Alma Illery Medical Center

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 07/17/2024. The laboratory was found to be out of compliance with the following condition: 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and interview with Technical Supervisor (TS) #2, the laboratory director (LD) failed to be present for a reasonable period of each working day in each laboratory for which he is director from 10/18/2022 to the day of survey as required by PA State regulations. Findings include: 1. The PA State regulation 5.22 (g) states: "A director shall be present for a reasonable period of each working day in each laboratory for which he is director." 2. The Laboratory Director's position responsibilities signed by the LD on 09/20/2019 states, "The Laboratory Director must be accessible to the laboratory to provide on-site, telephone or electronic consultation as needed. If the laboratory director delegates his responsibilities, he remains responsible for ensuring that all duties are properly performed." 3. On the day of survey, 07/17/2024 at 8:19 am, an interview with TS #2 (CMS 209 personnel #2) revealed that the Laboratory Director visited the laboratory every few months from 10 /18/2022 to 07/17/2024. 4. TS #2 confirmed the findings above on 07/17/2024 at 10: 55 am. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 observation of the laboratory, lack of documentation, and interview with technical supervisor (TS) #2 the laboratory failed to perform and document the maintenance/ function checks for 1 of 1 centrifuge and 1 of 1 microscope used to perform microscopic urinalysis examinations from 10/18/2022 to the day of survey. Findings Include: 1. The laboratory's Quality Assessment policy states, "Records of all maintenance and service must be maintained including but not limited to: routine maintenance, as needed maintenance, startup and shutdown logs, and preventative maintenance conducted by authorized service technicians. This applies to analyzers, microscopes, centrifuges, diH2O systems, etc." 2. On the day of survey, 07/17/2024, the laboratory failed to provide the maintenance/function check records for the following instrumentation: - 1 of 1 microscope used to perform microscopic urinalysis examinations, due 6/22/2024. - 1 of 1 Hamilton Bell centrifuge due 11/21/2023. 3. The above findings were confirmed by TS #2 on 07/17/2024 at 10:55 am. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the Beckman Coulter AU480 and TOSOH AIA 360 analyzer calibration verification (CV) records and interview with technical supervisor (TS) #2, the laboratory failed to perform CV for 23 of 27 analytes on the Beckman Coulter AU480 analyzer and 1 of 1 analyte on the TOSOH AIA 360 analyzer at least once every 6 months from 10/14/2022 to 07/17/2024. Findings include: 1. On the day of the survey, 07/17/2024 at 9:28 am, review of the laboratory's CV records revealed the laboratory failed to perform CV at least once every 6 months on the Beckman Coulter AU480 and TOSOH AIA 360 analyzers for the following analytes from 10/14/2022 to 07/17/2024: Beckman Coulter AU480 -Albumin -Alkaline Phosphatase (ALP) - -- 2 of 4 -- Alanine aminotransferase (ALT) -Amylase -Aspatartate aminotransferase (AST) - Blood urea nitrogen (BUN) -Bilirubin, Direct -Bilirubin, Total -Calcium -Chloride - Sodium -Potassium -Cholesterol, Total -Creatinine Kinase (CK) -Glucose -Lactate dehydorgenase (LDH) -Gamma-glutamyl transferase (GGT) -Cholesterol, HDL -Iron, Total -Phosphorus -Triglycerides -Protein, total -Uric acid TOSOH AIA 360 -Prostate specific antigen (PSA) 2. The laboratory performed 51,116 chemistry examinations in 2023 (CMS 116 estimated annual volume). 3. TS #2 confirmed the findings above on 07/17/2024 at 10:55 am. *REPEAT DEFICIENCY D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of records, and interview with Technical supervisor (TS) #2, the laboratory director failed to provide overall management and direction of the laboratory in accordance with 493.1445 from 10/18 /2022 to 07/17/2024. Refer to D6094, D6103 D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the 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 lack of documentation, review of the laboratory's Quality Assessment (QA) policy and interview with technical supervisor (TS) #2, the Laboratory Director (LD) failed to ensure a QA program was established and maintained to ensure the quality of services provided by the laboratory from 1/23/2023 to the date of survey. Findings include: 1. The laboratory's QA policy states, "Conduct bimonthly Quality Assessments to review current policies and their effectiveness. Any changes to policy needed to address problems during the previous 2 months will be made during this QA, if not already done. The effectiveness of previous

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the Beckman Coulter AU480 and Tosoh AIA 360 analyzers calibration records and interview with technical supervisor # 2 (TS), the laboratory failed to perform calibration verification (CV) for 27 of 27 analytes on the Beckman Coulter AU480 analyzer and for 1 of 1 analytes on the Tosoh AIA 360 analyzer at least every 6 months from 08/13/2020 to the date of survey. Findings include: 1. On the day of the survey, 10/18/2022 at 12:15 pm, the laboratory could not provide 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 -- documentation of CV performed at least every 6 months on the Beckman Coulter AU480 and Tosoh AIA 360 analyzers for the following analytes from 08/13/2020 to the date of survey: A. Beckman Coulter AU480 -Albumin -Alkaline Phosphatase (ALP) -Alanine aminotransferase (ALT) -Amylase -Aspatartate aminotransferase (AST) -Blood urea nitrogen (BUN) -Bilirubin, Direct -Bilirubin, Total -Calcium - Chloride -Sodium -Potassium -Cholesterol, Total -Carbon dioxide (CO2) -Creatinine Kinase (CK) -Creatinine -Gamma-glutamyl transferase (GGT) -Glucose - Cholesterol, HDL -Iron, total -Lactate dehydorgenase (LDH) -Magnesium -Phosphorus -Protein, total -Triglycerides -Uric acid -Glycohemoglobin A1c B. Tosoh AIA 360 -Prostate- specific antigen (PSA) 2. The laboratory performed 42,478 chemistry examinations in 2021 (annual volume listed on CMS 116 form). 3. TS #2 confirmed the findings above on 10/18/2022 around 2:30 pm. D5505 BACTERIOLOGY CFR(s): 493.1261(a)(3) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(3) When each batch (prepared in-house), lot number (commercially prepared), and shipment of antisera is prepared or opened, and once every 6 months thereafter. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Technical Supervisor (TS)#2, the laboratory failed to document the quality control (QC) for the Streptex latex Agglutination test kit for the identification of streptococcus bacteria from 08/17/2020 to 10/18/2022. Findings include: 1. On the day of the survey, 10/18/2022 at 11:00am. The laboratory could not provide QC records for positive and negative reactivity for each lot number and each shipment of the Streptex latex agglutination test kits used for the identification of streptococcus serotyping from 08/17/2020 to 10/18/2022. 2. The TS#2 confirmed the above finding on 10/18/2022 at 02:30pm. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the 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 lack of Quality Assurance (QA) documentation and interview with testing personnel #2 (TP), the Laboratory Director (LD) failed to ensure a QA program was maintained and documented to ensure the quality of services provided by the laboratory from 08/17/2020 to the date of survey. Findings include: 1. On the date of survey, 10/18/2022 at 12:30 pm, the laboratory could not provide documentation for the periodic QA evaluation performed to assess the laboratory's pre-analytical, analytical, and post-analytical processes from 08/17/2020 to 10/18/2022. 2. The laboratory performed 54,270 non waived tests in 2021 (annual volume listed on CMS 116 form). 3. TP #2 confirmed the findings above on 10/18/2022 around 02:30 pm. * Repeat Deficiency D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of the laboratory competency assessment records and interview with technical supervisor #2 (TS), the TS failed to evaluate and document the annual competency assessment for 4 of 4 testing personnel (TP) who performed testing in microbiology, immunology, chemistry, and hematology from 08/17/2020 to the date of survey. Findings include: 1. On the day of survey 10/18/2022 at 09:17 am, the TS could not provide annual competency assessment records for 4 of 4 TP (CMS 209 personnel #2, #3, #4, and #5) who performed the following examinations from 01/01 /2021 to 12/31/2021: -Chemistry (Beckman AU480 and Tosoh AIA-360) - Hematology (Beckman AcT 5diff AL) -Urinalysis (Clinitek Status) -Manual differentials -Urinalysis microscopics -SSA for Urine Protein -Urine Cultures - Antimicrobial Sensitivities -Throat screens (Group A) -Vaginal/Rectal screen (Group B) -Sickle Cell Screen -Sedimentation Rate (ESR) -Rapid plasma reagin (RPR) - Rheumatoid Factor (RF) -Mononucleosis Screen -Serum, human chorionic gonadotropin (hCG) -Urine, human chorionic gonadotropin (hCG) 2. Further review of competency assessment records revealed that the TS evaluated 4 of 4 TP (CMS 209 personnel #2, #3, #4, and #5) for their testing performance for only the following analyzers/testing performed in 2020 and 2022: -Microbiology Antibiotic Susceptibility -API 20E -AU480 Chemistry analyzer -AcT 5diff-AL analyzer -Tosoh AIA-360 analyzer 3.The laboratory performed 54,270 non waived examinations in 2021 (annual volume listed in CMS 226 form). 4. TS #2 confirmed the findings above on 10/18/2022 around 02:30 pm. -- 3 of 3 --

Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the 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 interview of the Laboratory Supervisor & Testing Personel 1 and review of the laboratory records, the Laboratory Director failed to establish and maintain a Quality Assessment program, for 2 of 2 years, from 05/07/2018 through 08/13/2020. Findings include: 1. On the day of the survey (08/13/2020), the laboratory failed to produce a Quality Assessment policy. 2. During the survey at approximately (16:00 08 /13/2020), the Laboratory Supervisor confirmed the above finding. 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 D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of Beckman Coulter AU480 and Tosoh AIA 360 Analyzers calibration records and interview with General Supervisor (GS) #2, the laboratory failed to perform calibration verification (CV) on the Beckman Coulter AU480 and Tosoh AIA 360 Analyzer at least every 6 months from 2017 to the date of survey. Findings include: 1. On the day of survey, 05/07/2018, review of Beckman Coulter AU480 and Tosoh AIA 360 Analyzer CV, revealed that the laboratory has not 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 -- performed CV at least every six months. No current calibration verification record were available at the time of inspection. 2. In 2017: 40, 359 Chemistry tests were performed on patients. 3. In 2018 (January 1st to May 7th) 15,664 Chemistry tests were performed on patients. 4. GS #2 confirmed the finding above on 05/07/2018 around 2:00 pm. 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 the review of Urine Microscopic Analysis Quality Control (QC) records and interview with the General Supervisor (GS) #2, the laboratory failed to document QC for Urine Microscopic Analysis each day of patient testing from 2017 to the date of survey. Findings Include: 1. On the date of survey 05/09/2018, review of Urine Microscopic QC records, revealed the laboratory has reference material available for Urine Microscopic analysis QC but not documented. 2. In 2017: 669 Urine Microscopic Analysis were performed on patients. 3. In 2018 (January 1st to May 7th) 288 Urine Microscopic tests were performed on patients 4. The GS#2 confirmed the findings above on 05/07/2018 around 02:45 pm. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Quality Control (QC) records and interview with the General Supervisor (GS) #2, the laboratory failed to test the manual differential stain (Fisher Brand Hema-Quik II) for reactivity each day of patient testing from 2017 to the date of survey. Finding Include: 1. On the day of survey, 05/07/2018, review of QC records revealed, the laboratory did not document manual differential stain reactivity each day of patient in 2017 and 2018. GS #2 stated " it is performed but not documented". 2. In 2017 : 1,027 differentials were performed on patients. 3. In 2018 (January 1st to May 7th) 419 differentials were performed on patients. 4. The GS #2 confirmed the findings above on 05/07/2018 around 3:45 pm. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or -- 2 of 4 -- concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of Antimicrobial Susceptibility test Quality Control (QC) Records, and interview with the General Supervisor (GS) #2, the laboratory failed to check QC for Antimicrobial Susceptibility QC each day of patient testing from 2017 to the date of survey (17 of 17 months). Findings Include: 1. On the day of survey, 05/07/2018, review of Antimicrobial Susceptibility test Quality Control (QC) Records, revealed that that the laboratory performed QC on a weekly bases in 2017 and 2018. 2. The Laboratory could not produce a Individual Quality Control Plan (IQCP), for performing Antimicrobial Susceptibility test Quality Control (QC) on a weekly bases. 3. In 2017: 256 Antimicrobial Susceptibility tests were performed. 4. In 2018 (January 1st to May 7th) 98 Antimicrobial Susceptibility tests were performed. 5. GS #2 confirmed the findings above on 05/07/2018 around 3:00 pm. D5781