Warren Skin Care Center, Pa

Summary Statement of Deficiencies D3007 FACILITIES CFR(s): 493.1101(b) (b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of temperature records, and interview with the histotechnician, the laboratory failed to ensure that 1 of 1 thermometer /hygrometer used to monitor operating conditions when histopathology examinations were performed from 07/11/2025 to 08/01/2025 was accessible during the time of the survey. Findings include: 1. On the day of survey 08/01/2025 at 10:26 am, while touring the laboratory, the surveyor discovered the 1 of 1 thermometer/hygrometer used to monitor operating conditions when histopathology examinations were performed from 07/11/2025 to 08/01/2025 was not accessible in the laboratory during the time of the survey. 2. The laboratory failed to produce the thermometer /hygrometer used to monitor the room temperature and humidity of the laboratory when requested by the surveyor on the day of the survey. 3. During an interview with the histotechnician on 08/01/2025 at 10:55 am, the histotechnician confirmed the findings above and stated, "the laboratory moved to the new location on 07/11/2025 and monitored the room temperature and humidity using a portable thermometer /hygrometer that was not onsite during the inspection." D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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. 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 observation of the laboratory and interview with the histotechnician, the laboratory failed to ensure that 1 of 3 reagents used to perform hematoxylin and eosin (H&E) staining for microscopic histopathology slide examinations was not used beyond the expiration date from 07/28/2024 to date of survey. Findings include: 1. On the day of survey 08/01/2025 at 10:26 am while touring the laboratory, the surveyor discovered the following 1 of 3 expired reagents used to perform H&E staining for microscopic histopathology slide examinations from 07/28/2024 to 08/01/2025: - 1 opened bottle of Mercedes Scientific Hematoxylin Stain Solution, Gill III (Lot #2219919 expired 07/28/2024) 2. The laboratory performed 109 histopathology examinations in 2024 (CMS 116, estimated annual volume, dated 07/26/2025). 3. The histotechnician confirmed the findings above on 08/01/2025 at 10:55 am. -- 2 of 2 --

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of patient mohs microscopic examination maps and interview with the histotechnician, the laboratory failed to ensure each test requisition (mohs maps) solicits the address of the laboratory from August 2021 to the day of survey. Findings include: 1. The Mohs Maps list the following addresses: - 755 Memorial Parkway #204, Philipsburg, NJ 08865. - 2209 Lehigh Street, Easton, PA 18042. 2. On the day of survey, 11/10/2021, review of a sampling of Mohs maps (2 of 2) revealed, the laboratory mohs maps did not include the address of the laboratory where samples were collected (755 Schoenersville Road, Bethlehem, PA 18017). 3. During an interview on 111/10/2021 around 9:10 am, the histotechnician confirmed all mohs maps have not been updated to include the address of the laboratory at 755 Schoenersville Road, Bethlehem, PA 18017. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 review of the laboratory procedure and interview with the histotechnician, the laboratory failed to have their laboratory procedure signed and dated by the current laboratory director (LD) from August 2021 to the day of survey. Findings include: 1. On the day of survey, 11/10/2021, a review of the laboratory procedure sheets revealed, the Mohs laboratory procedure in use was not signed and dated by the LD for the new laboratory location. 2. The histotechnician confirmed the finding above on 11/10/2021 around 8:35 am. 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 the review of a sampling of patient test reports and interview with the histotechnician, the laboratory failed to include on their test reports the exact location where mohs microscopic examinations were analyzed from August 2021 to the day of survey. Finding Include: 1. The Mohs final reports list the following addresses: - 755 Memorial Parkway #204, Philipsburg, NJ 08865. - 2209 Lehigh Street, Easton, PA 18042. - 755 Schoenersville Road, Bethlehem, PA 18017. 2. On the day of survey, 11 /10/2021, a review of a sampling of test reports (2 of 2) revealed, the mohs microscopic examination test reports did not state which one of the three laboratory addresses tests were reported from August 4, 2021 to November 10, 2021. 3. During the interview on 11/10/2021 around 8:45 am, the histotechnician confirmed neither the electronic medical record system or patient test reports state, which address mohs micrographic examinations were analyzed. 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 laboratory procedure and interview with the histotechnician, -- 2 of 3 -- the laboratory director (LD) failed to ensure quality assessment (QA) programs were established to assess the quality of laboratory services provided from August 2021 to the day of survey. Findings Include: 1. On the day of survey, 10/06/2021, the laboratory could not provide a QA procedure to assess the laboratory's pre-analytic, analytic and post analytic phases of testing. 2. The laboratory could not provide documentation of periodic assessment of the laboratory from August 2021 to November 2021. 3. The histotechnician confirmed the findings above on 11/10/2021 around 9:20 am. -- 3 of 3 --