Danner Laboratory

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's verification of performance specifications documentation for the Hologic instrument and interviews with the laboratory director (LD) and compliance officer (CO) it was determined that the laboratory failed to verify performance specifications and update protocol in place with the effective date and signature of approval by the laboratory director. The findings included: 1. On the day of the survey September 24, 2024, at approximately 1:45 p.m. the documentation of verification of performance specifications for the Hologic instrument in place had not been reviewed, approved, signed, and dated by the laboratory director. 2. The LD and CO affirmed on September 24, 2024, that the laboratory failed to update protocols for the current verification of performance specification performed in the laboratory for the Hologic instrument and that the effective date and the laboratory director's signature were missing. 4. The laboratory's testing declaration form stated that the laboratory processes approximately 33,000 patients' cytology test annually. 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 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 -- the laboratory's patient population. This STANDARD is not met as evidenced by: Based on the lack of a complete laboratory verification of performance specifications for the Hologic instrument and interviews with the laboratory director (LD), compliance officer (CO) and testing personnel (TP) on September 24, 2024, the laboratory failed to provide an established verification of performance specifications documentation comparable to those established by the manufacturer. The findings included: 1. Based on review of the laboratory's documentation for verification procedure for the Hologic Thin Prep 5000 serial number 93162123DO instrument at the time of survey, it was found that the documentation was incomplete. Performance specifications for accuracy, precision, reportable range, and reference range method of validation were incomplete. 2. The LD, CO, and TP affirmed at the time of the survey on September 24, 2024, at approximately 1:40 p. m. that the testing and documentation for verification provided at the time of the survey were incomplete as indicated in 1. 3. Based on the testing declaration submitted at the time of survey, the laboratory performed and reported approximately 33,000 cytology tests for which the Hologic instrument was used with incomplete verification of performance specifications. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policies and procedures, proficiency testing records, validation of new tests established in the laboratory, five (5) randomly selected patients test records, and interviews with the laboratory director, compliance officer, and testing personnel on September 24, 2024; it was determined that the laboratory director is cited herein due to failure to ensure that several aspects of the preanalytic and analytical phases of the laboratory testing were monitored. See D5407, D5421, and D6107. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's records of personnel training, competency -- 2 of 3 -- evaluation, laboratory policies and procedures, five (5) randomly selected patient testing records, and interview with the laboratory 's compliance officer (CO) the laboratory failed to provide records showing that the laboratory director (LD) has authorized, delegated, and approved lab personnel of any responsibilities and duties in writing. The findings include: 1. The laboratory did not have any records of written delegation and authorization of responsibilities and duties by the LD for the laboratory's technical supervisor/general supervisor. In addition, the responsibilities of the technical supervisor/general supervisor, and testing personnel (TP) were not specified in writing. 2. On September 24, 2024, at approximately 1:00 p.m. the CO affirmed that the LD did not assign, delegated, and authorized in writing duties and responsibilities to the laboratory personnel including the TS and TP. 3. The laboratory testing declaration form, signed by the LD on 09/24/2024 stated that the laboratory performs 33,000 cytology tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A focus survey was completed on December 16, 2022. It was determined that Immediate Jeopardy (IJ) existed for the following condition level deficiencies: Cytology- 42 CFR 493.1221 Laboratory Director- 42 CFR 493.1441 Technical Supervisor- 42 CFR 493.1447 D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews the laboratory failed to establish written policies and procedures for nine laboratory test processes (refer to D5403); failed to ensure that written procedures were approved, signed and dated by the Laboratory Director prior to use (refer to D5407); failed to follow manufacturer's instructions for the Becton Dickinson (BD) SurePath Pap Test and Hologic ThinPrep test system (refer to D5411); failed to establish performance specifications when the laboratory modified the Hologic ThinPrep test system manufacturer's instructions (refer to D5423); failed to ensure that the required maintenance for the Hologic ThinPrep 2000 Processors was performed, as specified by the manufacturer (refer to D5429); failed to test staining materials for intended reactivity of the Papanicolaou stain (refer to D5473); failed to follow written policies and procedures for an annual statistical evaluation of the required laboratory statistics (refer to D5629); failed to establish written policies and procedures for the establishment and reassessment of individual workload limits (refer to D5633 and D5637); failed to establish and follow written policies and procedures to ensure the laboratory maintained records of the total number of slides examined and the total number of hours spent examining slides per 24-hour period (refer 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 22 -- D5645); failed to establish written policies and procedures to document workload limits (refer to D5647); failed to establish written policies and procedures to ensure all nongynecologic preparations were reviewed by a Technical Supervisor and the report signed to reflect technical supervisory review (refer to D5653); failed to establish written policies and procedures to ensure unsatisfactory gynecologic patient specimens were identified and reported as unsatisfactory, and failed to identify and report four of four gynecologic tests as Unsatisfactory (refer to D5655); and failed to establish written policies and procedures to ensure corrected test reports indicated the basis for the correction on the test report (refer to D5659). D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview the laboratory failed to establish written policies and procedures to assess the diagnostic competency of the Laboratory Director/Technical Supervisor. The laboratory failed to assess the diagnostic competency of one of one Technical Supervisors in 2020, 2021 and to the date of the survey in 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to assess the diagnostic competency of the Laboratory Director/Technical Supervisor. 2. The Survey Team requested and the laboratory failed to provide documentation that assessed the diagnostic competency of one of one Technical Supervisors in 2020, 2021 and to the date of the survey in 2022. Technical Supervisor includes: -Laboratory Director/Technical Supervisor 3. During an interview on December 13, 2022 at 2:00 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor, Cytotechnologist A and Staff A. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems in the general laboratory phases of cytology testing to include assessing the diagnostic competency of the Laboratory Director/Technical Supervisor. Cross refer to D5209 Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory phases of testing to include assessing the diagnostic competency of the Laboratory Director/Technical Supervisor. 2. The Survey Team requested and the laboratory failed to provide documentation of general -- 2 of 22 -- laboratory quality assessment activities during 2020, 2021 and to the date of the survey in 2022. a. The laboratory failed to document a system for monitoring and evaluating the diagnostic competency of the Laboratory Director/Technical Supervisor. (See D5209) D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of 68 laboratory policies and procedures, laboratory records and interview the laboratory failed to follow one written policy and procedure. Findings include: 1. The laboratory failed to follow the procedure BURLINGTON AUTOMATED GYN STAINING PROCEDURE, which stated: "Change the reagents and stains according to schedule. Wash the staining dishes after completing 650 slides." a. The Survey Team reviewed records titled THINPREP STAIN MAINTENANCE for January through the date of the survey in 2022. The records were used to document the number of slides stained and when the stains and solutions were changed. The laboratory exceeded the number of slides that were allowed to be stained prior to changing the stains and solutions on 16 dates. Dates include: -01/31 /22 (745 slides stained) -02/09/22 (675 slides stained) -02/24/22 (664 slides stained) -03/04/22 (692 slides stained) -03/11/22 (669 slides stained) -03/21/22 (711 slides stained) -03/29/22 (678 slides stained) -04/06/22 (678 slides stained) -04/15/22 (704 slides stained) -04/25/22 (689 slides stained) -05/03/22 (662 slides stained) -06/07/22 (685 slides stained) -07/12/22 (686 slides stained) -08/31/22 (667 slides stained) -09 /12/22 (699 slides stained) -10/07/22 (677 slides stained) 2. During an interview on December 13, 2022 at 2:00 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor, Cytotechnologist A and Staff A. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) result reports, and interview with the laboratory personnel, it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent is unsatisfactory performance. The findings included as follows: a. The laboratory performed beta B Strep group and enrolled its proficiency testing (PT) programs with CAP (College of American Pathologists), DS - Group B Strep Detection. b. The laboratory failed to attain an overall testing event score of at least 80 percent was unsatisfactory performance. c. The laboratory attained scores of 0% for beta B Strep identification for Q2 2020 and Q1 2022 CAP DS PT events which were unsatisfactory performance. d. The laboratory performed beta B Strep identification in approximately 9 patient specimens monthly. e. The laboratory personnel affirmed (8/12/2022 @ 12:45PM) that the laboratory attained scores of 0% for beta (B) Strep identification for Q2 2020 and Q1 2022 CAP DS PT events which were unsatisfactory performance. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding 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 3 -- condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the laboratory records and patient test result reports, and interview with the laboratory personnel, it was determined that the laboratory failed to indicate the test report date to ensure the test result reports were released timely. The findings included as follows: a. The laboratory failed to indicate a "Reported Date" on its patient test result reports. b. Laboratory use a computer system to print out its cytology patient test result reports. b. Base on review of 8 patient test result for both Gyn cytology and Non-gyn Cytology reports, two Gyn patient reports provided no "DATE OF REPORT:" and other two showed 8/12/2022, which was a date the report was printed, NOT the real "DATE OF REPORT:" for the test result reports. c. The laboratory provided two in consist of printing formats in "DATE OF REPORT:" as follow: ID # Date Received Date of Report 0027865 10/19/21 blank 0011979 5/14/21 blank 0003008 2/7/2022 8/12/2022 0010015 4/18/2022 8/12/2022 d. The laboratory personnel confirmed (8/12/2022 @ 12:25 PM) that was the computer system problems for the inconsistency. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) result reports, and interview with the laboratory personnel, it was determined that the laboratory director failed to ensure the proficiency testing samples were tested as required under subpart H of 42 CFR part 493. The findings included as follows: a. The laboratory performs beta B Strep group and enrolled with CAP (College of American Pathologists) proficiency testing (PT) programs, DS - Group B Strep Detection, b. The laboratory director failed to ensure the laboratory to attain an overall testing event score of at least 80 percent was unsatisfactory performance, see D-2020. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory records, and interview with the laboratory personnel, it was determined that the laboratory director failed to ensure the quality assessment programs were established and maintained to provide accuracy, reliability, and timely of the patient test result reports, and to assure the quality of laboratory services provided and to identify failures in quality as they occur. The findings included as follows: a. The laboratory director failed to ensure the quality assessment programs were established and maintained to assure the accurate, reliable, and timely -- 2 of 3 -- of the patient test result report and to provides mandatory formats include the "DATE OF REPORT" to assure the turnaround time of the patient result report, see D-5805 -- 3 of 3 --

Summary Statement of Deficiencies 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the speciality of Bacteriology in two out of three consecutive testing events constituting unsuccessful PT performance. (See D2028) 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 -- D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the speciality of Bacteriology in two out of three consecutive PT events, as follows: 2019 Q3 2020 Q2 Bacteriology 0% 0% Q2 = Second testing event Q3 = Third testing event b. Failure to achieve satisfactory performance for the speciality in two of three consecutive PT resulted in an initial unsuccessful performance for Bacteriology. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) -- 2 of 2 --