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Based on staff interview and document review, the governing body failed to ensure that all services provided by contractors and outside vendors were safe and effective, objectively analyzed by the hospital's quality assessment performance improvement (QAPI) program, and the results presented to the governing body annually, in accordance with leadership bylaws and hospital policy, for 8 of 12 services reviewed (engineering services, teleradiology, linen, radiation quality control and safety, and 3 compounding pharmacy entities).

This failure put patients and staff at risk for injuries or adverse events resulting from unsafe or unreliable equipment, supplies, and operational systems on which the hospital relied to diagnose and treat patients.

Findings:

In a 5/8/19 at 10:30 a.m. interview, the hospital President indicated that the hospital did utilize the products and services of entities not directly owned or controlled by the hospital in order to provide patient care services. For some entities, formal contracts or agreements between the local hospital and the vendor, or between the hospitals' regional or national partners and the vendor, were documented. For other entities, the acquisition of services was not formal, but was arranged through periodic business orders and purchases. The President stated that the vendor services were evaluated by the departments or service lines who utilized them, and the results were reported to the local hospital's quality management committee (QMC), medical staff executive committee (MEC), and ultimately to the governing board (GB) annually to determine if vendor services were safe and effective.

Review of a sample of 12 formal written contracts confirmed that the hospital utilized the services of outside vendors for many patient care related services, including medical equipment and system engineering, radiation quality control and safety, medication procurement, surgical attire, physician services, and remote telehealth services.

Review of the 2018 Summary Report Patient Care Contract Services submitted by the QMC to the MEC on 1/17/19, and to the GB on 1/24/19, indicated that the services for 8 of 12 sampled contracts (engineering services, teleradiology, linen, radiation quality control and safety, and 3 compounding pharmacy entities) were not included in the annual evaluation report. Review of the MEC and GB minutes from January 2018 to March 2019 indicated no other evaluations for the 8 vendors were documented.

In a 5/9/19 at 2:11 p.m. interview, the Director of Quality and Risk Management (DQRM) confirmed that evaluations of the 8 vendors were not included in the annual Summary Report Patient Care Contract Services and not captured by the QAPI program.

Review of the 6/15/12 GB bylaws noted on page 11 that the GB was responsible for assuring that health care services provided at the hospital were "high quality, safe, effective, efficient and consistent with community standards." The GB was further responsible for monitoring ongoing quality assessment, patient safety, and assuring that the medical staff participated in the measurement, assessment and improvement of clinical and non-clinical processes affecting patient care.

Review of a policy titled "Management of Patient Care Contract Services," approved 1/25/18, set expectations that care, treatment and service provided by contract entities shall be provided in a safe and effective manner. "There shall be a written contractual agreement with each contract entity providing care, treatment and service ... Each department will be responsible for measuring how well the performance expectations are met ... Contract services will be evaluated using the Contract Services Evaluation Summary Form ... Quality reports from Contracted Services are sent to Quality Management Committee at least annually ... Evaluations are sent to the [MEC] for review and input at least annually."

Review of the Medical Staff Bylaws, approved 7/26/18, directed the medical staff on page 8 "to account to the governing body for the quality of patient care through regular reports and recommendations concerning the implementation, operation and results of the quality review and evaluation activities." Listed under the duties of the MEC on page 106 was item (p), "Reviewing the quality, safety and appropriateness of clinical services provided by contract Physicians or through contractual arrangements or other agreement."

Based on staff interview and document review, the governing body failed to maintain a complete list of contracted services to ensure adherence to the authorized scope and authority, and accountability for all outside vendors providing patient care related services. Although the governing body did not direct the hospital to maintain such a list as required by this regulation, the list presented did not contain 5 of 12 patient care contracted services reviewed (radiation quality control and safety vendor, linen vendor, and 3 compounding pharmacy vendors).

Findings:

In a 5/6/19 at 10:30 a.m. interview, the interim perioperative manager (IPM) stated that the surgical clothing worn by patients and staff in that unit was provided by an outside linen vendor.

In a 5/6/19 at 10:30 a.m. interview, the Director of Imaging (DIM) indicated that radiation safety testing of several imaging machines, and measurements of the badge exposures to radiation worn by hospital staff, were conducted by an outside radiation safety vendor.

In a 5/8/19 at 10:30 a.m. interview, the Chief Medical Officer (CMO) indicated that the hospital acquired medications from several outside pharmacies, including compounding pharmacies.

Twelve contracts were selected for review on 5/9/19. Included in the sample were contracts for the referenced radiation quality control and safety vendor, the referenced linen vendor, and 3 referenced compounding pharmacy vendors.

On 5/6/19 the hospital presented a list (also provided to its accrediting agency) of its contracted services. The list contained 28 items. The list did not, however, include the referenced radiation quality control and safety vendor, the referenced linen vendor, and the 3 referenced compounding pharmacy vendors.

In a 5/9/19 at 2:11 p.m. interview, the Director of Quality and Risk Management (DQRM) confirmed that the hospital's list of contracted services did not include the referenced radiation quality control and safety vendor, the referenced linen vendor, and the 3 referenced compounding pharmacy vendors.

The hospital presented no policy or governance guideline that required it to maintain a complete and accurate list of contracted services that included the scope and nature of all the patient care related services provided by outside entities.

Based on staff interview and document review, the medical staff failed to apply procedures to grant privileges for transesophageal echocardiography (TEE, placement of an ultrasound imaging device into the esophagus during a medical procedure to visualize and measure structure and function of the heart and blood vessels from the cavity behind the heart; TEE required advanced skills and specialized training) in accordance with medical staff bylaws and medical staff privileging criteria for minimum case volume, for 1 of 4 physician files reviewed (Medical Doctor-MD 1).

Specifically, the medical staff granted TEE privileges repeatedly to MD 1 for 5 years, without evidence that MD 1 had performed TEE throughout those years.

This failure to ensure recent and sufficiently frequent physician performance and competence of a specialized skill put patients at risk for injury or adverse outcome from care by a physician whose skills may have lapsed.

Findings:

Review of the Medical Staff Bylaws, approved 7-26-18, documented under Section V for Clinical Privileges, item 5.3, "each Clinical Service will be responsible for developing criteria for granting Clinical Privileges ... Each Clinical Service's approved criteria for granting Privileges shall be included in the Clinical Service's Rules."

Item 5.4-2 noted, "The Medical Staff shall make an objective and evidence based decision with regard to each request for Privileges. Requests for Clinical Privileges shall be evaluated on the basis of the Member's education, training, experience, current demonstrated professional competence and judgment, ... applicant's clinical performance at this Hospital and in other settings, ... performance of a sufficient number of procedures to develop and maintain the Practitioner's skills and knowledge and compliance with any specific criteria applicable to the Privileges."

Item 5.5-1-a noted, "The purpose of proctoring shall be to evaluate the Member's proficiency in the exercise of Clinical Privileges initially granted, suitability to continue ... as a condition of renewal of privileges ... a privilege that has been performed so infrequently that it is difficult to assess the Member's current competence."

Item 5.5-4 further directed, "Any Member who fails to complete the required number of proctored cases within the time frame established shall be deemed to have voluntarily withdrawn his or her request for [relevant Privileges.]"

In a collaborative review of physician files on 5/7/19 at 9:30 a.m., the Medical Staff Coordinator (MSC) indicated that TEE privileges for MD 1 were approved by the clinical service chair on 6/9/14. The criteria for TEE were completion of 10 cases in the previous 2 years, or completion of a residency training program where TEE was taught. MD 1 completed an anesthesia residency training program in 2014. MD 1 provided a 2014 procedure list from the residency program to show successful performance of TEE, thereby meeting the privileging criteria for TEE.

In 2016 MD 1 reapplied for TEE privileges. On the privilege request form, MD 1 documented "no" for meeting the minimum threshold volume of 10 TEE cases in past 2 years. MD 1's case volume report for activity in the hospital between 2/9/14 and 2/9/16 did not list TEE. Yet, TEE privileges were approved by the clinical service chair on 5/5/16.

In 2018 MD 1 again reapplied for TEE privileges. On the privilege request form, MD 1 documented "no" for meeting the minimum threshold volume of 10 TEE cases in past 2 years. The privilege form now added that 1 "proctoring" (observation) evaluation was required. MD 1's case volume report for activity in the hospital between 3/21/16 and 3/21/18 did not list TEE. Yet, TEE privileges were approved by the clinical service chair on 6/6/18.

MSC also stated that there was no evidence in file that MD 1 performed TEE since 2014, and no proctoring evaluation had been completed.

In a 5/7/19 at 2:30 p.m. interview, MD 5 (who previously served as an anesthesia clinical service chair and currently served on the regional credentials review committee) stated that privilege requests were rigorously scrutinized to ensure that medical staff members met the privileging criteria set by each clinical service. When the minimum threshold volume was not achieved, MD 5 expected the privilege to not be approved, or for additional training to be ordered, or for proctoring to be ordered, or some other remedy. MD 5 thought it unusual for a specialized skill to be granted over 2 or 3 reappointment cycles when minimum threshold volume was not achieved. MD 5 did not think many anesthesia service members possessed TEE privileges or currently performed TEE very often.

In a 5/8/19 at 2:15 p.m. interview, MSC stated that of the nearly 600 medical staff members, only 3 anesthesia providers and 3 cardiologists possessed TEE privileges at the hospital. MSC indicated that a list of TEE's performed between 2017 and 2019 showed several by the 3 cardiologists, but none were found for the anesthesia providers, including MD 1.

Based on interview and record review, the hospital failed to perform pain assessments for 2 patients (Patients 5 and 9), out of a sample size of 70, when pain assessments were not documented.

This failure had the potential to cause unnecessary pain and prolonged recovery for Patients 5 and 9.

Findings:

1. Patient 5 was admitted to the hospital with diagnoses which included a dislocated hip.

A review of 5's electronic health record (EHR) indicated pain was not assessed between 5/6/19 at 3 p.m. through 9 p.m. (6 hours). The EHR further indicated Patient 5's pain had increased within this six hour time period.

During an interview with the Med/Surg Director of Nursing (DON MS Tele) on 5/7/19 at 9:45 a.m., the DON MS Tele confirmed a pain assessment was not done for Patient 9 for six hours.

2. Patient 9 was admitted to the hospital with diagnoses which included abdominal surgery.

A review of Patient 9's EHR indicated pain was not assessed between 5/6/19 at 1 p.m. through 5/7/19 at 12 p.m. (11 hours).

During an interview with DON MS Tele on 5/7/19 at 9:30 a.m., the DON MS Tele stated, "She [Patient 9] should get a pain assessment every four hours...I'd expect to see it [pain assessment documentation] with the flow sheet and the assessment together....There should be documentation at least two more times during the day and once at night for pain assessment."

A review of the hospital's policy titled "Pain Management," revised on 5/25/17, indicated pain assessments are documented per unit standard.

A review of the hospital's policy titled "Basic Unit Standards: Intensive Care Unit, Medical Telemetry, Surgical Acute Unit," revised on 1/24/19, indicated the standard for the frequency of pain assessments with telemetry patients must be done at least every four hours.

Based on observation, interview, and record review, the facility failed to ensure medications were administered as ordered by the physician in accordance with manufacturer's recommendations and the facility's policy and procedure to prevent administration errors.

Famotidine (Brand: Pepcid - for acid reflux) injected into the peripheral vein of Patient 14 was administered faster than rate ordered by the physician and manufacturer's recommendations

Findings:

During a medication pass observation conducted on 5/8/19, at 9:10 a.m., with Registered Nurse (RN) 62, the following was observed:

RN 62 withdrew 2 ml (milliliter) from the injectable famotidine 20 mg/2 ml vial into a syringe and administered via intravenous push (IVP - pushing in the content of the syringe into vein) route to Patient 14 in approximately 20 seconds.

Review of the patient's medical record indicated the following:

There was a physician order for famotidine 20 mg (milligram) IVP every 12 hours on 5/4/19 and the comment, "IV Push rate: 20 mg/2 min (minute)"; and

There was documentation of administration of famotidine 20 mg on 5/4/19, at 9:16 a.m. on the medication administration record (MAR).

In an interview on 5/8/19, at 9:35 a.m., RN 62 did not indicate she was aware of the 2-minute injection via IVP and agreed the infusion was faster that it should have been.

According to the manufacturer of famotidine 20 mg/2 ml for injection:

"...inject over a period of not less than 2 minutes..."

The facility's policy and procedure titled, "Medication Management Administration" with the last approval date of "01/24/2019" was reviewed and indicated:

"...Administer medication based on an appropriate order from a Provider...

Follow the IV Administration Guidelines to administer IV medications..."

According to the facility's "IV Drug Administration Guidelines for Adult Patients" with the last board approval date of "10/26/2017":

"...Famotidine (Pepcid)...IV Push...20 mg/2 min(minutes)..."

Based on interview and document review, the facility failed to monitor unauthenticated (unsigned) physician orders and suspend physician privileges for such delinquencies in a timely manner, as defined by more stringent California state law, Title 22 California Code of Regulations Section 70751(g), requiring completion of medical records within two weeks following the patient's discharge.

This failure resulted in noncompliance with both facility policies and medical staff rules regarding medical record completion with the potential to cause inaccurate quality and care information compromising safe patient care.

Findings:

The facility's 2018 Medical Staff Rules and Regulations (Governing Body Approval - July 26, 2018) on page 24, section XV. Medical Records, under item "C." Completion of the Record, 1. Timely Completion, item "b)" state "Medical Records must be completed promptly and authenticated or signed by a Practitioner within fourteen (14) days following the patient's discharge. Under item "c)" these rules further state "Members who fail to complete medical records within seven (7) days of discharge will be sent a letter advising him or her that the medical record will become delinquent in seven (7) days. The letter will inform the Member that if the medical record is not completed, including dictation and signature, within the following seven (7) day period, the Member shall be placed under a limited suspension in the form of withdrawal of admitting and other related privileges (Bylaws 6.3-6). The suspension shall continue until lifted by the Chief of Staff or his or her designee once the medical records are completed."

The facility's policy and procedure "Suspension Process" last reviewed 2/2019 and contained in the Health Information Management Department's Policy and Procedure Manual references Joint Commission Standards, CMS Conditions of Participation, 482.24 and Title 22 with the purpose "To ensure the completeness of the medical record for the continuing of patient care ...."

In an interview on 5/8/19 at 1:35 p.m. with the Director, Health Information Management (DHIM), she confirmed that her department has not been suspending physicians who are not completing their orders. The DHIM further stated that monitoring of incomplete orders and suspension for delinquencies was discontinued back in 2013 system-wide with the implementation of CPOE (Computerized Physician Order Entry), and the responsibility was shifted to Nursing staff. The DHIM has been in her position since July 2018 but has worked for the system for fifteen years and has not received monitoring information regarding incomplete orders. Health Information Management Department resources are provided in conjunction with a system-wide contract with an outside business services provider. The DHIM verbalized understanding of the requirement under the Medical Record Services Condition of Participation section 482.24(c)(1) that all patient medical record entries, including physician orders, must be complete, dated, timed and authenticated (authentication requires verification of the responsible author who must verify the accuracy of the entry).

Based on observation, interview, and record review, the facility failed to ensure storage of emergency medications inside the Neonatal Crash Cart used during emergency life-threatening events, was implemented in accordance with the facility's policy and procedure.

The content of the crash cart did not match the content list available outside the cart. This failure had the potential to delay emergency treatments.

Findings:

During a tour of the Family Birth Center (FBC) on 5/7/19, at 9:30 a.m., there was a Neonatal Crash Cart medication content list which did not match the medication content list available outside the cart.

The following medications were indicated available inside the cart but not available:

One 5-ml (milliliter) ready-to-use syringe containing atropine (medication used to increase heart rate) 0.1 mg/ml (milligram per milliliter); and
One 5-ml ready-to-use syringe containing lidocaine (medication used to correct irregular heart rhythm) 10 mg/ml.

The following medication was not listed as available inside the cart but available:

Two 10-ml ready-to-use syringe containing sodium bicarbonate (medication used to maintain blood acid/base balance) 4.2% (0.5 milliequivalent per milliliter).

In an interview on 5/7/19, at 9:45 a.m., the Director of Family Birth Center (DFB) stated the medication list outside the cart needed to be updated.

In a concurrent interview, the Pharmacy Manager (RXM) stated the content list was updated in 2017 and agreed the old list would need to be replaced with the updated list.

The facility's policy and procedure titled, "Emergency Medications/Crash Cart Locks" with the last approval date of "09/25/2018" was reviewed and indicated:

"...Crash Carts - Emergency medication supplies are maintained in Crash Carts at designated areas throughout the institution. Crash Carts contain both medications and medical supplies which are commonly used during cardiac or respiratory resuscitative (rescue) efforts...

Contents of the emergency boxes and earliest expiration date shall be available on the outside of the box...

The pharmacist or technician will inspect the drug supply monthly as part of a monthly unit inspection. Any identified irregularities noted upon unit inspection are reported within 24 hours to the Pharmacy Director and Nursing Unit Leadership in accordance with the Medication Control and Storage Inspection policy..."

According to CDPH (California Department of Public Health) AFL (All Facilities Letter) 05-02,

"...This letter is intended to provide guidance for the establishment, storage and use of emergency medications...

Ensure approved policies and procedures are developed establishing the content of emergency supplies, procedures for use, restocking and sealing the emergency supply. The policies and procedures should be current, based on clinical standards of practice and periodically reviewed...

The content list must accurately and comprehensively reflect all medications in the cart..."

Based on observation, interview, and document review, the facility failed to ensure compounding and repackaging of medications were consistent with federal regulations and standards of practice, consistent with the facility's policy and procedure when:

1. One compounded sterile preparations (CSPs: sterile mixed medications for administration to patients) in the Pharmacy IV (intravenous - by vein) Room was prepared with more complex manipulations than recommended by USP <797> standards under the current Pharmacy IV Room status.

This failure had the potential for Pharmacy staff to compound unsafe CSPs due to potential for increased opportunities for micro-organism contamination; and

2. One repackaged unit-dose medication was assigned a longer expiration date by the Pharmacy compared to the facility's policy and procedure and FDA (Food and Drug Administration) recommendations.

This failure had the potential for sub-potent, sub-sterile medications to be administered to the facility patients.

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP's drug standards are enforceable in the United States by the Food and Drug Administration.

USP Chapter <797> provides procedures and requirements for CSPs. General Chapter <797> describes conditions and practices to prevent harm to patients that could result from microbial contamination, excessive bacterial endotoxins, variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations.

Findings:

1. On 5/6/19, at 1:30 p.m., the Pharmacy IV Room was inspected. The IV Room provides sterile environment for the Pharmacy staff to prepare CSPs.

In an interview on 5/6/19, at 2 p.m., the Director of Pharmacy (DOP) stated the Pharmacy IV Room did not meet the USP <797> air changes per hours (ACPH) requirement in the ante-area of the IV room to be able to assign the beyond use date (BUD) allowed for low-risk sterile compounded medications. Instead, the IV room was used as a segregated compounding area with the shorter assigned BUD of 12 hours as allowed by the USP <797> under that condition.

BUD is defined in USP <797> as the date or time after which a CSP shall not be stored or transported. The date is determined from the date or time the preparation is compounded.

Review of the Pharmacy compound log indicated one of the medications compounded did not meet the USP <797> definition of low-risk compounding.

On 5/5/19, one CSP, thiamine (vitamin B1 supplement) 500 mg (milligram) in 0.9% sodium chloride 100 ml (milliliter) was prepared by the Pharmacy using one 100-ml sodium chloride 0.9% IV fluid and three 2-ml vials of thiamine 200 mg/2 ml (milligram per milliliter).

According to USP <797>:

"Low-Risk Conditions...

The compounding involves only transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container or packages (e.g., bag, vial) of sterile products or administration container/device to prepare the CSP..."

In an interview on 5/6/19, at 2:45 p.m., the Pharmacy Manager (RXM) agreed there was one too many vials of thiamine to be considered low-risk compounding.

In a concurrent interview, RXT 1, a pharmacy technician, stated sterile compounding in the IV room would not exceed two vials and three punctures with the needle and that compounding using three vials of thiamine would be unusual.

The facility's policy and procedure titled, "Compounded Sterile Preparations (CSPs)" with the last approval date of "06/28/2018" was reviewed and indicated:

"...Microbial Contamination Risk Levels...

Low Risk CSP: A CSP that contains no more than three commercially available ingredients (including diluents) and involves no more than two punctures into the final bag...

For sterile preparations compounded in an ISO (engineering standards) Class 5 PEC (controls to ensure sterility) located in a segregated sterile compounding area, the beyond use date shall not exceed 12 hours...

Only Low-risk preparations may be compounded in a segregated sterile compounding area..."

2. During a tour of the Pharmacy on 5/6/19, at 1:14 p.m., there were four 30-ml (milliliter) mineral oil (lubricant laxative) unit-dosed bottle with the expiration date of 4/10/20. These 30-ml bottles were unit-dosed from the larger bulk mineral oil bottles by the Pharmacy. These repackaged unit-dosed bottles were given an expiration date of one year from the date they were repackaged by the Pharmacy.

The facility's policy and procedure titled, "Extemporaneous Medication Preparation" with the last approval date of "1/13" was reviewed and indicated:

"Extemporaneous Medications...

When repackaging bulk medications (100's and pints)...

Expiration dating: (One year or the manufacturer's expiration date, whichever is less.)..."

The U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), January 2017 was reviewed and indicated:

"...FDA-approved drug product with a specified in-use time...If the drug product being repackaged is an FDA-approved drug product that specifies in the labeling a time within which the opened product is to be used (an "in-use" time), the repackaged drug product is assigned a BUD (beyond use date) (1) that is established in accordance with the in-use time on the drug product being repackaged; or (2) that is the expiration date on the drug product being repackaged, whichever is shorter...

FDA-approved drug product without an in-use time or unapproved drug product:

For nonaqueous formulations, the BUD does not exceed six months or the expiration date of the drug product being repackaged, whichever is shorter...

For water-containing oral formulations, the BUD does not exceed 14 days or the expiration date of the drug product being repackaged, whichever is shorter..."

The facility provided document which was used to provide education to Pharmacy staff dated, 4/24/2018 was reviewed and indicated:

"Oral Bulk Liquid Medications Packaged in to Unit Dose Containers: When repackaging bulk liquid medications into oral syringes, the following will be used to determine BUD...

180 days for non-aqueous formulations...
14 days for water-containing formulations..."

In an interview on 5/6/19, at 1:20 p.m., both the Director of Pharmacy (DOP) and the Pharmacy Manager (RXM) agreed the expiration date on the repackaged bottles of mineral oil was not correct and should have been 6 months.

Based on staff interview and document review, the hospital failed to ensure Registered Dietitians were scheduled to meet patient nutrition needs seven days per week when Registered Dietitians (RD) were scheduled Monday through Saturday in a general acute hospital operating seven days per week.

Failure to provide full coverage for nutritional aspects of patient care by Registered Dietitians put patients at risk of compromised nutrition status.

Findings:

The Hospital is a General Acute Hospital with 105 licensed beds providing care seven days per week to critically ill patients. Review of the hospital weekly average census for April, 2019, showed admissions ranged between 70.5 admissions on Sundays and 84.3 admissions on Thursdays.

Review of the Clinical Dietitian Job description dated 4/25/2016, showed the Job Summary was to provide medical nutritional therapy to patients by assessing nutritional status, developing a plan of care to maintain or improve nutritional status, periodically evaluating the patients' response to the care plan, modifying diets as required for optimal outcomes, and counseling patients or families about food requirements, eating habits, and therapeutic nutrition.

Review of the RD/Diet Assistant Schedule Dated April 14 to May 11, 2019, showed no Registered Dietitian coverage scheduled on Sundays.

During an interview with RD 1 and RD 2 on 5/7/2019 at 1:00 p.m., they explained the RDs were on call for Sunday coverage. RD 2 explained the RDs would work from Monday to Saturday to meet the required time lines established for patient nutrition assessments. RD2 stated RDs could be called in if needed, but the RD would not be available to provide ongoing assessments or contact with family or patients if needed on Sunday as they would be available Monday through Friday.

Based on observation and interview the Hospital failed to ensure air gaps (fixtures that prevent back-flow) were maintained to prevent backflow of waste discharge sewage in to food production equipment.

Failure to maintain sanitary standards and equipment in safe operating condition puts patients at risk of food borne illness.

Findings:

Food and Drug Agency Food (FDA) Code 2017 5-202.13 Backflow Prevention, Air Gap. "An air gap (unobstructed vertical space between the water outlet and the flood level of a fixture) between the water supply inlet and the flood level rim of the plumbing fixture, equipment or non- food equipment shall be at least twice the diameter of the water supply inlet and may not be less than 25 mm (1 inch)."

On 5/6/2019 at 2:00 p.m., two preparation sinks and one dishwasher machine's water discharge pipes were observed to be below the floor level rim of the floor sinks. In the event of sewage back up, this would allow waste water to contaminate food production and the dishwashing machine. Registered Dietitian (RD) 1 acknowledged the discharge pipes were in or at the floor level.

On 5/7/2019 at 1:30 p.m., an interview with RD1 and Facilities Worker 1 (F1) and F2 acknowledged the three areas did not meet the standard clearance of a required air gap and would initiate repairs to correct the situation.

Based on observation, interview and document review, the facility failed to maintain a system for controlling sources of infections in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and regulations when:

1. Floors in the C-Section Operating room were not disinfected after procedures.
2. Instruments ready for use, in a minor general surgery instrument tray, were not maintained according to infection control standards.

Findings:

1. On May 6, 2019, at 10:15 a.m., during an observation and interview during the turnover cleaning of the C-Section Operating Room, EVS 1 stated the product she used for the disinfection of the floor for the turnover cleaning was Prominence. She stated that the dwell time for the product was 5 minutes. In the housekeeping closet, Environmental Services Technician (EVS 1) presented the dispenser for the product. The product was Prominence, which is a floor cleaner not a disinfectant. This was validated by the IP.

On May 6, 2019 at 10:15 a.m., during an interview with Registered Nurse (RN) 6, she stated the facility adopted the Association for peri-Operative Registered Nurses (AORN), as one of the nationally recognized guidelines for infection control program in perioperative services.

On May 6, 2019 at 1:30 p.m., during an interview with Environmental Services Manager (Mgr 1), he stated the product that should be utilized for the cleaning and disinfection during the turnover of any operating room is Virus II 256, a disinfectant. He stated he had already replaced the product and performed just in time training with the EVS staff for the proper procedure and product to be used for turnover cleaning of the C-Section Operating Room.

According to the AORN (Association for Peri-Operative Registered Nurses) Guidelines for Perioperative Practice (2019), Environment of Care Section III.c.5, "The floors and walls of operating and procedure rooms should be cleaned and disinfected after each surgical or invasive procedure if soiled or potentially soiled (eg, by splash, splatter, or spray)."

2. On May 6, 2019, at 10:30 a.m., in perioperative services, a minor general surgery tray was inspected. Out of eighty-three instruments, 2 were found to have engraving on the surface and one instrument was found to have some residue on the distal end. These findings were validated by Infection Preventionist (IP) and RN 6, and taken to CSPD (Central Supply, Processing and Distribution Department) and validated by the Sup 1.

On May 6, 2019, at 10:15 a.m., during an interview with RN 6, she stated the facility adopted the Association for peri-Operative Registered Nurses (AORN), as one of the nationally recognized guidelines for the infection control program in perioperative services. According to AORN (2019), Guideline on Instrument Cleaning: "Items that are not clean or do not function correctly can put a patient at risk for injury or SSI (Surgical Site Infections). Inspection and evaluation provide an opportunity to identify soiled or damaged instruments and to remove these items from service until they are cleaned or repaired; cleanliness; correct alignment; corrosion, pitting, burrs, nicks, cracks; sharpness of cutting edges; wear and chipping of inserts and plated surfaces; [and] other defects. Use of instruments that are not thoroughly cleaned, are damaged, or do not function correctly poses a risk to patient safety."

Based on staff interview and document review, the General Acute Care Hospital (GACH) failed to validate the competency of Family Birth Center Registered Nurses (FBC RNs) to perform examinations using a sterile speculum (instrument used to help visualize the vagina and cervix).

This failure precluded the GACH from evaluating RN clinical performance of this skill, assuring that care was provided by staff able to safely meet patient needs.

Findings:

Review of Clinical Laboratory statistics for February - April, 2019, reflected 12 physician-ordered fetal fibronectin (fFN) tests ordered to determine short-term risk of premature birth. Medical record review indicated collection for nine of the tests (Patients 49 - 57) was done by five FBC RNs (RNs 7 - 10 and RN 62).

Review of staff educational files revealed that while RNs 7 - 10 and RN 62 had completed Medical Screening Examination Standardized Procedure competencies and the Vaginal Exams portion of the "Labor & Delivery Skills Checklist," there was no specific documentation that the nurses had demonstrated proficiency in sterile vaginal speculum examination.

Review of the 7/26/18, "Medical Staff Rules and Regulations" reflected, "All patients who present to...the Labor and Delivery Unit, and who request examination and treatment for...active labor, shall be evaluated for the existence of...active labor. This screening examination may be performed by the following persons...In the Labor and Delivery Unit (L & D): by a...registered nurse (RN) who has been determined by the L & D nurse manager to be qualified and experienced in obstetrical nursing and who is required to follow standardized procedures approved by the Medical Staff."

Review of the 4/27/17, "Obstetric Medical Screening Exam Standardized Procedure" indicated, "The Registered Nurse may perform this function under the following circumstances...Evaluation of Preterm Labor [labor which begins before 37 weeks of pregnancy]...Obtain physician order for vaginal speculum exam for Fetal Fibronectin testing as appropriate...."

The GACH's 5/26/16, "Admission, Transfer and Discharge Criteria - FBC policy reflected, "Nursing Responsibility for Labor Admission Criteria...Perform a complete assessment according to the Obstetrical Medical Screening Standardized Procedure as soon as possible upon arrival...."

The 7/27/17 "Family Birth Center Basic Care Standards" indicated, "Labor and Delivery registered nurses with validation of performance can complete the following...Sterile speculum exams...."

During a 10:46 a.m., 5/8/19 interview, the Director of the Family Birth Center (DFBC) indicated she was unable to locate clinical competencies for sterile speculum vaginal exams in the educational files of RNs 7 - 10 and RN 62. The DFBC indicated the exams were "done rarely" but thought a competency had been developed.