The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

PARADISE VALLEY HOSPITAL 2400 EAST 4TH ST NATIONAL CITY, CA 91950 Aug. 20, 2015
VIOLATION: GOVERNING BODY Tag No: A0043
Based on interview and record review, the hospital did not have an effective governing body that carried out the functions required by a governing body when:

1. The Hospital failed to ensure that an effective quality assessment and performance improvement program (QAPI) was implemented when the hospital failed to ensure monitoring of the sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) program to identify competency issues in the pharmacy IV compounding area. The pharmacy identified that eight technicians failed an initial gloved fingertip competency test. The hospital did not analyze the test data and create a corrective action. The eight technicians continued to compound IVs. These failures resulted in the potential, from 1/1/15 to 8/18/15, for 7,301 patients to be exposed to preventable infections from 4,322 contaminated IV medications (A 273 #1)

2. The hospital failed to ensure the intravenous (IV, directly into a vein) sterile (germ free) compounding (mixing) area was free of dust, stains, and foreign (black & brown) material. Dust, stains, and foreign material, were present on surfaces in the ante (area to prepare for mixing IVs) and buffer (area for mixing IVs) rooms. These failures resulted in the potential, from 1/1/15 to 8/18/15, for 7,301 patients to be exposed to preventable infections from 4,322 contaminated medications. (A 501 #2)
3. The hospital failed to ensure an air pressure gauge was installed between the buffer (area to mix sterile (germ free) intravenous (IV, directly into a vein) medications) and the ante-area (area to prepare for mixing IVs). The hospital did not install an air pressure gauge to monitor the pressure differential (difference) between the buffer and the ante-area. This failure resulted in the potential, from 1/1/15 to 8/18/15, for 7,301 patients to be exposed to preventable infections from 4,322 contaminated medications.
(A 501 #3)
4. The hospital failed to ensure air pressure differentials (differences) between the buffer room (area to mix sterile (germ free) intravenous (IV, directly into a vein), ante-room (area to prepare to mix IVs), and general pharmacy, were documented on a log at least every work shift. The hospital did not maintain a log of air pressure differentials between the buffer room, ante-room, and general pharmacy. These failures resulted in the potential, from 1/1/15 to 8/18/15, for 7,301 patients to be exposed to preventable infections from 4,322 contaminated medications. (A 501 #4)

5. Duplicate or incomplete medication orders, which had the potential to result in increased variability and risk of harm to patients from a medication error or adverse reaction, were not clarified by nurses. (A 405 #s 1, 2, 3)

6. The hospital failed to ensure medication orders with the same pain scale were reviewed for therapeutic duplication. This failure had the potential to place the patient at risk for overdose on narcotic pain medications.
(A 500)

7. The hospital failed to ensure safe and proper use of a single dose medication vial. This failure could result in the loss of integrity of the medication and potentially harm patients by not providing the expected therapeutic effect. (A 505 #1)
8. The hospital failed to ensure potentially deteriorated medication was not available for patient use in the hospital and stored in accordance with the manufacturer's stipulations. This failure could place patients at risk for treatment failure during episodes of angina (chest pain). (A 505 #2)
9. The hospital failed to ensure outdated medication was removed from one area in the hospital. This failure may result in ineffective medication administered to patient. (A 505 #3)
10. The hospital failed to ensure medication was available for potential medical emergency in the operating room. This failure could contribute to increased risk for adverse outcomes for patients during medical emergencies. (A 951)
11. The Infection Control Committee Chairperson, who was a physician and interventional cardiologist, was not held accountable to complete mandatory training and education regarding Infection Control. (A 748)

12. The Infection Control Preventionist (ICP) did not consistently and systematically implement the hospital's Infection Control Program, policies and procedures, in accordance with her job description and established goals and plans. In addition, documentation, related to the ICPs 2015 surveillance and auditing results in the Operating Room, (OR) was falsified in an attempt to show that the ICPs surveillance practices were current. (A 749 #s 1, 2, 12)

13. There was no documented evidence that the contracted dialysis service had a dialysis policy in place that was approved by the hospital's governing body. (A 84)

14. The hospital failed to ensure that the special care nursery, Operating Room (OR), and the Emergency Department (ED) were maintained to ensure an acceptable level of cleanliness, safety and quality.
(A 724 #s 1, 2, 3)




The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Governing Body.
VIOLATION: CONTRACTED SERVICES Tag No: A0084
Based on observation, interview and record review, Hospital A failed to ensure that its dialysis contract was implemented in a safe and effective manner. Hospital and contracted dialysis staff were inconsistently implementing two different policies and procedures related to the use of personal protective equipment (PPE - clothing and equipment worn to protect and prevent the spread of infection) and how to address medical emergencies for all patients receiving dialysis.

Failure to ensure that all staff consistently implemented policies and procedures could lead to unsafe practices related to dialysis care and services.

Findings:

On 8/17/15 at 11:10 A.M., a tour of Hospital A's 5th Floor Telemetry unit (constant monitoring of patient's cardiac status) was conducted with the Respiratory Care Manager (RCM) and a charge nurse (Registered Nurse - RN responsible for the care of the unit) 21. Two patients were observed receiving dialysis (also known as hemodialysis - filter of toxins in the blood via artificial kidney machine) in a tandem room accompanied by a hemodialysis nurse (RN) 25.

On 8/17/15 at 11:15 A.M., an interview was conducted with RN 21. RN 21 stated that staff follow the hospital's current dialysis policy which included; if an emergency related to one or both patients who received dialysis in the tandem room occurred, the primary nurse assigned to care for the patient, had the responsibility to assist the hemodialysis nurse.

On 8/17/15 at 11:20 A.M., an interview was conducted with Patient 24's primary nurse (RN) 22. RN 22 stated that he did not receive any training related to care of a dialysis patient and was unable to verbalize how to intervene during a medical emergency during dialysis.

According to the hospital's current policy and procedure titled "Dialysis, Acute", dated 3/14, the policy indicated that under emergencies, the charge nurse would provide the back-up support for dialysis services rendered. This current policy contradicted RN 21's verbal response to a medical emergency during dialysis.

On 8/17/15 at 2:15 P.M., an interview was conducted with RN 25, the Contract Dialysis Chief Executive Officer (CDCEO) and the Respiratory Care Manager (RCM). RN 25 stated that staff follow the contract dialysis policy which included; in the event of patient emergencies in the tandem dialysis room, the hemodialysis nurse calls the CDCEO, and the patient's Physician to get an order to stop the dialysis. In addition, RN 25 stated the unit charge nurse had the responsibility to assist the hemodialysis nurse with any dialysis patient medical emergency. In addition, the CDCEO stated that the contract dialysis policy and procedure was currently being revised and had not been approved by the hospital's Medical Executive Committee (MEC). Furthermore, during the interview, the CDCEO and the RCM acknowledged that the hospital staff and the contracted dialysis staff were inconsistent with which dialysis policy was to be implemented.

A review of the hospital's "Dialysis Services Agreement", dated 12/1/14, (dialysis contract) was conducted. The dialysis contract stipulated that "The Hospital shall retain professional and administrative responsibility for the services rendered."

On 8/19/15 at 2:15 P.M., during a group interview, the Chief Nursing Officer (CNO) stated that the hospital's expectation was for the hospital staff to implement the hospital's dialysis policy; and the contracted dialysis staff were expected to implement the contracted dialysis services policy. In addition, the hospital's Administrator (Admin) stated that the hospital's expectation was for all staff to follow the hospital's dialysis policy and procedure. The CNO stated that the MEC Minutes, dated 5/12/15, indicated that the contracted dialysis policy was reviewed and blessed by the MEC. However; the CNO acknowledged that the CDCEO, contracted dialysis staff and hospital staff were not educated related to which policy would be implemented. In addition, the hospital was unable to provide the dialysis policy which was documented as approved by the MEC on 5/12/15.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, interview, record and document review, Hospital A failed to provide care in a safe setting when staff did not implement their own "Observation Levels, Sitters" policy, for 1 of 35 sampled patients (28). Certified Nursing Assistant (CNA) 26 was observing two patients simultaneously when one patient required a 1:1 (constant observation to include eye contact and contact within approximately 12 feet of patient at all times per the hospital's policy) observation.

Failure to implement the hospital's Sitter and Observation policy impeded the staff from meeting and providing the patient's required safety needs.

Findings:

On 8/17/15 at 10:35 A.M., CNA 26 was observed seated in a chair placed outside of Patient 27 and 28's room.

On 8/17/15 at 10:45 A.M., an interview was conducted with CNA 26, and the Respiratory Care Manager (RCM). During the interview, CNA 26 stated that she was assigned as the sitter to care for Patient 27 and Patient 28. CNA 26 stated that Patient 27 required a sitter for safety related to unpredictable behavior. CNA 26 explained that Patient 28 required a sitter because of a 5150 hold (involuntary psychiatric hold due to danger to self or others, and/or gravely disabled). CNA 26 stated she was aware that Patient 28 required a sitter for 1:1 observation. She acknowledged that 1:1 observation had not been provided to Patient 28.

A review of Patient 27's medical record was conducted. Patient 27 was admitted to Hospital A on 8/11/15, per the Admission/Registration record, dated 8/11/15.

According to Patient 27's observation record, dated 8/17/15, CNA 26 documented the following in 15 minute increments: the reason for the patient's close observation, the patient's location and behavior. The documentation indicated that Patient 27 had unpredictable behavior on 8/17/15.

Patient 28 was admitted to Hospital A on 8/16/15 per the Admission/Registration record, dated 8/16/15.

According to an Involuntary Patient Advisement (5150) form, Patient 28 was placed on a 5150 hold from 8/16/15 through 8/19/15, due to being identified as gravely disabled (unable to provide for one's own food, clothing or shelter) as evidenced by frequent falls and disorganized/paranoid delusions (a fixed, false belief that one is being harmed or persecuted by a particular person or group of people).

According to the hospital's policy and procedure titled "Observation Levels, Sitters", dated 4/2014, the policy indicated that the patient to sitter ratio is 1:1 (one-to-one) for patients on a 5150 hold. The policy defined 1:1 as constant observation to include eye contact and contact within approximately 12 feet of patient at all times. The policy stipulated to "Never leave the patient unsupervised or unattended for any reason at any time."

The hospital's policy and procedure titled " Patient Rights", dated 4/2012, indicated that a patient has the right to receive care in a safe setting.

A joint interview with CNA 26 and the RCM was conducted on 8/17/15 at 11:45 A.M. CNA 26 and the RCM acknowledged that Patient 28 did not receive 1:1 observation in accordance with the hospital's policy.
VIOLATION: QAPI Tag No: A0263
Based on interview, record and document review the hospital did not ensure that an effective quality assessment and performance improvement program (QAPI) was implemented when the hospital:


1. Failed to ensure the analysis of pharmacy data collected on gloved fingertip competency testing (test for putting on sterile (germ free) gloves and gowns required for compounding (mixing) intravenous (IV, directly into a vein) medications). Prior to 3/25/15 the hospital did not test for gloved fingertip competency. Between 3/25/15 to 4/3/15 the hospital tested 11 pharmacy technicians for gloved fingertip competency. The test results showed eight pharmacy technicians (Pharmacy Technicians (1, 3, 4, 5, 6, 7, 9, and 11) failed the competency test. The pharmacy did not analyze the data and create a corrective action. The pharmacy did not report the data to the performance improvement committee (oversees the improvement activities in the hospital). The performance improvement committee did not analyze the date and create a corrective action. These failures resulted in the potential, from 1/1/15 to 8/18/15, for 7,301 patients to be exposed to preventable infections from 4,322 contaminated IV medications (A 273 #1).

2. The hospital failed to ensure consistent surveillance was performed by the Infection Control Preventionist (ICP), in multiple hospital patient care areas and departments, in an effort to collect, track and trend data pertaining to IC activities, processes, policy and procedures compliance. (A 273 #s 2, 4, 5)

3. Failure to ensure that a physician, who was designated as the Infection Control Committee Chairperson for the hospital, received the required training and/or certification. (A 748)

4. Failed to initiate and conduct an infection control project in a manner that met the needs of the hospital staff and visiting public. (A 297)

5. Failed to demonstrate further analysis related to its hand hygiene compliance rate data. (A 273 #3)

6. The hospital failed to ensure medication orders with the same pain scale were reviewed for therapeutic duplication for one patient. This failure potentially exposed patients to adverse effects which may have resulted from avoidable medication errors. (A 283 #1)
7. The hospital failed to implement corrective action to address weaknesses identified in the medication occurrence reports. This failure potentially exposed patients to adverse effects which may have resulted from avoidable medication errors. (A 283 #2)

The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Quality Assurance Performance Improvement (QAPI).
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on observation, interview, and record review, the hospital failed to ensure consistent data collection and analysis to track processes of care, hospital services and operations for performance improvement activities as evidenced by the following:

a. The hospital failed to ensure the analysis of pharmacy data collected on gloved fingertip competency testing (test for putting on sterile (germ free) gloves and gowns required for compounding (mixing) intravenous (IV, directly into a vein) medications). Prior to 3/25/15 the hospital did not test for gloved fingertip competency. Between 3/25/15 to 4/3/15 the hospital tested 11 pharmacy technicians for gloved fingertip competency. The test results showed eight pharmacy technicians (Pharmacy Technicians (1, 3, 4, 5, 6, 7, 9, and 11) failed the competency test. The pharmacy did not analyze the data and create a corrective action. The pharmacy did not report the data to the performance improvement committee (oversees the improvement activities in the hospital). The performance improvement committee did not analyze the date and create a corrective action. These failures resulted in the potential, from 1/1/15 to 8/18/15, for 7,301 patients to be exposed to preventable infections from 4,322 contaminated IV medications.
b. The hospital failed to ensure consistent surveillance was performed by the Infection Control Preventionist (ICP), in multiple hospital patient care areas and departments, in an effort to collect, track and trend data pertaining to IC activities, processes, policy and procedures compliance.

c. The hospital failed to demonstrate further analysis of its data related to hand hygiene compliance rates. Hospital staff questioned and verbalized concerns related to who and how the data was collected and the surveillance techniques used. There was no documented evidence to demonstrate that an analysis had been performed to address those staff concerns and questions. An inaccurate and incomplete collection of data combined with questionable surveillance techniques could lead to a misrepresentation of compliance rates, and impede the hospital from reaching its set goals.


Findings:

1. During a concurrent tour and interview, on 8/17/15 at 9:55 am, in Hospital A's pharmacy, Director of Pharmacy (DPH 1) identified the IV sterile compounding area. Inspection of the area showed that it consisted of two rooms. The ISO Class 8 (measurement of particles in the air, lower number equals less particles in the air) ante-room (area to prepare supplies for mixing IVs) was separated from the general pharmacy by walls and a door. Further inspection showed the ante-room was separated from the ISO Class 7 buffer room (room for mixing IVs) by walls and a door. Continued inspection showed the buffer room contained two IV compounding hoods (device to maintain a clean IV mixing area).

During a concurrent tour and interview, on 8/17/15 at 10:45 am, in Hospital A's ISO Class 7 buffer room, Pharmacy Technician (Pharm Tech 1) identified an IV compounding hood. DPH 1 was asked to describe the types of IVs mixed in the buffer room. DPH 1's description included low (low-risk of bacterial contamination (antibiotics)) and medium (medium-risk of bacterial contamination (Total Parenteral Nutrition (TPN, IV food))) risk level medications.

During a concurrent observation, interview, and record review, on 8/18/15 at 2:45 pm, in Hospital A's pharmacy, DPH 1 identified a refrigerator. Inspection of the refrigerator showed it contained an IV medication. Inspection of the medication label showed Penicillin G Potassium (antibiotic) 3 million units, date prepared: 8/17/15, expires 8/23/15 (6 days), refrigerate. Pharm Tech 1 was asked to describe how the hospital determined the expiration (beyond use date) for the medication. Pharm Tech 1 identified, on the ante-room wall, a document titled Pharmacy Compounding USP 797 Risk Level Assessment. Pharm Tech 1 stated the document was used to assign the beyond use dates to the IVs mixed in the IV hoods.

During a concurrent interview and administrative record review, on 8/18/15 at 2:58 pm, DPH 1 and Pharm Tech 1 were asked to describe the quality assurance processes for the IV sterile compounding area. Pharm Tech 1's description included, on 4/1/15, Hospital A started the process to test all compounding staff for initial gloved fingertip/thumb competency. DPH 1 and Pharm Tech 1 reviewed the quality assurance culture results, of the gloved fingertip testing, and stated that 8 out of 11 pharmacy technicians failed the 4/1/15 test. DPH 1 was asked to describe the hospital's plan to improve the test results. DPH 1 stated that the hospital did not have a documented corrective action plan. DPH 1 stated the testing results had not been reported to the pharmacy and therapeutics (P and T, manages medications use in the hospital) committee. DPH 1 acknowledged the testing results should have been reported to the P and T committee.

During a concurrent interview and administrative record review, on 8/19/15 at 8:20 am, DPH 1 identified the TPN monitoring forms. Review of the forms, from 1/1/15 to 8/18/15, showed Hospital A mixed 34 bags of TPN.

During a concurrent interview and administrative record review, on 8/19/15 at 8:35 am, DPH 1 identified the non-premixed IV orders YTD (1/1/15-8/18/15) report. DPH 1 reviewed a 50 page sample of the 1,070 page report. DPH 1 stated the 50 page sample of the report documented Hospital A mixed 202 IV medications. Based upon a sample of 50 pages, of the 1070 page report, Hospital A mixed 4,288 IVs.

During a concurrent interview and administrative record review, on 8/19/15 9:07 am, DPH 1 identified the Period Inpatient Location Statistics report (patient census). DPH 1 reviewed the report and stated Hospital A admitted 7,301 patients from 1/1/15-8/18/15.

During an interview, on 8/19/15 at 2:25 pm, Chief Nursing Officer (CNO) acknowledged 8 of 11 pharmacy technicians failed the initial gloved fingertip/thumb sampling quality assurance test. CNO stated that it was the hospital's expectation that the test results were to have been reported to the pharmacy & therapeutics and performance improvement committees.

During an interview, on 8/19/15 at 3:50 pm, Director of Nursing/Director of Performance Improvement (DON/PID) acknowledged that he had oversight of the hospital's performance improvement program. DON/PID acknowledged 8 of 11 pharmacy technicians failed the initial gloved fingertip/thumb test. In addition, DON/PID acknowledged the test data had not been reported to the hospital's performance improvement program. DON/PID stated the hospital's performance improvement program would have analyzed the data and developed a plan to correct the failure. DON/PID further stated that it was the hospital's expectation for this data to have been reported to performance improvement.

An administrative record review, of the quality assurance culture, collected 3/25/15-4/3/15, for Pharmacy Technicians (1-11) showed finger tip analysis was taken for left and right hands. Continued review showed eight Pharmacy Technicians (1, 3, 4, 5, 6, 7, 9, and 11) tested positive (failed the test) for bacteria growth.

An administrative record review, of the hospital's policy and procedure for IV Admixture & Sterile Products Aseptic Technique (Approval: P&T October 2014) showed, Key Elements, B.1 "Both the Clean Room and the Gown Room, comprising the IV Preparation area, comply with the California State Board of Pharmacy (USP) 797 Regulations." The hospital references USP <797> in the IV Admixture & Sterile Products Aseptic Technique policy and procedure.

An administrative record review, of the Pharmacy Compounding USP 797 Risk Level Assessment, Beyond Use Dating, showed, "Low-Risk Compounding Requirements...Prepared in ISO Class 5 laminar flow hood...Located in ISO Class 8 Clean Room with Ante Room." The hospital references USP <797> in determining beyond use dating (expiration dating).

The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines...USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP 35/NF 30). The USP revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from (1) microbial contamination (nonsterility), (2) excessive bacterial toxins..." If a hospital puts all the practice and quality standards into place as described in USP <797>, the hospital can assign beyond use dates (date beyond which an IV product cannot be started) to compounded IV products as described in USP <797>.

An administrative record review, of the USP <797> Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 50) showed Competency Evaluation of Garbing (dressing) and Aseptic (clean) Work Practice, "The risk of contaminating a CSP (compounded sterile IV) prepared under low-risk level and medium-risk level conditions is highly dependent on proper hand hygiene (cleaning) and garbing practices..." Continued review showed, "Gloved Fingertip Sampling-All compounding personnel shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure zero cfu (bacteria growth) no less than three times before initially being allowed to compound CSPs for human use...After completing the initial gowning and gloving competency evaluation, re-evaluation of all compounding personnel for this competency shall occur at least annually for personnel who compound low- and medium-risk level CSPs...before they are allowed to continue compounding CSPs for human use." The hospital did not perform the gloved fingertip sampling test until 3/25/15. The hospital had the test results that showed eight pharmacy technicians failed the test. The hospital allowed the eight pharmacy technicians to continue to compound IV medications.

An administrative record review, of the USP <797> Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 53) showed, Action Levels, Documentation, and Data Evaluation, "The value of viable microbial monitoring of gloved fingertips and surfaces of components and the compounding environment are realized when the data are used to identify and correct an unacceptable work practice. Sampling data shall be collected and reviewed on a routine basis as a means of evaluating the overall control of the compounding environment..." Continued review showed, "Any cfu count that exceeds its respective action level (see Table 4) should prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures, and air filtration efficiency within the aseptic compounding location..." Further review showed, "When gloved fingertip sample results exceed action levels after proper incubation, a review of hand hygiene and garbing procedures as well as glove and surface disinfection procedures and work practices shall be performed and documented. Employee training may be required to correct the source of the problem." The hospital did not act on the data showing 8 of 11 pharmacy technicians failed the test.










2. On 8/17/15 at 9:50 A.M., a tour and observations of the Operating Room (OR) were conducted with the Chief Nursing Officer (CNO), the Infection Control Preventionist (ICP), the Administrator (Admin.) and the OR Charge Nurse (CN).

Gastrointestinal (pertaining to stomach and intestines) Technician (GT) 1 was observed cleaning an endoscope (an instrument used to examine the inside of the body and usually introduced via a natural opening such as the mouth or anus) in a supply room. GT 1 did not wear protective goggles or a face shield. GT 1 was cleaning the scope in an open container of clear fluid that was approximately 18 by 36 inches in size. Next to the container of clear fluid was a plastic jug marked "alcohol". Within approximately 2.5 feet of the open container of clear fluid were wrapped trays of instrument sets, per the package labels.

On 8/17/15 at 10:00 A.M. an interview was conducted with GT 1. GT 1 stated the open container contained water that he was cleaning the scope with. GT 1 confirmed that alcohol was also used in the process of cleaning and drying the scope. GT 1 stated he cleaned the scope in the supply room because the other area designated for cleaning was too small for all of the equipment. GT 1 acknowledged that he was required to wear protective eyewear such as goggles or a faceshield, but did not because they "fogged up" when he wore them.

Per GT 1's job description his primary responsibility was to assist the physician during invasive GI procedures. Per the job description he was responsible for the containment of contamination during and after procedures, to be in compliance with the IC manual, blood borne pathogens standards, Center for Disease Control Guidelines, and demonstrating appropriate use of personal protective equipment (PPE) which included the use of goggles.

On 8/17/15 at 10:20 A.M., an interview was conducted with the ICP. The ICP acknowledged that GT 1 was not wearing appropriate PPE. The ICP confirmed that the wrapped instrument trays, within 2.5 feet of where GT 1 was cleaning the scope, contained sterile instruments. The ICP acknowledged that the sterility of the wrapped instrument sets could become compromised if they became wet from any splashing from the open tray of water. The ICP also confirmed that the OR followed the Association of Operating Room Nurses (AORN) standards and practices.

On 8/17/15 at 11:00 A.M. an observation of OR 1 was conducted. Operating RoomTechnicians (ORT) 1 and 2 were dressed in sterile surgical gowns and gloves and were assisting in a surgical procedure. Neither ORT wore protective eye goggles or face shields. The OR CN and the ICP acknowledged that both ORTs did not implement the ORs IC policy and procedures.

Per the 2015 AORN standards, guidelines for perioperative practice, Recommendation XV, "sterilized materials should be labeled and stored in a manner to ensure sterility..." Recommendation XVa. " The shelf life of a packaged sterile item should be considered event-related. Events that may compromise the sterility of a package include: moisture penetration."

Per the 2015 AORN standards, guidelines for high level disinfection, Recommendation II a., "Appropriate PPE should be worn during cleaning and decontamination. PPE protects the worker from hazardous chemicals and exposure to blood and other potentially infectious materials."

Per the isopropyl alcohol Material Safety Data Sheet (MSDS), alcohol could cause serious eye irritation. Precautionary statements included: wear eye and face protection.

The hospital's policy and procedure entitled "Infection Control Operating Room", dated December 2012, was reviewed. Per the policy, "facial masks and protective eyewear will be worn with procedures potentially creating splash or aerosolozed secretions to the face or eyes of any staff."

On 8/17/15 at 11:15 A.M., an interview was conducted with the ICP. The ICP stated that she conducted random audits of the OR to ensure compliance with the hospital's IC policies and procedures and other related standards of practice for OR personnel. The ICP stated that her last audit in the OR was in March of 2015.

On 8/18/15 at 1:00 P.M. an interview was conducted with the Administrator and the CNO. Per the Administrator, the ICP acknowledged altering and falsifying the OR audit record to make it appear as though she was current in her surveillance of that department. She informed them that she had not performed any audits in the OR in 2015 and that "the year just got away from her." The ICP was immediately terminated by the facility and was no longer available during the survey.

On 8/19/15 at 11:00 A.M. a review of the ICPs infection control inspection logs was conducted. Per the ICPs audit and inspection logs, the last documented audit dates of hospital departments and patient care units, by the ICP, were as follows: Intensive Care Unit (ICU) 3/2014; Cardiac Cath Lab 2/2014; 5 North (telemetry) 4/2014; 2 West (inpatient rehab) 3/2014; 6 North (Med-Surg) 3/2014; Sterile Processing 3/2014; endoscopy 3/2014, OR 7/2014. There was no evidence in the inspection log that the pharmacy had been inspected or audited by the ICP.
A review of the ICPs job description was conducted on 8/19/15. Per the job description, the ICP was responsible to make routine facility rounds to evaluate compliance with infection control/prevention policies and procedures.

According to a document entitled "Infection Control Goals for 2015", dated March 2015, one of the specific goals for the ICP was surveillance of cleaning and sterilization of equipment used in radiology, OR and all sterile procedures." The ICP activity listed to accomplish that goal was "random monthly observation visits to Central Sterilization, OR, radiology, dietary, EVS (environmental services), and ER (emergency room ).

The ICP had not consistently surveilled key departments and patient care areas in the hospital in an effort to collect, track and trend, and analyze data pertaining to IC practices for performance improvement purposes.






3. A review of the hospital's hand hygiene compliance rate data was conducted. According to the Infection Control Surveillance Summary 2015, the hospital's hand hygiene compliance rate (before and after patient contact) for 2014 was 65%. For the following months in 2015, the hand hygiene compliance rate was:

57% in January
60% in February
58% in March
49% in April
62% in May

The hospital's goal was to be 100% compliant with hand hygiene. The hospital data showed that the hospital had not met their goal in 2014. The hospital data in 2015 continued to show the hospital's inability to meet their goal for hand hygiene compliance.

According to the hospital's Infection Control Plan and Risk Assessment, dated 4/2015, the hospital listed items that needed improvement and on the list was hand hygiene compliance.

According to a document titled "Infection Control Goals for 2015", dated 3/2015, one of the specific goals for the Infection Control Preventionist (ICP) was hand hygiene surveillance. The ICP activity listed house wide surveillance and an action plan to randomly sample 30 subjects per month to include hospital staff in various disciplines such as nurses, physicians, respiratory staff, dietary staff, and radiology staff. There was no documented evidence to demonstrate that the house wide surveillance and the random sampling of 30 subjects per month had been performed.

Per the hospital's Performance Improvement Committee Meeting Minutes, dated 3/3/15, hand hygiene was discussed and the ICP was working on observations, at an 80% compliance rate. There was no documented evidence to show the data collection and analysis that occurred for the reported 80% compliance rate.

A review of the hospital's Pharmacy & Therapeutics/Infection Control Committee Meeting Minutes, dated 4/8/15, was conducted. The ICP was not present and the infection control data was presented by the Director of Nursing/Performance Improvement Director (DON/PID). Per the minutes, the first quarter data related to the hospital's hand hygiene surveillance was 61% with a total of 238 observations made for compliance after patient care. Under "action" section, the ICP was to continue to educate physicians and staff. The ICP was to monitor all areas and address issues as needed. There was no documented evidence to demonstrate that this action was carried out by the ICP.

The ICP was not available to be interviewed.

On 8/19/15 at 2:15 P.M., a group interview was conducted with the members of the infection control and performance improvement committee. The Administrator (Admin), the Chief Nursing Officer (CNO), the DON/PID, the Chief Medical Officer (CMO), Nurse Director of Intensive Care Services (NDIC), Nurse Director of Maternal Child (NDMC), Physician 1 and the Director of Laboratory (DOL) were present. The hospital's hand hygiene compliance rate (before and after patient contact) was discussed. The hospital's goal was to be 100% compliant with their hand hygiene. However, the hospital was 64% compliant in 2014 and current data showed in May 2015 that the hospital was at 62%. The DOL verbalized concerns regarding the hospital-wide hand hygiene compliance rate data. He questioned who and how the hand hygiene compliance data was collected. Physician 1 stated that hand hygiene was discussed at the medical staff level. He stated that the medical staff also questioned the hand hygiene compliance rate, as they expressed their 100% compliance with hand hygiene practices. Physician 1 stated that the data collection related to hand hygiene compliance may not have been accurate.

A review of the hospital's Performance Improvement Plan (PIP), last reviewed on 7/2015, was conducted. Per the PIP, under performance data, aggregation and analysis, "Data collected will be used to monitor the effectiveness and safety of services, quality of care, identify opportunities for improvement, and changes that will lead to improvement." "Data is systematically aggregated and analyzed, using statistical tools and techniques, on an ongoing basis to determine if levels of performance, patterns, or trends vary substantially from those expected..." "Data that the organization considers for collection to monitor performance may include: ... staff suggestions for improving patient safety...." The PIP also stipulated that "Hospital will take action and develop measures of success on indicators that fall below the expected performance."

A follow-up interview with the DOL was conducted on 8/20/15 at 12:55 P.M. The DOL stated that there were monthly reports that were generated to demonstrate the department's compliance with hand hygiene. The DOL explained that within the laboratory department the Lead performed their own hand hygiene surveillance and monitoring which revealed 100% compliance. He also mentioned that the American Society of Microbiology's (ASM - professional organization that the laboratory recognized) threshold for blood culture contamination was 3.0%. He stated that the hospital's blood culture contamination was 1.1% which was below the ASMs threshold which was an indicator that good hand hygiene practices were in place at the hospital. The DOL stated that he had a private discussion with the ICP to discuss his concerns with the hand hygiene compliance rates, surveillance techniques and data collection. He acknowledged that there was no follow-up or further analysis done by the ICP to address his concerns.

A joint interview with the CNO and the DON/PID was conducted on 8/20/15 at 1:10 P.M. The CNO stated that with regards to the hand hygiene surveillance and data collection, attempts were made to increase the sample size as the hospital had identified that their number of observations were very low. Per the DON/PID, he confirmed that several physicians expressed their concerns regarding the hospital hand hygiene compliance rate. The DON/PID stated that the ICP should have followed-up and performed an analysis to address the hospital staff's concerns related to the hand hygiene compliance rate, surveillance techniques and how the data collection was performed.

The ICP's infection control surveillance binder and audit logs were reviewed. There was no documented evidence to demonstrate that any hand hygiene audits or surveillance had been performed in 2015. There was no documented evidence to demonstrate that further analysis had been performed when hospital staff questioned the hand hygiene compliance rates and the surveillance techniques used to obtain the data.







4. A review of the hospital's "Dialysis Service Agreement" (contract), dated 12/1/14, was conducted. The dialysis contract indicated that the "Company" (dialysis vendor) would participate fully in the hospital's quality assurance program to include infection control and risk management.

On 8/17/15 and 8/19/15, several hospital and contracted dialysis staff were interviewed. The interviews were inconsistent with the hospital's policy and procedure for dialysis specific to the donning of personal protective equipment (PPE - protective clothing and equipment worn to prevent the spread of infection).

On 8/19/15 at 11:50 A.M., an interview was conducted with the Director of Telemetry (DOT). The DOT was asked to address the inconsistent verbal responses from hospital and contracted dialysis staff related to the hospital's current dialysis policy. The DOT stated that in the past, staff compliance related to care of patients who received dialysis, was monitored via a "Dialysis Staff Evaluation Form (DSEF)." The DOT stated that the DSEF was given to all the nursing units where dialysis was performed in the hospital. Per the DOT, the hospital nurses would fill out the DSEF and return it to her. According to the DOT, identified concerns from the DSEF were discussed with the contracted dialysis supervisor. The DOT explained that the DSEF was a tool used to monitor contracted dialysis staff's compliance with the hospital's policy and procedure related to dialysis care. The DOT stated that the DSEF had not been completed since 11/25/14; therefore, no dialysis surveillance had been performed. The DOT stated that no dialysis data to include compliance with infection control practices had been collected or presented to the hospital's Performance Improvement committee since November 2014.

On 8/19/15 at 2:15 P.M., during a group interview, the DSEF was discussed with the DOT, Chief Nursing Officer (CNO), Director of Nursing/Performance Improvement
Director (DON/PID), and the Administrator (Admin).
The DOT restated that the DSEFs were used in random audits to surveille dialysis care provided in the hospital, which was last performed in November 2014. She stated that there were no benchmarks or goals established related to performance improvement projects for dialysis. The DON/PID stated that no dialysis data to include compliance with infection control practices had been presented to him and that he was not aware of any performance improvement projects for dialysis.

5. On 8/18/15 at 8:35 A.M., an observation of a colonoscopy procedure (visualization of the large intestine via insertion of a scope) was conducted. Medical Doctor (MD 21) was observed without a protective mask or face shield (PPE - personal protective equipment worn to prevent the spread of infection).

On 8/18/15 at 8:35 A.M., an interview was conducted with MD 21. MD 21 stated he chose not to wear the PPE because he wore prescription glasses and the face shield fogged his glasses.

The hospital's policy and procedure titled "Infection Control GI Lab" dated 6/2013, included "Procedure Attire G.2. Facial masks and protective eyewear will be worn with procedures potentially creating splash or aerosolized secretions to the face or eyes of any staff."

On 8/18/15 at 2:00 P.M., an interview was conducted with an Operating Room (OR) nurse, Registered Nurse (RN) 27. RN 27 stated that all staff are expected to wear appropriate PPE in accordance with the hospital's GI policy. In addition, RN 27 stated that the OR staff and the OR Director were aware that MD 21 had a history of non compliance with wearing the face mask and face shield during endoscopic procedures.

The IP job description included the following:

B.1. Conducts regular surveillance to determine the presence of infections.
B.12. Makes routine facility rounds to evaluate compliance with infection control/prevention policies and procedures.

The hospital's Infection Control Goals for 2015 included:

Implementation and coordination of all aspects of infection prevention and control plan for the hospital; daily rounds on all units investigating proper isolation precautions set in place on appropriate patients and adherence to all isolation policies and procedures; surveillance of cleaning and sterilization of equipment used in the OR and all sterile procedures; random monthly observation visits to the OR. These goals were not met when, there was no documented evidence of regular IP surveillance and rounding to collect data related to staff compliance with IC policies and procedures in the endoscopy suite since 11/25/14.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on observation, interview, and document review, the hospital failed to address weaknesses that could contribute to medication errors as evidence by:
1. The hospital failed to ensure medication orders with the same pain scale were reviewed for therapeutic duplication for one patient.
2. The hospital failed to implement corrective action to address weakness identified in the medication occurrence reports.
These failures potentially exposed patients to adverse effects which may have resulted from avoidable medication errors.

Findings:
1. On 8/18/15 starting at 9:40 A.M, reconciliation of medication order was conducted after the morning medication pass observation with the charged nurse (RN 51) of the medical surgical unit and the Director of Pharmacy (DPH 1). Review of the clinical record for Patient 51 showed that she was prescribed two similar narcotic pain medications by her physician for mild pain with the exact same pain scale (the 0 to 10 numeric pain distress scale; "0" represents "no pain" and "10" represents the most severe pain the patient has experienced) of 1 to 3. The two active narcotic pain medications for Patient 51 were written as followed:
a. Acetaminophen with codeine 300-30 milligrams (mg) tablet: give 2 tablets by mouth every 4 hours as needed for mild pain (1 to 3).
b. Hydrocodone with acetaminophen 5-325 milligrams (mg): give 1 tablet by mouth every 4 hours as needed for mild pain (1 to 3).
However, further review of Patient 51's clinical record did not show there was no clear instruction to the nurse regarding the use of which pain medications for administration to the patient with mild pain.
When the Charged Nurse (RN 51) was asked which of the two pain medications would be administered to Patient 51 when there was documented mild pain, she acknowledged either of the pain medication could potentially be administered. In the interview with the DPH 1 on 8/18/15 at 9:55 A.M., he agreed the orders were written ambiguously and acknowledged the pharmacist reviewing the pain medication orders should have identified and clarified both orders for potential duplicative therapy.
Review of the hospital policy entitled "Medication Error Reduction Plan Policy" dated 10/2014 on page 1 under Key Elements; it read "Medication Error Reduction plan involves many components which together facilitate the assurance of a safe environment with respect to medication use. The components provide a framework for the continuous quality improvement of the process. The components followed in the plan are listed below as key elements ... G. Medication orders are written clearly and transcribed accurately. H. All medication orders are reviewed for appropriateness."

2. Review of the hospital's Medication Error Reduction Plan (MERP) documents from the year 2012 forward with the Director of Pharmacy (DPH 1) showed that the hospital had identified weakness on a monthly basis from its internally generated medication occurrence reports. Further review of the documents entitled "Performance Improvement Reporting Data for Medication Occurrences" for 2013, 2014 and 2015 revealed the exact same "Action Plan" which stated "Continued staff counseling and education at staff meeting and counseling on an individual basis. Medication errors module to be assigned to pharmacists and pharmacy technicians. Data to be submitted to Patient Safety Committee ..." However, there was neither documented evidence from the MERP confirming that the hospital had implemented specific corrective action to address weaknesses nor evidence of evaluation for their effectiveness.
On 8/20/15 at 10:45 A.M. when the DPH 1 was asked to provide documented evidence as to the specific corrective actions taken for addressing the weaknesses identified from the medication occurrence reports and the subsequent evaluation of their effectiveness, he then acknowledged there was none documented in the MERP. And he further agreed the hospital MERP should have been focusing more on using its internally generated medication occurrence reports to develop or implement correction action plan with input from all hospital committees involved.
Review of the hospital MERP entitled "Plan to Eliminate or Substantially Reduce Medication-Related Errors" date 10/2014 on page 13 under "XII Process", it read "MERP Revisions & Update 2013-2014 F. The Performance Improvement Committee will act as the initial guiding force for guidance of the MERP ...H. Assessment: Establish a baseline assessment and then periodically review the effectiveness of the plan to reduce medication-related errors. 4. Data collection becomes our baseline assessment and starting point for the assault on performance and quality improvement with patient safety in mind ...6. The process and plan of action is assessed continuously."
VIOLATION: QAPI PERFORMANCE IMPROVEMENT PROJECTS Tag No: A0297
Based on observation, interview and record review the hospital failed to initiate and conduct an infection control project in a manner that met the needs of the hospital staff and visiting public. The selection and implementation of a sanitizing product, which required the use of personal protective equipment (PPE), was initiated without the development or approval of policy and procedure for appropriate use. The product posed a potential risk for skin irritation when the appropriate PPE was not made available in the public areas where the product was provided for use.

Findings:

During a joint observation and interview on 8/17/15 at 9:30 A.M., the Hospital A's Emergency Department (ED) was toured with the Director of Nursing/Performance Improvement Director (DON/PID). A round shaped white colored metal bracket was observed attached to a wall in the waiting room of the ED. The observed bracket included a sign with the words "Not For Use On Skin" in red colored print. The observed bracket held an opened purple topped pop-up container of disposable sanitizing wipes. The container label included the instructions "not for use on skin...wear gloves", in small print. The container indicated that a 2 minute contact time was needed for product effectiveness. No disposable gloves were observed in the waiting room area. The DON/PID stated that the container of sanitizing wipes was intended for use on soiled surfaces in the ED waiting area and had been placed in the area "last flu season" by the Infection Control Preventionist (ICP). The DON/PID acknowledged that the sanitizing wipes were accessible to patients and visitors as well as hospital staff. The DON/PID acknowledged that PPE/disposable gloves were not available in the ED waiting area and that instructions for the use of the sanitizing wipes was not clearly posted.

During an observation and interview on 8/18/15 at 11:00 A.M., a public common hallway between Intensive Care Unit (ICU) North and ICU South was toured with the DON/DPI. The hallway included 2 wall mounted telephones which communicated into the respective ICUs. A round shaped white colored metal bracket was observed attached to the wall area near each of the telephones. The observed bracket included a sign with the words "Not For Use On Skin" in red colored print. Located above each bracket was another sign which included the words "Wipes are for Phone ONLY". The observed bracket held an opened purple topped container of disposable sanitizing wipes. The container label included the instructions "not for use on skin...wear gloves", in small print. The container indicated that a 2 minute contact time was needed for product effectiveness. No trash receptacles or disposable gloves were observed in the hallway area. The DON/PID stated that containers of sanitizing wipes had been placed in the area "last flu season" by the Infection Control Preventionist (ICP). The DON/PID acknowledged that the sanitizing wipes were accessible to patients and visitors as well as hospital staff. The DON/PID acknowledged that neither PPE/disposable gloves or a trash receptacle were available in the area and that instructions for the use of the sanitizing wipes was not clearly posted.

During a joint interview on 8/17/15 at 4:30 P.M., the Infection Control Perventionist (ICP) stated that the observed sanitizing wipes in the ED waiting and ICU hallway entrance areas were intended for sanitizing the telephone receivers. The ICP stated that she had implemented the telephone sanitizing practice "last Fall during flu season" and that the hospital had changed product vendors for the sanitizing wipes. The ICP stated that she had not developed a specific policy or procedure, or sought approval, for the use of the sanitizing wipes in the public areas of the hospital. The ICP stated that the observed sanitizing wipes were to be used with disposable gloves in order to avoid skin contact, which could cause skin irritation. The ICP acknowledged that she had not noticed that PPE/disposable gloves were not available in the observed areas, where the sanitizing wipes were available for use. The DON/PID stated that the hospital had "a gap in the system."

A review of the facility policy and procedure entitled Infection Control Program, approved "February 2014", included "Departmental policies and procedures for infection control will reviewed and/or revised as an ongoing practice...The Infection Control Program at this Hospital incorporates the following in a continuing cycle...Select and implement the best techniques to minimize adverse outcomes...Evaluate and monitor the results and revise techniques as needed. "

A review of the ICP job description summary included "Develops, reviews, revises and coordinates the implementation of all organization-wide policies and procedures related to infection prevention/control....Participates in the evaluation of products and equipment from the infection control and patient safety standpoint."

During a hospital leadership meeting on 8/19/15 at 2:00 P.M., the DON/DPI stated that hospital products and/or infection control practices "should be monitored monthly by the Environment of Care Committee", which included the participation of the ICP. In addition, the DON/DPI stated that the implementation of the new products and practices should have been identified and monitored by the ICP and the Environment of Care (EOC) committee. The DON/PDI acknowledged that implementation and surveillance had not occurred as expected. The DON/PID stated that there was "no excuse" for the absence of education and PPE for the public use of the observed sanitizing wipes.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on observation, interview and record review the hospital failed to ensure that Registered Nurses (RNs) at Hospital A clarified duplicate and/or incomplete orders for pain medications for 3 of 35 sampled patients (1, 11, 12). Failure to clarify duplicate or incomplete medication orders had the potential to result in increased variability and risk of harm to patients from a medication error or adverse reaction.

Findings:

1. On 8/17/15 at 2:00 P.M., a tour and observation of the Post Anesthesia Care Unit (PACU) was conducted with the Chief Nurse Officer (CNO) and Administrator (Admin.).

Patient 1 was observed laying on the gurney in the PACU. Patient 1 was admitted to the PACU following a cervical discectomy with fusion procedure (a surgical procedure in the neck area of the spine).

A review of the post operative pain medication orders was conducted with the CNO. A written order for hydromorphone (a narcotic pain reliever) 0.2 milligrams (mg.) every 10 minutes as needed for a pain level of 4-6 (moderate pain) for a maximum dose of 2.0 mg. was prescribed by Certified Registered Nurse Anesthetist (CRNA) 1. CRNA 1 also prescribed Fentanyl (powerful sedative and pain medication) 50 micrograms (mcg.) for a pain level of 4-6 (moderate pain) for a maximum dose of 100 mcg. There was no prioritization directions given as to which pain medication should be administered to Patient 1 first for a moderate level of pain.

On 8/17/15 at 2:15 P.M., an interview was conducted with Registered Nurse (RN) 1 who was assigned to Patient 1. RN 1 stated she would likely choose to administer the Fentanyl first to Patient 1, since it was shorter acting than Dilaudid, in case there were any respiratory problems. RN 1 stated she relied on her nursing experience and her own judgment to determine which drug to administer first.

A review of the hospital's policy and procedure entitled "Prescribing Medications", and last reviewed September 2014, was conducted. Per the policy, "a pharmacist to review all orders fro appropriateness and completeness. Medication orders are to be clear and accurate. According to the policy and procedure "Physician Orders Giving, Receiving, Authenticating", last reviewed October 2013, "Orders that are illegible or improperly written will not be carried out until rewritten or clarified and understood by the licensed or certified professional."

On 8/17/15 at 2:30 P.M., an interview was conducted with CRNA 2, the Director of Pharmacy (DOP), and the CNO. The DOP confirmed that a pharmacist was responsible for the review of all PACU medication orders prior to administration of the medications. CRNA 2 acknowledged that the duplication of orders for pain medication, as in the case of Patient 1, allowed for some variability in interpretation by RNs, based on experience and judgement. The CNO acknowledged that having an RN determine which drug to administer first to the patient, required the RN to practice outside of her professional scope of practice. The CNO confirmed that when an order is not prioritized, the RN should clarify with the prescriber, to decrease any variability and potential risk to the patient. The CNO acknowledged that the orders were incomplete and duplicate for Patient 1.






2. On 8/17/15 at 9:18 A.M., a tour and observation of the hospital's 10 bed intensive care unit (ICU - South) was conducted with the Nurse Director of Intensive Care Services (NDIC).

On 8/17/15 at 10:37 A.M., Patient 11 was observed awake and sitting up in bed receiving a breathing treatment.

Patient 11 was admitted to Hospital A on 8/12/15 with diagnoses that included acute renal failure (a sudden loss of kidney function) and gastrointestinal bleed (all forms of blood loss from the stomach and intestinal tract, from the mouth to the rectum) per the Facesheet, dated 8/12/15.

A review of Patient 11's medical record related to pain management was conducted on 8/18/15 at 3:20 P.M. A physician's order, dated 8/12/15 at 7:15 P.M., for tramadol (a narcotic pain reliever) 50 milligrams (mg) by mouth every 6 hours as needed for a pain level of 4-6 (moderate pain) was to be administered to Patient 11. A second physician's order, dated 8/12/15 at 6:15 P.M., for oxycodone/acetaminophen (both a narcotic and non-narcotic pain reliever, also known as Percocet) 5-325 mg (1 tablet) by mouth every 4 hours as needed for a pain level of 4-6 (moderate pain) was also to be given to Patient 11. There was no further direction from the physician as to which pain medication would be administered first to address Patient 11's moderate pain.

An interview and joint record review with RN 12 was conducted on 8/18/15 at 3:25 P.M. RN 12 was Patient 11's primary nurse. RN 12 stated that based on her discussions with Patient 11, tramadol was not an effective pain medication for him. RN 12 stated she would have administered Percocet to address Patient 11's moderate pain. She did acknowledge that there were two moderate pain medications ordered for Patient 1, which was considered a duplicate order. She stated that duplicate orders should be clarified with the physician prior to administration.

A review of the hospital's policy and procedure titled "Prescribing Medications", and last reviewed September 2014, was conducted. Per the policy, "a pharmacist to review all orders for appropriateness and completeness. Medication orders are to be clear and accurate. According to the policy and procedure "Physician Orders Giving, Receiving, Authenticating", last reviewed October 2013, "Orders that are illegible or improperly written will not be carried out until rewritten or clarified and understood by the licensed or certified professional."

An interview and joint record review with the NDIC was conducted on 8/18/15 at 3:33 P.M. The NDIC stated that duplicate pain medication orders should be clarified with the physician by the RN prior to the administration of the medication.

An interview with the Director of Pharmacy (DPH 1) on 8/20/15 at 11:49 A.M. DPH 1 stated that both the nursing and the pharmacy staff had a responsibility to ensure that medication orders were complete and not a duplicate. DPH 1 acknowledged that a duplicate order should have been clarified by the pharmacy staff during their review of all medication orders. DPH 1 also explained that duplicate orders needed to be clarified by the RN because the order did not give the RN the steps or directive that delineates which medication to administer for Patient 11's moderate pain.

3. On 8/20/15 at 8:27 A.M., a tour and observation of the Labor and Delivery (L&D) was conducted with the Nurse Director of Maternal Child (NDMC) and the charge nurse (RN 13).

On 8/20/15 at 10:23 A.M., Patient 12 was observed walking slowly towards the special care nursery with her spouse and an RN.

Patient 12 was admitted to Hospital A on 8/18/15 for the induction of labor (the initiation of childbirth by artificial means prior to its spontaneous onset with the goal of a vaginal delivery) per the History and Physical, dated 8/19/15.

A review of Patient 12's medical record was conducted with RN 13 on 8/20/15 at 10:25 A.M. A physician's order, dated 8/19/15 at 9:00 P.M., for ibuprofen (also known as Motrin, used to reduce fever and treat pain or inflammation) 600 milligrams (mg) by mouth every 6 hours as needed for pain. There was no pain scale listed with the medication order.

An interview and joint record review with RN 14 was conducted on 8/20/15 at 10:50 A.M. RN 14 stated that an indication to include a pain scale was a required element in a pain medication order. RN 14 stated that she should have clarified Patient 12's pain order with the physician because the order was incomplete without a pain scale.

A review of the hospital's policy and procedure titled "Prescribing Medications", and last reviewed September 2014, was conducted. Per the policy, "a pharmacist to review all orders for appropriateness and completeness. Medication orders are to be clear and accurate. According to the policy and procedure "Physician Orders Giving, Receiving, Authenticating", last reviewed October 2013, "Orders that are illegible or improperly written will not be carried out until rewritten or clarified and understood by the licensed or certified professional." The policy stipulated that the prescriber of the medication order should "... Provide the purpose of the medication when writing or giving the order."

An interview with the NDMC was conducted on 8/20/15 at 11:15 A.M. The NDMC stated that Patient 12's medication order for Motrin did not contain an indication with a pain scale for when the medication was to be administered. She stated that without the pain scale the pain medication order was not a complete order. The NDMC stated that the RN needed to clarify the medication order with the physician prior to the administration of medication.

An interview with the Director of Pharmacy (DPH 1) on 8/20/15 at 11:49 A.M. DPH 1 stated that Patient 12's medication order for pain was an incomplete order because the indication did not include the pain scale. DPH 1 stated that both the nursing and the pharmacy staff had a responsibility to ensure that all medication orders were complete.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on interviews and document reviews, the hospital failed to ensure the provision of pharmaceutical services and care that meets the needs of the patients when:


1. The hospital failed to ensure it reviewed sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) procedures to correct the failure of 8, out of 11, pharmacy technicians tested for gloved fingertip competency (test for putting on sterile (germ free) gloves and gowns required for compounding IV medications). Prior to 3/25/15 the hospital did not test for gloved fingertip competency. Between 3/25/15 to 4/3/15 the hospital tested 11 pharmacy technicians for gloved fingertip competency. The test results showed eight pharmacy technicians failed the competency test. The hospital did not review hand hygiene (cleaning) and garbing (dressing) procedures as well as glove and surface disinfection procedures and work practices. These failures resulted in the potential, from 1/1/15 to 8/18/15, for 7,301 patients to be exposed to preventable infections from 4,322 contaminated medication (A 501 #1).
2. The hospital failed to ensure the intravenous (IV, directly into a vein) sterile (germ free) compounding (mixing) area was free of dust, stains, and foreign (black & brown) material. Dust, stains, and foreign material, were present on surfaces in the ante (area to prepare for mixing IVs) and buffer (area for mixing IVs) rooms. These failures resulted in the potential, from 1/1/15 to 8/18/15, for 7,301 patients to be exposed to preventable infections from 4,322 contaminated medications. (A 501 #2)
3. The hospital failed to ensure an air pressure gauge was installed between the buffer (area to mix sterile (germ free) intravenous (IV, directly into a vein) medications) and the ante-area (area to prepare for mixing IVs). The hospital did not install an air pressure gauge to monitor the pressure differential (difference) between the buffer and the ante-area. This failure resulted in the potential, from 1/1/15 to 8/18/15, for 7,301 patients to be exposed to preventable infections from 4,322 contaminated medications. (A 501 #3)
4. The hospital failed to ensure air pressure differentials (differences) between the buffer room (area to mix sterile (germ free) intravenous (IV, directly into a vein), ante-room (area to prepare to mix IVs), and general pharmacy, were documented on a log at least every work shift. The hospital did not maintain a log of air pressure differentials between the buffer room, ante-room, and general pharmacy. These failures resulted in the potential, from 1/1/15 to 8/18/15, for 7,301 patients to be exposed to preventable infections from 4,322 contaminated medications. (A 501 #4)

5. Duplicate or incomplete medication orders, which had the potential to result in increased variability and risk of harm to patients from a medication error or adverse reaction, were not clarified by nurses. (A 405 #s 1, 2, 3)

6. The hospital failed to ensure medication orders with the same pain scale were reviewed for therapeutic duplication. This failure had the potential to place the patient at risk for overdose on narcotic pain medications.
(A 500)

7. The hospital failed to ensure safe and proper use of a single dose medication vial. This failure could result in the loss of integrity of the medication and potentially harm patients by not providing the expected therapeutic effect. (A 505 #1)
8. The hospital failed to ensure potentially deteriorated medication was not available for patient use in the hospital and stored in accordance with the manufacturer's stipulations. This failure could place patients at risk for treatment failure during episodes of angina (chest pain). (A 505 #2)
9. The hospital failed to ensure outdated medication was removed from one area in the hospital. This failure may result in ineffective medication administered to patient. (A 505 #3)
10. The hospital failed to ensure medication was available for potential medical emergency in the operating room. This failure could contribute to increased risk for adverse outcomes for patients during medical emergencies. (A 951)



The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Pharmaceutical Services.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on interview and record review, the hospital failed to ensure medication orders with the same pain scale were reviewed for therapeutic duplication for one patient. This failure has the potential to place patient at risk for overdose on narcotic pain medications.
Finding:
On 8/18/15 starting at 9:40 A.M, reconciliation of medication order was conducted after the morning medication pass observation with the charged nurse (RN 51) of the medical surgical unit and the Director of Pharmacy (DPH 1). Review of the clinical record for Patient 51 showed that she was prescribed two similar narcotic pain medications by her physician for mild pain with the exact same pain scale (the 0 to 10 numeric pain distress scale; "0" represents "no pain" and "10" represents the most severe pain the patient has experienced) of 1 to 3. The two active narcotic pain medications for Patient 51 were written as followed:
a. Acetaminophen with codeine 300-30 milligrams (mg) tablet: give 2 tablets by mouth every 4 hours as needed for mild pain (1 to 3).
b. Hydrocodone with acetaminophen 5-325 milligrams (mg): give 1 tablet by mouth every 4 hours as needed for mild pain (1 to 3).
However, further review of Patient 51's clinical record did not show there was no clear instruction to the nurse regarding the use of which pain medications for administration to the patient with mild pain.
When the Charged Nurse (RN 51) was asked which of the two pain medications would be administered to Patient 51 when there was documented mild pain, she acknowledged either of the pain medication could potentially be administered. In the interview with the DPH 1 on 8/18/15 at 9:55 A.M., he agreed the orders were written ambiguously and acknowledged the pharmacist reviewing the pain medication orders should have identified and clarified both orders for potential duplicative therapy.
Review of the hospital policy entitled "Dispensing of Medications" dated 9/2014 on page 1under "Key Elements", it read "B. The pharmacist will check the patient's diagnoses in relationship to the medications ordered. If there are any questions regarding the appropriateness of the medication ordered, the pharmacist will contact the prescribing physician. C. Any ambiguity in a prescriber's order will be clarified by the pharmacist prior to entry of the order into the patient's electronic medication profile, or verifying the physician's order in POM. Ambiguities may include questions about dosage, therapeutic duplication
VIOLATION: PHARMACIST SUPERVISION OF SERVICES Tag No: A0501
Based on observation, interview, and record review, the hospital failed to ensure pharmaceutical sterile (germ free) compounding (mixing) services were provided in a safe manner as evidenced by:

1. Based on observation, interview, and record review, the hospital failed to ensure it reviewed sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) procedures to correct the failure of 8, out of 11, pharmacy technicians tested for gloved fingertip competency (test for putting on sterile (germ free) gloves and gowns required for compounding IV medications). Prior to 3/25/15 the hospital did not test for gloved fingertip competency. Between 3/25/15 to 4/3/15 the hospital tested 11 pharmacy technicians for gloved fingertip competency. The test results showed eight pharmacy technicians failed the competency test. The hospital did not review hand hygiene (cleaning) and garbing (dressing) procedures as well as glove and surface disinfection procedures and work practices. These failures resulted in the potential, from 1/1/15 to 8/18/15, for 7,301 patients to be exposed to preventable infections from 4,322 contaminated medications.

2. Based on observation, interview, and record review, the hospital failed to ensure the intravenous (IV, directly into a vein) sterile (germ free) compounding (mixing) area was free of dust, stains, and foreign (black & brown) material. Dust, stains, and foreign material, were present on surfaces in the ante (area to prepare for mixing IVs) and buffer (area for mixing IVs) rooms. These failures resulted in the potential, from 1/1/15 to 8/18/15, for 7,301 patients to be exposed to preventable infections from 4,322 contaminated medications.

3. Based on observation, interview, and record review, the hospital failed to ensure an air pressure gauge was installed between the buffer (area to mix sterile (germ free) intravenous (IV, directly into a vein) medications) and the ante-area (area to prepare for mixing IVs). The hospital did not install an air pressure gauge to monitor the pressure differential (difference) between the buffer and the ante-area. This failure resulted in the potential, from 1/1/15 to 8/18/15, for 7,301 patients to be exposed to preventable infections from 4,322 contaminated medications.

4. Based on observation, interview, and record review, the hospital failed to ensure air pressure differentials (differences) between the buffer room (area to mix sterile (germ free) intravenous (IV, directly into a vein), ante-room (area to prepare to mix IVs), and general pharmacy, were documented on a log at least every work shift. The hospital did not maintain a log of air pressure differentials between the buffer room, ante-room, and general pharmacy. These failures resulted in the potential, from 1/1/15 to 8/18/15, for 7,301 patients to be exposed to preventable infections from 4,322 contaminated medications.

Findings:

1. During a concurrent tour and interview, on 8/17/15 at 9:55 A.M., in Hospital A's pharmacy, Director of Pharmacy (DPH 1) identified the IV sterile compounding area. Inspection of the area showed that it consisted of two rooms. The ISO Class 8 (measurement of particles in the air, lower number equals fewer particles) ante-room (area to prepare for mixing IVs) was separated from the pharmacy by walls and a door. Continued inspection showed a room pressure monitoring gauge mounted on the wall between the ante-room and the general pharmacy. Further inspection showed the ante-room was separated from the buffer room (room to mix IVs) by walls and a door. Further inspection showed the buffer room contained two IV hoods (device to maintain a clean are for mixing IVs).

During a concurrent tour and interview, on 8/17/15 at 10:45 A.M., in Hospital A's pharmacy IV sterile compounding ISO Class 7 buffer room, Pharmacy Technician (Pharm Tech 1) identified an IV hood and a medication refrigerator. DPH 1 was asked to describe the types of IVs mixed in the buffer room. DPH 1's description included low (low risk of bacterial contamination) and medium (medium risk of bacterial contamination (Total Parenteral Nutrition (TPN, IV food))) risk level medications.

During a concurrent observation, interview, and record review, on 8/18/15 at 2:45 pm, in Hospital A's pharmacy, DPH 1 identified a refrigerator. Inspection of the refrigerator showed an IV medication. Inspection of the medication label showed Penicillin G Potassium (antibiotic) 3 million units, date prepared: 8/17/15, expires 8/23/15 (6 days), refrigerate. Pharm Tech 1 was asked to describe how the hospital determined the expiration (beyond use date) for the medication. Pharm Tech 1 identified, on the ante-room wall, a document titled Pharmacy Compounding USP 797 Risk Level Assessment.

During a concurrent interview and administrative record review, on 8/18/15 at 2:58 pm, DPH 1 and Pharm Tech 1 were asked to describe the quality assurance processes for the IV sterile compounding area. Pharm Tech 1's description included, on 4/1/15, the hospital started testing all compounding staff for an initial gloved fingertip/thumb competency. DPH 1 and Pharm Tech 1 reviewed the quality assurance culture results and stated that 8 out of 11 staff failed the 4/1/15 test. DPH 1 was asked to describe the hospital's corrective action plan to improve the test results. DPH 1 stated that the hospital did not have a documented corrective action plan. DPH 1 stated the testing results had not been reported to the pharmacy and therapeutics (P and T, manages medication use in the hospital). DPH 1 acknowledged the testing results should have been reported to P and T.

During a concurrent interview and administrative record review, on 8/19/15 at 8:20 am, DPH 1 identified the TPN monitoring forms. Review of the forms, from 1/1/15 to 8/18/15, showed Hospital A mixed 34 bags of TPN.

During a concurrent interview and administrative record review, on 8/19/15 at 8:35 am, DPH 1 identified the non-premixed IV orders YTD (1/1/15-8/18/15) report. DPH 1 reviewed a 50 page sample of the 1,070 page report. DPH 1 stated the 50 page sample of the report documented Hospital A mixed 202 IV medications. Based upon a sample of 50 pages, of the 1,070 page report, the hospital mixed 4,288 IVs.

During a concurrent interview and administrative record review, on 8/19/15 9:07 am, DPH 1 identified the Period Inpatient Location Statistics report (patient census). DPH 1 reviewed the report and stated Hospital A admitted 7,301 patients from 1/1/15-8/18/15.

An administrative record review, of quality assurance culture, collected 3/25/15-4/3/15, for Pharmacy Technicians (1-11) showed finger tip analysis was taken for left and right hands. Continued review showed eight Pharmacy Technicians (1, 3, 4, 5, 6, 7, 9, and 11) tested positive for bacteria growth.

An administrative record review, of the hospital's policy and procedure for IV Admixture & Sterile Products Aseptic Technique (Approval: P&T October 2014) showed, Key Elements, B.1 "Both the Clean Room and the Gown Room, comprising the IV Preparation area, comply with the California State Board of Pharmacy (USP) 797 Regulations." The hospital references USP <797> in the IV Admixture & Sterile Products Aseptic Technique policy and procedure.

An administrative record review, of the Pharmacy Compounding USP 797 Risk Level Assessment, Beyond Use Dating, showed, "Low-Risk Compounding Requirements...Prepared in ISO Class 5 laminar flow hood...Located in ISO Class 8 Clean Room with Ante Room." The hospital references USP <797> in determining beyond use dating (expiration dating).

The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines...USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP 35/NF 30). The USP revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from (1) microbial contamination (nonsterility), (2) excessive bacterial toxins..." If a hospital puts all the practice and quality standards into place as described in USP <797>, the hospital can assign beyond use dates (date beyond which an IV product cannot be started) to compounded IV products as described in USP <797>.

An administrative record review, of the USP <797> Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 50) showed Competency Evaluation of Garbing and Aseptic Work Practice, "The risk of contaminating a CSP (compounded sterile IV) prepared under low-risk level and medium-risk level conditions is highly dependent on proper hand hygiene and garbing practices..." Continued review showed, "Gloved Fingertip Sampling-All compounding personnel shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure (zero cfu) no less than three times before initially being allowed to compound CSPs for human use...After completing the initial gowning and gloving competency evaluation, re-evaluation of all compounding personnel for this competency shall occur at least annually for personnel who compound low- and medium-risk level CSPs...before they are allowed to continue compounding CSPs for human use." The hospital first started testing for gloved fingertip sampling between 3/25-4/3/15. The data showed 8 out of 11 pharmacy technicians failed the test.

An administrative record review, of the USP <797> Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 50) showed Personnel Training and Competency Evaluation of Garbing, Aseptic Work Practices, and Cleaning/Disinfection Procedures, "Personnel who prepare CSPs shall be trained conscientiously and skillfully by expert personnel and through multimedia instruction sources and professional publications in the theoretical principles and practical skills of garbing procedures, aseptic work practices, achieving and maintaining ISO Class 5 (see Table 1) environmental conditions, and cleaning and disinfection procedures...In the event that cleaning and disinfection procedures are also performed by other support personnel (e.g., intuitional environmental services, housekeeping), thorough training of proper hand hygiene, garbing, and cleaning and disinfection procedures shall be done by a qualified aseptic compounding expert. After completion of training, support personnel shall routinely undergo performance evaluation of proper hand hygiene, garbing, and all applicable cleaning and disinfecting procedures conducted by a qualified aseptic compounding expert." The hospital first started testing for gloved fingertip sampling between 3/25-4/3/15.

An administrative record review, of the USP <797> Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 53) showed, Action Levels, Documentation, and Data Evaluation, "The value of viable microbial monitoring of gloved fingertips and surfaces of components and the compounding environment are realized when the data are used to identify and correct an unacceptable work practice. Sampling data shall be collected and reviewed on a routine basis as a means of evaluating the overall control of the compounding environment..." Continued review showed, "Any cfu (bacteria) count that exceeds its respective action level (see Table 4) should prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures, and air filtration efficiency within the aseptic compounding location..." Further review showed, "When gloved fingertip sample results exceed action levels after proper incubation, a review of hand hygiene and garbing procedures as well as glove and surface disinfection procedures and work practices shall be performed and documented. Employee training may be required to correct the source of the problem." The hospital did not review hand hygiene and garbing procedures as well as glove and surface disinfection procedures and work practices after eight pharmacy technicians failed gloved fingertip sampling.

2. During a concurrent tour and interview, on 8/17/15 at 9:55 am, in Hospital A's pharmacy, Director of Pharmacy (DPH 1) identified the IV sterile compounding area. Inspection of the area showed that it consisted of two rooms. The ISO Class 8 (measurement of particles in the air, lower number equals fewer particles) ante-room was separated from the general pharmacy by walls and a door. Continued inspection showed a room pressure monitoring gauge on the wall between the ante-room and the general pharmacy. Further inspection showed the ante-room was separated from the ISO Class 7 buffer room by walls and a door. Further inspection showed the buffer room contained two IV hoods (device to maintain a clean work area for mixing IVs).

During a concurrent tour and interview, on 8/17/15 at 10:10 am, in Hospital A's pharmacy IV sterile compounding ante-room, Pharmacy Technician (Pharm Tech 1) was asked to describe the process for cleaning the walls and ceiling. Pharm Tech 1 stated the walls and ceiling were cleaned by housekeeping on an as needed schedule. Inspection of the shiny metal trim, separating the flooring from the wall, to the right of a yellow biohazard container, showed it was covered with a layer of black and brown material. The material wiped off on a paper towel. Inspection of the ceiling showed staining of the tiles and the support rails. Pharm Tech 1 acknowledged the metal trim was covered with a layer of black and brown material. Pharm Tech 1 acknowledged the ceiling tiles and support rails were stained.

During a concurrent tour and interview, on 8/17/15 at 10:45 am, in Hospital A's pharmacy IV sterile compounding ISO Class 7 buffer room, Pharm Tech 1 identified an IV hood and a medication refrigerator. Inspection of the IV hood showed a layer of dust on the top metal surface. Inspection of the refrigerator showed a layer of dust on the top surface. Pharm Tech 1 inspected the areas described above and acknowledged they were covered with a layer of dust. DPH 1 was asked to describe the types of IVs mixed in the buffer room. DPH 1's description included low (low risk of bacterial contamination (antibiotics)) and medium (medium risk of bacterial contamination (Total Parenteral Nutrition (TPN, IV food))) risk level medications.

During a concurrent observation, interview, and record review, on 8/18/15 at 2:45 pm, in Hospital A's pharmacy, DPH 1 identified a pharmacy refrigerator. Inspection of the refrigerator showed an IV medication. Inspection of the medication label showed Penicillin G Potassium (antibiotic) 3 million units, date prepared: 8/17/15, expires 8/23/15 (6 days), refrigerate. Pharm Tech 1 was asked to describe how the hospital determined the expiration (beyond use date) for the medication. Pharm Tech 1 identified, on the ante-room wall, a document titled Pharmacy Compounding USP 797 Risk Level Assessment.

During a concurrent interview and administrative record review, on 8/19/15 at 8:20 am, DPH 1 identified the TPN monitoring forms. Review of the forms, from 1/1/15 to 8/18/15, showed Hospital A mixed 34 bags of TPN.

During a concurrent interview and administrative record review, on 8/19/15 at 8:35 am, DPH 1 identified the non-premixed IV orders YTD (1/1/15-8/18/15) report. DPH 1 reviewed a 50 page sample of the 1,070 page report. DPH 1 stated the 50 page sample of the report documented the hospital mixed 202 IV medications. Based upon a sample of 50 pages, of the 1,070 page report, Hospital A mixed 4,288 IVs.

During a concurrent interview and administrative record review, on 8/19/15 9:07 am, DPH 1 identified the Period Inpatient Location Statistics report (patient census). DPH 1 reviewed the report and stated Hospital A admitted 7,301 patients from 1/1/15-8/18/15.

An administrative record review, of the M and P Shift Technician Daily Activity Logs (January 2015-August 2015) did not document the cleaning of the ante-room walls and ceiling.

An administrative record review, of the hospital's policy and procedure for IV Admixture & Sterile Products Aseptic Technique (Approval: P&T October 2014) showed, Key Elements, B.1 "Both the Clean Room and the Gown Room, comprising the IV Preparation area, comply with the California State Board of Pharmacy (USP) 797 Regulations." The hospital references USP <797> in the IV Admixture & Sterile Products Aseptic Technique policy and procedure.

An administrative record review, of the Pharmacy Compounding USP 797 Risk Level Assessment, Beyond Use Dating, showed, "Low-Risk Compounding Requirements...Prepared in ISO Class 5 laminar flow hood...Located in ISO Class 8 Clean Room with Ante Room." The hospital references USP <797> in determining beyond use dating (expiration dating).

The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines...USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP 35/NF 30). The USP revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from (1) microbial contamination (nonsterility), (2) excessive bacterial toxins... " If a hospital puts all the practice and quality standards into place as described in USP <797>, the hospital can assign beyond use dates (date beyond which an IV product cannot be started) to compounded IV products as described in USP <797>.

An administrative record review, of the USP <797> Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 47) showed, Cleaning and Disinfecting the compounding Area, "Environmental contact is a major source of microbial contamination of CSPs (compounded sterile IVs). Consequently, scrupulous attention to cleaning and disinfecting the sterile compounding areas is required to minimize this as a source of CSP contamination." Continued review showed, "The cleaning and disinfecting practices and frequencies in this section apply to ISO Class 5 (see Table 1) compounding areas for exposure of critical sites as well as buffer areas, ante-areas...Compounding personnel are responsible for ensuring that the frequency of cleaning is in accordance with the requirements stated in Table 3. Continued review showed, "Work surfaces in the ISO Class 7(see Table1) buffer areas and ISO Class 8 (see Table 1) ante-areas as well as segregated compounding areas shall be cleaned and disinfected at least daily, and dust and debris shall be removed when necessary from storage sites for compounding ingredients and supplies..." Further review showed, "In the buffer or clean area, ante-area, and segregated compounding area, walls, ceilings, and shelving shall be cleaned and disinfected monthly." Hospital A's pharmacy IV sterile compounding area was not maintained clean and free of dust.

3. During a concurrent tour and interview, on 8/17/15 at 9:55 am, in Hospital A's pharmacy, Director of Pharmacy (DPH 1) identified the IV sterile compounding area. Inspection of the area showed that it consisted of two rooms. The ISO Class 8 (measurement of particles in the air, lower number equals fewer air particles) ante-room was separated from the general pharmacy by walls and a door. Continued inspection showed a room pressure monitoring gauge on the wall between the ante-room and the general pharmacy. Further inspection showed the ante-room was separated from the ISO Class 7 buffer room by walls and a door. Continued inspection did not show a pressure monitoring device in the ante-room. Further inspection showed the buffer room contained two IV hoods (device to maintain a clean work area for mixing IVs). Continued inspection did not show a pressure monitoring device in the buffer room.

During a concurrent tour and interview, on 8/17/15 at 10:30 am, in Hospital A's pharmacy IV sterile compounding ante-room, DPH 1 was asked to describe the process for monitoring the air pressure differential between the buffer room and ante-room. DPH 1 stated the hospital did not install a device to monitor the air pressure differential between the two rooms.

During a concurrent tour and interview, on 8/17/15 at 10:45 am, in Hospital A's pharmacy IV sterile compounding ISO Class 7 buffer room, Pharmacy Technician (Pharm Tech 1) identified an IV hood and a medication refrigerator. DPH 1 was asked to describe the types of IVs mixed in the buffer room. DPH 1's description included low (low risk of bacterial contamination (antibiotics)) and medium (medium risk of bacterial contamination (Total Parenteral Nutrition (TPN, IV food))) risk level medications.

During a concurrent observation, interview, and record review, on 8/18/15 at 2:45 pm, in Hospital A's pharmacy, DPH 1 identified a refrigerator. Inspection of the refrigerator showed an IV medication. Inspection of the medication label showed Penicillin G Potassium (antibiotic) 3 million units, date prepared: 8/17/15, expires 8/23/15 (6 days), refrigerate. Pharm Tech 1 was asked to describe how the hospital determined the expiration (beyond use date) for the medication. Pharm Tech 1 identified, on the ante-room wall, a document titled Pharmacy Compounding USP 797 Risk Level Assessment.

During a concurrent interview and administrative record review, on 8/19/15 at 8:20 am, DPH 1 identified the TPN monitoring forms. Review of the forms, from 1/1/15 to 8/18/15, showed Hospital A mixed 34 bags of TPN.

During a concurrent interview and administrative record review, on 8/19/15 at 8:35 am, DPH 1 identified the non-premixed IV orders YTD (1/1/15-8/18/15) report. DPH 1 reviewed a 50 page sample of the 1,070 page report. DPH 1 stated the 50 page sample of the report documented the hospital mixed 202 IV medications. Based upon a sample of 50 pages, of the 1,070 page report, Hospital A mixed 4,288 IVs.

During a concurrent interview and administrative record review, on 8/19/15 9:07 am, DPH 1 identified the Period Inpatient Location Statistics report (patient census). DPH 1 reviewed the report and stated Hospital A admitted 7,301 patients from 1/1/15-8/18/15.

An administrative record review, of the hospital's policy and procedure for IV Admixture & Sterile Products Aseptic Technique (Approval: P&T October 2014) showed, Key Elements, B.1 "Both the Clean Room and the Gown Room, comprising the IV Preparation area, comply with the California State Board of Pharmacy (USP) 797 Regulations." The hospital references USP <797> in the IV Admixture & Sterile Products Aseptic Technique policy and procedure.

An administrative record review, of the Pharmacy Compounding USP 797 Risk Level Assessment, Beyond Use Dating, showed, "Low-Risk Compounding Requirements...Prepared in ISO Class 5 laminar flow hood...Located in ISO Class 8 Clean Room with Ante Room." The hospital references USP <797> in determining beyond use dating (expiration dating).

The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines...USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP 35/NF 30). The USP revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from (1) microbial contamination (nonsterility), (2) excessive bacterial toxins..." If a hospital puts all the practice and quality standards into place as described in USP <797>, the hospital can assign beyond use dates (date beyond which an IV product cannot be started) to compounded IV products as described in USP <797>.

An administrative record review, of the USP <797> Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 45) showed Pressure Differential Monitoring, A pressure gauge or velocity meter shall be installed to monitor the pressure differential or airflow between the buffer area and the ante-area and between the ante-area and the general environment outside the compounding area. The results shall be reviewed and documented on a log at least every work shift (minimum frequency shall be a least daily) or by a continuous recording device. The pressure between the ISO Class 7 (see Table 1) and the general pharmacy area shall not be less than 5 Pa (0.02 inch water column)." The hospital did not install a pressure gauge to monitor the pressure differential between the buffer area and the ante-area.

An administrative record review, of the USP <797> Guidebook to Pharmaceutical Compounding-Sterile Preparations (CSP) (2008, pg. 33) showed, Low-Risk Level CSPs with 12-Hour or Less BUD, "If the PEC (hood)...is a laminar airflow workbench (LAFW)...that cannot be located within an ISO Class 7 (see Table 1) buffer area, then only low-risk level nonhazardous and radiopharmaceutical CSPs pursuant to a physician's order for a specific patient may be prepared, and administration of such CSPs shall commence within 12 hours of preparation..."

4. During a concurrent tour and interview, on 8/17/15 at 9:55 am, in Hospital A's pharmacy, Director of Pharmacy (DPH 1) identified the IV sterile compounding area. Inspection of the area showed that it consisted of two rooms. The ISO Class 8 (measurement of particles in the air, lower number equals fewer air particles) ante-room was separated from the general pharmacy by walls and a door. Continued inspection showed a room pressure monitoring gauge on the wall between the ante-room and the general pharmacy. Further inspection showed the ante-room was separated from the ISO Class 7 buffer room by walls and a door. Further inspection showed the buffer room contained two IV hoods.

During a concurrent tour and interview, on 8/17/15 at 10:30 am, in Hospital A's pharmacy IV sterile compounding ante-room, DPH 1 was asked to describe the process for monitoring the air pressure differential between the buffer room and ante-room. DPH 1 stated the hospital did not install a device to monitor the air pressure differential between the two rooms

During a concurrent tour and interview, on 8/17/15 at 10:45 am, in Hospital A's pharmacy IV sterile compounding ISO Class 7 buffer room, Pharmacy Technician (Pharm Tech 1) identified an IV hood and a medication refrigerator. DPH 1 was asked to describe the types of IVs mixed in the buffer room. DPH 1 description included low (low risk of bacterial contamination (antibiotic)) and medium (medium risk of bacterial contamination (Total Parenteral Nutrition (TPN, IV food))) risk level medications.

During a concurrent observation, interview, and record review, on 8/18/15 at 2:45 pm, in Hospital A's pharmacy, DPH 1 identified a refrigerator. Inspection of the refrigerator showed an IV medication. Inspection of the medication label showed Penicillin G Potassium (antibiotic) 3 million units, date prepared: 8/17/15, expires 8/23/15 (6 days), refrigerate. Pharm Tech 1 was asked to describe how the hospital determined the expiration (beyond use date) for the medication. Pharm Tech 1 identified, on the ante-room wall, a document titled Pharmacy Compounding USP 797 Risk Level Assessment.

During a concurrent interview and administrative record review, on 8/19/15 at 8:20 am, DPH 1 identified the TPN monitoring forms. Review of the forms, from 1/1/15 to 8/18/15, showed Hospital A mixed 34 bags of TPN.

During a concurrent interview and administrative record review, on 8/19/15 at 8:35 am, DPH 1 identified the non-premixed IV orders YTD (1/1/15-8/18/15) report. DPH 1 reviewed a 50 page sample of the 1,070 page report. DPH 1 stated the 50 page sample of the report documented Hospital A mixed 202 IV medications. Based upon a sample of 50 pages, of the 1,070 page report, the hospital mixed 4,288 IVs.

During a concurrent interview and administrative record review, on 8/19/15 9:07 am, DPH 1 identified the Period Inpatient Location Statistics report (patient census). DPH 1 reviewed the report and stated Hospital A admitted 7,301 patients from 1/1/15-8/18/15.

An administrative record review, of the hospital's policy and procedure for IV Admixture & Sterile Products Aseptic Technique (Approval: P&T October 2014) showed, Key Elements, B.1 "Both the Clean Room and the Gown Room, comprising the IV Preparation area, comply with the California State Board of Pharmacy (USP) 797 Regulations." The hospital references USP <797> in the IV Admixture & Sterile Products Aseptic Technique policy and procedure.

An administrative record review, of the Pharmacy Compounding USP 797 Risk Level Assessment, Beyond Use Dating, showed, "Low-Risk Compounding Requirements...Prepared in ISO Class 5 laminar flow hood...Located in ISO Class 8 Clean Room with Ante Room." The hospital references USP <797> in determining beyond use dating (expiration dating).

The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines...USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP 35/NF 30). The USP revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from (1) microbial contamination (nonsterility), (2) excessive bacterial toxins..." If a hospital puts all the practice and quality standards into place as described in USP <797>, the hospital can assign beyond use dates (date beyond which an IV product cannot be started) to compounded IV products as described in USP <797>.

An administrative record review, of the USP <797> Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 45) showed Pressure Differential Monitoring, A pressure gauge or velocity meter shall be installed to monitor the pressure differential or airflow between the buffer area and the ante-area and between the ante-area and the general environment outside the compounding area. The results shall be reviewed and documented on a log at least every work shift (minimum frequency shall be a least daily) or by a continuous recording device. The pressure between the ISO Class 7 (see Table 1) and the general pharmacy area shall not be less than 5 Pa (0.02 inch water column)." The hospital did not maintain a log of the pressure differentials between the buffer area and the ante-area and between the ante-area and the general environment outside the compounding area.
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, the hospital failed to ensure:
1. safe and proper use of a single dose medication vial. This failure could result in the loss of integrity of the medication and potentially harm patients by not providing the expected therapeutic effect.
2. potentially deteriorated medication was not available for patient use in the hospital and stored in accordance with the manufacturer's stipulations. This failure could place patients at risk for treatment failure during episodes of angina (chest pain).
3. outdated medication was removed from one area in the hospital. This failure may result in ineffective medication administered to patient.
Findings:
1. The hospital sterile compounding cleanroom in the inpatient pharmacy was visited on 8/17/15 with the Director of Pharmacy (DPH 1) and the pharmacy lead technician (Pharm Tech1) starting at 10:10 A.M. A single dose vial (SDV) of Octreotide acetate (an injectable medication to decrease the amount of growth hormone) 0.1 milligram (mg) per milliliter (ml) was found in the cleanroom refrigerator. The SDV was opened and resealed with a foil seal.
In the interview with the Pharm Tech1 at 10:45 A.M., she acknowledged the remainder of SDV should be discarded after opening, and the SDV was meant to be used for one patient only.
Review of the hospital Policy and Procedure entitled "Expiration Dates of Medications" dated on 10/2014 and on page 2 under the dosage forms section, it read "Single dose vials, ampules. As labeled; after syringe transfer for immediate patient use, discard remainder. The remaining contents of an unused medication will be disposed of using proper disposal procedures ..."

2. On 8/17/15 at 11:10 A.M., during an inspection of the medication stocked in hospital main pharmacy, about 10 bottles of intravenous (IV) Nitroglycerin (medication to treat episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels)) were stored exposed to light on top of a pharmacy shelf. The bottles did not have an expiration date other than the manufacturers ' and the Director of Pharmacy (DPH1) was unable to determine if the medication was deteriorated.
The manufacturer of nitroglycerin stipulates on its package insert (a document provided along with a prescription medication to provide additional information about that drug) under "How Supplied" section of the document, it read in part, "Exposure of pharmaceutical products to heat should be minimized ... Protect from light until time of use."
In an interview with DPH1 on 8/17/15 at 11:13 A.M., he confirmed the IV nitroglycerin bottles on the pharmacy shelf were not adequately protected from light after reading the medication label on one of the bottles.
Review of the hospital policy entitled "Medication Storage and Safety" dated 10/2014 on page 1 under Key Elements: it read "B.1 Light-sensitive medications will be stored and dispensed in an appropriate protective container and/or ultraviolet light inhibitive poly-bag."


3. Page 2 of the hospital policy and procedure entitled "Medication Storage and Safety" dated on 10/2014 and under the subheading "Key Elements" it read, "F. Medications will not be kept in stock after the expiration date on the label."
During an inspection visit to the radiology department of the hospital on [DATE] with Director of Pharmacy and the Radiology Manager (RAM 1) at 3:45 P.M., one 230 milliliters (ml) tube of Barium Sulfate esophageal paste (contrast media that helps doctor examine the tube that connects the mouth and stomach) 40% W/V with expiration dates of July 2015 was found on top of an Omnicell machine (automatic medication dispensing cabinet) located in the medication room of the department.
In a concurrent interview with the RAM 1 at 4:00 P.M., he acknowledged the medication should have been removed from the area and placed in the pharmacy return container.
VIOLATION: SAFETY FOR PATIENTS AND PERSONNEL Tag No: A0536
Based on observation, interview and document review, the hospital failed to develop and implement a policy and procedure that provided complete guidance for the storage, maintenance, and inspection of lead aprons and shields. Failure to properly store, maintain, and inspect lead aprons and shields did not ensure the integrity of those items in an effort to prevent unnecessary exposure to radiation.

Findings:

On 8/17/15 at 9:50 A.M., a tour and observations of the Operating Room (OR) were conducted with the Chief Nursing Officer (CNO), the Infection Control Preventionist (ICP), the Administrator (Admin.) and the OR Charge Nurse (CN).

A rack of lead aprons and shields was observed in a supply room. Two of the aprons were folded and laying on the floor, and several others were folded and were laid across the rack. The remainder of the aprons were hung on arms of the rack. Some of the aprons and shields were marked with an identification number or had a separate identification tag attached, and others were not.

Another rack of aprons and shields was observed in the main hallway of the OR. That rack also had unmarked aprons and shields and some were folded and laid across the rack.

On 8/17/15 at 11:30 A.M., an interview was conducted with the Radiology Manager (RM). Per the RM, the lead aprons and shields were not supposed to be folded, as that practice could cause cracks in the protective lead and cause unnecessary radiation exposure. The RM stated that the aprons and shields should be hung on one of the arms of the rack. The RM also acknowledged that the lead aprons and shields were not consistently tagged or marked which would prevent an accurate accounting of the those shields for inspection purposes and quality control. According to the OR CN, radiology staff were responsible for the lead aprons and shields that were in the OR. However, per the CNO, it was a joint effort between OR and radiology staff to ensure that the lead aprons and shields were stored properly. The annual inspection of the aprons and shields was the responsibility of the radiology staff, per the RM.

A review of the hospital's policy entitled "Safety Inspection of Lead Shields", and last reviewed on October 2014, was conducted with the RM. The policy provided guidance related to the annual inspection of the shields and maintenance of an inventory log book regarding those inspections only. The policy did not address the proper storage of the shields and assign responsibility for the tasks.

On 8/17/15 at 11:40 A.M., the RM and CNO acknowledged that the policy did not provide adequate guidance and directions pertaining to the storage and maintenance of the lead aprons and shields.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observation, interview, and record review, the hospital failed to ensure that the special care nursery, Operating Room (OR), and the Emergency Department (ED) were maintained to ensure an acceptable level of cleanliness, safety and quality. A layer of dust and dirt was found in the special care nursery. Failure to ensure the special care nursery was clean and free from an accumulation of dust and dirt had the potential to negatively affect all patients. Per the Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN - a professional organization), neonates with their immature (underdeveloped) immune system had an increase risk or predisposition to infections.

In addition, the hospital failed to ensure that the special care nursery was equipped and stocked with necessary supplies to care for their newborn population. Several endotracheal tubes (a flexible plastic tube placed in the mouth and down into the trachea to provide an airway) in various sizes were found in discolored packaging commingled with ready to use newborn supplies in the special care nursery supply cabinet. Several arterial blood gas syringes (a syringe used to test blood from an artery, a blood gas analysis) were found expired and accessible for use in the special care nursery supply cabinet.

The availability and accessibility of expired nursery supplies and/or supplies in discolored packaging, had the potential to negatively impact all newborn patients with underdeveloped immune systems. This failure posed a risk of product failure or contamination to a fragile patient population.

Findings:

1. On 8/20/15 at 8:45 A.M., a tour of the hospital's special care nursery was conducted with the Nurse Director of Maternal Child (NDMC) and the Nurse Director of Intensive Care Services (NDIC). The special care nursery supply cabinet was inspected. The top row of individual compartments were pulled. A visible layer of dust and dirt was noted at the base of the compartments.

An interview with Registered Nurse (RN 11) was conducted on 8/20/15 at 8:56 A.M. RN 11 stated that the nursery nurses were responsible for the stocking and cleanliness of the nursery. She stated that she had been working the dayshift (7:00 A.M. to 7:30 P.M.) for the past 6 months and could not recall seeing the Infection Control Preventionist (ICP) in the nursery.

An interview with the Environmental Services Manager (EVSM) was conducted on 8/20/15 at 9:10 A.M. The ESM stated that EVS staff were responsible for "high dust" cleaning which entailed the cleaning of high surfaces. She pointed to the top of the nursery supply cabinet as an area that EVS staff would have been responsible for cleaning.

An interview with the NDMC was conducted on 8/20/15 at 9:18 A.M. The NDMC stated that infection control was the responsibility of everyone. She stated that there should not be any dust in the nursery. She stated that the nursery nurses were responsible for checking equipment, supplies and ensuring that the nursery was clean. She stated that the special care nursery did not have a formal process in place for checking supplies and ensuring the cleanliness of the unit.

A review of the Environment of Care (EOC) Safety Inspections 2015 schedule was conducted on 8/20/15. Per the EOC Safety Inspection schedule, the special care nursery was inspected in 2/2015 by Group A. Group A consisted of the Director of Plant Operations (DPO), the Public Safety Manager (PSM), and the Emergency Preparedness Manager (EPM). There was no documented evidence to demonstrate that the ICP had conducted an inspection of the special care nursery in 2015.

A telephone interview was conducted with the DPO on 8/20/15 at 2:40 P.M. The DPO confirmed that the last time an EOC inspection was conducted in the special care nursery was in 2/2015. He stated that the ICP did not participate in the inspection of the special care nursery. He explained that their inspection was limited to ensuring that hand sanitizers were available, general cleanliness, and the proper use of personal protective equipment. He stated that the special care nursery was due for an inspection this month (8/2015).

2. On 8/20/15 at 8:45 A.M., a tour of the hospital's special care nursery was conducted with the Nurse Director of Maternal Child (NDMC) and Nurse Director of Intensive Care Services (NDIC). The special care nursery supply cabinet was inspected. Six arterial blood gas syringes were found with an expiration date of 5/2015. There were six 3.0 French endotracheal tubes, five 3.5 French endotrachial tubes, and four 4.0 French endotracheal tubes that were found in discolored packaging.

An interview with Registered Nurse (RN 11) was conducted on 8/20/15 at 8:56 A.M. RN 11 stated that there should not be any expired or opened nursery supplies in the special care nursery supply cabinet. She stated that nursery supplies found in discolored packaging should have been removed and discarded. She stated that the nursery nurses were responsible for checking their supplies to ensure that they were stocked and that there were no expired or opened items accessible for use. She stated that the last time the nursery was restocked was 2 months ago. She also stated that there was no schedule in place to demonstrate how often supplies were checked.

An interview with the NDMC was conducted on 8/20/15 at 9:18 A.M. The NDMC stated that infection control was the responsibility of everyone. She stated that there should not be any dust in the nursery. She stated that the nursery nurses were responsible for checking equipment, supplies and ensuring that the nursery was clean. She stated that the special care nursery did not have a formal process in place for checking supplies and ensuring the cleanliness of the unit. She acknowledged that expired items and supplies in discolored packaging found in the special care nursery supply cabinet should have been removed and discarded.






3. During a concurrent tour and interview, on 8/17/15 at 2:45 P.M., in Hospital A's operating room, Certified Registered Nurse Anesthetist (CRNA 2) identified a supply cabinet. Inspection of the cabinet showed a thin layer of dust covered the top glass surface. CRNA 2 inspected the top of the cabinet and acknowledged it was covered with a thin layer of dust. CRNA 2 stated the top of the cabinet was not cleaned to meet the hospital's expectation.

During a concurrent tour and interview, on 8/17/15 at 2:50 P.M., in Hospital A's operating room, at the nursing station, a ceiling panel was identified. Inspection of the ceiling panel showed a stain covered half of it. A quarter of the stain was colored red brown. Registered Nurse 41 and Registered Nurse 42 inspected the ceiling panel and acknowledged it was stained.

During an observation, on 8/18/15 at 11:00 A.M., in Hospital A's emergency department, outside room 1, an air intake vent was identified. Inspection of the vent showed it was covered with a black material. Inspection of the ceiling tiles, next to the vent, showed they were covered with a black material.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observations, interviews, record and document review, the hospital failed to ensure that their infection control program was systematically and consistently implemented as evidenced by:

1. The hospital failed to ensure pharmaceutical sterile (germ free) compounding (mixing) services were provided in a safe manner to prevent infections. (A 501 #s 1, 2, 3, 4)

2. Failure to ensure that the physician designated as Chairperson for the Infection Control Committee and, who was not an infectious disease physician or specialist, was qualified through ongoing education, training, experience, or certification to oversee the infection control program.
(A 748 & A 756)

3. Failure to provide documented evidence that the Infection Control Preventionist (ICP) consistently and systematically implemented the hospital's Infection Control Program, policies and procedures, in accordance with her job description and established goals and plans. In addition, documentation, related to the ICPs 2015 surveillance and auditing results in the Operating Room, (OR) was falsified in an attempt to show that the ICPs surveillance practices were current. (A 749 #s 1, 2, 6 )

4. Operating Room and Endoscopy Staff did not wear, and one physician refused to wear, personal protective equipment (PPE) per hospital policy and procedure (A 749 #s 1, 12)

5. Methicillin-resistant Staphylococcus aureus (Bacteria resistant to some antibiotics- MRSA) swab testing was not conducted for two sampled patients who met positive MRSA screening criteria. (A 749 #s 9, 10)
6. Hospital and contracted dialysis staff were unable to verbalize appropriate Personal Protective Equipment (PPE) to be worn when caring for patients undergoing hemodialysis. (A 749 # 7a)
7. A lack of documented evidence to demonstrate that consistent routine infection control surveillance was conducted by the Infection Control Preventionist in numerous hospital departments and patient care units to include pharmacy, OR, telemetry, nursery, rehab since 1/2015. (A 749 #s 1, 2, 7b, 8, 12)
8. Areas in the Emergency Department, OR, and newborn nursery were visibly dirty and dusty. (A 724 # 1, 3 & A 749 #4)
9. Bins lined with red biohazard waste bags were observed in an open corridor. (A 749 #5)

10. Disposable sanitizing wipes, which required use with personal protective equipment (PPE) and specific contact time, were available for use in public areas without the availability of PPE or directions for proper use. (A 749 #3)
11. Sequential compression devices (SCDs) were reapplied onto one patient's legs after the SCDs were found on the floor. (A 749 #11)


The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Infection Control.
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and document review, the hospital failed to ensure that the physician designated as Chairperson for the Infection Control (IC)Committee and, who was not an infectious disease physician or specialist, was qualified through ongoing education, training, experience, or certification to oversee the infection control program. Failure to ensure that a professional, who was designated as an Infection Control leader in the hospital, received the required training and/or certification, had the potential to impact the overall effectiveness of the Infection Control Program, and it's policies and procedures.

Findings:

On 8/20/15 at 9:15 A.M., a review of Medical Doctor (MD)1's credentialing file was done with the Director of Medical Staff Credentialing (DMSC). Medical Doctor 1 was appointed as the Chairperson for the Infection Control Committee in January of 2014, per the DMSC. MD 1 was board certified in internal medicine. MD 1's board certification in cardiology expired on [DATE]. Per the DMSC, MD 1 was appointed as the Chairperson for the IC Committee in January of 2014 for a 2 year term. Per the DMSC, the Infection Control Preventionis (ICP) had also reminded MD 1 he was required to complete the specialized training in IC.

The ICP was unavailable for an interview.

A review of MD 1's credentialing file showed no training, education or certification related to infection control or infectious diseases. The DMSC stated that she was aware that there was State mandated continuing medical education training required for the IC Chairperson. She was aware that the required training was specific to infection surveillance, prevention, and control. The DMSC stated that she had sent reminder emails to MD 1 regarding the mandated training, but he consistently stated he was "busy". The DMSC confirmed that MD 1's term as the IC Committee Chairperson would end in January of 2016, or in 5 months, and he had not completed the required IC training.

According to the Medical Staff bylaws the duties of the IC Committee included but were not limited to: a) developing a hospital-wide infection control program and maintaining a surveillance over the program; b) developing a system for reporting, identifying, and analyzing the incidence and cause of nosocomial infections, including assignment of responsiblity for the ongoing collection and analytic review of such data, and follow-up activities; c) developing and implementing a preventative and corrective program designed to minimize infection hazards, including establishing, reviewing and evaluating aseptic, isolation and sanitation techniques; d) developing, reviewing and approving policies and procedures related to infection surveillance, prevention and control, including defining special indications for isolation requirements; e) reviewing sensitivities of organisms specific to the facility; and f) assisting in formulation of policies relative to hospital/employee health.

On 8/20/15 at 2:30 P.M., a telephone interview was conducted with MD 1. MD 1 confirmed he was a "interventional cardiologist." MD 1 acknowledged that he had not participated in the required IC training. MD 1 stated he took full responsibility for "putting it off."
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, record and document review, the hospital failed to provide documented evidence that the Infection Control Preventionist (ICP) consistently and systematically implemented the hospital's Infection Control (IC)Program, policies and procedures, in accordance with her job description and established goals and plans. Failure to consistently surveille IC practices and monitor compliance with hospital wide IC policies and procedures, and provide follow up on identified IC activities, had the potential to increase, rather than mitigate, the risk of healthcare-associated infections and disease transmission for all patients and staff. In addition, documentation, related to the ICPs 2015 surveillance and auditing results in the Operating Room, (OR) was falsified in an attempt to show that the ICPs surveillance practices were current. These findings were at Hospital A.

Findings:

1. On 8/17/15 at 9:50 A.M., a tour and observations of the Operating Room (OR) were conducted with the Chief Nursing Officer (CNO), the Infection Control Preventionist (ICP), the Administrator (Admin.) and the OR Charge Nurse (CN).

Gastrointestinal (pertaining to stomach and intestines) Technician (GT) 1 was observed cleaning an endoscope (an instrument used to examine the inside of the body and usually introduced via a natural opening such as the mouth or anus) in a supply room. GT 1 did not wear protective goggles or a face shield. GT 1 was cleaning the scope in an open container of clear fluid that was approximately 18 by 36 inches in size. Next to the container of clear fluid was a plastic jug marked "alcohol". Within approximately 2.5 feet of the open container of clear fluid were wrapped trays of instrument sets, per the package labels.

On 8/17/15 at 10:00 A.M. an interview was conducted with GT 1. GT 1 stated the open container contained water that he was cleaning the scope with. GT 1 confirmed that alcohol was also used in the process of cleaning and drying the scope. GT 1 stated he cleaned the scope in the supply room because the other area designated for cleaning was too small for all of the equipment. GT 1 acknowledged that he was required to wear protective eyewear such as goggles or a faceshield, but did not because they "fogged up" when he wore them.

Per GT 1's job description his primary responsibility was to assist the physician during invasive GI procedures. Per the job description he was responsible for the containment of contamination during and after procedures, to be in compliance with the IC manual, blood borne pathogens standards, Center for Disease Control Guidelines, and demonstrating appropriate use of personal protective equipment (PPE) which included the use of goggles.

On 8/17/15 at 10:20 A.M., an interview was conducted with the ICP. The ICP acknowledged that GT 1 was not wearing appropriate PPE. The ICP confirmed that the wrapped instrument trays, within 2.5 feet of where GT 1 was cleaning the scope, contained sterile instruments. The ICP acknowledged that the sterility of the wrapped instrument sets could become compromised if they became wet from any splashing from the open tray of water. The ICP also confirmed that the OR followed the Association of Operating Room Nurses (AORN) standards and practices.

On 8/17/15 at 11:00 A.M. an observation of OR 1 was conducted. Operating RoomTechnicians (ORT) 1 and 2 were dressed in sterile surgical gowns and gloves and were assisting in a surgical procedure. Neither ORT wore protective eye goggles or face shields. The OR CN and the ICP acknowledged that both ORTs did not implement the ORs IC policy and procedures.

Per the 2015 AORN standards, guidelines for perioperative practice, Recommendation XV, "sterilized materials should be labeled and stored in a manner to ensure sterility..." Recommendation XVa. " The shelf life of a packaged sterile item should be considered event-related. Events that may compromise the sterility of a package include: moisture penetration."

Per the 2015 AORN standards, guidelines for high level disinfection, Recommendation II a., "Appropriate PPE should be worn during cleaning and decontamination. PPE protects the worker from hazardous chemicals and exposure to blood and other potentially infectious materials."

Per the isopropyl alcohol Material Safety Data Sheet (MSDS), alcohol could cause serious eye irritation. Precautionary statements included: wear eye and face protection.

The hospital's policy and procedure entitled "Infection Control Operating Room", dated December 2012, was reviewed. Per the policy, "facial masks and protective eyewear will be worn with procedures potentially creating splash or aerosolozed secretions to the face or eyes of any staff."

On 8/17/15 at 11:15 A.M., an interview was conducted with the ICP. The ICP stated that she conducted random audits of the OR to ensure compliance with the hospital's IC policies and procedures and other related standards of practice for OR personnel. The ICP stated that her last audit in the OR was in March of 2015. A request was made to see evidence of surveillance in the OR by the ICP, and the random audit results.

On 8/18/15 at 8:50 A.M., an interview and review of the ICP's OR audit results for 2015 were reviewed with the ICP. The ICP presented 3 documents entitled "Checklist for Infection Prevention Observations in Surgery." They were dated 2/12/15, 4/19/15 and 5/4/15. The 2/12/15 and 4/19/15 audit sheets were not complete and areas to be surveilled were left blank. The audit form dated 5/4/15 showed that the number "15" which represented the year, was initially a "13" and it appeared as though the number 3 was altered to look like a number "5". The document listed the medical record number of the patient's surgical case that was audited. It also named the type of procedure which was a laparoscopic appendectomy (appendix removal) performed and audited on 5/4/15.

On 8/18/15 at 9:15 A.M. a review of the patient's medical record, who underwent a laparoscopic appendectomy and whose case was audited by the ICP on "5/4/15", was reviewed with the CNO. Per the Medical Record,, the patient underwent a laparoscopic appendectomy on 5/4/13, not 5/4/15, therefore, the audit could not have been performed in 2015 as documented by the ICP.

On 8/18/15 at 9:20 A.M. the Administrator and CNO were informed regarding the discrepancy concerning the OR audit results and the evidence presented by the ICP.

On 8/18/15 at 1:00 P.M. an interview was conducted with the Administrator and the CNO. Per the Administrator, the ICP acknowledged altering and falsifying the OR audit record to make it appear as though she was current in her surveillance of that department. She informed them that she had not performed any audits in the OR in 2015 and that "the year just got away from her." The ICP was immediately terminated by the facility and was no longer available during the survey.

A review of the ICPs job description was conducted on 8/19/15. Per the job description, the ICP was responsible to make routine facility rounds to evaluate compliance with infection control/prevention policies and procedures. Per the job description, the ICP was required to "conduct business in an ethical and trustworthy manner at all times when dealing with patient, visitors, physicians, and fell ow employees."

According to a document entitled "Infection Control Goals for 2015", dated March 2015, one of the specific goals for the ICP was surveillance of cleaning and sterilization of equipment used in radiology, OR and all sterile procedures." The ICP activity listed to accomplish that goal was "random monthly observation visits to Central Sterilization, OR, radiology, dietary, EVS (environmental services), and ER (emergency room ).

2. a. A review of the Infection Control Preventionist's (ICPs) job description was conducted on 8/19/15. Per the job description, the ICP was responsible to make routine facility rounds to evaluate compliance with infection control/prevention policies and procedures.

Per the Infection Control Program Plan, last reviewed in February 2014, The IC Management functions were delegated to the IC Practitioner/Infection Control Committee to investigate and follow-up on clinical issues.

According to a document entitled "Infection Control Goals for 2015", dated March 2015, one of the specific goals for the ICP was surveillance of cleaning and sterilization of equipment used in radiology, OR (Operating Room) and all sterile procedures." The ICP activity listed to accomplish that goal was "random monthly observation visits to Central Sterilization, OR, radiology, dietary, EVS (environmental services), and ER (emergency room ). Another establish goal was "implementation and coordination of all aspects of infection prevention and control plan for the hospital."

On 8/19/15 at 11:00 A.M. a review of the ICPs infection control inspection logs was conducted. Per the ICPs audit and inspection logs, the last documented audit dates of hospital departments and patient care units, by the ICP, were as follows: Intensive Care Unit (ICU) 3/2014; Cardiac Cath Lab 2/2014; 5 North (telemetry) 4/2014; 2 West (inpatient rehab) 3/2014; 6 North (Med-Surg) 3/2014; Sterile Processing 3/2014; endoscopy 3/2014, OR 7/2014. There was no evidence in the inspection log that the pharmacy had been inspected or audited by the ICP.
b. On 8/19/15 at 11:10 A.M. a review of the Governing Board Meeting Minutes dated October 27/2014 was conducted. Per the minutes, the annual Infection Control Surveillance Summary was presented. An IC risk assessment was completed in January of 2014. Per the assessment, the "biggest risk" was the patient population coming from Skilled Nursing Facilities (SNFs) with existing infections.

According to the 2015 IC Plan and Risk Assessment, approved by the Safety Committee, Leadership including Department Managers, Performance Improvement (PI), and the Medical Staff Director for IC, "Community Acquired Pneumonia" was identified and prioritized as the number 2 risk to the facility. The goal established to address that risk was "outreach to Skilled Nursing Facilities." Strategies and interventions included staff and community education by Infection Control. The method of evaluation included a "SNF log."

On 8/19/15 at 2:15 P.M., an interview was conducted with numerous leaders, department managers, the Medical Staff Director for IC (MSDIC), the Chief of Staff, the Director of Nurses (DON)/Performance Improvement Director (PID), the Administrator, and the Chief Nurse Officer. No one, including the MSDIC, the DON/PID, or the CNO, was able to verbalize or express knowledge of the "SNF log". The telemetry unit manager stated that the hospital had a "lunch" for the SNFs. There was no documented evidence of a SNF log, education, or other activities performed by IC to address community acquired pneumonia, as identified in the 2015 IC Plan and Risk Assessment.

A review of the PI Meeting Minutes dated 3/3/2015 and 6/30/2015 was conducted. There were no reports or follow up from IC concerning this hospital identified risk.

c. According to the DON/PID, he had oversight of the IC program since June 2015. Per the DON/PID, the ICP directly reported to him.

On 8/20/15 at 10:30 A.M., a list of patients who had undergone a surgical procedure since 12/14/2014 was reviewed with the DON/PID. Per the DON/PID, the ICP had used the list as a means to track surgical site infections and follow up as needed. Per the DON/PID the ICPs tracking system and documentation was incomplete and inconsistent, and it was difficult to determine what type of follow-up or secondary follow-up, if any, had been performed for some cases. According to the DON/PID, the ICP had also not met deadlines related to other IC data.

According to the hospital's Infection Control Program Plan, dated February 2014, Infection Control at the hospital allowed for a systematic, coordinated and continuous approach.

Per the ICPs job description, the ICP was responsible for the identification of healthcare associated infections consistent with pre-established definitions and provided appropriate documentation and follow-up.

The ICP was unavailable for an interview as she had been terminated by the hospital on [DATE].














3. During a joint observation and interview on 8/17/15 at 9:30 A.M., the Hospital A's Emergency Department (ED) was toured with the Director of Nursing/Performance Improvement Director (DON/PID). A round shaped white colored metal bracket was observed attached to a wall in the waiting room of the ED. The observed bracket included a sign with the words "Not For Use On Skin" in red colored print. The observed bracket held an opened purple topped pop up container of disposable sanitizing wipes. The container label included the instructions "not for use on skin...wear gloves", in small print. The container indicated that a 2 minute contact time was needed for product effectiveness. No disposable gloves were observed in the waiting room area. The DON/PID stated that the container of sanitizing wipes was intended for use on soiled surfaces in the ED waiting area and had been placed in the area "last flu season" by the Infection Control Preventionist (ICP). The DON/PID acknowledged that the sanitizing wipes were accessible to patients and visitors as well as hospital staff. The DON/PID acknowledged that PPE/disposable gloves were not available in the ED waiting area and that instructions for the use of the sanitizing wipes was not clearly posted.

During an observation and interview on 8/18/15 at 11:00 A.M., a public common hallway between Intensive Care Unit (ICU) North and ICU South was toured with the DON/DPI. The hallway included 2 wall mounted telephones which communicated into the respective ICUs. A round shaped white colored metal bracket was observed attached to the wall area near each of the telephones. The observed bracket included a sign with the words "Not For Use On Skin" in red colored print. Located above each bracket was another sign which included the words "Wipes are for Phone ONLY". The observed bracket held an opened purple topped container of disposable sanitizing wipes. The container label included the instructions "not for use on skin...wear gloves", in small print. The container indicated that a 2 minute contact time was needed for product effectiveness. No trash receptacles or disposable gloves were observed in the hallway area. The DON/PID stated that containers of sanitizing wipes had been placed in the area "last flu season" by the Infection Control Preventionist (ICP). The DON/PID acknowledged that the sanitizing wipes were accessible to patients and visitors as well as hospital staff. The DON/PID acknowledged that neither PPE/disposable gloves or a trash receptacle were available in the area and that instructions for the use of the sanitizing wipes was not clearly posted.

During a joint interview on 8/17/15 at 4:30 P.M., the ICP stated that the observed sanitizing wipes in the ED waiting and ICU hallway entrance areas were intended for sanitizing the telephone receivers. The ICP stated that she had implemented the telephone sanitizing practice "last Fall during flu season" and that the hospital had changed product vendors for the sanitizing wipes. The ICP stated that she had not developed a specific policy or procedure that had been approved, for the use of the sanitizing wipes in the common public areas of the hospital. The ICP stated that the observed sanitizing wipes were to be used with disposable gloves in order to avoid skin contact, which could cause skin irritation. The ICP acknowledged that she had not noticed that disposable gloves were not available in the observed areas, where the sanitizing wipes were available for use. In addition, the ICP acknowledged that a trash receptacle, for the sanitizing wipe disposal, was not available in the ICU area hallway. The DON/PID stated that the hospital had "a gap in the system."

A review of the facility policy and procedure, entitled Infection Control Program approved "February 2014", included "Departmental policies and procedures for infection control will reviewed and/or revised as an ongoing practice...The Infection Control Program at the Hospital incorporates the following in a continuing cycle...Surveillance, prevention and control of infections throughout the organization."

A review of the ICP job description summary included "Develops, reviews, revises and coordinates the implementation of all organization-wide policies and procedures related to infection prevention/control....Makes rounds on patient care units and departments to assure compliance with infection control policies, procedures and regulatory requirements."

A review of the hospital's Infection Control Goals for 2015, dated March 2015 and authored by the ICP, included "Goal...Implementation and coordination of all aspects of the infection prevention and control plan for the hospital...Education of all disciplines on latest developments in infection prevention and control." The planned "Activity" included "Monthly Safety rounds with Engineering. Reviewing all IC [infection control] policies with EVS [environmental services] and inpatient units...Random monthly observation visits to Central Sterilization, OR [operating room], Radiology, Dietary, EVS, ER [emergency room /department].

During a hospital leadership meeting on 8/19/15 at 2:00 P.M., the DON/PID stated that hospital products and/or infection control practices "should be monitored monthly by the Environment of Care Committee", which included the ICP's participation and surveillance.

A review of the Environment of Care (EOC) Safety Inspections 2015, indicated a monthly pre-planned matrix inspection schedule which rotated through various areas of the hospital. The inspection schedule assigned "Teams" of staff that had then been designated into "Groups" of 3 staff members. The ICP was designated to "Group D". A review of Group D's surveillance logs indicated that the ICP's last participation with the EOC inspections occurred on "3/30/2015". That inspection had included the ED area, however, the inspection had not identified the use of sanitizing wipes in the absence of PPE/gloves. There was no evidence of the ICP's participation in the surveillance of the observed ICU area.

During a joint interview on 8/20/15 at 1:10 P.M., the Administrator (Admin.), Chief Nursing Officer (CNO) and DON/PID acknowledged that the ICP had initiated the use of sanitizing wipes in public areas of the hospital on her own initiative and without the development and/or approval of a policy and procedure. The Admin., CNO and DON/PID acknowledged that the hospital had not provided needed PPE/gloves and education with regard to use of the sanitizing wipes.






4. On 8/20/15 at 8:45 A.M., a tour of the hospital's special care nursery was conducted with the Nurse Director of Maternal Child (NDMC) and the Nurse Director of Intensive Care Services (NDIC). The special care nursery supply cabinet was inspected. The top row of individual compartments were pulled. A visible layer of dust and dirt was noted at the base of the compartments.

An interview with Registered Nurse (RN 11) was conducted on 8/20/15 at 8:56 A.M. RN 11 stated that the nursery nurses were responsible for the stocking and cleanliness of the nursery. She stated that she had been working the day shift (7:00 A.M. to 7:30 P.M.) for the past 6 months and could not recall seeing the Infection Control Preventionist (ICP) in the nursery.

An interview with the Environmental Services Manager (EVSM) was conducted on 8/20/15 at 9:10 A.M. The EVSM stated that EVS staff were responsible for "high dust" cleaning which entailed the cleaning of high surfaces. She pointed to the top of the nursery supply cabinet as an area that EVS staff would have been responsible for cleaning.

An interview with the NDMC was conducted on 8/20/15 at 9:18 A.M. The NDMC stated that infection control was the responsibility of everyone. She stated that there should not be any dust in the nursery. She stated that the nursery nurses were responsible for checking equipment, supplies and ensuring that the nursery was clean. She stated that the special care nursery did not have a formal process in place for checking supplies and ensuring the cleanliness of the unit.

A review of the Environment of Care (EOC) Safety Inspections 2015 schedule was conducted on 8/20/15. Per the EOC Safety Inspection schedule, the special care nursery was inspected in 2/2015 by Group A. Group A consisted of the Director of Plant Operations (DPO), the Public Safety Manager (PSM), and the Emergency Preparedness Manager (EPM). There was no documented evidence to demonstrate the ICP's involvement specific to the infection control surveillance of the special care nursery in 2015.

The Infection Control Preventionist (ICP) was not available to be interviewed.

A review of the Infection Control Preventionist's (ICPs) job description was conducted. Per the job description, the ICP was responsible to make routine hospital rounds to evaluate compliance with infection control/prevention policies and procedures.

Per the Infection Control Program Plan, last reviewed in February 2014, The IC Management functions were delegated to the IC Practitioner/Infection Control Committee to investigate and follow-up on clinical issues.

A telephone interview was conducted with the DPO on 8/20/15 at 2:40 P.M. The DPO confirmed that the last time an EOC inspection was conducted in the special care nursery was in 2/2015. He stated that the ICP did not participate in the inspection of the special care nursery. He explained that their inspection was limited to ensuring that hand sanitizers were available, general cleanliness, and the proper use of personal protective equipment. He stated that the special care nursery was due for an inspection this month (8/2015).

The ICP's infection control surveillance binder and audit logs were reviewed. There was no documented evidence to show that surveillance or audits of the special care nursery had been performed by the ICP in 2015.

5. On 8/17/15 at 1:25 P.M., a tour and observation of the hospital's 5 bed intensive care unit (ICU - North) was conducted with the Nurse Director of Intensive Care Services (NDIC). Two bins lined with red biohazard waste bags were observed in the corridor in front of the soiled utility room door. An inspection of the bins were conducted with the NDIC. One bin contained a suction canister, suction tubing and blood product tubing. The suction canister and tubing contained bodily fluids. The second bin contained a yellow gown that may have been exposed to bodily fluids per the NDIC.

An interview with the NDIC was conducted on 8/17/15 at 1:30 P.M. The NDIC stated that the environmental services (EVS) staff and the nursing staff had a responsibility to ensure that bins were placed in their appropriate locations. The NDIC stated that the two bins with biohazard waste should have been placed in the red biohazard bin located in the soiled utility room.

An interview and joint observation with EVS staff 1 was conducted on 8/17/15 at 1:40 P.M. EVS staff 1 stated that EVS staff were responsible for ensuring that biohazard waste bins were placed in the red biohazard bin in the soiled utility room. EVS staff 1 acknowledged that the two bins with the biohazard waste should not have been left in the corridor in front of the soiled utility room.

A review of the hospital's policy and procedure titled "Hazardous Materials/Waste Policy and Procedure", last reviewed on 1/2012, was conducted. The policy indicated that all hazardous materials shall be disposed of as a hazardous waste at the point it was determined to be no longer beneficial to the organization. Per the same policy, it stipulated that "The Environmental Services Department shall collect these containers when full. They shall be stored in the hazardous waste storage area."

An interview with the Environmental Services Manager (EVSM) was conducted on 8/20/15 at 9:10 A.M. The EVSM stated that EVS staff were responsible for ensuring that biohazard waste bins were placed in the soiled utility room. The EVSM stated that biohazard waste bins should not have been placed in an ICU corridor. She stated that an ICU corridor was a clean area and with the placement of biohazard waste bins in a clean area raised a concern for contamination.

The Infection Control Preventionist (ICP) was not available to be interviewed.

Per the Infection Control Program Plan, last reviewed in February 2014, The IC Management functions were delegated to the IC Practitioner/Infection Control Committee to investigate and follow-up on clinical issues.

The ICP's infection control surveillance binder and audit logs were reviewed. There were 3 Infection Control General Environmental Inspection audits found for the ICU. The audits were performed on 3/18/14, 3/25/14 and 3/26/14. The ICU audit performed dated 3/26/14, had identified noncompliance in the following 4 areas of the audit:

1) There was employee food and/or water at the nurse's station;
2) The air vents were not clean;
3) Open intravenous bags without date, time and initials; and
4) Extra linen on chairs, floors and hampers.

Per each noncompliance, the comment section of the audit was blank. There was no documented evidence to show actions taken with regards to the identified noncompliance and if any follow-up had been performed related to the ICU audit findings. In addition, there was no documented evidence to demonstrate that surveillance or audits had been performed in the ICU in 2015.

6. A review of the Infection Control Preventionist's (ICPs) job description was conducted. Per the job description, the ICP was responsible to make routine facility rounds to evaluate compliance with infection control/prevention policies and procedures.

Per the Infection Control Program Plan, last reviewed in February 2014, The IC Management functions were delegated to the IC Practitioner/Infection Control Committee to investigate and follow-up on clinical issues.

A review of the hospital's hand hygiene compliance rate data was conducted. According to the Infection Control Surveillance Summary 2015, the hospital's hand hygiene compliance rate (before and after patient contact) for 2014 was 65%. For the following months in 2015, the hand hygiene compliance rate was:

57% in January
60% in February
58% in March
49% in April
62% in May

The hospital's goal was to be 100% compliant with hand hygiene. The hospital data showed that the hospital had not met their goal in 2014. In 2015, the hospital data per month also showed that the hospital's hand hygiene compliance rate was well below their goal.

According to the hospital's Infection Control Plan and Risk Assessment, dated 4/2015, the hospital listed items that needed improvement and on the list was hand hygiene compliance.

According to a document titled "Infection Control Goals for 2015", dated 3/2015, one of the specific goals for the Infection Control Preventionist (ICP) was hand hygiene surveillance. The ICP activity listed house wide surveillance and an action plan to randomly sample 30 subjects per month to include hospital staff in various disciplines such as nurses, physicians, respiratory staff, dietary staff, and radiology staff. There was no documented evidence to demonstrate that the house wide surveillance and the random sampling of 30 subjects (audit) per month had been performed.

The ICP's infection control surveillance binder and audit logs were reviewed. There were four "Infection Control - Hand Hygiene Surveillance" documents found. Two documents did not contain a date and had a combined total of 10 hand hygiene observations. One document was dated 9/18/14 and contained 7 hand hygiene observations. The last document was dated "12/14" with 10 hand hygiene observations which was completed by the ICP. There was no documented evidence to show that infection control surveillance or audits for hand hygiene had been performed or collected by the ICP in 2015.







7 a. On 8/17/15 at 11:10 A.M., a tour of Hospital A's 5th Floor Telemetry unit (constant monitoring of patient's cardiac status) was conducted with the Respiratory Care Manager (RCM) and a charge nurse (Registered Nurse- RN 21 responsible for the care of the unit). Patient 22 and Patient 24 received dialysis (also known as hemodialysis - filter of toxins in the blood via artificial kidney machine) in a tandem room accompanied by a hemodialysis nurse (RN) 25.

On 8/19/15 at 11:15 A.M., an interview was conducted with RN 21. RN 21 stated that staff followed the hospital's current dialysis policy when wearing personal protective equipment (PPE - protective clothing and equipment worn to prevent the spread of infection). She stated that the policy included the following: staff wore a gown, gloves and mask during the entire time patients received dialysis.

On 8/19/15 at 11:25 A.M., an interview was conducted with RN 26 (a contracted dialysis staff). RN 26 stated that staff followed the contracted dialysis policy when wearing PPE. She stated that the policy included the following: staff wore a gown, gloves and mask whenever the patient's port (opening of dialysis catheter) was accessed. She stated that if staff were not accessing the port, staff were only required to wear gloves.

On 8/19/15 at 11:35 A.M., an interview was conducted with the Contract Dialysis Chief Executive Officer (CDCEO), the Respiratory Care Manager (RCM) and the Director of Telemetry (DOT). The CDCEO, the RCM and the DOT acknowledged that the hospital and the contracted dialysis staff provided inconsistent verbal responses related to the use of PPEs during dialysis care.

On 8/17/15 at 2:15 P.M., the CDCEO stated that the contract dialysis policy and procedure was currently being revised and had not been approved by the hospital's Medical Executive Committee (MEC).

The MEC Minutes, dated 5/12/15, indicated that the "[Vendor Name] dialysis policy" was reviewed and approved by the MEC. The hospital was unable to provide the dialysis policy which was documented as approved by the MEC on 5/12/15.

On 8/19/15 at 2:15 P.M., during a group interview, the Chief Nursing Officer (CNO) stated that the hospital's expectation was for the hospital staff to implement the hospital's current dialysis policy. She explained that the contracted dialysis staff were expected to follow the contracted dialysis policy. However, the Administrator (Admin) stated that the hospital's expectation was for all staff (to included contracted services staff) to follow the hospital's current dialysis policy and procedure.

Hospital A's current policy and procedure titled "Dialysis, Acute", dated 3/2014, did not provide guidelines to staff related to PPE used when providing care for a dialysis patient.

On 8/19/15 at 3:06 P.M., the CNO stated that the CDCEO, hospital and contracted dialysis staff were not educated related to the dialysis policy which was approved by the MEC in May 2015. The CNO and the Admin acknowledged that the hospital and contracted dialysis staff inconsistently verbalized the use of PPEs during dialysis care. They also acknowledged that the hospital's current dialysis policy did not include PPE guidelines for staff.

b. A review of the Infection Control Preventionist's (ICPs) job description was conducted. Per the job description, the ICP was responsible to make routine hospital rounds to evaluate compliance with infection control/prevention policies and procedures.

The hospital's Infection Control Goals for 2015 included daily rounds on all units investigating proper isolation precautions set in place on appropriate patients and adherence to all isolation policies and procedures.

On 8/19/15 at 2:30 P.M., during a group interview, the Director of Nursing/Performance Improvement Director (DON/PID) stated that the ICP performed her IC surveillance during Environment of Care (EOC) rounds.

A review of the Environment of Care (EOC) Safety Inspections 2015 schedule (to include EOC rounds) was conducted on 8/20/15. Per the EOC Safety Inspection schedule, the 5th Floor Telemetry unit and the 6th Floor Medical Surgical unit were inspected on 1/29/15 by Director of Plant Operations (DPO), the P
VIOLATION: LEADERSHIP RESPONSIBILITIES Tag No: A0756
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and document review, when hospital leadership had knowledge of Infection Control (IC) training noncompliance, they failed to enforce the mandated training and education requirements for Medical Doctor (MD) 1, who was the Chairperson of the Infection Control Committee. Failure to enforce mandated IC continuing medical education training and requirements for a physician who was designated as a IC leader within the hospital, and who had oversight of all IC activities within the hospital, did not ensure that the physician was knowledgeable concerning current principles and practices for preventing transmission of infectious agents within the hospital.

Findings:


On 8/20/15 at 9:15 A.M., a review of Medical Doctor (MD)1's credentialing file was done with the Director of Medical Staff Credentialing (DMSC). Medical Doctor 1 was appointed as the Chairperson for the Infection Control Committee in January of 2014, per the DMSC. MD 1 was board certified in internal medicine. MD 1's board certification in cardiology expired on [DATE]. Per the DMSC, MD 1 was appointed as the Chairperson for the IC Committee in January of 2014 for a 2 year term. Per the DMSC, the Infection Control Preventionis (ICP) had also reminded MD 1 he was required to complete the specialized training in IC.

The ICP was unavailable for an interview.

A review of MD 1's credentialing file showed no training, education or certification related to infection control or infectious diseases. The DMSC stated that she was aware that there was State mandated continuing medical education training required for the IC Chairperson. She was aware that the required training was specific to infection surveillance, prevention, and control. The DMSC stated that she had sent reminder emails to MD 1 regarding the mandated training, but he consistently stated he was "busy". The DMSC confirmed that MD 1's term as the IC Committee Chairperson would end in January of 2016, or in 5 months, and he had not completed the required IC training.

According to the Medical Staff bylaws the duties of the IC Committee included but were not limited to: a) developing a hospital-wide infection control program and maintaining a surveillance over the program; b) developing a system for reporting, identifying, and analyzing the incidence and cause of nosocomial infections, including assignment of responsiblity for the ongoing collection and analytic review of such data, and follow-up activities; c) developing and implementing a preventative and corrective program designed to minimize infection hazards, including establishing, reviewing and evaluating aseptic, isolation and sanitation techniques; d) developing, reviewing and approving policies and procedures related to infection surveillance, prevention and control, including defining special indications for isolation requirements; e) reviewing sensitivities of organisms specific to the facility; and f) assisting in formulation of policies relative to hospital/employee health.

On 8/20/15 at 2:30 P.M., a telephone interview was conducted with MD 1. MD 1 confirmed he was a "interventional cardiologist." MD 1 acknowledged that he had not participated in the required IC training. MD 1 stated he took full responsibility for "putting it off."

On 8/20/15 at 2:50 P.M., an interview was conducted with the Chief Nurse Officer (CNO) who was also a member of the hosptal's Governing Body. The CNO confirmed that she had knowledge concerning MD 1's noncompliance with the mandated training requirement for the physician who was designated as the IC Committe Chairperson. She acknowledged she should have taken action to ensure that the training was completed by MD 1.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation and interview, the hospital failed to ensure medication was available for potential medical emergency in the operating room. This failure could contribute to increased risk for adverse outcomes for patients during medical emergencies.
Findings:
At 3:15 P.M. on 8/17/15, the [DIAGNOSES REDACTED] (MH) emergency cart and supply in the Operating Room (OR) area were inspected with the Certified Registered Nurse Anesthetist (CRNA 2). The list of MH medications was found in a blinder on top of the MH cart. Review of the medication list did not show there was any cold normal saline (sodium chloride 0.9%) solution for injection available in the OR refrigerator. In the interview with the CRNA 2 at 3:30 P.M., he acknowledged there was no cold intravenous (IV) saline solution in the OR department.
The [DIAGNOSES REDACTED] Association of the United States (MHAUS) provides guideline on what medications should be available in a MH cart. And according to the latest reference dated 3/23/15, it states a minimum of 3000 milliliters (ml) of refrigerated cold saline solution for intravenous (IV) cooling should be included.
Review of the hospital policy entitled "[DIAGNOSES REDACTED]" dated 10/2014 on page 4 under "[DIAGNOSES REDACTED] Cart Contents", it lists under medication "normal saline 1000 cc, 2 in drawer, 4 in refrigerator."