Methodist Hospital,The

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. 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 review of the laboratory's policies, the laboratory's accuracy assessment records for 2023, and staff interview, the laboratory failed to have documentation of performing two of two twice annual accuracy assessments for Mohs slide interpretations in 2023. Findings include: 1. A review of the laboratory's policy titled 'Mohs Laboratory Procedure' revealed the following: "Proficiency by a consulting dermatopathologist or another Mohs surgeon will be done two times a year." 2. A review of the laboratory's accuracy assessment records revealed the laboratory failed to have documentation of performing 2 accuracy assessments for Mohs slide interpretations in 2023. 3. In an interview on 10/29/24 at 10:25 a.m. in the break room, after review of the records, the manager of operations confirmed the above findings. 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, a random review of patient's histopathology slides from November 2023 to August 2024, and staff interview, the laboratory failed to follow its policy for the of labeling slides for three of seven patient's histopathology slides reviewed. Findings include: 1. A review of the laboratory's policy titled 'Labeling of Frozen Section Slides' revealed the following: "Slides are to be labeled before frozen sections are cut - Information to be written with a slide marking pen on the frosted end of the slide must be obtained from the Digital photo that was delivered with the tissues. - Line 1 - Surgery Accession (Case) # and lesion designation (A, B, etc.) - Line 1 - Patient Name: Last name, First initial (first slide of each case)" 2. A random review of patient slides from November 2023 to August 2024 revealed the following patient's slides were not labeled as required per the laboratory's policy: Accession number: 23G427 Date: 11/21/23 - slide did not include the patient's first initial Accession number: 24G070 Date: 2/26/24 - slide did not include the patient's first initial Accession number: 24G218A Date: 8/5/24 - slide did not include the patient's first initial 3. In an interview on 10/29/24 at 10:35 a.m. in the break room, after review of the records, the manager of operations confirmed the above findings. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the Weekly Microscope Maintenance Records, patient test records, and staff interview, the laboratory failed to have documentation of performing the weekly microscope maintenance procedures for three of forty two days from October 2023 to October 2024. Findings include: 1. A review of the laboratory's policy titled 'Microscope Care' revealed the following: "Weekly Maintenance: a. Wipe down microscope with alcohol wipes. To remove fingerprints or oil, wipe with gauze moistened with xylene or mixture of ether (70%) and alcohol (30%). b. Clean all lenses with lens paper." 2. A review of the Weekly Microscope Maintenance Records from October 2023 to October 2024 revealed the laboratory failed to have documentation of performing the weekly microscope maintenance procedures for the following 3 days: 10/9/23 11/21/23 10/21/24 3. A review of patient test records revealed the following patients were tested on days when the weekly microscope maintenance procedures were not documented: Date tested: 10/9/23 Patient Case Numbers: 23G346, 23G347, 23G348, 23G349, 23G350, 23G351, 23G352, 23G353, 23G354, 23G355, 23G356 Date tested: 11/21/23 Patient Case Numbers: 23G417, 23G418, 23G419, 23G420, 23G421, 23G422, 23G423, 23G424, 23G425, 23G426, 23G427 Date tested: 10/21/24 Patient Case Numbers: -- 2 of 3 -- 24G281, 24G282, 24G283, 24G284, 24G285, 24G286, 24G287, 24G288 4. In an interview on 10/28/24 at 10:50 a.m. in the break room, after review of the records, the manager of operations confirmed the above 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 a review of laboratory's policies, the laboratory's Slide Check- Off Sheets, patient test records, and staff interview, the laboratory failed to document the intended reactivity of the Toluidine blue stain for MOHS histopathology slides each day of use for three of eighteen days from July to November 2023. Findings include: 1. A review of the laboratory's policy titled 'Control Slides' revealed the following: "The first frozen section of the day (tumor tissue from the first lesion) serves as the stain control slide. It is checked by the histotechnician first and by the surgeon/pathologist when he /she becomes available. The slide check-off sheet will be completed by the histotech and MD. Any needed changes or adjustments are made." 2. A review of the laboratory's Slide Check- Off Sheets from July to November 2023 revealed the laboratory failed to have documentation of the intended reactivity for the Toluidine blue stain on the following 3 days: 7/31/23 8/7/23 11/27/23 3. A review of patient test records revealed the following patients were tested on days when the intended reactivity of the Toluidine blue slide was not documented: Date tested: 7/31/23 Patient Case Numbers: 23G295, 23G296, 23G297, 23G298, 23G299, 23G300, 23G301, 23G302, 23G303, 23G304, 23G305 Date tested: 8/7/23 Patient Case Numbers: 23G306, 23G307, 23G308, 23G309, 23G310, 23G311, 23G312, 23G313, 23G314, 23G315 Date tested: 11/27/23 Patient Case Numbers: 23G428, 23G429, 23G430, 23G431, 23G432, 23G433, 23G434, 23G435, 23G436, 23G437 4. In an interview on 10/28/24 at 10:40 a.m. in the break room, after review of the records, the manager of operations confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . 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 a review of the laboratory's policies, a random review of patient's histopathology slides from July 2021 to December 2022, and staff interview, it was revealed that the laboratory failed to follow its policy for labeling slides for one of five patient's histopathology slides reviewed. Findings include: 1. A review of the laboratory's policy titled 'Labeling of Frozen Section Slides' revealed the following: "Slides are to be labelled before frozen sections are cut - Information to be written with a slide marking pen on the frosted end of the slide must be obtained from the Digital photo that was delivered with the tissues. - Line 1 - Surgery Accession (Case) # and lesion designation (A, B, etc.) - Line 1 - Patient Name: Last name, First initial (first slide of each case)" 2. A random review of patient slides from July 2021 to December 2022 revealed the following patient's slides were not labeled as required per the laboratory's policy: Accession number: 21G214 Date: 7/19/21 - slide did not include the patient's first initial 3. An interview with the manager of operations on 12 /12/22 at 9:55 a.m. in the break room, after review of the records, confirmed the above findings. 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 -- 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: I. Based on a review of laboratory's policies, the laboratory's Slide Check- Off Sheets from March 2022 to November 2022, a review of patient test records, and staff interview, it was revealed that the laboratory failed to document the adequacy of the Toluidine Blue stain for Mohs histopathology slides each day of use for three of ten days reviewed from March 2022 to November 2022. Findings: 1. A review of the laboratory's policy titled 'Staining Procedures' revealed the following: "The routine stain for frozen sections in this Mohs surgery lab is Toluidine Blue, 0.5% aqueous. The first frozen section of the day (tumor tissue from the first lesion) serves as the stain control slide. It is checked by the histotechnician first and by the surgeon /pathologist when he/she becomes available. The slide check-off sheet will be completed by the histotech and M.D." 2. A review of the Slide Check - Off Sheets from March 2022 to November 2022 revealed a column for the pathologist to place a check mark, indicating the Toluidine Blue stain of the control slide was adequate for patient use. 3. Further review of the laboratory's Slide Check- Off Sheets revealed no documentation of the pathologist's check mark for the Toluidine Blue stain on the following 3 days: 3/21/22 11/14/22 11/21/22 4. A review of patient test records revealed the following patients were tested on days when the stain was not documented as adequate: Date 3/21/22 Patients: 22G080, 22G081, 22G082, 22G083, 22G084, 22G085, 22G086, 22G087, 22G088, 22G089, 22G090, 22G091 Date 11/14 /22 Patients: 22G304, 22G305, 22G306, 22G307, 22G308, 22G309, 22G310, 22G311, 22G312, 22G313 Date 11/21/22 Patients: 22G314, 22G315, 22G316, 22G317, 33G318, 22G319, 22G320, 22G321, 22G322, 22G323, 22G324, 22G325 5. An interview with the manager of operations on 12/12/22 at 9:55 a.m. in the break room, after review of the records, confirmed the above findings. II. Based on a review of laboratory's policies, the laboratory's Slide Check- Off Sheets, a review of patient test records, and staff interview, it was revealed that the laboratory failed to follow its policy by not documenting the histotechnician and the pathologist's check of the adequacy of the Toluidine Blue stain for Mohs histopathology slides each day of use for 10 of 48 days reviewed from July 2021 to December 2022. Findings: 1. A review of the laboratory's policy titled 'Staining Procedures' revealed the following: "The routine stain for frozen sections in this Mohs surgery lab is Toluidine Blue, 0.5% aqueous. The first frozen section of the day (tumor tissue from the first lesion) serves as the stain control slide. It is checked by the histotechnician first and by the surgeon /pathologist when he/she becomes available. The slide check-off sheet will be completed by the histotech and M.D." 2. A review of the Slide Check - Off Sheets from July 2021 to December 2022 revealed a column for the pathologist and a column for the histotechnicican to place a check mark, indicating the Toluidine Blue stain of the control slide was adequate for patient use. 3. Further review of the laboratory's Slide Check- Off Sheets revealed no documentation of the pathologist's check mark for the Toluidine Blue stain on the following 10 days: 7/12/21 7/19/21 2/21/22 3/28 /22 4/4/22 10/3/22 11/7/22 11/12/22 11/28/22 12/5/22 4. A random review of patient test records revealed the following patients were tested on days when the stain was not -- 2 of 3 -- documented as adequate by the pathologist: Date 7/19/21 Patients: 21G214 Date 4/4 /22 Patients: 22G092, 22G093, 22G094, 22G095, 22G096 Date 10/3/22 Patients: 22G283, 22G284, 22G285, 22G286, 22G287 Date 11/7/22 Patients: 22G294, 22G295, 22G296, 22G297, 22G298 Date 11/28/22 Patients: 22G326, 22G327, 22G328, 22G329, 22G330 Date 12/5/22 Patients: 22G337, 22G338 5. An interview with the manager of operations on 12/12/22 at 9:55 a.m. in the break room, after review of the records, confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 the laboratory maintenance policy for the cryostat instrument in the procedure manual, maintenance logs from 2020 to 2021, and an interview revealed the laboratory failed to follow the its lab policy to defrost instruments every 6 months in 2020. The findings were: 1. Review of the laboratory Maintenance policy in procedure manual revealed "Every 6 months defrost" for the instruments under Maintenance section. 2. Review of the maintenance log for cryostat#1 from 1/6/20 to 4 /19/21 revealed no documentation of defrost maintenance for the instrument every 6 months. 3. Review of the maintenance log for cryostat#2 from 10/12/20 to 4/19/21 revealed no documentation of defrost maintenance for the instrument every 6 months. 4. Review of CMS 116 revealed the annual test volume of cryosectioning is 321. 5. An interview with the laboratory manager on 4/20/21 at 10:45am in the breakroom confirmed the above findings. D5601 HISTOPATHOLOGY 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 -- CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of control slides policy in the laboratory procedure manual, H & E stain quality QC logs in 2020, and an interview revealed the laboratory failed to document H & E stain quality QC by the testing personnel (TP) for 4 of 10 days reviewed. The findings were: 1. Review of Control Slides policy in the procedure manual revealed: "it is checked by the histotechnician first and by the surgeon /pathologist when he/she becomes available. The slide check-off sheet will be completed by the histotech and M.D.." 2. Review of H & E stain quality QC logs from 1/7/19 to 4/19/21 revealed the laboratory failed to document H&E stain quality for 4 of 10 days. 3/16/20 6/22/20 10/26/20 12/28/20 3. Review of CMS 209 signed by the laboratory director revealed the pathologist is the same as the TP. 4. Random review of patient reports from 3/16/20 to 12/28/20 revealed 8 patient were performed on the above dates with no documentation of the stain quality controls. 3/16/20 Patient case# 103 3/16/20 Patient case# 104 6/22/20 Patient case# 133 6/22/20 Patient case# 134 10 /26/20 Patient case# 239 10/26/20 Patient case# 240 12/28/20 Patient case# 319 12/28 /20 Patient case# 320 5. An interview with the laboratory manager in the breakroom on 4/20/21 at 1225 confirmed the above findings. 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: Based on review of the laboratory's policies in procedure manual, and an interview revealed the laboratory quality assessment policy failed to monitor, assess, and correct problems in analytical systems. Refer to D5401 and D5601 -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 review of the laboratory records from 2017 and 2018 and confirmed in an interview, the laboratory failed to document at least twice annually the accuracy of 2 of 2 tests in 2017 and 1 of 2 tests in 2018. a) Mohs b) grossing Findings were: a) Mohs 1. A review of laboratory testing records from 2017 and 2018 revealed no documentation of the laboratory verifying the accuracy for the Mohs test for 2017. b) grossing 2. A review of laboratory testing records from 2017 revealed no documentation of the laboratory verifying the accuracy for grossing in 2017. A review of laboratory testing records from 2018 revealed 1 of 2 documentation of the laboratory verifying the accuracy for grossing for 2018. No documentation was provided for the 2nd annual accuracy assessment for 2018. 3. An interview with the manager on 5/23/19 at 1115 hours in the break room confirmed the above findings. D5785