Highlands Hospital

Summary Statement of Deficiencies D0000 A recertification survey was conducted by the Pennsylvania State Agency at Highlands Hospital on 11/18/2025 and 11/19/2025. The laboratory was found out of compliance with the following conditions: 493.801 Condition: Enrollment and testing of samples. 493.1230 Condition: General Laboratory Systems. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) reports, lack of documentation, and interview with general supervisor (GS) #3, the laboratory failed to enroll in an HHS approved PT program for 2 of 2 non-waived regulated analytes listed in Subpart I from 01/01/2025 to 11/18 /2025. Findings include: 1. On the date of the survey, 11/18/2025 at 10:30 am, the laboratory failed to provide documentation for the enrollment in an HHS approved PT Program for the following 2 of 2 non-waived regulated analytes listed in Subpart I from 01/01/2025 to 11/18/2025: - Gram Stain (Bacteriology) - Blood Gases: pH, pCO2, pO2 (Routine Chemistry) 2. GS #3 confirmed the findings above on 11/18 /2025 at 03:30 pm. D2009 TESTING OF PROFICIENCY TESTING SAMPLES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) proficiency testing (PT) records and interview with General Supervisor (GS) #3 , the Laboratory Director (LD)/designee failed to sign 7 of 162 CAP PT attestation statements for hematology, chemistry and microbiology testing performed from 11/15/2023 to 11/18/2025. 1. The CAP PT attestation forms stated, "The laboratory director and the testing personnel must sign this form." 2. On the day of the survey, 11/18/2025 at 10:30 am, the laboratory failed to provide attestation statements signed by the LD/designee for the following 7 of 162 CAP PT events performed from 11/15/2023 to 11/18/2025: - Urine Drug Testing: Screening (UDS-A 2024) - Clostridoides (Clostridium) dificile Detection Survey (CDF-B 2024) - Coagulation-Limited Survey (CGL-C 2023) - Rapid Group A Strep Antigen Detection Survey (D6-B 2024) - General Chemistry and Therapeutic Drugs Survey (C-B 2024) - Reticulocyte Survey (RT3-A 2024) - Rapid Group A Strep Antigen Detection Survey (D6-A 2025) 3. GS #3 confirmed the findings above on 11/18/2025 at 03:30 pm. 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, lack of documentation, and interview with General Supervisor (GS) #3, the laboratory failed to monitor and document temperature and humidity to ensure operating conditions were met when 1 of 1 chemistry test (Whole Blood Glucose) was performed using the Accu-Chek Inform II glucose meter from 11 /15/2023 to 11/19/2025. Findings include: 1. On the day of the survey, 11/19/2025 at 10:00 am, review of the manufacturer's instruction for use stated, " Use the test strips at temperatures between 16 to 35 degrees Celcius. Use the test strips between 10 - 80% relative humidity." 2. The laboratory failed to provide documentation for temperature and humidity readings taken to ensure operating conditions were met for 1 of 1 chemistry test (Whole Blood Glucose) performed using the Accu-Chek Inform II glucose meter from 11/15/2023 to 11/19/2025. 3. GS #3 confirmed the findings above on 11/19/2025 at 10:30 am. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. -- 2 of 7 -- This CONDITION is not met as evidenced by: Based on lack of documentation, record review, and interview with General Supervisor (GS) #3, the laboratory failed to meet applicable general laboratory systems requirements in 493.1235 for 23 of 23 months from 11/15/2023 to date of survey. Refer to D5209 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 lack of documentation, record review, and interview with General Supervisor (GS) #3, the laboratory failed to follow established procedures to assess the competency of 2 of 5 General Supervisors for their supervisory responsibilities performed in the laboratory from 11/15/2023 to the date of the survey. Findings Include: 1. The laboratory's Competency Assessment Policy stated, "A Competency Assessment is required for all Testing Personnel, Technical Consultants, Technical Supervisors and General Supervisors of the Penn Highlands Connellsville Laboratory. Frequency: All Testing Personnel will have a competency assessment performed semiannually during the first year the individual test patient specimens and then annually thereafter. The Laboratory Director or Technical Supervisor will assess the competency of the General Supervisor annually, in writing". 2. On the day of survey, 11/18/2025 at 9:24 am, the laboratory failed to provide competency assessment records for 2 of 5 GS (CMS 209 GS #2 and #3, dated 11/13/2025), for their supervisory responsibilities performed in the laboratory from 11/15/2023 to 11/19 /2025. 3. GS#3 confirmed the above findings on 11/19/2025 at 10:30 am. Repeat Deficiency ** D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with General Supervisor (GS) #3, the laboratory failed to verify the required performance specifications for Chemistry testing performed on 1 of 1 ALCOR MiniSED, SN 02573 before reporting patient results from 3/26/2024 to 11/18/2025. Findings Include: 1. On the day of survey, 11/18/2025 at 11:30 am, the laboratory could not provide documentation for the verification of the following performance -- 3 of 7 -- specifications perfromed for 1 of 1 ALCOR MiniSED, SN 02573 before reporting patient results from 3/26/2024 to 11/18/2025: - Reportable range - Reference intervals /normal values 2. GS #3 confirmed the above findings on 11/18/2025, at 11:45 am. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) (b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (b)(2)(i) Accuracy. (b)(2)(ii) Precision. (b)(2)(iii) Analytical sensitivity. (b) (2)(iv) Analytical specificity to include interfering substances. (b)(2)(v) Reportable range of test results for the test system. (b)(2)(vi) Reference intervals (normal values). (b)(2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review, lack of documentation and interview with General Supervisor (GS) #3, the laboratory failed to establish performance specifications before reporting patient test results when modifying an FDA-cleared/approved test system for platelet count (PLT) examinations performed on 1 of 1 Beckman Coulter DxH 600 hematology analyzer using sodium citrate anticoagulant from 11/15/2023 to 11/18 /2025. Findings include: 1. Review of the Beckman Coulter DxH 600 manufacturer's instructions for use stated, "Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended." 2. On the day of the survey, 11/18/2025 at 1:45 pm, the laboratory failed to provide documentation for the performance specifications established when performing PLT counts using sodium citrate anticoagulant (blue top tube) on 1 of 1 Beckman Coulter DxH 600 hematology analyzer using sodium citrate anticoagulant from 11/15/2023 to 11/18/2025. 3. GS #3 confirmed the findings above on 11/18/2025 at 2:00 pm. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A. Based on lack of maintenance records, and interview with General Supervisor (GS) #3, the laboratory failed to perform and document the maintenance and function checks as defined by the manufacturer for 15 of 15 traceable thermometers used to ensure acceptable storage and operating temperatures were met in the laboratory from 11/15/2023 to 11/19/2025. Findings include: 1. During observation in the laboratory on 11/19/2025 at 10:15 am, the following thermometers were observed in use in the laboratory for storage of reagents, supplies, calibrators, and quality control: 2 room temperature/humidty thermometers S/Ns: 209022 and 32838 11 refrigerator thermometers, S/Ns: 4689, 218613, 24715, 196982, 197009, 20632, 43860, 91533, -- 4 of 7 -- 24707, 9895, and 27960 2 freezer thermometers, S/Ns: 20337 and 21758 2. The laboratory failed to provide documentation of maintenance and function checks as defined by the manufacturer for 15 of 15 traceable thermometers used to ensure acceptable storage and operating temperatures were met in the laboratory from 11/15 /2023 to 11/19/2025. 3. GS #3 confirmed the above findings on 11/19/25 at 10:30 am. B. Based on review of procedures, maintenance records, and interview with General Supervisor (GS) #3, the laboratory failed to perform and document 1 of 4 quarterly maintenance check as defined by the manufacturer for the Beckman Coulter iChem Velocity used for urinalysis examinations from 11/15/2023 to 11/18/2025. Findings include: 1. On the day of survey, 11/19/2025 at 9:30 am, review of the laboratory's maintenance records revealed The laboratory failed to perform and document the quarterly manufacturer recommended maintenance check in October 2025 for the Beckman Coulter iChem Velocity used for urinalysis examinations from 11/15/2023 to 11/18/2025. 2. GS #3 confirmed the findings above on 11/19/2025 at 2:00 pm. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). This STANDARD is not met as evidenced by: Based on record review and interview with the General Supervisor (GS) #3, the laboratory failed to establish and maintain a policy that ensured compliance with testing and distribution records for emergency release of blood (606.160(b)(3)(v)) for 2 of 4 emergency transfusion requests from 11/15/2023 through 11/19/2025. Findings include: 1. The laboratory's Emergency Release of Blood Procedure stated, "10. Immediately have the physician sign the emergency Transfusion Request form. If the physician is not able to sign, have the RN in charge of the patient sign and date the Emergency Transfusion Request form. (If the patient is being given type-specific units, then immediately have the physician or RN sign the Patient/Donor Compatibility Verification Form PRBC also). These forms MUST BE SIGNED by the physician or RN in charge of the patient BEFORE the units are released." 2. On the day of the survey, 11/18/2025 at 2:53 pm, review of the laboratory's Emergency Release Blood Procedure revealed the laboratory failed to establish and maintain a policy that ensured compliance with blood and blood product distribution for emergency release, including signature of requesting physician obtained before or after release (606.160(b)(3)(v)) from 11/15/2023 to 11/18/2025. 3. Further review of the laboratory's Emergency Transfusion Request forms revealed the laboratory failed to ensure the following 2 of 4 emergency transfusion requests were signed by the requesting physician from 11/15/2023 to 11/19/2025: - Emergency Transfusion Request, Unit #: W18272518096900H, signed by Registered Nurse (RN) on 6/17 /2025. - Emergency Transfusion Request, Unit #: W1822407826800U, signed by RN on 7/21/2024. 4. GS#3 confirmed the above findings on 11/19/2025 at 10:30 am.. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test -- 5 of 7 -- results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with General Supervisor (GS) #3, the laboratory failed to evaluate twice a year the relationship between test results using different methodologies for 2 of 2 comparison studies performed for hematology methodologies used from 11/14/2023 to 11/18/2025. Findings include: 1. On the day of the survey, 11/18/2025 at 1:30 pm, the laboratory failed to provide documentation for the evaluation performed twice a year ( 2 of 2 comparison studies) to monitor and evaluate the relationship between the following methodologies used for hematology examinations performed from 9/28/2023 to 9/17 /2025: - EDTA vs Sodium Citrate tubes for Platelets 2. GS # 3 confirmed the findings above on 11/18/2025 at 2:30 pm. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on record review and interview with General Supervisor (GS) #3, the laboratory director (LD) failed to ensure that verification procedures used were adequate to determine the accuracy, precision, and other pertinent performance characteristics before reporting patient results for hematology examinations for erythrocyte sedimentation rates (ESR) performed on 1 of 1 ALCOR MiniSED analyzer from 3/26/2024 to 5/3/2024. 1. On the date of the survey, 11/18/2025 at 12: 35 pm, review of instrument logs and verification and performance specification reports revealed that testing on the ALCOR MiniSED began on 3/26/2024. and the LD reviewed and approved the method for patient testing on 5/3/2024. 2. Further review of the verification of performance specifications revealed the LD reviewed and approved the verification of performance specifications for 1 of 1 Alcor MiniSED analyzer on 05/03/2024. 3. During interview, 11/18/2025 at 02:30 pm, GS #3 confirmed the findings above and stated, "the laboratory performed 74 ESR examinations from 3/26/2024 to 5/3/2024 prior to the review and approval of the verification procedures by the LD." D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on lack of documentation, record review, and interview with the General Supervisor (GS) #3, the Technical Supervisor failed to follow established procedures to assess the competency of 1 of 8 Testing Personnel (TP) that performed -- 6 of 7 -- immunohematology, chemistry, hematology and urinalysis examinations in the laboratory from 11/15/2023 to the date of the survey. Findings Include: 1. The laboratory's Competency Assessment Policy stated, "A Competency Assessment is required for all Testing Personnel, Technical Consultants, Technical Supervisors and General Supervisors of the Penn Highlands Connellsville Laboratory. Frequency: All Testing Personnel will have a competency assessment performed semiannually during the first year the individual test patient specimens and then annually thereafter. The assessment will be completed by the Technical Supervisor". 2. On the day of survey, 11/18/2025 at 9:24 am, the laboratory failed to provide competency assessment records for 1 of 8 TP (CMS 209 TP #1, dated 11/13/2025), that performed immunohematology, chemistry, hematology and urinalysis examinations in the laboratory from 11/15/2023 to 11/19/2025. 3. GS#3 confirmed the above findings on 11/19/2025 at 10:30 am. -- 7 of 7 --

Summary Statement of Deficiencies D2154 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(b) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) proficiency testing (PT) records and interview with General Supervisor (GS) #3, the laboratory failed to attain an overall testing event score of 100 percent for 1 of 3 events for Immunohematology in 2023. Findings include: 1. On the day of survey 11/14/2023 at 11:26 am, review of CAP PT records revealed the laboratory received a score of 90% for ABO/RHO typing for the CAP PT 2023 J-A Event . 2. GS #3 confirmed the above finding on 11/15/2023 at 3:45 pm 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 General Supervisor #3 (GS), the laboratory failed to ensure that the State of Pennsylvania (PA) regulations were met regarding having a supervisor on site during all normal scheduled working hours in which tests were performed from 09/14/2021 to the dates of the survey. Findings include: 1. The PA regulations (5.23(b)(1) states: "A general supervisor who meets all the requirements of subsection (a)(1), (2) or (3) and is on the laboratory premises during all normal scheduled working hours in which tests are being performed." 2. On Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- the day of the survey, 11/14/2023 at 9:53 am, review of the laboratory personnel report (PA State) and personnel credentials revealed that the laboratory failed to ensure that the PA regulations were met regarding having a qualified supervisor on site during all hours of patient testing from 09/14/2021 to 11/15/2023. 3. GS #3 confirmed the findings above on 11/15/2023 at 3:45 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's competency training and assessment records and interview with General Supervisor (GS) #2, the laboratory failed to follow a competency assessment procedure to assess the competency of 1 of 3 General Supervisors (GS) for their supervisory responsibilities in 2023. Findings Include: 1. The laboratory's Competency Assessment-Laboratory procedure states, "The Laboratory Director or Technical Supervisor will assess the competency of the General Supervisor annually, in writing." 2. On the days of survey, 11/14/2023 and 11 /15/2023, the laboratory could not provide site specific documentation of the annual competency assessment for 1 of 3 GS (CMS-209 personnel #2) for their supervisory responsibilities in 2023. 3. GS #2 confirmed the above findings on 11/15/2023 around 3:45 pm. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with General Supervisor (GS) #3, the laboratory failed to verify twice annually the accuracy of Direct Antiglobulin Test (DAT) and Trichomonas microscopic examinations (wet prep) performed from 09/14 /2021 through the days of survey. Findings include: 1. On the days of survey, 11/14 /2023 and 11/15/2023, the laboratory could not provide documentation of the twice annual verification of accuracy for DAT and Wet Prep microscopic examinations performed from 09/14/2021 through the days of survey. 2. The laboratory reported an annual volume of 711 immunohematology examinations and 258 Microbiology examinations (CMS-116). 3. GS #3 confirmed the findings above on 11/15/2023 at 3: 45 pm D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. -- 2 of 13 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, operator manuals, and interview with general supervisor #4 (GS), the laboratory failed to have a complete written procedure manual for chemistry testing performed that met the requirements of 493.1251 from 09 /14/2021 to the date of the survey. Findings include: 1. On the day of the survey, 11/14 /2023 at 03:55 pm, review of the procedure manuals for chemistry testing revealed the operators manuals were used to perform testing on the Beckman Coulter AU680 chemistry analyzer from 09/15/2021 to 11/14/2023: 2. Review of the operators manual revealed that the test system instructions used failed to include the following requirements of 493.1251: - Step by step performance of the procedure including test calculations and interpretation of results - Preparation of slides, solution, calibrators, controls, reagents, stains, and other material used in testing. - Control procedures - Calibration and calibration verification procedures. -

Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Quality Control records,and personnel interview with the Laboratory Supervisor and the Lead Technician, the laboratory failed to perforn end user quality control for each batch or shipment of media, before or concurrent with initial use . Findings: 1. Sterility of media and ability to support or inhibit growth was not documented for BD BACTEC Soybean-Casein Digest Broth, used on the Bactec FX40. 2. BD BACTEC Soybean-Casein Digest Broth, aerobic lot # 1061233 & anaerobic lot # 1039579 were used on the Bactec FX40, the date of the survey. 3. 894 incubate only specimens were run on the Bactec FX40 from 03/08/2021 to 09/14 /2021. 4. During the survey (approximately 15:00 09/14/2021), the Laboratory Supervisor confirmed the above findings. 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 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 technical consultant (TC), the laboratory failed to establish a complete competency assessment procedure to assess the competency of testing personnel (TP) who performed Microbiology, Chemistry, Hematology, Immunohematology, Serology, Parasitology, Toxicology, Urinalysis tests and for consultants in 2018. Findings Include: 1. On the day of survey, 06/18/2019, the laboratory failed to provide a complete written policy on how to assess the competency of testing personnel (TP) who Microbiology, Chemistry, Hematology, Immunohematology, Serology, Parasitology, Toxicology, Urinalysis tests and for consultants. 2. The laboratory could not provide competency assessment records for the following personnel in 2018: - 1 of 1 Initial 6 month competency for TP#13. - 12 of 13 TP who performed Microbiology, Chemistry, Hematology, Immunohematology, Serology, Parasitology, Toxicology, Urinalysis tests. - 1 of 1 TC / general supervisor. 3. In 2018, 514,165 patient tests were analyzed. 4. The TC confirmed the findings above on 06/18/2019 around 09:00 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) 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 -- -- (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 calibration verification (Cal Ver.) records and interview with the technical consultant (TC), the laboratory failed to perform cal. ver. on 2 of 2 Beckman Coulter AU680 analyzers and on 1 of 1 Siemens Rapid Point 500 analyzer, once every 6 months in 2018. Findings include: 1. On the day of survey, 06/18/2019, the TC could not provided documentation of cal. ver. performed on 2 of 2 Beckman Coulter AU680 analyzers and 1 of 1 Siemens Rapid Point 500 analyzer performed every 6 months in 2018. 2. In 2018, 339, 125 specimen were analyzed on the Beckman Coulter AU680 analyzers. 3. In 2018, 1,820 specimen were analyzed on the Siemens Rapid Point 500 analyzer. 4. The TC confirmed the finding above on 06/18/2019 around 02:30 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 review of quality control (QC) records and interview with the technical consultant (TC), the laboratory failed to document QC procedures each day of patient testing for 7 of 7 Wet Mount microscopic examinations, 1129 of 1129 erythrocyte sedimentation rate (ESR) tests performed on the Polymedco Sedimat 15 Plus Automated Sedrate analyzer and 378 of 378 Clostridium difficile (C. diff) tests performed on the Alere C. diff Quik Check Complete kits from 2018 to the date of survey. Findings Include: 1. On the day of survey, 06/18/2019, review of quality control records revealed the laboratory did not document QC procedures performed each day of patient testing for 7 of 7 Wet Mount microscopic procedures, 1129 of 1129 ESR tests and 378 of 378 c.diff tests from 2018 to 06/18/2019. 2. In 2018, 5 Wet Mount Microscopic Examination were analyzed. 3. In 2019 (01/01/2019 to 06/18 /2019), 2 Wet Mount Microscopic Examination were analyzed 4. In 2018, 828 ESR tests were analyzed. 5. In 2019 (01/01/2019 to 06/18/2019), 401 ESR tests were -- 2 of 3 -- analyzed. 6. In 2018, 2030 c. diff tests were analyzed. 7. In 2019 (01/01/2019 to 06/18 /2019), 980 c. diff tests were analyzed 8. The TC confirmed the findings above on 06 /18/2019 around 01:00 pm. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with the technical consultant (TC), the laboratory failed to document visual inspection on each lot/shipment of BioMrieux Chromogenic Medium Identification (CHROMID) methicillin-resistant Staphylococcus aureus (MRSA) Culture Media used for throat culture screens from 10 /17/2017 to the date of survey. Findings include: 1. On the day of survey, 06/18/2019, the TC could not provided documentation of visual inspection performed on each lot /shipment of the BioMrieux CHROMID MRSA culture media received from 10/17 /2019 to 06/18/2019. 2. The TC confirmed the finding above on 06/18/2019 around 11: 45 am. -- 3 of 3 --

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 and performance evaluations from the proficiency testing organization College of American Pathology (CAP), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: Primidone which is of the specialty Toxicology. The laboratory had unsatisfactory scores for the 2nd event of 2018 and the 3rd event of 2018. See D2118. D2118 TOXICOLOGY CFR(s): 493.845(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 or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER 155 report and performance evaluations from the proficiency testing organization College of American Pathologists (CAP), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the anayte: Primidone which is in the specialty of Toxicology in which the laboratory is certified under CLIA. The laboratory had unsatisfactory scores for the 2nd event of 2018 and the 3rd event of 2018 for the analyte listed above. Findings include: 1. CAP 2018 Event 2 for Primidone the score was 0% and was unsatisfactory. 2. CAP 2018 Event 3 for Primidone the score was 0% and was unsatisfactory. -- 2 of 2 --