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Based on medical record review and staff interview, the facility failed to ensure the status of advanced directives were determined and documented for 3 of 22 sample patients (#12, #13, #18). The findings were:

1. Review of the medical record showed patient #12 was admitted on 3/24/14 and discharged on 4/2/14. The medical record failed to show any documentation related to the patient's right to have an advanced directive followed or information provided to create/formulate an advanced directive.

2. Review of the medical record showed patient #13 was admitted on 5/19/14 for a planned surgery. The medical record failed to show any documentation related to the patient's right to have an advanced directive honored or information provided to create/formulate an advanced directive.

3. Review of the medical record showed patient #18 was admitted on 4/27/14 due to shortness of breath and was discharged on 4/30/14. The medical record failed to show any documentation related to the patient's right to have an advanced directive followed or information to create/formulate an advanced directive.

4. Interview with the interim CCO on 6/5/14 at 10:10 AM verified the information related to advanced directives was not available in these patients' records. She further stated the information was to be assessed during the admission process according to the policy and procedure and then documented in the record.

Based on staff interview and review of OR humidity logs, the facility failed to ensure an acceptable humidity level was maintained in 2 of 2 ORs (OR room #1, OR room #2). The findings were:

Review of the facility operating room humidity log for May 2014 showed the following recorded humidity levels were under the required 20%-60%: OR room #1 was at 16% on 5/12/14. OR room #2 was at 9% on 5/1/14, 15% on 5/3/14, 14% on 5/8/14, and 15% on 5/12/14. The documentation showed these were days the facility utilized the ORs. However, the facility failed to show any corrective action was taken when unacceptable humidity levels were recorded. Interview with CRNA #1 on 6/4/14 at 1:10 PM verified the facility had an ongoing issue with relative humidity levels in both OR suites. Interview with the maintenance director on 6/5/14 at 8 AM revealed he was unaware the relative humidity in both OR suites was an issue, and the facility failed to have a plan with a specific timeframe to address this problem.

Based on staff interview and review of credentialing files and hospital bylaws, the facility failed to follow their established credentialing and privileging procedures for 7 of 7 current practitioners. The findings were:

On 6/5/14 beginning at 8:35 AM credentialing and privileging files for current practitioners were reviewed; relevant portions of the current hospital bylaws were reviewed at the same time. The survey sample consisted of 7 practitioners (providers #1 through #7) including allied health providers, CRNAs, active staff, courtesy staff, and remote (teleradiology) staff. Collectively, these documents revealed the following discrepancies between actual practice and established procedures:

1. All 7 sample files (providers #1 through #7) showed incomplete and inconsistent use of forms developed and implemented by the facility to regulate the processes for credentialing and privileging. Specifically, the Medical Executive Committee (MEC) was required by hospital bylaws (Article VI, Appointment and Reappointment; Article VII, Determination of Clinical Privileges) reviewed and approved 3/26/13, to recommend in writing approval of appointment or reappointment applications. In all 7 files reviewed, one or both the appointment/reappointment and request for clinical privileges was incomplete and no recommendation to accept or deny the application was made. Further, the Board or Trustees (BoT) failed to document approval of the appointment/reappointment request as required by established facility procedures. In 3 of 7 files, the Trustees issued a letter acknowledging reappointment, but failed to include a statement defining clinical privileges, failed to include a signature and date to validate the announcement, or included date discrepancies (i.e., letter dated prior to the actual committee meeting).

2. In 1 (provider #7) of 7 files reviewed, the MEC and BoT stated conditional acceptance of the provider's request for reappointment pending completion of required continuing medical education (CME) training. The conditional approval was dated 5/8/13 and established a requirement for all CME to be completed within 90 days. However, as of 6/5/14, 13 months after issuing conditional approval, the credentialing file contained no evidence to show the conditions of approval were met and, further, that full reappointment was approved by the BoT.

3. Interview with credentialing staff #1 on 6/5/14 beginning at 8:55 AM confirmed that the 7 files reviewed contained incomplete or inconsistent information and, in all cases, failed to clearly establish MEC and BoT actions on applications for appointment, reappointment, or requests for clinical privileges. She further acknowledged the lack of documentation to clarify the resolution of conditional acceptance for provider #7.

Based on observation, medical record review, staff interview, and review of policies and procedures, the contract physician procedure list, manufacture's instructions and product label information the facility failed to ensure provision of services requirements were met which involved infection control and care plan issues. The facility failed to ensure infection control practices were adequate which included use of an expired disinfecting product, ensuring flooring integrity in both OR suites, ensuring single use brushes were used only once for cleaning endoscopes, ensuring hand hygiene prior to re-gloving, and ensuring contracted physicians utilized adequately cleaned and disinfected cystoscopes and suction equipment during procedures (refer to C-278). In addition, the facility failed to ensure 5 of 5 ice machines available for patient use were adequately cleaned (refer to C-279). Further, the facility failed to develop a policy and procedure to ensure oversight of contract services which included urology and otolaryngology services. This resulted in the facility failure to ensure cystoscopes and suction machines were cleaned and sterilized to prevent infection (refer to C-273). Also, the facility failed to ensure a care plan was developed for 2 of 22 patients (C-298). The accumulated impact of these failures resulted in the determination that the facility failed to meet the Condition of Participation for the Provision of Services.

Based on observation, policy and procedure review, contract physician procedure list review, and staff interview, the facility failed to ensure policies and procedures were in place related to oversight of contract physician services. The findings were:

1. Review of policies and procedures failed to show the facility had developed a policy to include services provided by contracted physicians. Review of a procedure list concerning contracted physicians revealed a contracted obstetrician performed the following cystoscopic procedures outside of the OR environment in an OB suite: patient #28 on 1/8/14, patient #29 on 2/5/14, patient #30 on 2/19/14, patient #31 on 2/19/14, patient #32 on 6/4/14, and patient #27 on 7/17/13. Observation in the on-site outpatient clinic on 6/4/14 at 2 PM revealed supply carts in exam room #4 and in the adjacent procedure room had a suction machine with a suction canister and connected tubing. Interview at that time with the outpatient clinic manager confirmed the two supply carts belonged to the contracted otolaryngologist, and were available for patient use. The manager also confirmed the facility failed to ensure the suction equipment was properly cleaned and disinfected.

2. Interview with the quality manager and CRNA #1 on 6/4/14 at 1:10 PM confirmed the facility failed to develop a policy regarding oversight of services performed by contracted physicians. They further confirmed the facility failed to place safeguards in place to ensure the OB suite in which cystoscopic procedures were performed was adequately disinfected, the scopes were adequately cleaned and disinfected, or that adequate aseptic technique was used during the procedures. In addition, they confirmed the facility failure to develop a policy regarding contract physician services resulted in failure to ensure the suction equipment in the outpatient clinic, brought to the facility by the contracted otolaryngologist and available for patient use, was adequately cleaned and disinfected.

Based on observation, staff interview, review of policies and procedures, review of manufacturer's instructions, and review of product label information, the facility failed to ensure safe and sanitary conditions in 3 of 6 patient care areas as evidenced by expired products used on a washer/disinfection machine, failure to properly disinfect laryngoscope blades, reuse of single-use items during endoscope reprocessing, and failure to apply stringent hand hygiene practices. The facility further failed to identify and repair cuts and punctures in the floors of 2 of 2 ORs. In addition, the facility failed to require practitioners to demonstrate that patient care equipment brought into the hospital for patient procedures was properly disinfected prior to use. The findings were:

1. Tour of the sterile processing area adjacent to the operating suites on 6/3/14 beginning at 8:20 AM revealed 1 of 3 concentrated wash solutions used in an automated surgical instrument washer/disinfection machine were expired. The label on the surgical lubricant concentrate showed an expiration date of October 2013. The sterile processing technician stated in interview on 6/3/14 at 9:05 AM that she checked expiration dates, but missed the expired product. The IP further confirmed in interview on 6/3/14 at 9:15 AM that expired products were not to be used in sterile processing.

2. Interview with the cardio/respiratory department director on 6/3/14 beginning at 3:40 PM revealed staff kept laryngoscope blades in the department in the event of an emergent need to intubate a patient. The director further stated the blades were reused after washing with an enzyme-based detergent; she acknowledged the laryngoscope blades were not subjected to a high-level disinfectant or sterilized after washing. Subsequent observations in the outpatient procedure room on 6/4/14 at 2 PM revealed a stock of 8 laryngoscope blades were maintained in this area. It was confirmed in interview with the IP on 6/4/14 at 2:10 PM that these blades were similarly washed in an enzyme-based detergent, but not processed through high-level disinfection.

The Centers for Disease Control and Prevention (CDC) published a nationally accepted guideline, Guidelines for Sterilization and Disinfection, 2008. The CDC guideline states that semi-critically items, specifically laryngoscope blades, should be processed through a high-level disinfection cycle prior to reuse; the stated intent of the CDC recommendation is to prevent the potential transmission of infection between patients. Welch-Allen, the manufacturer of the laryngoscope blades observed in the facility, further requires high-level disinfection between uses.

3. Observation of flexible endoscope reprocessing was observed on 6/4/14 beginning at 10:50 AM; observation of a 47 minutes period revealed the following non-compliance practices:
a. The OR technician opened a single-use channel brush and used the brush to clean the first of two endoscopes used in an earlier procedure. She then proceeded to clean the second endoscope with the same single-use brush. She stated in interview on 6/4/14 at 11:10 AM that she used the same brush on both endoscopes when they came from the same patient. Review of the brush packaging showed the manufacturer labeled the product for single-use only, not for multiple uses on the same patient. The IP was present for the observations and subsequent interview, she confirmed the channel brush was single-use only and the practice of reusing, even among endoscopes from the same patient, did not meet the stated requirements of the manufacturer.
b. The OR technician was observed to change her gloves 5 times during endoscope reprocessing, including when transitioning from dirty to clean equipment. At no time during the 47 minute observation did she perform hand hygiene. Interview with the IP during the observation confirmed the need to perform hand hygiene when changing gloves; she acknowledged the observed practice was not consistent with acceptable practices for endoscope reprocessing.

4. Observation in ORs #1 and #2 on 6/3/14 beginning at 1:35 PM showed the flooring in both rooms had cuts and punctures through the flooring material, leaving the flooring unsealed and non-cleanable. The OR manager stated in interview on 6/3/14 at 1:40 PM that he had not previously seen the cuts in the flooring and confirmed the need to maintain a sealed, intact surface in surgical areas.

5. Observation in the on-site outpatient clinic on 6/4/14 at 2 PM revealed 2 supply carts in exam room #4 and the adjacent procedure room. Each cart had a suction machine with a suction canister and connected tubing. At that time, the outpatient manager confirmed the contracted otolaryngologist owned and supplied the carts and supplies. He further confirmed the facility failed to ensure the suction machines were adequately cleaned and disinfected.

Review of a facility supplied list showed a contracted physician performed the following cystoscopic procedures outside of the OR environment in an OB suite: patient #28 on 1/8/14, patient #29 on 2/5/14, patient #30 on 2/19/14, patient #31 on 2/19/14, patient #32 on 6/4/14, and patient #27 on 7/17/13.

Interview with the quality manager and CRNA #1 on 6/4/14 at 1:10 PM confirmed the facility did not supply or clean equipment brought in by contracted physicians in the on-site outpatient clinic, and did not supply or clean cystoscopes used by the contracted physician in the OB suite. Further, they confirmed the facility failed to provide monitoring or oversight concerning contracted physicians to ensure that supplies, equipment, and scopes were cleaned and disinfected for patient use.

Based on observation and staff interview, the facility failed to ensure 5 of 5 ice and water dispenser units (the emergency department [ED], obstetrics [OB], Medical/surgical, intensive care unit [ICU], and the cafeteria) were maintained in a sanitary state. The findings were:

Observation on 6/5/14 at 11:10 AM showed the ice and water dispenser units throughout the facility were not clean. These included the following:
a. The dispenser unit located in the ED was noted to have a thick whitish brown moist build-up on the drip tray. Additionally, the plastic part where the ice/water dispensed from was soiled with a white and brownish build-up on the interior side.
b. The dispenser located in the ICU was not clean with the drip tray having brown and white build-up and the the plastic part where the ice/water dispensed from was soiled with a moist white and green build-up on the interior side.
c. The OB unit ice and water dispenser was soiled with a build-up of hard water deposits around the dispensing spout and there was a rust colored liquid pooled in the drip tray.
d. The medical/surgical floor ice and water unit was also noted to have a build-up on the drip tray and the plastic dispenser spouts.
e. The ice and water dispenser located in the cafeteria was also noted to need more frequent cleaning with build-up on both the catch tray and the plastic dispenser spouts.

According to Food Code 2013, U.S. Public Health Service 4-601.11: "(A) EQUIPMENT FOOD-CONTACT SURFACES and UTENSILS shall be clean to sight and touch. (B) The FOOD-CONTACT SURFACES of cooking EQUIPMENT and pans shall be kept free of encrusted grease deposits and other soil accumulations. (C) NonFOOD-CONTACT SURFACES of EQUIPMENT shall be kept free of an accumulation of dust, dirt, FOOD residue, and other debris."

Interview with the interim CCO on 6/5/14 at 11:10 AM while observing these units revealed the equipment was not in a clean condition. She stated there had been a recent meeting related to whose responsibility it was to keep the water and ice dispensers clean and sanitary, and the new procedures were not yet implemented.

Based on medical record review and staff interview, the facility failed to develop a written plan of care for 2 of 22 sample patients (#10, #12). The findings were:

1. Review of the medical record showed patient #12 was admitted on 3/24/14 and was discharged on 4/2/14. The patient had diagnoses that required "emergency detention" status due to safety. Record review showed there was not a care plan developed related to the patient's needs during the 10 day stay.

2. Review of the medical record showed patient #10 was admitted on 3/6/14 and was discharged the same day. The patient had diagnoses that required "emergency detention" status for safety. Review showed there was not a care plan developed related to the patient's needs.

3. Interview with the interim CCO on 6/5/14 at 10:10 AM verified there was no written care plans developed for these patients
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Based on medical record review, staff interview, and policy and procedure review, the facility failed to ensure informed consents were completed for 2 of 22 sample patients (#4, #7) who required informed consents. The findings were:

1. Review of the medical record showed patient #4 was admitted on 4/18/14 with a diagnosis of active labor. Review of two anesthesia informed consents showed the forms were left blank at the top of the document where the name of the patient should have been, and the name of the CRNA or physician should have been. In addition, the date the patient signed was left blank on the documents, and the space for the CRNA or physician to sign and date were left blank.

2. Review of the medical record revealed patient #7 was admitted on 6/2/14 with mental status changes. The record included a consent form for blood or blood product transfusion. The form was left blank at the top of the document where the name of the patient should have been and the patient signature line was blank. The consent included a note that showed "the patient is confused with critical lab values implied consent. No family available." The consent had two RN signatures; however, the date and time was blank.

3. Interview with the interim CCO on 6/5/14 at 10:10 AM confirmed all informed consents should be completed in the spaces provided, including signatures with the dates the consents were signed.

4. According to the facility policy and procedure titled, "Obtaining Patient Consent for Surgery, with a last legible review date of 4/1/10, "The RN will provide the proper forms for the patient to sign after the physician has explained the impending procedure to the patient...The forms must be properly signed, dated, and witnessed by the RN, with the procedure or alternate procedures clearly written...It is the physician's responsibility to explain procedures, risks, and alternatives to the patient. It is important to distinguish between the process of obtaining patient's informed consent and the clerical function of obtaining patient's signature on a consent form, he/she is performing merely a ministerial or administrative function."

Based on observation and staff interview, the facility failed to safeguard the confidentiality of patient record information in 2 of 2 ancillary storage sites (ambulance garage, nursing dormitory). The findings were:

Observation on 6/3/14 at 8:20 AM confirmed the maintenance director had access to multiple boxes of closed medical records stored throughout the ambulance garage. Interview with the maintenance director at that time showed all maintenance staff had access to the ambulance garage. Observation on 6/3/14 at 8:50 AM showed the maintenance director had access to multiple boxes of closed medical records stored in the basement of the nursing dormitory in 5 separate rooms. At that time he stated maintenance staff, as well as boarders (who were medical professionals working at the facility), could enter the building. The basement door was missing the doorknob, and had no lock. At that time, within the building the maintenance director led the surveyor up to the first floor to the day room area where boarders resided, and stated the door to the day room area should have been locked. Interview with the quality director on 6/3/14 at 9:25 AM showed there were 9 boarders in the nursing dormitory besides herself. She further stated the maintenance staff and boarders would not have a need to know information contained in the closed medical records stored in the ambulance garage and nursing dormitory.