Childrens Skin Center Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at CHILDRENS SKIN CENTER PA from 05/14/2025 to 05/15/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: -D2000 CFR 493.801 Enrollment and Testing of Samples. 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 lack of records and staff interview, the laboratory failed to enroll in a Proficiency Testing (PT) program approved by the Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) for Mycology since January 2025. Findings included: 1. Review of test menu listed on Form CMS-116 signed by Laboratory Director on 04/29/2025, revealed that the laboratory performed the Fungal Detection Test using the Hardy Dermatophyte Test Medium slant (DTM SLANT). 2. Review of Patient tests results revealed that the Laboratory tested 116 patients from 01/10/2025 to 05/13/2025. 3. No PT records found for 2025. 4. During an interview on 05/14/2025 at 12:30 PM, the office manager confirmed that the facility failed to enroll in PT since January 2025, she explained that the laboratory was not aware of the change of the DTM test to a Regulated test and that the laboratory must enroll in PT. 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 D0000 A recertification survey conducted on 4/7/2023 found the CHILDRENS SKIN CENTER PA clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 observation, records review, and interview, the laboratory failed to document the monitoring of the fridge temperature. The laboratory was required to store its test media and cultures at 2-8 C to maintain their viability, but there was no temperature monitoring documentation for the fridge temperatures over the past two years. The findings include: 1. On 4/07/23, the surveyor observed the refrigerator 2-8 C storage requirement for i) Remel Dermatube Dermatophyte Test Media, Ref # R241045, lot # 602249, ii) Thermo Scientific Culti-Loops Trichophyton interdigitale, Ref # R4608300, lot # 584250, and iii) Thermo Scientific Culti-Loops Escherichia coli, Ref # R4607050, lot # 613448. 2. A record review on 4/7/23 discovered that the testing person had not been keeping a log to document the monitoring of the refrigerator temperature during the last two years. 3. In an interview on 4/7/23 at 1pm, the testing person stated that they had not been documenting the daily monitoring of the fridge temperature over the past two years. 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 D0000 A recertification survey completed on 06/15/2021 found that the CHILDRENS SKIN CENTER PA clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 Laboratory Director (LD) interview, the laboratory failed to do competency evaluation for 3 out of 7 testing personnel (TP) in 2020. Findings include: -Review of CMS 209 Laboratory Personnel Report dated and signed by the LD on 06/7/2021 revealed that there were 7 TP (A, B, C, D, E, F and G). -Review of personnel records revealed that the laboratory failed to have documentation of competency assessment for TP (A, B and C) in 2020. During an interview on 06/15 /2021 at 12:30 pm, with LD, she confirmed that the laboratory failed to have competency assessment for the TP of reference in 2020. 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 staff interview, the laboratory failed to perform twice a 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 -- year accuracy verification of fungal cultures in 1 out of 2 years reviewed (2019-2020) Findings include: -Quality Assurance records review revealed that the laboratory performs the accuracy verification using peer review. Peer review records revealed that the laboratory performed one verification in June 2019, no records found of a second peer review in 2019 During an interview on 06/15/21 at 12:30 p.m., the laboratory director stated that they performed the 2 evaluations in 2019 but confirmed that the laboratory had no documentation on site during the survey to proof that they perfomed the twice a year accuracy verification for the fungal culture in 2019. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 8/22/2019 found that the Childrens Skin Center PA clinical laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of