Florida Clinical Laboratory Inc D/B/A

Summary Statement of Deficiencies D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews it was determined that the laboratory failed to follow written policies and procedures for the evaluation and comparison of three of six laboratory statistics and failed to document three of six required annual statistics for 2019 and 2020. Findings include: 1. The laboratory failed to follow the written procedure titled CYTOLOGY QUALITY MANAGEMENT-STATISTICAL DATA which stated: "Statistical Data is collected using the GenECyS Reporting Tool. Records are maintained on the following: a. # of specimens by specimen type b. # of specimens by diagnosis c. # of unsatisfactory specimens by diagnosis and client d. # of total cytology cases examined e. # of gyn cases where cytologic and histologic diagnoses are discrepant f. # of cases where a rescreen of a negative resulted in reclassification as a malignant or pre- malignant result g. # High grade cases researched for previous negatives." 2. The Survey Team requested and the laboratory failed to provide three of six required 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 -- annual statistics for 2019 and 2020: a. # of specimens by specimen type b. # of specimens by diagnosis c. # of total cytology cases examined. 3. During an interview on April 13, 2021 at 3:40 the Cytology Supervisor confirmed that the numbers on the CYTOLOGY DIAGNOSTIC SUMMARY document failed to include the total number of cases that were evaluated. The numbers did not include the number of cases received from other locations and only included the number of cases that were accessioned at the laboratory being surveyed. a. The Survey Team requested and the Cytology Supervisor failed to explain the following disparities in 2019 statistical documents provided by the Cytology Supervisor: -QUALITY MANAGEMENT PERFORMANCE SUMMARY 2019: Total # Cases Reported: 126,621 Total # Cases Screened: 155,500 b. The Survey Team requested and the Cytology Supervisor failed to explain the following disparities in 2020 statistical documents provided by the Cytology Supervisor: -QUALITY MANAGEMENT PERFORMANCE SUMMARY 2020: Total # Cases Reported: 102,834 Total # Cases Screened: 128,992 - CYTOLOGY DIAGNOSTIC SUMMARY 2020: Total # Cases: 101,971 4. During an interview on April 14, 2021 at 11:00 AM the Laboratory Director/Technical Supervisor A confirmed these findings. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interviews, the Survey Team determined that the laboratory failed to meet the specified requirements for gynecologic cytology proficiency testing (PT) examination in 2017 and 2018. The laboratory failed to administer the PT as required by the proficiency test provider's instructions (refer to D2015). The cumulative effect of this systemic problem resulted in the laboratory's failure to meet certification requirements to accurately and reliably evaluate patients' gynecologic cytology slides for 2017 and 2018. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of PT records and interviews it was determined that the laboratory failed to administer the PT examination as required by the proficiency test provider's laboratory proctor instructions. Findings Include: 1. The Survey Team reviewed the COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PAP PROFICIENCY TEST (PT) PROCTOR PACKET INSTRUCTIONS which stated: -"Only the assigned proctors are permitted to open the slideset box and verify contents of the testing materials." -"The 10 challenges are packaged in a small, white Styrofoam box with a security seal attached. The proctor is responsible for removing the seal and discarding it." -"Distribute the kit instructions, and individual result form, and the matching Challenge Interpretive Menu and set of challenges to the examinee." -"Record the examinees start time in the area located on the individual result form." -"Monitor the test environment to make sure there is no communication among examinees regarding the result form, the challenge interpretation menu, or the test challenges." -"Observe the time and collect all test materials from the examinee after 2 hours, whether or not he or she has completed the test." -"Record the examinees stop time on the result form. Have the examinee sign in the area marked 'Examinee signature.' Sign your name by 'Proctor signature.'" 2. During an interview on June 25, 2019 at 8:30 AM the Cytology Supervisor stated the following, when asked about the laboratory's PT proctors and PT testing activities: a. Proctors: -"The laboratory had two PT Proctors (Proctor A and Proctor B)." -"Proctor A works every-other Saturday and came in on Mondays during the PT because Proctor B did not work Mondays." -"Proctor A proctored the 2017 and 2018 PT events." -"I'm not a Proctor." b. Pre-Test Activities: - "I opened the PT (slideset) boxes and verified the contents of the test materials." -"I matched up the PT forms and the slides and put the slides into trays before they go to the Cytotechnologists." c. PT Testing Event Activities: -"The Cytotechnologist or the proctor documents the start time of the PT. This varies and depends." -"Upon completion of the PT, the tray of PT slides and the PT (result) forms are placed on my desk." -"Either the Cytotechnologist or the proctor cleans the slides prior to passing the slides onto the next Cytotechnologist. It varies and depends." 3. During an interview with the Cytology Supervisor on June 25, 2019 at 8:30 AM the Survey Team determined that the Cytology Supervisor was not Proctor A or Proctor B. The Cytology Supervisor performed the activities of the cytology laboratory proctor. 4. During an interview on June 25, 2019 at 9:30 AM, Cytotechnologist E stated the following: -"The time for the PT is announced but not monitored." -"When finished with the PT, everything is turned into the Cytology Supervisor or the Cytology Supervisor's office." -"The Cytology Supervisor enters the PT stop time." - "Sometimes I clean the slides; depends if the slides are going to a pathologist or not." - "The Cytology Supervisor, or whoever, faxes the results." 5. During an interview on June 25, 2019 at 10:10 AM, Cytotechnologist F stated the following: -"The Cytology Supervisor distributes the PT slide test." -"Slides are given to the proctor or the Cytology Supervisor when done." 6. During an interview on June 25, 2019 at 1:20 PM, Cytotechnologist G stated the following: -"I go to the Cytology Supervisor and ask for my PT slides." -"The Cytology Supervisor enters the PT start time." -"When finished with the PT, I take the slides and forms back to the Cytology Supervisor. Every time I have taken the PT I give the slides back to the Cytology Supervisor." -"I clean the slides when I receive them." 7. During an interview on June 26, 2019 at 1:40 -- 2 of 10 -- PM, Cytotechnologist C stated the following: -"The Cytology Supervisor gives the PT slides and forms to me." -"When finished with the PT, I return everything to the Cytology Supervisor." -"The Cytology Supervisor fills in the start and stop times on the form." -"I do not know and have not met the proctor (Proctor A)." 8. During an interview on June 28, 2019 at 10:58 AM, Proctor A stated the following: -Proctor A "could not remember" if all steps of the PT pre-testing activities were performed by Proctor A. -Proctor A "did not always" distribute the individual PT event slides and forms. -Proctor A "did not always" collect the slides and forms upon completion of the PT event. -Proctor A "did not always" clean the slides prior to passing the slides on to the next Cytotechnologist. -Proctor A "was present on Sunday and Monday, but not always present when the PT was administered over three days." -Proctor A "signs but does not complete" the verification and attestation forms. -Proctor A "does not totally understand the PT process but the Cytology Supervisor tells (Proctor A) what to do." -Proctor A "does not mail the slides back to CAP; Cytology Supervisor does that." 9. The survey team reviewed COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PAP PROFICIENCY TEST (PT) PROCTOR PACKET INSTRUCTIONS and CMS-approved GYN Proficiency Testing Result Forms and determined that the consecutive testing start and stop times did not allow time between the individual PT events for the required duties of the proctor. a. The COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PAP PROFICIENCY TEST (PT) PROCTOR PACKET INSTRUCTIONS stated the proctor duties TESTING EVENT PROCEDURE FOR THE PROCTOR as follows: -"If you are not familiar with the examinee, request proof of identification before starting the testing event." -"Distribute the kit instructions, an individual result form, and the matching Challenge Interpretive Menu and set up challenges to the examinee." -"Instruct the examinee to read the kit instructions carefully." -"Verify that the examinees PTR number is correctly printed on the result form by matching it to the PTR number listed on the roster." -"Record the examinees start time in the area located on the individual result form.' -"Observe the time and collect all test materials (set of challenges, result form, Challenge Interpretation Menu, kit instructions) from the examinee after two hours, whether or not he or she has completed the test." -"Record the examinees stop time on the result form. Have the examinee sign in the area marked 'Examinee" signature'. Sign your name by 'Proctor signature.'" -"Record the examinees unique, 8-digit result form kit number, unique PTR number, name, test date, and your initials on the PAP PT slide set verification and attestation form." -"Remind the examinee not to communicate with any individual regarding the challenges, the interpretations, or any aspect of the task until the testing event has been completed." -"Fax the result form immediately after the examinee is done. Do not wait until the end of the test event to fax the result form." -"Determine the transfer of the challenges and results form. CT's (Cytotechnologists) and primary screener pathologists must always receive a clean unmarked set of challenges." b. The COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PAP PROFICIENCY TEST (PT) PROCTOR PACKET INSTRUCTIONS stated the proctor duties PROCEDURE FOR CLEANING GLASS SLIDES as follows: -"Place slides on a white paper towel." -"Swipe the back of the slide with alcohol to remove any fingerprints." -"Swipe the front of the slide, beginning below the label, back and forth until the ink marks are no longer visible." -"Wipe both sides of the slide with clean alcohol to remove all of the ink and then use a dry paper towel to finish." -"Check slides under the microscope to confirm there are no stray marks on the slide." 10. The survey team reviewed four PT test result forms from slide set #37382, for the PT event on October 09, 2017. Proctor A failed to identify PT discrepancies with the consecutive testing of specimen start and finish times on three of four CMS-approved GYN Proficiency Testing Result Forms. Forms include: - Result Form for Cytotechnologist J: Start Time: 10:30 AM Stop Time: 11:30 AM - -- 3 of 10 -- Result Form for Cytotechnologist G: Start Time: 11:30 AM Stop Time: 12:45 PM - Result Form for Cytology Supervisor: Start Time: 12:45 PM Stop Time: 1:30 PM a. The consecutive testing start and stop times did not allow time between the PT events for proctor duties as required by the PT test provider. b. During an interview on June 25, 2019 at 8:30 AM, the Cytology Supervisor stated "maybe the time was not precise." c. During an interview on June 28, 2019 at 9:58 AM, when asked to explain the same start time and stop time recording on result forms, Proctor A stated, "No way that could happen." 11. The survey team reviewed three PT test result forms from slide set #37383, for the PT event on October 09, 2017. Proctor A failed to identify PT discrepancies with the consecutive testing of specimen start and finish times on three of three CMS-approved GYN Proficiency Testing Result Forms. Forms include: -Result Form for Cytotechnologist I: Start Time: 9:15 AM Stop Time: 10:45 AM - Result Form for Cytotechnologist F: Start Time: 10:45 AM Stop Time: 12:30 PM - Result Form for Cytotechnologist D: Start Time: 12:30 PM Stop Time: 1:30 PM a. The consecutive testing start and stop times did not allow time between the PT events for proctor duties as required by the PT test provider. 12. The survey team reviewed two PT test result forms from slide set #37362, for the PT event on October 09, 2018. The proctor failed to identify PT discrepancies with the consecutive testing of specimen start and finish times on two of two CMS-approved GYN Proficiency Testing Result Forms. Forms include: -Result Form for Cytotechnologist H: Start Time: 7:45 AM Stop Time: 9:00 AM -Result Form for Cytology Supervisor: Start Time: 9:00 AM Stop Time: 10:00 AM D5625 CYTOLOGY CFR(s): 493.1274(c)(3) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (3) For each patient with a current HSIL, adenocarcinoma, or other malignant neoplasm, laboratory review of all normal or negative gynecologic specimens received within the previous 5 years, if available in the laboratory (either on-site or in storage). If significant discrepancies are found that will affect current patient care, the laboratory must notify the patient's physician and issue an amended report. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and review of gynecologic specimen slides it was determined that the laboratory failed to identify five of nineteen prior negative specimens as having a more significant lesion than initially reported. Findings include: 1. The laboratory failed to follow the procedure HSIL FIVE YEAR LOOKBACK REVIEW, which stated: "All prior negative cases are first reviewed by a Cytotechnologist authorized to perform Quality Control Review. If a discrepancy is found, the slides and reports are referred to a Pathologist for review." 2. The Survey Team reviewed nineteen prior negative cases from nineteen current High-Grade Squamous Intraepithelial Lesions (HSIL's) from June 2018 through February 2019. a. The Survey Team Pathologist confirmed on June 28, 2019 that the laboratory did not identify five of nineteen prior negative specimens as having a more significant lesion than was originally reported. Prior Negative Cases Include: -#610394445 -#610561748 -#610562297 -#610751925 -#610804795 D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) -- 4 of 10 -- (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews it was determined that the laboratory failed to establish written policies and procedures to ensure the workload limit for nine of nine Cytotechnologists was reassessed at least every six months in 2017 and 2018. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe how the laboratory would reassess the workload limit of the Cytotechnologists at least every six months and adjust when necessary. 2. The Survey Team requested and the laboratory failed to provide records of workload limit reassessments for nine of nine Cytotechnologists at least every six months in 2017 and 2018. Cytotechnologists include: -Cytology Supervisor -Cytotechnologist C - Cytotechnologist D -Cytotechnologist E -Cytotechnologist F -Cytotechnologist G - Cytotechnologist H -Cytotechnologist I -Cytotechnologist J 3. During an interview on June 27, 2019 at 9:10 AM the Cytology Supervisor stated "we don't do that every six months. We just did it initially when they started working and didn't change it until last month." 4. During an interview on June 27, 2019 at 3:55 PM the Laboratory Director/Technical Supervisor A stated "there was no reason to reassess or change the workload. Nothing had changed." D5639 CYTOLOGY CFR(s): 493.1274(d)(2)(i) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the Following: (d)(2) The maximum number of slides examined by an individual in each 24-hour period does not exceed 100 slides (one patient specimen per slide; gynecologic, nongynecologic, or both) irrespective of the site or laboratory. This limit represents an absolute maximum number of slides and must not be employed as an individual's performance target. In addition-- (d)(2)(i) The maximum number of 100 slides is examined in no less than an 8-hour workday; This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, interviews and review of laboratory records it was determined that the laboratory failed to follow written policies and procedures to ensure that the maximum workload limit did not exceed 100 slides in each 24-hour period for eight of nine Cytotechnologists in 2017 and 2018 and seven of eight Cytotechnologists to the date of the survey in 2019. Findings include: WLUs: Workload Load Units 1. The laboratory failed to follow the procedure CYTOTECHNOLOGIST DAILY WORKLOAD DOCUMENTATION, which stated: "Individual maximum daily workload limits are established by the technical supervisor/medical director as mandated by CLIA '88. Allowable WLUs may not exceed 12.5 slides/hour and 100 slides/workload units (WLUs or the equivalent of 1 slide) in a 24 hour period." 2. During an interview on June 24, 2019 at 11:25 AM the Cytology Supervisor stated that "prior to May 28, 2019, the Cytotechnologists were assigned a workload limit of 115 slides/day. The workload limit was increased to 120 slides/day on May 28, 2019." 3. The Survey Team reviewed laboratory records titled CYTOTECHNOLOGIST WORKLOAD LIMITS -- 5 of 10 -- & OUTSIDE CYTOLOGY EMPLOYMENT prior to May 28, 2019. Technical Supervisor A documented on the records that the maximum workload limit for eight of nine Cytotechnologists employed during 2017 and 2018 was 115 slides/day. Cytotechnologists include: -Cytotechnologist C -Cytotechnologist D - Cytotechnologist E -Cytotechnologist F -Cytotechnologist G -Cytotechnologist H - Cytotechnologist I -Cytotechnologist J 4. The Survey Team reviewed laboratory records titled CYTOTECHNOLOGIST WORKLOAD LIMITS & OUTSIDE CYTOLOGY EMPLOYMENT, signed by the Laboratory Director/Technical Supervisor A on May 28, 2019. The records stated that the maximum workload limit for seven of eight Cytotechnologists was 120 slides/day. Cytotechnologists include: - Cytotechnologist A -Cytotechnologist B -Cytotechnologist C -Cytotechnologist D - Cytotechnologist E -Cytotechnologist F -Cytotechnologist G 5. During an interview on June 27, 2019 at 3:55 PM the Laboratory Director/Technical Supervisor A confirmed these findings. D5655 CYTOLOGY CFR(s): 493.1274(e)(4) (e) Slide examination and reporting. The laboratory must establish and follow written policies and procedures that ensure the following: (e)(4) Unsatisfactory specimens or slide preparations are identified and reported as unsatisfactory. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and microscopic review of gynecologic cytology specimen slides it was determined that the laboratory failed to follow written policies and procedures to ensure that unsatisfactory gynecologic cytology specimen slide preparations were identified and reported as unsatisfactory. The laboratory failed to microscopically identify and report nineteen of thirty-one gynecologic cytology cases sampled from April through June 2019 as being "Unsatisfactory for Evaluation." Findings include: 1. The laboratory failed to follow the procedure SPECIMEN ADEQUACY AND UNSATISFACTORY SPECIMENS, which stated: "An adequate specimen for liquid base should contain an estimated minimum of at least 5000 well-preserved squamous cells." 2. The laboratory microscopically examined and signed out cases with less than 5000 well-preserved squamous cells as being "Satisfactory for Evaluation." 3. The laboratory failed to microscopically identify and report nineteen of thirty-one gynecologic cytology cases as being "Unsatisfactory for Evaluation." Cases include: -204807450 -204796402 -204813271 -204806122 -204811675 -204796189 -610932096 -610934253 -610934743 -610935299 -610951160 -610964421 -610965333 -610965552 -610965761 -610965829 -610965841 -610966258 -610966301 4. These findings were confirmed by the Survey Team Pathologist on June 28, 2019. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: -- 6 of 10 -- Based on review of laboratory policies and procedures, laboratory records, gynecologic cytology slides and interviews it was determined that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems in the analytic phases of cytology testing. Cross refer to D5625, D5655 Findings include: 1. The Survey Team randomly reviewed 217 negative gynecologic cases/slides and corresponding laboratory records from April, May and June 2019. The cases were evaluated by the laboratory as part of their quality control review program. a. The laboratory failed to identify eight diagnostic discrepancies during the quality control review. Cases include: -204796189 -204806636 -204806746 -610932096 -610934224 -610934253 -610934743 -610935299 b. The Survey Team Pathologist confirmed on June 28, 2019 that the laboratory failed to detect the eight diagnostic errors as part of the laboratory's quality control review program. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, specimen slides and interviews it was determined that the laboratory failed to have a Laboratory Director who provides overall management and direction in accordance with 493.1445 of this subpart. The Laboratory Director failed to ensure compliance with applicable regulations (refer to D6079); failed to ensure that testing of samples for the gynecologic cytology PT program in 2017 and 2018 was performed in accordance with 493.801 (refer to D6089); and failed to ensure that analytic quality assessment programs were followed (refer to D6094). The cumulative effect of these systemic problems resulted in the Laboratory Director's inability to provide overall management and direction of cytology in accordance with 493.1445 of this subpart. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, specimen -- 7 of 10 -- slides and interviews it was determined that the Laboratory Director failed to assure compliance with the applicable regulations and ensure that all the duties of the Laboratory Director were performed. Cross Refer to D5625, D5637, D5639, D5655 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 PT records and interviews the Survey Team determined that the Laboratory Director failed to ensure testing of samples for the gynecologic cytology PT program in 2017 and 2018 was performed in accordance with 493.801 which requires the duties of the proctor to be performed by the proctor. Cross Refer to D2015 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 laboratory policies and procedures, laboratory records, gynecologic cytology specimen slides and interviews it was determined that the Laboratory Director failed to ensure that quality assessment programs were followed to assure the quality of laboratory services and identify failures in quality as they occur. Cross refer to D5791 D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on review of gynecologic specimen slides and corresponding final test reports it was determined that the Technical Supervisor failed to verify the accuracy of 29 gynecologic test reports (refer to D6115). The cumulative effect of these practices resulted in the Technical Supervisor's inability to provide technical supervision requirements of 493.1451 of this subpart. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, -- 8 of 10 -- including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on the microscopic review of 1416 random negative gynecologic cases/slides and the corresponding final test reports from April, May and June 2019 and confirmation by the Survey Team Pathologist on June 28, 2019 it was determined that the Technical Supervisor failed to verify the accuracy of 29 gynecologic tests. 1. 204806126 06/22/2019 Imaged ThinPrep Pap Test (I-TPPT) LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Atypical Squamous Cells, cannot exclude High-Grade Squamous Intraepithelial Lesion 2. 610934224 04/15/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Atypical Squamous Cells, cannot exclude High-Grade Squamous Intraepithelial Lesion 3. 610962198 06/13/2019 FocalPoint Guided Imaging System (GS) LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Atypical Squamous Cells, cannot exclude High-Grade Squamous Intraepithelial Lesion 4. 204806194 06/22/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Atypical Glandular Cells 5. 204806636 06/18/2019 I- TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Atypical Glandular Cells 6. 204806746 06/24 /2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Low-Grade Squamous Intraepithelial Lesion 7. 204807466 06/18/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Low-Grade Squamous Intraepithelial Lesion 8. 204811663 06/22/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Low-Grade Squamous Intraepithelial Lesion 9. 610962134 06/13/2019 GS LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Low-Grade Squamous Intraepithelial Lesion 10. 610966311 06/24/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Low-Grade Squamous Intraepithelial Lesion 11. 204796189 06/24 /2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 12. 204796402 06/22/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 13. 204806122 06/22/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 14. 204807450 06/22/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 15. 204811675 06/23/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 16. 204813271 06/23/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 17. 610932096 04/15/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 18. 610934253 04/15/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: -- 9 of 10 -- Unsatisfactory for Evaluation; scant cellularity 19. 610934743 04/15/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 20. 610935299 04/15/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 21. 610951160 05/20/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 22. 610964421 06/22/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 23. 610965333 06/24/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 24. 610965552 06/24/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 25. 610965761 06/25/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 26. 610965829 06/24/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 27. 610965841 06/25/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 28. 610966258 06/24/2019 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity 29. 610966301 06/24/2019 GS LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM PATHOLOGIST DIAGNOSIS: Unsatisfactory for Evaluation; scant cellularity D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 10 of 10 --