SURVEYOR Volume 2024 | No. 2 Quality Review Edition
Volume 2024 | No. 2
SURVEYOR
TABLE OF CONTENTS
BOARD OF COMMISSIONERS Brock Slabach, MPH, FACHE I Chair CHIEF OPERATIONS OFFICER, NATIONAL RURAL HEALTH ASSOCIATION Maria (Sallie) Poepsel, PhD, MSN, CRNA, APRN Vice Chair OWNER AND CHIEF EXECUTIVE OFFICER, MSMP ANESTHESIA SERVICES, LLC Mark S. Defrancesco, MD, MBA, FACOG I Secretary PAST PRESIDENT, AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS Leonard S. Holman, Jr., RPh I Treasurer HEALTHCARE EXECUTIVE AND CONSULTANT Roy G. Chew, PhD I Immediate Past Chair PAST PRESIDENT, KETTERING HEALTH NETWORK John Barrett, MBA I Board Member-at-Large SENIOR CONSULTANT, QUALITY SYSTEMS ENGINEERING Gregory Bentley, Esq. PRINCIPAL, THE BENTLEY WASHINGTON LAW FIRM Jennifer Burch, PharmD PHARMACIST/OWNER, CENTRAL PHARMACY, CENTRAL COMPOUNDING CENTERS José Domingos PRESIDENT AND CHIEF EXECUTIVE OFFICER, ACCREDITATION COMMISSION FOR HEALTH CARE Richard A. Feifer, MD, MPH, FACP CHIEF MEDICAL OFFICER, INNOVAGE Denise Leard, Esq. ATTORNEY, BROWN & FORTUNATO Marshelle Thobaben, RN, MS, PHN, APNP, FNP PROFESSOR, HUMBOLDT STATE UNIVERSITY
03 CORNER VIEW
04 FROM THE PROGRAM DIRECTOR
05 FREQUENT DEFICIENCIES IN CLINICAL LABORATORIES
LEADERSHIP TEAM
José Domingos PRESIDENT AND CHIEF EXECUTIVE OFFICER Patrick Horine, MHHA VICE PRESIDENT, ACUTE CARE SERVICES Matt Hughes VICE PRESIDENT, CORPORATE STRATEGY Barbara Sylvester, RN, BBA, MSOLQ DIRECTOR, REGULATORY AFFAIRS AND QUALITY
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Volume 2024 | No. 2
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Welcome to the 2024 Surveyor Quality Review. Each year, program-focused editions of this CORNER VIEW publication analyze compliance with ACHC standards over 12 months of surveys. This year’s data span initial and renewal surveys conducted between June 1, 2023, and May 31, 2024. ACHC-accredited organizations use the data to benchmark their performance by comparing these frequently-cited standards against their own survey report. There is value for non-accredited organizations, too. Because ACHC standards are closely aligned with CMS requirements, the information is relevant regardless of how your organization achieves its Medicare certification. For programs outside the Medicare regulations, the value remains. ACHC standards represent an important risk management/quality improvement framework. Reviewing the kinds of issues that arise in your peer organizations is an opportunity to act preemptively to manage your own risks. This is a critical business function in all healthcare settings. We know that some standards consistently present more compliance challenges than others. Frankly, if we offered only a list of frequent deficiencies, this publication wouldn’t vary much from year to year. Instead, Surveyor Quality Review gives insight into trends by quoting findings and offering practical tips to avoid citations. Some standards appear almost annually because of a large number of required elements. Perhaps a policy needs clarification, or staff members were not fully trained on a revision that impacts their work. Perhaps new or contract employees were not adequately oriented to a requirement for documentation, or employees made a change in their workspace that compromises fire safety. For a complex standard, any of these examples represents a potential deficiency and a risk to the organization, its staff, or its patients.
By sharing the observations of ACHC Surveyors, we offer an expert’s perspective on the most current issues impacting organizations. Trends by Program
Internally, we use these data to guide the development of educational resources. Laboratories seeking to renew their ACHC
MISSION STATEMENT
accreditation in 2024 were also surveyed in 2022. The program leader has included comparative comments in the introduction to the program findings. When we experience a large uptick in the number of initial surveys, as we have for several programs in this period, those difficult standards are likely to be prominent as new organizations confront them for the first time. However, we hope to see at least incremental improvement in standards that appeared as frequent deficiencies for this cohort of organizations three years ago. If we don’t see triennial improvements for some of the most frequently cited standards, it means we need to give more educational focus to these in the resources (webinars, workshops, tools) we offer. It is never ACHC’s intention to leave clients wondering about what is expected. To the contrary, our goal is to provide a range of resources that engage and enrich the experience of continuous quality improvement in the healthcare markets we serve. In this year’s first issue of Surveyor , I wrote about team collaboration and handoffs. Remember that ACHC serves as an extension of your team, ready to confer and coach. With Surveyor Quality Review , we are passing an evidence-based guidance tool to you. I hope you grasp it firmly and run with it!
Accreditation Commission for Health Care (ACHC) is dedicated to delivering the best possible experience and to partnering with organizations and healthcare professionals that seek accreditation and related services.
José Domingos President & CEO
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Volume 2024 | No. 2
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FROM THE PROGRAM DIRECTOR
The 2020 merger of ACHC and HFAP included significant efforts to provide a smooth transition for existing HFAP customers and a warm welcome to new and transitioning organizations. Because laboratories are surveyed on a two year-cycle, this year’s data analysis represents the second time we are able to compare survey results under the ACHC brand. Trending the Data The newest standard to rise above the 20% deficiency rate was 02.02.05 Personnel competency assessment policies . This standard is closely related to this year’s top deficiency ( 02.02.04 Testing personnel competency and evaluation ). Standard 02.02.04 was cited on 36% of the surveys in this year’s report, climbing from a rate of 28% in 2022. It identifies six elements of competency that must be assessed for every individual on every test they perform. Standard 02.02.05 requires that competency be defined for specific roles. Together, these deficiencies indicate a need for special attention to the details of competency assessment. Labs can come at this from two directions to ensure compliance: an inventory of all tests performed with associated competencies cross referenced to a list of all testing personnel. This includes individuals assigned the role of assessor, i.e., Laboratory Director or Technical Consultant. The other standard that was cited on more than a third of all surveys ( 03.02.07 Quality control for waived tests ) also showed declining performance from 2022 when it was cited on just over a quarter of surveys. Waived testing often occurs outside the laboratory environment, but the laboratory retains responsibility for quality. Surveyors noted that QC was often ignored for this category of commonly administered tests.
The last of the three standards cited more often in this report than two years ago was 04.02.05 , which noted proficiency testing failures. The uptick was less dramatic, from 23% to 27%, but PT failures may correlate with personnel competency. Correcting one may well serve to correct the other. PT testing issues also interrupt laboratory efficiency by limiting testing with specific analytes until improvement is evidenced through corrective action. Standard 06.08.01 , which requires comparison of testing results when the same test is performed using differing methods or equipment, saw improvement, from a 28% rate of deficiency in 2022 to below 20% this year. Finally, 06.02.01 Essential Conditions was noted on 27% of surveys. The standard addresses requirements for water quality, temperature, humidity, and protection from electrical surges for reagents, specimens, and test systems. Tracking, documenting, and maintaining consistent environment conditions remains a consistent challenge. Four standards that just missed the threshold are also detained on the following pages. The laboratory teams hopes you find this information useful. We stand ready to assist with trouble shooting or guiding you to educational resources at any time.
CLINICAL LABORATORY ACCREDITATION
FREQUENT DEFICIENCIES FROM LAB SURVEYS
60%
50%
40%
30%
James Liggins Program Director
20%
10%
0%
DRX1-4A
DRX4-2H
DRX4-2J
DRX4-7A
DRX4-8A
DRX5-1A
DRX7-5B
DRX7-12D
Organization and Administration
Human Resource Management
Provision of Care and Record Management
Risk Management: Infection and Safety Control
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CHAPTER 2: LABORATORY PERSONNEL 02.02.04 Testing personnel competency and evaluation 02.02.05 Personnel competency assessment policies Overview of the requirement:
Policies and procedures establish competency assessment for all individuals who perform patient testing or who report patient test results. The technical supervisor/consultant is responsible for assessing and documenting the competency of staff to perform test procedures and report results based on required elements and intervals for evaluations. Compliance is assessed through document review, response to interview, and observation. Surveyors noted policies that did not include competency assessment for all roles, or that failed to include the six minimum requirements for evaluation. Incomplete documentation was noted with dates of assessment or signatures of assessors omitted.
Comment on deficiencies:
Frequency of citation:
02.02.04: 36%; 02.02.05: 24%
Examples of surveyor findings:
02.02.04 n The laboratory was not evaluating competency using all six required elements for each test or test system. n Two of two contracted respiratory therapists records showed no competency assessments at six months, at one year, and annually thereafter. n Competency assessments for the general laboratory staff lacked sufficient detail, e.g., assessment dates and CLIA element notations for required tasks. n Multiple laboratory and bold gas personnel competency assessment records lacked an assessor’s signature/initials. n Tube direct antiglobulin (DAT) testing was not identified as requiring competency assessment, so no blood bank personnel had been assessed for this test. 02.02.05 n The laboratory does not have policies and procedures to assess competency based on position responsibilities. n The laboratory did not define how competency would be assessed for the positions of Technical Supervisor and General Supervisor. n Create a tracking document for all testing personnel that lists each test or test system they perform. n Ensure that all six required elements are evaluated for each test system. n Ensure competency assessment twice in the first year that a particular test is performed and annually thereafter for all testing personnel. This applies to all moderate and high complexity testing even if it is performed outside of the laboratory, including point of care testing.
ACHC Clinical Laboratory accreditation covers all levels of complexity and all clinical settings from point-of-care waived tests performed in a physician office to high complexity testing in independent or hospital- based laboratories.
Testing Specialties
n Chemistry
n Hematology n Histocompatibility n Immunohematology ABO Group Rh Type Antibody Detection Antibody Identification Compatibility Testing
n Microbiology Bacteriology Mycology Parasitology Virology n Pathology Cytology
n Radiobioassay
Routine Chemistry Urinalysis Endocrinology Toxicology n Clinical Cytogenetics n Diagnostic Immunology General Immunology Syphilis Serology
Tips for complianc e:
Histopathology Oral Pathology
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CHAPTER 4: PROFICIENCY TESTING 04.02.05 Unsuccessful performance by analyte
n Ensure that competency assessments are completed by individuals in appropriate roles. The initial competency must be completed by an individual qualified as a Technical Supervisor (high complexity testing) or Technical Consultant (moderate complexity testing). Annual competency assessments can be completed by General Supervisors in the high complexity testing environment. n Audit personnel files periodically for inclusion and completeness of competency assessments.
Overview of the requirement:
For a specific analyte or test, if two or more consecutive events are unsatisfactory, the analyte/test is deemed unsuccessful participation. This requires suspension of that testing pending corrective action and demonstrated improvement. Surveyors review documentation of testing events to confirm satisfactory performance. The standard is cited when the laboratory fails to achieve two of three consecutive testing events fails to achieve successful performance.
Comment on deficiencies:
CHAPTER 3: PROVIDER PERFORMED MICROSCOPY AND WAIVED TESTING 03.02.07 Quality control for waived tests
Frequency of citation:
24%
Examples of surveyor findings:
n Review of documentation revealed unsuccessful performance for CA 15-3, parathyroid hormone, and ESR for consecutive testing events. Proficiency testing investigations have been submitted and accepted. n Review of documentation and interview with the Laboratory Manager revealed unsuccessful PT performance for body fluid crystals. Proficiency testing investigations were previously reviewed and accepted and testing has been discontinued. n Conduct a complete investigation of all proficiency testing results that are less than 100%. Issues may be first evident with a score of 80%. n Investigate the cause of all failures. Initial failures become repeat failures if only cursory initial investigations are completed. n Ensure that test results are submitted by the program due dates.
Overview of the requirement:
The laboratory must maintain and follow current manufacturer’s instructions for waived tests including those for quality control. The laboratory reviews QC findings prior to reporting patient results and takes corrective action when QC identifies results outside of acceptable ranges. Compliance is assessed through response to interviews and document review. These standards were most often cited when the frequency of QC did not match the manufacturer’s instructions, or the laboratory did not follow its own policies regarding documentation of quality control.
Comment on deficiencies:
Tips for compliance:
Frequency of citation:
33%
Examples of surveyor findings:
n The laboratory is performing inconsistent quality control for hemoglobin, microalbumin, influenza A, B, or COVID with long periods of no QC. n QC was not performed for eight months in 2023 on urine hCG. n Review of documentation and staff interviews revealed that incorrect pH and specific gravity ranges were recorded on the Clinitek urinalysis QC log sheet resulting in QC values being compared to incorrect ranges. n Ensure that there is a formal procedure for each test method or that the manufacturer’s package insert is available to provide a detailed procedure for each test. Manufacturer instructions are typically found as part of the package insert available with each test kit. If the test kit does not include a package insert, instructions should be accessible on the manufacturer’s web site.
Tips for compliance:
Accuracy in results of waived tests is not less important to quality patient care than that of higher complexity testing.
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CHAPTER 6: ANALYTIC SYSTEMS 06.02.01 Essential conditions
Overview of the requirement:
Conditions under which reagents/specimens are stored, test system operated, and results reported are specifically defined with regard to water quality, temperature, humidity, and protection from variations in electrical current that are required for. Compliance is assessed through interviews and document review. Most deficiencies related to room humidity-levels or freezer temperatures that were documented as out of range without corrective action. Other deficiencies stemmed from monitoring instruments that were not certified.
Comment on deficiencies:
Frequency of citation:
27%
Examples of surveyor findings:
n Temperature and humidity were frequently logged well outside of acceptable range with no remedial action documented. n Chemistry products were not stored according to manufacturer’s temperature requirements. During the survey, all items were moved to a freezer that met the temperature requirements. n Humidity reading were below the lowest measurable level by the hygrometer in use (20%) making it impossible to know if humidity was within the acceptable range of 10-80%. n Humidity in the blood gas laboratory was below the acceptable range of 5-85% for 25 days in January, 19 days in February and 13 days in March. Logs noted “manager aware” with no indication of corrective action. n The laboratory did not have a National Institute of Standards and Technology (NIST) certified thermometer or humidistat. n Educate staff on the importance of maintaining essential conditions. n Ensure that all temperature and humidity monitoring equipment have a current certification of calibration. n Log temperature/humidity on a regular basis so that lapses are identified and appropriate corrective action measures taken. Be sure to document all review activities.
06.06.06 Qualitative procedure controls Overview of the requirement:
Positive and negative controls must be used daily for all qualitative procedures when patient samples are examined. Compliance is evaluated through interview and review of documentation. Most deficiencies noted that controls were not used on each day of patient testing. This could be acceptable, but requires a documented individualized quality Control plan (IQCP).
Comment on deficiencies:
Frequency of citation:
18%
Examples of surveyor findings:
n Review of photomicrographs of all possible microscopic components is not performed and documented when wet mounts and KOH preparations are examined. n The procedure for eosinophil estimations lacks instructions that a positive and negative control should be performed each day of patient testing. The hematology lab technician confirmed that no quality control is performed for eosinophil estimations. n Positive and negative external controls are not performed for fetal fibronectin on each day of patient testing. The laboratory’s procedure FFN-1 Fetal Fibronectin states that liquid external quality control will be performed with each new lot number or shipment. This QC frequency variance requires an individualized quality control plan (IQCP). n Use photo micrographs or charts to meet control requirements for manual microscopic examinations.
Tips for compliance:
Note that materials that permit a wide range of acceptable temperature and/or humidity must still be maintained within that range.
Tips for compliance:
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06.08.05 Calibration/Control Failures Overview of the requirement:
06.08.01 Comparison of test results
When control or calibration materials fail to meet established criteria for acceptability, the laboratory must document corrective actions. Patient test results from the unacceptable test run must be evaluated for accuracy. Compliance is assessed through interview and document review. Surveyors noted a lack of policy or process for reevaluation of patient test results after QC identifies a failure. In a few cases, policies exist but were not followed.
Overview of the requirement:
If the same test is performed using different methods, different instruments, and/or at multiple locations, the laboratory must compare results at least twice annually and review against written criteria for acceptable variation in test values. Compliance is assessed through interview and document review. Deficiencies were cited for missing policies and for failure to perform comparison studies for specific testing methods.
Comment on deficiencies:
Comment on deficiencies:
Frequency of citation:
18%
Examples of surveyor findings:
n The laboratory failed to evaluate patient test results back to the last acceptable quality control run when a quality control failure was corrected by changes made to the test system. Examples include EXL-LM Vitamin B12 recalibrated. EXL-LM Lipase was recalibrated, new reagent lot. EXL-200 Ammonia, EXL-200 ALT, EXL-LM Valproic acid, EXL-LM T Uptake - new flex reagents opened. n No process or policy exists to evaluate patient test results back to the last acceptable QC run when a test run fails and is corrected by recalibration, reagent replacement, or troubleshooting. Examples of test run failures without patient lookbacks include: 1-3SD failure for triglyceride - resolved by recalibration, 1-3SD failure for TSH - resolved by replacing the reagent and recalibration, 2-2SD failure for AST - resolved by recalibration, 2-2SD failure for AST - resolved by recalibration. n Laboratory policy states that the Laboratory Director or Technical Consultant will evaluate all patients tested since the last acceptable control run. There was no documentation of this review for failures on the Monthly QA Checklist as specified in the policy. Examples of failures that required a change to the system such as calibration or a change in reagents include: ethanol, albumin, and total bilirubin tests within the past 12 months. n Audit for a policy and procedure that addresses the standard requirement. n Train staff on the requirement. n Perform regular review of QC logs to ensure that the process included patient result look backs.
Frequency of citation:
18%
Examples of surveyor findings:
n Comparison studies between automated differential and manual differential are not being performed. There is no policy in place to perform differential comparison studies. n No correlations were being performed between the Sysmex XN analyzers and manual differentials. n The laboratory was not performing correlations for the three methods (i.e., vision, manual gel, and manual tube) used for ABO/Rh blood types, antibody screens, and antihuman globulin (AHG) crossmatches. n Laboratory policy QA-16 did not list all tests and methods to correlate and did not specify the criteria for the selection of samples or the criteria to use for the evaluation of acceptability between methods. n No comparison of test results have occurred in the last two years for drug screens between the Dimension and the Alere iCup drug screen methodologies.
Tips for compliance:
Develop a list of tests/equipment that require comparison testing.
Tips for compliance:
n Develop written policy and procedures for performing comparison studies that includes criteria for evaluation and acceptable performance. n Develop a calendar/schedule to ensure that the comparison studies are completed twice each year. n If correlations fail to meet the acceptable performance as outlined in the organization’s policy, take and document corrective actions.
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NOTES
CHAPTER 8: IMMUNOHEMATOLOGY AND TRANSFUSION SERVICES 08.02.01 Temperature Alarm System
Overview of the requirement:
A 24-hour audible alarm system is required for temperature controlled storage of blood and blood products. The alarm system is monitored daily for proper functioning. Compliance is assessed through observation, interview, and document review. Most deficiencies were cited when alarm activation was at variance with identified safe ranges for the products stored. Other observations included allowing a temperature range that extends beyond the recommended limits.
Comment on deficiencies:
Frequency of citation:
22%
Examples of surveyor findings:
n Room temperature was not documented every four hours when platelets were being stored as per laboratory policy. n Alarm activation records showed that the platelet incubator activated at 19.8 degrees and 24.2 degrees on [date], 19.8 degrees and 24.6 degrees on [date], 19.9 degrees and 24.5 degrees on [date], and the plasma freezer at -17.0 degrees [date]. These activation temperatures are all outside of the acceptable storage ranges for those products. n The log used for the blood storage refrigerator listed an upper temperature limit of 8° Celsius that does not comply with the upper limit of 6°C allowed for blood storage. Actual temperatures had not exceeded 6°C. n Review storage requirements for blood and blood products and ensure that policies and logs reflect the relevant guidelines. n Check accuracy of alarm settings. Conduct daily monitoring of alarms for ongoing function. n Log room temperatures for platelet storage within strict time frames.
Tips for compliance:
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ACHC Redefining the Culture of Accreditation
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SURVEYOR 2024, NO. 2
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