HospitalInspections.org

Based on observation, a review of documentation, interviews with staff and a tour of the facility, the facility failed to ensure that the provision of services requirements were met as evidenced by failing to ensure proper medication storage and security as well as the failure of nursing staff to administer medications in accordance with acceptable standards of practice.

Findings were:

1. The facility failed to ensure that rules for the storage, handling, and dispensation of drugs and biologicals were followed. The facility also failed to ensure that the drug storage area was administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs. As evidence by: The storage of schedule II and III drugs in rolling medication carts, that are taken out of the medication room, compromises the security of these drugs. Schedule II drugs should be double locked according to professional standards. Narcotic drugs are being wasted incorrectly, per interview, also increasing a risk for diversion. The inability to establish/account for the remaining balance of liquid narcotics also compromises security and increases the risk for diversion. The facility must have consistent method for securely maintaining inventory and being accountable for the balance of liquid narcotic medications after they are dministered. The availability of such a large quantities of scheduled drugs to all nursing staff also increased the risk for diversion of drugs at the facility. The facility is currenlty not ensuring the effective, safe, and secure storage of controlled drugs at the facility.

2. The facility failed to ensure services furnished by contractors were reviewed and complied with all applicable conditions of participation and standards for the contracted services. Cross Refer To: A1044

Based on observations, tour, interview, and review of documentation the facility failed to ensure that rules for the storage, handling, and dispensation of drugs and biologicals were followed. The facility also failed to ensure that the drug storage area was administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs.

Findings were:

Findings were:

According to the Drug Enforcement Administration, Department of Justice Title 21 Code of Federal Regulations PART 1300-END found at https://www.deadiversion.usdoj.gov/21cfr/cfr/index.html stated in part,
"SECURITY REQUIREMENTS

§1301.71 Security requirements generally.

(a) All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Administrator shall use the security requirements set forth in Secs. 1301.72-1301.76 as standards for the physical security controls and operating procedures necessary to prevent diversion. Materials and construction which will provide a structural equivalent to the physical security controls set forth in Secs. 1301.72, 1301.73 and 1301.75 may be used in lieu of the materials and construction described in those sections.

(b) Substantial compliance with the standards set forth in Secs. 1301.72-1301.76 may be deemed sufficient by the Administrator after evaluation of the overall security system and needs of the applicant or registrant. In evaluating the overall security system of a registrant or applicant, the Administrator may consider any of the following factors as he may deem relevant to the need for strict compliance with security requirements:
(1) The type of activity conducted (e.g., processing of bulk chemicals, preparing dosage forms, packaging, labeling, cooperative buying, etc.);
(2) The type and form of controlled substances handled (e.g., bulk liquids or dosage units, usable powders or nonusable powders);
(3) The quantity of controlled substances handled;
(4) The location of the premises and the relationship such location bears on security needs;
(5) The type of building construction comprising the facility and the general characteristics of the building or buildings;
(6) The type of vault, safe, and secure enclosures or other storage system (e.g., automatic storage and retrieval system) used;
(7) The type of closures on vaults, safes, and secure enclosures;
(8) The adequacy of key control systems and/or combination lock control systems;
(9) The adequacy of electric detection and alarm systems, if any including use of supervised transmittal lines and standby power sources;
(10) The extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any;
(11) The adequacy of supervision over employees having access to manufacturing and storage areas;
(12) The procedures for handling business guests, visitors, maintenance personnel, and nonemployee service personnel;
(13) The availability of local police protection or of the registrant's or applicant's security personnel;
(14) The adequacy of the registrant's or applicant's system for monitoring the receipt, manufacture, distribution, and disposition of controlled substances in its operations; and (15) The applicability of the security requirements contained in all Federal, State, and local laws and regulations governing the management of waste.

(c) When physical security controls become inadequate as a result of a controlled substance being transferred to a different schedule, or as a result of a noncontrolled substance being listed on any schedule, or as a result of a significant increase in the quantity of controlled substances in the possession of the registrant during normal business operations, the physical security controls shall be expanded and extended accordingly. A registrant may adjust physical security controls within the requirements set forth in Secs. 1301.72-1301.76 when the need for such controls decreases as a result of a controlled substance being transferred to a different schedule, or a result of a controlled substance being removed from control, or as a result of a significant decrease in the quantity of controlled substances in the possession of the registrant during normal business operations.

(d)Any registrant or applicant desiring to determine whether a proposed security system substantially complies with, or is the structural equivalent of, the requirements set forth in Sec. Sec. 1301.72-1301.76 may submit any plans, blueprints, sketches or other materials regarding the proposed security system either to the Special Agent in Charge in the region in which the system will be used, or to the Regulatory Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current mailing address.

(e) Physical security controls of locations registered under the Harrison Narcotic Act or the Narcotics Manufacturing Act of 1960 on April 30, 1971, shall be deemed to comply substantially with the standards set forth in Secs. 1301.72, 1301.73 and 1301.75. Any new facilities or work or storage areas constructed or utilized for controlled substances, which facilities or work or storage areas have not been previously approved by the Administration, shall not necessarily be deemed to comply substantially with the standards set forth in Secs. 1301.72, 1301.73 and 1301.75, notwithstanding that such facilities or work or storage areas have physical security controls similar to those previously approved by the Administration.

(f) A collector shall not employ, as an agent or employee who has access to or influence over controlled substances acquired by collection, any person who has been convicted of any felony offense relating to controlled substances or who, at any time, had an application for registration with DEA denied, had a DEA registration revoked or suspended, or has surrendered a DEA registration for cause. For purposes of this subsection, "for cause" means in lieu of, or as a consequence of, any Federal or State administrative, civil, or criminal action resulting from an investigation of the individual's handling of controlled substances ...
§1301.75 Physical security controls for practitioners.

(a) Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.

(b) Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances ....

§1308.12 Schedule II.

(a) Schedule II shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the Controlled Substances Code Number set forth opposite it.
(b) Substances, vegetable origin or chemical synthesis. Unless specifically excepted or unless listed in another schedule, any of the following substances whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(1) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate excluding apomorphine, thebaine-derived butorphanol, dextrorphan, nalbuphine, naldemedine, nalmefene, naloxegol, naloxone, and naltrexone, and their respective salts, but including the following:
(i) Codeine 9050
(ii) Dihydroetorphine 9334
(iii) Ethylmorphine 9190
(iv) Etorphine hydrochloride 9059
(v) Granulated opium 9640
(vi) Hydrocodone 9193
(vii) Hydromorphone 9150
(viii) Metopon 9260
(ix) Morphine 9300
(x) Noroxymorphone 9668
(xi) Opium extracts 9610
(xii) Opium fluid 9620
(xiii) Oripavine 9330
(xiv) Oxycodone 9143
(xv) Oxymorphone 9652
(xvi) Powdered opium 9639
(xvii) Raw opium 9600
(xviii) Thebaine 9333
(xix) Tincture of opium 9630 ...

(c) Opiates. Unless specifically excepted or unless in another schedule any of the following opiates, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, dextrorphan and levopropoxyphene excepted:
(1) Alfentanil 9737
(2) Alphaprodine 9010
(3) Anileridine 9020
(4) Bezitramide 9800
(5) Bulk dextropropoxyphene (non-dosage forms) 9273
(6) Carfentanil 9743
(7) Dihydrocodeine 9120
(8) Diphenoxylate 9170
(9) Fentanyl 9801
(10) Isomethadone 9226
(11) Levo-alphacetylmethadol 9648
[Some other names: levo-alpha-acetylmethadol, levomethadyl acetate, LAAM]
(12) Levomethorphan 9210
(13) Levorphanol 9220
(14) Metazocine 9240
(15) Methadone 9250
(16) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl butane 9254
(17) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic acid 9802
(18) Pethidine (meperidine) 9230
(19) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine 9232
(20) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate 9233
(21) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid 9234
(22) Phenazocine 9715
(23) Piminodine 9730
(24) Racemethorphan 9732"
(25) Racemorphan 9733
(26) Remifentanil 9739
(27) Sufentanil 9740
(28) Tapentadol 9780
(29) Thiafentanil 9729 ..."

According to https://www.deadiversion.usdoj.gov/schedules/, Schedule II and III drug are described as follows:
"Schedule II/IIN Controlled Substances (2/2N)

Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence.
Examples of Schedule II narcotics include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®), oxycodone (OxyContin®, Percocet®), and fentanyl (Sublimaze®, Duragesic®). Other Schedule II narcotics include: morphine, opium, codeine, and hydrocodone.

Examples of Schedule IIN stimulants include: amphetamine (Dexedrine®, Adderall®), methamphetamine (Desoxyn®), and methylphenidate (Ritalin®).

Other Schedule II substances include: amobarbital, glutethimide, and pentobarbital.

Schedule III/IIIN Controlled Substances (3/3N)

Substances in this schedule have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.

Examples of Schedule III narcotics include: products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with Codeine®), and buprenorphine (Suboxone®).

Examples of Schedule IIIN non-narcotics include: benzphetamine (Didrex®), phendimetrazine, ketamine, and anabolic steroids such as Depo®-Testosterone."

According to https://www.deadiversion.usdoj.gov/pubs/manuals/sec/sec_req.htm
"Security Requirements For Practitioners

Practitioners include physicians, dentists, veterinarians, researchers, hospitals, pharmacies, or other persons registered to do research, to dispense, or to use in teaching or chemical analysis a controlled substance in the course of professional practice.
Minimum security standards for practitioners are set forth in the regulations(Title 21 CFR 1300 to end) and are to be used in evaluating security. They may not necessarily be acceptable for providing effective controls and operating procedures to prevent diversion or theft of controlled substances. For example, a hospital that keeps large quantities of controlled substances on hand may need a safe or vault similar to the requirements for a distributor. The same reasoning also applies to other practitioners. A practitioner's overall security controls will be evaluated to determine if they meet the intent of the law and regulations to prevent theft or diversion.

Minimum Standards for Practitioners' Handling of Controlled Substances

Controlled substances must be stored in a securely locked cabinet of substantial construction. Pharmacies have the option of storing controlled substances as set forth above, or concealing them by dispersal throughout their stock of non-controlled substances.

Even though the Federal regulations do not specifically define locked cabinet construction, the intent of the law is that controlled substances must be adequately safeguarded. Therefore, depending on other security measures, a wooden cabinet may or may not be considered adequate. In an area with a high crime rate, a strong metal cabinet or safe may be required.

Some of the factors considered when evaluating a practitioner's controlled substances security include:
1. The number of employees, customers and/or patients who have access to the controlled substances.
2. The location of the registrant (high or low crime area).
3. Use of an effective alarm system.
4. Quantity of controlled substances to be kept on hand.
5. Prior history of theft or diversion.

Again, an overall evaluation of the practitioner's security will be made by DEA using the general and minimum security requirements as outlined in this manual to assure that the controlled substances are stored securely.

Other Security Controls for Practitioners

In order to minimize the opportunities for theft or diversion of controlled substances, practitioners have an obligation not only to provide effective physical security, but also to initiate additional procedures to reduce access by unauthorized persons as well as to provide alarm system where necessary."

Facility based policy entitled "DRUG VERIFICATION & WASTAGE OF CONTROLLED MEDS" stated in part,
"When controlled substances are wasted, 2 licensed nurses will witness the medication being wasted and both will sign the wastage form. All wasted meds will be wasted in the sink or Sharps Container so that they cannot be retrieved."

Facility based policy entitled "Controlled Substance Policy/Procedure-Storage" stated in part,
"Policy:
A. Schedule II controlled substances as defined by Federal and State laws shall be stored in double locked storage.
B. All Schedule III, IV, and V controlled substances as defined by state and federal law shall be stored in locked storage.
C. Strict controlled distribution is maintained ....

B. A completed controlled substances inventory is taken every year in the last
week of April or the first week of May... perpetual inventory of controlled drugs will contain the following information:
( 1) Name of Drug
(2) Strength of Drug ...
(8) Balance on hand

C. Storage ...
(3) A double locked storage cabinet is located on the nursing unit for all Controlled Schedule II controlled substances and at least a single locked storage area for Schedule III, IV, and V controlled substances."

Facility based policy entitled, "Controlled Substance Policy-Floor Stock Replacement" stated in part,
"2. Nursing Responsibility
A. The Director of Nursing or nursing designee is responsible for the proper storage and accounting of controlled substances on the nursing unit
B. A double locked storage cabinet is located on each nursing unit for all Schedule II controlled substances and a single locked storage are for Schedule III, IV, and V Controlled substances.
C. The appropriate administration record which list date, time, room number, patient name, physician, and dosage must be completed and signed by the nurse giving the controlled substance.
D. All controlled substances held in double locked storage are to be counted by one nurse from each shift at the shift change. The nurse accepting the keys to the locked storage will be held responsible for the accuracy of the count. The nurse from the completed shift must remain until the count is correct. The count sheet is to be kept in the front of the Controlled Substance Notebook, and is to be signed by both nurses at each shift change."

Facility based policy entitled, "Passing Medications" stated in part,
"B. The nurse pushes the cart from room to room. It is permissible if space permits, to push the cart into the patient's room, except in isolation."

During a tour of the facility on 01/08/20 in the nurse's medication room it was observed there were 2 rolling medication carts available. Both carts had a top locking drawers. Staff members were asked what was in these drawers. Staff member #1 and 18 verified both drawers contained narcotics/controlled drugs.

The two drawers were opened and observed by surveyors to contain the following medications (including schedule II, III, and IV controlled substances):
Drawer 1
Meperdine 50 mg
Meperdine 100 mg
Morphine 1 mg/cc
Nalbuphine 10 mg
Hydromorphone 2 mg/cc
Fentanyl 25 mcg/hr -patches
Midazolam 5 mL/5 cc
Midazolam 5 mg/5 mL

Drawer 2
Acetaminophen + Codeine 300 mg/30 mg
Zolpidem 5 mg
Morphine Sulfate 15 mg
Alprazolam 0.5 mg
Temazepam 15 mg
Tramadol 50 mg
Lyrica 50 mg
Diazepam 5 mg
Diphenoxylate and Atropine 2.5/0.025 mg
Clonazepam 0.5 mg
Lorazepam 0.5 mg
Chlordiazepoxide 25 mg
Hydrocodone Bitrat + APAP 5 mg/325 mg
Hydrocodone Bit/APAP 10 mg/325 mg
Hydrocodone Bitrat + APAP 10 mg/325 mg
Hydrocodone Bit + APAP 7.5 mg/325 mg
Oxycodone 5 mg
Oxycodone 5 mg
Donnatal Elixir 5 cc = 1 tsp
Acetaminophen with Codeine suspension 120 mg/12 mg/5 mL
Promethazine VC with Codeine 5 cc = 1 tsp
Cheratussin AC 5 cc = 1 tsp

The liquid medications in Drawer #2 (Donnatal Elixir, Acetaminophen with codeine suspension, Promethazine VC with Codeine, and Cheratussin AC) were observed stored in brown opaque multi-use bottles with no increment measurements or measuring method visible on the bottles. Staff member #18 was asked how the balance of the remaining liquid medication was accounted for at the facility. The staff member stated the facility utilized forms supplied in the narcotic count book. These forms include a tear off receipt for each dose. The balance count goes from 1-24. This balance sheet reflects the number of doses administered to the patient and/or wasted, however it does not indicate the balance/measurement of medication remaining in the bottle. Staff member #18 was asked how they knew what the balance was remaining in these bottled narcotic medications when performing the narcotic count each shift. The surveyors observed the bottles had no measurements indicated or increments demarked on which to assess the remaining balance. The staff member replied they used the forms in the count book (which only reflected doses 1-24 and not actual balances of remaining liquid medication after administration) and that "it should be right". This staff member was unable to identity or verify the actual amount that should be remaining in bottles of liquid medication contained in the narcotic drawer.

Staff members #1 and 18 stated that these rolling medication carts were sometimes rolled out into the units to administer routine medications. This means the above schedule II and III drugs are only secured with one lock when taken outside the medication room for drug administration. These two carts contained a large quantity of schedule II and III drugs which warrants a need for increased security to prevent diversion. According to facility based policy and professional standards, a double locked storage cabinet should be utilized for all Schedule II controlled substances

Staff member #18 was asked how waste of controlled substances was handled. The staff member stated the waste was placed in the trash can attached to the medication carts. They stated another staff member "told us we can't use the sharps container anymore". According facility based policy, medications should be wasted in the sink or sharps container.

In an interview on 01/09/20 with staff member #20 (pharmacist) they stated the rolling carts should not be taken out of the medication room and onto the treatment floor. Staff member #20 was notified that a staff nurse had stated they took the cart out of the room at times. The staff member agreed that would compromise the security of the scheduled/controlled drugs. This staff member was also informed current facility policy supports the practice of taking the carts out of the medication room.

Staff member #20 was asked how the facility keep track of the remaining medication in the large bottles of oral suspension stored in the narcotic drawer. This staff member stated the bottle should be marked with increments to track the volume remaining. Staff member #20 was notified the bottles observed by the surveyors were opaque and had no measurement or increment markings present on the bottle. They replied, "well they should".

Staff member #20 was asked if wasting narcotics in the trash was an approved practice at the facility. The staff member replied "No it should be wasted in the sink or in the sharps container".

Staff member #20 was asked why the facility had such large quality of schedule II and III drugs available to be easily accessed by nursing staff in the medication room. Typically, this facility only has a census of two patients. The facility also has a full pharmacy (which had sechuled drugs avaiable for administration) that operates during business hours Monday through Friday. This is a very large volume of schedule II and III is available and accessible to all nursing staff by obtaining the key to the cart. Staff member #20 replied that all those scheduled medications are not routinely administered at the facility, however the physicians prefer having those meds available. The pharmacist stated "We probably don't need all of them in there".

The storage of schedule II and III drugs in rolling medication carts, that are taken out of the medication room, compromises the security of these drugs. Schedule II drugs should be double locked according to professional standards. Narcotic drugs are being wasted incorrectly, per interview, also increasing a risk for diversion. The inability to establish/account for the remaining balance of liquid narcotics also compromises security and increases the risk for diversion. The facility must have consistent method for securely maintaining inventory and being accountable for the balance of liquid narcotic medications after they are dministered. The availability of such a large quantities of scheduled drugs to all nursing staff also increased the risk for diversion of drugs at the facility. The facility is currenlty not ensuring the effective, safe, and secure storage of controlled drugs at the facility.

Based on review of facility documents and staff interview, the facility failed to ensure services furnished by contractors were reviewed and complied with all applicable conditions of participation and standards for the contracted services.


Findings included:

Review of the contract list, which included contract pharmacist, dietary consultation services, social director, and laboratory services, revealed no review of services provided to ensure compliance with all applicable conditions of participation and standards for the contracted services provided.

In an interview with staff #1 and #16 on the morning of 1/9/20, they were unsure if services provided were evaluated. The above was verified during the interview.

Based on review of facility documents, review of medical records and staff interview, the facility failed to ensure all information necessary to monitor the patient's progress were documented.

Findings included:

Facility-based medical staff bylaws stated in part, "Medical Records: (a) Timely Completion: After written warning of delinquency for failure to complete medical records in timely fashion (i.e. 30 days post discharge), a practitioner's clinical privileges ... are automatically suspended ..."

Facility-based medical staff rules and regulations stated in part, "Part Three: General Responsibility for and conduct of care:
3.1 Generally: A member of the medical staff shall be responsible for the medical care and treatment of each patient in the hospital, for the prompt completeness and accuracy of those portions of the medical record for which he is responsible ..."

Facility-based Medical Staff Bylaw Addendum to Accommodate the Swing Bed Program stated in part, "7. The record for each patient admitted to the Swing Bed Program will address the following by the physician:
...15. Accurate, complete and timely medical records shall be required and maintained on every person admitted to the Swing Bed Program in accordance with the Hospital's Medical Staff Bylaw Rules and Regulations, and established Policies and Procedures.
...20. All patients in the Swing Bed Program shall be seen by their attending physician at least weekly, and more often if medically necessary. Documentation of that visit's finding shall be made in the physician's progress notes at the time of the visit."

Facility-based policy titled "Swing Bed Program Admission Policies" stated in part, "Physician's Responsibility:
The attending physician of the Swing Bed patient is responsible for the preparation of the complete medical record. Physician rfesponsibility [sic] includes:
...2. Medical Physical and History (on chart within 48 hours) - The history and physical can be brought forward from the qualifying acute stay care providing it is updated or the admission progress note contains a statement that no changes are needed.
...4. Progress Notes - All Patients
A. At admission: *Purpose for Swing Bed admission; *goals; *Planned treatment; *Does the patient know diagnosis and prognosis? If not, why?
B. Following each physician visit include description of patient's progress, update goals, and anticipated length of continued stay ..."

Facility-based swing bed policy titled "Other patient services" stated in part, "Nutritional therapy - After the patient has been admitted to Swing Beds, the Nutritional Counselor will make the initial assessment within 72 hours ..."

Facility-based swing bed policy titled "Patient Activity Program" stated in part, "1. The Swing Bed Program will provide activities for the patient. Activities are essential to create an environment that is near to the home situation ...
2. Patient are encouraged to participate in planned activities and opportunities will be provided for patient involvement (both individual and group) in the planning and implementation of the activity programs.
3. The activities are planned, coordinated, and provided in such a way that they address problems of self-care and Activities of Daily Living.
4. The program is designed to offer the patient a choice among a variety of activities ...
Functions: ...2. Programs designed to meet the following ... provide opportunities for meaningful socialization and problem-solving; Provide activities that supplement the rehabilitation program; maintain activity records.
...Practice: ...B. Planning an Activity Program for each patient based on those assessed needs, including activities in the community post-discharge.
C. Implementing the Activity Plan in cooperation with the patient, family, and other staff members.
D. Revising the Plan as needs are met or changed."

Review of the three of three (#6, 7, and 8) medical records for swing bed patients revealed no physician progress notes, no consistent documentation of activities plan and program, and no discharge summaries. These patients discharged 1/18/19, 2/11/19 and 9/17/19, respectively; several months past the 30-day requirement.

When asked if these could have been scanned in, staff #21 stated they would be in the medical record if scanned. Staff #21 stated, "They [physician documentation] could be back there in a box, but I can't get to it."

Facility-based Medical Staff Rules and Regulations stated in part, "Part five: Discharge of Patients
5.1 Required order: A patient may be discharged only on the written order of the attending practitioner ...
5.3 Leaving against medical advice [AMA]: If a patient desires to leave the hospital against the advice of the attending practitioner or without proper discharge, the attending practitioner shall be notified and the patient will be requested to sign the appropriate release form ...

Part Seven: Inpatient Medical Records
...7.7-2 Discharge Summary: (a) In General: A discharge summary must be recorded for all patients ..."

Review of the medical record for patient #15 revealed they presented to the ER on 10/26/18 and were admitted the same day. On 10/27/18, they discharged AMA on 10/26/18; no order or release form was noted.

In an interview with staff #1, they stated, "There should be an order."

The above was confirmed in an interview with staff #1 on the afternoon of 1/9/20.

Based on review of facility documents, observation, and staff interview, the facility failed to ensure the infection prevention and control program employed methods for preventing and controlling the transmission of infections within the CAH.

Findings included:

Review of facility documents revealed no policies related to the GlideScope video laryngoscope.

Review of the GlideScope video laryngoscope [GVL], user's manual stated in part, "Cleaning the GVL and Cobalt Video Baton
The GlideScope GVL is a non-sterile reusable device. To avoid cross-contamination. The GlideScope Video Laryngoscope must be disinfected immediately after each use.
The Cobalt Video Baton may be wiped with 70% isopropyl alcohol solution between uses and may be placed in the video baton cradle after the GVL Stat has been removed.
...Weekly Inspections
Once a week, inspect the exterior surfaces of the GlideScope System components: GVLs, GVL Stats, video batons, cables, and video monitor ...
Cleaning the GlideScope GVL
The GlideScope GVL is a non-sterile reusable device. To avoid cross-contamination, the GlideScope Video Laryngoscope must be disinfected immediately after each use.
*Do not place the GlideScope GVL in the cradle, in the hard shell case, or other storage until all cleaning procedures have been completed ...
Approved Disinfection Methods:
The following high-level disinfectants are approved for use: NOTE: Read and coply with product use instructions in all applications.
MetriCide
Immerse the GVL in MetriCide for 20 minutes to complete the requirement. Rinse with sterilized water. After cleaning, thoroughly dry the blade with a clean towel (paper or cloth). Store in a clean environment."

GlideScope User's Manual stated in part, "Ensure that, at a minimum, the monitor and video baton cradle are disinfected when visibly soiled and on a regular basis as per a schedule established by the medical care facility or provider (such as after use on each patient or once daily or weekly).
...Caution: Meticulous cleaning must precede any disinfection process, to ensure all foreign matter is removed from the surface of the device. This allows the active ingredients of the chosen process to reach all the surfaces of the device ..."

Observation of the GVL on the afternoon of 1/9/20 revealed it was placed in an open plastic bag that was not labeled with date or staff name.

In an interview with staff #8 on 1/8/20, when asked when the GVL was cleaned, they were unsure. When asked if there was a schedule, they denied one.

In an interview with staff #1 and #16 on the afternoon of 1/8/20, when asked if they admitted patients with infectious disease such as VRE [vancomycin-resistant enterococcus] or MRSA [methicillin-resistant Staphylococcus aureus], they agreed these types of patients were admitted. When asked how their soiled linen was handled, they stated, "They're put in red bags" but were unable to answer what happened after that.

In an interview with staff #19, a laundry worker, when asked how they handle biohazard linen, they stated they soak the linens before placing them in the washer. When asked how they clean the washing machine and/or dryer after an infectious person, they stated "The whites are soaked in bleach." When asked if there was a process for cleaning the machines in between use, they denied there was.

In an interview with staff #10, when asked for policies related to the laundry, they stated there were no policies for the laundry staff. When asked if there was a process to clean between infectious patients, they stated there was no process.

In an interview with staff #10, the dietary supervisor, on the afternoon of 1/8/20, when asked about what the J-512 sanitizer is used for, they stated, "For anything we don't put in the dishwasher ... measuring cups, knives ..." When asked how often the concentration should be checked, they stated, "Each meal."

Review of the J-512 sanitizer logs on 1/8/20 revealed inconsistent documentation August through December of 2019 and January of 2020. The logs stated in part, "Date; Time; PPM [parts per million, concentration range of sanitizer] (200-400); Morning; Lunch; Supper ..." and revealed the following:
*In August 2019, only the following were checked: 8/6 at 1:10 pm 200; 8/7 at 1:00 pm 200, 8/13 at 8:30 am 200; and 8/14 at 11:30 am 200.
*In September 2019, only the following were checked: 9/16 at 8:30 am 200 and at 11:00 am 400; 9/17 at 8:30 am 200
*In October 2019, the sanitizer was consistently checked 10/1-5; 10/8-13; the following were not documented at all: 10/6, 10/7, 10/14-31.
*In November 2019, the sanitizer was consistently checked 11/6-14; the sanitizer was checked once a day on: 11/2-5; 11/15, 16, and 20; the following were not documented at all: 11/1, 11/17-19, 11/21-30.
*In December 2019, the sanitizer was only checked on the following: 12/3 all meals; 12/4 at 7 am 400 and 1 pm 200; 12/30 all meals; and 12/31 at 8:30 am 400. All other days were undocumented.
*In January 2020, the sanitizer was only checked on the following: ½ at 10:00 am 400; 1/3 at 6:00 am 200; 1/6 at 6:00 am 200 and 1:00 pm 200; 1/7 at 8:30 am 200; 1/8 was up-to-date and checked at 8:30 am 400 and 10:30 am 200.

On the morning of 1/9/20, when asked for a policy related to the sanitizer, staff #10 stated there currently wasn't one but it should be checked three times a day. The above was confirmed in an interview with the dietary supervisor on the morning of 1/9/20.

Based on review of facility documents, observations, and staff interview, the facility failed to ensure the infection prevention and control maintained a clean and sanitary environment as the facility failed to:
A. maintain a clean and sanitary environment.
B. ensure sterilization of all supplies and equipment were under the supervision of a person qualified by education and training who participated in a documented continuing education program or received initial orientation.
C. ensure biological indicators were included in at least one run each week.
D. ensure preventive maintenance of all sterilizers were performed according to individual adopted, implemented and enforced policy on a scheduled basis, using the sterilizer manufacturer's service manual as a reference.

Findings included:

A. "OSHA/Blood Borne Pathogen Regulations Policy #138-030-060" stated in part "The facility provides sufficient housekeeping and maintenance personnel to maintain the interior and exterior of the facility in a safe, clean, orderly, and attractive manner."

The Centers for Disease Control and Prevention (CDC) article, Guidelines for Environmental Infection Control in Health-Care Facilities 2003 Updated July 2019 found at: https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines-P.pdf, states on page 54 that "Moist environments and aqueous solutions in health-care settings have the potential to serve as reservoirs for waterborne microorganisms. Under favorable environmental circumstances (e.g., warm temperature and the presence of a source of nutrition), many bacterial and some protozoal microorganisms can either proliferate in active growth or remain for long periods in highly stable, environmentally resistant (yet infectious) forms."

According to APIC: Preventing Infection in Ambulatory Care, Winter 2011/2012; found at ahttp://apic.org/Resource_/TinyMceFileManager/Education/Preventing-Inf-in-Amb-Care-Winter2012-FINAL.PDF. "Supplies must be: Removed from shipping cartons or cardboard boxes before storage to prevent contamination with soil/debris that may be on cartons ...Do not leave outer shipping boxes in clinical areas (due to risk of environmental contamination)."

The following was observed on a tour of the facility on the afternoon of 1/8/20:
* In the kitchen a standing fan was observed being used to dry flatware after being washed. In an interview on 01/08/20 staff member #10 verified the fan was routinely used to assist in drying dishware, this presents the potential for contamination with dust and debris being circulated in the air flow of the fan. An overhead light cover was missing and several were chipped with holes exposing it to the area below. A table, countertop and desk had chipped and peeling laminate, making it impossible to clean.
* Throughout the facility, items were observed stored under sinks. In the central supply/sterilization area, pharmacy, and treatment room in the emergency room. Cleaning supplies, coffee supplies, and patient care items (urine hats and tissues) were observed stored under these sinks. These sinks had so many items stored underneath the sink piping was obscured from clean visibility. This presents a risk for contamination due to the risk for leaks and a moist environment that increases the chance of bacteria growth in these areas.
*In the central supply area, approximately 8 large external shipping containers were observed on shelves above opened patient care items. External shipping containers are exposed to a number of environmental contaminants en route to their final destination and are considered dirty items.
*The sterilization room contained several external shipping boxes where instruments were being cleaned. Behind the sterilizer, the drywall was peeling and chipping, making it impossible to clean.
*Throughout the facility, cracked and discolored ceiling tiles and cracks in the drywall were noted which presents a risk for contamination due to the risk of leaks, bugs, and other debris entering the patient-care areas.
*Clean utility room storage with exposed baseboards, cracked ceiling tiles and chipped walls
*In the laundry area, behind the washing machine the wall was chipped and peeling with drywall missing, exposing the area behind. The table where clean linens were folded had chipped and peeling laminate and legs that were discolored and chipping. A hole behind the desk with a piece of corrugated cardboard covering the area. Baseboards were missing and ceiling tiles were cracked and discolored in the area clean laundry was being folded.

The above was confirmed during the tour with staff #1.

B. Review of the personnel file for the staff responsible for sterilization revealed no education and training related to sterilization of supplies and no participation in a documented continuing education program.

In an interview with the staff responsible for sterilization, when asked what training they had, they stated they reviewed the manual and follow that. When asked if there was a checklist or orientation, they denied there was any. When asked what continuing education they received, they stated they had not received any.

C. Review of facility-based document in-service titled "Table Top Sterilizers" stated in part, "AAMI [Association for the Advancement of Medical Instrumentation] recommends that routine biological testing be performed at least weekly but preferably daily ... The more often the sterilization process is monitored the more likely you are to detect a sterilization process failure ... Proper functioning of steam sterilization cycles should be verified by the routine use of biological indicators ..."

In an interview with staff #8 on 1/8/20, when asked how often biologicals are run, they stated, "We don't use them often, I run them with the first load [of the day] when they're used."

D. Review of the Midmark Self-Contained Steam Sterilizer manual stated in part, "Maintenance: To assure proper operation and maximum sterilizer life, carefully follow all recommendations for periodic maintenance. Recommended maintenance is easy to do and takes very little time.
...The user is responsible for establishing a periodic maintenance procedure to assure correct operation of equipment and reliable sterilization of loads. Contact your local Midmark distributor or service representative to develop a program for planned maintenance.

...Daily Maintenance:
*Clean External Surfaces: A) Wash the exterior of the sterilizer each day ...
*Clean sterilizer door/dam gaskets. A) Examine gaskets for possible damage.
B) Clean gaskets and mating surfaces with a damp cloth.

...Weekly Maintenance:
*Clean Chamber/Trays (including Rack and Plate)
A) Disconnect the upper portion of the reservoir drain tube from the panel clips ...
B) Remove the trays, tray rack, and tray plate from the sterilizer ...
C) Wash trays, rack, plate, and inside of chamber with mild soap or Speed-Clean and distilled water.
D) Refill reservoir with distilled water.

...Monthly Maintenance
*Clean Chamber/Plumbing
A) With a cooled chamber, drain the sterilizer's reservoir and refill with clean, distilled water ...
*Remove/Clean Door & Dam Gaskets
A) Remove door and dam gaskets from chamber door, then remove the gasket ring from the door gasket.
B) Clean gaskets and ring with SpeedClean, distilled water, and a soft brush ...
*Check Pressure Relief Valve ..."

In an interview with staff #8 on the afternoon of 1/8/20, when asked if the manufacturer's recommendations were followed, they stated, "No, we hardly use it." There was no policy related to sterilizer preventive maintenance. When discussed manufacturer recommendations, staff #8 verified their understanding.

The above was confirmed in an interview with staff #1 on the afternoon of 1/9/20.

Based on review of facility documents, review of medical records and staff interview, the facility failed to ensure when discharge of a resident was anticipated, each resident had a discharge summary that included, but not limited to, a recapitulation of the resident's stay and a final summary of status.


Findings included:

Facility-based policy titled "Swing Bed Program Admission Policies" stated in part, "Physician's Responsibility: ...6. Final Diagnosis - The physician will determine and document the Final Diagnosis."

Review of the three of three (#6, 7, and 8) medical records for swing bed patients revealed no discharge summaries for each patient.

In an interview with staff #1, they stated discharge summaries were not completed on swing bed patients, only on acute care patients.