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Based on interview with the hospital's Clinical Pharmacy Coordinator (CPC),Vice President of Operations (VPO), and review of the clinical record for Patient 1 (P1) the hospital failed to ensure :

A. P1's insulin drip had been administered according to the physician's order, and
B. The insulin drip (medication for high blood sugar - a high alert medication according to the hospital's policy and procedure) contained documentation of an independent double check during the infusion of this patient's insulin drip.

Findings:

A) Record review with the hospital's CPC and the VPO on 7/3/18, at 5:00 p.m. revealed P1 had been admitted to the hospital on 6/21/18 and started on an insulin drip on 6/21/18 at 7:49 p.m. The patient's physician had written the following order:
" ...Regular insulin 0.1 units/kg as intravenous bolus then 0.1 units/kg/hour continuous iv (intravenous) infusion. Target glucose (sugar) reduction rate is 50-75 mg/dl per hour (accuchecks every hour). - - If hourly glucose (blood sugar) reduction is less than 50 mg/dl, double the infusion rate. - - If hourly glucose reduction rate is greater than 75 mg/dl, decrease infusion rate by 50% when blood glucose reaches 250 mg/dl, decrease insulin to 3 units/hr and titrate to maintain blood glucose 150-200 mg/dl as follows (accuchecks every 2 hours): If blood glucose is greater than 400 = call physician, if blood glucose is between 300-399 = increase the infusion rate by 3 units/hour, if blood glucose is between 201-299 = increase infusion rate by 1 unit/hour, if blood glucose is between 150-200 = no change in the infusion rate, if blood sugar is between 100-149 = decrease the infusion rate by 1 unit/hour, if blood glucose is between 75-99 = decrease the infusion rate by 2 units/hour, if blood glucose is less than 75 = stop the infusion and call the physician."

The hospital was unable to provide documentation of P1's insulin infusion rate on 6/21/18 from 7:49 p.m. to 11:26 p.m. (for almost 4 hours of the infusion).
Additionally, based on the physician's order above the following adjustments should have been made, but were not made to P1's insulin infusion rate:

1) On 6/22/18, at 1:45 p.m., the physician's order indicated P1's insulin drip should have been decreased by 1 unit/hour based on the patient's current blood glucose of 115, but no change was made by the nurse to P1's insulin infusion rate, contrary to the physician's insulin order.

2) On 6/22/18, at 2:45 p.m., the physician's order indicated P1's insulin drip should have no change to the insulin infusion rate based on the patient's current blood glucose of 158, but the insulin infusion rate had been increased by 2 units/hour by the nurse contrary to the physician's insulin order.

3) On 6/22/18, at 4:45 p.m., the physician's order indicated P1's insulin drip should have been decreased by 1 unit/hour based on the patient's current blood glucose of 123, but no change was made by the nurse to P1's insulin infusion rate, contrary to the physician's insulin order.

4) On 6/22/18, at 5:10 p.m., the physician's order indicated P1's insulin drip should have been decreased by 1 unit/hour based on the patient's current blood glucose of 132, but no change was made by the nurse to P1's insulin infusion rate, contrary to the physician's insulin order.

5) On 6/22/18, at 6:15 p.m., the physician's order indicated P1's insulin drip should have been decreased by 1 unit/hour based on the patient's current blood glucose of 131, but no change was made by the nurse to P1's insulin infusion rate, contrary to the physician's insulin order.

6) On 6/22/18, at 7:15 p.m., the physician's order indicated P1's insulin drip should have been decreased by 1 unit/hour based on the patient's current blood glucose of 147, but no change was made by the nurse to P1's insulin infusion rate, contrary to the physician's insulin order.

7) On 6/23/18, at 10:40 a.m., the physician's order indicated P1's insulin drip should have been decreased by 1 unit/hour based on the patient's current blood glucose of 144, but no change was made by the nurse to P1's insulin infusion rate contrary to the physician's insulin order.

8) On 6/23/18, at 11:45 a.m., the physician's order indicated P1's insulin drip should have had no change based on the patient's current blood glucose of 178, but the nurse increased P1's insulin infusion rate by 1 unit, contrary to the physician's insulin order.

B) Review of the hospital's policy and procedure entitled: "High-Risk/High-Alert Medications" dated 11/2017 reads: "Purpose: To identify those medications that have a high likelihood to contribute to medication errors. To establish and implement safety measures for the use of these medications to help prevent the occurrence or errors ...Intravenous High Alert medications shall be infused via a programmable smart pump ...Independent Double Check (IDC) shall be performed by two licensed healthcare professionals on the initial set up of the smart pump, including but not limited to, selection of the appropriate medication from the drug library, data entry of correct concentration, volume to be infused, and rate of infusion ...Documentation of these IDCs shall be required for selected medications ...". Under attachment A of the hospital's policy and procedure it states: "Insulin (intravenous, subcutaneous), Documentation Required for Independent Double Check." Under Appendix 1, number 3 under Administration, states: "Double check per facility policy for proper pump settings when administering insulin drips."

Review of the hospital's: "Diabetes Blood Glucose Record", for patient P-1 during the administration of her insulin drip (between 6/22/18 at 7:49 pm to 6/24/18 at 10:30 am), did not demonstrate any documentation of an Independent Double Check for this insulin infusion. This document clearly states the "Nurses Signature" must be included on this document for each infusion rate and changes.

Based on observation, interview, and document review, the hospital failed to ensure that the pharmaceutical services met the needs of all of their patients as evidenced by their failure to:

1) Compound sterile intravenous medication in a safe and effective manner as outlined in USP-NF 797 (State Board of Pharmacy Regulation). (Refer to A-501)

2) Recalibrate (maintain accuracy) the TempTrak transmitters(monitors) for all of the Pharmacy medication refrigerators. (Refer to A-491)

3) Implement the hospital's established policy and procedure for the investigation of controlled drug losses. (Refer to A-509)

4) Administer a high alert/high risk medication in accordance with the patient's physician order and document in the patient's medical record the independent double check by nursing as outlined in the hospital's policy and procedure. (Refer to A-405)

The cummulative effect of these systemic problems resulted in the inability of the hospital's pharmaceutical services to direct staff in such a manner to meet the pharmaceutical needs of the hospital's patients in accordance with the hospital's policies and procedures, drug references and acceptable standards of practice.

Based on interview with the hospital's Chief Operating Officer (COO) and review of the manufacturer's "TempTrak" product literature the hospital failed to recalibrate their refrigerator temperature monitoring devices as outlined in the product manufacturer's literature.

Findings:

TempTrak's manufacturer's literature indicated their monitors and transmitters are used to ensure constant temperature and humidity levels are maintained. In the manufacturer's latest literature it reads: " ...Under normal use conditions Cooper-Atkins instruments and probes experience insignificant drift and maintain stated accuracy, even over extended time periods. However, thermal and physical stress will cause temperature instruments and probes to drift over time. Therefore, periodic calibration of (company name) instruments and probes or any manufacturer's products is a sound and recommended practice. Periodic calibration is also required by many industry standards and regulations. The only way to be absolutely certain an instrument is accurate is to perform periodic calibration ...(Name of Company) Corporation recommends periodic calibration of instruments and probes against known traceable standards ... initially, annual calibration is recommended, but subsequent frequency may be increased or decreased based upon calibration history or an institution's identified protocol."

Interview with the hospital's Chief Operation Officer (COO) on 7/3/18, at 2:50 p.m., the COO indicated the hospital's oldest pharmacy medication TempTrak transmitter is 4 years old and all the other medication refrigerator TempTrak units are on average 2 to 3 years old. The hospital was unable to provide any evidence that their TempTrak medication refrigerator transmitters had ever been recalibrated. The hospital COO also acknowledged during the interview the facility had no calibration history for any of the TempTrak Pharmacy medication refrigerator units and the facility had not developed an institutional identified protocol.

Based on interview and review of the hospital's certification Intravenous (IV) compounding report from a clean room vendor, the hospital failed to provide evidence the mold which had been found in a fungal air sample near a work table, (inside the segregated compounding room) had been remediated and the air near the table resampled.

Findings:

Review of the hospital's policy and procedure entitled: "Compounded Sterile Preparations (CSP); General Provisions, Standard Procedures, and Definitions", dated 5/2014, states: " ... Sterile product compounding shall be performed in compliance with current information from USP-NF Chapter 797, State Board of Pharmacy Laws and Regulations ...".Interview with the Director of Pharmacy (DOP) and the Clinical Pharmacy Coordinator (CPC) on 6/26/18 at 10:45 am revealed that the Pharmacy's most current copy of their intravenous room certification report showed that the Pharmacy's segregated compounding room (the location where intravenous solutions are prepared for patient administration), had grown 7 colony forming units (CFU) of a mold (Cladosoporium) in an air sample from the right corner of a work table. The hospital Pharmacy staff were unable to provide any additional information in regards to any corrective actions which the hospital had taken to remediate this mold sample obtained the hospital's segregated compounding room.

USP-NF Chapter 797 states the following: " ...Regardless of the number of Colony Forming Units (CFUs) identified in the compounding facility, further corrective actions will be dictated by the identification of microorganisms recovered (at least by genus level) by an appropriate credentialed laboratory of any microbial bioburden captured as a cfu using an impaction air sampler. Highly pathogenic microorganisms (e.g., Gram-negative rods, ... molds and yeasts) can be potentially fatal to patients receiving Compounded Sterile Products (CSPs) and shall be immediately remedied, regardless of cfu count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist." By the hospital continuing to compound CSP at 150 CSPs per day, this put every patient who received a CSP at risk for developing a highly pathogenic infection from these products.

On 6/27/18, at 1:15 p.m., an IJ (immediate jeopardy) was called with the hospital's administration based on the mold, which had been identified in the Pharmacy's segregated compounding room. When the hospital's administration contacted the hospital's previously used hood certification testing company later that day to schedule a new recertification test, the company asked the hospital administrator if anyone from the hospital had kept a copy of the company's recertification report from March 22, 2018. The certification company scanned over a copy of the March 22, 2018 report to the facility. This report was subsequently provided by the hospital CEO (Chief Executive Officer) to the Pharmacy surveyor at 5:35 p.m. on 6/27/18. After the Pharmacy surveyor reviewed the report and determined the information on the report showed the air-sample had been retaken at the same location of the original air sample. The results indicated there was no longer any mold present, the IJ for the Pharmacy portion of the survey was lifted (abated) at 5:55 p.m. on 6/27/18.

Based on Interview with the Director of Pharmacy (DOP) ,Clinical Pharmacy Coordinator (CPC), and review of the hospital's Drug Enforcement Administration (DEA) drug loss reports (form DEA 106) the hospital's DOP failed to provide evidence of : " .... at minimum participated in the investigation of the facts (e.g. missing medications, audits reports, charting records, interviews, obtaining statements) to determine next steps", as outlined in the hospital's policy and procedure.

Findings:

Interview with the DOP and CPC on 6/27/18, at 11:30 a.m., revealed hospital incidents of drug losses/possible drug diversions. The DOP revealed having not participated in the investigation of the facts to determine the next steps in the corrective action plan with the unit Nurse Managers.

Review of the hospital's policy and procedure entitled: "Medication Diversion Prevention guide book", under the section entitled: "Director of Pharmacy Role and Responsibility: states: " ...ensure all investigative results are summarized, and that recommendations and actions are identified and documented in the MDT meeting minutes...Leads, or at minimum participates in the investigation of the facts (e.g. missing medications, audits reports, charting records, interviews, obtaining statements) to determine next steps."

The following are incidents obtained from the DOP's files which were reported to the DEA and/or the California State Board of Pharmacy, but the hospital's DOP was unable to provide evidence she had lead or at minimum participated in the investigation of the facts (e.g. missing medications, audits reports, charting records, interviews, obtaining statements) to determine next steps with the Unit Nursing Managers for each of these incidents:

1) On 6/2/17, the hospital's Pharmacy reported to the DEA one Traveler Nurse (which had been employed by the hospital had removed one tablet of Oxycodone 10mg with Acetaminophen (Tylenol) from the hospital's Automated Drug Delivery Device (ADDD) on May 22, 2017, but there was no record that this scheduled narcotic medication had ever been administered to a patient or disposed of by waste. This medication was never recovered by the hospital.

2) On 3/27/2017, the hospital's Pharmacy reported to the DEA one 5 milliliter (ml) cup of Guaiatussin with Codeine had been lost by the hospital. This medication was never recovered by the hospital.

3) On 9/12/17, the hospital's Pharmacy reported to the DEA an ampule of the scheduled controlled drug Hydromorphone 1 milligram (mg)/ 1 ml had been removed from the hospital's ADDD system. ½ of the 1 ml dose of this scheduled narcotic medication had been administered to one patient, but the remainder of this medication had not been documented as wasted nor had this medication ever been found.

4) On 8/19/2017, one of the hospital's Pharmacy Technician's had been filling an ADDD using a medication cart. While the Pharmacy Technician had been filling the ADDD, with his back to the hallway door, an unknown employee entered through the door of the room and walked back out of the room with 5 tablets of the scheduled medication Lorazepam (Ativan) before the Pharmacy Technician was able to get a good luck at the other employee. This medication has never been found by the hospital.

5) On 3/7/18, a Pharmacy Technician had been given 12 ampules of Fentanyl 50 micrograms (mcg)/1ml vials. The facility's report showed that all 12 ampules of Fentanyl had been delivered but 2 ampules of Fentanyl were later found missing by two Physician's during their work-shift from the same ADDD which this Pharmacy Technician had filled earlier. This Pharmacy Technician later resigned from the facility and the missing ampules of the scheduled narcotic medication Fentanyl were never found.

Based on observation, record review, and interview, the facility failed to provide safe anesthetizing locations for the patients they serve as evidenced by;

Relative humidity (RH) levels that were out-of-range and with incomplete and missing documented corrective actions.
RH levels in anesthetizing locations that were not maintained in accordance with equipment instructions-for-use (IFUs).
Failure to calibrate and develop a protocol for calibration of sensors used to monitor RH.
Using a temporary alteration to the heating, ventilating, and air-conditioning (HVAC) system controlling the surgical suite. (Refer to 701).

The cumulative effect of these systemic problems resulted in the inability of the hospital to ensure safe quality health care services were provided to patients within acceptable standards of practice.

Based on observation, record review, and interview, the facility failed to maintain the anesthetizing locations. This was evidenced by relative humidity (RH) levels that were out-of-range and with incomplete and missing documented corrective actions, by RH levels in anesthetizing locations that were not maintained in accordance with equipment instructions-for-use (IFUs), by the failure to calibrate and develop a protocol for calibration of sensors used to monitor RH, and by a temporary alteration to the heating, ventilating, and air-conditioning (HVAC) system controlling the surgical suite. This affected all anesthetizing locations in the Main Hospital and TOSH. This could result in the failure to maintain RH within required parameters, by the increased risk of OR equipment failure, by the inability to control RH levels with the hospital's mechanical system, and the decreased reliability of sensors used to monitor ambient conditions in anesthetizing locations.

NFPA 99, Health Care Facilities Code, 2012 Edition.
9.3.1.1 Heating, cooling, ventilating, and process systems serving spaces or providing health care functions covered by this code or listed within ASHRAE 170, Ventilation of Health Care Facilities, shall be provided in accordance with ASHRAE 170.

American Society of Heating, Refrigerating and Air Conditioning Engineers, Inc. (ASHRAE) 170, Ventilation of Health Care Facilities, 2008.
Class A surgery: provides minor surgical procedures performed under topical, local, or regional anesthesia without preoperative sedation. Excluded are intravenous, spinal, and epidural procedures, which are Class B or C
surgeries.
Class B surgery: provides minor or major surgical procedures performed in conjunction with oral, parenteral, or
intravenous sedation or performed with the patient under analgesic or dissociative drugs.
Class C surgery: provides major surgical procedures that require general or regional block anesthesia and/or
support of vital bodily functions.

TABLE 7-1 Design Parameters
Function of Space: RH (%)
Classes B and C operating rooms: 30 - 60
Operating/surgical cystoscopic rooms: 30 - 60
Delivery room (Caesarean): 30 - 60
Class A Operating/Procedure room: 30 - 60

On 4/19/13, the Centers for Medicare & Medicaid Services (CMS) released memorandum S&C: 13-25-LSC & ASC titled "Relative Humidity (RH): Waiver of Life Safety Code (LSC) Anesthetizing Location Requirements; Discussion of Ambulatory Surgical Center (ASC) Operating Room Requirements." The memorandum stated: "The 2012 edition of NFPA 99 has adopted the 2008 edition of the American Society for Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE) Standard 170, Ventilation of Health Care Facilities. Addendum D of the ASHRAE standard requires RH in anesthetizing locations to be maintained between 20 - 60 percent. In addition, this ASHRAE standard has been incorporated into the Facility Guidelines Institute (FGI) 2010 Guidelines for Design and Construction of Health Care Facilities, and has been approved by the American Society for Healthcare Engineering of the American Hospital Association and the American National Standards Institute."

Centers for Medicare & Medicaid Services (CMS) memorandum "S&C: 15-27-Hospital, CAH & ASC Potential Adverse Impact of Lower Relative Humidity (RH) in Operating Rooms (ORs)" stated "it has come to light that an RH level <30% is not compatible with the instructions for use (IFUs) for some sterile supplies and electro-medical equipment used in operating rooms" and "CMS expects hospitals, CAHs and ASCs to follow the current IFUs for supplies and equipment used in their ORs."

Findings:

During a facility tour, record review, and interview with ADM 2 from 6/28/18 to 7/3/18, the temperature and humidity logs were provided and the heating, ventilating, and air-conditioning (HVAC) system for the surgical suite was observed.

All Buildings

6/28/18

At 7:45 a.m., the facility's policy and procedure (P&P) for Monitoring temperature and humidity was reviewed. The policy was effective July 2015 and revised January 2016.

The P&P stated that temperature and relative humidity (RH) levels were continuously monitored by an automated system called TempTrak. Table A on the P&P indicated that an RH range of 20% - 60% was to be maintained in operating rooms (ORs), catheterization labs (Cath Labs), procedure rooms, interventional radiology (IR), and caesarean section (C-Section) Rooms.

The P&P stated that Facilities Management would monitor RH levels through Temptrak and any action taken, in the event RH is out-of-range, would be documented by Facilities.

The P&P stated that in the event RH continued to be out of range, or moisture accumulated on the walls or horizontal surfaces, the room was to be closed.

The P&P also stated mold inspections would be completed weekly or when deemed appropriate based on RH levels to ensure patient safety.

The P&P cites the American Institue of Architects' Academy (AIA) 2006 Guidelines, the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) Standard 170, 2012 Life Safety Code NFPA, and the Association for the Advancement of Medical Instrumentation (AAMI) ST79 as references for their P&P.

Main Hospital

6/28/18

1. Temperature and humidity logs provided on 6/28/18 indicated that RH levels fell out-of-range in June 2018 at the following locations:

a. In C-Section Room 1, the RH was recorded as greater than 60% during 14 days of the month. The out-of-range RH levels ranged from 61% to 72%.
b. In C-Section Room 2, the RH was recorded as greater than 60% during 12 days of the month. The out-of-range RH levels ranged from 62% to 76.7%.
c. In Cath Lab 1, the RH was recorded as greater than 60% during 9 days of the month. The out-of-range RH levels ranged from 63% to 68%.
d. In Cath Lab 2, the RH was recorded as greater than 60% during 12 days of the month. The out-of-range RH levels ranged from 62% to 74.7%.
e. In Cath Lab 3, the RH was recorded as greater than 60% during 17 days of the month. The out-of-range RH levels ranged from 61.7% to 78%.
f. In OR 1, the RH was recorded as greater than 60% during 26 days of the month. The out-of-range RH levels ranged from 61% to 78%.
g. In OR 2, the RH was recorded as greater than 60% during 26 days of the month. The out-of-range RH levels ranged from 61% to 72.7%.
h. In OR 3, the RH was recorded as greater than 60% during 25 days of the month. The out-of-range RH levels ranged from 62% to 75%.
i. In OR 4, the RH was recorded as greater than 60% during 26 days of the month. The out-of-range RH levels ranged from 61% to 73.7%.
j. In OR 5, the RH was recorded as greater than 60% during 18 days of the month. The out-of-range RH levels ranged from 61% to 75%.
k. In OR 6, the RH was recorded as greater than 60% during 26 days of the month. The out-of-range RH levels ranged from 61% to 74%.
l. In Cardiovascular (CV) 1, the RH was recorded as greater than 60% during 27 days of the month. The out-of-range RH levels ranged from 63.7% to 90.7%.
m. In CV 2, the RH was recorded as greater than 60% during 27 days of the month. The out-of-range RH levels ranged from 62% to 76%.
n. In Cystoscopy (Cysto) Room, the RH was recorded as greater than 60% during 14 days of the month. The out-of-range RH levels ranged from 61.7% to 76%.
o. In IR, the RH was recorded as greater than 60% during 13 days of the month. The out-of-range RH levels ranged from 62.4% to 79.7%.

Under the column for "Actions Taken" on the log for all the rooms, staff indicated that Facilities was informed and that the mold assessment was current/documented on days the RH was out-of-range. For IR, the staff also indicated that the "fire risk assessment" was completed on days the RH was out-of-range.

At 8:40 a.m., the Temptrak monitor at the Engineering Office was observed. The 8:30 a.m. readings for RH were:

a. OR 1 - 66.3%
b. OR 2 - 64%
c. OR 3 - 73%
d. OR 4 - 62%
e. OR 5 - 63%
f. OR 6 - 65%
g. OR 7 - 57%
e. CV 1 -77%
f. CV 2 - 78%

All RH levels greater than 60% appeared in a red box on the screen and all RH levels between 20% and 60% appeared in a green box on the screen.

During an interview at 8:49 a.m., FAC 1 stated that Temptrak records the temperature and humidity levels every 15 minutes. He said that the red boxes indicate that levels are out-of-range. He stated that the Facilities only take action if called by staff in the procedural areas and Facilities will try to lower RH by raising the temperature. He stated that the Facilties personnel do not keep a log of all corrective actions taken. ADM 2 stated that a log was kept during business hours.

The Facilities Management Department Service Call Log provided only had corrective actions noted since 6/19/18 and did not address all the instances the RH was out of range and at all locations. One note stated that they received a call from IR at 7:49 a.m., on 6/27/18, with a RH of 79% but that "staff declined to change humidity levels." One note stated that Facilities received a call from Special Procedure Rooms 1, 2, and 3 because of high RH but "staff declined to raise temps." On 6/26/18, at 7:50 a.m. in Cath Labs 1 and 2, and at 8:10 a.m. in IR, it was noted that staff "declined" to adjust temperatures to lower RH. Six other entries in the log noted calls received about humidity but there were no documented corrective actions.

During an interview at 8:57 a.m., on 6/29/18, FAC 1 confirmed if staff in the surgical department do not want to make any changes to lower RH then Facilties will not make any changes and procedures would continue with RH levels out of range.

2. At 3:43 p.m., IFUs for two pieces of equipment used in the ORs and other procedural areas were provided. For both equipment, Bovie and Datapad, the operating RH humidity was listed as 30% to 75%. The Bovie was present in all ORs and procedural areas.

The humidity logs indicated that RH went above 75% in the following rooms and on the following days:

OR 1:
a. 6/24/18 - 78%

Cath Lab 3:
b. 6/24/18 - 78%

CV1:
c. 6/5/18 - 77%
d. 6/21/18 - 90.7%
e. 6/22/18 - 77.3%
f. 6/23/18 - 76%
g. 6/25/18 - 76%
h. 6/26/18 - 76%
i. 6/27/18 - 75.7%
j. 6/28/18 - 76%

CV2:
k. 6/27/18 - 76%
l. 6/28/18 - 76%

Cysto:
m. 6/17/18 - 76%

IR
n. 6/4/18 - 76.3%
o. 6/27/18 - 79.7%
p. 6/28/18 - 79%

The facility failed to ensure that RH levels in procedural areas are maintained in accordance with equipment IFUs.

Main Hospital and TOSH:

6/28/18

3. At 10:31 a.m., reading from the Temptrak indicated that Cath Lab 1 had an RH level of 69%.
During a concurrent interview, ADM 2 stated that the sensor in Cath Lab 1 might be broken because the temperature readings were off by 10 degrees when compared with a reading from a handheld device. He said the facility did not compare RH readings from the sensor and another source.

During an interview at 3:10 p.m., on 7/2/18, ADM 2 stated that the facility did not calibrate the Temptrak sensors.

At 10:25 a.m., on 7/3/18, the manual with instructions for Temptrak sensor maintenance and calibration was provided. Temptrak sensors are used throughout the hospital and used to monitor conditions in anesthetizing locations and other critical areas. The manual stated "initially, annual calibration is recommended but subsequent frequency may be increased or decreased based upon calibration history or an institution's identified protocol." The facility did not provide a protocol or P&P for maintenance of Temptrak sensors.
During a concurrent interview, ADM 2 and ADM 3 both confirmed that calibration was not conducted and the facility did not establish a maintenance protocol for Temptrak calibration.


Main Hospital

6/28/18

4. During an interview at 8:30 a.m., ADM 2 stated that the HVAC system that controls most of the procedural areas did not have a built dehumidification or humidification system. He said, that as a temporary solution to ongoing high RH levels, the facility would put in portable 12-ton spot coolers that would air-condition air going into the HVAC system and help lower humidity.

During an interview at 9:35 a.m., FAC 2 stated that the facility had tried this spot cooler method before and it worked to lower humidity.

During an interivew at 9:51 a.m., ADM 2 stated that the spot coolers were previously used in Summer 2016, while the HVAC system was undergoing a repair, and one of the side effects was that humidity was lowered.

During an interview at 3:37 p.m., ADM 2 stated that the facility applied for an emergency permit from the Office of Statewide Health Planning and Development (OSHPD) to install the portable spot coolers.

An email dated 6/28/18, at 7:35 p.m., indicated that OSHPD granted the facility authorization to install the spot coolers prior to issuance of a building permit. The email from OSHPD stated "this authorization does not waive the plan approval and permit process" and "authorization to proceed has been granted for project S181475-56-00 via CAN 2-108. Please be sure to comply with the requirement addressed in the CAN."

Code Appliance Notice (CAN) 2-108 states: "Such permits shall be limited as to time of service, but shall not be permitted for more than 180 days. The building official is authorized to grant extensions for demonstrated cause."

The spot coolers were installed outside the Southwest Wing and flexible ductwork went from the coolers on the ground floor to the air intake on the roof one floor above.

During an interview at 9:35 a.m., on 7/2/18, ADM 2 confirmed that the spot cooler intervention affects all procedural areas except Cath Labs and C-Section Rooms.

The facility failed to ensure their mechanical ventilation system can adequately maintain temperature and humidity levels in accordance with accepted guidelines and equipment IFUs.

Based on observation, interview, and record review, the hospital failed to ensure the surgical services department met the needs of all of their patients as evidenced by their failure to:

1). Maintain humidity in 10 of 10 Operating Rooms (ORs), two of two of labor and delivery caesarean section rooms (CSR), three of three cardiac catheterization laboratory (CCL-cath lab) rooms, three of three special procedures/gastrointestinal (GI) rooms, one of one interventional radiology (IR) room, and one OR sterile supply room . From 6/1/18 to 6/26/18, the humidity range in the above mentioned areas were from 60.2 % to 90.7%, all above the recommended range. (Refer to A-951 and 701).

2). Ensure medical equipment in the OR's were not exposed to out of range humidity, (Refer to A-951 and 701).

3). Ensure portable empty oxygen tanks were segregated from the full portable oxygen tanks, (Refer to A-951).

4). Ensure 4 towel clamps (instrument use to hold human tissue and/or towels together during surgery) were not sterilized with box locks (where the joint of the instrument connect) in closed positions and ensure two straight scissors and one wire scissor in the GI lab were not sterilized in closed positions. (Refer to A-951).

The cumulative effect of these systemic problems resulted in the inability of the hospital's surgical services department to meet the surgical service needs of the hospital's patients in accordance with the hospital's policies and procedures, and acceptable standards of practice.

Based on observation, interview, and record review, the facility failed to ensure:

1. Recommended Humidity ranges were followed throughout the hospital OR's, procedure rooms and sterile supply rooms.

2. Follow policy and manufacturer guidelines related to surgical equipment in the OR's..

3. Empty oxygen tanks were segregated upon storage from full portable tanks,

4. Ensure sterilization was performed according to ASHRAE guidelines and hospital policy.

These failures had the potential to result in fires, outbreaks of surgical site infections, and compromise to the health and safety of patients.
.
Findings:

1. During an observation on 6/26/18, at 9:00 a.m.,Technician 2 (Tech 2) was recording OR humidity values obtained from a computer onto the OR Humidity Log (report recording daily temperature and humidity).

During an interview with Tech 2 on 6/26/18, at 9:02 a.m.,Tech 2 indicated the out of range OR humidity values/range are reported to licensed nurse 4 (LN 4) and to administration 2 (ADM 2).

Review of the OR Humidity Log report from 6/1/18 to 6/26/18 indicated out of 10 ORs (including the Cysto and the two CV rooms 1 and 2 ) the humidity range were from 61.0 % to 90.7%. above the range of 20-60%.

Further review of the OR humidity logs from 6/1/18 to 6/26/18 revealed the following :

1. In two of two L&D C-section rooms the humidity ranged from 61.3% to 76.7.%.
2. In three of three CC ORs the humidity ranged from 61 % to 76.7.%.
3. In three of three GI ORs the humidity ranged from 61 % to 71%.
4. One of one IR rooms (11) had a humidity range from 62.4% to 76.3.% .
5. One of one CS room had a humidity range from 61% to 65%.

The humidity range documented on the OR humidity log from 6/1/18 to 6/26/18 were above the ANSI and ASHRAE recommended range.

NFPA 99, Health Care Facilities Code, 2012 Edition.
9.3.1.1 Heating, cooling, ventilating, and process systems serving spaces or providing health care functions covered by this code or listed within ASHRAE 170, Ventilation of Health Care Facilities, shall be provided in accordance with ASHRAE 170.

American Society of Heating, Refrigerating and Air Conditioning Engineers, Inc. (ASHRAE) 170, Ventilation of Health Care Facilities, 2008.
Class A surgery: provides minor surgical procedures performed under topical, local, or regional anesthesia without preoperative sedation. Excluded are intravenous, spinal, and epidural procedures, which are Class B or C
surgeries.
Class B surgery: provides minor or major surgical procedures performed in conjunction with oral, parenteral, or
intravenous sedation or performed with the patient under analgesic or dissociative drugs.
Class C surgery: provides major surgical procedures that require general or regional block anesthesia and/or
support of vital bodily functions.

TABLE 7-1 Design Parameters
Function of Space: RH (%)
Classes B and C operating rooms: 30 - 60
Operating/surgical cystoscopic rooms: 30 - 60
Delivery room (Caesarean): 30 - 60
Class A Operating/Procedure room: 30 - 60

On 4/19/13, the Centers for Medicare & Medicaid Services (CMS) released memorandum S&C: 13-25-LSC & ASC titled "Relative Humidity (RH): Waiver of Life Safety Code (LSC) Anesthetizing Location Requirements; Discussion of Ambulatory Surgical Center (ASC) Operating Room Requirements." The memorandum stated: "The 2012 edition of NFPA 99 has adopted the 2008 edition of the American Society for Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE) Standard 170, Ventilation of Health Care Facilities. Addendum D of the ASHRAE standard requires RH in anesthetizing locations to be maintained between 20 - 60 percent. In addition, this ASHRAE standard has been incorporated into the Facility Guidelines Institute (FGI) 2010 Guidelines for Design and Construction of Health Care Facilities, and has been approved by the American Society for Healthcare Engineering of the American Hospital Association and the American National Standards Institute."

Centers for Medicare & Medicaid Services (CMS) memorandum "S&C: 15-27-Hospital, CAH & ASC Potential Adverse Impact of Lower Relative Humidity (RH) in Operating Rooms (ORs)" stated "it has come to light that an RH level <30% is not compatible with the instructions for use (IFUs) for some sterile supplies and electro-medical equipment used in operating rooms" and "CMS expects hospitals, CAHs and ASCs to follow the current IFUs for supplies and equipment used in their ORs."

During an interview with licensed nurse (LN 4), on 6/27/18, at 9:11 a.m., LN 4 confirmed the out of range values for all the ORs and specialty procedural areas. LN 4 stated, "There is not a lot we can do to change the high humidity other than to raise the temperature and our surgeons don't like that, they like it cold. The temperature/humidity values are reported to me everyday and almost everyday we do nothing unless there is actual condensation in the room then we shut the room down for the day. Once a week we do mold checks in all the ORs. The mold checks are done by Environmental Services (janitorial services) they physically check all the walls and dark places looking for mold. Humidity has always been high in our ORs, at certain times of the year it's even higher."

2. During an observation on initial tour on 6/25/18, at 3:15 p.m., one cautery machine (equipment used to stop bleeding) was stored in all ORs and a heart-lung/Cardiopulmonary bypass machine (CBM-equipment used to take over the function of the heart and lung during surgery) was stored in CV rooms 1 and 2.

The undated manufacturer's instructions for the cautery machine entitled "Force Triad Energy Platform" indicated, (page 9-3) the relative humidity range should be 30%-75%.

The undated manufacturer's operating instructions for the CBMs entitled "Operating Instructions" indicated, relative humidity range of 30%-75%.

Review of the OR daily humidity log on 6/26/18, at 11:54 a.m., dated from 6/1/18 to 6/26/18, indicated CV rooms 1 and 2, the humidity were 61.7 % to 90.7 %. On 9 of those days from 6/1/18 to 6/26/18 the humidity was above 75%. The recorded humidity range were all above the manufacturer's recommendation for the equipment.

During an interview with ADM 2 on 6/27/18, at 9:15 a.m., ADM 2 stated, "The hospital follows guidelines for temperature and humidity as recommended by American National Standards Institute (ANSI), American Society for Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE), and American Society for Healthcare Engineering (ASHE). ADM 2 further indicated in addition to those guidelines the facility relied on administration 11 (ADM 11) for consult.

ADM 2 provided a copy of the Healthcare Guidelines and Standards published by ANSI/ASHRAE/ASHE Standard 170, dated 2013. The report indicated on Table 7-1 the Relative Humidity range of 20-60% .

Review of the guidelines provided by ADM 2 concur with the humidity range of 20-60 %.

In an interview with ADM 11, on 7/2/18, at 3:22 p.m., ADM 11 stated, "It is my understanding that the equipment in the operating rooms should remain at a humidity range, which would allow it to perform in the way it is intended. If we noticed this was not occurring we would contact the manufacturer to determine what ill effects it would have on the equipment over a prolonged time-period as this is what would cause the equipment to malfunction. However, I have not been made aware of or consulted on the humidity being out of range in any of our ORs."

The facility's policy and procedure entitled "Monitoring of Temperature and Humidity" last revised 6/2016, indicated, "It is the policy of the Hospital to ensure safe environmental temperature and humidity levels." Optimum Temperatures for all operating rooms 68-75 degrees Fahrenheit and Relative Humidity range 20-60%." The facility's policy and procedure does not mention the process to notify ADM 11 regarding the use of OR equipment in high humidity areas and out of range himidity in the OR .

On 6/27/18 at 6:50 p.m., the IJ related to the out of range humidity in the 10 of 10 ORs, two of two CSRs, three of three CCL rooms, three of three GI rooms, one of one IR, and one OR sterile supply room was abated when an acceptable action plan was submitted and accepted.

On 6/28/18 at 1:30 p.m. the IJ regarding the out of range humity in the ORs was put back in place when 9 of 10 operating rooms (ORs1, 2,3,4,5,6,Cysto room, CV1 and CV2) continued to be out of compliance with the ANSI/AHRAE humidity recommendations and facility policy and procedure entitled "Monitoring of Temperature and Humidity" dated 6/16.

On 7/2/18 at 11:15 a.m.,the IJ was abated when all ORs and procedural areas were within recommended humidity levels by ANSI/ASHRAE and faciltiy policy.




3. During an initial observation and concurrent interview with licensed nurse 4 (LN 4), on 6/25/18, at 3:00 p.m., in the surgical suites area an empty E-size portable oxygen tank was found in the storage racks together with the full oxygen tanks. LN 4 observed the empty oxygen tank and stated, "The black cap usually indicates it is full, but this oxygen tank is empty and it should not have been in this section."

The facility's policy and procedure titled "Portable Oxygen Tank Storage-Safety" with revised date 4/2018, indicated, "E-size medical cylinder will be segregated in Full, In Use, and Empty storage racks.

4. During an initial observation in the central sterile processing room (area where surgical instruments are cleaned and sterilized) on 6/27/18, at 9:20 a.m., 4 towel clamps (surgical instrument used to clamp towels or hold human tissue together) were found with the lock box closed (where the joints of the instruments connect) inside of a surgical major tray, which was sterilized and prepared for surgical use.

During an observation and concurrent interview with central sterile technician (TECH1) on 6/26/18, at 9:35 a.m., a drawer in the gastrointestinal (GI) room 2 contained two peel pouches with straight scissors, and one peel pouch with a wire scissor, which were steam sterilized in the closed position. TECH 1 acknowledged the instruments were sterilized closed and stated, "Yes, they should be in the open position."

An interview with ADM 7, on 6/27/18, at 9:22 a.m., ADM 7 confirmed the finding and stated, "Yeah, those lock boxes should have been sterilized opened."

The facility policy and procedure titled "Disinfection And Sterilization" dated 1/14, indicated, "Sterilizing agent must contact all surfaces. Open all lock boxes on instruments"