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.

MARIAN REGIONAL MEDICAL CENTER 1400 E CHURCH ST SANTA MARIA, CA 93454 May 6, 2015
VIOLATION: PATIENT RIGHTS: ADVANCED DIRECTIVES Tag No: A0132
Based on interview and record review, the hospital failed to ensure staff were knowledgeable with the advance directive process for one of five staff interviewed (Registered Nurse 13 [RN 13]) which had the potential to result in staff failing to honor the patient's specific health care requests.

Findings:

During an interview with RN 13, on 5/5/15 at 3:30 PM, she stated that if a patient had an advance directive but it was not in the patient record, then without that advance directive on file, full resuscitation measures would be initiated in the event of an arrest situation (a condition when the patient's heart stops beating and/or stops breathing).

The hospital policy and procedure titled "Advance Health Care Directive", dated 2/2012, indicated "If the individual had completed an Advance Directive but does not have a copy for placement in the medical record, an Interim Directive must be completed by nursing. This Interim Directive should reflect the desires/wishes of the individual that are contained in the original Advance Directive and is only effective in the interim period prior to the arrival of the original document to the medical record."

The hospital policy and procedure titled "Do Not Resuscitate Guidelines", dated 2/2012, indicated "If a patient has executed a valid Advance Health Care Directive or other advance directive, this should be noted in the record as required by the Patient Self Determination Act. The patient's wishes regarding cardiopulmonary resuscitation should be complied with unless challenged by some overriding ethical principle."
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
Based on observation, interview, and record review, the hospital failed to ensure the order for restraints for two of seventeen sampled patients (1 and 2) was clear to staff to ensure the proper restraints were utilized as intended for the protection of the patient.

Findings:

1. During an observation of Patient 1 on 5/4/15 at 9 AM, she was in bed with a soft wrist restraint on both the left and right wrist.

During a concurrent interview and review of the electronic clinical record for Patient 1 with Registered Nurse (RN) 2, on 5/4/15 at 2 PM, the physician's order, dated 5/2/15 at 2 PM, indicated to monitor Patient 1 every two hours, the restraint time limit was for 24 hours, and the type of restraint was a "2 point". RN 2 was asked what type of restraint was a "2 point" restraint and she was not able to provide an answer.

2. During an observation of Patient 2 on 5/4/15 at 9:15 AM, he was in bed with a soft wrist restraint on both the left and right wrist.

During a concurrent interview and review of the electronic clinical record for Patient 2 with RN 1, on 5/4/15 at 3 PM, the physician's order, dated 5/4/15 indicated to monitor Patient 2 every two hours, the restraint time limit was for 24 hours, and the type of restraint was a "2 point". RN 1 stated the ordering physician did not scroll down the list far enough and that the current order was not specific as to what limb was to be restrained.

During a review of the electronic physician order set for restraints on 5/5/15 at 10:45 AM, the system had twenty-seven options for the type of restraints that could be ordered. The hospital policy and procedure titled "Restraints-use of", dated 11/2014, indicated the requirements for ordering restraints included the type of restraint to be applied. There was no definition for the different types of restraints that could be ordered by the physician indicated in the policy.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0175
Based on interview and record review, the hospital failed to ensure four of seventeen sampled patients (1, 2, 3, and 16) were monitored during the use of restraints as indicated in the hospital policy and procedure which had the potential to result in harm to patients in restraints or unnecessary restraint use.

Findings:

1. During a concurrent interview and record review of the clinical record for Patient 1 with Registered Nurse (RN) 2, the restraint monitoring documentation was reviewed in the electronic medical record. There was no monitoring documented on 5/3/15 from 2 PM through 9 PM and on 5/4/15 from 9 AM through 1 PM. This was verified with RN 2.

2. During a concurrent interview and record review of the clinical record for Patient 2 with RN 1, the restraint monitoring documentation was reviewed in the electronic medical record. The restraint monitoring documentation indicated the following:

a. for 4/30/15, at 3:08 PM, the type of restraint was missing.
b. for 5/1/15, at 5 AM, indicated that Patient 2 was agitated. No other monitoring components were present.
c. for 5/1/15, at 11:11 PM, the restraint monitoring documentation was missing.
d. for 5/1/15, at 2:38 PM, the restraint monitoring documentation did not indicate the type, circulation, sensation, or mobility, or level of consciousness.
e. for 5/2/15, at 9:10 AM, 5/2/15 at 11:10 AM, 5/2/15 at 6:33 PM, the restraint monitoring documentation was missing.
f. for 5/2/15, at 6:33 PM, the restraint monitoring documentation was incomplete and did not indicate level of consciousness, type of restraint, toileting offered, fluid/nourishment offered.
g. for 5/2/15, at 10:58 PM, the only documentation was that Patient 2 had an indwelling catheter.

The missing documentation was verified with RN 1.

3. During a concurrent interview and record review of the clinical record for Patient 3 with RN 6, there was no restraint monitoring documented on 4/28/15 from 4 PM through 8 PM, on 5/1/15 from 5 PM through 8 PM and on 5/4/15 from 12 noon through 3 PM. This was verified with RN 6.

4. During a concurrent interview and record review of the clinical record for Patient 16 with RN 13, on 5/5/15 at 3:30 PM, there was no restraint monitoring documented on 5/2/15 from 1 AM to 8 AM and on 5/3/15 from 7 AM through 9 AM. This was verified with RN 13.

The hospital policy and procedure titled "Restraints-Use Of," dated 11/2014, indicated the monitoring of the patient in restraints shall be at a minimum every two hours for non-violent restraints. The policy also indicates the following will be monitored: physical and emotional well being of the patient, vital signs, circulation, hydration and hygiene needs, skin integrity, level of distress and agitation, mental status, cognitive functioning, less restrictive measure if possible, changes in behavior, and whether restraints have been applied, removed, or reapplied.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on interview and record review, the hospital failed to:

1. Aggregate and report restraint data for one of four departments (Emergency Department [ED]) that use restraints to the quality improvement committee and the governing board which had the potential to result in inaccurate information to monitor the quality of care provided to patients.

2. Measure the incidence of restraint utilization for four of four departments which had the potential to result in a lack of monitoring towards the hospital's restraint reduction plan.

Findings:

1. During a concurrent interview and record review of the Quality Improvement Plan 2015 with Senior Director of Critical Care (SDOCC) on 5/4/15 at 1 PM, the "Restraints" project report, dated 4/21/15 was reviewed. The departments included in the restraint project report were critical care, medical/surgical and telemetry units. This report was presented to the Quality Improvement Committee, the Medical Executive Committee and the governing board. The SDOCC stated the emergency department also used restraints and this department had a separate data collection and was reported to the quality committee in 3/2015. The SDOCC was unable to provide documentation of the ED data collection in the minutes of the meeting.

2. During a concurrent interview and record review of the Quality Improvement Plan 2015 with SDOCC on 5/4/15 at 1:50 PM, the "Restraints" project report, dated 4/21/15, was reviewed. The project focused on documentation compliance measuring restraint start and stop times, completed restraint orders, two-hour monitoring, assessments completed each shift, restraint care plan initiated and restraint education completed. There was no assessment of the incidence of restraint utilization for each department or aggregated restraint incidence for the hospital.

The hospital policy and procedure titled "Restraints-Use of", dated 11/2014, indicated "1. The organization will make all reasonable efforts to reduce the use of restraints. To accomplish this, a performance improvement process will be utilized...Collection of data on the incidence and reason(s) for restraint use in care settings where such use occurs... Aggregation and analysis of the data to determine if patterns, trends or clusters of restraint use are evident and to understand why restraints are used..."
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
Based on interview and record review, the hospital failed to ensure performance evaluations for two (Registered Nurse [RN] 10, Lead Technician [LT] 1) of 16 sampled employees were done per their Policy and Procedure. This failure had the potential of not having competent staff to provide patient care.

Findings:

During a concurrent interview and record review, with the Human Resources Director (HRD), on 5/6/15, at 10:50 AM, the latest performance evaluation for RN 10 was on 7/2012. The HRD confirmed the findings and stated, "He was hired on 4/19/12. His 90 days performance evaluation was done on 7/13/12. There were no performance evaluations for RN 10 since then."





During a concurrent review of the employee file for LT 1 with the Director of Surgical Services (DSS) on 5/6/15, at 11:30 AM, the last completed performance evaluation was dated 10/17/13. There was no documentation of annual competencies for 2014 or 2015 found in the file. This was verified by DSS.

The hospital policy and procedure titled "Performance Evaluations" revised on 12/2008, under Policy read, "Performance Evaluations will be conducted upon 90 days of continuous employment and upon the annual anniversary date in the job."
VIOLATION: CONTENT OF RECORD - INFORMED CONSENT Tag No: A0466
Based on interview and record review, the hospital failed to ensure consent forms were properly filled out prior to having the patient sign for one of 17 sampled patients (1) which had the potential to result in a lack of knowledge regarding the procedure and/or confusion with the procedure or provider.

Findings:

During a concurrent interview and review of the clinical record for Patient 1 with Registered Nurse (RN) 2 on 5/4/15 at 2 PM, the consent for open heart surgery, dated 4/23/15 listed her cardiologist as the surgeon. RN 2 verified that the wrong doctor was listed on the consent form. The consent for insertion of a dialysis catheter and hemodialysis (a procedure used to remove toxins from the blood through a catheter when the kidneys have failed) was not dated. This was verified by RN 2. She stated the consent form must be dated.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview, and record review, the hospital failed to ensure a sanitary environment was maintained for controlling sources of infections in accordance with hospital policies and procedures and nationally recognized standards of practices and guidelines ([AAMI] Association for the Advancement of Medical Instrumentation - a nationally recognized organization which provides standards, support and guidance for healthcare technology and sterilization professionals and AORN [Association of periOperative Registered Nurses] is a nationally recognized organization which provides standards, recommended practices and guidelines for the perioperative registered nurse) when:

1. Expired intravenous fluids (IVF) and supplies were observed in the perioperative areas (this includes the preoperative, intraoperative and post operative areas).
2. The Central Processing Department ([CPD] is the area which is divided into the decontamination of supplies, preparation and packaging of supplies, sterilization and clean, sterile storage) failed to ensure hinged instruments remained open during the sterilization (process used to render a product free from any viable micro-organisms i.e. bacteria, spores, viruses) process.
3. The temperature and humidity in the CPD was not monitored daily.
4. The temperature ranges that were not within AAMI standards were not followed up on according to the hospital's policy and procedure.
5. The plant operation department had audible alarms not set within AAMI standards.
6. There was no competency evaluation of the Director of the CPD.

These failed practices had the potential to result in the spread of infections to the patients.

Findings:

1A. During an observation of the post anesthesia care unit ([PACU]-postoperative care area) with the Director of Surgical Services (DSS) and the Director of Emergency Services (DES), on 5/4/15 at 10:10 AM, the following was observed:

a. 3 - 500 cubic centimeter (cc) bags of D5 (Dextrose 5%) NS (Normal Saline) with an expiration date of 12/2014.
b. 6 - 1000 cc bags of D5 NS with an expiration date of 11/2013.
c. 2 - 500 cc bags of D5 0.2%NS with an expiration date of 1/2015.

During a concurrent interview with the DSS, on 5/4/15, at 10:10 AM, she was asked who was responsible to ensure, the IVFs available for patient use, were not expired. She replied it was not her staff's responsibility in the PACU, but it was the responsibility of the staff in the CPD.

During an interview with Distribution Clerk (DC) 1 in the CPD, on 5/4/15, at 12:14 PM, she stated she worked in the clean storage area in the CPD. When she was asked if she was responsible for ensuring no expired IVFs/supplies were in the PACU, she replied no. No additional information was provided.

1B. During an observation of the "Central Core Area" (the area in the perioperative area with the semi-restrictive and restrictive environment) and concurrent interview with the DSS, on 5/4/15, at 1:03 PM, the following expired supplies were observed:

a. One - "Flexitip Applicator" with an expiration date of 11/2013,
b. One - "ENT Applicator Kit" with an expiration date of 4/2014,
c. Two - "ENT Applicator Kit" with an expiration date of 6/2014,
d. Ten - "Rapid Rhino 5.5 cm Anterior..." with an expiration date of 2/2015,
e. One - "Vent tube" with an expiration date of 11/2012,
f. One - "Vent tube" with an expiration date of 4/2013,
g. Three - "Vent tube" with an expiration date of 12/2013,
h. Three - "Vent tube" with an expiration date of 10/2014,
i. Five - "ENT Navigation system" with an expiration date of 3/1/15,
j. Four - "ENT Navigation system" with an expiration date of 11/28/14,
k. One - "Adhesive Pack" with an expiration date of 1/16/14,
l. One - "Adhesive Pack" with an expiration date of 4/26/14.

The DSS acknowledged, it was the responsibility of the nursing staff in the perioperative area, to check for expired outdated supplies in this area. No additional information was provided.

1C. During a concurrent observation and interview with the Chief Nursing Officer (CNO), on 5/4/15, at 1:03 PM, the medication cabinet in Operating Room 7 was found containing outdated sterile medical supplies:

a. Two - "Codman, Peanut Disector" with an expiration date of 6/2012,
b. Eleven - "Sorin Goup-Iver lock" (for femoral cannulation) with an expiration date of 2/2015,
c. Five - "Double Venous Cannulation" with an expiration date of 5/2014.

The CNO confirmed the findings, took the medical supplies out and no further information was provided.

1D. During a concurrent observation and interview with the DSS, on 5/4/15, at 1:15 PM, the medication storage in the substerile area, outside of the operating room was found containing outdated sterile medical supplies:

a. Two - "Micro ENT (Ear, Nose, Throat) Blade Downcutting" with an expiration date of 7/16/13,
b. One - "Instrument Tracker" with an expiration date of 10/29/14,
c. One - "Adhesive Pad" with an expiration date of 8/7/14,
d. Five - "Micro Feather Ophthalmic Scalpel" with an expiration date of 8/2013,
e. Eight - "XCEL Bladeless Trocar" with an expiration date of 3/2015.

The DSS confirmed the findings and stated, "Yes, those supplies were expired."

The hospital policy and procedure was requested several times for surgical supply storage and ensuring expired outdated surgical supplies were not available for patient use. No policy and procedure was provided.

2. During an observation of the clean storage area of the CPD and concurrent interview with Lead Technician (LT) 1 of the CPD, on 5/4/15, at 12:38 PM, five forceps in the blue peel pouches (used to package instruments for sterilization which allow for the sterilization of the contents and allows for the sterility of the contents until they are opened) were observed in the closed position. She stated, "We were trying to find a product to keep [hinged instruments] open, but we weren't happy with it..." When she was asked how long has the department been searching for a product to keep the hinged instruments open, she said for the past two weeks. She stated, the CPD follows AAMI professional standards of practice for the preparation and assembly of the surgical instruments.

During an observation of the "Central Core Area" (the area in the perioperative area with the semi-restrictive and restrictive environment) and concurrent interview with DSS, on 5/4/15, at 1:03 PM, there were greater than 20 hinged instruments in blue peel pouches, in the closed position. She was asked to open two blue peel pouches to validate the hinged instruments were in the closed. The DSS acknowledged, the hinged instruments were completely closed. She stated, the hospital follows AAMI standards and AORN standards of practice.

During a subsequent interview with LT 1, on 5/6/15, at 8:01 AM, she was informed there were greater than 20 hinged instruments in blue peel pouches, in the closed position observed in the Central Core Area of the perioperative area. She stated, "Probably they (referring to the hinged instruments) went through (the sterilization process) closed."

The hospital policy and procedure titled, "STERILE INSTRUMENTS - ASSEMBLY AND WRAPPING", revision date of 5/2009 read in part, "The purpose of this operating instruction is to establish guidelines regarding the assembly and wrapping of all instrument sets, trays, and single items for sterilization..." Under the procedure subheading it read in part, "...Place sets/trays on the sterilization rack so that the steam will contact with all surfaces to ensure uniform sterilization."

The 2011 AAMI standards of professional practice provided by the hospital, under Chapter 8 "Packaging, preparation, and sterilization", section 8.4.4, page 76, read in part "... b) Instruments should be positioned to allow the sterilant to come into contact with all surfaces c) All jointed instruments should be in the open or unlocked position with ratchets not engaged... specifically designed devices can be used to hold the instruments in the open position..."

The 2014, Perioperative Standards and Recommended Practices published by AORN was reviewed. Direction was given that, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces and instruments with hinges should be opened..."

3. During an interview with LT 1, on 5/6/15, at 8:25 AM, she stated the temperature of the CPD (decontamination area and the assembly room [preparation and packaging]) should be monitored daily. She stated, they maintained a log for the daily temperatures.

During a concurrent interview with LT 1, on 5/6/15, at 8:30 AM, the temperature and humidity logs for the assembly room were reviewed for the months of 3/2015, 4/2015 and 5/2015. The temperature and humidity was not documented daily. LT 1 acknowledged it was not monitored and documented daily.

During a concurrent interview with LT 1, on 5/6/15, at 8:35 AM, the temperature and humidity logs for the decontamination room were reviewed for the months of 3/2015, 4/2015, and 5/2015. The temperature and humidity was not documented daily. LT 1 acknowledged it was not monitored and documented daily.

The hospital policy and procedure titled, "TEMPERATURE AND HUMIDITY FOR PROCEDURAL, PROCESSING AND STERILE STORAGE LOCATIONS", effective date 3/2015, indicated "Temperature will be monitored and logged daily..."

4. During a concurrent interview with LT 1, on 5/6/15, at 8:30 AM, the temperature and humidity logs for the assembly room were reviewed for the months of 3/2015, 4/2015, and 5/2015. On the top of the log (handwritten) were ranges which indicated the acceptable temperature range (68 to 73 degrees Fahrenheit [F]) for the assembly room. A further review of the log was conducted and it was noted that on 3/9/15 and 4/27/15, the temperatures were outside of the acceptable parameters. LT 1 stated when the temperatures were outside the acceptable parameters, the staff should generate a work order in the computer and then the maintenance department would adjust the temperature.

During a concurrent interview and record review with LT 1, on 5/6/15, at 8:35 AM, the decontamination room logs were reviewed for the months of 3/2015, 4/2015, and 5/2015. On the top of the log (handwritten) was the acceptable temperature range (60 to 65 degrees F). There were 60 temperature entries on the log. All 60 temperature entries were out of the acceptable parameter of 60 to 65 degrees F. LT 1 was asked to provide evidence that work orders were generated to notify the maintenance department. She acknowledged they did not notify the maintenance department. LT 1 indicated the acceptable parameters the CPD followed was the 2006 AAMI standards which indicated the following acceptable parameters:

Decontamination room - 60 to 65 degrees Fahrenheit (F)
Preparation and Packaging room (assembly room) - 68 to 73 degrees F
Clean and Sterile Storage room - 75 degrees F or lower.

During an interview with Director of Plant Operations (DPO), on 5/6/15, at 12 PM, a review of the computer generated work orders was conducted. From 1/2015, to current there were no work orders generated for the unacceptable ranges in the assembly room on 3/9/15 and 4/27/15. A further review was conducted and there were no computer generated work orders for the 60 unacceptable temperature ranges (noted in the decontamination room) that were noted in 3/2015, 4/2015 or 5/2015.

The hospital policy and procedure titled, "TEMPERATURE AND HUMIDITY FOR PROCEDURAL, PROCESSING AND STERILE STORAGE LOCATIONS", effective date 3/2015, indicated "Maintenance of a safe patient and staff environment of care." Under the policy subheading it indicated, the following parameters...

"Clean/Sterile Store Rooms...59-86 degrees F...
Soiled/Decontaminated...60-65 degrees F...
Prep (Preparation)/Packaging...68-75 degrees F..." Under the procedure subheading it indicated, "Temperature will be monitored and logged daily. Variations outside the documented ranges will be reported to engineering..."

5. During a concurrent interview with DPO, the CNO and the contractor (C 1) in the Plant Operations Department, on 5/6/15, at 9:27 AM, the computer screen indicated the current temperature in the decontamination room of the CPD was 65.6 degrees F. C 1 was asked if he was aware what the audible alarms were set at to alarm in the CPD areas. He was unable to respond, he did state, "I think they're OK with anything in the 60's (in the decontamination room)." The DPO stated, they were set to OSHA (Occupational Safety and Health Administration) guidelines.

During a concurrent interview with the DPO and review of the "2007 CALIFORNIA MECHANICAL CODE" provided by DPO, on 5/6/15, at 11:52 AM, it was noted there were no specific temperature parameters set for the Decontamination room, Preparation and Packaging room (assembly room), or the Clean and Sterile Storage room; therefore, DPO indicated that according to 315.1.6 of the "2007 CALIFORNIA MECHANICAL CODE" it read in part, "For all other occupied areas, heating systems shall be designated to provide 70 (degrees [F]) to 75 (degrees [F]) temperature..."

He was informed the CPD followed the 2006 AAMI standards which indicated the following acceptable parameters:

Decontamination room - 60 to 65 degrees Fahrenheit (F)
Preparation and Packaging room (assembly room) - 68 to 73 degrees F
Clean and Sterile Storage room - 75 degrees F or lower.

The DPO was not aware the CPD followed AAMI standards. No additional information was provided.

6. During an interview with the DSS, on 5/6/15, at 11:45 AM, the DSS stated she was the Director of the the Surgical Services and the Director of the CPD. The DSS stated, she became responsible for the CPD sometime "last year". Although she was not certain what month last year. She was informed of the issues identified throughout the survey process with the CPD.

During a review of DSS' "Annual Performance Evaluation" dated 9/10/14, it was titled, "DIRECTOR SURGICAL SERVICES", the performance evaluation contained no documented evidence the DSS demonstrated competency to oversee the CPD.

During a subsequent interview with the DSS, on 5/6/15, at 12:10 PM, she was asked how did she demonstrate competence to oversee the CPD. After reviewing her 9/19/14, "Annual Performance Evaluation", she acknowledged there was no documented evidence her competency was assessed to oversee the CPD.

The hospital's policy and procedure titled, "PERFORMANCE EVALUATIONS" effective date of 6/1989, indicated in part, "...Marian Regional Medical Center has established and will maintain a comprehensive program of employee Performance Evaluation and the communication and documentation of that evaluation to the employee. Performance Evaluations will be conducted upon 90 days of continuous employment and upon the annual anniversary date in the job. Additionally, employees will be evaluated within 90 days of a change in job classification or job responsibility..."

The hospital's policy and procedure titled, "STAFF COMPETENCY" effective date 1/1997, indicated in part, "Marian Regional Medical Center has established this policy to ensure that the competence of all staff members...is assessed, maintained, demonstrated and improved continually. Competency is assessed upon initial assignment... Competency is assessed on an ongoing basis through the department competency assessment programs..."
VIOLATION: INFORMED CONSENT Tag No: A0955
Based on interview and record review, the hospital failed to ensure documentation of an informed consent by the physician prior to the procedure for one of 17 sampled patients (1) which had the potential to result in a lack of information regarding the risks and benefits of the procedure to make an informed choice.

Findings:

During a concurrent interview and review of the clinical record for Patient 1 with Registered Nurse (RN) 2, on 5/4/15 at 2 PM, she reviewed the clinical record and could not find documentation by the physician for the informed consent including risks and benefits for the procedure of heart catheterization and angioplasty (a procedure where the circulation of the heart is viewed and blockage of the circulation is opened with a specialized balloon) and conscious sedation. RN 2 stated the physician is supposed to document the informed consent discussion in his notes.