Hayman Salib Md Hematology Oncology

Summary Statement of Deficiencies D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. 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 the testing personnel #1 (TP), the laboratory failed to test API and CAP PT samples for routine chemistry, endocrinology, general immunology, and hematology in the same manner as patient specimens from 2021 to the date of survey. Findings include: 1. On the date of survey, 06/29/2023 at 10:40 am, during an interview, TP#1 stated that "PT samples were run twice on two separate days, then they select which result to report." 2. On the day of survey, 06/29/2023 at 11:09 am, the laboratory could not provide a written proficiency testing policy. 3. TP #1 confirmed the findings above on 06/29/2023 around 03:10 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 3 -- This STANDARD is not met as evidenced by: Based on review of the competency assessment records and interview with the testing personnel #1 (TP), the laboratory failed to establish written policies and procedures to assess the competency 1 of 1 technical consultant (TC) for the supervisory responsibilities from 08/06/2021 to the day of survey. Findings include: 1. On the date of survey, 06/29/2023 at 11:48 am, the laboratory could not provide a competency assessment procedure to assess 1 of 1 TC for their supervisory responsibilities from 08 /06/2021 to 06/29/2023. 2. The laboratory could not provide competency assessment records for 1 of 1 TC for the supervisory responsibilities in 2021, 2022 and 2023. 3. The laboratory could not provide documentation for responsibilities and duties for TC. 4. TP#1 confirmed the findings above on 06/29/2023 around 03:00 pm. *Repeat deficiency. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the American proficiency institute (API) proficiency testing (PT) records and interview with the testing personnel #1 (TP), the Laboratory Director failed to ensure 2 of 2 chemistry PT results were reviewed and

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with testing personnel (TP) #1, the laboratory failed to provide the PT attestation statements signed by the analyst and the laboratory director from 2019 and 2020. Findings Include: 1. On the day of survey, 08/06/2021, the following API PT attestation statements were not signed by the analyst and the laboratory director in 2019 and 2020: a. Chemistry: - 2019 Event #3. - 2020 Event #1. b. Hematology: - 2019 Event #2. 2. TP#1 confirmed the findings above on 08/06/2021 around 08:30 am. *** REPEAT DEFICIENCY. 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 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 -- Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on lack of documentation and interview with testing personnel (TP) #1, the laboratory failed to provide documentation of SARS-CO-V-2 antibody test results reported to the appropriate agencies as required for 1,588 of 1,588 patients tested from 08/17/2020 to 08/06/2021. Findings Include: 1. On the day of survey, 08/06/2021, TP#1 was unable to provide documentation of SARS-CoV-2 antibody tests performed on the Beckman Coulter Access 2 analyzer reported to the Pennsylvania National Electronic Disease Surveillance System (PA - NEDSS). 5. From 08/17/2020 to 08/06 /2021 the following number of SARS-CoV-2 specimen were analyzed on the Beckman Coulter Access 2. - Total: 1588. - Positive: 471. - Negative: 1,117. 6. TP#1 confirmed via email on 08/09/2021 around 1:50 pm, that the laboratory did not report SARS-CoV-2 results to local/state agencies. 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 procedures and interview testing personnel (TP) #1, the laboratory failed to establish a competency assessment procedure to assess 2 of 2 testing personnel (TP) and 1 of 1 technical consultant (TC) for competency in 2019, 2020 and 2021. Findings include: 1. On the day of survey, 08/06/2021, the laboratory could not provide a competency assessment procedure to assess the competency for 2 of 2 TP who performed testing on the Alfa Wassermann Ace Axcel, Beckman coulter Access 2 and the Sysmex XN - 450 in 2019, 2020 and 2021. 2. The laboratory could not provide competency assessment records for 1 of 1 TC performed in 2019, 2020 and 2021. 3. TP#1 confirmed the findings above on 08/06/2021 around 08:00 am. *** REPEAT DEFICIENCY. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the American proficiency institute (API) proficiency testing (PT) records and interview with testing personnel (TP) #1, the Laboratory Director failed to ensure all PT reports received, were reviewed and

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with testing personnel (TP) #1, the laboratory failed to provide the PT attestation statements signed by the analyst and the laboratory director from 2019 and 2020. Findings Include: 1. On the day of survey, 08/06/2021, the following API PT attestation statements were not signed by the analyst and the laboratory director in 2019 and 2020: a. Chemistry: - 2019 Event #3. - 2020 Event #1. b. Hematology: - 2019 Event #2. 2. TP#1 confirmed the findings above on 08/06/2021 around 08:30 am. *** REPEAT DEFICIENCY. 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 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 -- Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on lack of documentation and interview with testing personnel (TP) #1, the laboratory failed to provide documentation of SARS-CO-V-2 antibody test results reported to the appropriate agencies as required for 1,588 of 1,588 patients tested from 08/17/2020 to 08/06/2021. Findings Include: 1. On the day of survey, 08/06/2021, TP#1 was unable to provide documentation of SARS-CoV-2 antibody tests performed on the Beckman Coulter Access 2 analyzer reported to the Pennsylvania National Electronic Disease Surveillance System (PA - NEDSS). 5. From 08/17/2020 to 08/06 /2021 the following number of SARS-CoV-2 specimen were analyzed on the Beckman Coulter Access 2. - Total: 1588. - Positive: 471. - Negative: 1,117. 6. TP#1 confirmed via email on 08/09/2021 around 1:50 pm, that the laboratory did not report SARS-CoV-2 results to local/state agencies. 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 procedures and interview testing personnel (TP) #1, the laboratory failed to establish a competency assessment procedure to assess 2 of 2 testing personnel (TP) and 1 of 1 technical consultant (TC) for competency in 2019, 2020 and 2021. Findings include: 1. On the day of survey, 08/06/2021, the laboratory could not provide a competency assessment procedure to assess the competency for 2 of 2 TP who performed testing on the Alfa Wassermann Ace Axcel, Beckman coulter Access 2 and the Sysmex XN - 450 in 2019, 2020 and 2021. 2. The laboratory could not provide competency assessment records for 1 of 1 TC performed in 2019, 2020 and 2021. 3. TP#1 confirmed the findings above on 08/06/2021 around 08:00 am. *** REPEAT DEFICIENCY. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the American proficiency institute (API) proficiency testing (PT) records and interview with testing personnel (TP) #1, the Laboratory Director failed to ensure all PT reports received, were reviewed and

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: Hematocrit (Hct) and Platelets which are in the specialty of Hematology. The laboratory had unsatisfactory scores for the 2nd event of 2020 and the 1st event of 2021. 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 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: Hematocrit (Hct) and Platelets which are in the specialty of Hematology. The laboratory had unsatisfactory scores for the 2nd event of 2020 and the 1st event of 2021. Findings Include: 1. API Hematology 2020 Event #2: - Hct score was 0%. - Platelets score was 0%. 2. API Hematology 2021 Event #1: - Hct score was 60%. - Platelets score was 60%. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based upon a review of American Proficiency Institute (API) Proficiency Testing (PT) records and interview with Testing Personnel (TP) #1, the laboratory failed to maintain copies of 7 of 11 attestation statements and 4 of 11 attestation statements were not signed by the Laboratory Director (LD) in 2017 and 2018. Findings include: 1. On the day of survey, 12/19/2018, review of API PT records (2017 Event 1 - 2018 Event 2) revealed, the following missing attestation statements and attestation statements that were not signed by the LD: Missing attestation statements: - 2017 Chemistry Event #1 and #3 - 2017 Hematology Event #3 - 2018 Chemistry Event #1 and #3 - 2018 Hematology Event #1 and #2 Attestation statements not signed by the LD: - 2017 Chemistry and Hematology Event #2 - 2018 Chemistry Event #2 - 2018 Hematology Event #3 2. TP#1 confirmed the above findings on 12/19/2018 around 2: 05 PM. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- 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) #1 and Laboratory Director (LD), the LD failed to assess the competency of 1 out of 1 TP who performs chemistry and hematology testing from 2017 to the date of survey. Findings include: 1. Review of the Laboratory Quality Assurance Plan procedure manual (IV), under Training and Continuing Education of Personnel states, "Employee competency will be reviewed annually". 2. On the day of survey, 12/19/2018, review of TP#1's records revealed, the LD never assessed the competency of TP#1 for performing chemistry and hematology tests in 2017 and 2018. 3. The laboratory performed 45, 000 patient testing in 2017. 4. The LD confirmed that TP was hired January 2017 but their competency was never assessed on 12/19/2018 around 2:30 PM. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on the review of the Beckman Coulter Access 2 procedure manual and interview with Testing Personnel (TP) #1, the Laboratory Director (LD) failed to approve and sign the Beckman Coulter Access 2 procedure manual before use in 2018. Findings include: 1. On the day of survey, 12/19/2018, review of procedure manuals revealed, the Beckman Coulter Access 2 procedure manual was not approved and signed by LD. 2. In 2018: 15,000 patient tests were performed. 3. The LD and TP#1 confirmed the findings of the above on 12/19/2018 around 2:45 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: A. Based on a review of BioRad Liquichek Immunoassay Plus Controls, Levels 1, 2 and 3 package insert, review of quality control records, interview with Testing Personnel (TP) #1, and observation of controls stored in a refrigerator, the laboratory failed to monitor and document the conditions of storage for 3 out of 3 vials of BioRad Plus Controls from 2017 to the date of survey. Findings include: 1. The -- 2 of 4 -- BioRad Liquichek Immunoassay Plus Control, Levels 1, 2 and 3 package insert under STORAGE AND STABILITY states, "This product will be stable until the expiration date when stored unopened at -20 to -70 C. Thawed Unopened: When thawed and stored unopened at 2 - 8 C, this product will be stable as follows: - All Analytes: 30 days Except: - Androstenedione: 25 days - Prolactin, PSA (Free) and PSA (Total): 14 days - Estradiol: 8 days - Folate: 4 days Date of thaw should be noted. Thawed Opened: Once thawed, opened, and stored tightly capped at 2 to 8 C, this product will be stable as follows: - All analytes: 14 days Except: - Estradiol: 5 days - Folate: 4 days Once thawed, do not refreeze this product. Discard the remaining material. This product is shipped under frozen conditions." 2. On the day of survey, 12/19/2018, the laboratory could not provide documentation of monitoring the temperature of the refrigerator controls were stored in. 3. 3 out of 3 bottles of BioRad Liquichek Immunoassay Plus Controls, Levels 1, 2 and 3 were stored in refrigerator located in the laboratory. 4. TP#1 confirmed the findings above on 12/19/2018 around 04:30 PM. ** C = Celsius B. Based on a review of Refrigerator temperature records and interview with Testing Personnel (TP) #1, the laboratory failed specify and document the system control limits (reference range) for storage of chemistry and hematology Controls stored in the refrigerator in the laboratory from 2017 to the day of survey. Findings Include: 1. On the day of survey, 12/19/2018, the review of refrigerator temperature logs revealed: - 2017 (01/03/2017- 12/29/2017) 4 out of 11 logs did not include refrigerator temperature reference ranges. - 2018 (01/01/2018- 12/18/2018) 14 out of 14 logs did not include refrigerator temperature reference ranges. 3. In 2018: 45,000 patient tests were performed. 4. Interview with TP#1 confirmed the above findings on 12/19/2018 around 04:30 PM 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 review of BioRad Liquichek Immunoassay Plus Control, Levels 1, 2 and 3 package insert and observation of controls stored in a refrigerator, the laboratory failed to label expiration dates for 3 out of 3 bottles of controls indicating their stability from 2017 to the date of survey. Findings include: 1. The BioRad Liquichek Immunoassay Plus Control Levels 1, 2, and 3 package insert under STORAGE AND STABILITY states, "This product will be stable until the expiration date when stored unopened at -20 to -70 C. Thawed Unopened: When thawed and stored unopened at 2 - 8 C, this product will be stable as follows: - All Analytes: 30 days Except: - Androstenedione: 25 days - Prolactin, PSA (Free) and PSA (Total): 14 days - Estradiol: 8 days - Folate: 4 days Date of thaw should be noted. Thawed Opened: Once thawed, opened, and stored tightly capped at 2 to 8 C, this product will be stable as follows: - All analytes: 14 days Except: - Estradiol: 5 days - Folate: 4 days Once thawed, do not refreeze this product. Discard the remaining material. This product is shipped under frozen conditions." 2. On the day of survey, 12/19/2018, the Surveyors observed that 3 out of 3 bottles of BioRad controls were in use, were not labeled -- 3 of 4 -- indicating the opened or stability expiration date on the controls to determine if they were used beyond the required manufacturer's stability dates. 3. Interview with TP #1 confirmed the findings above on 12/19/2018 around 4:30 PM ** C = Celsius 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 review of laboratory records, interview with Testing Personnel (TP) #1 and the Laboratory Director (LD), the LD failed to maintain the laboratory's quality assessment program to ensure the quality of services provided in the laboratory from 2017 to the date of survey. Findings include: 1. The Laboratories Quality Assurance plan states "To ensure high quality tests results that accurately reflect the status of the patient. To identify and correct issues through an ongoing review and education process." 2. On the day of survey, 12/19/2018, review of the following documents revealed the labortaory failed to follow their Quality Assurance plan: - The Beckman Coulter Access 2 Validation Data, revealed the LD did not review and sign before the instrument was put into use. - Proficiency attestation forms (See D2015). - Labeling controls (See D5415). - Conditions of storage (See D5413) 3. Review of temperature logs revealed the LD did not review and approve 25 out of 25 refrigerator temperature logs in 2017 and 2018. 4. The LD and TP#1 confirmed the findings above on 12/19 /2018 around 4:30 PM. -- 4 of 4 --