St Luke's Clinic - Dermatology Wood River

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on a review of laboratory records and an interview with the laboratory lead on 1 /27/2022 the laboratory failed to verify the accuracy of potassium hydroxide (KOH) testing for 2021. The findings include: 1. A review of the laboratory records identified that the laboratory failed to verify the accuracy for KOH testing at least biannually for 2021. 2. An interview with the laboratory lead on 1/27/2022 at 12:01 pm confirmed that the laboratory failed to verify the accuracy of KOH testing for 2021. 3. The laboratory reports performing 60 KOH tests annually. 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 a review of competency assessments, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with the laboratory lead on 1/27/2022, the laboratory failed to establish and follow written policies and procedures to assess testing personnel in accordance with 42 C.F.R. 493.1451(b)(7)(8) for 2021. The findings include: 1. A review of competency assessment records 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 -- identified one (1) of two (2) testing personnel listed on the CMS 209 failed to have documentation of annual competency for mapping and tissue grossing which included the six parameters as listed in 493.1451(b)(8) for 2021. 2. A review of competency assessment records identified two (2) of two(2) testing personnel listed on the CMS 209 failed to have documentation of annual competency for KOH testing which included the six parameters as listed in 493.1451(b)(8) for 2021. 3. An interview with the laboratory lead on 1/27/2022 at 11:58 confirmed the above findings. 4. The laboratory reports performing 573 KOH and histopathology tests annually. 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 record review of laboratory logs, cryostat manual and an interview with the laboratory lead on 1/27/2022, the laboratory failed to document humidity and room temperature as required for operation of the Avantik cryostats while performing Mohs procedures. The findings include: 1. A review of the manual for the Avantik cryostats identified that the operational humidity is less than or equal to 60% and the operating temperature is 5-35 C. 2. A review of the laboratories logs identified that the laboratory failed to document humidity and room temperature for 2021. 3. An interview with the laboratory lead confirmed that the laboratory fail to document humidity room temperature. 4. The laboratory reports performing 513 Mohs procedures annually. -- 2 of 2 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a random review of Mohs patient slides and interview with the laboratory histotechnician on 11/17/2020, the laboratory failed to follow written policies and procedures for specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. The findings include: 1. Based on a random review of Mohs patient slides from April 2018 through June 2020, patient A from 1/3 /2019 on the Mohs log, with case number 19-005 had four (4) slides listed in the log. The histotechnician pulled the slides for case number 19-005 and slide number four was labeled with case number 19-005, 1/3/2019, stage I, 1-4 and patient B's name. Patient B was on the line below patient A in the Mohs log and listed as case number 19-006. 2. The histotechnician then pulled the Mohs slides for patient B, case number 19-006. The Mohs log showed that patient B, case number 19-006, had eight (8) slides, the histotechnician was only able to retrieve seven (7) slides with patient B's name and case number 19-006 from 1/3/2019 . 3. An interview with the histotechnician on 11/17/2020 at 12:30 pm, confirmed that these were the only slides for patients A and B for 1/03/2019 case numbers 19-005 and 19-006 respectively. 4. There were three (3) Mohs procedures performed on 1/3/2019 and the laboratory reports performing 100 Mohs procedures annually. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation and an interview with the laboratory director on 11/17 /2020, the laboratory failed to discontinue use of reagents, solutions, culture media, control materials, calibration materials, and other supplies that have exceeded their expiration date, have deteriorated, or are of substandard quality. The findings include: 1. The laboratory has two microscopes for potassium hydroxide (KOH) testing and at each microscope one bottle of testing reagent, 10% potassium hydroxide, is stored. Based on direct observation, both locations had a bottle of 10% potassium hydroxide with lot number 451533 that expired on 8/21/2020. 2. An interview with the laboratory director on 11/17/2020 at 12:40 pm confirmed that the expired 10% potassium hydroxide was being used for patient testing. 3. The laboratory reports performing 50 KOH tests annually. D5603 HISTOPATHOLOGY CFR(s): 493.1273(b)(f) (b) The laboratory must retain stained slides, specimen blocks, and tissue remnants as specified in 493.1105. The remnants of tissue specimens must be maintained in a manner that ensures proper preservation of the tissue specimens until the portions submitted for microscopic examination have been examined and a diagnosis made by an individual qualified under 493.1449(b), (l), or (m). (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a random review of Mohs patient slides and interview with the laboratory histotechnician on 11/17/2020, the laboratory failed to retain stained slides, specimen blocks, and tissue remnants as specified in 493.1105. The remnants of tissue specimens must be maintained in a manner that ensures proper preservation of the tissue specimens until the portions submitted for microscopic examination have been examined and a diagnosis made by an individual qualified under 493.1449(b), (l), or (m). The findings include: 1. The histotechnician pulled slides for patient B, case number 19-006, listed in the Mohs log on 1/3/2019. The log listed that there were eight (8) slides for case 19-006. The histotechnician was only able to retrieve seven (7) slides for this case number. See D5311 2. An interview with the histotechnician on 11/17/2020 at 12:30 pm, confirmed that these, seven (7) slides, were the only slides for case 19-006, patient B on 1/3/2019. 3. There were three (3) Mohs procedures performed on 1/3/19 and the laboratory reports performing 100 Mohs procedures annually. -- 2 of 2 --

Summary Statement of Deficiencies 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 an interview with the laboratory histotechnician and a record review, the laboratory failed to verify the accuracy of potassium hydroxide (KOH) at least twice annually since the last survey on May 18, 2016. Findings: 1. A record review revealed the laboratory failed to document the accuracy of KOH, used for the detection of fungal elements on the skin, at least semiannually since the last survey on May 18, 2016. 2. An interview on March 20, 2018 at 11:00 AM, with the laboratory histotechnician, confirmed the laboratory failed to document the accuracy of KOH at least semiannually. 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 an interview with the laboratory histotechnician and a procedure manual review, the laboratory director failed to approve, sign, and date the MOHS procedure manual since the last survey on May 18, 2016. Findings: 1. A review of the procedure manual for the laboratory revealed it failed to include the laboratory director's 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 -- signature and date it was approved. 2. An interview on March 20, 2018 at 10:30 AM, with the laboratory histotechnician, confirmed the laboratory director failed to sign and date the procedure manual. 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 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 an interview with the laboratory histotechnician and patient report reviews, the testing personnel failed to include the result of a potassium hydroxide (KOH) test in the patient's electronic medical record on July 27, 2017. Findings: 1. A review of patient KOH test reports revealed 1 out of 3 patient reports failed to include the result of the KOH test in the patient's electronic medical record. 2. An interview on March 20, 2018 at 11:30 AM, with the laboratory histotechnician, confirmed the testing personnel failed to include the negative KOH test result in the patient's electronic medical record performed on July 27, 2017. -- 2 of 2 --