Psoriasis And Eczema Treatment Center

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the Medical Assistant (MA), the laboratory failed to label one of one aliquot of mineral oil used for scabies testing with preparation and expiration dates. Findings include: 1. The surveyor observed one aliquot of mineral oil in the laboratory on 12/19/2024 at 9:15 am without preparation or expiration date indicated on the bottle. 2. A laboratory policy titled "Quality Control", Section II, Page 18, "Reagents, Materials and Supplies," states, " Reagents.... must be labeled and must not be used when they have exceeded their expiration dates...". 3. An interview conducted on 12/19/2024 at 9:26 am with the MA confirmed that the aliquot was not labeled with a preparation or expiration date. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 observation and interview with the Medical Assistant (MA), the laboratory 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 -- failed to ensure that mineral oil used in scabies testing was not expired. Findings include: 1. The surveyor observed one of one bottle of mineral oil with an expiration date of 1/2018 in the laboratory on 12/19/2024 at 9:15 am. 2. An interview conducted on 12/19/2024 at 9:26 am with the MA confirmed the mineral oil was expired. 3. A laboratory policy titled "Quality Control", Section II, Page 18, "Reagents, Materials and Supplies," states, " Reagents....must be labeled and must not be used when they have exceeded their expiration dates...". -- 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 record review and interview with the laboratory liaison (LL), the laboratory failed to verify the accuracy of the potassium hydroxide (KOH) and scabies preparation testing for 1 (2022) of 1 and a half years reviewed. Findings include: 1. A review of the laboratory's "CLIA Manual" revealed a lack of documentation of the twice annual verification of accuracy testing for KOH and scabies preparations for 2022. 2. An interview on 11/22/2022 at 10:07 am, the LL confirmed the laboratory did not perform and documentation twice annual verification of accuracy testing for KOH and scabies preparations for 2022. ***Repeat deficiency from 4/12/2021 survey *** Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 record review and interview with the Office Manager, the laboratory failed to evaluate testing personnel competency in 2020 for 3 (Testing Personnel 1-3) of 3 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's "Personnel Competency Policy and Procedure" revealed a section stating, "All testing personnel must be reviewed for their ability to perform testing correctly and accurately. Testing personnel will be reviewed prior to testing patients' specimens to ensure that all personnel have the appropriate education and experience, have received that appropriate training for the type and complexity of services offered, and have demonstrated that they can perform all testing operations reliably, and can provide and report accurate results. Testing personnel must be reviewed every six months during the first year of testing and annually thereafter." 2. A review of the laboratory's competency records revealed a lack of a documented competency assessment for the following testing personnel in 2020: a. Testing Personnel #1 performing microscopic tissue examinations and scabies preparations. b. Testing Personnel #2 performing Potassium Hydroxide (KOH) preparations. c. Testing Personnel #3, hired 2/3/20, semiannual competency for the performance of KOH preparations. 3. An interview on 4/12/21 at 1:42 pm with the Office Manager confirmed the above findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) 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 -- 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 record review and interview with the Office Manager, the laboratory failed to verify the accuracy of its Potassium Hydroxide (KOH) preparations, Scabies preparations, and microscopic tissue examinations at least twice annually for 1 (2020) of 2 years reviewed. Findings include: 1. A review of the laboratory's records revealed a lack of documentation of two verification of accuracy testing events performed for the following tests in 2020: a. KOH preparations, one of two events was performed. b. Scabies preparations, no events performed. c. Microscopic tissue examinations, no events performed. 2. An interview on 4/12/21 at 1:42 pm with the Office Manager confirmed the laboratory did not verify the accuracy of its testing twice annually for the tests listed above. 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 record review and interview with the Office Manager, the laboratory failed to ensure positive patient identification on test reports for 1 (Patient ME9) of 9 patient test records reviewed. Findings include: 1. A review of patient test records revealed Patient ME9 had a Potassium Hydroxide (KOH) preparation performed on 3/19/20. The test report did not include an identification number or a date of birth for positive patient identification. 2. An interview on 4/12/21 at 2:00 pm with the Office Manager confirmed the test report did not include an identification number or a date of birth for positive patient identification. ***This is a repeated deficiency from the 5/9/19 recertification survey*** -- 2 of 2 --

Summary Statement of Deficiencies 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 lack of documentation and interview with a staff member, the laboratory failed to monitor and document the room temperature and humidity in the microscope room for 2 (May 2017 to May 2019) of 2 years. Findings include: 1. A review of the Optech Microscope Operator's Manual revealed the environment temperature range for operation is between 5 and 40 degrees C and the relative humidity range is less than 80%. 2. An interview with a staff member on 5/9/19 at 9:39 am confirmed room temperature and humidity readings had not been performed and documented for the microscope room. 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 2 -- 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 patient chart audit and an interview with a staff member, the laboratory failed to document the date reported on 2 (#1 and #2) of 23 test reports reviewed. Findings include: 1. A chart audit of 23 patients revealed 2 patients were missing the date the tests were reported on the final report. 2. An interview with a staff member on 5/9/19 at 11:30 am confirmed the dates were absent. -- 2 of 2 --