Whalen Dermatology Of Pittsburgh

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 policy and record reviews, lack of documentation and interview with the Laboratory Director (LD), the laboratory failed to monitor and document temperatures to ensure proper storage of mycosel agar plates and accurate and reliable test reporting of mycology examinations for 22 of 52 weeks in 2024 and 14 of 24 weeks in 2025. Findings include: 1, The laboratory's Procedure for Fungal/Dermatophyte collection states: " Clinical Consultant will gently press patient sample(skin scrapings) on to the mycosel agar plate. Incubate at room temperature (59-86F). Incubate for minimum of 2 weeks." 2. On the day of survey, 06/23/25 at 1:30 pm, review of the laboratory's temperature logs revealed the laboratory failed to monitor and document the following temperatures to ensure proper storage of mycosel agar plates and accurate and relaiable test reporting of mycology examinations in 2024 and 2025: - Room temperature (laboratory's acceptable range 59 to degrees Fahrenheit): 22 of 52 weeks in 2024 and 14 of 52 weeks in 2025 - Refrigerator temperature (laboratory's acceptable range 36-46 degrees Fahrenheit) : 22 of 52 weeks in 2024 3. The hours of laboratory testing are Monday-Thursday 08:00 am to 04:30 pm and Friday 08:00 am to 12:30 pm (CMS 116). The laboratory could not provide documentation of temperatures taken on days the laboratory was closed. 4. The laboratory performed 60 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 -- mycology examinations in 2024 (CMS 116 estimated annual volume). 5. The LD confirmed the above findings on 06/23/25 at 2:30 pm. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Control (QC) log, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to document a positive and negative control each day of patient testing for Scabies (Parasitology) examinations performed for 2 of 2 years from 7/12/2023 to the day of the survey. Findings include: 1. On day of survey, 06/23/2025 at 01:25 pm, the laboratory failed to provide documentation of a positive and negative control each day of patient testing for Scabies examinations performed for 2 of 2 years from 7/12/2023 to 6/23/2025. 2. The laboratory performed 60 parasitology examinations in 2024 (CMS 116 estimated annual volume). 3. The LD confirmed the above findings on 06/23/25 02:25 pm. -- 2 of 2 --

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 a lack of competency procedure and interview with the Medical Assistant (MA), the laboratory failed to establish a competency procedure to assess 4 of 4 Testing Personnel (TP) who performed testing in Mycology and Parasitology from 7 /27/2021 to the day of the survey. Findings Include: 1. On the day of the survey, 07/12 /2023 at 11:52 AM, the laboratory could not provide a competency assessment procedure to assess competency for 4 of 4 TP (CMS 209 Personnel #1, #2, #3, #4) who performed fungal and scabies examinations from 2021 to 2023. 2. The laboratory failed to provide any fungal and scabies competency assessment record for TP#1, TP#2, TP#3, and TP#4 (CMS 209). 3. MA confirmed the findings above on 07/11 /2023 around 12:54 PM. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. 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 -- This STANDARD is not met as evidenced by: Based on a lack of Quality Control (QC) log and interview with the Medical Assistant (MA), the Laboratory Director (LD) failed to establish and maintain QC for Scabies testing in Parasitology from 07/15/2021 to the day of the inspection. Findings include: 1. On the day of the survey, 07/12/2023 at 12:24 PM, the laboratory failed to provide QC procedure for the scabies testing in Parasitology. 2. The laboratory failed to provide QC documentation for scabies testing from 2021 to the day of the survey. 3. MA confirmed the above findings on 07/12/2023 at 12:54 PM. -- 2 of 2 --

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 review of laboratory procedures and interview with the medical assistant, the laboratory failed to establish a competency assessment procedure to assess the competency of 4 of 4 testing personnel (TP) performing dermatophyte test medium (DTM) screening, Potassium hydroxide (KOH) microscopic examinations and scabies microscopic examination from 2019 to the day of survey. Findings include: 1. On the day of survey, 07/15/2021, the laboratory could not provide a competency assessment procedure to assess the competency of 4 of 4 TP performing DTM screenings, KOH microscopic examinations and scabies microscopic examination from 07/15/2019 to 07 /15/2021. 2. Review of records revealed in 2019 and 2020 competency assessment for 4 of 4 TP were not performed. 3. Review of 2021 Competency assessment records for KOH and scabies microscopic examinations performed for 4 of 4 TP revealed, competencies were not assess for each test separately. 4. The medical assistant confirmed the findings above on 07/15/2021 around 12:45 pm. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: 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 -- Based on review of laboratory records and interview with the medical assistant, the laboratory failed to document test requisitions for potassium hydroxide (KOH) and scabies microscopic examinations from 2019 to the day of survey. Findings include: 1. On the day of survey, 07/15/2021, the laboratory could not to provide test requisitions for KOH and scabies microscopic examinations performed from 07/15 /2019 to 07/15/2021. 2. The medical assistant confirmed on 07/15/2021 around 1:15 pm, that verbal orders were made for KOH and scabies microscopic examinations, but they were not documented. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records and interview with the medical assistant, the laboratory failed to check and document each batch or shipment of the Hardy Diagnostics Mycobiotic agar for its ability to support growth, select or inhibit specific organisms (end user QC) from 2019 to the date of survey. Findings Include: 1. On the day of survey, 07/15/2021 review of QC records revealed, the laboratory did not perform end user QC on the Hardy Diagnostics Mycobiotic agar used for dermatophyte test medium screening from 07/15/2019 to 07/15/2021. 2. The dermatophye screening policy did not mention specific media QC procedures. 2. The medical assistant confirmed the findings above on 07/15/2021 around 1:00 pm. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the quality assurance (QA) policy and interview with the medical assistant, the laboratory director failed to ensure quality assessment (QA) programs were assessed and maintained bi annually to assure the quality of laboratory services provided in 2020 and 2021. Findings Include: 1. The Quality Assurance policy states, Procedure: Quality control. #6. "A quality assessment will be done bi-annually by the laboratory director. 2. On the date of survey, 07/15/2021, the laboratory could not provide QA activities performed bi annually in 2020 and 2021. 3. The medical assistant confirmed the findings above on 07/15/2021 around 12:50 pm. -- 2 of 2 --