Satish A Shah Md Laboratory-Hanover Cancer Ctr

Summary Statement of Deficiencies D0000 A recertification survey was conducted by the Pennsylvania State Agency at Chesapeake Uro Asc LLC on 06/25/2026. The laboratory was found out of compliance with the following conditions: 493.1100 Condition: Facility administration 493.1250 Condition: Analytic systems 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). This CONDITION is not met as evidenced by: Based on record review and interview with the LaboratorySupervisor (LS), the laboratory failed to comply with the state of Pennsylvania code Chapter 5.22 for Responsibilities of owner and director, as required under 493.1101 for 2 of 2 years from 07/26/2024 to 06/25/2026. Refer to D3009. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with the Laboratory 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 -- Supervisor (LS), the laboratory failed to provide documentation of quality control (QC) and maintenance for 1 of 1 Contour glucometer from 07/26/2024 to 06/25/2026. Findings include: 1. The Contour glucometer instruction manual stated: "You should perform a control test when: - Using your meter for the first time. - You open a new bottle or package of test strips. - You think your meter may not be working properly. - You have repeated, unexpected blood glucose results." 2. Further review of the Contour glucometer instruction manual revealed,"Clean and disinfect your meter once a week." 3. On the day of survey, 06/25/2026 at 11:30 am, the laboratory failed to provide documentation of QC and maintenance performed for 1 of 1 Contour glucometer (S/N F993117) from 07/26/2024 to 06/25/2026. 4. The LS confirmed the above findings on 06/25/2026 at 12:45 pm. ***Repeat deficiency*** D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of temperature records, observation of the laboratory, and interview with the Laboratory Supervisor (LS), the laboratory failed to monitor and document refrigerator and room temperatures as required under 493.1252 to ensure operating conditions were met for the proper storage of hematology reagents and to ensure reliable test system operation of the Medonic M Series analyzer on weekends and holidays for 23 of 23 months from 07/26/2024 to 06/25/2026. Refer to D5413. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 review of temperature records, observation of the laboratory, and interview with the Laboratory Supervisor (LS), the laboratory failed to monitor and document refrigerator and room temperatures to ensure operating conditions were met for the proper storage of hematology reagents on weekends and holidays for 23 of 23 months from 07/26/2024 to 06/25/2026. Findings Include: 1. On the day of the survey, 06/25 /2026 at 11:00 am, review the laboratory's temperature logs from revealed that the laboratory failed to monitor and document refrigerator and room temperatures on weekends and holidays for 23 of 23 months from 07/26/2024 to 06/25/2026. 2. During -- 2 of 5 -- observation of the laboratory the surveyor discovered the following reagents stored in the laboratory: - Boule Con Diff quality control High- manufacturer's recommended storage temperature: 2-10 degrees Celsius - Boule Con Diff quality control Normal- manufacturer's recommended storage temperature: 2-10 degrees Celsius - Boule Con Diff quality control Low- manufacturer's recommended storage temperature: 2-10 degrees Celsius - Boule Enzymatic Cleaner- manufacturer's recommended storage temperature: 15-30 degrees Celsius 3. The LS confirmed the findings above on 06/25 /2026 at 12:45 pm. ***Repeat deficiency*** D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with the Laboratory Supervisor (LS), the laboratory failed to establish and maintain a maintenance /function check policy to ensure equipment used in the laboratory for patient testing provided accurate and reliable test results for 2 of 2 years from 07/26/2024 to 06/25 /2026. Findings include: 1. On the day of survey, 06/25/2026 at 12:25 pm, review of laboratory procedures revealed the laboratory failed to establish a policy for maintenance/function checks performed for equipment used in the laboratory for patient testing for 2 of 2 years from 07/26/2024 to 06/25/2026. 2. The laboratory failed to provide maintenance/function check records for the following 1 of 1 thermometer and 2 of 2 thermometer/hygrometers used to monitor reagent storage: - Durac thermometer - ThermPro thermometer/hygrometer - Meade Instruments thermometer/hygrometer 3. The LS confirmed the findings above on 06/25/2026 at 12: 45 pm. D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview with the Laboratory Supervisor (LS), the Technical Consultant (TC) failed to provide technical oversight in accordance with 493.1413 for 2 of 2 years from 07/26/2024 to 06/25/2026. Refer to 6054. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on policy and record review, lack of documentation, and interview with the Laboratory Supervisor (LS), the Technical Consultant (TC) failed to assess the annual competency of 7 of 12 Testing Personnel (TP) for hematology examinations performed in 2025. Findings Include: 1. The laboratory's CLIA Quality Management Policy stated, "Competency Evaluations: 1) Employees responsible for nonwaived testing in Satish A. Shah Laboratory will not perform testing until they have been certified by the laboratory director as being competent to perform testing. 2) Competency will be evaluated at least semiannually during the first year the employee tests patient specimens. 2a)Thereafter, evaluations will be performed every six (6) for each laboratory test a person performs." 2. On the day of survey, 06/25/2026 at 10:10 am, the laboratory failed to provide competency assessment records for 7 of 12 TP (CMS 209, TP#1, TP#2, TP#3, TP#4, TP#7, TP#8, TP#10, dated 06/24/2026), who performed complete blood count (CBC) examinations in 2025. 3. The laboratory performed 30,228 Hematology examinations in 2025 (CMS 116 estimated volume, dated 06/24/2026). 4. The LS confirmed the finding above on 06/25/2026 at 12:45pm. ***Repeat deficiency*** D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of personnel qualification records and interview with the Laboratory Supervisor (LS), the laboratory failed to ensure 1 of 12 TP (CMS 209, personnel #11, dated 06/24/2026) met the minimum educational requirements under 493.1423 to perform moderate complexity testing from 03/23/2026 to 06/25/2026. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of personnel qualification records and interview with the Laboratory -- 4 of 5 -- Supervisor (LS), the laboratory failed to ensure that 1 of 12 testing personnel (TP) met the minimum educational requirements to perform moderate complexity testing from 03/23/2026 to 06/25/2026. Findings Include: 1. On the day of survey, 06/25/2026 at 10:10 am, the laboratory failed to provide documentation for the equivalency evaluation performed for education obtained from a foreign institution for 1 of 12 TP (CMS 209 personnel #11, dated 06/24/2026) who performed moderate complexity (hematology) examinations from 03/23/2026 to 06/25/2026. 2. The LS confirmed the findings above on 06/25/2026 at 12:45 pm. -- 5 of 5 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on document review and interview with the laboratory director (LD) and testing personnel #1 (CMS 209 #1), the laboratory failed to provide a procedure manual, quality control documentation and manufacturer function tests for the Contour glucometer from 11/02/2022 to the day of survey. Findings include: 1. On the day of survey, 07/27/2024 the laboratory failed to provide a manufacturer provided instruction manual for the Contour glucometer. 2. The Contour glucometer instruction manual states: "You should perform a control test when: - Using your meter for the first time. - You open a new bottle or package of test strips. - You think your meter may not be working properly. - You have repeated, unexpected blood glucose results. 3. The laboratory failed to provide documentation of QC for Contour glucometer from 11/01/2022 to the day of survey. 4. The Contour glucometer instruction manual states: "Clean and disinfect your meter once a week." 5. The laboratory failed to provide documentation of manufacturer required function tests for the Contour glucometer from 11/02/2022 to the day of survey. 6. The LD confirmed the above findings on 7/27 /2024 at 2:45 pm. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Laboratory Director (LD), the laboratory failed to establish and maintain a procedure to assess the competency of the laboratory's Technical Consultant (TC) for their supervisory responsibilities performed in 2024. Findings include: 1. On the day of survey, 07/26/2024, the laboratory failed to provide a written policy that reviews how to assess the competency of the laboratory supervisors for their regulatory responsibilities in 2024. 2. The LD confirmed the findings above on 07/26/2024 at 10:54 am. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure and manufacturer's operator manuals, and interviews with the laboratory director (LD) and testing personnel #1 (TP), the laboratory failed to have a complete written procedure manual for hematology testing performed that met the requirements of 493.1251 from 11/02/2022 to the day of the survey. Findings include: 1. On the day of the survey, 07/26/2024 at 12:00 pm, review of the laboratory's procedure manuals revealed the operators manual were used to perform testing on the following from 11/02/2022 to day of survey: - CBC on the CDS Medonic M-Series.. 2. Review of the operators manual revealed that the test system instructions used failed to include the following requirements: - Step by step performance of the procedure including test calculations and interpretation of results. - Control procedures. -

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of the competency assessment (CA) records and interview with the Laboratory Director (LD), the TC failed to assess the competency of 2 of 13 testing personnel (TP) who performed the Complete Blood Count (CBC) test from 9/24/2020 to 11/02/2022. Findings Include: 1. On the day of the Survey, 11/02/2022 at 11:40 AM, a review of the competency assessment records revealed, TP #1 (CMS 209) missing competency assessment for 2021 and TP #7 (CMS 209) missing 6 month's competency assessment (hired on June 2021) who performed CBC tests in 2021 and 2022. 2. The LD confirmed the finding above on 11/002//2022 at 12:46 PM. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(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 Laboratory Director (LD), the Technical Consultant (TC) failed to evaluate the test performance of 12 of 13 testing personnel (TP) through internal blind testing samples or external Proficiency Testing (PT) samples for Complete Blood Count (CBC) assay 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 -- examinations from 09/24/2020 to 11/02/2022. . Findings Include: 1. At the time of survey, 11/02/2022 at 11:43 AM, a review of the competency assessment records revealed, the laboratory failed to establish a procedure to assess test performance of 12 of 13 TP through internal blind testing samples or external PT samples from 2020 to 2022 who performed CBC examinations on the Medonic M series analyzer. 2. A review of 12 of 13 TP competency assessments revealed that they were missing the following point "Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples;" 3. The LD confirmed the findings above on 11/02/2022 around 12:46 PM. -- 2 of 2 --