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

KAISER FOUNDATION HOSPITAL - DOWNEY 9333 IMPERIAL HIGHWAY DOWNEY, CA 90242 Feb. 12, 2016
VIOLATION: MEDICAL STAFF - SELECTION CRITERIA Tag No: A0050
Based on interview and record review, the facility failed to delineate specific surgical privileges commensurate with each physician's individual competence in 3 of 5 sampled credentials files (Providers 1, 3, and 5). For 2 of 5 files (Providers 1 and 3), the delineation of privileges (DOP) included expansive language that negated the listings of specific procedures which followed. For 1 of 5 files (Provider 5), a broadly worded interventional radiology privilege included procedures for which the physician had not had the training required by the facility. Refer to A-945. The deficient practice had the potential to allow members of the medical staff to perform procedures for which they were not qualified.
VIOLATION: OPERATIVE REPORT Tag No: A0959
Based on interview and record review the facility failed to ensure that an operative report was completed or dictated immediately following surgery when 1 of 30 sampled patients, Patient 3 did not have written documentation of an operative report the day after the surgical procedure.

Findings:

Record review indicates Patient 3 had a bilateral breast reduction performed by Provider 6 on 2/10/16 at 11:10 AM. Review of Patient 3's medical record revealed no documentation of an operative report written or dictated immediately following surgery.

Review of facility's Policy and Procedure - Operative Note and Immediate Post-Operative Note (Reviewed 10/14) indicated: "1. Operative or other high-risk procedure reports are dictated or entered within 24 hours into (health system named) after an operative or other high-risk procedure" and "2. A post-operative other high risk procedure progress note must be entered in the medical record immediately after the surgery/procedure".

In an interview on 2/11/16 at 2:30 PM, Staff B acknowledged the lack of operative note written immediately after surgery and stated that she discussed this issue with Provider 6 who said he always writes an operative note but agreed that he did not do so for this operative procedure.
VIOLATION: CONSULTATION WITH MEDICAL STAFF Tag No: A0053
Based on interview and record review, the facility failed to ensure the quality of care provided at the hospital was discussed at 1 of 2 sampled direct consultations between the facility's medical director and the governing body. The deficient practice had the potential to reduce the governing body's involvement in the quality of care provided at the facility.

Findings:

In an interview on 2/9/16 at 1:20 p.m., Staff K stated consultations between the Quality and Health Improvement Committee (QHIC) of the governing body and the medical leadership of each medical center occur twice a year, once by web meeting in April, once face to face in the fall.

Review of attendance sheets for QHIC meetings dated 4/22/15 and 10/14/15 indicated Staff G (the medical director) was in attendance at both meetings. The QHIC minutes dated 10/14/15 indicated each hospital's surgical experience was discussed in breakout sessions. Review of "Suggested Questions for Hospitals" dated 10/14/15 and an attachment summarizing the facility's quality data indicated the quality of care provided at the facility was discussed on 10/14/15. By contrast, review of the QHIC agenda dated 4/22/15 indicated representatives of the hospitals would be present only for the portion of the meeting regarding "Physician Leadership in Culture". Review of the QHIC minutes dated 4/22/15 indicated that discussion concerned how physician leaders could contribute to a culture of safety at each medical center. No evidence was present in the agenda or minutes indicating that the facility's quality data was discussed at the meeting.

In an interview on 2/9/16 at 1:20 p.m., Staff K stated she could not demonstrate a dive into the Downey Medical Center's data on 4/22/15.
VIOLATION: CONTRACTED SERVICES Tag No: A0083
Based on interview and record review, the facility failed to maintain evidence that it had conducted an onsite inspection of its contracted linen service responsible for processing reusable surgical gowns. Refer to A-84. The deficient practice eliminated accountability that the hospital was performing its stated oversight of a contracted service, and had the potential to contribute to a health-care associated infection.
VIOLATION: CONTRACTED SERVICES Tag No: A0084
Based on interview and record review, the facility failed to maintain evidence that it had conducted an onsite inspection of its contracted linen service responsible for processing reusable surgical gowns. The deficient practice eliminated accountability that the hospital was performing its stated oversight of a contracted service, and had the potential to contribute to a health-care associated infection.

Findings:

Review of the hospital's list of contracted services dated 2015 indicated the hospital had a contract with a linen service which handled reusable gowns. The contracts list indicated the hospital had conducted on-site inspections of the contractor and the contractor had met requirements. Review of the hospital's contract with the linen service indicated it had been extended from 3/1/15 through 2/29/16. The contract specified the work to be done and methods to be used by the vendor, and an attached presentation from the vendor detailed the vendor's own quality assurance efforts during reprocessing of sterile gowns. The vendor's quality documentation indicated the vendor also manufactured medical devices in addition to reprocessing surgical gowns, and stated that its manufacturing activities were regulated by, but not approved by, the Food and Drug Administration (FDA). No documentation was present confirming that the hospital had conducted an on-site inspection of the vendor.

Review of the FDA Establishment Registration & Device Listing Database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm) indicated the vendor's facility from which the hospital obtained gowns (FDA registration 26) was registered as a manufacturer of surgical trays and a repackager of aerosol adhesive. The FDA registration at that location did not address reprocessing of surgical gowns.

In an interview on 2/12/16 at 11:50 a.m., Staff A stated he could not tell why the contracts list indicated the hospital had done an onsite inspection of the vendor. He stated the hospital owner's regional office might have done an onsite visit to the vendor, but that all he had was the contract itself and the vendor's presentation regarding its internal processes.
VIOLATION: OFF-CAMPUS EMERGENCY POLICIES AND PROCEDURES Tag No: A0094
Based on interview and record review, the facility failed to maintain a policy addressing appraisal of persons with emergencies at its off-campus outpatient surgery department. The deficient practice had the potential to cause inadequate handling of a potential emergencies.

Findings:

Review of the hospital's state license (effective 3/1/15) indicated the hospital operated an outpatient surgery facility at 9400 East Rosecrans Avenue in Bellflower. Mapping the distance between the hospital and its outpatient surgery facility using maps.google.com indicated the outpatient surgery facility was 1.3 miles drive from the hospital.

Review of the facility's policy "Medical Screening Exam and Treatment of Patients Seeking Emergency Medical Care" (approved 10/14) indicated it addressed actions to be taken on the hospital campus and surrounding areas. The policy defined the hospital campus as "the acute care hospital and property immediately adjacent to the main buildings. For the purpose of this policy, the hospital campus includes the physical licensed hospital structure and hospital property within 250 yards of the building and all parking areas and sidewalks. This does not include public streets, local restaurant or shops located within 250 yards of the main hospital." The policy did not indicate that it applied to the off-campus outpatient surgery facility.

In an interview on 2/12/16 at approximately 1:00 p.m., Staff B stated the outpatient surgery department was considered a unit and followed the inter-unit transfer policy in an emergency.

Review of the facility policy "Transfer: Inter-Unit Transfer of Patients" (revised 5/14) indicated it described processes to be followed while transferring a patient. The policy did not address staffing with personnel qualified to recognize an emergency, or initial treatment within the capabilities of the outpatient surgery department while awaiting transfer.
VIOLATION: PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT Tag No: A0145
Based on interview and record review, the facility failed to provide and ongoing training program when 8 of 10 sampled employees (Staff 1, 4, 5, 6, 7, 8, 9, 10) did not have current abuse training other than during orientation at hire date. Failure of the facility to provide an ongoing program with information regarding abuse and neglect with reporting requirements/updates has the potential for staff to lack current knowledge and underreport incidents of abuse.

Findings:

Record review indicated RN 1, date of hire 6/12/89, did not have documentation of ongoing abuse training other than initial training at date of hire.

Record review indicated RN 2, a contract nurse, hire date 12/14/15, had abuse training on 11/24/15, prior to employment at the facility.

Record review indicated RN 3, a contract nurse, hire date 6/8/15, had abuse training on 3/20/15, prior to employment at the facility.

Record review indicated RN 4, date of hire 6/12/89, did not have documentation of ongoing abuse training other than initial training at date of hire.

Record review indicated RN 5, date of hire 8/27/07, did not have documentation of ongoing abuse training other than initial training at date of hire.

Record review indicated RN 6, date of hire 10/25/04, did not have documentation of ongoing abuse training other than initial training at date of hire.

Record review indicated RN 7, date of hire 4/22/02, did not have documentation of ongoing abuse training other than initial training at date of hire.

Record review indicated RN 8, date of hire 11/19/07, did not have documentation of ongoing abuse training other than initial training at date of hire.

Record review indicated RN 9, date of hire 4/11/83, did not have documentation of ongoing abuse training other than initial training at date of hire.

Record review indicated RN 10, date of hire 1/9/12, did not have documentation of ongoing abuse training other than initial training at date of hire.

In an interview on 2/11/16 at 2:00 PM, Staff B stated abuse training is done at date of hire and not part of yearly competencies/inservices. Staff B provided facility's Policy and Procedure - Patient Rights - Protection from Abuse, Neglect, Harassment dated (10/14/14) which indicated policy statement: Train - The hospital and Medical Office Buildings (MOBs) during the orientation program and through an ongoing training program, provide all employees with information regarding abuse and neglect, and related reporting requirements, including prevention, intervention, and detection.

Review of Merriam Webster's dictionary defined ongoing as: continuing to exist, happen, or progress : continuing without reaching an end. Using this definition of ongoing, the facility failed to follow its own policy of providing an ongoing training program regarding abuse and neglect when the training offered was done at date of hire without subsequent training for employees.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on interview and record review, the facility failed to ensure testing for Clostridium difficile infection (CDI or Cdiff, an infection of the colon sometimes acquired in the hospital) was performed as expected. The deficient practice had the potential to reduce the accuracy of the hospital's data regarding health-care associated infections.

Findings:

Review of the document "Reduction of Hospital Onset Clostridium difficile" (1/16) indicated the hospital's goal was to reduce CDI rates by 20%. The document indicated the hospital had been sending stool specimens for CDI testing at the onset of diarrhea, except for patients who had recently had laxatives. The document indicated the hospital would begin testing the 3rd loose stool (instead of the first loose stool) at an unspecified time in 2016. Review of the undated document "SCAL [Southern California] Cdiff Related Metrics" indicated "Prompt Cdiff Testing Following Loose Stool Within 24 Hours" averaged 35% at the hospital for the period between 8/24 and 2/6 (year unspecified). Review of the "CLOSTRIDIUM DIFFICILE ASSOCIATED DISEASE" report to the hospital's Infection Prevention and Control Committee dated 1/26/16 indicated the actions taken included, "Continued education efforts in regards to: timely specimen collection..." Review of the hospital's "CDI Reduction Action Plan Log (09.2015-present)" indicated as of 1/18/16 the hospital was planning to test the 3rd loose stool instead of the 1st loose stool, and would be selecting a floor to "test changes before spreading house-wide".

In an interview on 2/11/16 at approximately 2:45 p.m., Staff L stated the facility had reviewed CDI testing and had conducted an educational event in November emphasizing CDI documentation and testing requirements.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on interview and record review, the facility failed to maintain consistent policies regarding internal reporting of adverse events. For 1 of 3 sampled adverse events, the facility also failed to consistently apply the resulting preventive measures to other parts of the hospital. The deficient practices resulted in different responses from hospital staff regarding to whom and how they would report, had the potential to allow safety problems to be prematurely dismissed, and had the potential to allow previously corrected causes of adverse events to be repeated in other parts of the hospital.

Findings:

1. In an interview on 2/8/16 at approximately 10:50 a.m., Staff C (a nurse) stated she would report adverse events to the physician on duty and her manager, and would submit an unusual occurrence report (UOR). In an interview on 2/8/16 at approximately 11:00 a.m., Provider 8 (a physician) stated he would report an adverse event to his chief (Provider 9) and to any colleagues necessary for patient management. Provider 8 did not mention a UOR or other form of reporting to the hospital's risk management department. In an interview on 2/8/16 at 11:11 a.m., Staff D (a nurse), stated she would report an adverse event to the physician on duty, her manager, and submit a UOR. In an interview on 2/8/16 at approximately 11:20 a.m., Staff E (a respiratory therapist) stated she would report an adverse event to her manager and submit a UOR, in addition to contacting the personnel necessary to care for the patient. In an interview on 2/8/16 at 5:16 p.m., Provider 9 stated if he received a report of an adverse event from a subordinate physician, he would escalate it to the hospital's medical director, the physician liaisons for risk management and quality, and the administrative manager of the department. After the surveyor asked about UOR's, Provider 9 stated the medical staff were able to fill out a UOR but usually went through the chief of the service. Provider 9 stated physicians could also call the risk management department themselves, depending on the situation.

Review of the hospital's "Event Reporting Policy" (revised 12/14) indicated events within the scope of the policy would be reported within Kaiser Permanente by the hospital risk manager or designee but did not state how the event would come to the attention of the risk manager. The policy included an attachment titled "Reporting of Adverse Events" which stated, "All identified events shall be immediately reported to your manager AND the Risk Manager who will begin the cascade of required notifications." The policy included a second attachment titled "Reportable Event Management Flow Chart" which indicated the physician or department administrator would report the event to the local risk management department.

Review of the hospital's "Unusual Occurrence Reporting" policy (revised 10/13) indicated "Any occurrence that meets the criteria for sentinel event, or is felt that immediate review is required due to possible quality of care or liability issues should be called to the respective Department Administrator/Supervisor and Risk Management/Administrator on Call immediately; in addition to completing an Unusual Occurrence Report- Online... The Unusual Occurrence Report- Online is initiated by anyone having knowledge of the occurrence... All persons having relevant knowledge regarding occurrence should be listed as a witness."

Review of the facility policy "Risk Management & Patient Safety" (2015) indicated "Any member of the healthcare team (licensed, non-licensed, physician) who has a concern regarding patient safety is obliged to escalate the issue until the concern is resolved. If, at any time, the healthcare team member feels that appropriate action has not been taken and/or the issue or concern has not been adequately addressed after use of "Safety Check", he/she has the responsibility to escalate the issue along the chain of command. Escalation involving the medical care of a patient is escalated up both the medical and administrative chain of command... Kaiser Permanente defines risk as the potential or actual injury to members/patients/employees or the loss of assets. Risks that should be reported immediately to the Risk Manager... Anonymously report errors, mistakes, concerns, and patient harm... to: -UOR-O (Unusual Occurrence Report-Online) -OOPS Line... -Your supervisor or manager -Risk Director..."

2. Review of an undated analysis titled "Verification Injury: Wrong Person Procedure" indicated that a surgical procedure was performed on the wrong patient in the NICU (neonatal intensive care unit) on 9/2/15. The document indicated the preventive measures to prevent similar problems in the future would include documenting informed consent in the electronic medical record rather than a paper medical record, having the electronic record open during the procedure, speaking to the patient's family prior to the procedure, and conducting simulations of how to properly resolve discrepancies identified during the time out prior to the procedure. Attached documents indicated that training and monitoring for implementation of the changes had been conducted in the NICU. No indication was present regarding what preventive measures, if any, had been taken to prevent similar problems in other parts of the hospital.

In an interview on 2/11/16 at 1:54 p.m., Staff M stated the preventive measures had recently been agreed and the facility was in the process of cloning them in other parts of the hospital. She stated she would provide some reports to substantiate what had been done.

Review of additional documents provided by Staff M indicated the hospital had conducted simulations of time-out discrepancies in the operating room and had audited its pre-procedure verifications in interventional radiology. No indications were present that the hospital had implemented any preventive measures in the adult ICU.

In an interview on 2/12/16 at 10:26 a.m., Staff M stated the ICU documented pre-procedure verifications on individual patient records, but the facility had not audited whether the process was being done correctly in the ICU.
VIOLATION: QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT Tag No: A0308
Based on interview and record review, the facility failed to maintain evidence that it had conducted an onsite inspection of its contracted linen service responsible for processing reusable surgical gowns. Refer to A-84. The deficient practice eliminated accountability that the hospital was performing its stated oversight of a contracted service, and had the potential to contribute to a health-care associated infection.
VIOLATION: OPERATING ROOM CIRCULATING NURSES Tag No: A0944
Based on observation and interview and record review, the facility failed to provide a circulating nurse, RN 3 (nurse that assists in managing the nursing care of a patient during surgery and observes for breaches in surgical asepsis, which is absence of bacteria, viruses, and other microorganisms) that followed procedure when RN 3 performed the surgical skin preparation (application of an antiseptic for removal of pathogens) using poor technique. Failure of the facility to provide nursing staff working within applicable policies and procedures had the potential to expose patient to surgical site infections.


Findings:
In an observation on 2/10/16 at approximately 11:25 AM, RN 3 performed the surgical skin preparation for Patient 3 undergoing a bilateral breast reduction. RN performed the surgical prep starting in the breast area and moved the prep solution sponges in a circular motion outward from the incision site including in the armpits of Patient 3. RN 3 then used the same sponges to go back over the breast area with sponges that had been used in the underarm area.

Record review of Association of periOperative Registered Nurses (AORN), a nationally recognized resource for operating room practices, indicates, Standard IV.d.2. The skin antiseptic should be applied starting at the incision site and moving away toward the periphery of the surgical site. The applicator should be discarded after contact with a peripheral or contaminated area. Another sterile applicator should be used for additional applications.

Failure of the facility to follow nationally recognized guidelines and standard of practice in performing nursing duties in the operating room has the potential to expose patients to contamination from bacteria and microorganisms on the skin's surface.
VIOLATION: SURGICAL PRIVILEGES Tag No: A0945
Based on interview and record review, the facility failed to delineate specific surgical privileges commensurate with each physician's individual competence in 3 of 5 sampled credentials files (Providers 1, 3, and 5). For 2 of 5 files (Providers 1 and 3), the delineation of privileges (DOP) included expansive language that negated the listings of specific procedures which followed. For 1 of 5 files (Provider 5), a broadly worded interventional radiology privilege included procedures for which the physician had not had the training required by the facility. The deficient practice had the potential to allow members of the medical staff to perform procedures for which they were not qualified.

Findings:

Review of Provider 1's credentials file indicated he was reappointed to the facility's medical staff on 5/13/15. Provider 1 was board certified in orthopedic surgery, but did not have a certificate of added qualifications in spine surgery. Review of Provider 1's delineation of privileges (approved 5/13/15) indicated he was granted "HOSPITAL CORE ORTHOPEDIC PRIVILEGES" but did not request and was not approved for "HOSPITAL CORE SPINE SURGERY PRIVILEGES". The DOP indicated the core spine surgery privileges required completion of a spine surgery fell owship. Review of the listing of procedures included in the core orthopedic privileges indicated they included "Evaluation, diagnosis and care, as well as surgical and non-surgical treatment... to correct or treat various conditions, illnesses or injuries of the musculoskeletal system (extremities, spine, and associated structures by medical, surgical and physical means including but not limited to... deformities, injuries and degenerative diseases of the spine..."

In an interview on 2/9/16 at 5:07 p.m., Staff F stated spine was separate from the orthopedic core privileges and that Provider 1 wouldn't do spine procedures. Staff F could not explain the apparent discrepancy between her statement and the wording of the orthopedic core privilege. In an interview on 2/9/16 at 5:32 p.m., Staff G stated the facility interpreted the core privilege as providing treatment except for the specific procedures subsequently listed. When the surveyor stated the wording of the core privilege did not match Staff G's interpretation, Staff G replied, "I hear what you're saying. But if there are no tick marks next to the specific procedures, they can't do them." In an interview on 2/10/16 at 2:43 p.m., Staff H stated the orthopedic core privileges included spine because orthopedic surgeons do a 4 month rotation in spine during their residency. When the surveyor asked why spine was separated into a separate core privilege if it was already included in the orthopedics core privilege, Staff H replied someone without a spine fell owship wouldn't do a surgical procedure on the spine, but would do evaluation and management of problems affecting the spine up to the point of surgery.

Review of Provider 3's file indicated he was reappointed to the facility's medical staff on 7/26/14. Provider 3 was board certified in head and neck surgery. Provider 3's DOP (approved 7/26/14) included "GENERAL/PEDIATRICS, including but not limited to" a list of procedures that followed. Provider 3's DOP included "HEAD and NECK, including but not limited to" a list of procedures that followed.

In an interview on 2/10/16 at 3:05 p.m., the surveyor asked Staff I what wasn't included. Staff I replied that a comprehensive list would be unmanageable and that the facility had previously been advised there were too many procedures on the DOP.

Review of Provider 5's file indicated he was reappointed to the facility's medical staff on 8/19/14. Provider 5 was board certified in diagnostic radiology and had completed a fell owship in cardiothoracic imaging. Provider 5's DOP (approved 8/19/14) indicated he had requested and been granted privileges to perform "Nonvascular Interventional Procedures, including GI tract family, Urinary procedures, Fertility (Fallopian tube) interventions, Ablation procedures." The DOP indicated interventional radiology (IR) privileges required either completion of an IR fell owship, subspecialty board certification in IR, or documentation of training and experience. Provider 5's file indicated he had not completed an IR fell owship, and was not certified in IR.

In an interview on 2/11/16 at 10:41 a.m., Staff J stated Provider 5's thoracic imaging fell owship included training on chest interventional procedures. Staff J did not explain what training had qualified Provider 5 to perform the remaining procedures outside the chest which were included in his IR privilege.
VIOLATION: HISTORY AND PHYSICAL Tag No: A0952
Based on interview and record review the facility failed to provide a complete and legible medical history and physical (H&P) for 1 of 30 sampled patients when Patient 13's H&P was not complete and used abbreviations that were not approved or and staff members were unable to determine what was documented or written. Failure of the facility to ensure an H&P that is complete and legible has the potential to affect the care plan for the patient and the overall well-being of patients undergoing an operative procedure.

Findings:
Record review indicated Patient 13's history and physical (H&P) dated 8/13/15 at 10:10 AM. indicated chief complaint: "preop fdp laceartion" and History of Present Illness: s/p fdp laceartion llf".

Further review of H&P indicated:
1. Physical exam - Decreased senation rdn
2. Vitals - see nursing admission nursing record
There was no documentation Provider 7 had examined Patient 13 other than Chest clear, CV RR
3. risks benefits alternatives discussed...informed consent obtained for surgery...norco...keflex
4. Bleeding infection anesthetic death scarring

In an interview on 2/11/16 at 3:00 PM, Staff M indicated that she was unaware of the abbreviations used (FDP laceartion, rdn, CV RR) and said that review of the H&P indicated some type of tendon/hand surgery was to be performed but was unable to explain norco and keflex listed in item 3 (above) as Patient 13 had no known allergies listed. In addition, RN 9 acknowledged that item 4 (Bleeding infection anesthetic death scarring) were probably the risks of the operative procedure listed.

Review of facility's Policy & Procedure - Abbreviations and Symbols (reviewed 9/14) noted: Any abbreviation that is ambiguous or uncommon must be spelled out. Review of Patient 13's H&P did not show definition listed for FDP, rdn, or CV RR.
(Spelling of words in deficiency are as written by Provider 7)
VIOLATION: POST-OPERATIVE CARE Tag No: A0957
Based on interview and record review the facility failed provide documentation of post-operative care for 1 of 30 sampled patients when Patient 22's medical record did not include summary of post-operative monitoring and there was no documentation that discharge criteria had been met. Failure of the facility to document post-operative care has the potential to adversely affect patient's health status and well-being.

Findings:

Record review indicated Patient 22 had a surgical procedure on 11/13/15. Review of the medical record indicated a flow sheet completed but no documentation that patient met the discharge criteria.

Review of facility's Policy & Procedure (P&P)- Discharge from Post anesthesia Care Unit (dated 5/14) indicated: 5. Clinical Record - documentation is done on the PACU record. Time and numbers are placed in the boxes each time score is evaluated. Review of facility's P&P - Discharge Criteria from Post Anesthesia Care Unit (rev.5/14) indicated discharge will occur only if all conditions met including, 2(f) Patient has a PASS score of 13 or 14. Patient 22's medical record indicated flow sheet but no Procedure and Anesthesia Scoring System (PASS) summary to indicate that patient had a score of 13 or 14 as indicated in the policy.

In an interview on 2/12/16 at 11:00 AM, __________ acknowledged that PACU flow sheet did not have PASS scoring documented in Patient 22's medical record.