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Based on observations, staff and patient interviews, clinical record review; and document review, the hospital failed to ensure the safety of a patient during a surgical procedure as evidenced by:

1. Staff not following the manufacturers' guidelines of alcohol-based pre-operative skin preparations prior to surgery. (Refer to Tag A-0951).

2. Not implementing and enforcing the hospital's policies and procedures of alcohol-based pre-operative skin preparations prior to surgery. (Refer to Tag A-0951).

3. Staff not trained and knowledgeable when using alcohol-based pre-operative skin preparations in anesthetizing surgical sites to reduce the risk of fire. (Refer to Tag A-0951)

The cumulative effect of these systemic problems resulted in the inability of the hospital's surgical services to ensure the provision of care in a safe environment.

Based on observations, staff and patient interviews, clinical record review, and document review, the hospital failed to ensure the safety of a patient (Patient 1) during a surgical procedure when staff did not follow the manufacturers' guidelines of alcohol-based pre-operative skin preparations prior to surgery; did not implement the hospital's policies and procedures of alcohol-based pre-operative skin preparations prior to surgery; and did not train staff to be knowledgeable in the use of alcohol-based pre-operative skin preparations in the operating room to reduce the risk of fire. Patient 1 sustained second degree burns to the left side of his neck from a thermal event (an event that causes extreme heat) creating undue pain; a potential source of infection, requiring additional medical treatment; and adding to the psychological distress of just learning he had lung cancer.
Findings:

Patient 1 was admitted to the hospital on 6/20/12 for a biopsy of the lungs due to a chest mass. Patient 1 was scheduled for a bronchoscopy (a technique of visualizing the inside of the airways for diagnostic and therapeutic purposes) and a mediastinoscopy (a means of obtaining a tissue diagnosis for thoracic (chest) masses).

During an interview on 6/27/12 at 11:50 a.m., Surgeon A stated Patient 1 had a "ZZ Top"-type beard, "elongated goatee-type beard to mid-chest, scraggly, and not groomed." In describing the preparation of the surgical site for the mediastinoscopy Surgeon A stated he "frequently does the surgical prepping of his patients for surgery" and indicated he did the surgical prep for the mediastinoscopy that was performed on Patient 1 on 6/20/12. Surgeon A gesturing with his hands described Patient 1's beard as "folded up and held in place with a towel and tape" by surgery staff. Surgeon A stated he used DuraPrep (a highly flammable, alcohol-based solution used for cleaning the surgical site) for the initial prepping of Patient 1 and "...uses DuraPrep for almost all the surgeries he performs." Surgeon A stated pre-operatively, towels were placed under Patient 1's neck. When asked if he checked the towels for wetness prior to the start of surgery, he stated he had not checked the towels to see if they were wet. "[I] didn't think to check." Surgeon A corroborated, "some of the prep could have dripped onto [Patient 1's] beard." Surgeon A went on to say while allowing the surgical prep solution to dry, he "scrubbed in." (applying mask, gown, gloves and scrubbing hands prior to a surgical procedure). [AORN (the Association of PeriOperative Registered Nurses) guidelines define the hand scrub time as lasting 3-5 minutes.]

During the same interview, in describing the thermal event, Surgeon A stated that after making the incision and using the cautery (a tool that uses a high-frequency electric current to cut and/or coagulate tissue), he "smelled something and saw smoke coming from under the drapes and off the beard" so he immediately pulled off the drape, dumped sterile water onto the beard and the surgical site, and checked the skin. "I [Surgeon A] could not see any damage to the neck."

Surgeon A stated after assessing the patient and the situation, Patient 1 was re-prepped with a different prep solution, which he could not recall the name of, and re-draped [Patient 1]. When queried as to why he was using a different solution, Surgeon A stated, "I didn't want to use same prep in case this prep was involved in this event." When shown the manufacturers' guidelines for DuraPrep and Chloraprep (the second, alcohol-based pre-operative skin preparation used) Surgeon A stated that he had never seen the manufacturers' guidelines for DuraPrep prior to this interview.

Surgeon A stated that he spoke with Patient 1 in PACU (post-anesthesia care unit or recovery room) and informed Patient 1 that "a thermal event happened with his beard and the skin appeared hurt on his neck..." Surgeon A re-examined Patient 1 and discovered a "first-degree burn on the neck," without blisters.


During an interview on 6/28/12 at 12:20 p.m., Anesthesiologist B was asked to describe the pre-op preparation of Patient 1 and the "thermal event." Anesthesiologist B did not think the pre-op removal of Patient 1's beard was an "issue" for him. "If it is part of the body image we don't try to destroy that image... He's a biker dude." When asked the color of Patient 1's hair/beard, Anesthesiologist B stated it was "gray." Anesthesiologist B stated, "The way the beard was secured (swept up and away from the face and secured in place with tape and a towel) "should have been adequate... We thought the hair was safe how we had it taped."

In continuing the interview, Anesthesiologist B stated, at the time of the thermal event, she saw "wisps of smoke" and smelled "hair burning." After [Surgeon A] immediately pulled the drapes off Patient 1, she noticed the prep (solution) had pooled in the hair of the beard and "the beard was wet." When asked how she could tell that the beard was wet, Anesthesiologist B stated, "It was like wet, as if it was wet with water." When asked if the hair was visibly wet, she stated, "Yes." Anesthesiologist B also stated, the skin on the left side of Patient 1's neck sustained "second degree burns." "There were two half-inch sized blisters in a "stuttering" or track-like pattern which ruptured immediately." "The hair was singed right above the blistered area."

Anesthesiologist B, she was asked who determines if a patient's hair is shaved or not, Anesthesiologist B stated, "It's a surgeon's call." She also corroborated that the oxygen delivered to the patient was via an endotracheal tube (a closed system that oxygen would not escape from) and there were no air leaks and the alarms never triggered any alerts.

During an interview on 6/28/12 at 10:40 a.m., Circulating Nurse G described Patient 1 as having a "mountain man's beard;" [the beard] came to about the nipples, full, scraggly, and no notable trimming or grooming. Circulating Nurse G went on to say that after the first procedure, the bronchoscopy, Patient 1 was prepped by Surgeon A for the mediastinoscopy using the DuraPrep applicator, applied from the chin to the nipples and shoulder to shoulder. Circulating Nurse G did not know the exact volume of solution contained in the DuraPrep applicator, but said, "It was probably about 20 cc (cubic centimeter, a unit of measure; same as milliliters)." She stated after Surgeon A started to make his incision, he went to use the hand-held cautery. Within seconds, Surgeon A stated, "Oh, my God. Why's there smoke?" and immediately removed the drapes from the patient.

Circulating Nurse G stated that when Surgeon A re-prepped Patient 1 following the thermal event he used ChloraPrep (another highly flammable, alcohol based prepping solution contained in the same-sized applicator as the DuraPrep (26 ml). Circulating Nurse G told Surgeon A at the time, "There is a flammable sticker on the label [of the ChloraPrep] and offered Beta Beta [Betadine (a non-flammable iodine-based solution)]; however Surgeon A chose ChloraPrep. Circulating Nurse G, in comparing DuraPrep and ChloraPrep stated, "They are basically the same. DuraPrep leaves a film and ChloraPrep wipes off easily." When queried about how long each solution takes to dry when on hair, Circulating Nurse G stated, "I don't know how long it takes the solution to dry."

In reference to not shaving the beard pre-operatively, Circulating Nurse G stated, "We were trying to respect the patient's wishes." She went on to say that she had not seen the burn area on Patient 1's neck until after the procedure and described the area as two (2) inches by four (4) inches in diameter, red, without blisters. Circulating Nurse G added that it looked like the "skin had peeled off half of the site..." When asked what she thought happened, Circulating Nurse G stated the team concluded that the patient's beard had caught on fire.

During an interview on 6/27/12 at 9:55 a.m., Compliance Officer, Risk Manager C was asked if a "Root Cause Analysis" had been done. She replied that it was not yet finished and presented the hospital's "Action Plan." When asked if photographs had been taken of Patient 1's neck or if the drapes and towels that were involved in the thermal event had been saved she replied, "No".

During a tour of Operating Room (OR) 1 and concurrent interview on 6/28/12 at 9:22 a.m., Circulating Nurse H was asked to describe the role of a circulating nurse. She stated the circulating nurse "oversees the room, makes sure the patient is safe...the circulator runs the room." Some of the circulator's duties include checking monitors; seeing if the anesthesiologist or the surgeon need anything; checking the bovie [cautery] and making sure it is ready to go with the settings adjusted to the surgeon's preferences; and monitoring the prep solution's dry time. When asked about her training specific to the OR, Circulating Nurse H stated she believes she has been trained about working in an oxygen-rich environment, prep solutions, and use of a bovie every year. During the same interview, the Manager Surgical Services E interjected that she doesn't think staff are trained about prep solutions at orientation. When asked to provide a DuraPrep applicator, Circulating Nurse H presented a 26 ml applicator. When asked if DuraPrep came in any other sizes, she stated she had not seen any other sizes, but was aware that ChloraPrep came in a smaller size. In continuing the interview, Circulating Nurse H was queried about what she would have done if she was faced with a situation similar to the thermal event on 6/20/12 involving Patient 1. She stated she would ask the surgeon to wait until the prep solution was dried before draping the patient, recommend that the surgeon use a non-flammable prep solution, ask the surgeon to put KY jelly (a water-based lubricant which can be used as a barrier) on the hair around the face and neck. Circulating Nurse H also stated that she did not know how you would tell when the prep solution was dried in hair. She added that in 33+ years as an OR nurse, she has never experienced a situation where a surgical team waited one hour for a prep solution to dry. During the same interview, The Compliance Officer, Risk Manager C interjected that Surgical Services uses AORN's (Association of peri-Operative Registered Nurses) standards, including those for fire prevention. During an interview on 6/27/12 at 2:35 p.m., Scrub Tech J was asked to describe the thermal event of 6/20/12 involving Patient 1. Scrub Tech J stated Patient 1 had a "big woolly beard; bushy, full and long." He stated, preoperatively, the surgical team worked to contain the beard for "about 10 minutes," asking ourselves, "What are we going to do with this?" After prepping Patient 1, the hair was "not visibly wet. It looked dry." When asked if the prep solution wicked onto the towels, he stated, "No." When asked how long the DuraPrep was allowed to dry, Scrub Tech J stated, "About 10 minutes."
In continuing the interview, Scrub Tech J stated, "We have always known about the risk of fire with flammable agents. We weren't sure if the fumes pooled under the drape. Alcohol is difficult. You can't always see the flames burning." Scrub Tech J stated that after the thermal event, he looked at the patient's neck and noticed it was red, with a couple of blisters, and the hair was charred. When asked what could have been done differently, Scrub Tech J stated, "We could have not respected the patient's wishes and shaved the beard. In hindsight, no beards now." He added, he thinks the beard caused the fire. When asked about the last time he was trained in the use of DuraPrep or ChloraPrep, Scrub Tech J stated, "Several years ago from the reps (sale representatives)."During an interview on 6/29/12 at 9:30 a.m., PACU Nurse I was asked to describe the left side of Patient 1's neck following surgery. She stated there were "three finger tip-sized open spots, like maybe he had blisters."During an interview on 6/27/12 at 1:50 p.m., the Assistant Nurse Manager Surgical Services F who is responsible for training the OR staff, was asked about the events of 6/20/12 involving Patient 1 and his role. He stated he was not in the room at the time, but was the first person outside the OR who heard about the event and called Risk Management and his supervisors. He also called the PACU and instructed them to keep Patient 1 in recovery. When asked if he was trained in the use of DuraPrep, Assistant Nurse Manager Surgical Services F replied that he was trained in its use by his preceptor at orientation approximately ten years ago and also read the product instructions and "guidelines", therefore "knew that it was flammable." When asked about the prep solution's drying time in relation to hair, he stated, "It's up to one hour." He added, "I wouldn't have waited an hour for the hair to dry." When asked what the OR policy states regarding the shaving of beards, he stated, "I don't know what to do if the patient doesn't want it shaved."

Concurrently, in the same above interview, Manager Surgical Services E who mentioned she had 20+ years of surgical experience, stated: "I absolutely don't think this [event] could have been prevented. It's unique to me to learn about the product in relation to hair." She added she knew the product was flammable, but had never experienced a problem before. "We were concerned about the patient's preferences and culture [in the community where many people have long hair and beards]."In an interview on 6/28/12 at 2:25 p.m., Patient 1 stated he was told of the incident by the nurse when he woke up from anesthesia and also from Surgeon A. When asked to describe the injury to his neck, Patient 1 stated the burn was painful, but is now like a sunburn with several blisters "in a line," the two largest being the size of "a dime or a nickel." When asked if, before the surgery, he told any staff about his desire to keep his beard intact, he stated, "It never came up. No one mentioned it, so I didn't mention it. It wasn't a big deal."In a second interview on 6/29/12 at 9:15 a.m., Circulating Nurse G was asked if she had a pre-op conversation with Patient 1 about his beard. She stated, "Yes, it came up in the general conversation," adding she told the patient OR staff would "do everything within our power to keep the beard." Circulating Nurse G also stated that she and Anesthesiologist B were both aware of the blistering on Patient 1's neck. In an interview on 6/29/12 at 9:35 a.m., the Director of Surgical Services D was asked if there was a policy regarding the prepping of patients with beards. She stated, "No," adding that hair is removed only when necessary and in the smallest amount possible. The Director of Surgical Services D was asked how she monitors to see if staff are following policies and procedures. She stated she monitors through observations and at the time of the annual staff evaluations. Regarding the availability of smaller sized DuraPrep applicators, the Director of Surgical Services D stated she did not know if DuraPrep came in a smaller 6 ml size, but that ChloraPrep did. When asked about any prior staff training regarding the use of prep solutions, the Director of Surgical Services D stated an inservice had been conducted in July 2011 about prep solutions as they related to infection control, but she did not have any sign-in sheets from that training. When asked about current training regarding the revised policy for surgical prep solutions, the Director of Surgical Services D stated a 10 minute "mini inservice" had been given to all OR staff who were not currently on vacation, leave, or sick. The other staff would be trained by the Manager Surgical Services E or the Assistant Nurse Manager Surgical Services F as they returned to work. She also stated her department was not responsible for the training of physicians, rather they are inserviced by medical staff. Since some physicians are on vacation, she stated it would take "a couple of weeks" to notify all physicians of the revised policy; she did not know if any physicians had been inserviced already. The Director of Surgical Services D corroborated that the OR policy and the manufacture's guidelines for DuraPrep had not been followed.

In an interview on 6/28/12 at 4:40 p.m., the Director of Surgical Services D stated, prior to the incident on 6/20/12, "No one has had any training on DuraPrep or ChloraPrep."
On 6/29/12, the following documents were reviewed:

The manufacturers' packaging for both DuraPrep and ChloraPrep indicated: "Patient Preoperative Skin Preparation for large prep areas below the neck (..."for largeareas..." in italics; "Warning," (in capital letters) and "Flammable" were highlighted in a box with black text and red background; and keep away from fire or flame.

The manufacturers' packaging also reflected the following:

To reduce the risk of fire, prep carefully ("Prep carefully" in capital letters). Do not use 26 ml applicator for head and neck surgery. Do not use on an area smaller than 8 in. x 10 in., use a small applicator instead. Solution contains alcohol and gives off flammable vapors ("flammable vapors" in red.) Do not drape or use ignition source (e.g. cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Avoid getting solution into hairy areas. Wet hair is flammable (in red text). Hair may take up to 1 hour to dry. Do not allow solution to pool. Remove solution-stained material from prep area.

The manufacturers' packaging also indicated the following:

Two warning symbols in red, one showing a cautery and a flame, and the other stating
"pooling" contained in a circle with a diagonal line across it. For procedures requiring less coverage [smaller than 15 x 30 in.], a smaller applicator is available [6 ml]... Do not use more than required for the area. 3M recommends all users participate in product in-service prior to use."
A notation [not printed with the full record] from the Surgical Case Record, dated 6/20/12, authored by Circulating Nurse G indicated: [sic] "DuraPrep was preformed by [Surgeon A] at 1245. Pt was draped bovie and suction hooked up. Case stared at 1246+ shortly after the bovie was used smoke and burning smell noted by [Surgeon A]. Case stopped, drapes removed [Surgeon A] noted pt bread smoking. Water applied and pt exam done. [Surgeon A] re-prepped with ChloraPrep and redraped. Surgery continued. At end of case it was noted that the left side of the pt neck had a blister. [Surgeon A] ordered Bacitracin [an antibiotic] oint to area. PR." An e-mail sent from the Director of Surgical Services D to "Surgery RN Coordinators," dated and timed 6/22/12 at 11:13 a.m., indicated, "As you know we had a smoldering beard on Wednesday, directly related to the use of DuraPrep. You may have already had an inservice from Assistant Nurse Manager Surgical Services F or seen postings in the ORs that we will no longer be using ChloraPrep or DuraPrep in the head/neck areas ["...we will no longer...in italics.] These preps also take at least an hour to dry on hair, which was the issue this past Wednesday. The prep was dry on the skin but not the hair. Please review the manufacturer instructions [italics] and then review with your physicians and discuss with your surgeons other prep options for each or your specialties..."An "excerpt" from the Quality Steering Committee minutes, dated 6/26/12, included the following under "Patient Safety: Reported Events: OR Fire. Compliance Officer, Risk Manager C went over the details of a main campus OR fire. She noted the circumstances surrounding a patient who was prepped for mediastinoscopy. Due to patient preference, the patient's beard was not shaved prior to procedure, but was securely taped. The patient was prepped with DuraPrep and ChloraPrep, and the prep was allowed to dry prior to procedure. Cautery was used at initiation of procedure, and smoke was observed coming from under the drape, which resulted in immediate responsive action. Package inserts indicate that DuraPrep and ChloraPrep should not be used in the head and neck area. Risk prevention strategy includes the discontinuation of the above-noted preps that were inappropriately used, reinforcement and education with surgical staff [regular type]. No action required--information only [in italics]."

The "Quality Risk Event Form," dated 6/20/12, under the heading of "Event Report," indicated [sic]: "Patient was prepped by doctor with DuraPrep then did a handwash, gown and gloved. Drapes applied, bovie and suction in place. Case started and bovie was used. Doctor noted smoke and burning odor and drapes were removed immed. the beard of our pt
had started on fire. Water applied and pt was exam by doctor. Pt was re-prepped with Chloraprep by doctor and doctor changed his gown and re-draped pt. Surgery proceeded and at end of case doctor re-exam pt and burn noted. Bacitracin oint ordered to be applied to area."

The hospital's "Action Plan," titled "OR Fire," dated June 2012, indicated under the Action Plan's "Findings", "DuraPrep and ChloraPrep were both used. Package inserts for each state not to use in the head and neck area" [sic]. "Some surgeons perform preps and hospital staff perform surgical preps--need same level of competency and competency assessment."

The hospital's policy titled, "Skin Preparation of the Patient," revised 2/2011, indicated, "If a flammable prep agent is used, additional precautions should be taken to minimize the risk of a surgical fire and patient burn injury." [The solution] must be used according to manufacturer's instruction; ensure that the prep solution doesn't pool or soak drapes and fully dries; staff should be familiar with the flammability characteristics of all prep agents; the prep agent should not contact fabric or be allowed to pool on or under body parts; pooled prep agents require longer periods of time for evaporation; if pooling occurs, the excess solution should be wicked away; any solution-soaked materials should be removed from the procedure room before draping or using electrosurgery, laser, or other heat source; prep agents should be allowed to dry and vapors dissipate before application of an incise drape or surgical drape, or use of electrosurgery, laser, or other heat source; all members of the team should be aware that the flammable prep agent has been used, the application site was dry before draping, no pooling occurred or has been correct [sic], and any materials soaked with prepping agent have been removed from the procedure room.

The hospital's policy titled, "Fire Plan in an Oxygen Enriched Atmosphere," revised 1/2005, indicated under "Preventive Measures," "Do not drape the patient until all flammable preps have dried."

The hospital's policy titled, "Electrosurgical Safety," revised 4/2008, indicated: "Take the following precautions during procedure:...Do not operate the ESU [Electrosurgical Unit, i.e. bovie] in the presence of flammable agents."

The "Annual Competency Review: RN Annual Competencies--Surgery/NCSC," dated 7/2011, did not include competency related to patient prepping solutions.

The "Competency Based Orientation Checklist: RN Basic Competencies--Operating Room," revised 8/2008, did not include competency related to patient prepping solutions, nor proper surgical prep of the head and neck.

The AORN study guide titled, "Fire Prevention in the Perioperative Suite," dated 2005 (taken from AORN Standards, Recommended Practices, and Guidelines, 2005), which was used for OR staff training in July 2011, indicated: Under "Orientation: Introduction: The Fire Triangle: Fuel: ...If alcohol is used for prepping, be aware that it is extremely flammable... Always allow adequate time for the completed prep to be visibly dry before draping, because vapors accumulate under drapes and provide a potentially dangerous situation.

Continued under the same AORN study guide: "Orientation: The Fire Triangle: Ignition: ...The Emergency Care Research Institute (ECRI) has stated that most OR fires can be traced to the use of electrosurgery...AORN's 'Recommended Practice IV for Electrosurgery' states that the ESU should be used in a manner that minimizes the potential for injuries.' 'Recommended Practice VI for Electrosurgery' further states that 'the ESU active electrode should not be used in the presence of flammable agents' (e.g. alcohol, tinctures of defatting agents). Ignition of these flammable agents has resulted in patient and personnel injuries."

Continued under the same AORN study guide: "If a Surgical Fire Occurs:...Once the fire has been extinguished, save all burned material and equipment so that the cause of the fire can be investigated." Under "Prevention of Surgical Fires:...Specific fire-prevention measures for the perioperative setting include the following:...Do not allow prep solutions to pool under the patient...Apply water-based gels to patient's beard, eyebrows, mustache, head, and pubic hair if an ESU is used near these areas."

AORN Perioperative Standards and Recommended Practices (2012): "Recommended Practices for Preoperative Patient Skin Antisepsis" included:

Recommendation III: "The antiseptic agent used should be selected based on the patient assessment...III.f. The antiseptic produce used for an individual patient should be based on...a review of written manufacturer's information..."

Recommendation VIII: "If a flammable prep agent is used, additional precautions should be taken to minimize the risk of a surgical fire and patient burn injury...VIII.a. Perioperative personnel should be familiar with the flammability characteristics of all prep agents stored or used in the patient care area; VIII.b. When flammable prep agents are used, they should be packaged in small quantities appropriate for a single application or be pre-packaged in a unit dose. Packaging in small quantities may minimize the risk of soaking materials adjacent to the prepped area and limits the amount left over for disposal; VIII.c. The prep agent should not contact fabric or be allowed to pool on or under body parts...Pooled prep agents require longer periods of time for evaporation...VIII.d. If pooling occurs, the excess solution should be wicked away. Any solution-soaked materials should be removed from the procedure room before draping or using electrosurgery...Solution-soaked materials are easily ignitable...VIII.e. The prep agent should be allowed to dry and vapors to dissipate before application of an incise drape or surgical drape, or use of electrosurgery, laser, or other heat source. The prep agent remains flammable until completely dry. Vapors occurring during evaporation are also flammable. Trapping of solution or vapors under drapes increases the risk of fire or burn injury. VIII.f. The use of a flammable prep agent should be discussed during the 'time out' period used to verify the surgical procedure and site...VIII.f.1. Active communication between surgical team members should include that a flammable agent was used, the application site was dry before draping, pooling of the prep solution did not occur or has been corrected, and any materials soaked with the prepping agent have been removed from the procedure room."

Recommendation IX: "Manufacturers' written recommendations and MSDS [Material Safety Data Sheets] for handling, storing, and heating of all skin preparation agents should be readily available, reviewed, and followed."

Recommendation XI: "Personnel should receive initial education, training, and competency validation on skin preparation agent selection, application procedures, and patient assessments. Initial competency validation, in addition to the annual review and evaluation of individual competency skills, should be performed to maintain proficiency in application of knowledge and use of critical thinking concerning performance of skin preparation...XI.b. Personnel should receive education and training on selection of skin preparation agents. Personnel should be knowledgeable about skin preparation agents, indications, contraindications, and special precautions to be used when handling flammable antiseptic agents...XI.d. Personnel removing hair should receive instruction on the risks associated with shaving, shaving alternatives, and proper hair-removal techniques...XI.e. Personnel should receive education and guidance on skin preparation for the types of procedures performed and precautions to be taken. Skin preparation techniques vary by surgical procedure and patient condition... XI.f. Administrative personnel should validate the competence of personnel participating in skin preparation activities."

Recommendation XIII: "Policies and procedures on the skin preparation of patients should be written, reviewed annually, and readily available within the practice setting."

Recommendation XIV: "A quality management program should be in place to evaluate skin preparation procedures and identify and respond to opportunities for improvement."