Brookside Clinical Lab Inc

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the CASPER 0155 report and graded results from the proficiency testing (PT) organization, College of American Pathologists (CAP), the laboratory failed to successfully participate in PT for Rheumatoid Factor, Qualitative (RF). The laboratory had unsatisfactory scores for the 1st and 2nd Event of 2025. Refer to D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) 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 -- (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER 0155D Report and graded results from the proficiency testing (PT) organization, College of American Pathologists (CAP), the laboratory failed to achieve an overall testing score of satisfactory performance for the general immunology analyte: Rheumatoid Factor, Qualitative (RF) . The laboratory had unsatisfactory scores for the 1st and 2nd event of 2025. Findings include: 1. Review of the CASPER 0155D report revealed the following unsatisfactory scores: - 2025 Event 1 RF: 0% - 2025 Event 2 RF: 0% 2. Further review of the laboratory's 2025 CAP PT agency's graded results confirmed the above findings resulting in unsatisfactory performance for the general immunology analyte: RF. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the CASPER 155 Report and graded results from the proficiency testing (PT) organization, College of American Pathologists (CAP), the laboratory failed to successfully participate in proficiency testing for the toxicology analytes: Carbamazepine (Carb) and Gentamicin (Gent). Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER 155 Report and graded results from the proficiency testing (PT) organization, College of American Pathologists (CAP), the laboratory failed to achieve an overall testing score of satisfactory performance for the toxicology analytes: Carbamazepine (Carb) and Gentamicin (Gent). The laboratory had unsatisfactory scores for C-C 2023 General Chemistry/Therapeutic Drugs (3rd event of 2023), C-A 2024 General Chemistry/Therapeutic Drugs (1st event of 2024), and C-B 2024 General Chemistry/Therapeutic Drugs (2nd event of 2024). Findings include: Subspecialty Year Event Score Carb 2023 3 60% Carb 2024 2 0% Gent 2024 1 0% Gent 2024 2 0% -- 2 of 2 --

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 record review and interview with the laboratory director (LD), the laboratory director (LD) failed to be present for a reasonable period of each working day in each laboratory for which he is director from 06/14/2022 to the day of survey as required by PA State regulations. Findings include: 1. The PA State regulation 5.22 (g) states: "A director shall be present for a reasonable period of each working day in each laboratory for which he is director." 2. According to the laboratory's "Responsibilities and Functions of the Clinical Laboratory Director" procedure, the LD should visit the laboratory monthly or as often as deemed necessary, communicate with the laboratory daily to cover any laboratory issues utilizing face time or skype to interact with employees or clients if necessary. 3. On the day of survey, 03/27/2024 at 12:34 pm, an interview with the LD revealed that he visited the laboratory 7 of 22 months from June 2022 to 03/27/2024. 4. The LD confirmed the findings above on 03 /27/2024 at 1:30 pm. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). 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 the American Proficiency Institute (API) and College of American Pathologists (CAP) proficiency testing (PT) records and interview with technical supervisor (TS) #2 and technical supervisor (TS) #3, the laboratory failed to verify the accuracy of the PT results obtained for 5of 5 CAP Chemistry and 1 of 6 API Microbiology testing events in 2022, 2023, and 2024. Findings Include: 1. On the day of survey, 03/27/2024 at 10:06 am., review of the laboratory's CAP and API PT records revealed that the laboratory did not verify the accuracy for the following analytes that were not scored by the PT agencies in 2022, 2023, and 2024: - CAP General Chemistry/Therapeutic Drugs- T3 Uptake/ Related Test 2022 CAP C-C, 2023 CAP C-A, C-B, C-C 2024 CAP C-A 2024 - 2024 API Microbiology 1st event UTI Pannel 2. The API Proficiency Testing performance Evaluation form states " Laboratories are responsible for documenting and performing

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's competency policy and interview with the Laboratory Director (LD), the laboratory failed to establish a procedure to assess the competency of 1 of 1 Clinical Consultant (CC) (on the CMS 209 form, listed as personnel #2) for their Consultant responsibilities in 2020 and 2021. Findings include: 1. On the day of survey 06/14/2022 at 09:05 am, the laboratory could not provide a policy that stated how to assess the competency for 1 of 1 CC their consultant responsibilities in 2020 and 2021. 2. The LD could not provide competency assessment records for 1 of 1 CC in 2020 and 2021 3. The LD confirmed the findings above on 06/14/2022 around 01: 15 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 the lack of documentation, observation of the lab and interview with the testing personnel (TP) #4, the laboratory failed to calibrate and document the expiration date on 6 of the 6 thermometers being used for monitoring reagent storage 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 -- temperature and 2 of 2 timer being used for chemistry and microbiology testing as defined by manufacturers. Findings include: 1.Observation of the lab on 06/14/2022 at 10:20 AM revealed that following thermometers did not have expiration date on them. Lot 90530268-Chemistry 1 refrigerator Lot 71170268-Chemistry 2 refrigerator Lot 71870551-Toxicology 2 refrigerator Lot 91300551- -20 freezer Lot 70890269-Room temperature Lot 02530268-Microbiology refrigerator 2.The following timers did not have expiration date Timer 1-Chemistry department Timer 2-Microbiology department 3.Calibration record review revealed that no calibration was performed on these thermometers and timers. 4. TP #7 confirmed the above findings on 06/14/2022 at 01:22 PM. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records for microbiology media and interview with Technical Supervisor (TS) #3, the laboratory failed to check and document each batch or shipment of microbiology media, for physical characteristics, its ability to support growth, select or inhibit specific organisms or produce a biochemical response from 06 /14/2020 to 06/14/2022. Findings Include: 1. On the day of survey 06/14/2022 at 10: 00 am, review of microbiology quality control records revealed, the laboratory did not document the visual checks for each batch or shipment for microbiology media from 06/14/2020 to 06/14/2022 2. Review of the microbiology quality control records revealed, the laboratory failed to use at least one organism to confirm the following media for its inhibitory and biochemical characteristics from 06/14/2020 to the day of survey: - Thayer Martin - Bile Esculin Azide Slant BE - Hecktoen Enteric 3. The TS#3 confirmed the findings above on 06/14/2022 around 01:15 pm D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) 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 the Antimicrobial Susceptibility test Quality Control (QC) Records, and interview with the Technical Supervisor (TS) #3, the laboratory failed to -- 2 of 3 -- check QC for Carbapenem-resistant Enterobacteriaceae (CRE) and the Extended Spectrum Beta-lactamase (ESBL) confirmation susceptibilities each day of patient testing from 06/14/2020 to the date of survey. Findings Include: 1. On the day of survey 06/14/2022 at 12:07 pm, review of the CRE and ESBL confirmation test Quality Control (QC) Records revealed, the laboratory performed QC on a weekly bases from 06/14/2020 to 06/14/2022 2. TS #3 confirmed the findings above on 06/14 /2022 around 01:15 pm. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Testing personnel (TP) #17, the laboratory failed to evaluate twice a year the accuracy of test results between 3 of 3 ThermoFisher Quant studio 3 Polymerase Chain Reaction (PCR) systems for Virology and Bacteriology testing in 2021. Findings include: 1. On the day of survey 06/14/2022 at 12:45 pm, review the laboratory could not provide comparison study records of patient test results between 3 of 3 Quant studio 3 PCR systems for Virology and Bacteriology testing from January 2021 to December 2021. 2. TP #17 confirmed the above finding on 06/14/2022 at 01:22 PM. -- 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 laboratory procedure manuals and interview with testing personnel (TP) #1, the laboratory failed to establish a procedure to assess the competency of 3 of 3 technical supervisors (TS) 3 of 3 technical consultants (TC) and 5 of 5 general supervisors (GS) in 2018 and 2019. Findings Include: 1. On the day of survey, 12/06/2019, the laboratory failed to provide a written policy to assess the competency of 3 of 3 TS's, 3 of 3 TC's, and 5 of 5 GS's in 2018 and 2019: 2. TP #1 confirmed the finding above on 12/06/2019 around 09:00 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. This STANDARD is not met as evidenced by: Based on review of laboratory temperature records and interview technical 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 -- supervisors (TS) #1 and testing personnel (TP) #1, the laboratory failed to document 1 of 1 room temperature, 9 of 9 refrigerator temperatures and 5 of 5 freezer temperatures each day of testing from 2018 to the day of survey. Findings Include: 1. On the day of survey, 12/06/2019, review of the laboratory's temperature records revealed, the laboratory did not document, 1 of 1 room temperature, 9 of 9 refrigerator temperatures and 5 of 5 freezer temperatures on Saturdays and Sundays when patient testing was performed from 01/17/2018 to 12/06/2019. 2. The laboratory room, 9 refrigerators and 5 freezers house reagents, quality control and calibration materials for all departments in the laboratory, (Routine chemistry, hematology, bacteriology, serology and toxicology). 3. In 2018 - 951,717 patient tests were performed in the laboratory. 4. TS#1 and TP#1 confirmed on 12/06/2019 around 9:45 am that, daily room, refrigerator and freezer temperatures were not documented on the weekends when testing was performed. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of urine sediment microscopic examination quality control (QC) records and interview with the testing personnel (TP) #1, the laboratory failed to document urine sediment microscopic examination QC each day of patient testing for 3 of 12 months in 2018. Findings Include: 1. On the date of survey, 12/06/2019, review of the urine sediment microscopic examination QC records revealed, the laboratory did not document QC each day of patient testing for 3 of 12 months in 2018 (October, November and December). 2. The TP #1 confirmed the finding above on 12/06/2019 around 11:00 am. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on, the review of the laboratory's quality control logs and an interview with the Technical Supervisor, the laboratory failed to document the testing of the reactivity of staining materials used for manual differential analysis from 2016 to the date of survey. Findings include: 1. On the date of survey 01/17/2018 at 12:22 pm, the surveyor reviewed the Hematology departments quality control logs and discovered there was no documentation for the testing of the reactivity of the staining material used for manual differential analysis. 2. On 01/17/2018 at 12:22 pm an interview with the Technical Supervisor revealed that no documentation was availble for the manual differantial stain quality. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. 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, the review of the laboratory's quality control records and an interview with the Technical Supervisor, the laboratory failed to document all control procedures performed for for each batch or shipment of media used for microbiology testing from 2016 to the date of survey. Findings: 1) On the date of survey 01/17/2018 at 11:49 am, the surveyor reviewed the microbiology quality control logs and discovered that the department did not document each batch of media for sterility, it's ability to support growth, its ability to produce a biochemical response and its physical characteristics. 2) 10,250 patient samples were tested. 3) On the date of survey 01/17 /2018 at 11:49 am an interview with the Technical Supervisor confirmed the findings above D5485 CONTROL PROCEDURES CFR(s): 493.1256(h) If control materials are not available, the laboratory must have an alternative mechanism to detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be documented. This STANDARD is not met as evidenced by: Based on, the review of laboratory quality control records and interview with Laboratory Supervisor, the laboratory failed to have an alternative mechanism to detect immediate errors for microscopic urinalysis performed from 2016 to the date of survey. Findings: 1) On the day of survey 01/17/2018 at 01:13 pm the surveyor reviewed the Urinalysis departments quality control logs and discovered no alternative control mechnism for microscopic urinalysis were performed and documented. 2) On 01/17/2018 at 01:13 pm an interview with the Laboratory Supervisor confirmed the findings above. 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 review of competency assessment records and interview with the Technical Supervisor (TS), the Technical Supervisor failed to evaluate and document the performance of the testing personnel # 6 at least semi-annually during the first year in 2016. Findings include: 1. At the time of survey, the laboratory was unable to provide a six month competency assessment record for testing personnel #6. 2. The TS confirmed the finding above on 1/17/2018 around 10:30 am. -- 2 of 2 --