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Volume 2025 | No. 2
Quality Review Edition THE Accreditation Resource for Data Nerds SURVEYOR
Volume 2024 | No. 2
SURVEYOR
TABLE OF CONTENTS
03 Corner View
04 From the Program Director
06 Frequent Deficiencies in Clinical Laboratories
BOARD OF COMMISSIONERS
LEADERSHIP TEAM
Brock Slabach, MPH, FACHE Chair CHIEF OPERATIONS OFFICER, NATIONAL RURAL HEALTH ASSOCIATION Maria (Sallie) Poepsel, PhD, MSN, CRNA, APRN Vice Chair OWNER AND CEO, MSMP ANESTHESIA SERVICES, LLC
Leonard S. Holman, Jr., RPh Treasurer HEALTHCARE EXECUTIVE AND CONSULTANT
José Domingos PRESIDENT AND CHIEF EXECUTIVE OFFICER, ACCREDITATION COMMISSION FOR HEALTH CARE Richard A. Feifer, MD, MPH, FACP CHIEF MEDICAL OFFICER, INNOVAGE
José Domingos PRESIDENT AND CHIEF EXECUTIVE OFFICER Patrick Horine, MHHA VICE PRESIDENT, ACUTE CARE SERVICES
John Barrett, MBA Officer-at-Large SENIOR CONSULTANT, QUALITY SYSTEMS ENGINEERING Gregory Bentley, Esq. PRINCIPAL, THE BENTLEY WASHINGTON LAW FIRM
Matt Hughes VICE PRESIDENT, COMMUNITY CARE SERVICES Jonathan Kennedy, CPA, MBA VICE PRESIDENT, FINANCE AND CORPORATE SERVICES
Denise Leard, Esq. ATTORNEY, BROWN & FORTUNATO
Mark S. Defrancesco, MD, MBA, FACOG Secretary WOMEN’S HEALTH CONNECTI CUT/PHYSICIANS FOR WOMEN’S HEALTH (RETIRED)
Marshelle Thobaben, RN, MS, PHN, APNP, FNP PROFESSOR, HUMBOLDT STATE UNIVERSITY
Jennifer Burch, PharmD OWNER, CENTRAL PHARMACY, CENTRAL COMPOUNDING CENTERS
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Volume 2025 | No. 2
SURVEYOR
CORNER VIEW WITH PRESIDENT & CEO, JOS É DOMINGOS
You made a great decision when choosing ACHC to accredit your laboratory. Whether you are new or have years of experience with us, I am confident that you have already felt first-hand our intense focus on customer service. Real support that builds your team ACHC doesn’t engage in “accreditation theatre” through complex scoring or by using your staff to perform our surveys. These practices give an illusion of rigor without adding any true value. Instead, we focus on real support designed to close any gaps between your current state and full standards compliance. We are known as Accreditation Nerds for our genuine belief in— and passion for—the efficacy of accreditation to enhance quality and safety in healthcare organizations. But we know it works best when those organizations understand and embrace continuous performance improvement. The Quality Review edition of Surveyor is an excellent place to start. This publication is a resource, demonstrating how ACHC program teams work to help you develop individual expertise within your organization, while recognizing that your staff may have varying levels of experience and current knowledge. The standards listed are the most frequently noted as non-compliant on recent surveys and the compliance tips provided are divided into categories to make them useful for individuals across a range of roles and expertise. “Accreditation Nerd Newbies” are just that: individuals new to the process of compliance with accreditation standards. ACHC uses a Plan- Do-Study-Act framework to organize standards. Even a “simple” standard may include multiple
elements for full compliance. Under Compliance tips for Nerd Newbies, we offer a clear summary of the expectations for each standard. “Accreditation Nerd Apprentices” understand the concepts of meeting and maintaining standards. Compliance tips for Nerd Apprentices focus on using data on hand to continuously assess how well your organization is performing. Finally, “Accreditation Nerd Trailblazers” are those individuals who are passionate about maximizing their organization’s capacity for excellence. They are enthusiasts who eagerly share their knowledge with colleagues to create a path forward. Nerd Trailblazers thrive on the goal of continuous improvement. Compliance tips for Nerd Trailblazers cover best practices designed to level up your organization. These tongue-in-cheek categories are our way of saying that it’s possible to approach accreditation seriously without being humorless. When we say that we want to help you develop your staff into a team of Accreditation Nerds, you immediately understand the goal. Partnership you can rely on Once a laboratory is ACHC-accredited, we become your ongoing partner, dedicated to meeting your needs. ACHC’s staff of Accreditation Nerds— account advisors, laboratory specialists , clinical educators, quality and regulatory, and other experts— thrive on being helpful. Review the information on the pages that follow confident that we’re ready to dig in to answer questions, provide feedback, offer suggestions, and direct you to any additional resources you need.
MISSION STATEMENT
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.
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SURVEYOR
FROM THE PROGRAM DIRECTOR
CLINICAL LABORATORY
CLIA mandates laboratory surveys on a two-year cycle. This allows for rapid identification and correction of gaps in compliance to ensure quality and consistency in testing for diagnostic purposes. I am pleased to share that, based on survey data collected from June 1, 2024, through May 31, 2025, ACHC-accredited laboratories continue to improve their compliance with our standards. This is true in aggregate as evidenced by the declining number of standards that are noted as deficiencies on at least 15% of the surveys conducted. It is also true at the level of individual standards, where performance has improved from the last survey cycle for this cohort of laboratories.
Trending the data In 2023, 12 standards reached the 15% threshold for inclusion in the Quality Review edition of Surveyor . This year, only seven standards met this criterion. Of these seven, six are repeated from 2023, but in every case, the frequency of citation declined as shown in the chart below.
The most challenging standards tend to be consistent year over year for each of ACHC’s accreditation programs. Often this is because they are broad in scope or include a large number of required elements. This is the third consecutive year that standard 06.02.01 Essential Conditions sits at the top spot. The requirements address water quality, temperature, humidity, and protection from electrical surges for reagents, specimens, and test systems. The good news this year is that it shows a 35% drop from 2023, an indicator that this cohort of laboratories has focused improvement efforts on tracking, documenting, and maintaining consistent environmental conditions. I hope you find this information useful. The ACHC Laboratory Accreditation Program team is here to support problem-solving and to guide you to educational resources. Please don’t hesitate to reach out to us!
Standard 2023 frequency 2025 frequency
01.04.07
17%
15%
02.02.04
32%
15%
02.02.05
27%
24%
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.
03.02.07
19%
17%
06.02.01
37%
24%
06.08.01
25%
15%
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
New in this year’s report is 05.05.04 Specimen Receipt/Acceptability and Rejection/Processing which was noted as a finding on 19% of the surveys conducted. ACHC Surveyors observed that these labs missed a requirement by failing to document the date and time each specimen was received. This detail can be important for the subsequent acceptance criteria.
Routine Chemistry Urinalysis Endocrinology Toxicology n Clinical Cytogenetics n Diagnostic Immunology General Immunology Syphilis Serology
James Liggins Program Director
Histopathology Oral Pathology
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Volume 2025 | No. 2
SURVEYOR
CLINICAL LABORATORY
CHAPTER 01: GENERAL LABORATORY 01.04.07 Eyewash/Emergency Shower Facilities Frequency of the citation: 15%
Overview of the requirement: An ANSI-compliant eyewash station or emergency shower is provided for immediate use within a 10-second travel time of locations where corrosive materials exist. Plumbed eyewash stations are tested weekly. Comment on deficiencies: Compliance is evaluated through observation and document review. Most deficiencies noted that the operation of the eyewash station was not with a single action to deliver tepid water. Other surveyors noted testing lapses. Examples of ACHC Surveyor findings: ■ The eyewash station does not have a mixing valve to deliver tepid water or single-action activation required by ANSI 358.1-2014. ■ Testing of the eyewash station is being performed monthly rather than on the required weekly schedule.
CLINICAL LABORATORY ACCREDITATION
FREQUENT DEFICIENCIES FROM CLINICAL LABORATORY SURVEYS
Compliance tips for:
30%
A documented risk assessment is expected to drive the decision regarding the need for ANSI-compliant eyewash stations and/or emergency showers. When a plumbed eyewash station is present, it must deliver tepid water using a single- action fixture. Testing through weekly station activation must be logged. ■ Audit for a documented risk assessment in locations without eyewash/ emergency shower within 55 feet of an area with corrosive chemicals. ■ Audit weekly activation logs. ■ Educate staff to alert facilities staff anytime corrosive chemical use is added to a new location. ■ Educate staff to alert facilities whenever a station activation fails (no flushing fluid, temperature out of 60-100⁰F range , etc.)
Nerd Newbies (understand the requirement)
25%
20%
Nerd Apprentices (audit for excellence)
15%
Nerd Trailblazers (prepare the path for others)
10%
5%
0%
01.04.07
02.02.04
02.02.05
03.02.07
05.05.04
06.02.01
06.08.01
Analytic Systems
General Systems
General Laboratory
Laboratory Personnel
Provider Performed Microscopy and Waived Testing
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CLINICAL LABORATORY
CHAPTER 02: LABORATORY PERSONNEL 02.02.04 Testing personnel competency and evaluation 02.02.05 Personnel competency assessment policies Frequency of the citation: 02.02.04 15%, 02.02.05 24%
Compliance tips for:
The intent of standard 02.02.04 is that the technical supervisor/consultant evaluates competency of all testing personnel based on six criteria at specific frequencies. Standard 02.02.05 ensures that those in consulting and supervisory positions demonstrate competency based on responsibilities defined by federal regulations in addition to the six criteria required for testing personnel if they are also performing testing on patient specimens. ■ Audit personnel files for inclusion and completeness of competency assessments. ٝ This applies to all moderate and high complexity testing even if it is performed outside of the laboratory, including point of care testing. ■ Create a tracking document for all testing personnel that lists each test or test system they perform. ٝ Ensure that all six required elements are evaluated for each test system. ٝ Ensure competency assessment twice in the first year that a particular test is performed and annually thereafter for all testing personnel. ٝ In hospital environments, ensure that testing personnel outside of the laboratory are included in the competency assessments.
Nerd Newbies (understand the requirement)
Nerd Apprentices (audit for excellence)
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 staff competency to perform test procedures and report results, in accordance with required elements and intervals for evaluations. Comment on deficiencies: 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.
Nerd Trailblazers (prepare the path for others)
Examples of ACHC Surveyor findings: 02.02.04
■ Competency was not being assessed for fecal fat testing and the tube method in the blood bank. ■ While all CLIA-required elements appear to have been addressed, there was no supporting documentation that included dates of performance of blind sample assessments for emergency department staff. ■ Competency assessments for the testing personnel in the radiology department who perform ACT moderate complexity testing did not include the six required CLIA competency assessment elements. ■ Training documentation, six-month competencies, and one-year competencies for testing for one individual performing waived testing and moderate complexity hematology testing were incomplete or missing. ■ Multiple test systems were not identified as needing competency assessments for the laboratory staff. Examples include tube direct antiglobulin (DAT) testing, gram stain, post-vas testing, manual cell count, wet prep, and CLO testing. As a result, the laboratory testing personnel were not deemed competent to operate these test systems. 02.02.05 ■ The laboratory did not have policies and procedures to assess competency based on CLIA position responsibilities. The Technical Supervisors and General Supervisors did not have documented competency assessments for their CLIA-named position responsibilities. ■ All personnel assessment documentation was incomplete. Final assessment dates verifying when the staff was competent to perform patient testing and pre-analytic functions were missing.
CHAPTER 03: PROVIDER PERFORMED MICROSCOPY AND WAIVED TESTING 03.02.07 Quality control for waived tests Frequency of the citation: 17%
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. Comment on deficiencies: Compliance is assessed through response to interviews and document review. Surveyors noted issues with: ■ QC frequency that did not match the manufacturer’s instructions. ■ Documentation of internal QC.
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CLINICAL LABORATORY
Compliance tips for:
Examples of ACHC Surveyor findings: ■ External controls are not being run on new lots/shipments of urine pregnancy kits. ■ Internal quality control tests were not documented. ■ Two levels of urine HCG quality control were not performed monthly as required by the manufacturer’s instruction. ■ External quality control was not being run monthly as required by the manufacturer’s instructions. Compliance tips for:
The standard requires that the laboratory document the date and time it receives each specimen. Policy must define criteria for acceptance, and the procedure for processing based on the type of testing to be performed. Unacceptable specimens are likewise defined, with the procedure for notifying an authorized person that the specimen was unsuitable for testing and the disposition of the rejected specimen. ■ Audit policy and procedure to ensure that all testing specialties are addressed with processing criteria. ■ Audit documentation for date and time of receipt. ■ Educate staff on documentation requirements. ■ Review and update policies and procedures whenever test systems change.
Nerd Newbies (understand the requirement)
Nerd Apprentices (audit for excellence)
Quality control is expected for each new shipment of kits/reagents, each change in lot number, and each new operator. Controls are handled the same way as patient samples and by the same personnel who perform patient testing.
Nerd Newbies (understand the requirement)
Nerd Trailblazers (prepare the path for others)
■ Audit external control runs. ■ Audit internal quality control documentation.
Nerd Apprentices (audit for excellence)
CHAPTER 06: ANALYTIC SYSTEMS 06.02.01 Essential conditions Frequency of the citation: 24%
■ Review contract/agreement templates to ensure that all required elements are captured. ■ Schedule contract review prior to expiration/renewal.
Nerd Trailblazers (prepare the path for others)
Overview of the requirement: Water quality, temperature, humidity, and protection from variations in electrical current are conditions that must be defined for storage of reagents/specimens, operation of test systems, and test results reported. When conditions are out of range, the laboratory must document corrective actions. Comment on deficiencies: Compliance is assessed through interviews and document review. Surveyors noted issues with:
CHAPTER 05: GENERAL SYSTEMS 05.05.04 Specimen Receipt/Acceptability and Rejection/Processing Frequency of the citation: 19% Overview of the requirement: Written policies and procedures define specimen receipt and criteria for acceptance and processing based on the testing specialty. Specimen rejection and disposition are included. Comment on deficiencies: Compliance is evaluated through interviews and document review. Time of specimen receipt is a required element which was noted as the source of most deficiencies. Examples of ACHC Surveyor findings: ■ The laboratory’s approved procedure manual requires a receipt time and a completion time. Mohs Specimen Maps and logs revealed that the laboratory failed to follow its policy and procedure. ■ The time that the laboratory receives specimens is not documented.
■ Uncertified or expired thermometers and humidistats. ■ Documentation that essential conditions are monitored. ■ Evidence of corrective action when conditions fall out of range.
Examples of ACHC Surveyor findings: ■ Log sheets recorded out of range issues without documented corrective actions.
ٝ The room humidity in the laboratory was out of the acceptable range in January, February, and March, for 21 days in April, and 10 days in October. ٝ Freezer 1 temperature was out of acceptable range for 2 days in June, 6 days in August, 4 days in September, and 2 days in October. ٝ Freezer 3 temperature was out of range for 5 days in August and 4 days in September. ٝ Refrigerator 3 temperature was out of range for 4 days in August and 2 days in October.
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CLINICAL LABORATORY
■ The laboratory’s policy for tests requiring correlations does not identify criteria of acceptability. ■ Comparison between EXL and the Triage meter failed to meet the laboratory-established criteria on 12/24 (Trop), 6/24 (CKMB), and 12/23 (Trop). Compliance tips for:
■ Water quality records and an interview with the laboratory supervisor revealed that bacterial cultures on the water systems supplying the chemistry analyzers were not performed in 2023. ■ Humidity measurements are taken each day and documented. However, no ranges were referenced on the log to allow staff to determine if readings fall within the acceptable range or require remedial action. Compliance tips for:
Humans vary, and so does equipment. This standard intends to demonstrate consistency through regular comparison testing to isolate and address any outlier results. ■ Develop a list of tests/equipment that require comparison testing. ■ Schedule semi-annual comparisons and audit for completion.
Nerd Newbies (understand the requirement)
The conditions under which materials are stored and tested must be defined and consistently maintained. This applies specifically to temperatures (room and refrigeration), humidity, water quality, and electrical current. Measurements are only as good as the equipment used, so NIST-certified or NIST-traceable tools are required. ■ Audit logs for daily entries. ■ Audit corrective action logs for alignment with reported conditions.
Nerd Newbies (understand the requirement)
Nerd Apprentices (audit for excellence)
■ Train staff on acceptable criteria and what to do in the event of an unacceptable comparison.
Nerd Trailblazers (prepare the path for others)
Nerd Apprentices (audit for excellence)
■ Train staff on acceptable ranges for essential conditions and what to do in the event of an unacceptable condition.
Nerd Trailblazers (prepare the path for others)
06.08.01 Comparison of test results Frequency of the citation: 15%
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. Comment on deficiencies: Compliance is assessed through interview and document review. Deficiencies were cited for:
ٝ Failure to perform comparison studies for specific testing methods. ٝ Lack of guidance on action to take in the event of unacceptable variance.
We’re here to help. To learn more, visit our website at achc.org , call us at (855) 937-2242 , or email customerservice@achc.org .
Examples of ACHC Surveyor findings: ■ Cell counts using the automated body fluid method were not compared to manual body fluid cell counts. ■ Blood bank tube vs. gel method comparisons were performed at one six month interval, but not at the next expected date. ■ A comparison of the Rapid Point blood gas analyzers was performed at installation (2 years prior to survey), but not since then.
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THE Accreditation Commission for Health Care
We’re here to help. To learn more, visit our website at achc.org , call us at (855) 937-2242 , or email customerservice@achc.org .
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