Pennsylvania Dermatology Partners - Douglassville

Summary Statement of Deficiencies D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of competency assessment records and interview with the Director of Lab Services (DLS) and the Laboratory Manager (LM), the Techinical Supervisor (TS) failed to assess the competency for 1 of 5 testing personnel (TP) ( CMS 209 personnel # 4) through external proficiency testing samples or internal blind testing samples for histopathology macroscopic examinations performed in 2022. Findings include: 1. On the day of the survey 06/04/2024 at 11:28 am, review of Laboratory Personnel Competency Assessment Tracking form revealed the TS did not include assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples for 1 of 5 TP (CMS 209 personnel #4) who performed gross examinations and specimen inking of frozen sections in histopathology in 2022. 2. DLS and LM confirmed the above findings on 06/04/2024 around 11:28 am. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. 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 documentation and interview with the Director of Lab Services (DLS) and the Laboratory Manager (LM), the Techinical Supervisor (TS) failed to evaluate the annual competency assessment for 2 of 5 Testing Personnel (TP) who performed macroscopic and microscopic examinations in histopathology laboratory in 2023. Findings include: 1. On the day of survey, 06/04/2024 at 11:30 am, the laboratory could not provide competency assessment records for 2 of 5 TP (CMS 209 TP #2 and #4) for their testing responsibilities of macroscopic and microscopic examinations performed in histopathology laboratory in 2023. 2. The DLS and LM confirmed the findings above on 06/04/2024 at 11:30 am. -- 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 lack of peer review records and interview with the Center Manager (CM), the laboratory failed to verify twice annually the accuracy of Moh's micrographic examination for 1 of 2 verifications in 2021. Findings Include: 1. On the day of survey, 09/14/2022 at 11:32 AM, a review of the laboratory's peer review policy revealed that verification of Moh's microscopic examination is required twice a year. 2. A review of peer review records revealed, the laboratory performed Moh's microscopic examination in 2021. The verification of Moh's microscopic examination was performed once, not twice as required. 3. The CM confirmed the findings above on 09/14/2022 at 12:48 PM. 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 microtome analyzers during the laboratory tour, lack of documents, and interview with the Laboratory Manager (LM), the laboratory failed to provide documentation for Annual maintenance on 1 of 1 Micron HM 310 microtome analyzer from 8/2020 to 9/2022. Findings include: 1. On the day of survey, 09/14 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 -- /2022 at 12:28 PM, a laboratory tour revealed that the laboratory failed to perform yearly maintenance on 1 of 1 Micron SM 310 analyzer from 2021 to the day of the survey. 2. The maintenance sticker observed at the time of survey on the analyzer indicated that the last maintenance was performed on 8/2020 and was due on 8/2021. 3. The LM confirmed the above findings on 09/14/2022 at 1:48 PM. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on lack of Immunohistochemistry staining negative quality control (QC) records and interview with the Laboratory Manager (LM), the laboratory failed to perform negative reactivity check for the Histopathology slides examined from 2021 through 2022. Findings include: 1. On the day of survey 09/14/2022 at 11:48 AM, a review of the laboratory's Immunohistochemistry procedure revealed that only positive control slides are required with each test slide. 2. The laboratory could not provide negative reactivity check readings for the Immunohistochemical stain slides from 2120 through the date of survey. 3. The LM confirmed the findings above on 09 /14/2022 at 12:48 PM. -- 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 review of peer review records, and interview with testing personnel (TP) #2, the Laboratory failed to perform twice annual verification of accuracy for mohs and dermatopathology examinations analyzed in 2019. Findings Include: 1. On the day of survey, 08/07/2020, TP #2 could not provide twice annual verification performed for mohs and dermatopathology examination analyzed in 2019. 2. TP#2 confirmed the findings above on 08/07/2020 around 09:10 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 observation of the laboratories and interview with Testing personnel (TP) #2, the laboratory failed to label tissue Marking dyes with open and expiration dates. Findings include: 1. On the date of survey 08/07/2020, observation of the Dermatology and Mohs laboratories revealed, the following Azed Scientific Tissue Marking Dyes did not have an open and expiration dates on the bottles: 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 5 -- Dermatology Laboratory: -1 of 1 bottle of Orange Azed Scientific Tissue Marking Dye. - 1 of 1 bottle of Violet Azed Scientific Tissue Marking Dye. b. Mohs Laboratory: -1 of 1 bottle of Orange Azed Scientific Tissue Marking Dye. - 1 of 1 bottle of Violet Azed Scientific Tissue Marking Dye. 2. Testing personnel #2 confirmed the findings above on 08/07/2020 around 10:20 AM. *** Repeat Deficiency*** 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 of the laboratories and interview with testing personnel (TP) #2, the laboratory failed to ensure expired reagents were not used beyond the expiration dates. Findings include: 1. On the date of survey 08/07/2020, observation of the Mohs laboratory revealed, the following Azed Scientific Tissue Marking Dyes had expired: - 1 of 1 bottle of Green Azed Scientific Tissue Marking Dye, expired 10/2019. - 1 of 1 bottle of Blue Azed Scientific Tissue Marking Dye, expired 10/2019. - 1 of 1 bottle of Black Azed Scientific Tissue Marking Dye, expired 10/2019. - 1 of 1 bottle of Yellow Azed Scientific Tissue Marking Dye, expired 04/2019. - 1 of 1 bottle of Red Azed Scientific Tissue Marking Dye, expired 10/2019. 2. Testing personnel #2 confirmed the findings above on 08/07/2020 around 10:20 AM. *** Repeat Deficiency*** D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of slide staining records and interview with testing personnel (TP) #2, the laboratory failed to document Immunohistochemical (IHC) slide stain QC performed on dermatopathology and mohs examinations in house from 01/18/2020 to 08/07/2020. Findings include: 1. On the day of survey, 08/07/2020, review of the dermatopathology and mohs examinations staining records revealed, the IHC stain QC were not performed and documented by the reading physician onsite (TP#1). 2. TP#2 confirmed the findings above on 08/07/2020 around 9:00 am. 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on review of laboratory quality assessment records and interview with testing personnel (TP) #2, the Laboratory Director failed to ensure quality assessment programs were maintained and documented to assure the quality of the dermatopathology and mohs laboratory services provided from January, 2018 to June, 2020. Findings include: 1. The CMS 2567

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 laboratory procedures manuals, interview with Histology Technologist (HT) and Mohs Technician (MT), the laboratory failed to have the current director's signature for the procedures currently in use. Findings include: 1. On the date of survey (01/18/2018), The first page of the Policies and Procedures manuals reviewed, stated, the Laboratory Director will review the manual yearly. 2. The laboratory director last reviewed the Dermatology procedure on 05/06 /2016 and the Mohs procedure manual on 05/16/2014. 3. The HT and MT confirmed the finding above on 01/18/2018 around 09:30 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 laboratory tour and interview with the Histology Technologist (HT) and Mohs Technician (MT), the laboratory failed to label Tissue Marking dyes with open and expiration dates. Findings Include: 1. On the date of survey 01/18/2018, 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 4 -- Dermatology and Mohs laboratory tours revealed the following Azed Scientific Tissue Marking Dyes did not have an open and expiration dates on the bottles: a. Dermatology Laboratory: 1 of 1 bottle of Orange Azed Scientific Tissue Marking Dye b. Mohs Laboratory: 1 of 1 bottle of Green Azed Scientific Tissue Marking Dye 1 of 1 bottle of Red Azed Scientific Tissue Marking Dye 1 of 1 bottle of Yellow Azed Scientific Tissue Marking Dye 1 of 1 bottle of Violet Azed Scientific Tissue Marking Dye 1 of 1 bottle of Orange Azed Scientific Tissue Marking Dye 1 of 1 bottle of Blick Black Water Proof India Ink 2. In 2016: 42,000 specimen were prepared. 3. The HT and MT confirmed the findings above on 01/18/2018 around 10:45 AM. 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 laboratory tour and interview with the Histology Technologist (HT) and Mohs Technician (MT), the laboratory failed to ensure expired reagents were not used beyond the expiration dates. Findings Include: 1. On the date of survey 01/18/2018, the Dermatology and Mohs laboratory tours revealed that the following Azed Scientific Tissue Marking Dyes: were expired: 1 of 1 bottle of Red Dye: Lot# 33852 Expiration: 09/2016 1 of 1 bottle of Violet Dye: Lot# 01306 Expiration: 12/2016 1 of 1 bottle of Yellow Dye: Lot# 26486 Expiration: 12/2015 1 of 1 bottle of Green Dye: Lot# 013016 Expiration: 12/2016 2. In 2016: 42,000 specimen were prepared. 3. The HT and MT confirmed the findings above on 01/18/2018 around 10:45 AM. 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, the review of laboratory records and interview with Histology Technologist (HT), the Laboratory Director failed to ensure that the quality assessment programs are maintained and documented to assure the quality of Dermatology laboratory services provided from 2016 to 01/2018. Findings Include: 1) On the day of survey (01 /18/2018), review of quality assessment policy revealed that the laboratory's quality assessment of the pre-analytic, analytic and post analytic phases were not documented for the Dermatology laboratory from 2016 to January 2018. 2) The HT confirmed the findings above on 01/18/2018 around 11:30 AM. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on review of competency assessment record and interview with the Histology Technologist (HT), the Technical Supervisor failed to evaluate and document the performance of the testing personnel #3 (TP#3) responsible for grossing and inking of dermatology specimen at least semi-annually during the first year. Findings include: 1. On the date of survey (01/18/2018), the laboratory was unable to produce documentation for testing personnel #3 semi-annual competency assessment during their first year (Started date of 01/07/2017). 2. The only competency assessment record for TP#3 available at the time of inspection, was performed on 12/12/2017. 2. The HT confirmed the findings above on 1/18/2018 around 9:45 AM. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on review of the CLIA ' s Laboratory Personnel Report (Form CMS-209), review of personnel qualification records, and interview with the Histology Technologist (HT) the laboratory failed to ensure that each individual performing High Complexity testing is qualified. Refer to D6171 D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training -- 3 of 4 -- program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of the CLIA ' s Laboratory Personnel Report (Form CMS-209), review of personnel qualification records, and interview with the Histology Technologist (HT) the laboratory failed to ensure that each individual performing High Complexity testing is qualified. Findings include: 1. The CMS 209 form signed by the Laboratory Director (01/17/2018), lists Individual #2 and #3 as a Testing Personnel (TP). 2. On the date of the survey (01/18/2018) the HT failed to provide the educational credential for TP#2 and #3, which are 2 of 6 TP in the laboratory. 3. The HT confirmed the finding above on 01/18/2018 around 11:00 AM. -- 4 of 4 --