted with an OR RN (RN #7) who stated since OR suites were terminally cleaned overnight staff did not clean them before the first procedure of the day unless they were visibly soiled. RN #7 further stated s/he felt there would not be enough time to clean OR suites before the first case of the day.

b) On 02/11/16 at 9:37 a.m., an interview was conducted with Director #1 who revealed OR suites were terminally cleaned each night between 7:00 p.m. and 4:00 a.m. Director #1 stated s/he did not think it was necessary to clean the OR suites in the morning before the first case of the day since they had been terminally cleaned the night before. This was in contrast to the AORN recommendation which stated all horizontal surfaces in the OR should be damp dusted before the first scheduled surgical or other invasive procedure of the day.

c) On 02/11/16 at 10:25 a.m., an interview was conducted with AVP #2 who confirmed cleaning horizontal surfaces in OR suites before the first scheduled case of the day had not been a standard expectation at the facility. AVP #2 further stated s/he was not aware of the AORN recommendation which stated all horizontal surfaces in the OR should be damp dusted before the first scheduled surgical or other invasive procedure of the day.

6. The facility did not ensure intravenous (IV) fluids stored in warming cabinets were safe for patient use.

a) On 02/09/16 at 10:55 a.m., a tour of the Main OR department revealed the following IV fluid bags stored in fluid warming cabinets past the expected discard date:

- In the sub-sterile room located between OR #7 and OR #8, one 1000 ml bag of Lactated Ringer's IV fluid was observed in a fluid warming cabinet with the date of 2/8 written on the bag.

- In the sub-sterile room located between OR #9 and OR #10, two 3000 ml bags of 0.9% Normal Saline IV fluid were observed in a fluid warming cabinet with the date of 2/5 written on the bag.

b) On 02/11/16 at 9:37 a.m., an interview was conducted with Director #1 who confirmed the date written on the IV fluid bags indicated the date the fluid should have been discarded. Director #1 explained the facility followed AORN guidelines and facility policies when storing IV fluids in the warming cabinets, which instructed to discard IV fluids in warming cabinets after 14 days.

c) On 02/11/16 at 10:25 a.m., an interview was conducted with AVP #2 who confirmed the expectation was for IV fluids in warming cabinets to be discarded when they were expired.

7. The facility did not ensure IV fluids were labeled to ensure safety for patient administration.

a) On 02/09/16 at 10:00 a.m., observations in Bay #5 of the Main Preop Unit revealed one 1000 ml bag of Lactated Ringer's IV fluid hanging on an IV pole at the head of the bed. IV tubing was attached to the bag of fluid; however, there was no label noted on the bag or tubing indicating when the tubing had been attached to the bag. This was in contrast to the policy which stated IV solution bags/bottles would be timed and dated when hung.

During the same observation, a Preop Unit RN (RN #9) stated s/he was preparing for a patient to arrive in Bay #5 and had attached the IV tubing to the bag of IV fluid. RN #9 further stated s/he did not have a chance to label the IV fluid bag but it should have been labeled with the date and time of when it was hung.

b) On 02/11/16 at 9:37 a.m., an interview was conducted with Director #1 who confirmed the expectation was for staff to label all IV fluids being administered to patients.

8. Staff in the Pre-Operative Unit did not ensure single use patient care supplies were stored in their protective packaging and safe for patient use.

a) On 02/09/16 at 9:45 a.m., a tour of the Main Preop Unit and the Main PACU was conducted. Observations during the tour revealed the following patient care supplies:

- In the Preop Unit Medication Room, two sets of IV tubing without the manufacturer's protective packaging were observed on a shelf.

- In Bay #5 of the PACU, one oxygen mask with the manufacturer's protective packaging ripped open was observed in the third drawer of a storage cart.

b) On 02/09/16 at 10:08 a.m., an interview was conducted with the Director of the Preop Unit and PACU (Director #8), who stated any patient care supplies found out of their packaging should not have been used and should have been discarded.

c) On 02/11/16 at 10:25 a.m., an interview was conducted with AVP #2 who stated opened supplies available for patient use was a sloppy practice and created a potential risk for patients to receive contaminated items.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.25, PHARMACEUTICAL SERVICES was out of compliance.

A-494 - Standard: Current and accurate records must be kept of the receipt and disposition of all scheduled drugs. The facility failed to maintain accurate drug records which showed disposition of controlled medications and reconciliation of any variances which occurred. Additionally, the facility failed to have a standard process to investigate improper practices regarding controlled medication which would minimize the time frame between detection and determination of the extent of loss or diversion. This failure created the potential for drug diversion and had the potential to affect all patients within the facility.

A-505 - Standard: Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use. The facility failed to ensure outdated medications were removed from stock according to the manufacture's expiration date. This failure created the potential for patients to receive expired medications.

Based on interviews and document review, the facility failed to maintain accurate drug records which showed disposition of controlled medications and reconciliation of any variances, which occurred during transfer from the pharmacy's Automatic Dispensing Cabinet (ADC) to the patient care units. Additionally, the facility failed to have a standard process to investigate improper practices regarding controlled medications, which would minimize the time frame between detection and determination of the extent of loss or diversion.

This failure created the potential for drug diversion and had the potential to affect all patients within the facility.

FINDINGS:

POLICY

According to the policy, Medication Diversion Prevention Policy (Section V-Preparing and Dispensing), for Automatic Dispensing Cabinets (ADC), the authorized staff member would stock the ADC and verify the inventory count. The verification could occur electronically (e.g. Pyxis CII Safe Compare Report) or the authorized staff member would print a proof of deliver report. This would be reconciled and signed by the Pharmacist, Administrator or Practice Manger, filed and stored.

Further, the policy noted any remaining controlled medication packaged in an amount larger than the dose being administered must be wasted immediately.

The CEO, Administrator, or Practice Manager, along with the Director of Pharmacy is responsible for controlled medication oversight, including tracking and reporting of inappropriate controlled medication usage.

Each facility should form a multidisciplinary team that is charged with developing a coordinated and systematic approach to prevention and detection of medication diversion.

1. Pharmacy staff did not reconcile Pyxis CII Safe Compare Reports (Compare Reports) to ensure controlled medications (a drug for which control and regulation has been declared due to the danger of addiction, abuse, physical and mental harm, trafficking by illegal means and the dangers from actions of those who have used the substances) removed from the pharmacy's ADC were delivered to the intended patient care unit. Additionally, the facility did not have a process in place to ensure the Compare Reports were printed and reconciled.

a) On 02/11/16 at 11:31 a.m., an interview was conducted with a Pharmacy Technician (PT #19) who stated the Compare Report would show controlled medications removed from the main pharmacy ADC not yet stocked at the intended unit's ADC. S/he further stated, at the end of each PT shift the Compare Report should have been printed and if there was a variance on the report, the PT should have noted the reason for the variance. PT #19 stated the report verified what medications were removed from the main pharmacy safe and sent to the patient care units. S/he further stated the report ensured everything removed from the pharmacy safe was delivered to the intended destination. PT #19 stated the report needed to be reconciled in order for variances to be investigated as soon as possible. PT #19 stated all PTs had been trained on the Compare Report process.

b) Review of the Compare Report, printed 12/10/15 at 4:00 p.m., revealed 20 Pregabalin 100 milligram (MG) capsules (a medication used to treat epilepsy, neuropathic pain, fibromyalgia and generalized anxiety disorder) were sent from the main pharmacy ADC with the intent to be stocked in the 6th floor ADC at 6:55 a.m. There was no evidence the controlled medication was stocked on the 6th floor at the time the report was printed. The variance listed on the report was not reconciled and lacked evidence of an investigation. Approximately 4 1/2 hours later a second Compare Report was printed at 8:27 p.m. The 20 Pregabalin 100 mg capsules remained listed on this report. The second report showed no evidence pharmacy staff investigated the variance. Four days lapsed without any evidence showing the 20 Pregabalin capsules were stocked in the 6th floor ADC.

c) The Compare Reports were not printed for 16 of 31 days for the month of December 2015. Out of the 15 days the reports were printed, only 3 of those days had a report for each shift (2 shifts per day). Furthermore, the reports lacked evidence pharmacy staff investigated and reconciled the variances listed on the reports.

Review of January 2016 Compare Reports revealed 9 of 31 days did not have Compare Reports printed. Out of the 22 days the reports were printed, only 6 of those days had a report for each shift (2 shifts per day).

d) Review of the Compare Report, printed on 02/04/16 at 4:33 p.m., revealed a variance for 10 Oxycodone CR 10 mg tablets (an opioid pain medication used to treat moderate to severe pain) which were sent from the main pharmacy's ADC to the Surgical Orthopedic Center (SOC) medication station at 4:24 p.m. There was no evidence pharmacy staff reviewed the Compare Report or printed follow up reports showing the medication was stocked in the SOC's ADC. The next Compare Report printed was dated 02/09/16 at 3:09 p.m. Four days lapsed without any evidence showing the controlled medication was received at the intended location.

e) On 02/10/16 at 1:08 p.m., an interview was conducted with the Director of Pharmacy (Pharmacist #14) who stated the Compare Reports were used to track the movement of controlled medications from the main pharmacy ADC to the patient care unit's ADCs. Pharmacist #14 stated if the controlled medication was not loaded into the unit's ADC, it would show on the Compare Report as a variance.

All pharmacy staff present for the interview confirmed a lapse of Compare Reports from 02/05/16 through 02/08/16. All agreed this was too long of a time frame to wait for a variance to be found.

f) On 02/12/16 at 11:15 a.m., an interview was conducted with Pharmacist #14 who stated the variance report was printed each shift so PTs could track the controlled medication transferred from the pharmacy ADC to the patient care unit ADC locations. Pharmacist #14 stated PTs were responsible for reviewing and reconciling the report each shift. S/he further stated the investigation process for the variances listed on the Compare Reports could use more detail.

Pharmacist #14 stated s/he was now aware of the missing Compare Reports, and stated the lack of reports and variance reconciliation could lead to a drug diversion being overlooked.

2. The facility failed to complete monthly Compare Report audits to ensure variances listed on the audits were reconciled.

a) On 02/10/16 at 1:08 p.m., the surveyor requested the monthly variance report audits for the prior 6 months.

At 5:07 p.m., (4 hours later), Pharmacist #14 provided the monthly Compare Report audits. Pharmacist #14 stated there may be "gaps" in the audits provided by him/her and the Pharmacy Clinical/Operations Specialist (Pharmacist #20) was still looking for the missing audits.

b) On 02/11/16 at 12:46 p.m., an interview was conducted with Pharmacist #20 who stated s/he was responsible for the monthly audits of the Compare Reports printed by the pharmacy technicians. Pharmacist #20 stated s/he was responsible for monitoring and reconciling the Compare Reports for variances.

Audits were requested for December 2015 and January 2016. Review of the audits, provided by Pharmacist #20, revealed the audits were not conducted until after the meeting with the surveyor on 02/10/16 at 12:30 p.m. (1 day prior). The Compare Reports attached to the audit sheets had a print date of 02/10/16 at 4:39 p.m. Pharmacist #20 was asked if audits were completed prior to the survey, and s/he stated "no." Pharmacist #20 then stated his/her priority was nursing diversion audits, and when s/he had time, the other pharmacy department audits would be done.

c) On 02/12/16 at 11:15 a.m., an interview was conducted with Pharmacist #14 who stated Pharmacist #20 audited the Compare Reports once a month to ensure the facility was tracking controlled medications dispensed from the pharmacy safe to the nursing units. Pharmacist #14 stated s/he was now aware of the missing audits and reports, and confirmed this failure could lead to a drug diversion being overlooked.



26833

3. The facil

Based on observation, interviews, and document review, the facility failed to ensure outdated medications were removed from stock according to the manufacturer's expiration date.
This failure created the potential for patients to receive expired medications.

FINDINGS:

POLICY

According to policy, Outdated Drugs/Drug Disposal, all medication stock will be inspected to insure the prompt removal of outdated drugs from stock and subsequent storage and disposition.

1. The facility failed to ensure outdated medications were removed from patient care units and not available for patient use.

a) On 02/10/16 at 8:51 a.m., a tour of the 7th floor Neuro/Spine unit was conducted with Director #27 and Charge Nurse #28. During the tour, 6 outdated multi-dose vials of 0.9% Sodium Chloride (30 milliliter vials) were found in the patient supply room. The vials had a manufacturer expiration date of November 2015. Charge #28 stated the Central Supply Department was responsible for monitoring outdated supplies. S/he further stated the outdated vials should have been discarded.

b) On 02/10/16 at 9:30 a.m., an interview was conducted with Pharmacist #30 who stated 0.9 % Sodium Chloride vials were used when intravenous antibiotics needed to be diluted prior to being administered to patients. Pharmacist #30 stated outdated medication vials should have been discarded per the manufacture's date on the vial.

c) On 02/11/16 at 11:31 a.m., an interview was conducted with Pharmacy Technician #19 who stated medications should have been discarded by the manufacturer recommendations printed on the vial.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.42, INFECTION CONTROL, was out of compliance.

A-0749 - Standard: The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. The facility failed to maintain appropriate infection control processes in the areas of humidity levels in the surgical department, integrity of patient care supplies, and cleaning/disinfection of surgical supplies, equipment and operating rooms. These failures created the potential for transmission of health care acquired infections to patients receiving care in the facility.

Based on observation, interviews and document review, the facility failed to maintain appropriate infection control processes in the areas of humidity levels in the surgical department, integrity of patient care supplies, and cleaning/disinfection of surgical supplies, equipment and operating rooms. Additionally, the facility failed to ensure staff followed infection control processes when performing patient care tests at the bedside in 1 of 1 observations conducted (Patient P).

These failures created the potential for transmission of health care acquired infections to patients receiving care in the facility.

FINDINGS:

POLICY

According to Temperature & Humidity Control in the Operating Room (OR), The current requirements per Association of periOperative Registered Nurses (AORN) and National Fire Protection Association are 20-60% humidity. If the temperature and humidity ranges fall out of the recommended levels, the OR staff will notify facilities management as soon as possible.

According to Reprocessing of Flexible Endoscopes, Hang the endoscope vertically with the distal tip hanging freely in a clean, well-ventilated, dust free area.

According to Surgery/Delivery In-Between Case Cleaning, Equipment and Supplies included a lobby dust pan and broom.

According to Terminal Cleaning Sterile & Delivery Areas, Equipment and Supplies included a lobby dust pan and broom.

According to Clinical Guidance: Blanket/Fluid/Solution Warming - Refrigeration Guidelines, For IV fluids in Fluid Warmers, remove on or before 14 days.

According to Temperature Control of Surgical Patients, The manufacturer's guidelines will be followed when bagged fluids are warmed through a fluid warming device.

According to Re-Use of Disposable Medical Supplies and Equipment, Single-use or disposable medical supplies and equipment shall not be re-used or resterilized. If a single-use sterile item is opened and not used, it shall be discarded.

According to Nova Bedside Glucose Policy, Standard precautions will be observed for the collection and handling of all blood specimens. Only the meter and the test strip to be used should go into a patient's room. For a finger puncture, cleanse the fingertip with soap and water and wipe dry with cotton ball or allow to air dry.

REFERENCE

According to the Association of periOperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2015:

Recommendation IVe.1. (page 276), The relative humidity in a restricted area should be maintained within a range of 20% to 60%.

Recommendation IX.a. (page 594), Flexible endoscopes should be stored in a closed cabinet and hanging in a secure vertical position. When flexible endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential development of an environment conductive to microbial growth in the endoscope.

Recommendation II.d. (page 13), Floors should be mopped with damp or wet mops. Dry methods of environmental cleaning (i.e., dusting, sweeping) should not be used in semi-restricted and restricted areas.

Recommendation II.b. (page 12), All horizontal surfaces in the OR (e.g., furniture, surgical lights, booms, equipment) should be damp dusted before the first scheduled surgical or other invasive procedure of the day.

Recommendation II.b.1 (page 530), Fluids kept in a warming cabinet should be labeled with an expiration date based on the manufacturer's recommendation for storage above room temperature.

According to the Manufacturer's Instructions for the Olympus Evis Exera II Ultrasound Gastrovideoscope, Hang the endoscope in the storage cabinet with the distal end hanging freely. Make sure that the insertion section hangs vertically and as straight as possible.

1. The facility used dry dusting brooms to clean OR suites.

a) On 02/11/16 at 10:55 a.m., a tour of the Main OR Department revealed the following brooms located in the restricted areas of the department:

- One broom was observed on a janitor's cart located in a hallway outside of OR #5, OR #6, OR #7, and OR #8.

- One broom was observed on a janitor's cart located in a hallway outside of the sub-sterile room located between OR #1 and OR #2.

- One broom was observed in the janitor's closet located in the restricted area of the surgical department.

b) On 02/09/16 at 12:45 p.m., an interview with two Environmental Service Staff Members (Employee #3 and Employee #4) was conducted. Employee #3 stated s/he would use brooms to sweep the OR suites. Employee #4 explained s/he would begin cleaning OR suites by using a black broom to sweep the floor followed by using a wet mop.

c) On 02/09/16 at 11:00 a.m., an interview was conducted with the Director of the OR (Director #1) who stated s/he was unaware that Environmental Staff were using brooms to sweep the floors in the OR suites. Director #1 further stated the expectation was for staff to first dry mop the floors and then use a wet mop. This was in contrast with AORN guidelines which stated damp or wet mops should have been used to mop floors.

d) On 02/11/16 at 3:39 p.m., an interview was conducted with the Infection Prevention Manager (IP #13) who confirmed the facility followed AORN guidelines for infection control practices in the surgical department. IP #13 stated s/he was unaware of brooms being used to sweep the OR suites and they should not have been used because of the possibility of aerosolizing infectious particles in the air.

An additional interview with IP #13 was conducted on 02/12/16 at 2:44 p.m. During this interview, IP #13 explained s/he would spend approximately 10-15% of his/her time focusing on infection control in the Surgical Department. IP #13 stated s/he would try to conduct monitoring rounds in one of the surgical units monthly which would involve looking for anything that would draw his/her attention to a breech in infection control. IP #13 then stated s/he did not document the rounds being done or if any findings were communicated to staff in the surgical department.

2. The facility did not store reprocessed endoscopes in a manner to avoid contamination or growth of microorganisms.

a) On 02/09/16 at 1:30 p.m., the Main OR department's endoscope storage cabinet was observed with a Surgical Technician (ST #5). Inside the storage cabinet an endoscope was observed hanging from a hook with the distal tip wrapped around the hook, which created a complete coil in the endoscope.

During the observation, ST #5 stated there probably was not ample space available when the scope was placed in the closet and that was the reason why it was looped around the hook. ST #5 then proceeded to readjust the endoscope to hang in a vertical position.

b) On 02/11/16 at 9:37 a.m., an interview was conducted with Director #1 who confirmed the expectation was for scopes to be stored in a vertical position after reprocessing in order to be able to dry completely.

c) On 02/11/16 at 3:39 p.m., an interview was conducted with IP #13 who stated the expectation was for endoscopes to be stored in a vertical position in order to decrease the risk of bacterial growth by allowing any residual water from reprocessing the endoscope to drain.

3. The facility did not clean OR suites in accordance with national standards of care before the first scheduled procedure of the day.

a) On 02/08/16 at 9:12 a.m., an interview was conducted with an OR Registered Nurse (RN #6) who stated s/he would not routinely clean the OR suite s/he was assigned to before the first scheduled procedure of the day unless s/he noticed something in the room that needed to be cleaned.

On 02/08/16 at 9:17 a.m., an interview was conducted with Surgical Technicians (ST #11 and ST #12). ST #11 revealed s/he was precepting ST #12 who was on orientation. ST #11 stated s/he would not wipe down horizontal surfaces in OR suites before the first case of the day because they had been terminally cleaned the night before.

On 02/10/16 at 1:44 p.m., an interview was conducted with an OR RN (RN #7) who stated since OR suites were terminally cleaned overnight staff did not clean them before

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.51, SURGICAL SERVICES, was out of compliance.

A-0951 - Standard: Delivery of Service - Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. The facility failed to ensure duties performed in the surgical department were conducted in accordance with established high standards of care and facility policies. This failure resulted in the potential for transmission of health care acquired infections to patients receiving care in the facility. In addition, this failure created the potential for unauthorized staff, patients, and visitors to divert or tamper with accessible medications and supplies. Furthermore, this failure created an increased risk of fire in the surgical department.

Based on observations, interviews, and document review the facility failed to ensure duties performed in the surgical department were conducted in accordance with established high standards of care and facility policies to ensure positive patient outcomes.

This failure resulted in the potential for transmission of health care acquired infections to patients receiving care in the facility. In addition, this failure created the potential for unauthorized staff, patients, and visitors to divert or tamper with accessible medications and supplies. Furthermore, this failure caused an increased risk of fire in the surgical department.

FINDINGS:

POLICY

According to Purchasing-Receiving/Medication Availability, Products will be stored under appropriate conditions to preserve integrity.

According to Temperature & Humidity Control in the Operating Room (OR), The current requirements per Association of periOperative Registered Nurses (AORN) and National Fire Protection Association are 20-60% humidity. If the temperature and humidity ranges fall out of the recommended levels, the OR staff will notify facilities management as soon as possible.

According to Reprocessing of Flexible Endoscopes, Hang the endoscope vertically with the distal tip hanging freely in a clean, well-ventilated, dust free area.

According to Surgery/Delivery In-Between Case Cleaning, Equipment and Supplies included a lobby dust pan and broom.

According to Terminal Cleaning Sterile & Delivery Areas, Equipment and Supplies included a lobby dust pan and broom.

According to Clinical Guidance: Blanket/Fluid/Solution Warming - Refrigeration Guidelines, For IV fluids in Fluid Warmers, remove on or before 14 days.

According to Temperature Control of Surgical Patients, The manufacturer's guidelines will be followed when bagged fluids are warmed through a fluid warming device.

According to Intravenous Therapy and Central Lines - Adult, IV solution bags/bottles will be timed and dated when hung.

According to Re-Use of Disposable Medical Supplies and Equipment, Single-use or disposable medical supplies and equipment shall not be re-used or resterilized. If a single-use sterile item is opened and not used, it shall be discarded.

REFERENCE

According to the Association of periOperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2015:

Recommendation IVe.1. (page 276), The relative humidity in a restricted area should be maintained within a range of 20% to 60%.

Recommendation IX.a. (page 594), Flexible endoscopes should be stored in a closed cabinet and hanging in a secure vertical position. When flexible endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential development of an environment conductive to microbial growth in the endoscope.
Recommendation II.d. (page 13), Floors should be mopped with damp or wet mops. Dry methods of environmental cleaning (i.e., dusting, sweeping) should not be used in semi-restricted and restricted areas.

Recommendation II.b. (page 12), All horizontal surfaces in the OR (e.g., furniture, surgical lights, booms, equipment) should be damp dusted before the first scheduled surgical or other invasive procedure of the day.

Recommendation II.b.1 (page 530), Fluids kept in a warming cabinet should be labeled with an expiration date based on the manufacturer's recommendation for storage above room temperature.

According to the Manufacturer's Instructions for the Olympus Evis Exera II Ultrasound Gastrovideoscope, Hang the endoscope in the storage cabinet with the distal end hanging freely. Make sure that the insertion section hangs vertically and as straight as possible.

1. The facility did not ensure medications and supplies used for the administration of medications were secured in a manner to avoid diversion or tampering.

a) On 02/09/16 at 9:45 a.m., a tour of the Main Preoperative (Preop) Unit and the Main Post Anesthesia Care Unit (PACU) was conducted with the Director of the Operating Room (Director #1) and a Registered Nurse in the Preop Unit (RN #9). Observations revealed the following unsecured medications and supplies:

- In Bay #9 of the Main Preop Unit, the top drawer of a storage cabinet was unlocked and revealed one 10 milliliter (ml) manufactured saline syringe out of its packaging and with no cap on the end of the syringe. The syringe was filled with an unknown clear liquid. The storage cabinet was accessible to patients, visitors, and staff. Upon finding the syringe, RN #9 stated the syringe should have been discarded and proceeded to empty the syringe of unknown liquid in a sink located at the nurses' station.

- In the "Difficult Intubation Cart" located adjacent to the Main PACU, the top drawer was unlocked and revealed one 50 ml bottle of topical 4% Lidocaine solution. The bottle was approximately 1/4th full of an unknown liquid. Upon finding the bottle, Director #1 stated medications should not have been stored in the "Difficult Intubation Cart" and proceeded to remove the bottle from the cart.

b) On 02/10/16 at 9:32 a.m., a tour of the Gynecological (GYN) OR was conducted with the Clinical Nurse Coordinator (CNC #10) of the Preop Unit and the PACU. Observation of GYN Preop Bay #5 revealed a storage cart with the top drawer unlocked which was filled with packaged prefilled saline syringes, needles, and syringes. The cart was accessible to patients, visitors, and staff. CNC #10 stated the drawer should have been locked at all times and proceeded to lock the drawer.

c) On 02/11/16 at 10:25 a.m., an interview was conducted with the Assistant Vice President of Surgical Services (AVP #2) who confirmed the expectation was for all medications to be secured from unauthorized use. AVP #2 stated the facility considered manufactured prefilled saline syringes to be medications that needed to be secured in the same way all medications were secured. AVP #2 further stated s/he had been conducting random monitoring checks throughout the surgical department; however, s/he was not documenting the performance of the monitoring checks or if any corrective actions or education were necessary as a result of the checks.

2. The facility did not maintain humidity levels in the Main OR suites at levels required by policies and national standards of care.

a) A tour of OR #7 was conducted on 02/09/16 at 12:15 p.m. with Director #1. Director #1 explained the facility followed AORN guidelines for determining the acceptable humidity levels in the OR, which were between 20-60%. Observation of the thermostat in OR #7 revealed the humidity level was 16.5%. Director #1 stated s/he would not be concerned if the humidity level fell below the accepted range. This was not in accordance with the policy which instructed staff to contact facilities management as soon as possible if temperatures and humidity ranges fell out of the required level.

Further observations from the same tour revealed the following OR suites' humidity levels:

- OR #8's humidity level was 16%.

- OR #2's humidity level was 15.9%.

b) Review of the Main OR Humidity Log from 01/01/16 to 02/09/16 (40 days total) revealed the following examples of humidity levels falling below the acceptable range:

- OR #1's humidity levels fell below the acceptable range 25 of 40 days reviewed. The lowest humidity level during the reviewed time frame was 6.3% on 02/04/16.

- OR #2's humidity levels fell below the acceptable range 26 of 40 days reviewed. The lowest humidity level during the reviewed time frame was 7.3% on 02/04/16.

- OR #3's humidity levels fell below the acceptable range 18 of 40 days reviewed. The lowest humidity level during the reviewed time frame was 6.9% on 02/04/16.

c) On 02/11/16 at 10:25 a.m., an interview was conducted with AVP #2 who confirmed the expected humidity range in the OR suites was between 20-60%. AVP #2 stated the reason it was important to keep humidity levels above 20% was to reduce the risk of fire or spark hazards in the OR.

3. The facility did not store reprocessed endoscopes in a manner to avoid contamination or growth of