Munson Healthcare Dba Heather Hill Care

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the Laboratory Director and TP failed to attest to the routine integration of proficiency testing (PT) samples into the patient workload using the laboratory's routine methods for three out of six College of American Pathologists (CAP) PT events for arterial blood gas (ABG) testing in the subspecialty of Routine Chemistry. This deficient practice had the potential to affect 300 out of 300 patient tests performed in this laboratory between 10/16/2023 and 09/24/2025. Findings Include: 1. Review of the laboratory's "ABG Proficiency Testing" policy and procedure, approved via signature and date by the Laboratory Director on 11/26/2024, did not find any instructions for the Laboratory Director and TP to attest to the routine integration of proficiency testing (PT) samples into the patient workload using the laboratory's routine methods for each testing event. 2. Review of the laboratory's 2023, 2024 and 2025 CAP PT documentation lacked documentation of the Laboratory Director and/or TP attestations on the following PT events: AQIS-C 2023 - no LD or TP attestations AQIS-A 2024 - no TP attestations AQIS-C 2024 - no LD attestation AQIS-B 2025 - no LD or TP attestations LD; Laboratory Director 3. The Inspector requested the laboratory's approved PT policy and procedure to include instructions for Laboratory Director and TP attestations on PT events and the laboratory's 2023, 2024 and 2025 CAP PT attestations signed by the Laboratory Director and TP from TP#1. TP#1 confirmed that the laboratory's PT policy and procedure did not include attestation instructions. TP#1 further confirmed the Laboratory Director did not attest to the routine integration of PT samples into the patient workload using the laboratory's 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 -- routine methods for the third events of 2023 and 2024 and the second event of 2025. TP#1 also confirmed the TP did not attest to the third event of 2023, the first event of 2024 and the second event of 2025. TP#1 was unable to provide the requested documentation on the date of the inspection. The interview occurred on 09/24/2025 at 9:25 AM. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the laboratory failed to evaluate and document actions taken for two unacceptable pCO2 (partial pressure of carbon dioxide) out of six College of American Pathologists (CAP) proficiency testing (PT) events in 2023, 2024 and 2025 in the subspecialty of Routine Chemistry. This deficient practice had the potential to affect 25 out of 25 patient pCO2 tests results from 10/20/2024 through 09/24/2025. Findings Include: 1. Review of the laboratory's 2023, 2024 and 2025 CAP ABG (arterial blood gas) PT documentation, provided on the date of the inspection, revealed the following unsatisfactory analyte testing scores without any documented evaluations: Third PT Event 2024 pCO2; 80% First PT Event 2025 pCO2; 80% 2. The Inspector requested the laboratory's documented investigation, technical assistance and TP training activities for the unacceptable pCO2 PT results from TP#1. TP#1 confirmed the laboratory did not investigate, document and implement any

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the laboratory failed to evaluate and document their assessments of the College of American Pathologists (CAP) Proficiency Testing (PT) analytes scored below 100% (percent). This deficient practice had the potential to affect all 150 patient Arterial Blood Gas (ABG) tests performed in this laboratory in the subspecialty of Routine Chemistry between the first PT testing events of 2022 and 2023. Findings Include: 1. Review of the laboratory's "ABG Proficiency Testing" policy and procedure, approved by the Laboratory Director on 01/03/2022 and provided for the inspection, did not find instructions to conduct and document the laboratory's assessment when the analytes are scored below 100% by the PT provider. 2. Review of the laboratory's 2022 and 2023 CAP PT documentation revealed the partial pressure of oxygen (pO2) was scored 80% for the first testing event of 2022 and the pH, pO2 and partial pressure of carbon dioxide (pCO2) were each scored 80% for the first testing event of 2023 with no documented evidence of any assessments for the unacceptable reported results. 3. TP#1 confirmed, in an electronic mail (email) on 05/24/2023 at 9:30 AM, that the laboratory did not evaluate/document the PT evaluations of the unacceptable results for AQI-A 2022/PO2=80%, AQI-A 2023/pH, PCO2 and PO2=80%. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it 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 -- can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 and an interview with Testing Personnel (TP) #1, the laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for arterial blood gas (ABG), sodium (Na), potassium (K) and ionized calcium (Ca++) testing for accuracy, precision and reportable range. This deficient practice had the potential to affect 125 out of 125 patient test results from the implementation of the iSTAT test system in July 2022 to 05/23/2023. Findings Include: 1. Review of the laboratory's policies and procedures provided for the inspection, did not find any instructions for any performance specification activities for the iSTAT test system that was implemented in July 2022. 2. The Inspector requested the laboratory's policy and procedure for performance specification activities and all performance specification documentation for the iSTAT test system from Testing Personnel (TP) #1. TP#1 confirmed, via a telephone conversation on 05/30/2023 at 11:12 AM, that the laboratory did not establish a policy and procedure for performance specification activities for ABG, Na, K and Ca++ testing procedures, did not conduct and document any performance specification activities and was unable to provide the requested documentation. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the laboratory failed to indicate the name and address of the laboratory location where the arterial blood gas (ABG), sodium (Na), potassium (K) and ionized calcium (Ca++) testing were performed on the final test reports. This deficient practice had the potential to affect 238 out of 238 patient ABG, Na, K and Ca++ tests performed in the subspecialty of Routine Chemistry between the last CLIA inspection on 10/12/2021 and 05/23/2023. Findings Include: 1. Review of a sample of the laboratory's 2023 patient final test reports provided for the inspection, revealed six out of six reports had the instrument ABG, Na, K and Ca++ result printouts attached to a template worksheet that was completed by hand, specific to the patient's information, scanned into the hospital's electronic medical record (EMR) system and then made available to the ordering provider. 2. Further review of the same six out of six sample of the laboratory's 2023 patient ABG, Na, K and Ca++ final test reports did not find any indication of the name and address of the laboratory location where the testing was -- 2 of 3 -- performed. 3. TP#1 confirmed, via an electronic mail (email) on 05/24/2023 at 9:30 AM, that the result forms had been recently updated and do not contain the laboratory's address. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: **This is a repeat deficiency as cited on the 02/27/2019 CLIA inspection.** Based on record review and an interview with Testing Personnel (TP) #1, the Technical Consultant (TC) failed to evaluate and document the second semi-annual competency of TP#1 and TP#6 who were responsible for moderate complexity arterial blood gas (ABG), sodium (Na), potassium (K) and ionized calcium (Ca++) testing procedures during the first year the individuals tested patient specimens utilizing the newly implemented iSTAT test system in January 2022. This deficient practice had the potential to affect all patient testing performed by two out of eight TP between 01/03 /2022 and 05/23/2023. Findings Include: 1. Review of the laboratory's Form CMS- 209, provided on the date of the inspection, approved, signed and dated by the Laboratory Director on 05/16/2023, revealed eight individuals listed as TP. 2. Review of the laboratory's "ABG Competency Assessment" policy and procedure, provided on the date of the inspection, approved, signed and dated by the Laboratory Director on 11/11/2015, found the following statements: "Policy ...competency assessment is completed...at six months of employment and then annually by all employees involved on the testing or reporting of Arterial Blood Gasses. Arterial Blood Gas Competency Assessment is to be performed by the lab director." 3. Review of the laboratory's 2022 and 2023 semiannual competency assessment records, provided for the inspection, did not find any record that a 12 month assessment was conducted on TP#1 and TP#6 during their first year of testing patient ABG specimens on the newly implemented iSTAT test system in 01/2022 as indicated below: TP#1 TP#6 Initial 01 /06/2022 04/22/2022 6 month 07/15/2022 10/19/2022 12 month not done not done 4. The Inspector requested the laboratory's second semiannual competency assessment records for TP#1 and TP#6, as indicated above from TP#1. TP#1 confirmed that the laboratory did not assess the 12 month competency of TP#1 and TP#6 during the first year of testing patient specimens on the newly implemented iSTAT test system and was unable to provide the requested documentation on the date of the inspection. The interview occurred via electronic mail (email) on 05/24/2023 at 9:30 AM. -- 3 of 3 --

Summary Statement of Deficiencies 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 record review and an interview with testing personnel (TP) #1, the laboratory failed to examine or test three out of three of the 2018 arterial blood gas (ABG), sodium (Na), potassium (K) and ionized calcium (Ca++) proficiency testing (PT) events or 15 out of 15 PT samples by five out of the six individuals listed as TP who routinely performed moderately complex ABG, Na, K and Ca++ testing in the laboratory. Findings Include: 1. Review of the laboratory's Form CMS-209, provided on the date of the inspection, revealed six individuals listed and credentialed by the Laboratory Director via signature and date on 02/26/2019, to perform moderately complex testing. 2. Review of the laboratory's "Proficiency Testing" policy and procedure, approved, signed, and dated by the Laboratory Director on 06/16/2017, revealed "All employees are required to participate in proficiency testing. An employee rotation log will be monitored by the department head/Supervisor." 3. Review of the laboratory's 2018 College of American Pathologists (CAP) ABG, Na, K and Ca++ PT records, provided on the date of the inspection, did not find that TP#2, TP#3, TP#4, TP#5 and TP#6 participated in PT testing in 2018, however revealed TP#1 performed them all. 4. The Inspector requested the laboratory's 2018 documentation indicating that TP#2, TP#3, TP#4, TP#5 and TP#6 participated in PT testing in 2018 from TP#1. TP#1 confirmed that TP#2, TP#3, TP#4, TP#5 and TP#6 did not participate in any PT activities in 2018, as required, and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 02/27/2019 at 8:20 AM. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: **This is a repeat deficiency as cited on the 04/03/2017 CLIA inspection** Based on record review and an interview with testing personnel (TP) #1, the laboratory failed to test three out of 15 of the 2018 arterial blood gas (ABG), sodium (Na), potassium (K) and ionized calcium (Ca++) proficiency testing (PT) samples the same number of times that it routinely tested patient samples. Findings Include: 1. Review of the laboratory's "Proficiency Testing" policy and procedure, approved, signed, and dated by the Laboratory Director on 06/16/2017, did not find any instructions to test PT samples the same number of times that it routinely tested patient samples. 2. Review of two out of three of the laboratory's 2018 College of American Pathologists (CAP) ABG, Na, K and Ca++ PT events, provided on the date of the inspection, revealed the laboratory tested PT samples more times than it routinely tested patient samples prior to the submission due date assigned by the PT provider for three out of 15 testing samples, as listed below: 2018 AQ-B-06; tested on 07/13/2018 TP time run pH /pCO2/ Na /Ca++ *52960 10:24:52 7.53/ 18 /149/1.08 52960 09:59:28 7.52/ 19 /151/1. 11 2018 AQ-C-13; tested on 11/08/2018 TP time run pO2 / Ca++ *52960 09:58:24 115 / 1.20 52960 10:17:48 113 / 1.19 2018 AQ-C-14; tested on 11/08/2018 TP time run pO2 *52960 10:01:44 75 52960 10:21:08 73 52960; instrument operator number for TP#1 pCO2; partial pressure of carbon dioxide Na; sodium Ca++; ionized calcium pO2; partial pressure of oxygen *; testing results reported 3. TP#1 confirmed the laboratory tested the above mentioned 2018 PT samples more times than it routinely tested patient samples prior to the result submission due date set by CAP. The interview occurred on 02/27/2019 at 9:05 AM. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and an interview with testing personnel (TP) #1, the laboratory failed to follow their written policies and procedures to assess the competency of TP performing moderately complex arterial blood gas (ABG), sodium (Na), potassium (K) and ionized calcium (Ca++) testing procedures by the Laboratory Director. This deficient practice had the potential to affect 100 percent (%) of the patient ABG, Na, K and Ca++ samples tested. Findings Include: 1. Review of the laboratory's Form CMS-209, approved, signed, and dated by the Laboratory Director on 02/26/2019, revealed six individuals listed as TP and one individual newly listed as a TC (also listed as TP#1). 2. Review of the laboratory's "ABG Competency Assessment" policy and procedure, approved via signature and date by the Laboratory Director in 06/2015 and provided on the date of the inspection, found the following statements: "Policy: ...Arterial Blood Gas Competency Assessment is to be performed by the lab director." "Procedure: ...5. The Lab director will evaluate through direct -- 2 of 9 -- observation the six areas of minimum requirements as defined by CLIA in this hospital's ABG Lab Competency Assessment." 3. Review of the laboratory's 2017 and 2018 competency assessment documentation, provided on the date of the inspection, revealed that the newly listed non-qualified TC had conducted all of the competency assessments for TP#2, TP#3, TP#4, TP#5 and TP#6 and TP#6, a non-listed/non- qualified TC, conducted the competency assessments for TP#1. 4. Review of the education documentation provided for the sole and newly listed TC and TP#6 revealed the individuals achieved an Associates in Specialized Technology degree in Respiratory Therapy and did not meet the minimum TC qualification requirements. 5. TP#1 confirmed that the individual newly listed as the sole TC and TP#6 did not meet the minimum TC qualification requirements, the laboratory did not follow their own policy and procedure and the Laboratory Director did not assess the competency of TP#1, TP#2, TP#3, TP#4, TP#5 and TP#6. The interview occurred on 02/27/2019 at 9: 22 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 record review and an interview with testing personnel (TP) #1, the laboratory failed to define criteria consistent with the manufacturer's instructions and document humidity conditions for reliable arterial blood gas (ABG), sodium (Na), potassium (K) and ionized calcium (Ca++) testing procedures on the GEM Premier 4000 analyzer and for test result reporting. This deficient practice had the potential to affect 100 percent (%) of the patient ABG, Na, K and Ca++ testing procedures performed. Findings Include: 1. Review of the laboratory's "Arterial Blood Gasses - GEM4000" policy and procedure manual, provided on the date of the inspection, did not find any instructions to monitor and document humidity conditions consistent with manufacturer's operating specifications. 2. Review of the "GEM Premier 4000 Reference Guide" revealed the following: "Ambient Environmental Requirements ... Relative Humidity Limits: 15-85% RH" RH; relative humidity 3. The Inspector requested the laboratory's policy and procedure for the humidity criteria consistent with the manufacturer's instructions and the humidity documentation from 2017, 2018 and 2019 from TP#1. TP#1 confirmed the laboratory did not establish a policy and procedure to monitor and document humidity criteria consistent with the manufacturer's instructions, did not monitor and document humidity in 2017, 2018 and 2019 and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 02/27/2019 at 11:15 AM. D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 unless HHS approves a procedure, -- 3 of 9 -- 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 postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and an interview with testing personnel (TP) #1, the laboratory failed to meet the post analytic systems requirements in 493.1291 for 100 percent (%) of the final test reports. Findings Include: 1. The laboratory failed to ensure that 100 percent (%) of the final test report indicated the name and address of the laboratory location in which the moderately complex arterial blood gas (ABG), sodium (Na), potassium (K) and ionized calcium (Ca++) testing procedures were performed. (Refer to D5805) 2. The laboratory failed to issue any corrected reports when the potassium (K) or any other test result was found to be incorrectly reported on the patients' final test reports. This deficient practice had the potential to affect 100 percent (%) of the patient testing performed. (Refer to D5821) 3. The laboratory failed to review the effectiveness of their quality assessment program of the post analytic systems. This deficient practice had the potential to affect 100 percent (%) of the patient testing performed. (Refer to D5893) D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and an interview with testing personnel (TP) #1, the laboratory failed to ensure that 100 percent (%) of the final test report indicated the name and address of the laboratory location in which the moderately complex arterial blood gas (ABG), sodium (Na), potassium (K) and ionized calcium (Ca++) testing procedures were performed. Findings Include: 1. Review of one of the laboratory's final test reports, printed out of the electronic medical record (EMR) and copied out of the patients' paper chart and provided on the date of the inspection, did not find any indication of the name and address of the laboratory location in which the moderately complex ABG, Na, K and Ca++ testing was performed. 2. The Inspector requested the laboratory's ABG, Na, K and Ca++ final test reports that indicated the name and address of the laboratory location in which the testing was performed from TP#1. TP#1 stated that the final test report is printed out of the EMR and put in the patients' paper chart. TP#1 confirmed that the name and address of the laboratory location in which the testing was performed was not indicated on 100% of the final test reports and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 02/27/2019 at 9:48 AM. D5821 TEST REPORT -- 4 of 9 -- CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on record review and an interview with testing personnel (TP) #1, the laboratory failed to issue any corrected reports when the potassium (K) or any other test result was found to be incorrectly reported on the patients' final test reports. This deficient practice had the potential to affect 100 percent (%) of the patient testing performed. Findings Include: 1. Review of the laboratory's 2018 "ABG Quality Assurance" logs, provided on the date of the inspection, revealed only one documented incident, on 10/06/2018, in which the K result was manually transcribed from the GEM4000 instrument printout into the electronic medical record (EMR) incorrectly. ABG; arterial blood gas 2. TP#1 stated, on 02/27/2019 at 9:48 AM, the TP manually enter the test results into the EMR from the GEM4000 instrument printout. The EMR final test report is printed out of the EMR, the instrument printout is affixed along the right margin of EMR report, a copy is generated which is provided to the ordering physician and the original is kept in the laboratory. The EMR is the final test report, is printed and put in the patients' paper chart. 3. Further review of the test records and final test report in the EMR, as well as the patients' paper chart, revealed the following: a. The K result indicated on the instrument printout is 4.4 b. The K result was manually transcribed into the EMR as 4.7 c. TP#4 conducted and documented quality assessment activities, including result transcription by TP#1, within seven days from the date tested. d. TP#4 corrected the reported K result on the laboratory's copy of the EMR report with the affixed instrument printout by putting one line through the incorrectly reported K result of 4.7 and hand wrote the correct K result, 4.4, next to it. 4. The Inspector requested the final test report filed in the patients' paper chart and the final test report printed out of the EMR from TP#1. TP#1 provided the requested documentation which did not indicate the corrected K result. 5. TP#1 confirmed the laboratory did not correct the final test report in the EMR, did not correct the final test report in the patients' paper chart and did not issue a corrected final test report for the incorrect patient K result reported. The interview occurred on 02/27/2019 at 9:48 AM. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of