Susquehanna Valley Women's Health Care

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 organization, American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate in proficiency testing for the routine chemistry analyte Sodium (Na). 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 review of the CASPER 155 report and graded results from American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) organization, the laboratory failed to successfully participate in PT for the routine chemistry analyte: Sodium (Na). The laboratory had unsatisfactory scores for the 3rd event of 2023 and 1st event of 2024. Findings include: Analyte Year Event Score PT Agency Na 2023 3 0% AAB-MLE Na 2024 1 40% AAB-MLE -- 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 organization, American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate in proficiency testing for the routine chemistry analyte Chloride (Cl). 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 review of the CASPER 155 report and graded results from American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) organization, the laboratory failed to successfully participate in PT for the routine chemistry analyte: Chloride (Cl). The laboratory had unsatisfactory scores for the 2nd and 3rd event of 2023. Findings include: Analyte Year Event Score PT Agency Cl 2023 2 0% AAB-MLE Cl 2023 3 0% AAB-MLE -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: A. Based on a review of laboratory procedure manuals and an interview with technical supervisor #1 (TS), the laboratory failed to establish a competency assessment policy to assess the competency of 3 of 4 technical consultants (TC), 3 of 4 technical supervisors (TS), and 3 of 4 general supervisors (GS) for their supervisory responsibilities from 10/08/2020 to the date of the survey. Findings include: 1. On the day of the survey, 01/05/2023 at 11:00 am, the laboratory could not provide a competency assessment policy to assess the competency of the following personnel for their supervisory responsibilities from 10/08/2020 to 01/05/2023: - 3 of 4 TC ( CMS 209 form, personnel #2, 11, and 36) - 3 of 4 TS (CMS 209 form, personnel #2, 11, and 36) - 3 of 4 GS (CMS 209 form, personnel #2, 11, and 36) 2. The laboratory could not provide documentation for the delegation of duties for the TS,TC,and GS (CMS 209 form, personnel #2, and 36). 3. TS #1 confirmed the findings above on 01 /05/2023 around 03:00 pm. *This is a repeat deficiency. B. Based on a review of the laboratory's competency procedure, annual competency records, and an interview with technical supervisor #1 (TS), the laboratory failed to establish a complete procedure that includes all six points of CLIA required for competency assessment for 37 of 38 testing personnel who performed testing in the areas of microbiology, diagnostic immunology, chemistry, and hematology from 10/08/2020 to the date of the survey. Findings include: 1. On the day of the survey, 01/05/2023 at 10:57 am, the competency assessment records reviewed at the time of survey did not include the six points of CLIA required for competency assessment. 2. Further review of the competency assessment records revealed 32 of 33 TP performing provider 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 11 -- microscopy were not assessed for each test analyzed (vaginal ferns, potassium hydroxide (KOH), and semen analysis) in 2021 and 2022. 3. The laboratory could not provide competency assessment documentation for 32 of 33 TP that performed wet mount examinations in 2021 and 2022. 4. TS #1 confirmed the findings above on 01 /05/2023 around 03:00 p.m. *This is a repeat deficiency. 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 the American Proficiency Institute (API), College of American Pathologists (CAP), and Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and an interview with Technical Supervisor #1 (TS), the laboratory failed to document the evaluation and verification activities for PT testing performed in microbiology, and chemistry from 10/08/2020 to the date of the survey. Findings Include: 1. On the day of the survey, 01/05/2023 at 09:30 am, a review of PT records revealed that the laboratory did not document the review 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 graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in proficiency testing for the analyte Cell Identification(Cell ID). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- 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 Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in proficiency testing for the analyte: Cell Identification (Cell ID). The laboratory had unsatisfactory scores for the 1st event of 2022, and 2nd event 2022. Findings include: Analyte Year Event Score Cell ID 2022 1 40% Cell ID 2022 2 16% -- 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 a review of the CASPER Report 155 report and graded results from the proficiency testing organization Medical Laboratory Evaluation (MLE), 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 Medical Laboratory Evaluation (MLE), 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 2020 and the 3rd event of 2020. Findings include: Analyte Year Event Score Chloride 2020 2 40%. Chloride 2020 3 40%. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of Laboratory procedure manuals and interview with the testing personnel (TP) #4, the laboratory failed to establish a competency assessment policy to assess the competency of 35 of 36 testing personnel (TP) who performed testing in the areas of Microbiology, Clinical Chemistry, Hematology, Serology, Urinalysis and 1 of 2 consultant competencies from 2018 to the day of survey. Findings include: 1. On the day of survey, 10/08/2020, the laboratory could not provide a competency assessment policy to assess the competency of 35 of 36 testing personnel (TP) who performed testing in the areas of Microbiology, Clinical Chemistry, Hematology, Serology, Urinalysis and 1 of 2 consultant competencies from 03/19/2018 to 10/08 /2020. 2. On the CMS 209 personnel form, TP # 11 (listed as a clinical consultant, technical consultant, technical supervisor and general supervisor) was not assessed for competency in 2018, 2019 and 2020. 3. Testing personnel performing provider preformed microscopy were not assessed for each test analyzed ( Vaginal ferns, KOH, wet mounts and semen analysis) in 2018, 2019 and 2020. 3. TP #4 confirmed the findings above on 10/08/2020 around 10:50 am. 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. 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 Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and interview with the testing personnel (TP) #4, the laboratory failed to identify problems that required a

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 Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in proficiency testing for the analyte Sodium. 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 Medical Laboratory Evaluation (MLE), the laboratory failed to successfully participate in proficiency testing for the analyte: Sodium, which is in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 1st event of 2019 and the 2nd event of 2019. Findings include: Analyte Year Event Score Sodium 2019 1 60%. Sodium 2019 2 60%. -- 2 of 2 --

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 the record review and interview with the General Supervisor (GS), the laboratory failed to examine the Hematology and Chemistry Medical Laboratory Evaluation (MLE) proficiency testing (PT) specimens (all 2017 and 2018 events) , in the same manner as it tests patient specimens. Findings including: 1. The laboratory's Attestation Statement of PT testing policy reviewed at the time of investigation, and signed by the former laboratory director states" Under my direction as laboratory director, all PT samples received, are tested and reported within the same guideline as patient specimens". 2. At the time of investigation on 3/19/2018, a review of MLE PT records and instrument print outs revealed that Hematology and Chemistry PT specimens were tested 2 - 5 times before reporting. a. On 2/7/18, ALT (MLE 2018, Event #1) sample #CH3 was tested twice with the results (286 and 287). The laboratory reported 285 (the average) on the MLE test report sheet. b.White blood count PT (MLE 2017 event 1, Sample HD - 5) was tested 3 times with the following results (7.7, 7.9, 7.7). On the MLE test report the laboratory reported 7.8. 3. The General Supervisor stated that the laboratory tested their proficiency specimens multiple times and sometimes averaged the results reported to MLE, while patient specimens were usually tested once. 4. The annual volume for Chemistry tests from 3 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 -- /9/16 through 3/9/17 - 43, 927. The annual volume for Hematology tests from 3/9/16 through 3/9/17 - 15, 305. ALT - Alanine Transaminase. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) record review and interview with the General Supervisor and Testing Personnel #1, the Laboratory failed to test the MLE PT Microscopy Procedure samples for (all events 2017 - 2018 ), with the laboratory's regular patient workload by personnel who routinely performed the testing in the Laboratory. Findings include: 1. Only medical providers routinely perform Microscopy Procedures. 2. Review of the MLE attestation statements, revealed only Testing Personnel who do not routinely perform Microscopy Procedures, ran the samples and signed the MLE attestation statements for (all events 2017 - 2018 ). 3. 34 of 34 medical providers did not participate in proficiency testing for Microscopy Procedures from 2017-2018. 4. During the survey on March 19, 2018 at 11:30 am, the Laboratory Supervisor confirmed the above findings. 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: By personnel interview of the General Supervisor and Testing Personell #1 and review of the Competency Records, the Laboratory failed to follow the Laboratory's written policies and procedures to assess competency, for 37 of 37 Testing Personnel from 2017 through the date of the survey (03/19/2018). Findings: 1. 3 of 3 Laboroatory Testing Personnel performing microbiology, diagnostic immunology, chemistry, and hematology had documentation of all platforms on a single sheet, which did not indicate the 6 Centers for Medicare and Medicaid Services (CMS) required procedures for competency as per the Laboratory Competency Policy in use. 2. 5 of 19 medical providers who performed Provider Performed Microscopy (PPM), had no director signature or date documented on competency performed between 09 /25/2017 and 01/11/2018. 3. 15 o f 34 medical providers who performed PPM, had no competency documented for 2017 through the date of the survey (03/19/2018). 4. The Quality Assessment Review Form used to document medical provider competency did not indicate the 6 CMS required procedures for competency. 5. During the survey, the General Supervisor confirmed, the above findings. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) -- 2 of 5 -- Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation and interview with the General Supervisor (GS), at the time of complaint investigation, the laboratory failed to monitor and document the incubation time for the Group B Strep specimens from 2016 to the day of investigation. There was no written proof that the laboratory followed manufacturer's instruction for the incubation time. Findings include: 1. The BD Max system used for Group B Strep (GBS) tests package insert (Principles of the procedure) states " Following incubation for over 18 hours at 37C in ambient air or 5% CO2 (Carbon dioxide), a 15 uL aliquot of Lim Broth is used for detecting the presence of GBS". 2. The laboratory was unable to provide documentation of the incubation time before adding the aliquot of Lim Broth to ensure manufacturer's instruction was followed. 3. 2318 patient specimens had Group B Strep tests from 3/19/16 through 3/19/17. 4. The GS interviewed on 3/19 /18 at 10:15 am revealed that the laboratory did not document the incubation time. Based on review of the Centaur manufacturer's instructions and a patient report, at the time of complaint investigation, the laboratory failed to follow manufacturer's instructions for the B HCG tests performed on all the Advia Centaur XP analyzer from 2016 through the day of investigation. Findings include: 1. The manufacturer stated linearity (assay range) of the Centaur for B Hcg (Beta human chorionic gonadotropin) is 2.0 mIU/mL 2. A patient report reviewed at the time of survey showed a value of less than 1 mIU/mL. 3. 2378 patients specimes had B Hcg tests from 3/19/16 through 3/19/17. 4. The GS confirmed the findings above on 3/19/18 at 10:24 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 observation and interview with the General Supervisor (GS), at the time of complaint investigation, the laboratory failed to monitor and document the temperature of the only Boekel Scientific complete culture control incubator used for Group B strep specimens from 2016 to the day of investigation. Findings include: 1. The GS interviewed on 3/19/18 at 10:05 am revealed that the laboratory did not document the temperature of the incubator. The laboratory could not produce the temperature record for the incubator from 2016 to the day of investigation. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) -- 3 of 5 -- 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 observation of expired reagent, and interview with the General Supervisor (GS), at the time of complaint investigation, the laboratory failed to ensure 8 different laboratory testing reagents, were not used after exceeding the expiration date. Findings include: 1. While on a tour of the laboratory with the GS at the time of survey, the following expired (exp)reagents and control materials were observed: 1 kit of Ora Quick HCV control lot# 006641747 exp. 06/30/2015 1 HIV Rapid test control pack lot#151000034 exp. 09/2017 1 bottle of DIL T4 reagent lot# 03D2836 exp. 10/09 /2016 1 bottle of FOB (Fecal Occult Blood) test control kit T1 - TCO2 negative control (Hemosure reagent) lot# LO210167796 exp. 02/2017 1 bottle of FOB test control kit T1 - TCO2 positive control (Hemosure reagent) lot# LO210167795 exp. 02 /2017 1 bottle of resolve microscope Immersion oil low viscosity lot# 123370 exp. 12 /2010 10 of 10 bottles of Siemens Advia Centaur total Hcg calibration material lot# 36600 exp. 02/05/2017 1 kit of CBC line Lot # CL120 Exp. 05/25/2017 2. General Supervisor interviewed around 10:25 am on March 19, 2018 confirmed the findings above. 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 quality control (QC) records and interview with General Supervisor (GS), the laboratory failed to document a complete IQCP for the Amnisure, Gardnerella, Candida and Trichomonas tests performed from 2016 through the day of complaint investigation. Findings include: 1. A review of the IQCP for the Affirm analyzer used for Gardnerella, Candida and Trichomonas test, showed there was no Quality Assessment plan (QA). 2. A review of the IQCP for the Amnisure test, showed there was no QA plan. 3. The laboratory performed one risk assessment for multiple tests. It did not address each test system. 4. The IQCP did not have the signature of the current Laboratory director. 5. According to the GS at the time of survey, Gardnerella, Candida and Trichomonas tests were performed on 3056 specimens and Amnisure test performed on 144 specimens from 3/19/16 through 3/19 /17. 4. The GS interviewed on 3/19/2018 at 09:45 am confirmed the findings above. Note: IQCP: Individualized quality control plan D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on review of patient records, and interview with the General Supervisor (GS), at the time of a complaint investigation, the laboratory failed to establish and follow written policies for an ongoing mechanism to monitor, assess amd when indicated, correct problems identified in the analytic systems specified in 493.1291. Findings include: 1. On 08/16/17, a patient CO2 result was reported as 3 mEq/L on the ABX Pentra 400 analyzer. The General Supervisor interviewed at 9:40 am on 3/19/18 said the ordering physician was notified and the result was removed completely from the patient's chart. The 08/18/17 report reviewed at the time of survey indicates that the CO2 result was removed from the patient's final report. 2. Investigation carried out at the time of survey revealed that the incident was not documented. There was no documentation of

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 the record review and interview with the General Supervisor (GS), the laboratory failed to examine the Hematology and Chemistry Medical Laboratory Evaluation (MLE) proficiency testing (PT) specimens (all 2017 and 2018 events) , in the same manner as it tests patient specimens. Findings including: 1. The laboratory's Attestation Statement of PT testing policy reviewed at the time of investigation, and signed by the former laboratory director states" Under my direction as laboratory director, all PT samples received, are tested and reported within the same guideline as patient specimens". 2. At the time of investigation on 3/19/2018, a review of MLE PT records and instrument print outs revealed that Hematology and Chemistry PT specimens were tested 2 - 5 times before reporting. a. On 2/7/18, ALT (MLE 2018, Event #1) sample #CH3 was tested twice with the results (286 and 287). The laboratory reported 285 (the average) on the MLE test report sheet. b.White blood count PT (MLE 2017 event 1, Sample HD - 5) was tested 3 times with the following results (7.7, 7.9, 7.7). On the MLE test report the laboratory reported 7.8. 3. The General Supervisor stated that the laboratory tested their proficiency specimens multiple times and sometimes averaged the results reported to MLE, while patient specimens were usually tested once. 4. The annual volume for Chemistry tests from 3 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 -- /9/16 through 3/9/17 - 43, 927. The annual volume for Hematology tests from 3/9/16 through 3/9/17 - 15, 305. ALT - Alanine Transaminase. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) record review and interview with the General Supervisor and Testing Personnel #1, the Laboratory failed to test the MLE PT Microscopy Procedure samples for (all events 2017 - 2018 ), with the laboratory's regular patient workload by personnel who routinely performed the testing in the Laboratory. Findings include: 1. Only medical providers routinely perform Microscopy Procedures. 2. Review of the MLE attestation statements, revealed only Testing Personnel who do not routinely perform Microscopy Procedures, ran the samples and signed the MLE attestation statements for (all events 2017 - 2018 ). 3. 34 of 34 medical providers did not participate in proficiency testing for Microscopy Procedures from 2017-2018. 4. During the survey on March 19, 2018 at 11:30 am, the Laboratory Supervisor confirmed the above findings. 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: By personnel interview of the General Supervisor and Testing Personell #1 and review of the Competency Records, the Laboratory failed to follow the Laboratory's written policies and procedures to assess competency, for 37 of 37 Testing Personnel from 2017 through the date of the survey (03/19/2018). Findings: 1. 3 of 3 Laboroatory Testing Personnel performing microbiology, diagnostic immunology, chemistry, and hematology had documentation of all platforms on a single sheet, which did not indicate the 6 Centers for Medicare and Medicaid Services (CMS) required procedures for competency as per the Laboratory Competency Policy in use. 2. 5 of 19 medical providers who performed Provider Performed Microscopy (PPM), had no director signature or date documented on competency performed between 09 /25/2017 and 01/11/2018. 3. 15 o f 34 medical providers who performed PPM, had no competency documented for 2017 through the date of the survey (03/19/2018). 4. The Quality Assessment Review Form used to document medical provider competency did not indicate the 6 CMS required procedures for competency. 5. During the survey, the General Supervisor confirmed, the above findings. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) -- 2 of 5 -- Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation and interview with the General Supervisor (GS), at the time of complaint investigation, the laboratory failed to monitor and document the incubation time for the Group B Strep specimens from 2016 to the day of investigation. There was no written proof that the laboratory followed manufacturer's instruction for the incubation time. Findings include: 1. The BD Max system used for Group B Strep (GBS) tests package insert (Principles of the procedure) states " Following incubation for over 18 hours at 37C in ambient air or 5% CO2 (Carbon dioxide), a 15 uL aliquot of Lim Broth is used for detecting the presence of GBS". 2. The laboratory was unable to provide documentation of the incubation time before adding the aliquot of Lim Broth to ensure manufacturer's instruction was followed. 3. 2318 patient specimens had Group B Strep tests from 3/19/16 through 3/19/17. 4. The GS interviewed on 3/19 /18 at 10:15 am revealed that the laboratory did not document the incubation time. Based on review of the Centaur manufacturer's instructions and a patient report, at the time of complaint investigation, the laboratory failed to follow manufacturer's instructions for the B HCG tests performed on all the Advia Centaur XP analyzer from 2016 through the day of investigation. Findings include: 1. The manufacturer stated linearity (assay range) of the Centaur for B Hcg (Beta human chorionic gonadotropin) is 2.0 mIU/mL 2. A patient report reviewed at the time of survey showed a value of less than 1 mIU/mL. 3. 2378 patients specimes had B Hcg tests from 3/19/16 through 3/19/17. 4. The GS confirmed the findings above on 3/19/18 at 10:24 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 observation and interview with the General Supervisor (GS), at the time of complaint investigation, the laboratory failed to monitor and document the temperature of the only Boekel Scientific complete culture control incubator used for Group B strep specimens from 2016 to the day of investigation. Findings include: 1. The GS interviewed on 3/19/18 at 10:05 am revealed that the laboratory did not document the temperature of the incubator. The laboratory could not produce the temperature record for the incubator from 2016 to the day of investigation. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) -- 3 of 5 -- 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 observation of expired reagent, and interview with the General Supervisor (GS), at the time of complaint investigation, the laboratory failed to ensure 8 different laboratory testing reagents, were not used after exceeding the expiration date. Findings include: 1. While on a tour of the laboratory with the GS at the time of survey, the following expired (exp)reagents and control materials were observed: 1 kit of Ora Quick HCV control lot# 006641747 exp. 06/30/2015 1 HIV Rapid test control pack lot#151000034 exp. 09/2017 1 bottle of DIL T4 reagent lot# 03D2836 exp. 10/09 /2016 1 bottle of FOB (Fecal Occult Blood) test control kit T1 - TCO2 negative control (Hemosure reagent) lot# LO210167796 exp. 02/2017 1 bottle of FOB test control kit T1 - TCO2 positive control (Hemosure reagent) lot# LO210167795 exp. 02 /2017 1 bottle of resolve microscope Immersion oil low viscosity lot# 123370 exp. 12 /2010 10 of 10 bottles of Siemens Advia Centaur total Hcg calibration material lot# 36600 exp. 02/05/2017 1 kit of CBC line Lot # CL120 Exp. 05/25/2017 2. General Supervisor interviewed around 10:25 am on March 19, 2018 confirmed the findings above. 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 quality control (QC) records and interview with General Supervisor (GS), the laboratory failed to document a complete IQCP for the Amnisure, Gardnerella, Candida and Trichomonas tests performed from 2016 through the day of complaint investigation. Findings include: 1. A review of the IQCP for the Affirm analyzer used for Gardnerella, Candida and Trichomonas test, showed there was no Quality Assessment plan (QA). 2. A review of the IQCP for the Amnisure test, showed there was no QA plan. 3. The laboratory performed one risk assessment for multiple tests. It did not address each test system. 4. The IQCP did not have the signature of the current Laboratory director. 5. According to the GS at the time of survey, Gardnerella, Candida and Trichomonas tests were performed on 3056 specimens and Amnisure test performed on 144 specimens from 3/19/16 through 3/19 /17. 4. The GS interviewed on 3/19/2018 at 09:45 am confirmed the findings above. Note: IQCP: Individualized quality control plan D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on review of patient records, and interview with the General Supervisor (GS), at the time of a complaint investigation, the laboratory failed to establish and follow written policies for an ongoing mechanism to monitor, assess amd when indicated, correct problems identified in the analytic systems specified in 493.1291. Findings include: 1. On 08/16/17, a patient CO2 result was reported as 3 mEq/L on the ABX Pentra 400 analyzer. The General Supervisor interviewed at 9:40 am on 3/19/18 said the ordering physician was notified and the result was removed completely from the patient's chart. The 08/18/17 report reviewed at the time of survey indicates that the CO2 result was removed from the patient's final report. 2. Investigation carried out at the time of survey revealed that the incident was not documented. There was no documentation of