HospitalInspections.org

Based on record review and interview, the hospital's Governing Body failed to ensure the QAPI program reflected the complexity of the hospital's services as evidenced by failing to include all hospital services in the QAPI program. This deficient practice was evident by failing to include the contracted hospital services of Physical Therapy, Occupational Therapy and Speech Therapy in the hospital's QAPI program.

Review of the Hospital's Quality Performance Improvement Plan revealed in part the following:
Scope: A standardized process to assure competency of care providers. Ongoing assessment of all patient care and organizational functions and outcomes data....Ongoing review of all patient care processes, outcomes and services provided in all hospital departments and each of the eleven major functions.

Review of the Hospital Database Worksheet, Exhibit 286 dated 09/28/17 revealed the hospital provided Physical Therapy, Occupational Therapy and Speech Therapy services under arrangement or agreement.

Review of the medical record for Patient #3 revealed the patient had received physical therapy services.

On 09/28/17 at 8:40 a.m., the hospital's quality improvement program was reviewed with S2CNO, who indicated she was responsible for QAPI. Review of the program revealed no documented evidence that the hospital services of Physical Therapy, Occupational Therapy, and Speech Therapy were included in the QAPI program. S2CNO confirmed the hospital's QAPI did not include quality indicators for the contracted services of Physical Therapy, Occupational Therapy and Speech Therapy.

30172


Based on record reviews and interviews, the Hospital failed to ensure the assignment of nursing personnel for patient care services was done in accordance with nursing personnel competence. This deficient practice was evidenced by failure of the Hospital to ensure annual competency evaluations for IV Conscious Sedation administration were documented for 6 (S2CNO, S6RN, S7RN, S8RN, S9RN, S10PMD) of 6 personnel reviewed for IV Conscious Sedation competency evaluations.

Findings:

A review of the LSBN (Louisiana State Board of Nursing) revealed in part: The Louisiana State Board of Nursing (LSBN) defined the scope of authorized practice for registered nurses regarding intravenous conscious/procedural sedation in September 1990 (npop 90.20) and determined the administration of intravenous conscious/procedural sedation was within the realm of practice of a registered nurse (RN) as delineated by the Board's specific criteria. Intravenous conscious/procedural sedation was defined as a state of mild to moderate sedation, permitting patient cooperation and tolerance of diagnostic and therapeutic medical procedures.
A. The RN (non- CRNA {Certified Registered Nurse Anesthetist}) shall have documented education and competency to include:
Knowledge of sedative drugs and reversal agents, their dosing, onset, duration, potential adverse reactions, drug compatibility, contraindications, and physiologic effects.
Advanced Cardiac Life Support
Skill in establishing an open airway, head-tilt, chin lift, use of bag-valve-mask device, oral and nasal airways, and emergency procedures. This includes rescuing a patient that may progress beyond deep sedation.
Demonstration of the acquired knowledge of anatomy, physiology, pharmacology, and basic cardiac arrhythmia recognition; the ability to recognize complications of undesired outcomes related to sedation/analgesia; appropriate interventions in compliance with standards of practice, emergency protocols or guidelines.
Demonstration of the knowledge of age specific considerations in regard to assessment parameters, potential complications, and appropriate interventions according to institutional protocol or guidelines.
Possession of the requisite knowledge and skills to perform and evaluate pre-procedure baseline, intra-procedure, and post-procedure clinical assessment of the patient undergoing sedation/analgesia.
Demonstration of the ability to use oxygen delivery devices, applying the principles of oxygen delivery and respiratory physiology.
Demonstration of the knowledge of the standards of practice and licensure related to the sedation/analgesia.
Application of the principles of accurate documentation in providing a comprehensive description of patient responses and outcomes.
B. Competencies will be measured initially during orientation and at least on an annual basis. A RN (non-CRNA) will not monitor an adult patient with an ASA classification higher than Class III.

A review of the hospital policy titled "Procedural Sedation", as provided by S2CNO (Chief Nursing Officer) as the most current, revealed in part: Procedural Sedation medication can be administered by a RN (Registered Nurse) who has demonstrated annual competency in the administration and monitoring of Procedural Sedation, shall have documented education and competency to include: ACLS (Advanced Cardiac Life Support), Skills in establishing an open airway, Basic cardiac arrhythmia recognition, Demonstrated knowledge of age specific considerations, and Documented competency of Procedural Sedation during orientation and annually. Procedural Sedation practices throughout the hospital shall be monitored and evaluated by the Anesthesia Department.

Review of the personnel files for S6RN, S7RN, S8RN, and S9RN (pain management nurses) revealed no documented evidence of annual skills competency evaluations for administration of IV Conscious Sedation as set forth by the Louisiana State Board of Nursing in the Declaratory Statement referenced above and per hospital policy.

In an interview on 9/28/17 at 11:30 a.m. with S5EA (Executive Assistant), she confirmed there were no documented skills competency assessments performed annually for nursing staff performing IV Conscious Sedation administration in the pain management unit. She indicated assessment of skills competency in the administration of IV
Conscious Sedation was performed upon hire only, unless a problem was identified requiring re-education. S5EA indicated a written test on IV Conscious Sedation (with no demonstration of skills competency component) was administered to staff annually.

In an interview on 09/28/17 at 11:55 a.m. with S10PMD she indicated that she was the Director of the Pain Management and Radiological Procedure Rooms. She indicated that most of the patient procedures performed in the Pain Management and Radiological Procedure Rooms were performed under IV (intravenous) Conscious Sedation by a RN. S10PMD indicated that all the RNs in her department are ACLS certified and have IV Conscious Sedation competency upon hire and annually. She indicated that she conducts the IV Conscious Sedation competency and demonstrated competency skills for all her RNs only upon hire and that annually the RNs only take an IV Conscious Sedation test without a repeat demonstration of any competency skills. S10PMD indicated that she was checked off by S2CNO, who was checked off by the prior CNO and not by anyone in the Anesthesia Department.














30984

Based on record review and interview, the hospital failed to ensure drug administration errors were documented in the patients' medical records for 1 (#17) of 2 (#17, #19) patients reviewed for medication errors.

Findings:

Review of the hospital policy titled, "Medication Errors", Policy #: PCS: 15-04, revealed in part: 8. Recording Errors in Patient's Record: The medication error and the action taken should be properly recorded in the patient's medical record.

Review of the hospital policy titled, "Medication Variance", (no policy number), revealed in part: Procedure: 1. When a medication variance occurs, the person who made the error, or if not available, the person who discovered the variance will: E. Document without reference to "error" or "mistake": a. Medication, b. Dose, c. Route, d. Date, e. Time, f. Signature, g. Physician notification details, h. Physician orders, i. Treatment given.

Patient #17
Review of the hospital's occurrence reports revealed a medication error involving Patient #17. Further review revealed Patient #17's at home medication dose of Clonazepam was 0.5 mg (milligrams) by mouth BID (twice a day). Review of Patient #17's medical record revealed Clonazepam was ordered as 5 mg by mouth BID. Patient #17 received 3 total doses of the wrong strength of Clonazepam. The medication variance was discovered on 01/11/17 at 9:00 a.m. Further review of Patient #17's entire medical record revealed the medication error had not been documented in the record.

In an interview on 09/27/17 at 10:36 a.m. with S4RN, she confirmed, after review of Patient #17's medical record, that the above referenced medication errors had not been recorded in the patient's medical record.

In an interview on 09/27/17 at 11:00 a.m. with S2CNO, she indicated it was her expectation that the medication errors would have been recorded in the patient's medical record.









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Based on observations, interviews and record reviews the Hospital failed to meet the requirements of the Condition of Participation in Infection Control as evidenced by:

1. Failing to ensure that the designated Infection Control Officer was qualified through experience, ongoing education and/or training to be responsible for the development and implementation of the hospital's Infection Control Program.
(see A-0748)


2. Failing to implement and maintain an effective, ongoing Infection Control Program designed to prevent, control, and investigate infection control breaches that included data collection with tracking, trending, and analysis activities through monitoring and active surveillance of the hospital's infection control practices in order to identify infection control breaches in all the areas of the hospital and to include monitoring for compliance with infection control policies, procedures, protocols and other infection control program requirements. This failed practice was evidenced by not implementing and maintaining an effective Infection Control Program. (see A-0749)

Based on record review and interview, the hospital failed to ensure that the designated Infection Control Officer was qualified through experience, ongoing education and/or training to be responsible for the development and implementation of the hospital's Infection Control Program.

Findings:

A review of the Infection Control Officer's employee file, S2CNO, revealed that she was the designated Infection Control Officer. A review of her employee file revealed no infection control training and/or experience and/or documented evidence of any infection control training/experience in the development and implementation of a hospital Infection Control Program.

In an interview on 09/28/17 at 1:00 p.m. with S2CNO, she indicated that she was the designated Infection Control Officer for the hospital and had been in that position since November 2016. S2CNO indicated that she had the basic annual infection control in-services that all the nurses received each year and that she had no specific training and/or experience in the development and implementation of an Infection Control Program. She indicated that she "had not done anything yet toward receiving training or getting experience" in developing and maintaining an Infection Control Program. S2CNO indicated that she had planned to get training in infection control, but had not had the time or the opportunity since becoming the Infection Control Officer in November 2016. S2CNO indicated that she had no documented evidence of infection control training/experience to present in the development and implementation of a hospital Infection Control Program.

Based on record review and interview the Infection Control Officer failed to implement and maintain an effective, ongoing Infection Control Program designed to prevent, control, and investigate infection control breaches that included data collection with tracking, trending, and analysis activities through monitoring and active surveillance of the hospital's infection control practices in order to identify infection control breaches in all the areas of the hospital and to include monitoring for compliance with infection control policies, procedures, protocols and other infection control program requirements. This failed practice was evidenced by not implementing and maintaining an effective Infection Control Program.

Findings:
A review of the hospital's policy titled "Infection Control Master Plan", as provided by S2CNO, as the most current, revealed in part: Routine surveillance will be conducted to identify trends. All trends will be investigated and reviewed. Results of infection control audits will be forwarded to managers for corrective action and trends reported to Quality Assurance.

A review of the Infection Control binder revealed in part: environmental raw data collection from the various departments each month, hand hygiene data, and SSI (surgical site infection) data. A further review revealed no documented evidence of tracking, trending, and analysis activities in order to identify infection control breaches in all the areas of the hospital (including the contracted services) and to include monitoring for compliance with infection control policies, procedures, protocols and other infection control program requirements.

In an interview on 09/28/17 at 1:30 p.m. with S2CNO she indicated that she had been the hospital's designated Infection Control Officer since November 2016. S2CNO was asked for any additional Infection Control Program documentation that included documented evidence of tracking, trending and analysis activities to identify infection control breaches with monitoring of compliance with infection control policies, protocols, and practices with corrective action plans. S2CNO indicated that she observes compliance with the hospital's infection control program, during hospital rounds, and handles the non-compliance issues at the time of the observation or emails the department managers the non-compliance issues for them to correct within their department. She indicated that she was not documenting these observations or activities for the purpose of tracking, trending, or analyzing. S2CNO further indicated that she was not tracking, trending, or analyzing any of the collected data from the various departments and she was not "quite sure what to do with the data" or how to implement an Infection Control Program. She indicated that she had reviewed the prior Infection Control Officer's binders and was unable to "make much sense of it". S2CNO was asked if she had performed an infection control risk assessment for 2016 or 2017. She indicated that she had not performed an infection control risk assessment for 2016 or 2017. S2CNO indicated that she had no documentation to present for review in the Infection Control Program that included data collection with tracking, trending, and analysis activities with corresponding corrective actions and evaluations.

Based on record reviews, observations, and interviews the hospital failed to ensure the hospital's Surgical Services followed acceptable professional standards of practice governing surgical services and infection control as evidenced by:
1) Failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the semi-restricted and restricted areas as evidenced by multiple observations of surgical attire breaches,
2) Failing to ensure that the hospital processed/sterilized surgical supplies according to MFU for the processing and sterilization of surgical items in paper-plastic peel pouches when double packaging as evidenced by failing to have a policy in place with the MFU for processing/sterilizing surgical items in a double-pouched packaging system, and
3) Failing to ensure that staff followed MFU for HLD processing as evidenced by not adhering to the MFU instructions for temperature monitoring of the HLD solution prior to use and by not adhering to test strip expiration beyond use dates prior to use

Findings:
1) Failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the semi-restricted and restricted areas as evidenced by multiple observations of surgical attire breaches,
The AORN Guidelines for Perioperative Practice, 2016 edition - Guideline for Surgical Attire: AORN recognizes the many diverse settings in which perioperative nurses practice and the surgical attire guideline is adaptable to all areas where operations or other invasive procedures may be performed.

Recommendation I revealed in part: All individuals entering the restricted surgical area (O.R. suite) should wear a surgical mask when scrubbed personnel, sterile supplies and/or sterile equipment are present. A surgical mask protects the patient from transfer of microorganisms. A mask that is securely tied at the back of the head and behind the neck decreases the risk of staff transmitting nasopharyngeal and respiratory microorganisms to patients. The mask should cover the mouth and nose and be secured in a manner to prevent venting. Masks with ear loops may not have been designed and intended for use as a surgical mask and may not provide a secure facial fit that prevents venting at the side of the masks. Surgical masks should not be worn hanging down from the neck. Surgical masks are intended to contain and filter droplets from the nasopharynx. The filter portion of the surgical mask harbors bacteria collected from the nasopharyngeal airway and should not be worn hanging from the neck. Surgical masks should be tied securely and discarded after each procedure or when soiled. Recommendation I further revealed in part: When in the semi-restricted or restricted surgical areas, all non-scrubbed personnel should wear a freshly laundered single use long sleeved scrub top or jacket snapped closed with the cuffs down to the wrists. Wearing the long-sleeved jacket snapped closed prevents the edges of the front of the jacket from contaminating a skin prep area or the surgical sterile field. Long sleeved attire helps contain skin squames shed from bare arms. All personal clothing, not laundered by a health care-accredited laundry facility, should be completely covered by the surgical attire. Undergarments such as T-shirts with a V-neck, and shirts with sleeves which can be contained underneath the scrub top, may be worn; if personal clothing extends above the scrub top neckline or below the sleeve of the surgical attire it should not be worn.
Recommendation II revealed in part: Only facility-approved, clean and freshly laundered surgical attire should be donned daily by all personnel entering or reentering the semi-restricted and restricted surgical areas to decrease the possibility of cross-contamination. Surgical attire should be laundered in a health care-accredited laundry facility either on-site or through a contracted service which incorporate OSHA and CDC guidelines and professional association's recommended practices that follow industry standards through the HLAC (Healthcare Laundry Accreditation Council). Home laundering cannot be monitored for quality, consistency or safety, and laundering may not meet the specified measures necessary to achieve a reduction in microbial levels in soiled surgical attire with measures that involve mechanical, thermal, and chemical components.

Recommendation III revealed in part: All personnel should cover head and facial hair, including the sideburns, the ears and the nape of the neck, when in semi-restricted and restricted areas. Human hair can be a site of pathogenic bacteria such as MRSA. Hair acts as a filter when it is uncovered and collects bacteria. A clean surgical head covering or hood that confines all hair and covers the ears, scalp skin, sideburns and nape of neck, to include beards, should be worn in the semi-restrictive and restrictive areas. The head covering or hood should be designed to minimize microbial dispersal. Skull caps (surgeon caps) may fail to contain the side hair above and in front of the ears and hair at the nape of the neck and the ears. Reusable head coverings, if worn, (cloth head coverings) should be laundered in a health care-accredited laundry facility or completely covered with a disposable bouffant hat.

Recommendation IX revealed in part: Restricted areas in a surgical suite includes the O.R. (operating room) and procedure rooms, the clean core and the scrub sink areas. People in the restricted areas are required to wear full surgical attire (scrub attire, head coverings, and shoe covers as applicable, and masks when sterile supplies and sterile personnel are present). The Semi-Restricted areas include the peripheral support areas of the surgical suite, the storage areas, the work areas, and corridors leading to the restricted areas of the surgical suite.


A review of the hospital policy titled "Procedural Attire", as provided by S2CNO as the current policy, revealed in part: Apparel from home may be worn under scrubs, provided the clothing is completely covered by the scrub attire. Apparel is laundered daily at the hospital's approved facility. All hair must be completely covered before entering the O.R. (Operating Room). If surgical caps are worn outside the surgical suite, they should be changed before re-entering. Mask is to cover mouth/nose completely. Masks should be discarded after use. Head and facial hair, including sideburns and neckline, should be covered when in the semi-restricted and restricted areas of the surgical suite.

Observations on 09/27/17 from 8:30 a.m. to 11:30 a.m., in the presence of S12DirOR, revealed the following surgical attire breaches in the semi-restricted and restricted surgical suite areas:

S27MD/Anes wearing a home laundered T-shirt that was not completely covered by the surgical attire; a surgeon's cap that did not completely cover all the hair on the head, neck, and sideburns; a surgery mask that was hanging around the neck; and wearing a jacket that was not snapped closed

S14NMT wearing a disposable bouffant hat that did not completely cover all the hair, beard, and ears; and wearing a jacket that was not snapped closed

S15NMT wearing a disposable bouffant hat that did not completely cover all the hair, beard, and ears; and wearing a jacket that was not snapped closed; and a surgery mask that was hanging around the neck

S17RTR, S18RTR with facial hair (beard) that was not completely covered by the surgical mask or head covering; a surgeon's cap that did not completely cover all the hair on the head, neck, sideburns, and ears; and a surgery mask that was hanging around the neck

S19RN/OR with facial hair (beard) that was not completely covered by the surgical mask or head covering; a surgeon's cap that did not completely cover all the hair on the head, neck, sideburns, and ears; a surgery mask that was hanging around the neck; and wearing a long surgical scrub gown instead of a surgical cover jacket;

S20RN/OR with a surgical mask not tied at the bottom causing venting and wearing a jacket that was not snapped closed

S16NMT, S21RN/OR wearing a jacket that was not snapped closed

S28MD, S22ST, S24InstTech, S25InstTech wearing a surgeon's cap that did not completely cover all the hair on the head, neck, sideburns, and ears

S26PA wearing a surgeon's cap that did not completely cover all the hair on the head, neck, sideburns, and ears; and a surgery mask that was hanging around the neck.

S29MD with facial hair (beard) that was not completely covered by the surgical mask or head covering; a surgeon's cap that did not completely cover all the hair on the head, neck, sideburns, and ears

S13CRNA wearing a long surgical scrub gown instead of a surgical cover jacket; a surgeon's cap that did not completely cover all the hair on the head, neck, and sideburns; and a surgery mask that was hanging around the neck.

S23ST with facial hair (beard) that was not completely covered by the surgical mask or head covering; a bouffant cap that did not completely cover all the hair on the head, neck, sideburns, and ears

In an interview on 09/27/17 at 11:45 a.m. with S12DirOR she indicated that she was the Director of Surgical Services and that the hospital followed AORN Guidelines for perioperative professional standards of practice. She was asked if she observed any surgical attire breaches in the semi-restricted and restricted areas during our tour of the surgical areas. S12DirOR OR indicated that she did not identify any surgical attire breaches in the semi-restricted and restricted areas during the tour of the surgical areas with the surveyor. S12DirOR was made aware of the multiple surgical attire breaches observed on 09/27/17 from 8:30 a.m. to 11:30 a.m. by the surveyor.

In an interview on 09/28/17 at 11:30 a.m. with S10PMD she indicated that she was the Director of the Pain Procedure Rooms and Radiological Rooms. She indicated that the procedures performed in her areas included in part: Steroid Lumbar Injections, Lumbar Nerve Blocks, Nerve Stimulators, Lumbar Punctures, Myelograms and other minor invasive pain management and radiological procedures. She indicated that the Pain Procedure Rooms and Radiological Rooms followed the AORN Guidelines for perioperative professional standards of practice. S10PMD indicated that the staff working in those procedure rooms wear surgical hats and masks and the staff creates a sterile field for each patient's procedure. The physicians perform hand scrubs and don sterile surgical gowns and gloves prior to patient procedures. She further indicated that the staff and the physician were allowed to wear scrubs that were home laundered and they were not required to don the fresh laundered surgical scrubs, provided from the contracted laundry/linen company, during patient invasive procedures performed in the Pain Procedure Rooms and Radiological Rooms. S10PMD indicated that since the procedures were not being conducted in an O.R. suite that the staff were allowed to wear home laundered scrubs. She indicated that they follow AORN Guidelines on all other surgical attire practices.

In an interview on 09/28/17 at 1:00 p.m. with S2CNO she indicated that she was the Infection Control Officer for the hospital and that the hospital followed AORN Guidelines for perioperative professional standards of practice. She indicated that she conducts routine environmental rounds in the surgical areas and pain management areas. She was asked if she had observed any surgical attire breaches in the semi-restricted and restricted areas during her rounds in those areas. S2CNO indicated that maybe she had identified jackets not being snapped closed and then she would inform S12DirOR of her observation, but she did not document any of these observations in infection control. She indicated that it was not her practice to formally document or tract her observations in surgical attire breaches in those areas during environmental rounds. S2CNO was made aware of the multiple surgical attire breaches observed on 09/27/17 from 8:30 a.m. to 11:30 a.m. by the surveyor and on 09/28/17 in interview.


2) Failing to ensure that the hospital processed/sterilized surgical supplies according to MFU for the processing and sterilization of surgical items in paper-plastic peel pouches when double packaging as evidenced by failing to have a policy in place with the MFU for processing/sterilizing surgical items in a double-pouched packaging system,

A review of the AORN Guidelines for Perioperative Practice, 2016 edition - Guideline for Packaging Systems: Recommendation VII revealed in part: Paper-plastic pouch packages should be used according to manufacturer's written instructions. Paper-plastic pouch packages should be used only for small, lightweight, low-profile items. Double paper-plastic pouch packaging may be used to facilitate containment of multiple small items to be sterilized. Double pouching should not be performed without written instructions from the pouch manufacturer indicating that this practice has been validated by the manufacturer. Unless otherwise specified by the manufacturer, when double pouching is used double paper-plastic pouch packages should be used in such a manner to avoid folding the inner package to fit into the outer package and with plastic to plastic part and paper part to paper part. Folding the edges of the inner peel packages and/or completely sealing the inner pouch may entrap air and inhibit the sterilization process. Writing or placing a label on the paper side of the pouch may compromise the barrier properties by causing damage to the package. The force of writing with a ball point pen or a pencil may cause perforation of the pouch. A marker with nontoxic ink may be used for writing on the plastic side of the pouch.

A review of the AORN Guidelines for Perioperative Practice, 2016 edition- Guideline for Packaging Systems: Recommendation III revealed in part: Sterilized items should be considered sterile until an event occurs to compromise the sterility of the sterile item. The sterility of sterile items is event related and not time related. The sterility of an item does not change with the passage of time, but may be affected by particular events.

A review of AORN Guidelines for Perioperative Practice, 2016 edition - Guideline for Sterilization: Recommendation XV revealed in part: Sterilized items should be labeled and stored in a manner to ensure sterility. Factors that contribute to contamination include air movement, humidity, temperature, location of storage, presence of vermin, whether shelving is open or closed, and properties of the packaging material.

A review of the hospital's Surgical Services Policy and Procedure manual, as provided by S2CNO, revealed no MFU policy on the hospital's use of paper-plastic pouch packages when used for processing items for sterilization.

An observation on 09/27/17 of the Sterile Central Processing and Supply Rooms, in the presence of S12DirOR, revealed multiple sterile surgical instruments and supplies packaged in paper-plastic peel pouches (double-pouched) where the inner paper-plastic peel pouch was folded on 3 sides in order to fit into the outer paper-plastic peel pouches. An observation further revealed that multiple sterile instruments and supplies that were not low profile or light weight were processed in double-pouched packages were the sterility of the sterile package and the seal may be compromised by the weight and/or bulkiness of the instruments within the paper-plastic peel pouches.

In an interview on 09/27/17 at 10:55 a.m. with S24InstTech and S25InstrTech, in the presence of S12DirOR, they indicated that the Instrument Technicians were responsible for the decontamination and sterile processing rooms. They indicated that it was routine practice for many surgical instruments that were sterilized in paper-plastic peel pouches, to be sterilized in double-pouched packages with the inner pouch sometimes being folded on all 3 sides. They further indicated that they have to double-pouch many of the instruments because many of them were too heavy or bulky for a single peel pouch package. They indicated that they were not aware that the use of (double-pouched) paper-plastic peel pouches in sterilization processing had to follow MFU and be validated in writing by the manufacturer for use as double-pouched system or that only low profile and light weight items could only be processed in paper-plastic peel pouches.

In an interview on 09/27/17 at 10:55 a.m. with S12DirOR she indicated that she was not aware that the use of (double-pouched) paper-plastic peel pouches in sterilization processing had to follow MFU and be validated in writing by the manufacturer for use as double-pouched system or that only low profile and light weight items could only be processed in paper-plastic peel pouches.

She further indicated that the hospital did not have a MFU policy in place for the use of (double-pouched) paper-plastic peel pouches used in the sterilization process. S12DirOR indicated that the hospital followed AORN Guidelines for perioperative professional standards of practice.


3) Failing to ensure that staff followed MFU for HLD processing as evidenced by not adhering to the MFU instructions for temperature monitoring of the HLD solution prior to use and by not adhering to test strip expiration beyond use dates prior to use

A review of AORN Guidelines for Perioperative Practice, 2016 edition - Guideline for High-Level Disinfectant, Recommendation IV revealed in part: High-Level Disinfectant (HLD) should occur at appropriate temperatures, contact time, and length of use. Improper use of HLD can cause contamination and lead to outbreaks. A test strip specific for the HLD solution and MEC (minimum effective concentration) of the active ingredient should be used for monitoring the solution potency prior to each use. The test strip expiration date should be checked before use. Critical and semi-critical items that are HLD for the required exposure time should be thoroughly rinsed with water according to MFU. Rinsing removes toxic and irritating residue that can result in tissue damage or staining. Rinsing critical and semi-critical items with sterile water prevents potential recontamination that could result from tap water.

A review of the hospital policy titled "Cidex OPA (HLD) Test Strip and Solution Quality Control", as provided by S2CNO as the most current, revealed in part: To outline the steps necessary to ensure the HLD test strips and solution are within acceptable quality control limits for appropriate HLD. Quality control will be performed on each new bottle of HLD Solution and test strips. Quality control will be performed on the solution for each disinfectant run. "Open date" labeling is required for both test strip bottles and for containers of the HLD solution.

A review of the MFU label for the HLD solution used in the surgery department indicated the temperature should be a minimum of 20 degrees Centigrade (68 degrees Fahrenheit) prior to each use.

A review of the MFU label for the specific MEC test strip used to monitor the HLD's solution potency prior to each use indicated that once the test strip bottle was opened, the MEC test strip bottle would expire in 90 days after opening.

A review of the surgery department's HLD log for July 2017 to present revealed that the monitoring of the solution's temperature prior to each use was not being documented as being monitored. A review of the HLD log further revealed that the test strip bottle expiration date was noted as 10/28/17.

In an interview on 09/27/17 at 11:15 a.m. with S25InstTech he indicated that the Instrument Technicians were responsible for the HLD in the sterile processing area and they were responsible for maintaining the HLD daily logs. He was asked if the HLD solution was temperature monitored prior to each use according to the MFU on the HLD label. S25InstTech indicated that he was not aware that the solution had to be temperature monitored prior to each use when used as a manual HLD solution. S25InstTech was asked about the MEC specific test strips for use with the HLD and the expiration date noted on the HLD logs. He indicated that the expiration date noted on the HLD log was the expiration date that was on the MEC test strip bottle and it was not the 90 day expiration date when the MEC bottle was opened. S25InstTech indicated that he was not aware that the MEC test strip bottle expired after 90 days after being opened. He further indicated that the above practice was the current practice being followed by all the Instruments Technicians.

In an interview on 09/27/17 at 11:15 a.m. with S12DirOR she indicated that she was not really aware of the MFU on the HLD solution and test strips. S12DirOR indicated that the hospital followed AORN Guidelines for perioperative professional standards of practice.

Based on record review and interview the hospital failed to maintain a complete Operating Room Register Log that included at least the following information: name of patient, age of patient or date of birth, patient's hospital identification number, date of procedure, operating room times, names of surgeons/assistants, names of nursing personnel, anesthesia and staff, type of anesthesia, procedure performed, and pre and post diagnosis as specified in the regulation. This failed practice was evidenced by an incomplete Operating Room Register log

Findings:
A review of the Operating Room Register Log, as provided by S2CNO, as the hospital's electronic Operating Room Register Log revealed no documentation in the log of the operating room times, name of the surgeon's assistant, names of nursing personnel, the anesthesia staff, type of anesthesia, and pre and post diagnosis.

In an interview on 09/27/17 at 12:00 p.m. with S2CNO she indicated that the Operating Room Register Log was electronic and the operating room times, name of the surgeon's assistant, names of nursing personnel, the anesthesia staff, type of anesthesia, and pre and post diagnosis were not included in the electronic Operating Room Register Log. S2CNO indicated that there was no other Operating Room Register Log maintained by the hospital.

In an interview on 09/27/17 at 12:25 p.m. with S11IT he indicated that the Operating Room Register Log was electronic and the operating room times, name of the surgeon's assistant, names of nursing personnel, the anesthesia staff, type of anesthesia, and pre and post diagnosis were not included in the electronic Operating Room Register Log. S11IT indicated that he did not have the electronic Operating Room Register Log set up to include all of the above surgery/procedure information. S11IT indicated that it may be a part of the electronic system software that he could set up, but he was not sure. He further indicated that some of the above information may be difficult to include or extract from the electronic software system.