Warren Skin Care Center, Pa

Summary Statement of Deficiencies D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with the Testing Personnel (TP), the laboratory director (LD) failed to ensure Quality Assessment (QA) programs were maintained to assure the quality of laboratory services and to identify failures in quality as they occur for 21 out of 21 months from May 2023 to February 2025. Findings include: 1. The laboratory's Quality Assurance policy states: " The Laboratory Director or an appropriate, designated staff member will conduct meetings with all relevant staff every month to communicate the results of

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 tour of the laboratory, observation of reagents and interview with the histopatholoy technician, the laboratory failed to document all open and expiration dates of reagents prior to use from 03/30/2019 to 03/30/2021. Findings include: 1. On the day of survey, 03/30/2021, while on tour of the laboratory, it was discovered that the laboratory did not document the open and expiration dates of 1 of 1 bottle of Davidson Tissue Marking Dyes (Blue) Lot# 571-813270. 2. The histopathology technician confirmed the finding above on 03/30/2021 around 12:45 pm. **** Repeat Deficiency. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the histopatholoy technician, the laboratory failed to perform the maintenance for 1 of 1 Olympus EX- 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 -- 41 microscope used to examine histology slides from 09/2019 to 03/30/2021. Findings include: 1. On the day of survey, 03/30/2021, observation of the laboratory revealed, 1 of 1 Olympus EX-41 microscope, Serial # 9E0947, maintenance sticker stated, "Due 9 /2019". 2. The laboratory was unable to provide documentation of maintenance performed on the Olympus EX-41 microscope after 09/2019. 3. The histopatholoy technician confirmed the findings above on 3/30/2021 around 12:45 pm. 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 review of laboratory procedures, observation of the laboratory and interview with the histopatholoy technician, the laboratory failed to establish a maintenance policy to ensure 1 of 1 Baldr room temperature thermometer can monitor temperatures accurately from 03/30/2019 to 03/30/2021. Findings include: 1. On the day of survey, 03/30/2021, observation of the laboratory revealed, 1 of 1 Baldr room temperature thermometer was in use to monitor the temperature of the laboratory, the thermometer did not have maintenance sticker. 2. The laboratory was unable to provide documentation of the last maintenance performed on the Baldr room temperature thermometer from 03/30/2019 to 03/30/2021. 3. The laboratory was unable to provide a maintenance policy for thermometers, where function check protocols are not provided by the manufacturer. 4. The histopatholoy technician confirmed the findings above on 3/30/2021 around 12:45 pm. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with the histopathology technician, the laboratory director (LD) failed to ensure quality assessment (QA) programs were established to assure the quality of laboratory services provided from 2019 to the day of survey. Findings include: 1. On the date of survey, 03/30/2021, the laboratory could not provide a QA procedure or documentation of periodic evaluation of the laboratory assess its pre-analytical, analytical, and post-analytical processes from 03/30/2019 to 03/30/2021. 2. The histopathology technician confirmed the finding above on 03/30/2021 around 12:30 pm. -- 2 of 2 --

Summary Statement of Deficiencies 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 observation, review of 1 of 1 procedure manual and interview with the histopathology technician, the laboratory failed to have the procedure manual in use, signed by the current director. Findings include: 1. On the day of survey,10/16/2018, review 1 of 1 histopathology procedure manual revealed that the procedure was not signed by the current laboratory director. 2. The histopathtology technician confirmed the finding above on 10/16/2018 around 8:45 am. 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 tour of the laboratory, observation of reagents, solutions and interview with the histopatholoy technician, the laboratory failed to label open and expiration dates, proper to use of reagents and solutions from 2017 to the day of survey. Findings Include: 1. On the day of survey, 10/16/2018, while on tour of the laboratory, it was discovered that the laboratory did not write the open and expiration dates on all 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 -- reagents and solutions in use from 05/02/2017 to 10/16/2018. 2. While on tour, it was discovered that the following items were not labeled with expirations dates: - 2 of 2 bottles of Blue Davidson Tissue Marking Dyes. - 1 of 1 bottle of EKI (Chemical Company) Ammonium Hydroxide 28-30%, 500 ml bottle, Lot#1428823. 3. The histopathology technician confirmed the findings above on 10/16/2018 around 09:15 am. -- 2 of 2 --