Abington Surgical Center

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 lack of documentation and interview with Laboratory Director (LD), the laboratory failed to establish a written policy to evaluate the competency of 5 of 5 Testing Personnel (TP) that performed microscopic examinations of frozen tissue sections using Hematoxylin and Eosin (H&E) stains from 11/02/2021 to the date of survey. Findings include: 1. On the day of survey 10/12/2023 at 10:00am, the laboratory could not provide a written policy to evaluate the competency of 5 of 5 TP that performed microscopic examinations of frozen tissue sections using H&E stains from 11/02/2021 to the date of survey. 2. LD confirmed the above findings on 10/12 /2023 at 11:10 am. 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 the laboratory procedure manual and interview with Laboratory Director (LD), the laboratory failed to establish a procedure for the verification of accuracy of microscopic examinations of frozen tissue sections using Hematoxylin and Eosin (H&E) stains performed from 11/02/2021 to the date of survey. Findings 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 -- include: 1. On the day of survey, 10/12/2023, the LD could not provide a procedure manual for the verification of accuracy of the microscopic examinations of frozen tissue sections using H&E stains performed from 11/02/2021 to the day of survey. 2. The laboratory reported an annual volume of 6 in Histopathology (CMS 116). 3. The LD confirmed the above findings on 10/12/2023 at 11:10am. 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 Laboratory Director (LD), the laboratory failed to perform and document maintenance on 1 of 1 Precision microscope from November of 2022 to date of survey. Findings include: 1. During the survey on 10/12/2023 at 10:37am the surveyor observed a sticker indicating a maintenance date of May 2022 and a due date of November 2022 for the Olympus BH-2 Precision microscope. 2. The laboratory could not provide records of maintenance performed on the Olympus BH-2 Precision microscope after May 2022. 3. Interview with LD on 10/12/2023 at 11:10am confirmed that no maintenance was performed since May 2022. 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 surveyor review of the Laboratory's Quality Assurance (QA) Program policy and interview with the Laboratory Director (LD), the LD failed to establish and maintain a QA program to ensure the quality of services provided by the laboratory from 11/02/2021 to date of survey. Findings include: 1. On the day of survey 10/12 /2023 at 10:33 am, the laboratory could not provide documentation of the periodic QA activities to assess the laboratory's pre-analytical, analytical and post-analytical processes from 11/02/2021 to date of survey. 2. The LD confirmed the above findings on 10/12/2023 at 11:10 am. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether -- 2 of 3 -- supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with Laboratory Director (LD), the LD failed to specify in writing the responsibilities and duties of 5 individual laboratory positions involved in patient testing from 11/02/2021 to date of survey. Findings include: 1. At the time of survey on 10/12/2023 at 9:49 am, review of the laboratory procedure manual revealed the manual did not include the job responsibilities for the following: - Laboratory Director (LD) - Clinical Consultant (CC) - Technical Supervisor (TS) - General Supervisor (GS) - Testing Personnel (TP) 2. LD confirmed the above findings on 10/12/2023 at 11:10am. 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. This STANDARD is not met as evidenced by: Based on a review of Laboratory Personnel Report (CLIA) CMS-209, Competency Assessment records and interview with Laboratory Director (LD), the Technical Supervisor (TS) failed to evaluate and document the semiannual competency for 1 of 5 Testing Personnel (TP) who performed microscopic examinations of frozen tissue sections using Hematoxylin and Eosin (H&E) stains in 2023. Findings include: 1. On the day of survey 10/12/2023 at 10:07 am, a review of Competency Assessment records and interview with LD revealed TP #4(CMS-209 personnel number 5) began performing microscopic examinations of frozen tissue sections using H&E stains in September of 2022. 2. At the time of survey, the laboratory could not provide documentation of the 2023 semiannual competency assessment for TP #4 upon request by the surveyor. 3. On 10/12/2023 at 11:10am LD confirmed the semiannual competency was not performed for TP #4. -- 3 of 3 --

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 the laboratory procedure manual and interview with the Laboratory Director (LD), the laboratory failed to establish a competency assessment procedure to assess the competency of 5 of 6 Clinical Consultants (CC) from 11/2 /2019 to 11/2/2021. Findings include: 1. On the day of survey 11/02/2021, the laboratory could not provide a written procedure to assess the competency of Clinical Consultants from 11/02/2019 to 11/02/2021. 2. The laboratory could not provide documentation of competency assessed for 5 of 6 CC. 3. The LD confirmed the findings above on 11/02/2021 at 9:40 a.m. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, review of peer review records, and interview with Laboratory Director (LD), the laboratory failed to include a peer review procedure for Hematoxylin and Eosin (H&E) microscopic examinations from 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 -- 11/02/2019 to the day of survey Findings Include: 1. On the day of survey, 11/02 /2021, the LD could not provide a peer review procedure manual for H&E microscopic examinations from 11/02/2019 to the day of survey. 2. The LD confirmed the finding above on 11/02/2021 at 10:13 a.m. -- 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 procedure manuals and interview with laboratory director (LD), the laboratory failed to establish a competency assessment procedure to assess the competency of 6 of 7 testing personnel (TP) who read histopathology slides and clinical consultant competency from 09/25/2017 to the date of survey. Findings include: 1. On the day of survey, 05/21/2019, the laboratory could not provide a written policy to assess the competency of TP who perform examination of histopathology slides and Clinical consultants. 2. The labortaory could not provide documentation of competency assessed for 6 of 7 TP and 6 of 7 clinical consultants in 2017, 2018 and 2019. 3. In 2017, 35 patient slides were analyzed. 4. In 2018, 34 patient slides were analyzed. 5. The LD confirmed the findings above on 05/21/2019 around 09:30 am. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of records and interview with the laboratory director (LD), the laboratory failed to define reference ranges for reagents stored at room temperature and the internal cryostat temperature from 09/25/2017 to the date of survey. Findings Include: 1. On the day of survey, 05/21/2019, a review of temperature logs sheets revealed the laboratory documented daily room temperature and cryostat temperature, but failed to document the reference ranges followed by the laboratory. 2. In 2017, 35 patient slides were analyzed. 3. In 2018, 34 patient slides were analyzed. 4. The LD confirmed the finding above on 5/21/2019 around 10:45 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 observation of reagents and interview with the laboratory director (LD), the laboratory failed to label The Davidson Marking Systems dyes (3 of 3 bottles), Royal marking dye (1 of 1 bottle), Azer Scientific Alcohol (2 of 2 bottles) and aliquots of ethyl alcohol (2 of 2 bottles) with open and expiration dates required proper to use from 2017 to the date of survey. Findings include: 1. While on tour of the laboratory (05/21/2019) it was observed that laboratory personnel did not document the open and expiration dates on the following reagent bottles prior to use: a) 1 of 1 Yellow The Davidson Marking Systems dye, Lot# 231-611330 b) 1 of 1 Blue The Davidson Marking Systems dye, Lot# (not legible) c) 1 of 1 Red The Davidson Marking Systems dye, Lot# 595621 d) 1 of 1 Black Royal Marking dye e) 2 of 2 bottles Azer Scientific Alcohol f) 2 of 2 aliquots of ethyl alcohol, made on 09/14/2015. 2. The LD could not provide a procedure describing steps taken when obtaining reagents from manufacturers that do not specify an expiration date. 3. In 2017, 35 patient slides were analyzed. 4. In 2018, 34 patient slides were analyzed. 5. The LD confirmed the findings above on 05/21/2019 around 10:00 am. 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 the laboratory's procedure manual, review of maintenance records, -- 2 of 4 -- observation of the Olympus BH-2 microscope and interview with the Laboratory Director (LD), the laboratory failed to establish a maintenance procedure and document the maintenance activities for 1 of 1 Olympus BH-2 microscope used for microscopic examination of histopathology slides from 09/25/2017 to the date of survey. Findings Include: 1. On the date of survey, 05/21/2019, the LD could not provide a maintenance policy for 1 of 1 Olympus BH-2 microscope. 2. Review of microscope maintenance records revealed, in 2018 and 2019 daily maintenance was not recorded. 3. While on tour of the laboratory, observation of the microscope revealed, the microscope was last serviced on 2011, the LD could not provide records of recent calibrations performed. 4. In 2017, 35 patient slides were analyzed. 5. In 2018, 34 patient slides were analyzed. 6. On 05/21/2019 around 9:50 am, the LD confirmed the findings above. 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 Patient Test Report and interview with Laboratory Director (LD), the laboratory failed to include on test reports the location where Tissue Pathology slides were read from 09/25/2017 to the date of survey. Finding Include: 1. On the day of survey, 05/21/2019, a review of some test reports (3 of 3) revealed the test reports did not include the correct address where the slides were being read. 2. Slides were read at Abington Surgical Center (2701 Blair Mill road, Willow Grove PA 19090) but Abington Jefferson Hospital (1200 Old York Road, Abington PA 19001) was listed on the final reports. 3. In 2017, 35 patient slides were analyzed. 4. In 2018, 34 patient slides were analyzed. 5. The LD confirmed the findings above on 05/21/2019 around 11:00 am. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with the laboratory director (LD), the laboratory failed to establish an approved procedure available to all personnel performing examination of histopathology slides for the specific location from 2017 to the date of survey. Findings Include: 1. On the day of survey, 05/21 /2019, review of the procedure manual revealed the cover page stated "Abington Surgical Center Procedures", but the polices and procedures inside were labeled with the name and address for Abington Jefferson Hospital. 2. The surveyor could not -- 3 of 4 -- distinguish if the policies belonged to either the Abington Surgical Center or Abington Jefferson hospital since they were labeled with the hospitals information. The LD is the CLIA LD for both locations. 3. In 2017, 35 patient slides were analyzed. 4. In 2018, 34 patient slides were analyzed. 5. On 05/21/2019 around 09:45 am, the LD mentioned he was unaware each laboratory with a different CLIA number needs their own separate polices and procedures. -- 4 of 4 --