Laboratory Corporation Of America Holdings

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Laboratory Corporation of America Holdings-Chesapeake on October 17-18, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a tour, review of proficiency testing records, lack of documentation, and interviews, the laboratory failed to perform test accuracy verification twice annually for hematology semen analysis sperm viability/vitality procedure in calendar year 2021 during the twenty-two months reviewed (January 2021 to October 17-18, 2022). Findings include: 1. During a laboratory tour at approximately 1:30 PM on 10/17/22, the inspector observed the laboratory utilizing a Medical Electronic Systems Sperm Quality Analyzer (SQA) for automated semen analysis testing. The inspector inquired regarding how accuracy assessments are determined for the semen analysis parameters. The technical consultant (TC) stated on 10/17/22 at approximately 2:00 PM, "We are enrolled in proficiency testing for semen analysis and receive two events each year." 2. Review of the laboratory's hematology semen analysis proficiency testing records from January 2021 to 10/17/22, a total of three events, revealed the following documentation for the semen analysis sperm viability/vitality parameter: 2021 College of American Pathology (CAP) Semen Analysis Module A - SEM 03, SEM 04 viability/vitality challenges were not graded. CAP noted "Laboratory response submitted as sample unsatisfactory"; 2021 American Proficiency Institute (API) Semen Analysis Event 3 - viability/vitality challenge responses were evaluated and graded 100%; 2022 API Semen Analysis Event 1 - viability/vitality challenge Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- responses were evaluated and graded 100 %. 3. The inspector requested to review additional PT or accuracy verification records for semen analysis viability/vitality testing documented in calendar year 2021. No documentation was available for review. The TC stated on 10/17/22 at approximately 4:00 PM, "In 2021, we switched to a different proficiency testing company because the CAP samples were not satisfactory. We enrolled with API in the summer of 2021 and received one event. We did not have any other PT events in 2021. We have finished one with API this year and expect another PT shipment later this month." 4. An exit interview with the laboratory supervisor on 10/18/22, at approximately 12 PM, confirmed the above findings. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on a review of the laboratory's Center for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), personnel files, lack of documentation, and an interview, the laboratory director (LD) failed to document competency assessment for one of two technical consultants (TC) in calendar year 2021. Findings: 1. Review of the laboratory's CMS 209 form revealed that the LD identified two TC's as also responsible for non-waived immunology, chemistry, and hematology testing during the twenty-two months reviewed (January 2021 to the date of the inspection on October 17-18, 2022). 2. Review of the available laboratory personnel files revealed no competency assessment documentation for "TC 1" for the duties of technical consultant. (See Personnel Code Sheet.) The inspector requested to review TC 1's competency assessment documentation encompassing the duties for the role of technical consultant. The lab supervisor stated on 10/17/22 at approximately 3: 00 PM: "I do not have it for you to review but we can get that completed." 3. An exit interview with the laboratory supervisor on 10/18/22, at approximately 12 PM, confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Labcorp of America Holdings-Chesapeake on September 19-20, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of policies and procedures, temperature logs, and an interviews, the laboratory failed to document monitoring of laboratory refrigerators, freezers, heat block warmer, room, and humidity temperatures according to their written policy for twelve (12) of twenty-one (21) months reviewed. Findings include: 1. Review of the Policy and Procedure Manual revealed a general laboratory policy (Temperature Monitoring, Policy #: LC-MV-CL-DOC-164) that stated: "temperatures are recorded on a daily basis on appropriate logs". 2. The inspector requested to review the laboratory temperature logs for January 2017 up to the date of survey on 9/19/18. The review of the available temperature records revealed documentation of refrigerators, freezers, heat block warmer, room temperatures, and room humidity for January 2018 to the date of the inspection on 9/19/18. The inspector requested to review temperature documentation in calendar year 2017 for the Danny Refrigerator 1 and 2, Danny Freezer 1, Danny Black Freezer, Danny White Freezer, Walk In Refrigerator, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- and the Fisher Scientific IsoTemp Heat Block. The technical consultant (TC) stated on 9/19/18 at approximately 2:30 PM: "We moved all of 2017 records to a storage facility. I have requested for them to be delivered for your review". During the second day of the survey, 9/20/18, at approximately 11:30 AM, the TC stated: "I apologize but the storage facility has outsourced the delivery of the records you requested and they are stating that they cannot deliver today." 3. In an interview with the TC, laboratory manager, and quality manager (via telephone conference call) at approximately 11:45 AM on 9/21/18, it was confirmed that the laboratory records failed to include documented monitoring of the laboratory refrigerators, freezers, heat block warmer, room temperatures, and room humidity according to their written policy for twelve (12) of twenty-one (21) months reviewed. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of instrument performance validation records, patient test logs, and an interview, the laboratory director (LD) failed to evaluate and verify the reportable range for Lipase and Hemoglobin A1c testing after moving the COBAS Integra 400 Plus analyzer into a new laboratory room on September 2, 2018. Findings include: 1. Review of the COBAS Integra 400 Plus analyzer performance verification documentation revealed no evaluation or verification by the LD of Hemoglobin A1c and Lipase reportable range for the Integra 400 Plus Serial Number 397971 after its move on September 2, 2018. The inspector requested to review documentation that the laboratory director verified the reportable ranges prior to patient testing. No documentation was available for review. 2. Review of the patient accessioning test log from the laboratory's information system revealed that the lab had reported fifty-three (53) Hemoglobin A1c and eight (8) lipase patient test results from 9/3/18 to the date of the survey on 9/20/18. 3. In an exit interview with the technical consultant, laboratory manager, and quality manager (attending via conference call) at approximately 11:45 AM on 9/20/18, it was confirmed that the laboratory director failed to evaluate and verify the reportable range for Lipase and Hemoglobin A1c, after relocating the COBAS Integra analyzer, prior to reporting sixty-one (61) patient results as outlined above. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on a review of instrument maintenance logs and interviews, the laboratory failed to document performance of required chemistry and hematology instrument daily, weekly, monthly, quarterly, semi-annual, and periodic maintenance for twelve (12) of twenty-one (21) months reviewed. Findings include: 1. Review of the laboratory's two (2) Roche Integra 400 Plus instrument maintenance logs revealed the following required duties for Instrument 1 (Serial Number 401468) and Instrument 2 (Serial Number 397971): Daily Activities- verify solutions, water supply, analyzer temperature, cassette temperature, cleaner temperature, removal of expired reagents; Daily Maintenance- change activator, prime fluid system, deproteinize probes, initialize ISE module, Prime ISE calibrators, activate electrodes, clean probes, electrode service; Weekly Maintenance- clean probes and splash guard, clean ISE tower, back up database, clean wash station, clean instrument; Monthly Maintenance- clean waste box fitting, clean ISE tower (manually); Electrode Replacement- Chloride (every 90 days), Lithium (every 120 days), Sodium (every 180 days), Potassium (every 180 days), Reference (every 720 days); Quarterly Maintenance- replace ventilation filters, replace external water reservoir filter; Semi-Annual Maintenance- Clean external water reservoir, clean waste reservoir, clean internal water reservoir, clean wash station, replace ISE tubing; Replacement of Probes- Probe B, Probe C, plunger pipette B and C, dosage pipette B and C, replacement of halogen lamp (every 800 hours). Review of the laboratory's COBAS e411 instrument maintenance logs revealed the following required duties: Daily- clean S/R probe, check reagent and system reagent rotor condensation; Weekly- clean incubator and aspiration station, clean sipper probe; Every Two Weeks- clean rinse stations, perform liquid flow cleaning. Review of the laboratory's Sysmex XS-1000i C hematology instrument maintenance logs revealed the following required duties: Daily- verify background, verify pressure vacuum; Weekly- power down IPU; Monthly- monthly rinse; Periodic- replace air pump, replace piercer. 2. Review of the available laboratory maintenance documentation, outlined above, revealed maintenance records for the nine (9) months of January 2018 to the date of the survey on September 20, 2018. The inspector requested to also review chemistry and hematology maintenance logs for calendar year 2017. The technical consultant (TC) stated on 9/19/18 at approximately 2:30 PM: "We moved all of 2017 maintenance records to a storage facility. I have requested for them to be delivered for your review". During the second day of the survey, 9/20/18 at approximately 11:30 AM, the TC stated: "I apologize but the storage facility has outsourced the delivery of the records you requested and they are stating that they cannot deliver today." 3. In an exit interview with the TC, laboratory manager, and quality manager (joined on conference call) at approximately 11:45 on 9 /20/18, it was confirmed that the laboratory failed to provide documentation of the performance of chemistry and hematology required instrument maintenance, outlined above, for twelve (12) of the twenty-one (21) months reviewed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced CLIA complaint investigation was conducted at Labcorp of America Holdings on April 10 & 11, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Specific deficiencies cited are as follows: D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on the tour of the reception and specimen collection area, review of policy, personnel training records and interviews, the personnel (phlebotomist A and B) did not maintain patient confidentiality during the registration process and collection of specimens for eleven (11) patients on April 10, 2018. Findings include: 1. Tour of the LabCorp reception and draw station area revealed the following: -The LabCorp daily patient login sheet was visible to anyone in the office. Ten (10) previous patients signed the sheet (to include first and last name) and was visible to other patients. - Patient A was asked to confirm name and date of birth, while patient B sat in a chair next to the reception desk. Patient A then disclosed his/her reason for visiting the physician that day to include health issues. -10 previously collected samples (that included name and date of birth), with accompanying LabCorp requisitions, were visible to Patient A and anyone who entered the draw station. 2. Review of the Lab Corp HIPPA Confidentiality Agreement & Acknowledgement document revealed the following statement: "It is the policy of LabCorp to protect the privacy rights and PHI of patients, their families, and their personal representatives as required by HIPPA. LabCorp information about a patient's PHI that an employee/agent may hear, see, or read, including documents recorded on paper, electronic/magnetic/optical media, conversations or film, must be kept confidential by all LabCorp employees/agents." Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- An interview with the General Supervisor of the phlebotomists stationed at the site, the Lab Corp Quality Manager for the region at approximately 3:00 PM on April 10, 2018 confirmed that personnel must complete electronic training each year as an agreement of employment to include annual HIPPA training. 3. Review of the Phlebotomist A and B training records revealed that Phlebotomist A signed the Lab Corp HIPPA Confidentiality Agreement & Acknowledgement document on October 2, 2011 and completed the annual LabCorp HIPPA electronic training on January 10, 2018. Phlebotomist B signed the Lab Corp HIPPA Confidentiality Agreement & Acknowledgement document on November 21, 2016 and completed the training on December 14, 2017. 4. An interview on April 11, 2018 at approximately 9:10 AM confirmed that the personnel (phlebotomist A and B) did not maintain patient confidentiality during the registration process and collection of specimens for eleven (11) patients. -- 2 of 2 --