Harper Branch Laboratory

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on December 18, 2023, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and College of American Pathologist (CAP) proficiency testing records for 2023, the laboratory failed to 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 -- achieve satisfactory performance (80% or greater) for the analyte partial pressure of carbon dioxide (PCO2) for two out of two consecutive events (event 2 and event 3), resulting in unsuccessful performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and College of American Pathologist (CAP) proficiency testing records for 2023, the laboratory failed to achieve satisfactory performance (80% or greater) for the analyte partial pressure of carbon dioxide (PCO2) for two out of two consecutive events (event 2 and event 3), resulting in unsuccessful performance. The findings included: 1. A review of the CASPER report 155 lists a score of "60%" for the CAP PCO2 2nd Event, a score of "40%" for the 3rd Event. 2. A proficiency desk review of the CAP proficiency testing records for 2023 confirmed that the laboratory received unsatisfactory scores for PCO2 during the CAP Routine Chemistry 2nd and 3rd event for 2023. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and CAP proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for analyte PCO2. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and CAP proficiency testing records, the laboratory director failed to ensure successful participation in an HHS -- 2 of 3 -- approved proficiency testing program for analyte PCO2 for two out of two events in 2023. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following standard deficiencies were cited as the results of a recertification survey on 01/25/2023, with an additional on-site visit on 03/02/2023. This facility was found to be IN compliance with the CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 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 direct observation, review of the manufacturer's instructions, laboratory policy, laboratory records, patient records, and confirmed in staff interview, the laboratory failed to ensure Cryostat temperatures were within operating specifications according to the laboratory policy for 11 of 11 months (09/2021 through 12/2021 and 04/2022 through 10/2022). Findings included: 1. During a tour of the laboratory on 01 /25/2023, at 3:00pm, one Cryostat (serial number 56579) was observed. 2. Review of the manufacturer's operation manual titled, "Microm HM550 Thermo Scientific CRYOSTAT MICROTOM" stated, "Technical Data ... Chamber temperature control -10C to -35C". 3. Review of the laboratory's policy titled "Frozen Sections of Fresh Tissue and Staining Procedure" (Reference: HIST 18, Effective: 07/11/2022, Version: 8.0) stated, "PROCEDURE ... B. Frozen Section Technique ... 5. The Cryostat temperature is verified. The range is: -30 to -20 C." 4. Review of the laboratory's "Northside PMG CryoStat Log" stated, "In Range Temp = -15 - -30C." The 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 -- laboratory's daily log temperature upper limit of -15C exceeded the laboratory's upper limit of -20C, as specified in their policy. 5. Review of the laboratory's patient records from 09/2021 through 12/2021 and 04/2022 through 10/2022, revealed 2 of 16 days patient testing was performed when CryoStat temperatures exceeded the laboratory's specified upper limit of -20C: a. Patient 010826 09/09/2021 CryoStat temperature: -19 C b. Patient 010955 09/13/2021 CryoStat temperature: -17C Word key: C = degrees Celsius H&E = Hematoxylin-Eosin 6. During an interview on 03/02/2023 at 11:15 am in the conference room, after review of the above records, the technical consultant confirmed the findings. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of laboratory policy/procedure, laboratory's quality control forms, and confirmed in staff interview, the laboratory failed to define the intended reactivity for the Hematoxylin and Eosin (H&E) stain to ensure predictable staining characteristics for 4 months (January, February, April and December) in 2021 and 3 months (January, February and March) in 2022. Findings included: 1. Review of the policy/procedure titled, "Frozen Sections of Fresh Tissue and Staining Procedure" revealed the laboratory's policy/procedure failed to include the intended reactivity and the predicted staining characteristics for the H & E Quality Control (QC) slide. 2. Review of the laboratory's quality control forms revealed a checkmark under a column titled "Good", indicating the stain quality of the H&E Control slide. The laboratory's quality control forms indicated the QC for the H&E stain was performed on the following days in January, February, and April of 2021: 01/15/2021 01/20 /2021 02/02/2021 02/19/2021 04/06/2021 04/09/2021 04/16/2021 04/22/2021 The laboratory's quality control form indicated the QC for the H&E stain was performed on the following days in December (2021), January, February, and March of 2022: 12 /02/2021 12/09/2021 01/04/2022 01/13/2022 02/01/2022 02/10/2022 03/01/2022 The laboratory failed to define the intended reactivity for the Hematoxylin and Eosin (H&E) stain to ensure predictable staining characteristics. 3. In an interview on 1/25 /2023 at 3:09 pm, after review of the records, the Technical Consultant (TC#2), confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies were cited during a recertification survey completed on 11 /18/2020 for the federal requirements of 42 CFR Part 493 for Laboratories. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on the review of testing personnel records, new test validations and interview with the Technical Consultant, the Technical Consultant failed to perform and document training for pH (a test for acidity) and pCO2 (partial pressure of carbon dioxide) after the tests were added to the laboratory's test menu for 5 testing personnel (TP #1-TP#5) of 5 (TP#1-TP#5). Findings are: A. Review of the validation records for pH and pCO2 using the i-STAT chemistry analyzer revealed the laboratory approved the new tests for patient testing 07/30/2020 B. Review of testing personnel records revealed no documentation of training on the new test systems for 5 (TP#1- TP#5) of 5 (TP#1-TP#5) testing personnel. C. During interview with the Technical Consultant on 11/18/2020 at 12:06 pm, he confirmed no training had been provided because the testing personnel had been trained on the same analyzer for other tests. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --