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Based on observation, staff interview, and review of quality council meeting minutes and records of QAPI activities, the governing body failed to require the hospital to conduct a causal analysis and implement performance improvement initiatives for problems in surgical safety (A940) and, further, failed to require anesthesia services to establish a QAPI program to assess the quality and safety of its services (A263). These deficiencies, in particular unresolved patient safety issues related to reprocessing medical devices, resulted in 2 immediate jeopardy situations in the past 4 months (November 8, 2011 and March 21, 2012). The systematic failure to identify and resolve potentially unsafe practices resulted in a determination the hospital did not meet the condition of participation for governing body.

Based on medical record review, staff interview, and review of policies and procedures, the provider failed to obtain advance directive information for 2 of 25 sample inpatients (#12, #14) for whom advance directives were required. The findings were:

1. According to the admission sheet, patient #12 was admitted to the TCU on 3/12/12. Review of the admission orders showed the physician included "DNR" [Do Not Resuscitate]. However, detailed review of the record failed to show evidence the patient had expressed a wish not to be resuscitated. On 3/20/12 at 3:30 PM RN #1 confirmed the advance directive information was not in the patient's TCU record. On 3/21/12 at 4:10 PM the interim unit manager stated advance directive information was to be placed in the new record when a patient changed to TCU status. He further stated this was not consistently done.

2. Review of the medical record for patient #14 showed s/he was admitted on 3/19/12. Further review of the medical record showed the area of advanced directives was not addressed. Interview with the unit manager on 3/21/12 at 2:50 PM confirmed the facility failed to address the area of advanced directives for the patient.

3. Review of the facility's policy and procedure, "Advance Directives," Number PCA 0200, last reviewed and revised 3/17/08 showed "Admission personnel will document in the medical record whether the patient has completed an advance directive and that information concerning advance directives has been given to the patient/significant other during the admission process."


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Based on observation, staff interview, and review of medical records and policies and procedures, the facility failed to ensure patient record information was maintained in a confidential manner for 6 of 19 patients (#5, #12, #13, #14, #15, #19) in the medical/surgical and TCU inpatient areas. The findings were:

Observation on 3/19/12 at 5:35 PM showed open containers attached to the wall beside each patient's door in the medical/surgical and TCU areas. East container held medical record information that protruded above the container approximately one and one half inches. Review of the medical record information in the containers for patients #5 and #12 on 3/20/12 showed they contained current nursing notes, care plans, patient education, and wound information, each with PHI including the patient's name, date of birth, medical record number, care and treatment information, and physician's name. Similar documents were also observed in the containers on the room doors for patients #13, #14, #15, and #19. Additionally, from 10:30 AM through 5 PM that day, various papers were observed to be folded back and sticking up above the medical record cover. These papers and the rest of the medical record information were available to numerous visitors and staff walking up and down the hallways. At 5 PM that day RN #2 stated this practice was to allow the nurses to have access to their notes when the physicians had the patient records. On 3/21/12 during an interview at 4:10 PM, the interim unit manager stated the partial records had been kept outside each door "for years" for the nurses' convenience. He confirmed the medical record information was not protected from unauthorized individuals.
According to the facility's policy and procedure, "Breach of Unsecured PHI," Number ADM-H 0240, last reviewed and revised on 11/16/11, unsecured PHI means the
medical record information "...is not secured through the use of approved technologies or methodologies." Further review showed that to be approved, PHI must be rendered "unusable, unreadable, or indecipherable to unauthorized individuals."

Based on observation, staff interview, and review of quality council meeting minutes and records of QAPI activities, the facility failed to investigate and resolve problems in their processes for reprocessing reusable medical devices. As detailed at A285, facility staff failed to recognize and resolve deficiencies in their methods for inspecting reusable LMAs during reprocessing or prior to subsequent surgery cases. The facility further failed to develop and implement ongoing QAPI initiatives in anesthesia services and prioritizes improvement activities to promote patient safety (A313). The cumulative effect of these systemic deficiencies increased preventable risks in surgical services and, further, resulted in a determination the facility failed to meet the condition of participation for quality assessment and program improvement.

Based on observation, staff interview, and review of quality council meeting minutes and records of QAPI activities, the facility failed to evaluate and resolve patient safety concerns with reusable medical devices. The facility further failed to develop and implement QAPI initiatives for its anesthesia services. The findings were:

1. Review of results from a complaint survey completed in November 2011 showed the facility was cited for failure to follow manufacturer's instructions for reprocessing reusable LMAs. The failures identified during the November 2011 survey resulted in a determination of immediate jeopardy (IJ) in the area of surgical services on 11/8/11; the IJ was abated on 11/9/11. Related findings were cited in the area of infection control.

Minutes from the hospital's November 2011 quality council meeting were reviewed on 3/21/12; these minutes briefly noted the survey results. However, there was no evidence to show whether the hospital conducted causal analysis of the deficiencies cited in surgical services. Neither was there any further documentation related to the problems cited with LMA reprocessing in subsequent quality council minutes or notes from monthly surgical services meetings. There was no evidence to show that staff considered and implemented a system for monitoring compliance with the manufacturer's instructions for LMA reprocessing.

The CNO and four other members of the hospital quality council were interviewed on 3/22/12 at 10:10 AM; the group acknowledged the facility failed to complete a causal analysis of deficient practices related to LMA inspection and reprocessing. The CNO further stated there were no records of the actions that might have been performed by the OR nurse manager and hospital quality coordinator regarding the November 2011 survey findings; neither of these individuals were currently employed by the facility.

2. Multiple interviews with ST #1 on 3/19/12 - 3/22/12 revealed she was responsible for revising policies and procedures for reprocessing LMAs after the November 2011 survey. She stated her supervisor, the OR manager, did not review her revised procedures, neither had he offered to assist her in developing enhanced oversight or monitoring of device reprocessing steps. The lack of management assistance and oversight was confirmed in a separate interview with ST #2 on 3/21/12 at 8:45 AM.

Interviews with the temporary interim OR manager on 3/20/12 at 9:20 AM and clinical nursing coordinator #2 on 3/20/12 at 3:30 PM further confirmed neither performed an oversight role in sterile processing nor were they aware of any monitoring activities established specifically for ensuring that reusable LMAs were inspected and reprocessed as required by the manufacturer or as defined by hospital policies and procedures.

3. As detailed in A940, the facility was cited on the present survey for recurring concerns in surgical services, concerns that resulted in a determination of IJ. The deficiencies cited in A940 are again related to the facility's failure to follow the manufacturer's instructions for reprocessing LMAs.

Based on observation, staff interview, and review of quality council meeting minutes and records of QAPI activities, the facility failed to ensure patient safety in surgical services was included among its performance improvement priorities. The findings were:

As described in A285, the facility failed to identify and investigate the causal elements of deficiencies cited for surgical services that resulted in an IJ determination in November 2011. The fundamental deficiency that defined the IJ was a failure to follow manufacturer's instructions for reprocessing reusable medical equipment, specifically reusable LMAs prepared for selected surgery cases. The failure to assess the systemic factors of its failures and to implement a successful performance improvement plan contributed to a subsequent IJ situation on 3/21/12 in surgical services, again related to concerns uncovered in the hospital's LMA reprocessing protocol. As detailed in A940, the facility failed to develop an effective system to ensure LMAs with cracked and deteriorated connector ends were identified and removed from service. It was further noted that quality council meeting minutes provided no evidence of causal analysis, directed interventions, or outcome measures to assess patient safety risks related to LMA reprocessing.

Based on observation, medical record and policy and procedure review, and staff interview, the provider failed to adequately assess 1 of 1 sample patients (#12) admitted into TCU status. The findings were:

Review of the admission sheet showed patient #12 was admitted to TCU on 3/12/12. Observation and an attempted interview in the patient's room at 4:05 PM on 3/20/12 showed the patient's dentures did not fit well; the upper dentures kept falling down, and the patient's speech was hard to understand. In addition, the patient was hard of hearing and was not wearing a hearing aid. During an interview on 3/20/12 at 5:20 PM, RNs #1 and #3 stated they had a dental adhesive but did not know if it had been applied, nor did they know if the patient even used an adhesive.
Review of the medical record showed the patient had not been assessed for use of dentures or a hearing impairment, and the section for discharge screening information was blank. According to the provider's policy and procedure, "Assessment, Admission, Reassessment: Inpatients" Number PCA 0210, last reviewed and revised 1/30/09, "An admission assessment will be completed on each inpatient within 24 hours of admission. A complete systems reassessment will be preformed a minimum of once every twenty-four (24) hours."
In an interview on 3/21/12 at 4:10 PM, the interim unit manager confirmed the assessment had not been completed. He stated he could not find documentation that showed the resident was asked about, or if s/he refused, denture adhesive.

Based on observation, medical record, staff interview, and review of policies and procedures, the facility failed to develop and maintain current, individualized, interdisciplinary care plans that were revised to meet the changing needs of 18 of 30 sample inpatients (#4, #5, #11, #12, #14, #15, #19, #20, #22, #24, #25, #26, #32, #34, #35, #36, #37, #38). The findings were:

1. Review of current care plans for patients #4, #5, #11, #12, #14, #15, #19, #20, #22, #24, #25, #26, #32, #34, #35, #36, #37, #38 showed the same generic care plan was utilized for each patient. Each care plan was set up with 12 focus areas (safety, fall risk, psychosocial, skin integrity, nutritional status, comfort, etc) an expected outcome, interventions, and an evaluation section for four days. Each patient's focus area, expected outcome, and interventions were the same. However, there was an area for an individualized goal included in each focus area. Some patients had generalized entries such as "No falls this shift" for the individualized goal of fall risk or "Will use call bell for assistance" for the individualized goal of safety, but specific, patient oriented goals were not developed for all focus areas.

2. Review of the care plan for patients #5 revealed one of the goals was to maintain an oxygen saturation above 90%. However review of the physician's orders showed the physician ordered the patient's saturation level to be maintained above 92%. In addition interventions provided by respiratory care services were not included in the care plan.

3. Observation on 3/20/12 at 9:35 AM revealed patient #4 was in bed and receiving nutrition per a tube feeding. Review of the care plan showed interventions and goals that addressed the patient's NPO (nothing by mouth) status but did not address the patient's tube feeding. Review of this care plan also showed the patient was currently receiving the BiPAP continuously and interventions provided by respiratory care services were not included in the care plan. Interview on 3/20/12 at 9:55 AM with RN #4 revealed the was no longer receiving the BiPAP continuously and the tube feedings were started on 3/18/12.

4. On 3/20/12 at 9:55 AM RN #4 and clinical coordinator #1 confirmed the care plans were generic, lacked individualization, and were not consistently revised with changes in each patient's condition. At 10:25 AM that day the clinical coordinator stated that all disciplines, including respiratory care, were to use the care plan because it was an interdisciplinary plan of care. During an interview on 3/21/12 at 3:05 PM, the CNO acknowledged the problem and stated the facility had initiatives planned to correct the care plans, but they had not been implemented.

5. According to the facility's policy and procedure, "Interdisciplinary Care Planning," Number PCA 0740, last reviewed and revised 3/17/08, "Each patient will have a plan of care that will focus upon individual patient needs...evaluated and updated as needed...Interdisciplinary collaboration and discussion will be utilized to determine and evaluate the plan of care."

Based on observation, staff interview, and review of nationally recognized standards for medication administration, the provider failed to ensure accepted standards of practice were maintained during administration of injectable medications. This failure affected 2 of 3 outpatients (#16, #17) and 1 of 1 inpatients (#4) observed for administration of intravenous (IV) medications. The findings were:

1. According to the CDC recommendations for Safe Injection Practices, updated 2011, the septum on the medication vial and intravenous ports should be disinfected before piercing. On 3/20/12 from 7:20 AM to 9 AM during the pre-operative and operative phase of patient #17's surgery, anesthesiologist #1 was observed drawing up and administering intravenous medications to the patient. The observation revealed the anesthesiologist did not disinfect the septum on the medication vials prior to withdrawing medication into the syringe; nor did he disinfect the intravenous ports prior to administering each medication. Observation from 9:20 AM to 9:58 AM during the pre-operative phase of patient #16's surgery revealed the anesthesiologist continued this practice. During an interview on 3/21/12 at 10 AM, the anesthesiologist acknowledged his failure to disinfect the vials and intravenous ports according to the CDC recommendations was not an acceptable standard of practice.

2. On 3/20/12 at 8:50 AM RN #4 was observed while preparing medications, including Phenobarbital, for IV administration for patient #4. In order to obtain the correct dose, the RN had to use syringes to measure the medication, and air bubbles became trapped with the medication in the smaller syringe. While attempting to remove the bubbles, the RN placed her fingers on the plunger of the syringe and moved it back and forth inside the barrel. This action contaminated the inside of the syringe and, therefore, the medication prior to the RN injecting it back into the vial and re-drawing the correct dose. When questioned about this technique, the RN stated she was unaware she had touched the plunger, thus contaminating it. She stated the syringe was "obviously not sterile" and discarded the syringe and the remainder of the medication in the vial. However, she also stated she would have administered the medication if not questioned by the surveyor.

3. According to Elkin, Perry, and Potter in "Nursing Interventions & Clinical Skills," 4th Edition, 2007: page 417, one should "Avoid touching" the plunger of a syringe. Review of the same reference on page 625 showed that prior to injecting an IV medication into an injection port, one should "...cleanse connection port with antiseptic swab. Allow to dry."

25745

Based on medical record review, staff interview, and policy and procedure review, the facility failed to administer medications in a timely manner for 1 of 30 sample patients (#5). The facility also failed to revise their policy and procedure concerning acceptable timeframes that met the requirements for medication administration. The findings were:

Review of the facility policy titled, "Administration of Medications," last revised 3/20/08, revealed the following, "Medication will be administered within 1 hour of scheduled administration time. (For example needs to be given at 1900 [7 PM] could be given at 1830-1930 [6:30 PM-7:30 PM])." No other timeframe information concerning medication administration was documented. During an interview on 3/21/12 at 10 AM, the acting pharmacy director confirmed the facility had failed to update their policy concerning administration of medications to include "Medications not eligible for scheduled dosing times; Medication eligible for scheduled dosing times; Administration of eligible medications outside of their scheduled dosing times and windows; and Evaluation of medication administration timing policies, including adherence to them....Policies and procedures for medications eligible for scheduled dosing times must also address: first dose medications, including parameters within which nursing staff are allowed to use their own judgement regarding the timing of the first and subsequent doses..."

The lack of clear policy guidance resulted in a 7-hour delay in administering Prednisone to patient #5. Review of the medical record for the patient showed an ED physician ordered Prednisone 60 milligrams twice daily on 3/19/12 at 2 PM; the patient was subsequently admitted to the medical unit the same day. Review of both the ED record as well as the clinical record following admission showed the patient did not receive the initial dose of Prednisone until 9 PM on 3/19/12. Further review showed no evidence a nursing evaluation was completed to determine that a 7-hour delay would not adversely affect the patient. On 3/22/12 at 8:10 AM the interim ED manager stated the administration schedule was determined by pharmacy computer application that defines all twice daily administration times as 9 AM and 9 PM. She further stated the current system does not include an option for implementing alternatives.

Based on medical record review, staff interview, review of facility policy and procedure, and medical staff bylaws, the facility failed to ensure physician's orders were dated, timed, and authenticated in a timely manner for 4 of 30 sample inpatients (#15, #24, #26, #34). The findings were:

Review of the facility policy titled, "Verbal Orders" last revised on 1/20/10 revealed, "The ordering practitioner will sign the order within 48 hours." Review of the current medical staff bylaws revealed physicians were required to date, time and sign all orders within 48 hours. The facility's failure to follow the above policy and medical staff bylaws was noted during review of the following medical records:

a. Review of the medical record for patient #15 on 3/20/12 at 2:30 PM revealed a telephone order for "Foley catheter to gravity drainage" dated 3/16/12 at 6:45 PM. The order was not authenticated by a physician. Further review revealed an order on 3/1/12 at 12 Noon to "Start Lovenox @ 2200 [10 PM] tonight, 30 mg Subq Bid" that was not authenticated by a physician.
b. Review of the medical record for patient #24 showed the patient had telephone orders for seclusion every four hours from 5/7/11 at 2:30 PM through 5/19/11 at 6 AM. The following orders were signed by the physician, but not timed or dated: the 5/17/11 order initiated at 7 PM, the 5/17/11 order initiated at 11 PM, the 5/18/11 order initiated at 3 AM, the 5/18/11 order initiated at 7 AM, the 5/18/11 order initiated at 6 PM, the 5/18/11 order initiated at 10 PM, and the 5/19/11 order initiated at 2 AM. In addition, the facility failed to clarify whether the 5/14/11 seclusion order for 3 PM was a physician's written order or a telephone order, and the RN did not sign, date, or time the order.
c. Review of the medical record for patient #26 revealed a telephone order for "seclusion only" dated 4/13/11 at 3:20 PM. The physician signed the order, but failed to date and time the order.
d. Review of the medical record for patient #34 revealed a telephone order concerning "OK to D/C [discharge] home today" dated 1/18/12 at 9:30 AM. The order was not signed by a physician until 2/6/12 at 8:40 AM (18 days).

Based on observation, staff interview and review of policies and procedures, the facility failed to ensure medications in 1 of 3 anesthesia carts were secure from unauthorized individuals. The findings were:

According to the policies and procedures entitled, "Administration of Medication", revised 3/20/08, "Medications will be stored such that no unauthorized persons can obtain access to the medications." Periodic observations on 3/20/12, 3/21/12 and 3/22/12 revealed the same anesthesia cart remained in the operating suite corridor area. The observation revealed the cart contained unlocked drawers with opened and unopened medications and supplies. The following medications were observed in the cart: Propofol, Succinylcholine, Recromium Bromide, Epinephrine, Sodium Bicarb, Lidocaine and Bupivacaine. Interview with clinical nursing coordinator #2 on 3/21/12 at 9:45 AM revealed the unlocked cart belonged to an anesthesiologist that had not used it since 3/14/12. The clinical nursing coordinator also stated her expectation was that the anesthesiologists secure their carts at the end of the day, because housekeeping staff have access to the area after the patient care staff leave. Observation on 3/20/12 at 6:15 PM revealed the supplies and medications in the cart were accessible to the housekeeping staff cleaning the surgical area.

Based on observation, staff interview, and product label review, the facility failed to ensure expired medications were not available for use in 1 of 8 patient care areas (surgery) and 1 of 2 outpatient areas (rehabilitation center). The findings were:

1. Periodic observations on 3/20/12, 3/21/12 and 3/22/12 revealed the same anesthesia cart remained in the operating suite corridor area. The observation revealed the cart had unlocked drawers; one that contained an opened and not dated multidose vial of Recromiun Bromide and a single dose vial of Sodium Bicarb that expired on 3/1/12. Interview with clinical nursing coordinator #2 on 3/21/12 at 9:45 AM revealed the unlocked cart belonged to an anesthesiologist that had not used it since 3/14/12. The clinical nursing coordinator stated the anesthesiologists were responsible for discarding the outdated medications in the anesthesia carts.

2. An observation at the outpatient rehabilitation center on 3/21/12 at 1:30 PM revealed 20 vials of injectable dexamethasone; each vial contained 30 cubic centimeters of medication. The vials were stored in the manager's office, and each vial had an expiration date of March 2010 on the product label. During an interview with the manager at that time, she confirmed the medication was available for use.

Based on observation, staff interview, and review of infection surveillance activities, the facility failed to perform active surveillance of patients with surgical implants for at least one year after a surgical procedure; the hospital reported an average of 500 surgical implants annually. The facility further failed to ensure 1 of 2 sterile storage areas were clean and sanitary and that sterile anesthesia devices were handled appropriately. In addition, facility staff failed to document quality control procedures for 1 of 2 automated reprocessing instruments for flexible endoscopy equipment. The findings were:

1. Interview with the ICP on 3/20/12 at 2:10 PM revealed the facility's post-operative infection surveillance program was principally based on incident data collected from follow-up appointments, medical record audits, and information filtered from laboratory reports. The ICP stated she had access to information on patients with follow-up appointments at the hospital's outpatient clinics, but was not able to directly monitor information for patent's that were seen at independent clinics. She stated that many of the hospital's orthopedic patients were followed by providers at independent clinics and, as a result, she did not have an active surveillance plan to monitor these patients for post-operative infections. The ICP acknowledged she did not systematically monitor patients with orthopedic implants for post-operative infections that were followed in an independent clinic setting. She further stated that she was aware nationally recognized guidelines recommended monitoring patients with surgically-implanted hardware for at least one year after surgery.

2. Observations in the surgical area on 3/19/12 through 3/21/12 showed the facility stored a portion of its sterile equipment, orthopedic instrument sets, and implantable hardware on open shelving in a room across from OR #4. The room had no door, dust barriers, partitions, or other means of isolating sterile items from non-sterile supplies or incidental foot traffic. It was further observed on 3/21/12 at 4:28 PM that equipment carts, tables, positioning devices, and patient gunneries were moved to this same open room after surgical cases were completed for the day. On 3/20/12 at 9:30 AM, insects and debris were observed in 4 of 4 ceiling light fixtures positioned immediately above shelves containing sterile supplies and instrument sets. Subsequent observations on 3/20/12, 3/21/12, and 3/22/12 showed these light fixtures had not been cleaned.

Interview with RN #5 on 3/20/12 at 5:40 PM revealed the sterile sets and supplies were an overflow from the main sterile storage room. Subsequent interview with ST #1 on 3/21/12 at 8:50 AM confirmed the sterile items were an overflow from the primary sterile storage room. She further acknowledged the area was not isolated from unnecessary traffic, had no dust barriers, and "...the lights really need to be cleaned..."

3. Observation on 3/20/12 at 2:35 PM showed endoscopy technician #1 removed a quality control test strip from an automated reprocessing instrument (Steris 1E). She interpreted the test strip results to ensure an effective concentration of disinfectant had cycled through the instrument and then discarded the test strip. When asked by the surveyor about documenting the quality control results, she stated she did not record the outcome of the test strip results. She further stated different departments operated the instrument and it might be necessary for one operator to unload another department's equipment after a reprocessing cycle was completed. She acknowledged the value of quality control records to verify high-level disinfection for each run cycle, particularly given that multiple individuals might be intermittently involved in the process.


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4. On 3/20/12 from 7:20 AM to 9:58 AM anesthesiologist #1 was observed providing anesthesia services pre-operatively, during the operation and post-operatively for patients #16 and #17. Observations at 8 AM revealed the anesthesiologist opened multiple sterile packaged OT tubes and related devices and placed them on the anesthesia cart in preparation for use at a later time. At that time he placed the insertion end of the device and attachments in the lower half of the opened package with the upper half extending above the package. Observation at 9:58 AM, revealed he had used two of the devices and five opened packages remained on the anesthesia cart. Observation at 6 PM revealed anesthesiologist #1 had departed and anesthesiologist #2 was preparing to depart after providing post anesthesia care. At that time, observation of the anesthesia cart that anesthesiologist #1 had used earlier that day revealed the cart was positioned in the operating room corridor area. A cloth draped over nine opened packages of OT tubes and related devices was observed on the anesthesia cart.

Interview with anesthesiologist #2 on 3/20/12 at 6:15 PM revealed it was necessary for the anesthesiologist to have at least one and sometimes two opened packaged OT tubes in the event of an emergency that required immediate intubation. He further stated a safe practice was to discard all opened supplies at the end of each day to avoid using supplies that have remained opened for prolonged periods of time.

During an interview on 3/21/12 at 10 AM, anesthesiologist #1 stated he routinely opened the packaged OT tubes and related devices, covered them with a cloth and left them on his anesthesia cart in preparation for use the following day. He also stated this practice made it difficult for him to ensure the opened devices did not have contact with contaminants after he left and before he used them.

Based on medical record review and staff interview the facility failed to provide post transfer care instructions for 1 of 2 patients (#32) transferred to another acute care hospital. The findings were:

Review of medical record for patient #32 revealed the patient was admitted on 1/11/12 and transferred to another acute care facility the following day on 1/12/12. On 1/11/12 a nasal screening culture to determine the patient's methicillin resistant staph acerous (MRSA) status was obtained; but the report of findings was not available prior to the transfer. The 1/12/12 final report stated "MRSA isolated-24 hours. Isolation of this organism requires contact precautions. CONTACT PRIMARY CARE PHYSICIAN. Called to [staff name] in ICU."

Further review of the medical record revealed no documentation indicating the receiving hospital was notified of the positive culture findings. Interview with the ICP on 3/22/12 at 1:48 PM revealed the facility policy was to notify receiving hospitals of all positive culture findings, including MRSA. She stated she was not notified of the positive findings for patient #32 and therefore, she did not notify the receiving hospital. She also stated this patient's "information fell through the crack" and she was puzzled as to how this happened.

Based on observation, staff interview, and review of manufacturer's instructions, the facility failed to implement systems to uniformly inspect the connector ends of LMAs prior to reuse. Of 13 LMAs immediately available for use in the surgical suite, 1 was discovered to have a broken plastic connecter end. In addition, of the 12 remaining LMAs, 2 were observed with significant crazing (surface cracks) that presented potential patient safety concerns. It was further discovered that the facility failed to inspect reusable LMAs for cracked or broken connectors as required by the manufacturer. The cumulative effect of this failure resulted in an immediate jeopardy situation due to the increased risk to patient safety. The findings were:

1. Observation on 3/20/12 at 4:28 PM revealed 1 of 2 LMAs on an anesthesia cart exhibited crazing (surface cracks) on the 15mm plastic connector end at the distal end of the device. Closer inspection of the affected LMA showed several cracks extended through the entire thickness of the connector wall and, further, pieces of the plastic tube were broken off.

Interview with RN #5 on 3/20/12 at 5:15 PM confirmed the observation of a cracked connector end, she further acknowledged her opinion that the LMA should not be reused in a surgical procedure.

2. On 3/20/12 the LMA manufacturer's instructions for reprocessing were reviewed and this literature revealed a requirement for users to check each device for crazing, in particular, excess deterioration that might cause the connector end to fail in use.

A manufacturer's technical representative stated in telephone interview on 3/21/12 at 6:54 AM that surface crazing occurred in devices following repeated autoclaving (steam sterilization). The technical representative further stated the progressive deterioration of the plastic connector could become a safety problem if pieces of the connector broke off during use and were aspirated by a patient. Patient safety concerns were the basis for the manufacturer's requirement to visual inspect each LMA during reprocessing and remove cracked and broken devices from service.

ST #1 stated in interview on 3/21/12 at 8:35 AM that she was not aware of the requirement to visually inspect the LMA connector ends and further confirmed inspection of the connector was not a part of the facility's protocol for reprocessing reusable LMAs. The ST demonstrated her database for tracking LMAs and monitoring the limited life of 40 reprocessing cycles for each device. She further reviewed with the surveyor the protocol used for reprocessing LMAs; the inflatable cuff on each device was inspected, but the integrity of the connector end was not inspected during reprocessing.

On 3/21/12 the technician inspected 39 LMAs immediately available in sterile storage or waiting for reprocessing; she discovered 11 devices with moderate crazing, one of which also had a cracked connector. The ST stated on 3/21/12 at 11:35 AM the cracked connector should have been removed from use.

3. Interview with the CNO on 3/22/12 at 8:10 AM revealed that hospital staff completed an inventory and inspection of all LMAs in the facility, but they were unable to recover 10 of 62 LMAs entered in the sterile processing database for reprocessing and tracking. She stated the missing LMAs might have been discarded by anesthesiologists if they discovered the devices were broken or otherwise unusable. She acknowledged the manufacturer's requirement to track each device by its unique serial number and monitor the number of times each LMA was reprocessed and reused.

Subsequent interview with the anesthesia director on 3/22/12 at 1:10 PM revealed his recollection that anesthesiologist occasionally discarded LMAs that were found to be unserviceable when removed from their sterile packaging. He further stated that he was not aware each device was individually coded with a unique serial number or that hospital personnel were required to track each device through its usable life, from initial receipt to final disposition. He acknowledged that communication between anesthesia and sterile processing would have assisted efforts to track LMAs and could contribute to an improved process for ensuring the reusable devices were reprocessed appropriately and safe for reuse.

4. The concern for patient safety in surgical services attributed to cracked and broken LMA connectors resulted in a determination of immediate jeopardy (IJ) on 3/21/12 at 11:05 AM. . The facility submitted an acceptable action plan on 3/22/12 at 8:20 AM; this plan outlined the collection and removal of all reusable LMAs from hospital services, distribution of the current inventory of single-use (disposable) LMAs to surgical services for scheduled cases, ordering and receiving single-use LMAs to resupply all services, and an executive meeting decision to use only single-use LMAs in the hospital. The IJ was abated following completion of these actions and verification by the survey team on 3/22/12 at 11:45 AM.

Based on review of surgical services polices, patient records and interview with staff, the facility failed to develop policies and procedures for use of alcohol based skin preparations in anesthetizing locations. In addition, they failed to document measures that were implemented to ensure patient safety during the use of alcohol based skin preparations for patients in anesthetizing locations. The findings were:

1. Review of randomly selected operative records revealed all lacked documentation regarding whether or not an alcohol based skin preparation was used and documentation regarding implementation of safety measures during the use of alcohol based skin preparations was also lacking. Review of the anesthesia and surgical policies and procedures revealed the facility did not have policies and procedures for the use of alcohol based skin preparations.

2. Interview with the CNO on 3/22/12 at 10:05 AM revealed the facility routinely used alcohol based skin preparations in anesthetizing locations, but their safety policy and procedures did not specifically address alcohol based skin preparations. She also said there was a lack of documentation and implementation because she was not aware of this regulatory requirement.

Based on review of committee meeting minutes, QAPI data and staff interview, the facility failed to ensure anesthesia services were integrated into the hospital-wide QAPI program. The anesthesia services failed to develop a system for monitoring the quality and appropriateness of anesthesia patient care. They failed to develop and implement policies and procedures for inspecting and maintaining anesthesia equipment. The systemic failure to identify and address safety issues resulted in a determination the hospital did not meet the condition of participation in anesthesia services. The findings were:

Interview with the director of anesthesia services on 3/22/12 at 1:15 PM revealed the following information: The anesthesia department was not involved in the hospital wide QAPI program. The department had not been involved in developing measures to address unsafe practices that were identified in November 2011 regarding reprocessing LMAs (refer to A285 for details). The lack of involvement was due to the expectation that the central services staff "would take care of it". The anesthesia department did not consistently participate in the development of policies and procedures regarding safety issues in the anesthetizing areas. A system for staff oversight and monitoring had not been implemented for anesthesia service. Prior to 3/21/12, he had not been aware of current issues regarding damaged LMAs that were packaged and available for patient use (refer to A940 for details).

Based on staff interview, the facility failed to inform those swing bed patients entitled to Medicaid benefits, in writing and at the time of admission or when the patient became eligible for Medicaid, of the items and services included under the State plan and for which the patient could not be charged; those other items and services offered and for which the patient could be charged, including the amount of charges for those services; when changes were made to the items and services. The findings were:

During an interview on 3/21/12 at 4:10 PM, the interim manager for the TCU stated he was unaware of any way to notify Medicaid patients of items and services paid for by Medicaid, those items and services that were the patient's responsibility (including the amount of the charges), and how patients were notified of any changes to those amounts. After checking with the facility, the manager reported on 3/22/12 at 10:12 AM that there was no process for providing Medicaid patients with that information.

Based on staff interview, the facility failed to implement a regulatory process for notifying patients and, if known, a family member or legal representative of the patient, a transfer or discharge necessary for the patient's welfare and the facility's inability to meet the patient's needs; a transfer or discharge for reasons affecting the health and safety of other individuals; a transfer or discharge due to the patient's failure to pay for a stay in the facility. The findings were:

During an interview on 3/21/12 at 4:10 PM, the interim manager for the TCU stated he was unaware of any process to provide written notice to any patient transferred or discharged due to issues affecting the patient's welfare and the hospital's inability to meet the patient's needs. He also stated there was no process to provide written notice to a patient transferred or discharged for issues affecting the health and safety of others in the facility or for failure to pay for a stay in the facility. He further stated he was unaware of the requirement. On 3/22/12 at 10:12 AM the manager confirmed lack of any notification process that met the regulatory requirements.

Based on observation, medical record review, and staff interview, the facility failed to develop and implement an activities program designed to meet the interests and physical, mental, and psychosocial needs of 1 of 1 sample swing bed patients (#12). The findings were:

Observation at various times on 3/20/12 from 10:30 AM through 5 PM showed patient #12 was either lying in bed or sitting in a chair in the room for meals. No other activity was observed. According to the admission face sheet, the patient was admitted to TCU (swing bed) status on 3/12/12. Review of the activity assessment form on 3/20/12 revealed it had not been completed. Review of the activity log showed the following activities were implemented:
a. "Mealtime discussion"
b. "Meals up in chair"
c. "1:1 staff interaction"
d. "Visit with family /friend"
e. "TV"
Further review showed that since 3/12/12 "Mealtime discussion", "Meals up in chair", and "1:1 staff interaction" were initialed on five days and checked for four days. "Visit with family /friend" and "TV" were each initialed once. Each activity was initialed or checked only for the day shift. Further, during interview with RNs #1 and #3 on 3/20/12 at 5:20 PM, neither RN was able to explain what was discussed or done in "1:1 staff interaction" or at "Mealtime discussions."
In an interview on 3/21/12 at 4:10 PM, the interim unit manager stated that activities should be meaningful for each patient. He confirmed the activity assessment had not been completed for patient #12 and; he acknowledged an assessment was necessary to establish and implement meaningful activities.