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Based on observation, interview, and record review, the Governing Body failed to be responsible for the conduct of the hospital when:
1. The facility failed to ensure there was a safe and sanitary environment, properly equipped and maintained to protect the health and safety of patients. (Cross Reference A-0700)
2. An effective quality assessment performance improvement program (QAPI) had not been implemented to assist in establishing expected practices and outcomes, monitoring for aberrance's and correcting deficient practices (Cross Reference A-0263).

The cumulative outcome of these failings meant the Governing Body did not ensure the safety and quality of care provided in the hospital.

Findings:

During a concurrent interview with ADM1 and ADM 16, on September 21, 2017, starting at 11:00 am, ADM16 indicated that hospital departments are responsible for identifying and implementing ongoing monitoring of high risk, high volume or problem prone processes. ADM1 and ADM 16 confirmed that there had not been any reports to the Governing Body related to the high risk and problem prone areas associated with temperature, humidity and ventilation control that included data, analysis, actions, or effectiveness of actions.

During a review of the "Quality Committee and Governing Body" minutes for calendar year 2017, minutes did not reveal any reports and or quality indicator data related to temperature and humidity monitoring or ongoing measurable monitoring of these areas being reported to the Governing Body.

Based on observation, interview and document review, the hospital failed to develop an effective and hospital-wide quality management program because:

1. The quality assurance (QA) program failed to focus on high-volume, high risk problem prone areas and lacked the development and trending of quality data indicators associated with operating room and environmental areas. (Cross reference A-0273, A-0308, A-0940 )

2. Although the hospital had a history of problems with equipment failures, and difficulty regulating temperature, humidity and ventilation that have the potential to affect safety of services and quality of care, these problem prone areas were not incorporated into the quality program. (Cross reference A-0700, A-0726, A-0940, A-0951)

The cumulative effect of these failings meant the hospital failed to develop and implement a quality assurance program to ensure the high quality of healthcare provided.

The hospital must use quality indicator data collected to monitor the effectiveness and safety of services and quality of care. Based on interview and record review, the facility failed to identify and track aspects of performance in high risk, high volume and problem prone areas in the:

1.Perioperative services. (cross reference A 0726, A0951 and A 0940)
2. Environment. (cross reference A0726)

This failure has resulted in missed opportunities to measure, analyze and track quality indicators to monitor and ensure the on-going safety of services.

Findings:

1) The facility policy entitled "Quality Management, Performance Improvement & Patient Safety Plan" dated April 25, 2017, indicated in part, "High priority is given to high volume, high risk or problem prone processes ....all departments will be responsible for identifying processes in their area that impact patient safety and are high volume, high risk, or problem prone."

2) During an interview with ADM2, on September 21, 2017, at 9:40 am, ADM2 stated, "The volume of operative/procedural cases is at least 1600 monthly." Adm2 further indicated that the monitoring of temperature and humidity in the operating rooms and the counting of instruments are high volume and high risk processes in the operative areas. When asked to review the ongoing monitoring activities of the high volume and high risk related to these areas, Adm2 indicated that to date none have been conducted by the perioperative services.

3) During a concurrent interview with ADM1 and ADM 16, on September 21, 2017, starting at 11:00 am, ADM1 indicated that hospital departments are responsible for identifying and implementing ongoing monitoring of high risk, high volume or problem prone processes. ADM1 and ADM 16 confirmed that there had not been any reports to the Quality Committee or Governing Body related to the high risk and problem prone areas associated with temperature and humidity that included data, analysis, actions, or effectiveness of actions.

4) A review of the year to date 2017, "Safety Committee," minutes, revealed there was no evidence of ongoing measurable data that was reported related to temperature and humidity monitoring, analysis, actions or effectiveness of actions.

5) During a review of the "Quality Committee and Governing Body" minutes for calendar year 2017, the minutes did not reveal any reports and or quality indicator data related to temperature and humidity monitoring nor ongoing measurable monitoring for instrument counting in operative areas being reported to the Quality Committee or Governing Body.

Based on observation, interview and record review, the hospital failed to ensure the QAPI program reflected the complexity of the hospital's organization and services to include operating room services, environmental services and contracted services, for quality and effectiveness. These failures created the risk of the patients receiving poor quality medical care in an unsanitary and unsafe environment.

Findings:

1. The hospital failed to ensure their QAPI program's quality processes were designed and implemented to ensure the quality and safety of patient care provided. (Cross reference to A-0700, A-0273, A-0726, A-0940, A-0951 ).

2. The QAPI Program failed to identify and prioritize opportunities for improvement to patient care including care provided in high volume, high risk, and problem prone areas such as the operating rooms and environmental areas.
(Cross reference to A-0273, A-0726, A-0710, and A-0940, A-0951).

Based on observation, interview, and record review, the hospital failed to ensure a comprehensive nursing care plan was initiated on three of 34 sampled patients when:

1. An updated care plan was not put in place for Patient N 400, who required a peripherally inserted central catheter (PICC line-a form of an intravenous access that can be used for a prolonged period of time).
2. The hospital staff failed to initiate a pain management care plan for Patient N 301, after the patient required extensive abdominal surgery.
3. A pain management care plan was not initiated for Patient N 506, who underwent a circumcision (removal of the foreskin from the penis) surgical procedure.

This failure had the potential to result in unmet treatment plans and or failure to identify patient care needs.

Findings:

Review of the Nursing: Scope and Standards of Practice, Second Edition, (2010) indicated "The Standards of Professional Nursing Practice are authoritative statements of the duties that all registered nurses, regardless of role, population, or specialty, are expected to perform competently. Standard 1 Assessment- collection of comprehensive data pertinent to the healthcare consumer's health (HCH) and/or the situation. Prioritizes data collection based on the healthcare consumer's immediate condition, or the anticipated needs of the healthcare consumer or situation. Standard 2 Diagnosis-analyzes the assessment data to determine the diagnosis or the issues. Identifies actual or potential risks to the HCH and safety or barriers to health... Documents diagnosis or issues in a manner that facilitates the determination of the expected outcome and plan (care plan). Standard 3 Outcome Identification-identifies expected outcome for a plan (care plan) individualized to the healthcare consumer or situation. Standard 4 Planning-developed's an individualized plan (care plan) considering the person's characteristics or situation to provide direction to other members of the health team and to provide continuity of the plan of care.

The facility policy and procedure entitled, "Plan for the Provision of Care", dated 1/17/13, page 4, indicated in part... "The plan of care and the medical record are the main communication tools for care providers to coordinate planning, assessing, organizing, providing and evaluating. All patient care disciplines use the plan of care for interventions and outcome goals, modifying it based on changes in the patient's condition."

1. During a concurrent interview with Adm 1, and record review of Patient N 400's clinical record, on 9/20/17, at 11 a.m., record revealed that Patient N 400 was admitted to the hospital with diagnosis of congestive heart failure (CHF - Congestive heart failure: Inability of the heart to keep up with the demands on it, with failure of the heart to pump blood with normal efficiency). Eleven days after Patient N 400's admission, the patient required a PICC line (Peripherally inserted central catheter). A review of the Patient Care Plan, on 9/20/17, did not include an update for care of the PICC line pre or post procedure.

ADM 1, while concurrently reviewing the clinical record, acknowledged the lack of care plan update stating, "Yes, we should have done that."



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2. A review of the clinical record for Patient N301, revealed the patient had an exploratory laparotomy (surgical operation where the abdomen is opened and abdominal organs examined for injury or disease), low anterior resection (surgery for rectal cancer and occasionally is performed to remove a diseased or ruptured portion of the intestine), and a colostomy (operation that creates an opening for the colon, or large intestine, through the abdomen) on 9/19/17. Review of the care plans for Patient N301, revealed there was no plan of care for potential pain.
During an interview with LN 13, on 9/20/17, at 4:35 p.m., LN 13 acknowledged and confirmed there was no pain care plan for Patient N301 in the clinical record. LN 13 explained she has been busy and had not had a chance to review Patient N301's care plans.

During an interview with Adm 9, and concurrent review of Patient N301's clinical record on 9/20/17, at 4:50 p.m., Adm 9 acknowledged there wasn't a pain care plan in the clinical record. Admin 9 explained that the reason there wasn't a pain care plan for this patient was because the patient had not complained of any pain. Adm 9 further explained that pain care plans are produced by the electronic medical record computer system the hospital utilizes and the system would only "trigger" an initiation of a pain care plan if the patient complains of pain. For example, when a patient is assessed for pain and the pain level is 1 or greater, the computer triggers a pain care plan to be initiated by nursing. However, if the patient's pain level is 0, then there is no computer trigger for nursing to initiate a pain care plan.

During an interview with Adm 19, on 9/21/17, at 2:39 p.m., Adm 19 confirmed that the hospital's electronic medical records computer system triggers the care plans for nursing to initiate. Adm 19 acknowledged that care plans should be initiated based on the anticipated needs of the patient or situation.


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3. The facility policy and procedure entitled, "Sucrose administration for Analgesia in Neonates", dated 4/1/13, indicated..."There is substantial evidence that 24% sucrose has analgesic and calming effects in newborn, when administered approximately two minutes prior to painful stimuli."

During a concurrent clinical record review of Patient N506, and interview with Adm 11, and nurse (LN 6), on 9/19/17, at 11 am, record revealed infant Patient N506 underwent circumcision, on 9/17/17, at 10:20 a.m.. Clinical record indicated that there was no pain management care plan in place for the circumcision procedure.

Clinical supervisor (ADM 12) and ADM 11, reviewed the clinical record of Patient N 506, and they were not able to locate a pain management care plan, or any documentation showing Patient N 506, had non pharmacological interventions prior to or during the circumcision. Patient N 506, underwent a painful procedure without non pharmacological interventions prior or during the circumcision.

Based on interview and record review, the hospital failed to:

1. Reassess patient's pain medication for three of 34 patients
(Patients N 200, N 201, and N 203), in accordance with acceptable standards of care and the hospital's policy and procedure.
This failure had the potential to provide inadequate pain control for patients.


Findings:

The facility policy and procedure entitled, "Pain Management Adult, Pediatric and Neonate", dated 11/06/2015, indicated..." II. Policy: It is the standard of care to assess and evaluate the response to pain management interventions to enable the patient to perform activities with no pain or a pain level acceptable to the patient...V. Procedure...1. Assessment, reassessment and management of pain is a patient's right...C. Re-assessment...3. Pain level will be reassessed after interventions. Time intervals between intervention and reassessment should be within 1 hour of the intervention or more frequent as needed...4. Notify physician of significant pain not relieved by ordered pain medication..."


1a) During review of the medical record of Patient N 200, with administrator (ADM 9), on 9/21/17, a physician's order dated 9/15/17, indicated oxycodone (opioid analgesic used for moderate to severe pain) 10 mg. (milligram) oral every four hours PRN (as needed) for pain scale, 1 tab (tablet) for pain 4-6 and 2 tabs for pain 8-10.

Another physician's order also dated 9/15/17, indicated Dilaudid (opioid analgesic used for moderate to severe pain) injectable 0.5 mg. IV (intravenous - through plastic tube delivering fluids/medications in the vein) every 2 hours PRN for pain level 7 to 10. For breakthrough pain not controlled by oral medications.

Further record review indicated that, on 9/16/17, at 12:30 p.m., Patient N 200 was administered 2 tablets for a pain level of 10. Patient N 200 was reassessed at 1:30 p.m. at a pain level of 10.

ADM 9 concurrently reviewed the patient record and was unable to find documentation of any other medications being administered, the physician being informed of the reassessment results, or any non-pharmacological interventions utilized.

b. During record review of Patient N 201 with ADM 9, on 9/21/17, physician's order dated 9/16/17, indicated Norco 5/325 mg. (an opioid combination drug- hydrocodone and acetaminophen that increases the effects of the hydrocodone used for moderate to moderately severe pain) 1 tab by mouth every four hours PRN breakthrough pain.

Review of the medication administration form indicated, on 9/18/17, Patient N 201 was given 1 tablet of Norco at 8:33 p.m. and reassessment was timed at 10:57 p.m.
ADM 9 agreed that the reassessment was beyond the time frame indicated by hospital policy.

c. During record review of Patient N 203, with ADM 12, on 9/22/17, physician's order dated 8/21/17, indicated Dilaudid 2 mg. by mouth every 4 hours PRN for pain level 6 to 10.

Review of the medication administration form indicated Patient 203 received 2 tabs of dilaudid at 7:29 p.m., and the reassessment was documented at 9:57 p.m.
ADM 12 agreed the reassessment was beyond the time frame indicated by hospital policy.

Drugs and biological's must be prepared and administered in accordance with the orders of the practitioner accepted standards of practice and in accordance with the approved medical staff policies and procedures.
Based on interview and record review, the facility failed to ensure medications were administered to one of 34 sampled patients (Patient 401), in accordance with the orders of the practitioner and accepted standards of practice when telephone orders (three) were not countersigned by the prescribing physician within 48 hours per hospital policy and procedures.

This failure resulted in the potential for compromising patient safety and quality of care since timing and dating of entries establishes a baseline for future actions or assessments and establishes a timeline of events.

Findings:

The facility policy and procedure entitled, "Medication Management", dated 4/19/17, page 2 indicated in part...,"5) Telephone Orders:...c. Prescribing physician (or on call) shall countersign orders for medications within 48 hours."

During a concurrent interview and record review of Patient 401 with Adm 1, on 9/20/17, at 4:20 p.m., clinical record revealed that license nurse ( LN 3), received a telephone order from Patient 401's physician for Fentanyl (a narcotic to treat severe pain) IV (a route of administration directly into the vein) times 1 now, and Ativan (a sedative to relieve anxiety) 0.5 mg times 1 now. The telephone order was received on 9/16/17, at 1:13 p.m., the order at time of review had not been countersigned by the physician.

On 9/17/17, at 8 a.m., LN 3 received a telephone order from Patient 401's physician to discontinue insulin (a hormone that controls blood sugar levels) and magnesium oxide (a mineral supplement used to treat low amounts of magnesium in the blood), this order at time of review had not been countersigned by the physician.

Adm1, after record review, stated, "They are not following the policy and procedure."

Based on observation, interview and record review, the facility failed to ensure there was a safe and sanitary environment, properly equipped and maintained to protect the health and safety of patients when:

1. There was equipment and multiple supplies stored in the egress corridors and elevator lobbies and some of the equipment obstructed access to fire pull stations and emergency shut-off valves for medical gas (refer to A0710).

2. The facility did not test 35 fire dampers in their heating, ventilating, and air conditioning (HVAC) system due to access issues identified in 2015 (refer to A0710).

3. The facility failed to anchor large electrical equipment against seismic activity in accordance with state safety standards.

4. The facility failed to ensure the risk of transmission of potentially infectious disease causing agents was reduced. (refer to A0724).

5. There was widespread use of portable air conditioners (ACs) in patient care corridors, pharmacy, and the laboratory (refer to A0726).

6. The facility failed to document corrective actions when temperature and humidity fell out of range in sterile areas (refer to A0726).

7. There was no documentation to show that failures identified during a March 2017 air balance assessment of critical areas were addressed and corrected (refer to A0726).

The cumulative effect of these systemic problems could result in the facility's inability to ensure the provision of quality patient care in a safe environment.

Based on observation, record review, and interview, the facility failed to maintain their equipment in accordance with the codes of the National Fire Protection Association (NFPA).

The facility was evidenced by equipment stored in the egress corridors and elevator lobbies, by fire pull stations and medical gas emergency shut-off valves that were obstructed by the equipment in the corridors, by the failure to segregate full and empty oxygen cylinders in storage, and by the failure to test all fire dampers in their air duct system. This affected seven of eight floors.

These deficiencies could result in the faster spread of smoke and fire through the air ducts, the increased risk in confusion in the event a full oxygen cylinder is required during an emergency, a delay in shutting off the piped-in medical gas, and a delay in accessing fire pull stations. The items stored in the egress corridor and the elevator lobbies could result in a delay in evacuation, the increased risk of injury to patients during an evacuation, and the faster spread of smoke and fire due to more combustibles in the corridor.

NFPA 101, Life Safety Code, 2012 Edition.
7.1.10.1 General. Means of egress shall be continuously maintained free of all obstructions or impediments to full instant use in the case of fire or other emergency.

7.2.13.2.2 The elevator lobby shall have a capacity of not less than 50 percent of the occupant load of the area served by the lobby. The capacity shall be calculated based on 3 ft^2 (0.28 m^2) per person and shall also include one wheelchair space of 30 in. × 48 in. (760 mm × 1220 mm) for every 50 persons, or portion thereof, of the total occupant load served by that lobby.

7.2.13.3 Elevator Lobby. Every floor served by the elevator shall have an elevator lobby. Barriers forming the elevator lobby shall have a minimum 1-hour fire resistance rating and shall be arranged as a smoke barrier in accordance with Section 8.5.

NFPA 72, National Fire Alarm Signaling Code, 2010 Edition.
17.14.5 Manual fire alarm boxes shall be installed so that they are conspicuous, unobstructed, and accessible.

NFPA 80, Standard for Fire Doors and Other Opening Protectives, 2010 Edition.
Chapter 19 Installation, Testing, and Maintenance of Fire Dampers
19.4.1.1 The test and inspection frequency shall then be every 4 years, except in hospitals, where the frequency shall be every 6 years.
19.4.3 Full unobstructed access to the fire or combination fire/smoke damper shall be verified and corrected as required.
19.4.4 If the damper is equipped with a fusible link, the link shall be removed for testing to ensure full closure and lock-inplace if so equipped.
19.4.9 All inspections and testing shall be documented, indicating the location of the fire damper or combination fire/smoke damper, date of inspection, name of inspector, and deficiencies discovered.
19.4.9.1 The documentation shall have a space to indicate when and how the deficiencies were corrected.
19.4.10 All documentation shall be maintained and made available for review by the AHJ.

NFPA 99, Health Care Facilities Code, 2012 Edition.
Chapter 5 Gas and Vacuum Systems
5.1.4.8.4 Zone valve boxes shall be installed where they are visible and accessible at all times.
Chapter 11 Gas Equipment
11.3.4.1 A precautionary sign, readable from a distance of 1.5 m (5 ft), shall be displayed on each door or gate of the storage room or enclosure.
11.3.4.2 The sign shall include the following wording as a minimum:
CAUTION: OXIDIZING GAS(ES) STORED WITHIN NO SMOKING
11.6.5.2 If empty and full cylinders are stored within the same enclosure, empty cylinders shall be segregated from full cylinders.
11.6.5.3 Empty cylinders shall be marked to avoid confusion and delay if a full cylinder is needed in a rapid manner.

Findings:

During a facility tour with staff from 9/20/17 to 9/21/17, the means of egress, emergency equipment, medical gas storage rooms, and maintenance records were reviewed. The basement, first floor, and second floor were partially sprinklered and the rest of the floors were nonsprinklered.

Seventh Floor:

1. On 9/20/17, at 10:11 a.m., there was one portable air-conditioner (AC), two IV poles, two vitals machines, a soiled linen bin, and an approximately two foot wide sign on metal stand in the corridor by Room 715. There was one workstation on wheels (WoW), and an approximately three foot wide sign, and four soiled linen bins in the corridor by Room 701.

Sixth Floor:

2. On 9/20/17, at 10:44 a.m., there was an approximately two foot wide sign and a portable AC that projected approximately three feet into the corridor by Room 601.

3. On 9/20/17, at 10:49 a.m., there was an IV pole with a feeding tube, three vitals machines, and two IV poles with medication pumps in the corridor of the sixth floor. Some of the equipment was covered in plastic. During a concurrent interview, license nurse (LN 7) revealed that the items were kept in the corridor.

4. On 9/20/17, at 10:50 a.m.,there was a portable AC that projected approximately three feet in the corridor by Room 611.

Fifth Floor:

5. On 9/20/17, at 11:06 a.m., there was a portable AC that projected approximately three feet into the corridor by Room 501. The AC also obstructed access to a fire pull station.

6. On 9/20/17, at 11:10 a.m., there was a gurney, six vital sign machines, two suction machines, two bear-huggers, and a blanket warmer in the corridor alcove in front of Elevators 1 and 5. Some of the equipment was covered in plastic. During a concurrent interview, LN 8 revealed that the items were stored there.

7. On 9/20/17, at 11:14 a.m., there was a portable AC that projected approximately three feet into the corridor by Room 511.

8. On 9/20/17, at 11:18 a.m, there was a portable AC that projected approximately three feet into the corridor by Room 516.

Fourth Floor:

9. On 9/20/17, at 11:26 a.m., there was a portable AC that projected approximately three feet into the corridor by Room 401.

10. On 9/20/17, at 11:27 a.m., there was a portable AC that projected approximately three feet into the corridor by Room 410.

11. On 9/20/17, at 11:30 a.m., there was a portable AC that projected approximately three feet into the corridor by Room 416.

Second Floor:

12. On 9/20/17, at 11:41 a.m., there was approximately a 2 1/2 foot wide sign in the egress corridor outside Labor and Delivery. The sign obstructed the egress corridor and access to a fire alarm pull station.

13. On 9/20/17, at 12:01 p.m., access to the emergency shut-off valves for the medical gas systems, serving Delivery Rooms A and B, was obstructed by two WoWs and two chairs.

Third Floor:

14. On 9/20/17, at 2:18 p.m., there were 20 plastic crates of supplies in the elevator lobby (Elevators 1, 2, and 3), directly outside Surgical Services. During an interview, Adm 2 stated that the supplies are kept there because there was not enough storage space.

15. On 9/20/17, at 2:41 p.m., there were empty oxygen cylinders in the rack designated for full oxygen cylinders in the utility room by Operating Room (OR 3). The room was also not equipped with the precautionary signage required for medical gas storage rooms. During an interview, Adm 15 stated that this was where the oxygen cylinders were stored and confirmed that there was no signage indicating the presence of oxygen in the room.

16. On 9/20/17, at 2:45 p.m., there were four IV poles directly in front of the panic bar of the exit door by the Post-Anesthesia Care Unit (PACU).

First Floor:

17. On 9/20/17, at 3:40 p.m., there was an approximately six foot wide table that projected approximately two feet into the corridor outside the Cath Lab. The table was in front of two emergency medical gas shut-off valves that service Cath Lab 2 and Cath Lab 2 Holding.
During a concurrent interview, LN 9 stated that the table remains in the corridor for supplies to be dropped off there.

18. On 9/20/17, 3:56 p.m., there was a portable AC in the means of egress by the entrance to the Emergency Department (ED).

19. On 9/20/17, at 4:01 p.m., there were 11 empty oxygen cylinders in the rack designated for "FULL/IN USE" cylinders in the ED oxygen storage room. The rack designated for "EMPTY" had no cylinders in it.

Record Review:

20. On 9/20/17, at 10:31 a.m., records revealed that the fire dampers in the heating, ventilating, and air-conditioning (HVAC) system were tested from 12/21/15 to 12/30/15. Fire dampers react to heat during a fire to prevent spread of smoke and fire through the air ducts, and are required to be tested every six years. The vendor noted that 35 fire dampers throughout the hospital could not be tested due to "access issues". There were untested dampers in the basement and on the first, second, third, and fourth floors, including surgical areas, neonatal intensive care unit, ED, among other patient care areas. No records were provided to show that this discrepancy was addressed.

Based on observation and interview, the facility failed to:

1. Ensure that electrical equipment is installed with the required safeguards. This was evidenced by supply dispensers that were not anchored or braced to withstand a seismic event. This could result in the sudden detachment of these large appliances from their electrical outlets during an earthquake and could increase the risk of an electrical fire and injury. This affected three of eight floors.

2. Implement it's cleaning, disinfection, and sterilization policy, to make sure the risk of tranmission of potentially infectious causing agents was reduced. This failure had the potential to spread infectious pathogens and/or disease within the facility.

1. NFPA 101, Life Safety Code, 2000 Edition.
4.6.1.2 Any requirements that are essential for the safety of building occupants and that are not specifically provided for by this Code shall be determined by the authority having jurisdiction.

NFPA 70, National Electrical Code, 2011 Edition.
90.7 Examination of Equipment for Safety. For specific items of equipment and materials referred to in this Code, examinations for safety made under standard conditions provide a basis for approval where the record is made generally available through promulgation by organizations properly equipped and qualified for experimental testing, inspections of the run of goods at factories, and service value determination through field inspections. This avoids the necessity for repetition of examinations by different examiners, frequently with inadequate facilities for such work, and the confusion that would result from conflicting reports on the suitability of devices and materials examined for a given purpose.
It is the intent of this Code that factory-installed internal wiring or the construction of equipment need not be inspected at the time of installation of the equipment, except to detect alterations or damage, if the equipment has been listed by a qualified electrical testing laboratory that is recognized as having the facilities described in the preceding paragraph and that requires suitability for installation in
accordance with this Code.

California Health and Safety Code HSC § 129895
(a) The office [OSHPD] shall adopt by regulations seismic safety standards for hospital equipment anchorages, as defined by the office, to include, but not be limited to, architectural, mechanical, and electrical components, supports, and attachments. Those regulations shall include criteria for the testing of equipment anchorages.
(b) Any fixed hospital equipment anchorages purchased or acquired on or after either the effective date of the regulations adopted pursuant to subdivision (a) shall not be used or installed in any hospital building unless the equipment anchorages are approved by the office.
(c) Manufacturers, designers, or suppliers of equipment anchorages may submit data sufficient for the office to evaluate equipment anchorages' seismic safety prior to the selection of equipment anchorages for any specific hospital building.
(d) The office may charge a fee based on the actual costs incurred by it for data review, approvals, and field inspections pursuant to this section.

Findings:

During a facility tour with staff from 9/20/17 to 9/21/17, equipment was observed.

Third Floor:

1. At 2:45 p.m., on 9/20/17, three approximately 6 foot tall supply cabinets, directly adjacent to Bay 1 in the Post Anesthesia Care Unit (PACU), were not seismically anchored.
During a concurrent interview, Eng 3 and Adm 5 confirmed the finding.

2. At 2:55 p.m., on 9/20/17, five approximately 6 foot tall supply cabinets in the Intensive Care Unit (ICU) were not seismically anchored.

Second Floor:

3. At 3:12 p.m., on 9/20/17, an approximately 6 foot tall supply cabinet, in Neonatal Intensive Care Unit (NICU) West, was not seismically anchored.

4. At 3:14 p.m., on 9/20/17, an approximately 6 foot tall supply cabinet, in NICU East, was not seismically anchored.

First Floor:

5. At 3:54 p.m., on 9/20/17, two approximately 6 foot tall supply cabinets in the Cath Lab Recovery (Room 154) were not seismically anchored.


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2. The hospital policy and procedure titled, "Cleaning, Disinfection and Sterilization", dated 10/22/15, indicated, "I. PURPOSE: A. To provide guidelines for the cleaning, disinfection and sterilization of medical equipment used during patient care...noncritical (devices that contact only intact skin such as stethoscopes)...D. Only clean equipment is stored in the clean equipment area...All other equipment that is not or cannot be cleaned immediately after use is placed in the dirty equipment area...Clean equipment that comes from Central Services (such as IV, PCA and feeding pumps) will be identified as clean and kept free of dust until use by enclosure in a bag..."

During tour of the fifth floor, on 9/21/17, at 10:25 a.m., with administrator (ADM 7), six vital sign (V/S) machines grouped together by the wall, and six feeding pumps in the bottom of a cart, were observed by the elevator. Five of the V/S machines were covered with plastic and the sixth was uncovered. Five of the feeding pumps were wrapped in plastic, one had a torn plastic wrap, exposing the feeding pump.

ADM 7 agreed with the observation. License nurse (LN 2) walked over and plugged the V/S machine without the plastic cover into a wall socket. LN 2 revealed that the area is used as a charging station as well as storage. LN 2 indicated the equipment in the area is clean if it has plastic covering it. The V/S machine without plastic covering was pointed out and LN 2 agreed that it was not clean any longer. LN 2 was shown the feeding pump at the bottom of the cart. LN 2 agreed there was no way to guarantee cleanliness of the feeding pump that was available for patient use.

Continuing the tour with ADM 8, on the fourth floor, at 11:05 a.m., two V/S machines were observed in the alcove by the elevators. One was covered in plastic and the other was uncovered. ADM 8 was shown the V/S machines. ADM 8 stated that the equipment are supposed to be "cleaned and rebagged", after use to indicate it is clean. Also observed, was a large plastic bag containing four pillows above a linen cart, and a plastic bag containing one pillow. ADM 8 revealed that there should only be one pillow to a plastic bag.

Based on observation, interview and record review, the facility failed to maintain adequate ventilation and air-conditioning in patient care areas and other areas that require temperature, humidity, and ventilation control. This was evidenced by the use of portable air conditioners (ACs) throughout the hospital, by the failure to adequately monitor temperature and humidity levels in sterile areas, and by no records of repairing deficiencies noted on an air balance survey report from March 2017. This affected seven of eight floors of the hospital and could result in increased risk of harm to patients.

2016 California Mechanical Code
Section 320.0 Air-Conditioning and Heating Systems
Section 320.1 Requirements for Hospitals and Optional Services Provided in Correctional Treatment Centers. [OSHPD 1 & 4]
The systems shall be designed to provide the temperatures and relative humidity for sensitive areas or rooms shown in Table 320.0. When outdoor humidity and internal sources are not sufficient to meet the requirements of Table 320.0, humidification shall be provided by means of the health-care facility air-handling systems. Temperature shall be individually controlled for each operating and delivery room. Burn unit patient rooms that require humidifiers to comply with Table 320.0 shall be provided with individual humidity control. All humidifiers shall use dry steam. Humidifiers shall be located within air handling systems or ductwork to avoid moisture accumulation in down-stream components, including filters and insulation.

Table 320.0 Heating, Cooling, and Relative Humidity Requirements for Sensitive Areas or Rooms.

Operating Room: 68 °F - 75 °F, 20% - 60%
Delivery Room, Caesarean Operating Room: 68 °F - 75 °F, 20% - 60%

Notes:
1. Thermostats and humidistats shall be either locally resettable and of the non-locking type or remotely resettable and of the locking type.
2. Systems shall be capable of maintaining the rooms within the range during normal operations. Lower or higher temperature shall be permitted when patients' comfort and/or medical conditions require those conditions.
3. The ranges listed are the minimum and maximum limits where control is specifically needed.

407.3.1 The ventilation systems shall be designed and balanced to provide the general air balance relationship to adjacent areas, shown in Table 4-A. The ventilation systems shall be balanced in accordance with the latest edition of standards published by the Associated Air Balance Council (AABC), the National Environmental Balancing Bureau (NEBB), or the Testing, Adjusting and Balancing Bureau (TABB).

407.4.1.4 No space above the ceiling may be utilized as an outside-air, relief-air, supply-air, exhaust-air, or return-air plenum.
Exceptions: Designs specifically approved by the enforcing agency.

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.

9.3.1.2 Laboratories shall comply with NFPA 45, Standard on Fire Protection for Laboratories Using Chemicals.

NFPA 45, Standard on Fire Protection for Laboratories Using Chemicals, 2011 Edition
8.3.1 Laboratory ventilation systems shall be designed to ensure that chemical fumes, vapors, or gases originating from the laboratory shall not be recirculated.

8.3.2 The location and configuration of fresh air intakes shall be chosen so as to avoid drawing in chemicals or products of combustion coming either from the laboratory building itself or from other structures and devices.

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 indicated: "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." The memorandum also indicated: "Facilities must monitor RH (relative humidity) levels in anesthetizing locations and be able to provide evidence that the RH levels are maintained at or above 20 percent. When outdoor humidity and internal moisture are not sufficient to achieve the minimum humidity level, then humidification must be provided by means of the hospital's or CAH's ventilation systems. In addition, facilities must provide evidence that timely corrective actions are performed successfully in instances when internal monitoring determines RH levels are below the permitted range."

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)" indicated "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 with staff from 9/20/17 to 9/21/17, heating, ventilating, and air-conditioning (HVAC) equipment was observed and records were reviewed.

Seventh Floor:

1. At 10:11 a.m., on 9/20/17, there was a portable AC by the nurses station, across from Room 720, and it was exhausted into the attic space in the corridor.
During a concurrent interview, Adm 4 stated that the hospital rented portable ACs to supplement cooling and said there were three portable ACs on this floor last week.

During an interview at 10:20 a.m., Adm 11 stated that there was a second portable AC in the unit yesterday by Room 701. She said that the intent was to cool down the unit and she stated that patients are provided with fans for additional cooling measures.

During an interview at 10:24 a.m., Engineer (Eng) 2 stated that the rooms on the Seventh Floor were all controlled by one thermostat in the attic. He said that the thermostats in the patient rooms control the radiator heaters in the window.

Sixth Floor:

2. At 10:44 a.m., on 9/20/17, there were three portable ACs in the corridor that were again exhausted into the attic space.
During a concurrent interview, Eng 2 stated that the patient rooms on the sixth, fifth, and fourth floors have individual temperature controls for cooling and heating but the portable ACs were used to supplement cooling due to high humidity.

At 10:56 a.m., the rooms on the sixth floor were observed to have no vents.
During a concurrent interview, Eng 2 stated that he was unaware that the rooms did not have air vents. He confirmed that the thermostats in the room only control the radiator heaters in the wall.

During an interview at 11:00 a.m., Eng 2 stated he was informed by Eng 1, over the phone, that cooling of all the rooms on the fourth, fifth, and sixth floor are controlled by the temperature in the corridor.

Fifth Floor:

3. At 11:06 a.m., on 9/20/17, there were three portable ACs in the corridor that were exhausted into the attic space. The rooms on the fifth floor do not have vents and only the radiator heaters in the walls.

Fourth Floor:

4. At 11:26 a.m., on 9/20/17, there were three portable ACs in the corridor that were exhausted into the attic space. The rooms on the fourth floor do not have vents and only the radiator heaters in the walls.

Second Floor:

5. During an interview at 11:47 a.m., on 9/20/17, LN 5 stated that nursing staff and technicians do not check the temperature and humidity in Delivery Rooms A and B. She stated that engineering staff were responsible for that.

At 11:48 a.m., the humidity in Delivery Room A was 62%.

At 11:58 a.m., the humidity in Delivery Room B was 64%.

Third Floor:

6. During an interview at 2:34 p.m., on 9/20/17, Adm 15 stated that circulator nurse check temperature and humidity, in addition to engineering, but was not sure if they did it all the time and they do not document it.

First Floor:

7. At 3:33 p.m., on 9/20/17, there was a portable AC in the histology area of the Lab and it was exhausted into the attic.
During a concurrent interview, Eng 3 stated that the AC was put in three weeks ago to supplement cooling of the air due to heat coming off of the new equipment.

8. At 3:35 p.m., on 9/20/17, there was a portable AC in the pathology area of the Lab and it was exhausted into the attic.

9. At 3:56 p.m., on 9/20/17, there was a portable AC near the main entrance into the Emergency Department (ED) that was exhausted into the attic.

10. At 3:59 p.m., on 9/20/17, there was a portable AC at the ED nurses station that was exhausted into the attic.

Basement:

11. At 4:22 p.m., on 9/20/17, there was a portable AC in Pharmacy that was exhausted into the attic.

During a telephone interview at 8:30 a.m., on 9/21/17, the Compliance Officer (CO) with the Office of Statewide Health Planning and Development (OSHPD) stated that hospitals require approval from OSHPD for the widespread use of the portable ACs. He confirmed that the facility did not obtain approval for their use. OSHPD would determine if the methods for exhausting the units, their placement in the egress corridors, and other factors were approved and safe.

At 10:06 a.m., on 9/21/17, invoices showed that the facility rented "spot coolers" (portable ACs) from 2/10/16 to 12/5/16. They were rented again on 6/15/17 and additional units were brought in on 6/30/17 and 8/4/17.

12. At 11:16 a.m., on 9/21/17, temperature and humidity logs were requested for ORs, delivery rooms, and Same Day Surgery (SDS). The facility's Temperature and Humidity Monitoring Policy indicated that relative humidity levels in these areas was to be maintained between 30 -60 %.

a. 12 out of 27 "Humidity and Temperature Log" documents provided for May 2017 did not have the locations specified and there were no logs specified for ORs 3, 4, and 6 and the delivery rooms and Same Day Surgery.
b. The humidity in OR 2 was above 60 % during 10 days in May 2017 and no corrective actions or follow up humidity readings were recorded.
c. The humidity in OR 5 was above 60 % during 7 days in May 2017 and no corrective actions or follow up humidity readings were recorded.
d. The humidity in OR 2 was above 60 % during 5 days in July 2017 and no corrective actions or follow up humidity readings were recorded.
e. The humidity in OR 3 was above 60 % during 9 days in July 2017 and corrective actions were recorded for 5 of those days indicating the temperature was adjusted. However, no follow up humidity readings were recorded for all 9 days.
f. The humidity in Delivery Room A was above 60 % during 7 days in July 2017 and no corrective actions or follow up readings were recorded.
g. The humidity in Delivery Room B was above 60 % during 13 days in July 2017 and corrective actions were recorded for 2 of those days indicating the temperature was adjusted. Again, no follow up humidity readings were recorded for all 13 days.
h. The humidity in SDS A was above 60 % during 10 days in July 2017 and engineering staff indicated that the temperature was adjusted. No follow up humidity readings were recorded for all 10 days.
i.There were no temperature and humidity readings recorded for SDS B from 7/1/17 to 7/7/17 and engineering indicated that the device was not working. On 7/13/17, engineering did not record temperature and humidity because the device was "out." From 7/27/17 to 7/31/17, engineering did not record temperature and humidity noting "N/A" or Not Applicable.

The facility failed to ensure that temperature and humidity logs were maintained and failed to provide evidence that out-of-range temperature and humidity values were adjusted back into compliance. The logs also showed that the temperature and humidity readings at all locations were taken between 2:00 a.m. and 7:00 a.m.

The facility used temperature and humidity readers that stored information about temperature and humidity in the areas they were located.

During an interview at 11:37 a.m., Adm 4 confirmed the finding about the humidity logs being incomplete. She stated that it was difficult to obtain the stored information from the readers so they do not utilize that function of the devices.

During an interview at 3:09 p.m., Eng 1 stated that one night shift engineer was responsible for all the temperature and humidity readings for 43 locations throughout the hospital and this may have caused the deficiencies in the documentation.

13. At 1:15 p.m., on 9/21/17, the facility provided a report of testing the air balance and room pressures in critical areas of the hospital on 3/20/17. The following deficiencies were noted by the vendor:

a. The room pressures for OR 7 and 8 failed.
b. The room pressure for Corornary Care Unit Patient Rooms C-1, C-2, C-3, C-4, C-5, C-6, C-7, C-8, C-9, and C-10 failed.
c. The room pressure and air exchanges per hour (ACH) for Coronary Care Unit Patient Room C-11 failed.
d. The room pressure and ACH for Intensive Care Unit (ICU) Room 226 failed.
e. The room pressures for Nursery West and Nursery East failed.
f. The room pressure for Neonatal Intensive Care Unit (NICU) West failed.
g. The room pressures and ACHs for Delivery Rooms A and B failed.
h. The room pressure and ACH for Same Day Surgery Room D failed.
i. The ACH for Same Day Surgery Room C failed.
j. The room pressure and ACH for the airborne isolation room (Room 624) failed.
k. The room pressure for Nuclear Medicine failed.
l. The room pressure for the NICU Isolation Room failed.
m. The room pressure and ACH for NICU Isolation Ante Room failed.
n. The rrom pressure for Cath Lab 3 failed.
o. The room pressures for Central Decontamination Room and Central Clean Room failed.
p. The room pressure and ACH for Same Day Surgery Soiled Utility failed.

The facility failed to provide a report from the vendor indicating that these deficiencies were addressed and corrected.

At 2:41 p.m., Adm 4 did not provide records of repairs and instead provided a copy of a new contract with another vendor to conduct air balance tests at the facility.
During a concurrent interview, she stated that this new vendor was in the process of checking the air balances.

Based on observation, interview, and record review, the hospital failed to ensure acceptable standards of practice were followed related to temperature and humidity ranges in operating rooms, sterile processing rooms and the endoscopy suites. (Refer to A-726).
The hospital failed to ensure proper counts in the Labor and Delivery surgical suite when a patient was discharged home with a 33 centimeter (12.9 inches) surgical instrument retained inside her abdomen. (Refer to A-0951).

The cumulative effect of these failings meant the hospital failed to implement and monitor the surgical services practices and conduct in order to ensure the safety and welfare of surgical patients and the provision of high quality healthcare.

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

1. Ensure surgical staff performed the instrument counts audibly and concurrently viewed a counted item for one of 34 patients (N300) as indicated by their policy and procedure.
2. Ensure ten of eleven endoscopes were stored without being in contact with dirty areas.
3. Ensure five of 34 patient (Patient N 103, N105, N106, N107 and N200) with an American Society of Anesthesia (ASA) risk category of 1/11, or 111/1V scheduled for surgery, had laboratory screening tests within three to seven days prior to surgery.
4. Ensue there was no peeling tape on surgical instruments.
5. Ensure Heating, Ventilation, and Air Conditioning (HVAC) temperatures were not out of range.
6. Ensure Cesarean-Section tray instrument count sheet was complete.
7. Ensure surgical instruments in sterilized tray were in the open position.
8. ensure surgical instruments in a sterilized tray were clean and disinfected prior to sterilization.
9. Ensure there was a method to weigh surgical trays in order to ensue sterility.
10. Ensure temperature of the enzymatic cleaner followed manufacturers instruction for soaking of surgical instruments.
11. Ensure Nursing staff were able to verbalize appropriate method of cleaning and disinfecting glucometers
12. Ensure Fluid warmer was in the appropriate temperature range and had a temperature log.
13. Ensure on surgical table pad intact without tares.
14. Ensure an anesthesia medication cart was locked when not attended.
15. Ensure a surgical table patient strap was cleaned and off the floor before use.
16. Ensure two of 34 patients (N301 and N304)intravenous access (HL) dressing were not dated and initialed.
17. Ensure surgical rooms and GI procedure rooms were not out of temperature and humidity range.

These failures had the potential to result in compromising the safety and welfare of surgical and non surgical patients.

Findings:.


34445


Findings:

1. The facility policy and procedure entitled "Counting Surgical Items and Prevention of Retained Surgical Items", dated 8/14, part 111 (A) 1. d) indicated "Surgical items are counted audibly and viewed concurrently by the operating room nurse/technician and the circulating nurse". Under number 7 the policy indicates "Counts must be performed in the same sequence each time. The count should begin at the surgical site and the immediate surrounding area, proceed to the Mayo stand and back table, and finally to the counted items that have been discarded from the field." Further review of the policy part D entitled "Instrument Counts", in #1 indicated "Instruments are counted on all procedures entering the abdominal and thoracic cavities in which the likelihood exists that an instrument could be retained...". Number 3 of the policy further indicated "Counts of instruments should be performed:

a. before the procedure has begun to establish a baseline count,
b. when wound closure begins,
c. at the time of permanent relief...

The clinical record for Patient N300 was reviewed, record revealed Patient N300 had a Caesarian section (delivery of a baby through a surgical incision in the mother's abdomen and uterus) and tubal ligation (tubes tied or permanent birth control) on 5/20/17. Patient N 300 was discharged home on 5/24/17. Patient N 300's return visit to the hospital emergency department (ED) dated 6/18/17 revealed Patient N300 had complained of abdomen pain radiating to her right leg, her pain was rated 10 out of a 1-10 pain scale. An abdomen/ pelvis CT scan (series of special X-rays) was performed which revealed the following; "There was an abnormal object in the pelvis." According to the ED doctor's note, dated 6/18/17, "Patient's gynecologist/obstetrician [doctor's name] was in to see the patient and will take the patient to surgery" to remove the foreign body visualized in the CT scan.

Patient N300's CT scan abdomen and pelvis results dated 6/18/17 were reviewed, the results revealed "There is a large oblong metallic density foreign body within the abdominal cavity extending from the left upper quadrant to the right lower quadrant measuring up to 33 centimeters (12.9 inches). This is likely a retained foreign body following surgery."

Technician 4 (Tech 4) (involved during the surgical procedure) was interviewed on 9/21/17 at 9:30 a.m., Tech 4 explained a baseline count was the "Initial" count, which consisted of the count of instruments, sponges, needles, and sharps (knife blades). The initial count was conducted with the surgical nurse calling out the names of listed instruments from a count sheet. The surgical nurse physically checked off the names on the count sheet after she stated they were present and counted.

The first count was performed, and counts were correct.

The "Second" count occurred at the surgical suturing of the peritoneum (Lining in the stomach area). Tech 4 stated several distractions occurred during this part of the count. The primary surgeon had dismissed the assistant surgeon at this point in the procedure. This meant she (Tech 4) had to be the assistant. Tech 4 described having to hold an instrument used to retract (hold back tissue) the wound with her right hand, while holding a needle holder (instrument used to hold the stitch) in her left hand in preparation for the surgeon's next step in the procedure. The attention to the surgeon's needs made it difficult for her (Tech 4) to visualize all of the items necessary for the count. When the circulating nurse named a countable item she (Tech 4) used her head to point toward the instrument, as her hands were not available. Patient N300 began to cough, Tech 4 wasn't able to visibly see Patient N300, but it sounded as if she (Patient N300) vomited. The surgeon asked for an instrument to hold back the wound as Patient N300's body movement caused an interruption in the surgical suturing of the wound (incision made to deliver baby). Tech 4 handed the surgeon the ribbon malleable retractor. The second count continued with the circulating nurse. No instruments were counted at this time. The Second count was documented as correct.

Tech 4 stated the "Third" count with the circulating nurse was with instruments only. Tech 4 explained, at this point during the count and with wound closing she (Tech 4) was still using both of her hands to retract and assist the surgeon. Tech 4 counted the instruments with the circulating nurse. Tech 4 stated that when counting instruments out of her range of vision she (Tech 4) used her head to point in the direction of where the instruments were usually placed. Tech 4 stated the ribbon malleable retractor was usually placed either inside or in the back of the basket, (wire metal basket which contained the instruments). Tech 4 stated she began counting the retractors starting with the one she was holding in the right hand to retract the skin, this being number 1 retractor, and continued counting toward the back of the table. Tech 4 counted verbally 1,2,...7. Tech 4 verbally said the number 8. However, she (Tech 4) did not see the 8th retractor (ribbon malleable retractor). Tech 4 acknowledged and confirmed not visualizing the 8th retractor (the ribbon malleable retractor) she "assumed" the ribbon retractor was behind or inside the basket in its usual place. According to Tech 4 the instrument count was correct during the third count, even though, the 8th retractor was actually never visualized by the staff.

Tech 4 stated the "Final" count was performed, no instruments count was repeated and the count was correct.

During an interview with licensed nurse LN 10 (involved during the surgical procedure) on 9/21/17 at 1:20 p.m., LN 10 explained the baseline count was the "Initial" count, which consisted of instruments, sponges, sharps (knife blades), needles, and cautery tip (instrument used to stop bleeding). The initial count was correct.

The "First" count was performed and the count was correct.

The "Second" count was performed with Tech 4. This count was with closing of the peritoneum (lining in the stomach area). During this count there was a distraction as the primary surgeon informed the assistant surgeon he could leave. The count continued, no instruments were counted during this count, and the count was correct.

The "Third" count with Tech 4 was the instrument count. LN 10 explained several distractions occurred during this count. The surgeon's phone rang several times during the count process before being answered by the anesthesiologist. Patient N300 might have thrown up (vomited), which is why the surgeon requested the use of the ribbon malleable retractor. The surgeon used the retractor to hold back Patient N300's tissues. Patient N300 was moving around a lot. LN 10 acknowledged and confirmed not seeing the 8th (ribbon malleable) retractor during this instrument count. LN 10 did not visualize the instrument basket to see if the malleable retractor was there. LN 10 stated she assumed the malleable retractor was inside or behind the basket, as usual. She remembered the instrument count being a correct count and there were no variances at the end of the case.

The "Final" count was performed, instruments were not counted again. The count was documented as correct.

During an interview with Admin 1 on 9/21/17 at 2:20 p.m., Admin 1 acknowledged the Labor & Delivery surgical staff did not perform visual and audibe instrument counts during the surgery for this patient (N300) as per the facility's policy and procedure.

This failure resulted in Patient N300 having a ribbon maleable retractor left inside her abdomen/pelvic area for four weeks causing her pain and the need for a second surgery with the use of general anesthesia to remove the retractor on 6/18/17.

2. The [Endoscope Brand] reprocessing manufacturer's manual (IFU) under storage and disposal part 1.7 Reprocessing before patient procedure, a warning indicated "Improper handling, such as touching a reprocessed endoscope and/or accessories with contaminated gloves, placing a reprocessed device on a contaminated hanger or surface, allowing devices to touch the floor, etc. will recontaminate the device."

The facility policy and procedure entitled "Cleaning and High Level Disinfection of Flexible Endoscopic Equipment", dated 4/17, on the storage part indicated "a. All endoscopes must be stored vertically in a clean..., dust free storage cabinet in accordance with manufacturer's IFU"

During a tour of the gastroenterology lab (unit that performs special gastro intestinal (GI) track procedures) on 9/19/17 at 4:10 p.m., nine of ten endoscopes (instrument introduced into the body to view internal parts) were observed with the end/tip of the scopes in contact with the floor chux (large disposable pad) inside the right side of the endoscope storage cabinet. And one endoscope was observed in contact with the side wall of the cabinet inside the left side of the endoscope storage cabinet.

During an interview with technician (Tech 5) on 9/19/17 at 4:35 p.m., Tech 5 explained the chux is always on the floor and that this is how normally the endoscopes are hanging inside the storage cabinet. Tech 5 was not aware that the endoscopes tip/end should not be in contact with the floor chux.

During an interview with Admin 17 on 9/19/17 at 4:12 p.m., Admin 17 acknowledged having the endoscopes be in contact with the floor or the side wall of the storage cabinet was a problem.

During an interview with Admin 2 on 9/19/17 at 4:20 p.m., Admin 2 acknowledged the endoscopes were no longer disinfected if the tip/end of scopes were in contact with the cabinet floor or wall.

3. The hospital policy and procedure entitled, "Preoperative Laboratory Screening Tests", dated 11/2016, indicated, " IV. Procedure: All patients scheduled to have surgery under general anesthesia at ( hospital name) must have appropriate laboratory screening tests documented on their medical record prior to performance of surgery. 1. Patients in the American Society of Anesthesia (ASA) risk categories I and II must have the appropriate screening tests within seven days prior to surgery 2. Patients in the American Society of Anesthesia (ASA) risk categories III and IV must have the appropriate tests within 72 hours prior to surgery ..."

During clinical record review of Patient N 200 with administrator (ADM 9), on 9/21/17, laboratory results indicated they were collected on 9/8/17. Patient N 200 had an ASA score of II. Surgery took place on 9/15/17. ADM 9 agreed the laboratory results were greater than seven days.

During clinical record review of Patient N 103 with administrator (Admin 9), on 9/20/17, doctors orders dated 9/19/17, included an order for laboratory work for surgery. The lab tests in the medical record were collected on 9/5/17. The ASA score was II.

During an interview with administrator (Admin 5), on 09/21/17, at 3 p.m., Admin 5 agreed that the laboratory results were greater than seven days prior to surgery and this was not within policy.

During a review of the clinical record for Patient N 105, with administrator (Admin 9), on 9/21/17, doctors orders dated 9/19/17, included an order for laboratory work for surgery. The lab tests in the medical record were collected on 8/25/17. The ASA score was III.

During an interview with administrator (Admin 5), on 09/21/17, at 3 p.m., Admin 5 agreed that the laboratory results were greater than three days prior to surgery and this was not within policy.

During a review of the clinical record for Patient N 106, with administrator (Admin 9), on 9/21/17, the doctors orders dated 9/19/17, included an order for laboratory work for surgery. The lab tests in the medical record were collected on 9/8/17. The ASA score was II.

During an interview with administrator (Admin 5), on 9/21/17, at 3 p.m., Admin 5 agreed that the laboratory results were greater than seven days prior to surgery and this was not within policy.

During a review of the clinical record for Patient N 107, with administrator (Admin 9), on 9/21/17, the doctors orders dated 9/19/17, included an order for laboratory work for surgery. The lab tests in the medical record were collected on 9/5/17. The ASA score was II.

During an interview with administrator (Admin 5) on 9/21/17, at 3 p.m., Admin 5 agreed that the laboratory results were greater than seven days prior to surgery and this was not within policy.

4. Record review of the policy and procedure entitled, "Preparation, Assembly, and Packaging of Instrumentation", dated 5/30/17, indicates, "Taped instruments will be inspected for cracks, chips or peeling and removed and replaced when necessary."

During a concurrent observation in the sterile processing department and interview with administrator (Admin 2), on 9/19/17, at 9:15 a.m., seven surgical instruments had cracked and or peeling surgical tape on sterilized instruments intended for surgical procedures.

During an interview with Admin 2, and sterile processing technician (Tech 1), on 9/19/17, Admin 2 and Tech 1, acknowledged that the surgical tape was lifting and peeling from several surgical instruments. Admin 2 indicated the department was working to remove all surgical tape from their instruments.

5. According to AORN (Association of peri-Operative Nurses) Standards of peri-Operative Nursing Practice, Guidelines for a Safe Environment of Care, Part 2 (2017): "The health care organization should create and implement a systematic process for monitoring HVAC (Heating, ventilation and air conditioning-HVAC the technology of indoor and vehicular environmental comfort. Its goal is to provide thermal comfort and acceptable indoor air quality) performance parameters and a mechanism for resolving variances. Personnel who identify an unintentional variance in the predetermined HVAC system parameters should report the variance according to the health care organization's policy and procedures. Rapid communication between affected and responsible personnel can help facilitate resolution of the variance. The temperature range in a restricted area should be 68° F to 75° F...and the humidity range 20% to 60%..."

The facility policy and procedure titled "Preparation, Assembly and Packing of Instrumentation" dated 5/30/17, indicates " ...environmental controls for the sterile processing preparation area requires: 1. Temperature of 66 to 75 degrees F.

On 9/19/17, at 10:40 a.m., during a tour and concurrent interview with Admin 2, in the sterile processing department, the temperature recording was out of range per hospital policy and AORN guidelines. The temperature was 77.5 degrees F in the preparation and assembly area of the sterile processing department. During a concurrent interview, Admin 2 confirmed the recordings were out of range frequently in this area, and engineering was in charge of correcting the variances.

During a review of the document titled, "Humidity and Temperature Log SPD-Decon. Middle", dated September 2017, 17 of 19 daily temperature entries were above the log's stated range of 68-73 degrees F. There was no documentation of attempts to correct the temperature by the engineering department.

During an interview with administrator (Admin 4), on 9/21/17, at 9:42 a.m., Admin 4 agreed that 17 of 19 temperatures recorded in September 2017, were above temperature parameters in the Sterile Processing prep and assembly area. Admin 4 agreed that it was the responsibility of the engineering team to correct, document, and reassess variances in temperature and humidity and they did not follow the process.

6. During an observation in the sterile processing area, a Cesarean Section (the delivery of a baby through a surgical incision in the mother's abdomen and uterus) surgical tray was opened, on 9/19/17, at 10:45 a.m. The count sheet (an inventory log of all the surgical instruments within the tray. This sheet is used by the operating room staff to count instruments) was incomplete. Staff did not record four of the surgical instruments.

During an observation and concurrent interview with sterile processing technician (Tech 2), on 9/19/17, at 11 a.m., Tech 2 indicated that he had forgotten to mark the inventory count sheet for four of the surgical instruments on the Cesarean Section tray count sheet.

Record review of the policy and procedure titled "Preparation, Assembly, and Packaging of Instrumentation", dated 5/30/17, indicated " ... instruments are sorted and set up using the count sheets and lists ..."

7. During an observation and concurrent interview with Admin 2, on 9/19/17, at 11:30 a.m., a sterilized Major
tray (an extensive and comprehensive surgical instrument tray used in general surgery) was opened, and a towel clamp was found to be in the closed and locked position. Admin 2 acknowledged the instrument was in the closed position, which would potentially not allow the sterilant (an agent used to destroy microorganisms) to reach all areas of the instrument.

The facility policy and procedure titled "Preparation, Assembly, and Packing of instrumentation" dated 5/30/17, indicated in part "hinged instruments must be unclamped in the "open" position for sterilization."

8. The facility policy and procedure entitled "Preparation, Assembly and Packing of instrumentation", dated 5/30/17, indicates, "Any device found to have residual soil must be immediately returned to the decontamination area and reprocessed."

During an observation and concurrent interview with Admin 3, on 9/19/17, at 11:38 a.m., a sterilized Minor tray (a basic surgical instrument set used in surgery) was opened, and a forceps was found with a dark sticky substance/debris in the teeth of the instrument. Admin 3 acknowledged the substance and that it should not be present.

9. The facility policy and procedure titled "Preparation, Assembly, and Packaging of Instrumentation", dated 5/30/17, indicates, " ...Instrument containment devices, including the contents, should not weigh over 25 pounds. All packing must conform to industrial standards, AORN and AAMI standards ..."

According to OR Manager, "Proper packaging ensures integrity of sterilization", February 19, 2016, indicates, "Sterilization is based on density. The total instrument set weight, including the weight of the instrument container, should not exceed 25 pounds. Because the sterilant must contact all surfaces, the instrument pan must be large enough to distribute all of the instruments so that they are exposed to the sterilant."

During an observation and concurrent interview with Admin 3, on 9/19/17, at 11:20 a.m., there was no scale available in the assembly and preparation area to weigh surgical trays. Admin 3 acknowledged there was no way to weigh the instrument trays in the sterile processing department and there should be.

10. During an observation and concurrent interview with sterile processing technician (Tech 3), on 9/19/17, at 11:56 a.m., there were several surgical instruments soaking in a large container of an enzymatic solution. Tech 3 was actively adding additional instruments to the solution after brushing them. Tech 3 indicated that the temperature of the enzymatic solution should be between 85-100 degrees F. Tech 3 then checked the temperature of the enzymatic solution and it was 75 degrees F.

A review of the Manufactures instructions for use of the enzymatic solution states " ...the optimum use temperature range of the ready to use enzymatic solution is 85-100 degrees F ..."


35399

11. The Center for Disease Control and Prevention article titled, "Infection prevention during Blood Glucose Monitoring and Insulin administration", indicated "...If blood glucose meters must be shared, the device should be cleaned and disinfected after every use, per manufacture's instructions, to prevent carry-over of blood and infectious agents."

Manufacture's recommendation glucose hospital meter by (Name of company) biomedical, pages six to four, indicated, "...when cleaning the meter follow the guidelines... commercial surface decontamination preparations that are approved for use by your facility can be used."

During a tour in the post partum unit, on 9/19/17, at 10:20 a.m., license nurse (LN 4) was asked to explain the process of disinfecting the blood glucose meter after every use (device that measure blood glucose levels). LN 4 explained that after using the glucose meter, she wipes it down with alcohol and or sani-wipe. LN 4 stated, "I usually clean it with alcohol, the sani wipe damages the meter, alcohol is sufficient, alcohol is standard, just alcohol."

During a tour in the labor and delivery unit, on 9/19/17, at 11 a.m., LN 5 was asked how to disiinfect a glucose meter between patient use. LN 5 stated "We use alcohol base for cleaning." LN5 was asked if she used anything else, responded alcohol base.

During an interview with LN 1, on 9/19/17, at 3:35 p.m., LN 1 was asked to explain the process of disinfecting the glucometer. LN 1 indicated that (product name) is used. When asked to state the dwell or wet time of the disinfectant to effectively sanitize, LN 1 was unable to state the proper use.

Review of the manufacturer's instructions for use, (product name), indicates that the contact or dwell time of the disinfectant is two minutes.


12.The facility policy and procedure entitled, "Temperature and Humidity Monitoring: Special Environments, Refrigeration Unit/Warmer storage", dated 10/22/15, pages 4-5 indicated, "... Blankets: 100-130 degrees Fahrenheit (43 degrees centigrade) Solutions for injection and irrigation in PVC and CR3 plastic flexible containers in their own wraps: May be warmed at a temperature not to exceed 40 degrees centigrade (104 F) and for a period no longer than two weeks. Solutions for irrigation in plastic pour bottles, may be warmed up to 40C (104F)... items requiring manual or automated daily temperature observation and daily record keeping are: IV and irrigation fluids."

Manufacture's recommendation (Name of company) letter to the hospital, dated 4/10/14, indicated ..."[Name of company] recommend the use of a controlled temperature warming cabinet that is monitored by a calibrated measurement device."

During a tour of Labor and delivery (L&D) unit and concurrent interviews with manager (Adm 10), obstetric technician (OB Tech 3), and director of the unit (ADM 11), on 9/19/17, at 11 a.m., in operating rooms A&B (OR A-B), two plastic bottles containing irrigation solution were found inside the blanket warmers, with no expiration date ( blanket warmer temperature goes up to 130 degrees Fahrenheit). OB Tech 3 stated, "not supposed to be in there, sorry I placed them in the morning, because I though it was a crash cesarean." ADM 10 discarded the bottles. The fluid warmer located on the hallway across nursing station showed a temperature of 104.6 F. Inside, were four bottles of intravenous fluids (IV). One without a date of expiration, and no evidence of daily temperature record keeping. Adm10 stated that engineering keeps a record of temperatures.

During a tour of L&D, on 9/20/17, at 3:30 p.m., and concurrent interview with ADM 1 and engineer (Eng 1), temperature display on the fluid warmer registered that it stopped since 9/19/17, at 1:44 p.m. Inside fluid warmer were bottles of irrigation solution (quantify), and IV fluids (quantify), ADM 10 removed the fluids and discarded them. ADM 11 contacted engineering. Eng 1 confirmed that this electronic device is local and that engineering department has no way to remotely know when the temperature goes out of range. Engineering does not keep a record of temperatures or alarms for this device.
These failures have the potential to cause scalding to patients and employees.

13. During an observation of OR # 6 cleaning process performed by patient care technicians and concurrent interview with Admin 15 on 9/19/17 at 10 a.m., the OR bed pad was observed with a pad tear approximately five inches long by one inch in width. The pads inside foam was exposed.

During a concurrent interview with Admin 15, Admin 15 acknowledged and confirmed the pad tear and stated "Yes, the pad needs to be replaced."

14. The facility policy and procedure entitled "Medication Storage and Medication Preparation Areas", dated 4/13, under procedure indicated "Surgery areas also store medications in lockable anesthesia carts. After each surgery case, the nurse and the anesthesiologist will inspect the surgery suite to assure that no medications are left unsecured. The anesthesiologist will ensure that the anesthesia cart is locked when unattended."

During an observation of OR # 3 and concurrent interview with Admin 7 on 9/19/17 at 10:25 a.m., the anesthesia cart was observed unlocked with the top drawer open. The medications inside the top drawer consisted of propofol (short-acting medication that results in a decreased level of consciousness and lack of memory for events), vecuronium, (general anesthesia medication to facilitate endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation), Rocuronium (neuromuscular blocker used in anesthesia to facilitate endotracheal intubation by providing skeletal muscle relaxation), Succinocholine (skeletal muscle relaxant) Etomidate (short-acting intravenous anaesthetic agent used for the induction of general anaesthesia and sedation for short procedures), Phelenylephine (to increase blood pressure), Buvicaine (local anesthetic), and other medications affecting the heart, lung, brain and stomach. The cart was unlocked during the cleaning process of the OR. Tech 6 was present in the OR, however, he was not aware that the cart was unlocked because he was busy cleaning the OR equipment. Tech 6 was not re-stocking the anesthesia cart medication supply at this time, either. The anesthesia cart had been left unlocked and unattended by the anesthesiologist.

During a concurrent interview with Admin 7, she explained the anesthesiologist had accompanied the patient to the post anesthesia care unit (PACU) and to see his other patients before his next surgical case. Admin 7 acknowledged anyone in that OR could help themselves to the medications inside the anesthesia cart since it was unlocked.

During an interview with medical doctor MD 1 on 9/19/17 at 10:45 a.m., MD 1 acknowledged leaving the anesthesia cart unlocked and open while he had accompanied the patient to the PACU.

During an interview with Admin 18 and concurrent review of the facility policy entitled "Medication Storage and Medication Preparation" dated 4/13 and "Personnel Who May Administer Medication", dated 8/16 on 9/21/17 at 10:40 a.m., Admin 18 acknowledged the anesthesia cart needs to be locked at all times except when being attended by the anesthesiologist. Admin 18 explained that the anesthesia, pharmacy and other trained technicians can have access to the anesthesia cart only when they are re-stocking the cart's medication supply. Nurses can have access to the anesthesia medication cart only if they are assisting the anesthesiologist with a request for a medication.

15. During an observation of the cleaning process in OR # 6 performed by patient care technicians and concurrent interview with Tech 6 on 9/19/17 at 10:15 a.m., the OR bed patient straps (Velcro straps used to keep patient on the OR table) were not cleaned during the cleaning process. In addition, the straps were in contact with the floor at the time the room was ready for the next patient's surgical procedure.

During a concurrent interview with Tech 6, he explained the OR table patient straps get replaced only if they are bloody, otherwise they don't get replaced. Tech 6 acknowledged the patient's bed straps were not cleaned and they should not be in contact with the floor at any time and if they are, the straps need to be cleaned before the next patient's surgical procedure.

16. The facility policy and procedure entitled "Intravenous Therapy Management", dated 8/15,
under dressings indicated "4. If inpatient, label dressing with date,and initials...."

During a tour of the post anesthesia care unit (PACU) and concurrent interview with LN 11 on 9/19/17 at 3:25 p.m., Patient N304 was observed with her intravenous access (HL) site dressing without any date or initials.

During a concurrent interview with LN 11, LN 11 acknowledged not dating and initialing the HL site dressing.

During the same PACU tour and concurrent interview with LN 12 on 9/19/17 at 3:35 p,m., Patient N301 was also observed with her intravenous access (HL) site dressing without any date or initials.

During a concurrent interview with LN 12, LN 12 acknowledged the date and initials on Patient N301's HL site dressing were missing.

17. The facility policy and procedure entitled "Temperatures and Humidity Monitoring: Special Environments, Refrigeration, Unit/Warmer Storage", dated 10/15, part J indicated "1. Relative Humidity 30-60%, 2. Temperature: Operating/surgical cystoscopic and delivery rooms--68-73 Fahrenheit. 3. Readings are monitored by Engineering, however if noted outside of these parameters, readings are to be reported to Engineering for assessment and mitigation if possible."

During a tour of the surgical department on 9/19/17 at 9:20 a.m., in operating room OR #2 the thermostat was observed indicating a humidity of 61% . At 9:35 a.m., in the main OR center court the thermostat that monitors the instrument storage (back area) was observed indicating a humidity of 63%.

During and interview with LN 14 on 9/19/17 at 9:30 a.m., LN 14 explained nursing does not check or monitor the OR humidity and temperature. Its the engineering personnel who check the ORs humidity and temperature every morning.

During and interview with LN 15 on 9/19/17 at 9:45 a.m., LN 15 explained nursing does not check or monitor the OR humidity and temperature. Its the engineering personnel who checks the ORs humidity and temperature every morning.

During an inteview with Admin 15 on 9/19/17 at 9:55 a.m., Admin 15 was asked to provide the humidity and temperature logs for the surgical services areas. She explained the surgical staff has nothing to do with the monitoring of the humidity and temperature of the ORs. The engineering department does that every day and they have the logs.

A copy of the July, August, and September 2017 Humidity and Temperature Logs for the surgical services were provided by Admin 4 on 9/19/17.

The "Humidity and Temperature Log" for July, 2017 were reviewed, the logs revealed that in the main OR 2 there were five dates when the humidity and the temperature were out of range. In the main OR 3 there were four dates when t