Logan Health - Chester

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a record review of the CMS-209 Laboratory Personnel Report form, testing personnel records, laboratory policies, and an interview with technical supervisor (TS) #1, the laboratory director failed to ensure one out of three testing personnel had the minimal education requirements to perform moderate complexity testing from November 22, 2022, to May 1, 2024. Findings: 1. A review of the CMS-209 Laboratory Personnel Report form listed testing personnel (TP) #3 as moderate complexity, and a review of their personnel records contained competency assessments authorizing them to perform moderate complexity testing from November 22, 2022, to May 1, 2024. 2. A review of the "Lab Prep Technician" job description revealed TP #3 failed to have the minimal educational requirement as stated, "post high school education". 3. An interview with TS #1 on May 1, 2024, at 4: 05 PM confirmed the laboratory director failed to ensure TP #3 had the minimal educational requirements to perform moderate complexity testing from November 22, 2022, to May 1, 2024. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 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 -- The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of testing personnel records, policies and interview with technical supervisor (TS) #1, the laboratory failed to ensure that one out of the three testing personnel listed on the CMS-209 Personnel Report Form had the appropriate educational background and applicable state licensure prior to performing moderate complexity testing. (See D6064 and 6065) D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on a record review of testing personnel files and an interview with technical supervisor (TS) #1, the laboratory failed to ensure one out of three testing personnel (TP) had an applicable state license to perform moderate complexity testing on human specimens from November 22, 2022, to May 1, 2024. Findings: 1. A review of TP #3 personnel records lacked an applicable Montana licensure to perform laboratory testing on human specimens. 2. An interview with TS #1 on May 1, 2024, at 10:30 AM confirmed TP #3 did not have an applicable Montana licensure to perform moderate-level testing on human specimens from November 22, 2022, to May 1, 2024. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of personnel files, the CMS-209 Laboratory Personnel Report (CLIA) form, and an interview with technical supervisor (TS) #1, the laboratory failed to ensure one out of three testing personnel had the appropriate educational background prior to performing moderate complexity testing from November 22, 2022, to May 1, 2024. Findings: 1. A review of TP #3 personnel records failed to have -- 2 of 3 -- a high school degree or equivalent prior to performing moderate complexity testing as authorized by their initial (11/22/2022), six-month (6/23/3023), and annual (11/20 /2023) competency assessments from November 22, 2022, to May 1, 2024. 2. An interview with TS #1 on May 1, 2024, at 10:35 AM, confirmed TP #3 was classified as a lab prep technician and failed to have a high school degree or equivalent prior to performing moderate complexity testing from November 22, 2022, to May 1, 2024. -- 3 of 3 --

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of chemistry, serology, immunology, and blood bank records and procedures, the laboratory failed to perform calibration verification every six months as required by their procedures (Refer to D5439); failed to establish and perform external quality controls as dictated by either their IQCP, policies and procedure or manufactures instructions (Refer to D5445); failed to perform and document quarterly alarm inspection checks (See D5555); failed to identify and document

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 of American Proficiency Institute (API), proficiency testing documentation for 2019, and interview with the general supervisor (GS)#1 the Lab Director or designee failed to sign and date the Attestation Statement. Findings: 1. Review of American Proficiency Institute (API), Proficiency Testing Attestation Statements for year 2019 lacked the Laboratory Director or designee signatures and dates. 2. Review of American Proficiency Institute (API), Proficiency Testing Attestation Statement states "Signatures Required - Testing personnel and laboratory director must physically sign an attestation statement for all PT results, and retain the signed statement (or a copy) for a minimum of 2 years. Either the attestation statement below or a copy of the printed form provided online can be used for this purpose." 3. Interview with the GS#1 on 3/24/2021 at 3:30 PM confirmed the lack of Laboratory Director or designee signatures and dates. 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 D0000 Based on an on-site recertification survey conducted on 2/28/18-3/1/18, deficiencies were cited for Liberty Medical Center in Chester, MT. 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 observation, record review, and interview, the laboratory failed to enroll for proficiency testing for three of four microbiology tests from 1/1/17 through 2/28/18. The findings include: A. Gram Stain 1. On 2/28/18 at 8:30 a.m., staff member A stated the laboratory was no longer performing microbiology with the exception of gram stain, methicillin resistant staphylococcus aureus (MRSA) cultures, methicillin susceptible staphylococcus aureus (MSSA) cultures, and back up cultures for streptococcus. 2. A review on 2/28/18 at 10:30 a.m. of the 2017 and 2018 American Proficiency Institute (API) documentation lacked proficiency testing enrollment for gram stain. 3. A review on 2/28/18 at 11:00 a.m. of the Test Volume worksheet included seven gram stains performed annually. 4. On 2/28/18 at 11:00 a.m., gram stain reagents were observed in a cupboard of the laboratory. 5. On 2/28/18 at 11:00 a. m., staff member A stated gram stains were run occasionally in the laboratory but proficiency testing was not enrolled. B. MRSA 1. On 2/28/18 at 8:30 a.m., staff member A stated the laboratory was no longer performing microbiology with the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- exception of gram stain, MRSA cultures, MSSA cultures, and back up cultures for streptococcus. 2. A review on 2/28/18 at 10:30 a.m. of the 2017 and 2018 API documentation lacked proficiency testing enrollment for MRSA chrome agar. 3. On 2 /28/18 at 11:00 a.m., staff member A stated proficiency testing was not enrolled for MRSA. 4. A review on 3/1/18 at 9:00 a.m. of the microbiology logbook included patient MRSA cultures. C. MSSA 1. On 2/28/18 at 8:30 a.m., staff member A stated the laboratory was no longer performing microbiology with the exception of gram stain, MRSA cultures, MSSA cultures, and back up cultures for streptococcus. 2. A review on 2/28/18 at 10:30 a.m. of the 2017 and 2018 API documentation lacked proficiency testing enrollment for MSSA chrome agar. 3. On 2/28/18 at 11:00 a.m., staff member A stated proficiency testing was not enrolled for MSSA. 4. A review on 3/1/18 at 9:00 a.m. of the microbiology logbook included patient MSSA cultures. 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 observation, record review, and interview, the laboratory failed to perform accuracy verification on three tests from 1/1/17 through 2/28/18. The findings include: A. Stool lactoferrin 1. On 2/28/18 at 8:30 a.m., a Leuko EZ stool lactoferrin kit was observed in the laboratory. 2. A review on 2/28/18 at 10:30 of the American Proficiency Institute (API) documentation lacked proficiency testing for the Leuko EZ kit. Accuracy verification data was not found. 3. On 2/28/18 at 10:30 a.m., staff member A stated the laboratory did not have proficiency testing for the Leuko EZ kit. B. Potassium hydroxide (KOH) preps 1. A review on 2/28/18 at 8:45 a.m. of the Test Volume worksheet included an annual test volume of three KOH preps. 2. A review on 2/28/18 at 10:30 of the API documentation lacked proficiency testing for KOH preps. Accuracy verification data was not found. 3. On 2/28/18 at 10:30 a.m., staff member A stated the laboratory did not perform proficiency testing for KOH preps. C. Wet preps 1. A review on 2/28/18 at 8:45 a.m. of the Test Volume worksheet included an annual test volume of six wet preps. 2. A review on 2/28/18 at 10:30 of the API documentation lacked proficiency testing for wet preps. Accuracy verification data was not found. 3. On 2/28/18 at 10:30 a.m., staff member A stated the laboratory did not perform proficiency testing for wet preps. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow a written procedure for Quality Management from 1/1/17 through 2/28/18. The findings include: A. Urine drug screens 1. A review on 2/28/18 at 3:25 p.m. of the Liberty Medical Center Urine Drug Screen patient log included controls run per new box. 2. A -- 2 of 6 -- review on 3/1/18 at 1:30 p.m. of the Liberty Medical Center Quality Management policy included "a positive and negative control will be run each day patient is tested, with the exception of weekends." 3. On 3/1/18 at 1:30 p.m., staff member B stated the Quality Management policy needs updating. B. DCA Vantage 1. A review on 2/28/18 at 2:00 p.m. of the Liberty Medical Center microalbumin/creatinine controls showed controls run per lot number. 2. On 2/28/18 at 2:00 p.m., staff member B stated the controls were run with new lots. 3. A review on 3/1/18 at 1:30 p.m. of the Liberty Medical Center Quality Management policy included "a external control will be run with each new lot number, each new shipment, or monthly-whichever is soonest before use for patient testing. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to sign approval of three procedures from 8/14/17 through 2/28/18. The findings include: 1. On 2/28 /18 at 8:30 a.m., staff member A stated the new Laboratory Director had not signed the policies and procedures. 2. A review on 3/1/18 at 9:30 a.m. of the Individualized Quality Control Plans (IQCPs) for the Siemens Stratus-CS, i-Stat, and DCA Vantage lacked a signature of approval from the current laboratory director. 3. A review on 3/6 /18 at 9:00 a.m. of the Aspen Central Office database showed the current laboratory director was entered on 8/14/17. 4. On 3/6/18 at 11:44 a.m., staff member A emailed the facility minutes with approval of the new Laboratory Director on 11/2/17. D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to establish and maintain historical in-house performance data for three of three plans reviewed. The findings include: 1. A review on 3/1/18 at 9:35 a.m. of three Individual Quality Control Plans (IQCPs) lacked historical in-house performance data, established by the laboratory in its own environment to demonstrate the stability of the test system supports the quality control (QC) frequency. a. Siemens Stratus-CS IQCP. b. DCA Vantage IQCP. c. i-Stat IQCP. 2. On 3/1/18 at 10:30 a.m., staff member A stated the data was not in the binder. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials -- 3 of 6 -- using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to include the number, type, and frequency of testing for three of three Individual Quality Control Plans (IQCPs) reviewed. The findings include: 1. A review on 3/1/18 at 9:45 a.m. of the IQCPs for the Siemens Stratus-CS, i-Stat, and DCA Vantage lacked a quality control plan (QCP) stating the number, type, and frequency of controls. A reference to another policy was not included. 2. On 3/1/18 at 10:30 a.m., staff member A stated the information was in a policy titled "Quality Management" instead of the IQCP. 3. A review on 3/1/18 at 1:30 p.m. of the Quality Management policy included "an external control will be run with each new lot number, each new shipment, or monthly- whichever is soonest before use for patient testing." 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 observation, record review, and interview, the laboratory failed to perform a positive and negative control every day of patient testing for five tests from 1/1/17 through 2/28/18. The findings include: A. Serum human chorionic gonadotropin (shCG) 1. On 2/28/18 at 8:30 a.m. a hCG kit was observed in the laboratory cabinet. 2. On 2/28/18 at 8:30 a.m., staff member A stated serum was used on the hCG kit. 3. A review on 2/28/18 at 1:30 p.m. of the Liberty Medical Center Individualized Quality Control Plan (IQCP) binder lacked an IQCP for serum hCG. 4. A review on 2 /28/18 at 2:45 p.m. of the Liberty Medical Center Quickvue Pregnancy Test patient log included nine days of patient results without controls. a. 1/12/17 b. 3/16/17 c. 3/31 /17 d. 7/31/17 e. 8/30/17 f. 9/6/17 g. 9/21/17 h. 10/19/17 i. 10/28/17 5. A review on 3/1 /18 at 1:30 p.m. of the Liberty Medical Center Quality Management Policy stated a "positive and a negative should be tested with each new lot or shipment" for serum pregnancy tests. B. Stool Lactoferrin 1. On 2/28/18 at 8:30 a.m. a Leuko EZ stool lactoferrin kit was observed in the laboratory. 2. A review on 2/28/18 at 1:30 p.m. of the Liberty Medical Center IQCP binder lacked an IQCP for stool lactoferrin. 3. A review on 2/28/18 at 2:58 p.m. of the Liberty Medical Center Leuko EZ patient log included five days of patient results without controls. a. 11/24/17 b. 1/2/18 c. 2/10/18 d. 2/12/18 e. 2/15/18 4. A review on 3/1/18 at 1:30 p.m. of the Liberty Medical Center Quality Management Policy lacked information on the controls for the Leuko EZ stool lactoferrin kit. C. Mononucleosis (mono) 1. On 2/28/18 at 8:30 a.m. a mono kit was observed in the laboratory cabinet. 2. On 2/28/18 at 8:30 a.m., staff member A stated -- 4 of 6 -- serum was used on the mono kit. 3. A review on 2/28/18 at 1:30 p.m. of the Liberty Medical Center IQCP binder lacked an IQCP for mono. 4. A review on 2/28/18 at 3: 08 p.m. of the Liberty Medical Center Infectious Mononucleosis patient log included fifteen days of patient results without controls. a. 2/9/17 b. 2/17/17 c. 4/5/17 d. 5/10 /17 e. 6/19/17 f. 7/12/17 g. 8/12/17 h. 8/30/17 i. 10/3/17 j. 10/20/17 k. 11/1/17 l. 11/10 /17 m. 11/16/17 n. 1/3/18 o. 2/14/18 5. A review on 3/1/18 at 1:30 p.m. of the Liberty Medical Center Quality Management Policy lacked information on the frequency of controls for the mono kit. D. Clostridium difficile (C. diff) 1. On 2/28/18 at 8:30 a.m. a Wampole C. diff kit was observed in the laboratory. 2. A review on 2/28/18 at 1:30 p.m. of the Liberty Medical Center IQCP binder lacked an IQCP for C. diff. 3. A review on 2/28/18 at 3:08 p.m. of the Liberty Medical Center C. diff patient log included one day of patient results without controls. a. 3/23/17 4. A review on 3/1/18 at 1:30 p.m. of the Liberty Medical Center Quality Management Policy included to perform a positive and negative control with each new lot or shipment. E. Urine drug screen 1. On 2/28/18 at 8:30 a.m. a Bio-Rad Tox/See urine drug screen kit was observed in the laboratory cabinet. 2. A review on 2/28/18 at 1:30 p.m. of the Liberty Medical Center IQCP binder lacked an IQCP for urine drug screens. 3. A review on 2 /28/18 at 3:25 p.m. of the Liberty Medical Center Urine Drug Screen patient log included 45 days of patient results without controls. a. 1/27/17 b. 2/14/17 c. 3/17/17 d. 3/25/17 e. 3/31/17 f. 4/6/17 g. 4/19/17 h. 4/26/17 i. 5/25/17 j. 6/13/17 k. 6/17/17 l. 7/10 /17 m. 7/29/17 n. 7/31/17 o. 8/1/17 p. 8/11/17 q. 8/13/17 r. 8/30/17 s. 8/31/17 t. 9/6/17 u. 10/5/17 v. 10/10/17 w. 10/18/17 x. 10/19/17 y. 10/25/17 z. 10/27/17 aa. 10/28/17 bb. 11/13/17 cc. 11/16/17 dd. 11/30/17 ee. 12/2/17 ff. 12/6/17 gg. 12/14/17 hh. 12/15 /17 ii. 12/22/17 jj. 12/29/17 kk. 1/4/18 ll. 1/19/18 mm. 1/21/18 nn. 1/25/18 oo. 1/30/18 pp. 2/1/18 qq. 2/16/18 rr. 2/18/18 ss. 2/22/18 4. A review on 3/1/18 at 1:30 p.m. of the Liberty Medical Center Quality Management Policy stated a "positive and a negative control will be run each day patient is tested." D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to establish criteria to determine acceptable quality control results in three of three Individual Quality Control Plans (IQCPs) reviewed. The findings include: 1. A review on 3/1/18 at 9:45 a.m. of the IQCPs for the Siemens Stratus-CS, i-Stat, and DCA Vantage lacked the criteria for acceptable quality control (QC) results. 2. On 3/1/18 at 10:30 a.m., staff -- 5 of 6 -- member A stated the information was in the Quality Management policy. 3. A review on 3/1/18 at 1:30 p.m. of the Quality Management policy lacked the criteria for acceptable QC results for the Siemens Stratus -CS, i-Stat, and DCA Vantage. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to regularly inspect the alarm on the blood bank refrigerator from 1/1/17 through 2/28/18. The findings include: 1. A review on 2/28/18 at 4:30 p.m. of the electronic temperature monitoring system on the blood bank refrigerator lacked abnormal temperatures from high and low alarm checks from 1/1/17 through 2/28/18. The temperature at which alarms went off was not documented due to the absence of alarm checks. 2. On 2/28 /18 at 4:30 p.m., staff member B stated the check on the alarm is the maintenance staff looking at the box every day. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the quality assessment plan (QAP) in three of three Individual Quality Control Plans (IQCPs) reviewed. The findings include: 1. A review on 3/1/18 at 10:00 a.m. of the IQCPs for the Siemens Stratus-CS, i-Stat, and DCA Vantage lacked a QAP. 2. On 3/1/18 at 10: 30 a.m., staff member A stated the QAP was not in the IQCPs. -- 6 of 6 --