Keystone Urology Specialists

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, lack of documentation and interview with the laboratory manager (LM), the Laboratory Director (LD)/designee and testing personnel (TP) failed to attest to the routine integration of samples into the patient workload for 2 of 4 API PT events performed in 2023 and 2 of 6 API PT events performed in 2024 for Chemistry and Hematology. Findings include: 1. On the day of survey 04/24/2025, review of the laboratory's API PT records revealed, the LD/designee and TP failed to document the attestation of the routine integration of samples into the patient workload for the following 2 of 4 API PT events performed in 2023 and 2 of 6 API PT events performed in 2024: - API 2023 Chemistry Core 2nd and 3rd Events - API 2024 Chemistry Core 3rd Event - API 2024 Hematology/Coagulation 2nd Event 2. The LM confirmed the findings above on 04/24/2025 at 12:06 pm. 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 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 -- 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 the laboratory's temperature logs, lack of documentation and interview with the laboratory manager (LM), the laboratory failed to document and define acceptable criteria for room temperature and humidity to ensure proper test system operating conditions and proper reagent storage were met for 1 of 1 Siemens Clinitek Advantus analyzer used to perform urinalysis examinations from 06/21/2023 to 04/24/2025. Findings include: 1. On the day of survey, 04/24/2025, review of the laboratory's temperature logs revealed the laboratory failed to document and define acceptable criteria for room temperature (manufacturer's acceptable range 18 to 30 degrees Celsius) and humidity (manufacturer's acceptable range 20 to 80 %) for 1 of 1 Siemens Clinitek Advantus analyzer (s/n KPS63092309) used to perform urinalysis examinations from 06/21/2023 to 04/24/2025. 2. The hours of laboratory testing are Monday-Friday 08:00 am to 05:00 pm (CMS 116). The laboratory could not provide documentation of temperature and humidity taken for 192 of 673 days when the laboratory was closed. 3. The laboratory performed 21,000 urinalysis examinations in 2024 (CMS 116). 4. The LM confirmed the above findings on 04/24/2025 at 12:06 pm. * REPEAT DEFICIENCY D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and 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 quality assurance (QA) records, lack of documentation and interview with the laboratory manager (LM), the Laboratory Director (LD) failed to ensure a QA program was maintained and documented to ensure the quality of services provided by the laboratory for 5 of 5 months from April 2024 to August 2024. Findings include: 1. The laboratory's Quality Assurance Program policy states, "A quality assurance checklist is completed by the Laboratory Supervisor monthly." 2. On the day of survey, 04/24/2025, the laboratory failed to provide documentation of the monthly QA checklist used to assess the laboratory's pre-analytical, analytical, and post-analytical processes for 5 of 5 months from April 2024 to August 2024. 3. The LM confirmed the findings above on 04/24/2025 at 12:06 pm. D8103 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(b)(c)(d) (b) General Requirements. As part of the inspection process, CMS or a CMS agent may require the laboratory to do the following: (b)(1) Test samples, including proficiency testing samples, or perform procedures. (b)(2) Permit interviews of all personnel concerning the laboratory's compliance with the applicable requirements of this part. (b)(3) Permit laboratory personnel to be observed performing all phases of the total testing process preanalytic, analytic, and postanalytic). (b)(4) Permit CMS or a CMS agent access to all areas encompassed under the certificate including, but not limited to, the following: (b)(4)(i) Specimen procurement and processing areas. (b)(4) -- 2 of 3 -- (ii) Storage facilities for specimens, reagents, supplies, records, and reports. (b)(4)(iii) Testing and reporting areas. (b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all records and data it requires. (c) Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. (d) Requirement to provide information and data. A laboratory must provide, upon request, all information and data needed by CMS or a CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the laboratory manager (LM), the laboratory failed to have the required records accessible for 1 of 3 testing specialties (histopathology) to review during the laboratory survey performed on 04/24/2025. Findings Include: 1. On the day of the survey, 04/24/2025 at 11:30 am, the laboratory could not provide the following records upon request: - Proficiency testing/peer review records for histopathology microscopic examinations performed from 06/21 /2023 to 12/01/2024. - Quality control records for stains used for histopathology microscopic examinations performed from 06/21/2023 to 12/01/2024. - Procedure manual used for histopathology microscopic slide preparations and examinations performed from 06/21/2023 to 12/01/2024. 2. The LM confirmed the findings above on 04/24/2025 at 12:06 pm. -- 3 of 3 --

Summary Statement of Deficiencies D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews the laboratory failed to establish and follow written policies and procedures for the establishment, reassessment and documentation of individual workload limits (refer to D5633, D5637 and D5647); failed to establish and follow written policies and procedures to ensure that workload limits would be prorated when examining slides in less than eight hours (refer to D5641); failed to establish and follow written policies and procedures to ensure the laboratory maintained records of the total number of slides examined and the total number of hours spent examining slides per 24-hour period (refer to D5645); and failed to establish and follow written policies and procedures to ensure unsatisfactory nongynecologic cytology slide preparations were identified and reported as unsatisfactory. (refer to D5655). D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview with Technical Supervisor A it was determined the laboratory failed to establish and follow written policies and procedures for the collection, labeling, storage and preservation, and transportation of nongynecologic specimens. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for the collection, labeling, storage and preservation, and transportation of nongynecologic specimens. 2. During an interview on March 18, 2024 at 1:30 PM, Technical Supervisor A confirmed these findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 competency assessment records and interview with testing personnel (TP) #5 (CMS 209), the laboratory failed to establish a competency assessment procedure to assess 2 of 2 technical supervisors (TS) for their supervisory responsibilities for Histopathology testing from 05/05/2021 to the day of survey. Findings Include: 1. On the day of survey, 06/22/2023 at 11:38 AM, the laboratory could not provide a competency assessment procedure to assess the competency for 2 of 2 TS (CMS 209 personnel #1, and #2) for their supervisory responsibilities for Histopathology testing from 07/14/2021 to the day of survey. 2. The laboratory could not provide competency assessment documentation for the 2 of 2 TS. 3. TP #5 confirmed the findings above on 06/22/2023 around 12:30 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). This STANDARD is not met as evidenced by: 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 -- Based on the review of the American Proficiency Institute (API) records and interview with testing personnel (TP) #3 (CMS 209), the laboratory failed to verify the accuracy of analytes assigned a proficiency testing (PT) score that does not reflect laboratory test performance for 1 of 1 chemistry PT event in 2023. Findings include: 1. On the day of the survey, 06/21/2023 at 12:15 PM, a review of API PT records revealed the laboratory received 0% on the following tests - API 1st Event Chemistry Core 2023- Albumin - API 1st Event Chemistry Core 2023- Alkaline Phosphate - API 1st Event Chemistry Core 2023 -Aspartate aminotransferase - API 1st Event Chemistry Core 2023- Total Bilirubin - API 1st Event Chemistry Core 2023- Total Calcium - API 1st Event Chemistry Core 2023- Chloride - API 1st Event Chemistry Core 2023- Creatinine - API 1st Event Chemistry Core 2023- Glucose - API 1st Event Chemistry Core 2023- Potassium - API 1st Event Chemistry Core 2023- Sodium - API 1st Event Chemistry Core 2023- Total Protein - API 1st Event Chemistry Core 2023- Blood Urea Nitrogen 2. The laboratory failed to provide the verification of accuracy for the analytes listed above that scored a 0% for API 1st Event Chemistry Core 2023. 3. TP #3 confirmed the above findings on 06/21/2023 at 14:30 PM. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with testing personnel (TP) #3 (CMS 209), the laboratory failed to document all proficiency testing evaluation and verification activities for 2 of 3 Microbiology and 3 of 3 Chemistry Core events in 2022. Findings Include: 1. On the day of survey, 06/21/2023 at 11:51 AM, a review of the API PT records revealed that the laboratory failed to document evaluations and verifications for the following events in 2023. - Microbiology-Bacteriology Molecular Bacti-Urine- 2022 1st Event- 97% - Microbiology- Bacteriology Molecular Bacti-Urine- 2022 2nd Event- 94% - Chemistry Core- Routine Chemistry- Albumin- 2022 1st Event- 80% - Chemistry Core- Routine Chemistry-Chloride- 2022 2nd Event- 80% - Chemistry Core- Routine Chemistry- Chloride- 2022 3rd Event- 80% 2. API 2022 1st Event Chemistry Core attestation form signed by the Laboratory Director said 100% grade was achieved for the event. 3. TP # 3 confirmed the above findings on 06/21/2023 at 14:50 PM. 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 observation of the temperature records, and an interview with the Testing Personnel (TP) #3 (CMS 209), the laboratory failed to define criteria for Humidity, -- 2 of 4 -- and Fridge Temperature for Histopathology testing from 05/05/2021 to the day of survey. Findings include: 1. On the day of the survey, 06/22/2023, a review of the laboratory's temperature logs revealed that the laboratory did not have acceptable Humidity, and Fridge Temperature ranges for 17 of 17 months of logs. 2. According to TP #3, Immunohistochemical stains were stored in the fridge and an observation of the laboratory revealed that Histopathology blocks were stored in the laboratory. 3. Interview with TP #5 confirmed the findings above on 06/22/2023 at 12:31 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 an observation of the laboratory and an interview with testing personnel (TP) #3 (CMS 209), the laboratory failed to perform and document maintenance as defined by the manufacturer and the frequency specified by the manufacturer for the thermometer used to record temperature for ABX Micros 60/ABX Micros ES 60 hematology, Access 2 Chemistry and Clinitek Advantus urinalysis reagent storage from 2021 to 06/21/2023. Findings Include: 1. On 06/21/2023 at 14:25 PM, an observation of the laboratory revealed that the following thermometers were used for recording Room Temperature (RT) and expired. -Traceable, S/N 192747163 Expired on 12/30/2021. 2. The following reagents were stored in the laboratory at RT. - NERL Reagent Grade Water for ABX Micros 60/ABX Micros ES 60 - 1 Pack. - Siemens Multistix 10 SG for - 2 Pack. - ABX Minidil LMG ABX Micros 60/ABX Micros ES 60- 1 Pack. - Access Wash Buffer II- 1 Pack. - Citranox- 1 Pack. - Contrad 70- 2 Pack. 3. Interview with TP #3 confirmed the findings above on 06/22/2023 at 11:30 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 a lack of documentation, observation of the laboratory, and an interview with testing personnel (TP) #3 (CMS), the laboratory failed to establish a maintenance protocol that ensures equipment performance for 2 of 2 pipettes and 2 of 2 thermometers used for Complete Metabolic Panel and Complete Blood Count testing from 05/05/2021 to 06/21/2023. Findings include: 1. At the time of the survey, on 06 /21/2023 at 14:10 PM, an observation of the laboratory revealed that the laboratory failed to document calibration activities for the following instruments. - MLA Pipette- Vistalab - MLA Pipette- Dimond PRO. - Therm PRO- Thermometer. - Traceble -- 3 of 4 -- Thermometer. 2. The laboratory failed to provide a calibration protocol for the accuracy of the pipettes and thermometer listed above. 3. TP ## confirmed the findings above on 06/22/2023 at 11:45 PM. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 Laboratory's Procedures Manual, competency records, and interview with technical supervisor (TS) #1 (CMS 209), and testing personnel (TP) #5 (CMS 209), the TS failed to evaluate the competency of 2 of 4 TP (TP#1 and TP#2, CMS 209) who performed histopathology slide review from 05/05/2021 through the date of the survey. Findings Include: 1. The Keystone Urology Employee Profile, Personnel Training, CE, Competency procedure section 4 states that All TP are subject to competencies per CLIA regulations. 2. On the day of survey, 06/22/2023, TS # 1 could not provide documentation of competency assessments performed for 2 of 4 TP who performed Histopathology Slide reviews from 2021 through the date of survey. 3. TS #1 and TP #5 confirmed the findings above on 06/22/2023 at 12:15 PM. 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 a review of the laboratory's competency assessment (CA) records and interview with technical supervisor (TS) #1 (CMS 209), TS #1 failed to assess test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples for 1 of 4 testing personnel (TP) who performed Grossing for Histopathology Testing from 05/05/2021 to 06/22/2023. Findings include: 1. On the day of inspection, 06/22/2023 at 11:30 AM, a review of TP competency assessment records revealed that the TS did not perform a competency assessment through previously analyzed specimens, external proficiency testing samples, or internal blind testing samples for 1 of 4 TP (CMS 209 TP#5) that performed grossing for histopathology testing from 2021 through the day of the survey. 2. The laboratory performed 8862 Histopathology Tests in 2022 (CMS 116). 3. Technical Supervisor (TS) #1 confirmed the above findings on 06/22/2023 at 11:48 AM. -- 4 of 4 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records and interview with the Testing Personnel (TP) #2, the laboratory failed to provide 1 of 3 API PT attestation statements for chemistry PT performed in 2020. Findings include: 1. On the day of survey, 05/05/2021, the TP#2 could not provide the 2020 chemistry 1st Event attestation statement. 2. The TP#2 confirmed the finding above on 05/05/2021 at 09:20 am. 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: A. Based on review of the laboratory's Employee Competency procedure and interview with Testing Personnel (TP) #2, the laboratory failed to have a complete policy to assess the competency of 2 of 2 laboratory personnel who performed the Clinical consultant (CC), Technical Supervisor (TS), and General Supervisor (GS) roles from 10/01/2018 to the date of survey. Findings include: 1. On the day of survey, 05/05/2020, the TP#2 could not provide a competency assessment policy to assess the competency of the following personnel from 10/01/2018 to the date of survey: - 2 of 2 CC (on CMS 209, listed as personnel #2 and #8) - 1 of 1 TS (on CMS 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 -- 209, listed as personnel #2) - 1 of 1 GS (on CMS 209, listed as personnel #8) 2. The TP#2 confirmed the finding above on 05/05/2021 around 12:20 p.m. B. Based on review of the laboratory's Employee Competency procedure, annual competency records, and interview with Testing Personnel (TP) #2, the laboratory failed to establish a complete procedure that includes all six components required for competency assessment for all TP who performed Post Vasectomy Vas Drop examinations from 10/01/2018 to the date of survey. Findings include: 1. On the day of survey, 05/05/2021, the Post Vasectomy Competency policy reviewed at the time of survey did not include the following: - Direct observations of performance of instrument maintenance and function checks - Assessment of test performance through testing previously analyzed specimens, internal blind samples or external proficiency testing samples - Assessment of problem-solving skills 2. The following number of specimens were examined for Post Vasectomy Vas Drop: - 10/01/2018 to 12/31/2018: 198 specimens - 2019: 700 specimens - 2020: 576 specimens 3. The TP #2 confirmed the findings above on 05/05/2020 around 12:20 p.m. 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 documentation and interview with the testing Personnel (TP)#2, the laboratory failed to verify twice annually the accuracy of Post Vasectomy examination tests performed from 10/01/ 2018 through the date of survey. Findings include: 1. On the day of survey, 05/05/2021, the laboratory could not provide documentation of verification of accuracy for Post Vasectomy examination tests performed from 10/01/2018 through the date of the survey. 2. The following Post Vasectomy Vas Drop examinations were performed: - 10/01/2018 to 12/31/2018: 198 specimens - 2019: 700 specimens - 2020: 576 specimens 3. The TP#2 confirmed the findings above on 05/05/2021 at 9:30 a.m. 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 observation of the laboratory and interview with the testing personnel (TP) #2, the laboratory failed to establish a maintenance policy to assess the maintenance /function for 2 of 2 Tempcheck red spirit thermometers used to monitor the temperature for refrigerators in the main laboratory and Cytology laboratory and 1 of 1 Thermo Fisher Scientific digital thermometer for room temperature in Cytology from 10/01/2018 to the day of survey. Findings Include: 1. On the day of survey, 05/05 -- 2 of 4 -- /2021, the laboratory could not provide a maintenance policy for the thermometers. 2. The laboratory could not provide maintenance records for the following thermometers used to store quality control materials: - 2 of 2 Tempcheck red spirit thermometers used to monitor the temperature of refrigerators: Main Laboratory Frigidaire Refrigerator (Cat#240043 Lot #81720550 ) Cytology Refrigerator (Cat#240043 Lot# 23000550) - 1 of 1 Thermo Fisher Scientific digital thermometer for cytology room temperature used to store reagents. 3. An expiration date of 04/13/2011 was observed on the sticker posted on the Thermo Fisher Scientific digital thermometer. 4. TP #2 confirmed the findings above on 05/05/2021 at 12:00 p.m. 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 Testing Personnel (TP) #2, the laboratory failed to include a positive control material each day of patient testing for urine sediment microscopic examination for casts and crystals from 10/01/2018 to the date of survey. Findings Include: 1. On the day of survey, 05/05/2021, review of urine sediment microscopic examination QC records revealed the laboratory did not include a positive control each day of patient testing for casts and crystals from 10/01/2018 to the date of survey. 2. The following urine sediment microscopic examinations were performed: - 10/01/2018 to 12/31/2018: 4931 specimens - 2019: 18,200 specimens - 2020: 13.421 specimens 3. The TP#2 confirmed the findings above 05/05/2021 at 11:15 a.m. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(4)(iv) Ensure that an approved

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 a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte Chloride. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 a review of the CASPER 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing for the analyte: Chloride, which is in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 2nd event of 2019 and the 1st event of 2020. Findings include: Analyte Year Event Score Chloride 2019 2 60%. Chloride 2020 1 40%. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of laboratory procedure manual (PM), reagent lot number log, and interview with laboratory testing personnel (TP) #2, the laboratory used expired Easy PAP stain in 2018. Findings include: 1. The laboratory staining PM, the laboratory director signed on 10/07/2018, states "All solutions are to kept fresh and close attention will be kept to the expiration dates." 2. The Easy PAP stain lot log reads as follows: Lot Number Expiration 7061 9/2/18 3. All (9 of 9) patient specimens (C18 512-521) stained using expired Easy PAP from 09/24 to 09/28 in 2018. 4. The TP #2 confirmed above findings on 10/01/2018 at 11:30 AM. ====================================== Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 a review of the CASPER Report 155 report and performance evaluations from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: White Blood Cell Differential which is in the specialty of Hematology. The laboratory had unsatisfactory scores for the 2nd event of 2017 and the 1st event of 2018. See D2130 D2130 HEMATOLOGY CFR(s): 493.851(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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive 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 performance evaluations from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: White Blood Cell Differential which is in the specialty of Hematology in which the laboratory is certified under CLIA. The laboratory had unsatisfactory scores for the 2nd event of 2017 and 1st event 2018. Findings include: 1. API 2017 Event 2 for White Blood Cell Differential the score was 7% and was unsatisfactory. 2. API 2018 Event 1 for White Blood Cell Differential the score was 7% and was unsatisfactory -- 2 of 2 --